EUROIMMUN Launches SARS-CoV-2 Test System to Detect T-Cell Response
14 January 2021 - Novel test supports vaccine development studies critical to aiding researchers in understanding immunity levels and disease progression
WALTHAM, Mass., January 14, 2021 -- PerkinElmer today announced that its EUROIMMUN business has launched a SARS-CoV-2 Interferon Gamma Release Assay (IGRA) for Research Use Only (RUO) to determine the activity of T-cells reactive to SARS-CoV-2, the pathogen causing COVID-19.
Evidence suggests that both pillars of the immune system, antibody and T-cell response, are important in understanding immunity against SARS-CoV-2 reinfections. IgG antibodies against the S1 subunit of the SARS-CoV-2 spike protein and specific long-lived T-cells are suspected to play the most relevant roles in virus neutralization and sustained immunity.
This novel IGRA uses whole blood samples for determination of T-cell activity against SARS-CoV-2 through detection of interferon gamma, an important signaling molecule of the immune system which is released by the T-cells upon contact with the virus. The detection system is based on the well-established ELISA technology and can be processed manually or automatically in most laboratory settings. For this reason, the assay can be a helpful tool in research studies evaluating the cellular immune response in SARS-CoV-2 infected or vaccinated individuals.
“There are still a lot of open questions with respect to the COVID-19 disease progression and the development of long-term immunity after infection or vaccination,” said Dr. Wolfgang Schlumberger, CEO of EUROIMMUN. “In order to help answer these questions, both the IGRA and our Anti-SARS-CoV-2 QuantiVacTM ELISA (IgG) allow researchers to study the immune response to the coronavirus much more comprehensively and broadly to learn about vaccine efficacy from different angles.”
The IGRA for RUO is the latest addition to EUROIMMUN’s comprehensive SARS-CoV-2-specific product portfolio, which includes real-time PCR tests, an antigen detection assay and multiple antibody tests, a dried blood spot solution, as well as automation systems for small, medium and high sample throughput.
About PerkinElmer
PerkinElmer enables scientists, researchers and clinicians to address their most critical challenges across science and healthcare. With a mission focused on innovating for a healthier world, we deliver unique solutions to serve the diagnostics, life sciences, food and applied markets. We strategically partner with customers to enable earlier and more accurate insights supported by deep market knowledge and technical expertise. Our dedicated team of about 14,000 employees worldwide is passionate about helping customers work to create healthier families, improve the quality of life, and sustain the wellbeing and longevity of people globally. The Company reported revenue of approximately $2.9 billion in 2019, serves customers in 190 countries, and is a component of the S&P 500 index. Additional information is available through 1-877-PKI-NYSE, or at www.perkinelmer.com.
Thermo Fisher Scientific Extends SARS-CoV-2 GlobalAccess Sequencing Program to Support Research on New Virus Strains
14 January 2021 - Subsidized technology available as global bodies call for sequencing to confirm COVID-19 mutations
CARLSBAD, Calif., Jan. 14, 2021 -- As scientists continue to identify new strains of the SARS-CoV-2 virus, including the B.1.1.7 UK variant that studies suggest is more transmissible, genetic sequencing is being used to track these strains and new ones that are emerging, as well as to trace transmission patterns within communities. Today, Thermo Fisher Scientific announced an extension of its SARS-CoV-2 GlobalAccess Sequencing Program to provide additional units of the Ion Torrent Genexus System* and Ion GeneStudio S5* Series sequencers at a subsidized price to further support global COVID-19 research and surveillance.
Understanding the virus's genetic code and new variants is critical to assist with genetic tracing and transmission interruption efforts. Further research is also needed to determine how new strains affect people who are infected and vaccine effectiveness. Thermo Fisher's next-generation sequencing (NGS) technology offers researchers fast, real-time sequencing-data acquisition and easy data sharing across the global scientific community, as suggested by the U.S. Food and Drug Administration (FDA) and European Centre for Disease Prevention and Control (ECDC).
"As new strains of the virus have emerged and continue to spread, genetic sequencing provides unique insights on the epidemiology of infection and transmission patterns," said Garret Hampton, president of clinical next-generation sequencing and oncology at Thermo Fisher Scientific. "When we first launched the GlobalAccess Sequencing Program in May, our intention was to accelerate multi-institutional efforts to map coronavirus transmission and epidemiological studies. We are excited to continue our support of global research efforts to help track the growing presence of new strains across the globe."
With only five minutes of hands-on time required, the Genexus System is the world's first turnkey NGS solution that is designed to deliver results in a day in a decentralized laboratory setting. The platform's ease of use and automation has been developed to provide researchers – regardless of expertise level – access to the power of NGS technology. When combined with the Ion AmpliSeq SARS-CoV-2 Research Panel, the platform provides laboratories with a powerful, specimen-to-report workflow to carry out infectious disease studies using minimal amounts of sample.
About Thermo Fisher Scientific
Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $25 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, improving patient diagnostics and therapies or increasing productivity in their laboratories, we are here to support them. Our global team of more than 75,000 colleagues delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services and Patheon. For more information, please visit www.thermofisher.com/globalaccess.
PerkinElmer SARS-CoV-2 RT-PCR Assay Receives FDA EUA for Asymptomatic Testing
14 January 2021 - Gold-standard testing of individuals without COVID-19 symptoms key to controlling the spread
WALTHAM, Mass., Jan. 14, 2021-- PerkinElmer, Inc. announced today that its PerkinElmer® New Coronavirus Nucleic Acid Detection Kit received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) to test individuals without symptoms or other reasons to suspect COVID-19 infection.
According to a new model from The Journal of the American Medical Association’s Open Network developed by researchers from the Centers for Disease Control and Prevention, close to 60% of total COVID-19 transmissions come from those who have no symptoms, signaling that silent spreaders are the ones most often passing the virus around without knowing it.
For asymptomatic carriers, diagnostic testing is essential to identify infected individuals, and thereby provides a better chance of getting infectious individuals into isolation to avoid spreading the disease further. The ability to quickly identify asymptomatic individuals provides significant public health value. Moreover, based on comparative data released by the FDA, the PerkinElmer test kit has the lowest Limit of Detection (LoD) among the authorized COVID-19 molecular diagnostic tests reported, deeming it the most sensitive assay. PerkinElmer’s RT-PCR assay originally obtained FDA EUA in the spring of 2020.
“The data is clear – it’s imperative we have reliable and accurate testing for asymptomatic individuals, especially as we’re seeing new strains of the virus appear that are even more contagious,” said Masoud Toloue, Ph.D., Vice President & General Manager, Diagnostics, PerkinElmer. “PerkinElmer is in a unique position to help this cause, as we’re one of the few suppliers to have an EUA for asymptomatic testing, maintain the most sensitive test on the market along with a strong supply chain, and have the capability to do sample pooling to save time and resources for diagnostic laboratories.”
Previously, the FDA issued EUA to allow sample pooling with the PerkinElmer New Coronavirus Nucleic Acid Detection Kit to increase the number of individuals who can be tested without increasing resources. Additional testing mechanisms, including the use of saliva as a sample type, are also on the horizon. SARS-CoV-2 testing using saliva is less invasive, reduces the risk of exposure to healthcare workers involved in sample collection, and lessens the need for frequent replacement of personal protective equipment.
PerkinElmer continues to work on the frontlines of improving COVID-19 testing. The Company’s comprehensive SARS-CoV-2 offerings span high throughput RNA extraction, RT-PCR, automation, ELISA, chemiluminescence, time-resolved fluorescence and lateral flow based serology testing.
About PerkinElmer
PerkinElmer enables scientists, researchers, and clinicians to address their most critical challenges across science and healthcare. With a mission focused on innovating for a healthier world, we deliver unique solutions to serve the diagnostics, life sciences, food, and applied markets. We strategically partner with customers to enable earlier and more accurate insights supported by deep market knowledge and technical expertise. Our dedicated team of about 14,000 employees worldwide is passionate about helping customers work to create healthier families, improve the quality of life, and sustain the wellbeing and longevity of people globally. The Company reported revenue of approximately $2.9 billion in 2019, serves customers in 190 countries, and is a component of the S&P 500 index. Additional information is available through 1-877-PKI-NYSE, or at www.perkinelmer.com
BD Advances Immunology Research by Enabling Researchers to Investigate 30 Immune Markers in a Single Experiment
13 January 2021 - The BD® AbSeq Immune Discovery Panel enables researchers to execute single cell experiments with high efficiency
FRANKLIN LAKES, N.J. (Jan. 13, 2021) – BD (Becton, Dickinson and Company), a leading global medical technology company, today announced the commercial release of the BD® AbSeq Immune Discovery Panel (IDP), a state-of-the-art, pre-titrated antibody-oligo based discovery tool designed to investigate 30 immune markers in a single experiment.
The BD® AbSeq IDP builds upon the advances of the BD® AbSeq Assay, which analyzes protein expression at the single-cell level using next-generation sequencing. The BD® AbSeq IDP now offers researchers convenience, reliability and flexibility as both a multiomics-enabled and cost-efficient tool to aid in immune research and discovery.
Also built upon BD antibody-oligo based technology, the BD® AbSeq IDP consists of 30 different specificities targeting most major immune markers, conveniently grouped together in a single tube. The panel helps enable immune cell type identification and the analysis of their activation and suppression status. Further, it allows researchers to include additional immune markers of interest.
“Antibody panels can have a significant impact on both basic and translational science. A well-designed panel allows for rapid implementation and reduces delays in experimental set up,” says Professor Fabio Luciani, Associate Professor, School of Medical Sciences, University of New South Wales, Australia. “Combined with single-cell technologies, high-dimensional antibody panels with oligo barcodes are powerful tools to identify the broad spectrum of immune cells in disease samples, and they also inform on molecular and cellular profiles that possibly drive further understanding of the disease.”
The IDP is designed to work on the BD Rhapsody™ Single-Cell Analysis System, alongside RNA and multiplexing assays.
“The 30-plex BD® AbSeq IDP helps enable sequencing-based immune cell phenotyping, which fits well among a broad audience in immunology and immuno-oncology fields,” said Xuhuai Ji, PhD, Genomics Manager, The Human Immune Monitoring Center (HIMC), Stanford Medicine Institute for Immunity, Transplantation and Infection, Palo Alto, California. “This new approach makes it easier for researchers to start designing and begin their new projects on the BD Rhapsody™ Single-Cell Analysis System.”
The BD® AbSeq IDP offers immunology researchers multiple benefits:
- One-Tube Convenience: 30 pre-titrated antibodies against major immune markers in a single tube
- Ease of Use: Lyophilized format; simply reconstitute to stain samples
- Reliability: Accompanied by comprehensive performance test data
- Flexibility: A great backbone panel that allows easy addition of more antibodies of interest
- Multiomics Enabled: Works along with RNA and multiplexing assays
- Great Value: Manage your sequencing costs
“With the development and availability of the BD® AbSeq IDP, BD expands our commitment to single-cell research and delivers robust, easy-to-use tools that offer researchers valuable and deeper insights,” said Brian Lilhanand, leader for Single-Cell Multiomics at BD Biosciences for BD. “Single-cell analysis tools like the BD® AbSeq Assay and BD Rhapsody™ Single-Cell Analysis System have helped expand our customers' ability to study cells of interest and drive rapid advancements in immunology, including drug treatment response and cell therapy.”
About the BD Single-Cell Multiomics Portfolio
To further knowledge of the immune system, BD empowers immunology researchers with a range of tools for multiomic analysis. BD advances the future of immunology research with the BD® AbSeq Assay, an innovative product that leverages 40 years of BD leadership in immunology research. The BD® AbSeq Portfolio currently encompasses more than 450 different clones of both mouse and human specificities. In addition, BD also offers customers the option to conjugate their in-house antibodies of interest with oligos compatible with the BD Rhapsody™ Single-Cell Analysis System to generate custom BD® AbSeq Antibodies.
BD has continued to build on its BD Rhapsody™ Single-Cell Analysis System, a complete system of reagents, instruments, software and targeted gene panels to offer additional single-cell analysis capabilities. These include the BD Rhapsody™ Whole Transcriptome Analysis Amplification Kit designed to analyze the entire transcriptome, targeted RNA panels and VDJ CDR3 protocols that enable researchers to identify TCR and BCR sequence information. Importantly, all BD assays are multiomics enabled and allow researchers to simultaneously analyze protein and RNA information at the single-cell level.
More information on the new BD® AbSeq Immune Discovery Panel is available here.
About BD
BD is one of the largest global medical technology companies in the world and is advancing the world of health™ by improving medical discovery, diagnostics and the delivery of care. The company supports the heroes on the frontlines of health care by developing innovative technology, services and solutions that help advance both clinical therapy for patients and clinical process for health care providers. BD and its 65,000 employees have a passion and commitment to help enhance the safety and efficiency of clinicians' care delivery process, enable laboratory scientists to accurately detect disease and advance researchers' capabilities to develop the next generation of diagnostics and therapeutics. BD has a presence in virtually every country and partners with organizations around the world to address some of the most challenging global health issues. By working in close collaboration with customers, BD can help enhance outcomes, lower costs, increase efficiencies, improve safety and expand access to health care. For more information on BD, please visit bd.com.
Mesa Biotech Receives 510(k) Clearance and CLIA Waiver for Its Accula Strep A Molecular Point of Care Test
13 January 2021 - Accula Strep A Test Further Expands Company’s Commitment to Bring Routine Testing Closer to the Patient
SAN DIEGO, CA, December 9, 2020 -- Mesa Biotech, developers of an affordable, easy to use, handheld testing platform for infectious disease diagnosis, today announced it has received 510(k) clearance and Clinical Laboratory Improvements Amendments (CLIA) waiver from the US Food and Drug Administration (FDA) for its Accula™ Strep A test. The Strep A cassette, for the molecular detection of Group A Streptococcus bacterial nucleic acid by rapid PCR, is cleared for diagnosing both children and adults and provides laboratory quality results in 30 minutes at the point of care (POC).
Accula Strep A is the third molecular POC diagnostic on the Accula platform to receive FDA clearance and CLIA waiver, following the company’s commercially available tests for Flu A/Flu B and RSV. In addition, the company received Emergency Use Authorization (EUA) for its SARS-CoV-2 cassette earlier this year. The ergonomically designed, simple to use Accula test, fits in the palm of your hand and is visually read, using reverse transcription-polymerase chain reaction (RT-PCR) technology to detect Strep A via throat, nasal or nasopharyngeal swab samples.
With the addition of Strep A, we continue to deliver on our promise of bringing rapid, molecular diagnostics to the point of need,” said Bruce Cary, Ph.D., Co-founder and Chief Scientific Officer, Mesa Biotech, Inc. “The current pandemic has accentuated the need for PCR testing at the point of care and we are excited to be spearheading developments in this area.”
Group A streptococcus (GAS) is the most common bacterial cause of acute pharyngitis, an inflammation of the pharynx causing a sore throat and accounts for 15 to 30 percent of cases in children and 5 to 20 percent of cases in adults. It is estimated that 616 million people worldwide has a pharyngitis from a GAS infection annually and more than 18 million develop a severe GAS infection. According to Pediatrics, GAS is easily and frequently spread among families, school-aged children and other close contacts via respiratory secretions, and infection peaks in the late winter and early spring.
“It is important to diagnose and treat Strep A infections promptly as it is contagious and secondary complications can develop, especially in children,” said Hong Cai, Ph.D., Co-founder and Chief Technology Officer, Mesa Biotech, Inc. “Our Accula testing platform enables healthcare providers to reach a rapid diagnosis and administer the appropriate treatment, thus reducing the amount of time the patient is sick, preventing long-term health problems and helping prevent the spread of infection.”
About Mesa Biotech Inc.
Mesa Biotech designs, develops, manufactures and commercializes next generation Rapid PCR tests, bringing the superior diagnostic performance of nucleic acid PCR amplification to the point-of-care (POC). Mesa Biotech’s Accula™ SARS-CoV-2 test was among the first POC tests to obtain Emergency Use Authorization. The company’s Flu A/Flu B and RSV tests have obtained CE Mark in the EU and 510(k) clearance and Clinical Laboratory Improvements Amendments (CLIA) waiver from the U.S. Food and Drug Administration (FDA).
For more information visit http://www.mesabiotech.com.
Reference: https://www.mesabiotech.com/press-release/mesa-biotech-accula-strep-a-510k-clearance/
Abbott announces fulfillment of federal government purchase of 150 million BinaxNOW™ COVID-19 rapid tests and is now ready to support commercial distribution
12 January 2021 - Abbott will complete the U.S. government order for 150 million BinaxNOW COVID-19 tests this week and will supply 30 million additional tests through March via a new government order. Company is in final stages of completing its self-funded capacity expansion across U.S. manufacturing sites. Abbott has the most advanced and comprehensive COVID-19 rapid test portfolio available today, including ID NOW, BinaxNOW, the BinaxNOW at-home test and the NAVICA app. Workplaces, universities, schools and other qualified organizations that need frequent and affordable testing can now directly procure BinaxNOW tests from Abbott.
ABBOTT PARK, Ill., Jan. 12, 2021 — Abbott is announcing today the fulfillment of the federal government's order of 150 million BinaxNOW™ COVID-19 Ag tests. These rapid tests were distributed through the Department of Health and Human Services (HHS) to states, territories and targeted entities, such as nursing homes, assisted living facilities, home health and hospice agencies, historically black colleges and universities (HBCUs), and the Indian Health Service.
Abbott is also in the final stages of completing its self-funded investment in U.S. manufacturing capacity and is now ready to make tens of millions of BinaxNOW tests available per month for direct purchase to organizations including schools, workplaces and pharmacies.
"We've intentionally developed the most comprehensive COVID testing portfolio and the most advanced family of rapid tests to have the greatest impact we can," said Robert B. Ford, president and chief executive officer, Abbott. "We're pleased to take this next step in making BinaxNOW and NAVICA available to support the opening of organizations, and get them to more places where people need them, such as schools and universities, workplaces and pharmacies."
The University of Wisconsin System will be the first customer in the U.S. to secure BinaxNOW at scale, procuring 480,000 tests over six months for use at its universities and branch campuses.
"The University of Wisconsin System strives to be a national leader in combating COVID-19 and our robust testing strategy is one of our most effective means to do it," said Tommy Thompson, president, University of Wisconsin System. "We will continue to be aggressive in acquiring and implementing tests at our universities and our partnership with Abbott is key to making this happen."
At the size of a credit card and with no equipment required, Abbott's BinaxNOW COVID-19 test—sold directly to qualified organizations for $5 per test—is already the country's most widely available and mass-produced rapid test, providing results in 15 minutes and detecting the virus when people are most infectious and therefore at the greatest risk of spreading it to others. An at-home, virtually and digitally guided version of the test is also available at $25 per test.
Abbott will continue supplying HHS with a total of 30 million tests between now and March 2021. A breakdown of the initial 150 million tests shipped to states, territories and targeted entities via HHS orders can be found here.
BinaxNOW and NAVICA work together to help organizations perform testing at scale
The BinaxNOW test can be paired with the no-charge NAVICA™ app, which was developed by Abbott to allow people who test negative to display that result through a temporary digital health certificate. People who test negative on BinaxNOW can receive a QR code (similar to a mobile boarding pass used to board an airplane) and organizations can scan and verify the information to manage entry into facilities that accept NAVICA.
"Since October 2020, Abbott has been providing testing for U.S. employees using BinaxNOW and the NAVICA platform. Through the thousands of employees who have been tested, Abbott has gained important insights on managing workflow and how to use NAVICA to allow people to store, access and display their test results," said Mary Moreland, executive vice president, human resources, Abbott. "Our experience shows that large organizations can effectively manage a high-throughput, rapid testing program across multiple sites and in different occupational settings."
Since the pandemic began, Abbott has developed the most advanced and comprehensive portfolio of COVID-19 tests across its testing platforms—from high-throughput molecular tests on its m2000™ RealTime and Alinity™ m lab-based systems; to serology tests on its Alinity i™ and ARCHITECT® i1000SR and i2000SR instruments; to rapid molecular tests on the ID NOW™ instrument; to rapid antigen test options on BinaxNOW (available in U.S.) and the Panbio™ COVID-19 Ag Rapid Test Device (available in countries outside the U.S.).
The company will continue to study the role of testing as more becomes known about the long term efficacy of vaccines and how testing can be deployed to track outbreaks and more confidently return to group settings.
About the BinaxNOW COVID-19 Ag Card Rapid Test
The BinaxNOW COVID-19 Ag Card is an assay for the qualitative detection of specific antigens to COVID-19 in the human nasal cavity. A simple nasal swab is used to collect specimens from people suspected of having an active infection.
Under FDA EUA, the BinaxNOW COVID-19 Ag Card is for use by healthcare professionals and can be used in point-of-care settings that are qualified to have the test performed and are operating under a CLIA (Clinical Laboratory Improvement Amendments) Certificate of Waiver, Certificate of Compliance or Certificate of Accreditation. Within these settings, the test can be performed by doctors, nurses, school nurses, medical assistants and technicians, pharmacists, employer occupational health specialists and more with minimal training and a patient prescription.
About Abbott
Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 107,000 colleagues serve people in more than 160 countries.
Regeneron announces U.S. government agreement to purchase additional COVID-19 antibody cocktail doses
12 January 2021 - New agreement covers 1.25 million additional doses of the casirivimab and imdevimab antibody cocktail, bringing total potential U.S. supply to over 1.5 million doses. Doses are being supplied for use pursuant to the FDA Emergency Use Authorization for high-risk patients with mild to moderate COVID-19 in order to reduce the risk of progression to severe COVID-19 and/or hospitalization.
TARRYTOWN, N.Y., Jan. 12, 2021 -- Regeneron Pharmaceuticals, Inc. today announced that the U.S. Department of Health and Human Services (HHS) and the Department of Defense (DOD) will purchase additional supply of the casirivimab and imdevimab antibody cocktail for use in non-hospitalized COVID-19 patients to meet the federal government's Operation Warp Speed goals. The government has said it will provide these doses at no cost to patients, though healthcare facilities may charge fees related to administration.
Under the new agreement, the government will purchase all finished doses of the casirivimab and imdevimab antibody cocktail delivered by June 30, 2021, up to 1.25 million doses. Under a previous agreement, Regeneron is already supplying doses to treat approximately 300,000 people, bringing the total potential purchase to over 1.5 million doses.
"COVID-19 continues to sicken hundreds of thousands of Americans every day and the people of Regeneron are committed to help," said Leonard S. Schleifer, M.D., Ph.D., President and Chief Executive Officer of Regeneron. "Tackling the COVID-19 pandemic will require a combination of public health measures, vaccines and therapeutics. We are pleased to work with the U.S. government to supply our antibody cocktail as an important weapon in this fight."
The U.S. government has said it will continue to coordinate allocation of the antibody cocktail to state and territorial health departments. Patients, caregivers and healthcare providers can find sites with COVID-19 antibody treatments through these links to the HHS or National Infusion Center Association locator tools.
"Patients in our antibody cocktail outpatient clinical trial experienced significant reductions in virus levels and required fewer medical visits for COVID-19, suggesting the therapy can help reduce the current burden on hospitals and healthcare systems," said George D. Yancopoulos, M.D., Ph.D., President and Chief Scientific Officer of Regeneron. "Additionally, as expected, the virus continues to mutate, with the possibility of developing resistance to any one antibody. The Regeneron cocktail of two antibodies, each targeting a different site on the virus, reduces the possibility of the virus becoming resistant."
The casirivimab and imdevimab antibody cocktail continues to be evaluated in clinical trials for the treatment of COVID-19 in certain hospitalized and non-hospitalized patients, including the open-label RECOVERY trial of hospitalized patients in the UK, and a trial for the prevention of COVID-19 in household contacts of infected individuals. To date, nearly 15,000 people have participated in casirivimab and imdevimab clinical trials.
The development and manufacturing of the antibody cocktail has been funded in part with federal funds from the Biomedical Advanced Research and Development Authority (BARDA), part of HHS, Office of the Assistant Secretary for Preparedness and Response, under OT number: HHSO100201700020C.
Details of the New Agreement
The current authorized dose for emergency use in non-hospitalized patients is 2,400 mg (1,200 mg casirivimab and 1,200 mg imdevimab) administered as a one-time infusion. Regeneron is evaluating the safety and efficacy of a lower 1,200 mg dose (600 mg casirivimab and 600 mg imdevimab) of the antibody cocktail in this 'outpatient' setting.
Under the agreement, the government will acquire doses at the lowest authorized dose. The government is obligated to purchase all finished doses supplied by June 30, up to 1.25 million doses total (an agreement value of up to $2.625 billion), and may accept doses after this date at its discretion. A number of factors may impact available finished supply by June 30, including manufacturing considerations and authorized dose levels. Regeneron expects to supply approximately 750,000 finished doses by the end of June based on the 2,400 mg dose level, with the vast majority supplied in the second quarter. Regeneron expects to fulfill the entire 1.25 million targeted doses if the 1,200 mg dose is authorized.
About the Regeneron Antibody Cocktail for COVID-19
Casirivimab and imdevimab is a cocktail of two monoclonal antibodies (also known as REGN10933 and REGN10987, respectively) and was designed specifically to block infectivity of SARS-CoV-2, the virus that causes COVID-19. The two potent, virus-neutralizing antibodies that form the cocktail bind non-competitively to the critical receptor binding domain of the virus's spike protein, which diminishes the ability of mutant viruses to escape treatment and protects against spike variants that have arisen in the human population, as detailed in Science.
In November 2020, the casirivimab and imdevimab antibody combination received Emergency Use Authorization (EUA) from the FDA for the treatment of mild to moderate COVID-19 in adults, as well as in pediatric patients at least 12 years of age and weighing at least 40 kg, who have received positive results of direct SARS-CoV-2 viral testing and are at high risk for progressing to severe COVID-19 and/or hospitalization. The clinical evidence from Regeneron's outpatient trial suggests that monoclonal antibodies such as casirivimab and imdevimab have the greatest benefit when given early after diagnosis and in patients who are seronegative and/or who have high viral load. The criteria for 'high-risk' patients are described in the Fact Sheet for Healthcare Providers. In the U.S., casirivimab and imdevimab are not authorized for use in patients who are hospitalized due to COVID-19 or require oxygen therapy, or for people currently using chronic oxygen therapy because of an underlying comorbidity who require an increase in baseline oxygen flow rate due to COVID-19.
Regeneron is collaborating with Roche to increase global supply of casirivimab and imdevimab. Regeneron is responsible for development and distribution of the treatment in the U.S., and Roche is primarily responsible for development and distribution outside the U.S. The companies share a commitment to making the antibody cocktail available to COVID-19 patients around the globe and will support access in low- and lower-middle-income countries through drug donations to be made in partnership with public health organizations.
About Regeneron
Regeneron is a leading biotechnology company that invents life-transforming medicines for people with serious diseases. Founded and led for over 30 years by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to eight FDA-approved treatments and numerous product candidates in development, all of which were homegrown in our laboratories. Our medicines and pipeline are designed to help patients with eye diseases, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, pain, infectious diseases and rare diseases.
Regeneron is accelerating and improving the traditional drug development process through our proprietary VelociSuite® technologies, such as VelocImmune, which uses unique genetically-humanized mice to produce optimized fully-human antibodies and bispecific antibodies, and through ambitious research initiatives such as the Regeneron Genetics Center, which is conducting one of the largest genetics sequencing efforts in the world.
For additional information about the company, please visit www.regeneron.com.
Ortho’s VITROS® SARS-CoV-2 Antigen Test for Accurate, Mass-Scale COVID-19 Testing is the First Widely-Available High-Volume Test to Receive FDA Emergency Use Authorization
12 January 2021 - Ortho’s VITROS® SARS-CoV-2 Antigen Test is the first high-volume COVID-19 antigen test to receive Food and Drug Administration (FDA) Emergency Use Authorization (EUA). With utility for mass-scale testing and same-day results for labs, Ortho’s latest COVID-19 solution can run up to 130 tests per hour. The test is run on Ortho’s high-volume VITROS® Systems, which are installed in over 5,600 laboratories around the world with 1,500 installed in the U.S.
12 January 2021 — Ortho Clinical Diagnostics, a global leader of in vitro diagnostics, today announced that its VITROS® SARS-CoV-2 Antigen Test, designed to detect active infection, has become the first high-volume COVID-19 antigen test to receive Food and Drug Administration (FDA) Emergency Use Authorization (EUA). U.S. distribution of the test commenced in November 2020 under an FDA Emergency Use Notification (EUN); the test was also granted CE Mark in November 2020.
Ortho’s antigen test comes at a critical time—a recent Rockefeller Foundation report estimates that the U.S. will need to increase coronavirus testing capacity by nearly 10-fold— from 21 million to 193 million tests per month—in order to reopen schools safely and protect nursing homes.
With utility for mass-scale testing and same-day results for labs, Ortho’s latest COVID-19 solution can run up to 130 tests per hour and immediately help hospitals and reference labs address testing backlogs, supply shortages, and delayed results.
“As the pandemic continues to devastate our communities and economy, laboratory professionals have been working under extraordinary circumstances to deliver critical COVID-19 testing data to patients, clinicians and communities,” said Chris Smith, chairman and chief executive officer, Ortho Clinical Diagnostics. “Even as vaccine inoculation programs roll out, mass-scale testing remains an essential tool in fighting COVID-19. Ortho’s accurate, high-volume COVID-19 antigen test can play a pivotal role in the global response to this virus.”
About the VITROS® SARS-CoV-2 Antigen Test
The VITROS® SARS-CoV-2 Antigen Test produces accurate, clinically reliable results on Ortho’s high-volume VITROS® Systems, which are installed in over 5,600 laboratories around the world. More than 1,500 VITROS analyzers are operational across the U.S.—including more than 500 located in rural regions, where coronavirus testing needs are especially urgent.
These analyzers normally run a broad menu of over 150 different tests from blood and body fluid samples, but now are also able to run samples derived from swabs. Additional analyzers are available for shipment and can be installed rapidly to further increase capacity since they don’t require an external water source to operate.
Ortho’s COVID-19 antigen test is an alternative to real-time polymerase chain reaction (PCR) testing, which although highly sensitive, can be expensive and require long processing times during testing surges. Roughly one-third of individuals who underwent a PCR test waited more than four days for a result—including 10% who waited more than 10 days, according to an article published by researchers from Harvard, Northeastern, Northwestern, and Rutgers.
Other COVID-19 diagnostic testing platforms, including rapid antigen tests, have limited capacity to run multiple tests simultaneously or require short time windows to read results, making it challenging to test more than a handful of patients at a time.
Ortho is currently able to deliver 5 million tests per month and can scale up to 15 million tests per month in February.
About Ortho’s VITROS® COVID-19 Testing Solutions
Ortho’s new SARS-CoV-2 Antigen Test is the latest addition to the company’s COVID-19 solutions, which include two COVID-19 antibody tests—Total and IgG—both of which have FDA EUA and CE Mark.
Because Ortho’s VITROS Systems are already installed worldwide, reporting times may be further improved because lab staff require no additional training, and the instruments are already connected to existing laboratory information systems and software. These systems are self-contained and do not require an external water source to run.
Abbott receives FDA 510(K) clearance for the first rapid handheld blood test for concussions
11 January 2021 - The test to help evaluate mild traumatic brain injury (TBI), commonly known as concussion, produces a result within 15 minutes after a plasma sample is inserted and will run on Abbott's i-STAT™ Alinity™ handheld device. Having a blood test available could help eliminate wait time in the emergency room and could reduce the number of unnecessary CT scans by up to 40%. The test simultaneously measures biomarkers UCH-L1 and GFAP, proteins found in the blood after a concussion or head trauma. Building on this initial clearance, Abbott is also working on a test that would use whole blood on i-STAT at the point of care, and developing a test for its Alinity™ i and ARCHITECT® core laboratory instruments under FDA breakthrough designation.
ABBOTT PARK, Ill., Jan. 11, 2021 -- Abbott has received 510(k) clearance for the first rapid handheld traumatic brain injury (TBI) blood test, which will help clinicians assess individuals with suspected mild TBIs, including concussions. The test will run on Abbott's handheld i-STAT™ Alinity™ platform. Tests results are available within 15 minutes after plasma is placed in the test cartridge.
TBIs, including concussions, are an alteration in brain function caused by an external force. This test measures specific proteins present in the blood after a TBI. A negative result on this test can be used to rule out the need for a head CT scan, a common tool used to diagnose concussion. For those who test positive, this test result complements CT scans to help clinicians evaluate whether someone has a TBI.
"Healthcare providers have been waiting for a blood test for the brain and now we have one," said Beth McQuiston, M.D., medical director for Abbott's diagnostics business. "You can't treat what you don't know and now physicians will be equipped with critical, objective information that will help them provide the best care possible, allowing patients to take steps to recover, prevent reinjury and get back to doing the things they care about most."
The test requires a small blood sample drawn from the arm, from which plasma is extracted with a centrifuge and applied to the test's cartridge. The cartridge is then inserted into the handheld instrument.
Abbott is also working on a whole blood test, which would eliminate the need for separation of plasma and could be used at the patient's side in a healthcare setting. Our vision for the future is that we'd have a 15-minute, portable test that can be used outside the traditional healthcare setting where people experience head injuries and need a quick evaluation, like sporting events.
Abbott has also received FDA breakthrough designation – which speeds assessment of tests through increased FDA interaction – for a TBI test that would run on its Alinity™ i and ARCHITECT® core laboratory instruments. This is part of Abbott's strategy to ensure that its tests are available both in the lab and in other settings where people need immediate answers and care.
The need for immediacy and accuracy in diagnosing TBI
Nearly 5 million people go to the emergency room for a TBI in the U.S. each year.
"Evaluating brain injuries is complex – and research shows that we only catch about half of those who show up to the hospital with a suspected TBI," said Geoffrey Manley, M.D., Ph.D., vice chair of neurological surgery at the University of California, San Francisco. "And beyond those who go to the hospital for a suspected TBI, many more never do. A test like this could encourage more people to get tested after a head trauma, which is important, because not receiving a diagnosis can be dangerous and may prevent people from taking the necessary steps to recover safely."
Survivors of TBI may experience impairment of memory, movement, sensation (e.g., vision and hearing), and emotional functioning (e.g., personality changes, psychological symptoms). Effects of TBI can last anywhere from a few days post-injury or may be permanent. People who sustain a TBI are more likely to have another one – similarly to how a sprained ankle or torn ligament is more susceptible to future injury.
These effects are worsened by misdiagnosis or lack of diagnosis. Abbott's blood test will give healthcare professionals an objective tool for evaluating people suspected of having an injury to the brain.
About the i-STAT Alinity TBI plasma test
The i-STAT Alinity TBI plasma test simultaneously measures biomarkers glial fibrillary acidic protein (GFAP) and ubiquitin carboxyl-terminal hydrolase L1 (UCH-L1) in blood plasma, two complementary biomarkers that, in elevated concentrations, are tightly correlated to brain injury. It provides test results with 95.8% sensitivity and greater than 99% negative predictive value.
The TBI blood test was developed in collaboration with the U.S. Department of Defense (DoD) – which has been dedicated to developing a solution for the objective detection and evaluation of TBI for more than a decade. The DoD, through U.S. Army Medical Research and Development Command's (USAMRDC) U.S. Army Medical Materiel Development Activity (USAMMDA), played a critical role in developing the test run on Abbott's i-STAT Alinity platform. The Transforming Research and Clinical Knowledge in Traumatic Brain Injury (TRACK-TBI) research team were the first to demonstrate how this TBI blood test can be used for the benefit of TBI patients in clinical care.
About Abbott
Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 107,000 colleagues serve people in more than 160 countries.
PerkinElmer to Acquire Oxford Immunotec Global PLC Financial Information
7 January 2021 - PerkinElmer to acquire Oxford Immunotec for USD 22.00 per share in cash. Transaction expected to be completed in the first half of 2021.
WALTHAM, Mass. & LONDON, Jan. 7, 2021 -- PerkinElmer, Inc. (“PerkinElmer”) and Oxford Immunotec Global PLC ("Oxford Immunotec" or the “Company”) are pleased to announce they have reached an agreement on terms under which PerkinElmer will acquire Oxford Immunotec (the “Acquisition”). It is intended that the Acquisition will be implemented by means of a U.K. High Court of Justice-sanctioned scheme of arrangement under Part 26 of the U.K. Companies Act 2006 between Oxford Immunotec and its shareholders (the “Scheme”).
Under the terms of the Acquisition, Oxford Immunotec shareholders will be entitled to receive USD 22.00 in cash for each outstanding ordinary share (“Oxford Immunotec Share”). The terms of the Acquisition value the Company’s entire issued and to be issued ordinary share capital at approximately USD 591 million, and the terms of the Acquisition represent a premium of approximately 28.3% to the closing price per share of USD 17.15 on January 5, 2021 (being the last practicable date prior to the date of this announcement (the “Announcement”)) and 53.5% to the 90 trading day volume-weighted average price per Oxford Immunotec Share of USD 14.34 for the period from October 8, 2020 to January 5, 2021 (being the last practicable date prior to the date of this Announcement). In addition, the terms of the Acquisition represent a premium of 99.2% to the Company’s enterprise value calculated using the 90-day volume weighted average price for the period from October 8, 2020 to January 5, 2021.
Through this Acquisition, PerkinElmer will grow its portfolio of advanced infectious disease testing solutions to include tuberculosis detection to better serve customers around the world. Moreover, the deal will enable PerkinElmer to combine its channel expertise and leading workflow and testing capabilities with Oxford Immunotec’s leading proficiencies in T cell immunology with its proprietary test kits for latent tuberculosis.
In terms of financial impact, PerkinElmer expects the Acquisition to be modestly accretive to non-GAAP earnings in year-one following the close, and PerkinElmer anticipates Oxford Immunotec’s sales growth will exceed that of its Diagnostics franchise for the foreseeable future.
Headquartered in Abingdon, UK, Oxford Immunotec is recognized as a global leader of proprietary test kits for latent tuberculosis. Its Interferon Gamma Release Assay (IGRA) offering identifies individuals who are infected with tuberculosis. Oxford Immunotec had approximately 275 global employees as of September 30, 2020 and reported total revenue from continuing operations of $73.7 million and $39.2 million as of the fiscal year ended December 31, 2019 and the nine months ended September 30, 2020, respectively.
Commenting on the Acquisition, Prahlad Singh, PhD, President and Chief Executive Officer of PerkinElmer, said: “Tuberculosis remains one of the leading infectious causes of death, with close to one quarter of the world’s population infected. We believe Oxford Immunotec’s diagnostic testing solution plays an important role in slowing the spread and saving lives. Oxford Immunotec’s highly sensitive test and their team’s passion for solving complex health issues make it a natural fit with PerkinElmer’s mission and together, we believe will accelerate development of robust solutions to help detect infectious disease.”
PerkinElmer's comprehensive global diagnostics portfolio includes solutions focused on:
1) Immunodiagnostics, in areas of immunology and infectious disease;
2) Reproductive Health, with a focus on newborn and prenatal testing; and
3) Applied Genomics, which includes fully automated sample to answer solutions around genomics and molecular testing.
Commenting on the Acquisition, Peter Wrighton-Smith, PhD, Chief Executive Officer of Oxford Immunotec, said: “We are delighted to be joining the PerkinElmer family. We believe this transaction is great for our shareholders, our employees and our customers. Access to PerkinElmer’s global reach and automation experience will enable us to accelerate our growth journey and make a growing impact in the field of infectious disease.”
The Board of Directors of each company has approved the transaction, which is expected to close in the first half of calendar 2021, subject to approval of Oxford Immunotec’s shareholders, court approval of the Scheme and other customary closing conditions. Upon the closing of the transaction, Oxford Immunotec will become a privately held company and Oxford Immunotec’s ordinary shares will no longer be listed on any public market.
Guggenheim Securities, LLC is acting as financial advisor to PerkinElmer. Wilmer Cutler Pickering Hale and Dorr LLP is acting as legal counsel to PerkinElmer as to matters of U.S. law and Hogan Lovells International LLP is acting as legal counsel to PerkinElmer as to matters of English law.
An affiliate of Perella Weinberg UK Limited (“Perella Weinberg Partners”) is acting as financial advisor to Oxford Immunotec. Covington & Burling LLP is acting as legal counsel to Oxford Immunotec.
About Oxford Immunotec
Oxford Immunotec is a global, high-growth diagnostics company. Oxford Immunotec’s vision is to bring energy and invention to a world in need of diagnostic truth. Oxford Immunotec is uniquely placed as the only company in the world offering regulated ELISPOT assays for T cell measurement, with approval around the globe. Oxford Immunotec’s leading product, the T-SPOT®.TB test, is used for diagnosing infection with Tuberculosis, the world’s largest cause of death from infectious disease. Oxford Immunotec has manufactured in excess of 20 million clinical T cell tests for TB infection. The T-SPOT.TB test has been approved for sale in over 50 countries, including the United States, where it has received pre-market approval from the Food and Drug Administration, Europe, where it has obtained a CE mark, as well as Japan and China. The Company is headquartered near Oxford, U.K. and in Marlborough, MA. Additional information can be found at www.OxfordImmunotec.com.
About PerkinElmer
PerkinElmer enables scientists, researchers and clinicians to address their most critical challenges across science and healthcare. With a mission focused on innovating for a healthier world, we deliver unique solutions to serve the diagnostics, life sciences, food and applied markets. PerkinElmer strategically partners with customers to enable earlier and more accurate insights supported by deep market knowledge and technical expertise. It has a dedicated team of about 14,000 employees worldwide who are passionate about helping customers work to create healthier families, improve the quality of life, and sustain the wellbeing and longevity of people globally. PerkinElmer reported revenue of approximately $2.9 billion in 2019, serves customers in 190 countries, and is a component of the S&P 500 index. Additional information is available through 1-877-PKI-NYSE, or at www.perkinelmer.com.
Labcorp Awarded CDC Contract to Study Variants of COVID-19 Virus and Improve Public Health Response
7 January 2021 - Genomic Sequencing Aims to Help Define Changes in Transmission and Identify New Mutations
BURLINGTON, N.C., Jan. 7, 2021 -- Labcorp, a leading global life sciences company, today announced that it has been awarded a contract from the Centers for Disease Control and Prevention (CDC) to provide genomic sequencing of samples of SARS-CoV-2, the virus that causes COVID-19.
This sequencing will aid the CDC in its goal of conducting a large-scale longitudinal genomic survey of the virus using a random set of samples collected from across the United States. The survey aims to provide important baseline information for national and state-level surveillance, help define changes in transmission, identify new variants of the virus, and improve the public health response to the virus. Through this program, the CDC aims to more than double the rate of genomic samples sequenced per week.
Labcorp will sequence the genomes of random de-identified samples that test positive for SARS-CoV-2 and will provide the CDC with completed sequences. This sequencing data will be combined with the results of similar efforts undertaken by national, state, academic, and private labs to help meet the CDC’s target goal.
“Better decision making starts with better data, and we are eager to help the CDC in its effort to improve the nation’s understanding of this virus and how to effectively fight it,” said Dr. Marcia Eisenberg, chief scientific officer at Labcorp. “This sequencing survey is a critical project to ensure our knowledge of COVID-19 improves even as the virus may mutate and change.”
About Labcorp
Labcorp is a leading global life sciences company that provides vital information to help doctors, hospitals, pharmaceutical companies, researchers, and patients make clear and confident decisions. Through our unparalleled diagnostics and drug development capabilities, we provide insights and accelerate innovations to improve health and save lives. With over 70,000 employees, we serve clients in more than 100 countries. Labcorp (NYSE: LH) reported revenue of $11.5 billion in FY2019. Learn more about us at www.Labcorp.com.
Trinity Biotech Announces CE Mark of its Covid-19 IgG ELISA Antibody Test
5 January 2021
DUBLIN, Ireland, January 5th, 2021 -- Trinity Biotech plc has achieved CE Mark approval and registration for its Covid-19 IgG ELISA antibody test, the Captia™ SARS-CoV-2 IgG ELISA.
Trinity Biotech has launched the test in countries throughout the European Union as well as other countries that recognise the CE Mark designation. This is in addition to our launch of the product in the US following submission under the FDAs Emergency Use Authorisation pathway.
Test Overview
The test uses a recombinant form of coronavirus spike protein to detect IgG antibodies which are the focus for SARS-CoV-2 vaccine development. The detection of IgG antibodies indicates either past exposure to the virus or the desired immune response following vaccination.
Trinity Biotech expects that the antibody test will have a number of uses, including:
- Assessing if an individual has previously had a SARS-CoV-2 infection and may now be assumed immune.
- Monitoring individuals in the weeks and months following vaccination, to assess the degree to which their immune system builds an antibody response to the virus.
- Assisting governments manage the prevalence of Covid-19 immunity in the population.
- Screening people prior to vaccination to avoid vaccinating individuals who already have a circulating antibody response, particularly in an environment where vaccine supply is constrained.
The instrumentation platforms that perform this type of ELISA test are available in virtually all clinical testing laboratories. Trinity Biotech have significant capacity for ELISA manufacture within their current operations and intend to leverage their existing distribution network to optimise the commercialisation of the test kit.
Performance Evaluation
A study of healthcare workers using the Trinity Biotech ELISA took place between June and October 2020. In addition to extensive internal testing, eighty-eight participants provided appropriate samples for calculation of the Sensitivity and Specificity at ≥14 days post Day 0 (date of oro/nasopharyngeal swab). Participants were tested with a PCR test and the Trinity Biotech ELISA.
Sensitivity: 95.9%
Specificity: 100.0%
A high Specificity value indicates the potential risk of a false positive result as low - this is a critical parameter when determining immune status and minimising the risk of an individual being incorrectly determined as having immunity.
About Trinity Biotech
Trinity Biotech develops, acquires, manufactures and markets diagnostic systems, including both reagents and instrumentation, for the point-of-care and clinical laboratory segments of the diagnostic market. The products are used to detect infectious diseases and to quantify the level of Haemoglobin A1c and other chemistry parameters in serum, plasma and whole blood. Trinity Biotech sells direct in the United States, Germany, France and the U.K. and through a network of international distributors and strategic partners in over 75 countries worldwide. For further information please see the Company's website: www.trinitybiotech.com
Illumina and Helix Collaborate to Assess Prevalence of New SARS-CoV-2 UK Variant (B.1.1.7) in the US and Develop National Surveillance Infrastructure
5 January 2021 - With support from the Centers for Disease Control and Prevention (CDC), Illumina and Helix have already identified more than 50 cases of the new variant in the US
SAN DIEGO, 5 January 2021 -- Illumina, Inc. and Helix today announced a collaboration to augment national surveillance infrastructure in the US to track the emergence and prevalence of novel strains of SARS-CoV-2 with support from the CDC. The combination of Illumina’s sequencing technology and expertise and Helix’s national COVID-19 testing footprint will significantly expand the country’s existing surveillance efforts to detect and characterize emerging variants of SARS-CoV-2.
The collaboration has already demonstrated results – identifying 51 of the first 54 cases of B.1.1.7, the highly transmissible variant first found in the UK, reported in the US. Over the past several weeks, Helix has analyzed recent positive samples and identified those with ‘S gene dropout’ on their diagnostic PCR assay, indicating the potential presence of the emerging B1.1.7 variant in different regions in the US. Illumina then sequenced a subset of these ‘S gene dropout’ samples using Illumina’s COVIDSeq Test, which identified the B.1.1.7 variant in 4 samples from California and Florida.
“Genomic surveillance is essential in fighting the pandemic. Illumina is pleased to partner with the CDC and Helix to provide accurate sequencing that can contribute to rapidly scaling genomic surveillance in the US to better understand the presence of B.1.1.7 and other variants as they emerge in our communities,” said Dr. Phil Febbo, M.D., Chief Medical Officer of Illumina.
“Having a robust surveillance effort in place is critical to understanding how the SARS-CoV-2 virus is evolving, and how our public health response needs to adapt,” said Dr. James Lu, M.D., Ph.D., co-founder and President of Helix. “By bringing together the strengths of Helix, Illumina, and the CDC, we were able to quickly evaluate the prevalence of this new variant and take learnings from this effort to better and more proactively characterize future strains that will emerge.”
Helix and Illumina are expanding the scope of their collaboration to examine a higher volume of samples on an ongoing basis for both the presence of B.1.1.7 and new strains. This will empower public and private entities to react quickly to any potential changes in pathogenicity of the virus or effectiveness of diagnostics, therapeutics, and vaccines.
About Illumina
Illumina is improving human health by unlocking the power of the genome. Our focus on innovation has established us as the global leader in DNA sequencing and array-based technologies, serving customers in the research, clinical, and applied markets. Our products are used for applications in the life sciences, oncology, reproductive health, agriculture, and other emerging segments. To learn more, visit www.illumina.com.
About Helix
Helix is the leading population genomics company operating at the intersection of clinical care, research, and genomics. Its end-to-end platform enables health systems, life sciences companies, and payers to advance genomic research and accelerate the integration of genomic data into clinical care. Powered by one of the world’s largest CLIA / CAP next-generation sequencing labs and its proprietary Exome+® assay, Helix supports all aspects of population genomics including recruitment and engagement, clinically actionable disease screening, return of results, and basic and translational research. In response to the COVID-19 public health crisis, Helix has launched a sensitive and scalable end-to-end COVID-19 test system to meet the needs of health systems, employers, governments, and other organizations across the country. Learn more at www.helix.com.
Quidel receives Emergency Use Authorization for moderately complex Solana® SARS molecular test for COVID-19 diagnosis
23 December 2020 - Proprietary RT-HDA Assay Yields Accurate Results from up to 11 Samples in 25 Minutes. Simplified Process Requires No Sample Extraction and Minimal Hands-on Time.
SAN DIEGO, 23 December 2020 -- Quidel Corporation (“Quidel”), a leading provider of rapid diagnostic testing solutions, cellular-based virology assays and molecular diagnostic systems, announced today that it has received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) to market its Solana® SARS-CoV-2 Assay, an isothermal Reverse Transcriptase - Helicase-Dependent Amplification (RT-HDA) assay intended for the qualitative detection of nucleic acid from SARS-CoV-2 in nasopharyngeal (NP) and nasal (NS) swab specimens in viral transport media from patients suspected of COVID-19 by their healthcare provider. Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, to perform high and moderate complexity tests.
The Solana® SARS CoV-2 offers a number of advantages over competing laboratory-based molecular diagnostic test protocols for COVID-19, including: a simple workflow with no sample extraction; a medium volume throughput design that is ideal for batch testing and improved laboratory efficiency; and a fast, 25-minute run time for up to 11 samples. The assay consists of two main steps: (1) specimen preparation, and (2) amplification and detection of target sequences specific to SARS-CoV-2 using Quidel’s proprietary isothermal Reverse Transcriptase – Helicase-Dependent Amplification (RT-HDA) in the presence of target-specific fluorescence probes. The Solana® instrument objectively measures and interprets a fluorescent signal, reports the test results to the user on its display screen, and can print out the results via an integrated printer.
Quidel’s Solana® bench-top instrument is designed for maximum space efficiency and ease of use. The small-profile instrument features an interactive touchscreen and barcode scanner for easy data entry, Ethernet and USB ports for data transfer and printing and compatibility with Dymo Label Writer systems. Solana® also comes with access to Quidel’s proprietary Virena® data management and surveillance ecosystem, which provides aggregated, de-identified testing data to public health authorities in near real time.
“With so many of our nation’s laboratories overwhelmed by demand for COVID-19 tests and under pressure to produce more timely results, there is a compelling societal need for the throughput and quick runtime offered by our new Solana® molecular testing technology,” said Douglas Bryant, president and CEO of Quidel Corporation. “Joining our Lyra® and Lyra® Direct assays for SARS-CoV-2, we now offer another molecular weapon in the fight against COVID-19 to quickly diagnose symptomatic patient populations. The Solana® SARS-CoV-2 Assay nicely complements our Sofia® and QuickVue® tests that are run at the point-of-care, for pre-symptomatic, asymptomatic and symptomatic patients. We are pleased to bring the benefits of our proprietary RT-HDA technology to detect COVID-19 to the marketplace and further democratize access to testing across the country. Solana® is a powerful diagnostic solution at a critical time.”
Solana® is an established Quidel brand with more than 1,000 instruments and ten different 510(k) cleared Solana® diagnostic assay applications in the market. In addition to laboratories, Solana® is ideal for use in small- to medium-sized hospitals that cannot afford the space requirements or expense of traditional diagnostic machinery. Solana® also eliminates the need for healthcare facilities to send patient test samples out for processing -- saving time and costs while reducing the backlog at central laboratories.
“We are proud of the commitment demonstrated by our Quidel team since the first day we started developing our PCR, rapid antigen and HDA tests for COVID-19,” Mr. Bryant added. “Our people have worked around the clock to create these life-saving diagnostic innovations and their ability to speed and scale production has been extraordinary.”
Solana® is a bench top instrument that combines Quidel’s proprietary helicase-dependent amplification (HDA) with fluorescence detection to deliver molecular results faster than ever before. Isothermal amplification eliminates thermal cycling, operating at one temperature in one tube to reduce the time to result to as little as 25 minutes. Solana®’s simplified workflow also avoids the need for specialized molecular operator training, making Solana easily adoptable in CLIA certified settings.
In addition to the Solana® SARS CoV-2 assay, Quidel’s Solana® instrument can run a suite of diagnostic assays and panels including Bordetella, C. Difficile, GAS, GBS, HSV 1+2/VSV, Influenza A+B, Respiratory Viral Panel, RSV + hMPV, Strep, and Trichomonas.
Background Information:
Quidel Corporation operates at the forefront of the battle against the coronavirus pandemic. Quidel received Emergency Use Authorization (EUA) from the FDA for its Lyra® SARS-CoV-2 Assay, a real-time RT-PCR test intended for the qualitative detection of nucleic acid from COVID-19 on March 17, 2020. Lyra® is a leading molecular test for COVID-19.
On May 8, 2020, Quidel was first to market in the U.S. with a rapid antigen test that delivers results in 15 minutes. Quidel's Sofia® SARS Antigen FIA set the bar for antigen test accuracy, proving to be in agreement with PCR results 96.7% of the time.
Quidel developed the first visually read lateral flow flu test, the QuickVue® Influenza A/B Test, which received FDA approval in September of 1999. QuickVue® was also the first flu test cleared by the FDA for use in CLIA-Waived point-of-care facilities like doctors’ offices, urgent care clinics and pharmacies.
QuickVue® is a market leading platform for visually diagnosing Influenza, respiratory syncytial virus (RSV), Strep A and a variety of other illnesses. Since its FDA approval in 1999, more than 150 million QuickVue® units have been sold.
Sofia® 2 is Quidel’s best-selling cartridge-based, instrument read rapid diagnostic system for infectious disease testing, which utilizes fluorescent chemistry design, an intuitive graphical user interface, and optics system to provide a highly accurate, objective and automated result in 15 minutes. The Sofia® 2 system also comes connected to Virena®, Quidel’s data management system, which provides aggregated, de-identified testing data to public health authorities in near real time.
Quidel recently doubled its production of Sofia® rapid antigen tests to the current rate of approximately two million tests per week. The company is building additional production lines that we expect will more than double current capacity once again. Our goal is to reach a run-rate of over 240 million tests per year by the third quarter of 2021.
About Quidel Corporation
Quidel Corporation is a leading manufacturer of diagnostic solutions at the point of care, delivering a continuum of rapid testing technologies that further improve the quality of health care throughout the globe. An innovator for over 40 years in the medical device industry, Quidel pioneered the first FDA-cleared point-of-care test for influenza in 1999 and was the first to market a rapid SARS-CoV-2 antigen test in the U.S. Under trusted brand names Sofia®, Solana®, Lyra®, Triage® and QuickVue®, Quidel’s comprehensive product portfolio includes tests for a wide range of infectious diseases, cardiac and autoimmune biomarkers, as well as a host of products to detect COVID-19. With products made in America, Quidel’s mission is to provide patients with immediate and frequent access to highly accurate, affordable testing for the good of our families, our communities and the world. For more information about Quidel, visit quidel.com.
Sysmex Obtains Marketing Approval for the HISCLTM IFN-λ3 Assay Kit, a Test Kit to Assist in Determining Exacerbation Risk in Novel Coronavirus (SARS-CoV-2)-Positive Patients
23 December 2020 - TARGET MARKET: JAPAN
23 December 2020 -- Sysmex Corporation obtained marketing approval on December 22, 2020 for the HISCL IFN-λ3 reagent, an interferon-λ3 kit.
The new product can be used in combination with the HISCL-5000/HISCL-800 Automated Immunoassay Systems to measure the serum level of interferon-λ3 (IFN-λ3) to provide information to assist in determining the exacerbation risk in SARS-CoV-2-positive patients.
Respiratory infections are diseases caused by pathogens infecting the respiratory system including the nasal cavity, pharynx, trachea, bronchi, and alveoli. These pathogens include viruses, bacteria, fungi, and parasites; the viruses include coronaviruses and influenza.
It has been reported that patients infected with SARS-CoV-2 experience cold symptoms, such as fever, as well as symptoms of respiratory infection, such as dysgeusia and dysosmia. Ninety percent of patients recover and experience mild or moderate symptoms, whereas 10% develop severe symptoms that require oxygen inhalation or ventilators. Severely affected patients have a characteristic clinical course in which they experience seemingly mild symptoms in the early stages of the disease, but then rapidly worsen to the point where oxygen ventilators are required.
Through joint research, Sysmex and the National Center for Global Health and Medicine have identified IFN-λ3, which is a useful biomarker for discriminating patients who are at high risk of worsening symptoms. It has been found that the blood level of IFN-λ3 rises rapidly several days before severe symptoms become apparent. IFN-λ3 has also been reported to be clinically useful for predicting the onset of severe symptoms resulting from the novel coronavirus disease (COVID-19) and for assisting with follow-up.
On December 22, 2020, Sysmex obtained marketing approval for the interferon-λ3 kit, the HISCL IFN-λ3 Assay Kit. This product can be used in combination with HISCL-5000/HISCL-800 Automated Immunoassay Systems to measure IFN-λ3 in serum, and thereby assist in determining the exacerbation risk in SARS-CoV-2-positive patients. A rapid reaction time of 17 minutes and an hourly throughput of 200 tests (in the case of HISCL-5000) ensure fast and efficient testing.
In clinical settings, being able to predict if a condition is likely to become more severe helps doctors focus on providing the most comprehensive treatment for high-risk patients. This means that limited medical resources can be allocated more efficiently, leading to a reduction in the psychological stress not only on patients and their families, but also on healthcare professionals.
Development of therapies which utilize the IFN-λ3 test results of patients under treatment as an indicator of exacerbation will, if successful, help to reduce disease severity and mortality, making more effective treatment a feasible prospect in the future.
Sysmex will contribute to research on COVID-19 and the establishment of its diagnosis and treatment through a variety of tests, including PCR, antigen, antibody, and cytokine tests, as well as existing hematology and hemostasis tests. We will also continue to investigate the clinical usefulness of other promising biomarkers.
Walgreens and Labcorp Make Pixel by Labcorp™ At-Home COVID-19 Collection Kit Available Through Walgreens Find Care®
21 December 2020 - Kit Can Allow More People to Get Tested, Helping Reduce the Spread of the Virus and Improving the Health of Communities
DEERFIELD, Ill. & BURLINGTON, N.C., Dec. 21, 2020 -- Labcorp, a leading global life sciences company that is focused on advancing health and guiding patient care decisions, and Walgreens today announced that the Pixel by Labcorp™ At-Home COVID-19 Collection Kit is now available from Labcorp through Walgreens Find Care®, a digital health platform available on the Walgreens app and Walgreens.com. Walgreens currently offers COVID-19 testing in more than 1,100 drive-thru locations across the country.
Using Walgreens Find Care®, customers can connect to the Pixel by Labcorp website to request the test after completing a short COVID-19 survey to determine eligibility. The kit will be shipped via FedEx Express Overnight to the customer’s home, where they can self-administer the test collection using a short nasal swab and send their sample back to Labcorp. Once processed by Labcorp, test results are accessed by the customer via the Pixel by Labcorp site. If a COVID-19 test is positive, a healthcare staff member will contact individuals directly by phone or mail to discuss next steps. Pixel by Labcorp has contracted with a physician network to provide independent physician services for testing. The Pixel by Labcorp At-Home COVID-19 Collection Kit is not a substitute for visits to a healthcare professional and is for use by adults 18 and older.
“Labcorp and Walgreens share a common goal of helping customers find easy and safe ways to get COVID-19 test results and make informed health decisions,” said Amy Summy, executive vice president and chief marketing officer, Labcorp. “We’re excited to expand our collaboration and make our popular and easy-to-use Pixel by Labcorp At-Home COVID-19 Collection Kit available to even more customers.”
Walgreens Find Care® helps patients manage their healthcare from the comfort of their own home, including accessing convenient in-person and virtual doctor visits for a range of services, such as scheduling a test in any of the Labcorp patient service centers nationally. In addition, Walgreens Find Care® can be used to book appointments for a range of services like urgent care, telehealth, for physician second opinions, mental health, and even optical services. The platform offers an integrated healthcare and pharmacy experience to empower people to get care when and how they need it from local and national providers they trust, all through the convenience of the Walgreens mobile app or online at Walgreens.com/findcare.
Currently through Walgreens Find Care®, patients can access more than 40 trusted providers that together offer more than 60 services and treat more than 100 conditions. The launch of additional features and providers on Walgreens Find Care® coincided with guidance from the Centers for Disease Control and Prevention (CDC) to use telehealth to help address medical needs while supporting social distancing, an important step in managing the impact of COVID-19.
“The expanded collaboration between Labcorp and Walgreens reflects both companies' shared objective to provide health services that help our communities,” said Giovanni Monti, senior vice president of healthcare services, Walgreens Boots Alliance. “We are committed to working together to make it even easier for our customers to get safe access to COVID-19 testing.”
Labcorp’s COVID-19 PCR test has not been FDA cleared or approved and has been authorized by the FDA under an emergency use authorization only for the detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens. The test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostic tests for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.
About Labcorp
Labcorp is a leading global life sciences company that provides vital information to help doctors, hospitals, pharmaceutical companies, researchers, and patients make clear and confident decisions. Through our unparalleled diagnostics and drug development capabilities, we provide insights and accelerate innovations to improve health and save lives. With over 70,000 employees, we serve clients in more than 100 countries. Labcorp (NYSE: LH) reported revenue of $11.5 billion in FY2019. Learn more about us at www.Labcorp.com or follow us on LinkedIn and Twitter @Labcorp.
About Walgreens
Walgreens (www.walgreens.com) is included in the Retail Pharmacy USA Division of Walgreens Boots Alliance, Inc. (Nasdaq: WBA), a global leader in retail and wholesale pharmacy. As America’s most loved pharmacy, health and beauty company, Walgreens purpose is to champion the health and wellbeing of every community in America. Operating more than 9,000 retail locations across America, Puerto Rico and the U.S. Virgin Islands, Walgreens is proud to be a neighborhood health destination serving approximately 8 million customers each day. Walgreens pharmacists play a critical role in the U.S. healthcare system by providing a wide range of pharmacy and healthcare services. To best meet the needs of customers and patients, Walgreens offers a true omnichannel experience, with platforms bringing together physical and digital, supported by the latest technology to deliver high-quality products and services in local communities nationwide.
Q BioMed Technology Partner Mannin Research Inc. Announced as Member of Canadian National COVID-19 Consortium
21 December 2020 - Group Secures $5.1M to Expand Platform for COVID Research
NEW YORK, December 21, 2020 – Q BioMed, Inc. is pleased to announce that its technology partner Mannin Research Inc. (MRI), a private Canadian biotechnology company, is a member of the Canadian national COVID Cloud consortium.
The platform will be used by MRI to help understand, predict, and treat COVID-19 with molecular precision.
MRI is developing a host-directed approach to treating patients with COVID-19 suffering from Acute Respiratory Distress Syndrome (ARDS). MRI is contributing to the development of the COVID-19 platform so as to provide information that will improve the effectiveness of its novel therapeutic for COVID-19 patients, code named MAN-19.
The Canadian national consortium will expand development of a software platform for genomics and health data and apply it to COVID-19 research and drug development utilizing $5.1M CAD in co-funding by Canada’s Digital Technology Supercluster and aims to increase Canada’s capacity to harness exponentially growing volumes of genomics and biomedical data to advance precision health. With a global death count of over 1.4 million people and record numbers of cases nationally, solutions that can help Canada respond to ongoing challenges of the pandemic are urgently needed.
The consortium is a collaboration between BioSymetrics, Centre of Genomics and Policy at McGill University, DNAstack, FACIT, Genome BC, Mannin Research, McMaster University, Microsoft Canada, Ontario Genomics, Ontario Institute for Cancer Research, Roche Canada, Sunnybrook Research Institute, and Vector Institute. It leverages past work of partners to address needs of infectious disease research with guidance from domain experts.
“We are very proud to contribute to such an important effort in Canada, as it will have an impact not only on Canadian’s healthcare but on COVID-19 patients around the world, as we learn more about the disease and ways we can treat patients with it”, said George N. Nikopoulos, President and CEO of Mannin Research Inc.
For more information, visit dnastack.com/solutions/covid-cloud.
About Mannin Research Inc.
Mannin Research is a research-stage biotechnology company focused on the discovery, development, and commercialization of first-in-class therapeutics for vascular diseases. Mannin Research main platform is built on the expertise in activation of Angiopoietin-Tie2 signalling pathway, a major regulator of vascular endothelium with a broad range of therapeutic applications.
Acute respiratory distress syndrome (ARDS) is a major severe complication of viral respiratory infections and the primary cause of mortality of COVID-19 patients. It is associated with profound vascular inflammation leading to pulmonary edema and hypoxemic respiratory failure. In the face of the global COVID-19 pandemic, Mannin Research is developing novel therapeutics to stabilize lung endothelial barrier integrity and reduce vascular leakage. These therapeutics offer novel virus-independent, host-directed strategies to support patients with critical respiratory illness and prevent negative outcomes.
About Digital Technology Supercluster
The Digital Technology Supercluster solves some of industry's and society's biggest problems through Canadian-made technologies. We bring together private and public sector organizations of all sizes to address challenges facing Canada's economic sectors including healthcare, natural resources, manufacturing and transportation. Through this 'collaborative innovation' the Supercluster helps to drive solutions better than any single organization could on its own. The Digital Technology Supercluster is led by industry leaders such as D-Wave, Finger Food Advanced Technology Group, LifeLabs, LlamaZOO, Lululemon, MDA, Microsoft, Mosaic Forest Management, Sanctuary AI, Teck Resources Limited, TELUS, Terramera, and 1Qbit. Together, we work to position Canada as a global hub for digital innovation. A full list of Members can be found here.
About the COVID-19 Program
The COVID-19 Program aims to improve the health and safety of Canadians and support Canada's ability to address issues created by the COVID-19 outbreak. In addition, the program will build expertise and capacity to anticipate and address issues that may arise in future health crises, from healthcare to a return to work and community. More information can be found here.
Please visit www.QBioMed.com for more information on our various pipeline products.
About Q BioMed Inc.
Q BioMed Inc. is a biotech acceleration and commercial stage company. We are focused on licensing and acquiring undervalued biomedical assets in the healthcare sector. Q BioMed is dedicated to providing these target assets; strategic resources, developmental support, and expansion capital to ensure they meet their developmental potential, enabling them to provide products to patients in need.
Beckman Coulter Launches one of the First High-Quality, High-Throughput COVID-19 Antigen Test Ideal for Mass Testing in the U.S.
18 December 2020 - The Access SARS-CoV-2 Antigen assay is offered to healthcare providers at $4, making reliable and frequent mass testing affordable. Assay’s limit of detection is 2 to 200 times lower therefore more sensitive than most point-of-care (POC) antigen tests. Test runs on Beckman Coulter’s analyzers capable of processing up to 200 samples per hour, enabling high throughput screening in just 30 minutes and addressing the scalability constraints of POC tests. Company is submitting for EUA and can ship up to 25 million tests per month.
BREA, CALIF., DEC. 18, 2020 — Beckman Coulter, a leader in clinical diagnostics, today announced the launch of a new test that addresses the three main barriers currently facing schools, businesses, hospitals and communities with the rollout of mass COVID-19 testing. The new Access SARS-CoV-2 Antigen assay is one of the first cost-effective high-quality, high-throughput COVID-19 test available in the U.S. with the volume, workflow and scalable flexibility needed to help fight the COVID-19 pandemic.
The Access SARS-CoV-2 Antigen assay has proven 93% Positive Percent Agreement (PPA) within seven days post symptom onset and 100% Negative Percent Agreement (NPA). Additionally, the assay and has a limit of detection of 33 TCID50/mL, which is 2 to 200 times lower and therefore more sensitive than the reported limits of detection for most of the available point-of-care (POC) antigen tests. Results of the Beckman Coulter antigen test can be delivered in as little as 30 minutes on the organizations’ immunoassay analyzers, including the DxI 800, a high-throughput analyzer capable of processing 200 samples per hour.
According to the Rockefeller Foundation, 4.3 million COVID-19 tests per day are recommended to help minimize infection spread and save lives. New York University economist Paul Romer suggested recently that number could be significantly higher. Currently, only about 1.8 million RT-PCR tests are performed daily in the U.S.
While several point of care (POC) antigen tests are now available to help increase testing beyond current levels, POC tests come with workflow challenges when scaled to large patient populations. Beckman Coulter’s SARS CoV-2 Antigen test is designed to address these challenges. The organization can deliver up to 25 million tests per month, and the assay separates sample collection and processing, enabling test providers to leverage the existing infrastructure and workflows.
Additionally, Beckman Coulter’s new assay is priced at $4 to all healthcare providers, including public and private institutions, governments and non-profits to enable frequent testing.
Beckman Coulter’s new antigen test is appropriate for many of the same populations as RT-PCR tests—individuals who are suspected of COVID-19 infection by their healthcare providers for various reasons, including known exposure or working in high-risk environments. According to the CDC, antigen tests can be used in high-risk settings, such as nursing homes, hospitals, universities and other group settings where repeat testing, coupled with relevant clinical information could identify COVID-19 infection to minimize transmission. In addition, the FDA recently stated that it is now allowing antigen and molecular diagnostic tests to be used off-label in testing asymptomatic patients, as directed by a prescriber for prescription-use tests.
The Beckman Coulter antigen test can be a reliable alternative for laboratories to manage test demand and decrease their testing turnaround times. Moreover, while POC antigen tests have a purpose in diagnosing COVID-19, they are difficult and resource intensive to address high-volume testing needs.
Dr. Feinglass added, “A point-of-care test that delivers a result in 15 minutes for a single individual cannot perform as efficiently when it’s asked to deliver results for larger populations; the workflow breaks down with too many manual steps in the process. Furthermore, a hospital must report positive results to regulatory bodies, and many POC tests require cumbersome manual recording of patient data into their EMR.”
In contrast to the cumbersome workflow of POC antigen tests, the Beckman Coulter antigen test samples are collected with a nasopharyngeal swab at the point of care and can be stored at room temperature for up to 24 hours and refrigerated for 48 hours while transporting to the laboratory for processing. The ability to separate the sample collection from sample processing allows for flexibility to meet the needs of all Beckman Coulter customers from small laboratories that operate a desktop analyzer, to large laboratories that implement automated, high-throughput analyzers for mass testing.
Whether on a desktop or high-throughput analyzer, results are delivered electronically to physicians, patient portals and health agencies, allowing clinicians to initiate proper treatment, isolate patients, and start contact tracing, helping to minimize the spread of COVID-19.
Nicholas Decker, MLS (ASCP) laboratory director at Memorial Healthcare, “RT-PCR is a great tool; however, it is not one-size fits all. Affordable antigen testing is battle tested and has the ability to turn a laboratory into a well-rounded partner for our providers and patients.”
Beckman Coulter is filing for Emergency Use Authorization of the assay with the U.S. Food and Drug Administration (FDA) and can immediately begin shipping 18 million tests per month, and ramp to 25 million tests per month by March 2021 to its customer base throughout the U.S. and Puerto Rico under Policy C. The test will be made available to markets accepting the CE Mark in January 2021.
To learn more about the $4 Access SARS-CoV-2 Antigen assay including how to place an order, or for the latest information on Beckman Coulter’s response to COVID-19, visit www.beckmancoulter.com/antigenassay.
About Beckman Coulter’s Suite of COVID-19 Testing Solutions
Beckman Coulter’s suite of COVID-19 assays includes the $4 Access SAR-CoV-2 Antigen assay, as well as two qualitative antibody assays: Access SARS-CoV-2 IgM and Access SARS CoV-2 IgG assay, and a SARS-CoV-2 semi-quantitative IgG assay. The company also has an interleukin 6 (IL-6) assay, can be used to aid physicians identifying a severe inflammatory response and determining the risk of intubation with mechanical ventilation in COVID-19 patients.
All of Beckman Coulter’s assay to address COVID-19 can be performed in automated or high-throughput immunoassay formats, as well as with Beckman Coulter’s Access 2 analyzer, a compact, table-top analyzer enabling high-quality serology testing to be carried out in small hospitals and clinics. Additionally, all of the assays seamlessly integrate into laboratory workflows making it easy to add these tests to routine blood tests performed during inpatient and wellness testing.
About Beckman Coulter
Beckman Coulter is committed to advancing healthcare for every person by applying the power of science, technology and the passion and creativity of our teams to enhance the diagnostic laboratory’s role in improving healthcare outcomes. Our diagnostic systems are used in complex biomedical testing, and are found in hospitals, reference laboratories and physician office settings around the globe. Beckman Coulter offers a unique combination of people, processes and solutions designed to elevate the performance of clinical laboratories and healthcare networks. We do this by accelerating care with a menu that matters, bringing the benefit of automation to all, delivering greater insights through clinical informatics and unlocking hidden value through performance partnership. An operating company of Danaher Corporation since 2011, Beckman Coulter is headquartered in Brea, Calif., and has more than 11,000 global associates working diligently to make the world a healthier place.
Quest Diagnostics and The Commons Project to Deliver Convenient Access to Lab Data -- Including COVID-19 Test Results -- Through the CommonHealth App
17 December 2020 - Android device users can now securely collect, store and share personal health data, including COVID-19 test results, from a single app Collaboration to include a privacy preserving way for individuals traveling internationally to confirm their vaccination information and COVID-19 status
SECAUCUS, N.J., Dec. 17, 2020 -- Quest Diagnostics, the world's leading provider of diagnostic information services, and The Commons Project, a non-profit public trust dedicated to building and operating global digital platforms and services for public good, today announced a collaboration that will give individuals more control over how and when they can access their data.
With the new collaboration, Quest Diagnostics also joins a handful of industry members of the Commons Project Foundation, which is focused on enabling people to access digital versions of their COVID-19 test results and vaccination records in order to more safely open international borders and resume economic activity.
Through the new collaboration, individuals can elect to access their Quest Diagnostics laboratory testing data through CommonHealth, the privacy-preserving Android app. The solution makes it easier for patients to access and review all their health data on a single, secure app.
"As patients navigate their health during the pandemic, and beyond, it is more important than ever to have their health data in one place," said Cathy Doherty, Senior Vice President and Group Executive, Clinical Franchise Solutions and Marketing for Quest Diagnostics. "By making Quest Diagnostics lab results accessible via CommonHealth, more individuals will have convenient access to their most critical and up-to-date health information, for better health decisions powered by diagnostic insights."
Approximately 55 percent of people in the United States are Android users. CommonHealth – available as a free download via Google Play – is the first and the only platform designed to allow users of the Android operating system to manage their medical records on Android-enabled devices and smartphones.
"As we expand our network with digital solutions that help people better manage their health, we need trusted members to help provide secure lab results and vaccination data in a timely and accurate way," said Dr. Brad Perkins, CMO, The Commons Project. "Our collaboration with Quest unlocks access to the world's largest database of clinical lab results for more than half the population that uses Android devices, putting them in control of their private health data."
CommonHealth aggregates health information, such as lab test results and vaccine information, from more than 320 U.S. hospitals and allows users to download, store, manage and share with other apps and services they trust. In doing so, Quest Diagnostics and The Commons Project intend to accelerate a shared vision to improve people's lives by giving them greater insight and control over their health data.
Quest's Commitment to Consumer Empowered Health
Quest Diagnostics has long been at the forefront of the movement for consumer empowerment in healthcare. The company was among the first diagnostic information services providers to offer free access to test results online and other channels. Its mobile app and patient portal, called MyQuest, provides its more than 14 million users a way to securely access and track their test results and other health data. The company's QuestDirect service provides dozens of tests for conditions ranging from heart health and sexually transmitted diseases. For added convenience, the company now offers at-home self-collection devices for tests including COVID-19 infection, diabetes, and hormones. Through its collaborations with Safeway and Walmart, Quest Diagnostics operates approximately 200 patient service centers in retail store locations, for the utmost in convenient access. Quest Diagnostics also provides next-generation sequencing and genotyping services for Ancestry.
About Quest Diagnostics
Quest Diagnostics empowers people to take action to improve health outcomes. Derived from the world's largest database of clinical lab results, our diagnostic insights reveal new avenues to identify and treat disease, inspire healthy behaviors and improve health care management. Quest annually serves one in three adult Americans and half the physicians and hospitals in the United States, and our 47,000 employees understand that, in the right hands and with the right context, our diagnostic insights can inspire actions that transform lives. www.QuestDiagnostics.com
About The Commons Project
The Commons Project is a non-profit public trust building global digital services and platforms for the common good. Founded with support from the Rockefeller Foundation and based in Switzerland, it was established to build and operate the shared platforms and services that neither governments nor tech companies are well-positioned to create. The Commons Project's public trust governance structure is designed to ensure that people's interests are served above all.
BD Surpasses 1 Billion Injection Device Orders in Support of COVID-19 Vaccination Efforts Around the World
16 December 2020
FRANKLIN LAKES, N.J., Dec. 16, 2020 -- BD (Becton, Dickinson and Company), a leading global medical technology company, today announced that it has received pandemic orders for needles and syringes totaling more than 1 billion injection devices to support global COVID-19 vaccination planning efforts.
This milestone reflects commitments from governments across the world, including the United States, Australia, Belgium, Canada, Germany, Netherlands, Saudi Arabia, Spain and the United Kingdom, among several others, as well as non-governmental organizations supporting vaccine deployment for developing countries.
Shipments are already underway and more than 300 million injection devices have been delivered around the world to date, with the remaining orders to be delivered between now and the end of 2021 to support vaccine administration. These devices are being shipped to governments or appointed distribution partners where they will then be distributed to health care facilities based on each country's individual distribution and allocation strategy. BD continues to be in discussions with governments and non-governmental organizations on the need to place orders immediately for delivery later in calendar year 2021 and 2022.
"This milestone is more than just a number – it represents hundreds of millions of people around the world, such as frontline workers and at-risk loved ones who will now be able to receive a vaccination the moment vaccines are available," said Rick Byrd, president of Medication Delivery Solutions for BD. "We recognize our manufacturing and supply chain teams who are working around the clock to make and deliver these essential devices throughout the world. From our decades of immunization experience, we also know our work doesn't stop at delivery. We are equally committed to providing resources to ensure health care communities globally have the right training tools and support on injection techniques to implement these campaigns."
The company continues to closely plan supply capabilities to ensure maximum volumes can be dedicated to COVID-19 efforts while minimizing disruption for routine health care and annual flu vaccination and childhood immunization programs.
In addition to supporting immediate efforts for COVID-19 vaccination readiness, BD is also working on multiple fronts to help ensure the global community is prepared for future pandemic vaccination efforts by:
- Partnering with the U.S. government on a $70 million capital project to further expand BD's operations and manufacturing capacity in Nebraska. The new capacity is expected to be online in summer 2021 and once completed, the federal government will have priority access to hundreds of millions of injection devices to support vaccination efforts for COVID-19 and future pandemics.
- Investing approximately $1.2 billion over a 4-year period to expand and upgrade manufacturing capacity and technology for pre-fillable syringes and advanced drug delivery systems to allow for continued growth of new injectable drugs and vaccines, but also provide surge capacity for increased pre-fillable syringe demand during times of pandemic response.
- Actively engaging with med-tech associations and research groups to address challenges, solutions and further innovation in support of a more sustainable future vaccine ecosystem.
BD is the largest manufacturer of injection devices in the world, producing billions of syringes and needles annually through its global manufacturing network. Learn more about BD's vaccination preparedness efforts at bd.com/vaccination.
In addition to ramping up manufacturing of needles and syringes, BD has been working closely with governments and multilateral organizations around the world to expand access to diagnostic testing and support treatment of COVID-19 patients. The company has supplied health care providers globally with millions of products used in of the fight against COVID-19, including swabs for flu and COVID-19 testing, rapid molecular diagnostic tests on the BD MAX™ System, 15-minute point-of-care antigen testing on the BD Veritor™ Plus System, infusion pumps, infusion sets and catheters. BD Biosciences instruments are also being used by researchers around the world to better understand the human immune response to COVID-19.
About BD
BD is one of the largest global medical technology companies in the world and is advancing the world of health by improving medical discovery, diagnostics and the delivery of care. The company supports the heroes on the frontlines of health care by developing innovative technology, services and solutions that help advance both clinical therapy for patients and clinical process for health care providers. BD and its 65,000 employees have a passion and commitment to help enhance the safety and efficiency of clinicians' care delivery process, enable laboratory scientists to accurately detect disease and advance researchers' capabilities to develop the next generation of diagnostics and therapeutics. BD has a presence in virtually every country and partners with organizations around the world to address some of the most challenging global health issues. By working in close collaboration with customers, BD can help enhance outcomes, lower costs, increase efficiencies, improve safety and expand access to health care. For more information on BD, please visit bd.com.
EUROIMMUN Launches Novel ELISA for Detection of SARS-CoV-2 Antigen in Acutely Infected Patients
16 December 2020 - Automatable and reliable COVID-19 test rounds out Company’s menu of offerings for acute diagnostics of the virus
WALTHAM, Mass. – December 16, 2020 – EUROIMMUN, a PerkinElmer, Inc. Company, today announced the launch of the CE marked SARS-CoV-2 Antigen ELISA for specific determination of the SARS-CoV-2 protein. The assay adds to the Company’s broad product portfolio for COVID-19 diagnostics and supports the molecular PCR tests to aid in diagnosing acute SARS-CoV-2 infections.
The Antigen ELISA is a laboratory test able to be applied in semi quantitative automatable detection of the SARS-CoV-2 nucleocapsid protein on a large scale. It is validated for swab sample material from the upper respiratory tract and is useful for testing individuals with acute symptoms that point to COVID-19 or who have had suspected contact with SARS-CoV-2. Validation data revealed 93.6% positive agreement (sensitivity) and 100% negative agreement (specificity) between results obtained with the Antigen ELISA and those obtained with a real time PCR test for detecting the virus. Based on the well-known ELISA technology, the SARS-CoV-2 Antigen assay can be performed in most diagnostic laboratory settings and automatically processed on all open ELISA platforms.
“Infection numbers are continuously increasing, and there is enormous pressure to provide sufficient test capacities. The availability of gold-standard PCR testing, however, is often challenged in acute COVID-19 outbreak situations. That’s why a reliable and automatable antigen detection test as our new ELISA can be a valuable supplement to help rapid identification of acutely infected individuals,” says Dr. Wolfgang Schlumberger, CEO of EUROIMMUN.
The SARS-CoV-2 Antigen ELISA is available in countries that recognize CE marking. Validation of saliva specimens for use with this assay is currently in process.
The assay is the latest of the comprehensive EUROIMMUN COVID-19 product portfolio and the third test to support acute COVID-19 diagnostics following the two molecular diagnostic systems: EURORealTime SARS-CoV-2 and EURORealTime SARS-CoV-2/Influenza A/B.
About PerkinElmer
PerkinElmer enables scientists, researchers and clinicians to address their most critical challenges across science and healthcare. With a mission focused on innovating for a healthier world, we deliver unique solutions to serve the diagnostics, life sciences, food and applied markets. We strategically partner with customers to enable earlier and more accurate insights supported by deep market knowledge and technical expertise. Our dedicated team of about 14,000 employees worldwide is passionate about helping customers work to create healthier families, improve the quality of life, and sustain the wellbeing and longevity of people globally. The Company reported revenue of approximately $2.9 billion in 2019, serves customers in 190 countries, and is a component of the S&P 500 index. Additional information is available through 1-877-PKI-NYSE, or at www.perkinelmer.com.
Abbott's BinaxNOW COVID-19 rapid test receives FDA Emergency Use Authorization for first virtually guided, at-home rapid test using EMED'S digital health platform
16 December 2020 - First at-home, virtually guided service to bring rapid, reliable and affordable testing into the home where the result is delivered in minutes. Abbott and eMed™ expect to deliver and administer 30 million BinaxNOW™ tests in the first quarter of 2021, with an additional 90 million in the second quarter. $25 cost for the test and service is the lowest available for at-home testing, which supports the home user to ensure a successful testing process. BinaxNOW is a highly portable, easy-to-use, 15-minute antigen test with no instrument that detects the virus when people are most infectious, which is critically important in slowing the spread of the virus. Service uses Abbott's complementary NAVICA™ app to enable the testing process and display authenticated BinaxNOW test results verified by a trained guide - and supports consumer confidence in testing at home.
ABBOTT PARK, Ill.,, Dec. 16, 2020 -- Abbott announced today that the U.S. Food and Drug Administration (FDA) has issued Emergency Use Authorization (EUA) for virtually guided at-home use of its BinaxNOW™ COVID-19 Ag Card rapid test for detection of COVID-19 infection. Abbott is bringing BinaxNOW, the most affordable and widely distributed rapid test into the home, where the result is delivered in minutes without the need to send it out for processing. The $25 cost for the test and service is the lowest currently available for at-home testing.
To facilitate the delivery of the BinaxNOW test to the home and the guided collection and testing process, Abbott has partnered with digital health solutions provider eMed™. This agreement furthers Abbott's vision of making as many tests as possible available in a variety of different settings to improve accessibility, support consumer confidence in testing at home, and help people start returning to living their daily lives with more normalcy.
Abbott and eMed expect to deliver and administer 30 million BinaxNOW at-home tests in the first quarter of 2021, with an additional 90 million in the second quarter. Scale is critical to provide broad access to people who need testing and Abbott has scale for all its eight COVID-19 lab and rapid tests. In fact, since launching BinaxNOW in August, Abbott has ramped up capacity to 50 million tests a month in its U.S. facilities that are currently being distributed through the federal government and is expanding further so even more people have access to the tests.
"As the pandemic has evolved, the need for rapid testing has only grown. Unfortunately, we're still hearing that many people can't access testing as quickly as they need it," said Robert B. Ford, Abbott's president and chief executive officer. "That's why Abbott is bringing our rapid BinaxNOW test and NAVICA platform into homes through this partnership with eMed, which allows us to maintain the integrity of the testing process, get even closer to people who need testing and help provide the confidence we need to help get back to living with a bit more normalcy."
The eMed service offering costs $25 a test, and eMed takes care of determining eligibility, the guided self-collection process, public health reporting requirements and gets people their results through their NAVICA app in a matter of minutes.
The eMed offering could also remove some of the obstacles that individuals, governments and organizations face when seeking to provide or perform testing. These include mobility issues for people with disabilities or who may not have a reliable form of transportation, inconvenient testing windows for people who work non-traditional hours or have childcare or eldercare responsibilities, and discouragingly long lines at testing centers.
"COVID-19 is the greatest public health threat our nation has experienced in a century," said Dr. Patrice Harris, CEO of eMed. "This pandemic has had devastating effects in every region of our country but particularly on seniors, essential workers and communities of color. FDA's authorization of Abbott's BinaxNOW test for home use is a breakthrough in the battle against COVID-19. I am proud to lead eMed's partnership with Abbott to democratize access to frequent, affordable, at-home testing with results in 15 minutes. Together we can help to mitigate the spread, save lives and support our return to school, work and play."
Through eMed and the NAVICA app, people can use authenticated BinaxNOW results to enter into venues that accept the NAVICA digital certificate. The virtually guided process preserves the integrity of the testing process and state-mandated reporting obligations, while ensuring equitable access to people who need tests through the prescription process. Real-time data generated from at-home testing can also help federal and state public health authorities to better understand the extent of an outbreak and take appropriate steps to control its spread.
How the at-home digital health service works
A person can access the eMed service through Abbott's NAVICA app, which can be downloaded from the Apple and Android app stores. Once eligibility requirements are met, the test kit is shipped directly to the home user or a pick-up location, allowing a person to remain isolated until their status is known.
Once a BinaxNOW test kit arrives at the home, the home user logs into the eMed portal for their guided testing session and can expect results in approximately 20 minutes. The eMed certified guide is available to answer questions throughout the testing process.
BinaxNOW at-home performance data
In an interim, ongoing analysis of data collected in the U.S. from four investigational sites – where people tested themselves or a child – on a total of 52 people ranging from less than one-year-old to 63 years of age, which included analyses of people by days post-symptom onset and Ct counts, results showed that BinaxNOW for at-home use delivered the following performance as compared to lab-based molecular PCR tests:
- Overall performance of 91.7% positive agreement (sensitivity) and 100% negative agreement (specificity) in people seven days or less post-symptom onset at all Ct counts.
- Performance of 100% positive agreement (sensitivity) in people seven days or less post-symptom onset with Ct counts of 33 or below. These are people who are most likely to be infectious and spread the virus to others due to their lower Ct values.
- The performance of BinaxNOW in the at-home setting is similar to performance in the larger post-authorization study (see section below in release).
There is a growing body of scientific literature and experience focused on the correlation between infectiousness, Ct counts and viral load. Specifically, scientific evidence suggests that at Ct counts in the 30s, the SARS-CoV-2 virus can't be replicated, meaning people are no longer infectious. This underscores the importance of frequent antigen testing to catch people with lower Ct counts while they are most contagious and need to self-quarantine.
- A study by La Scola et. al. published in the European Journal of Microbiology & Infectious Diseases, shows the inability to culture virus at Ct counts greater than or equal to 34.
- A recent study from the University of California-San Francisco of BinaxNOW in a real-life setting, which showed performance of 93.3% sensitivity and 99.9% specificity at a Ct count of 30 and below.
Ct counts are the number of times a PCR instrument must cycle through to amplify enough genetic material of the SARS CoV-2 virus for it to be detectable. The greater the amount of virus present (viral load), the fewer cycles required to detect the virus. A person with a higher viral load (and lower Ct count) is more likely to be infectious.
Updated BinaxNOW professional use data
As part of its submission to the FDA for at-home use, Abbott also released the latest clinical data for its BinaxNOW COVID-19 Ag Card professional use product (not inclusive of at-home data) to show real-world evidence of clinical utility and efficacy.
In data collected from ten clinical sites in 460 people ranging from 6 to more than 60 years of age, which included analyses of people by days post-symptom onset and Ct counts, results showed that BinaxNOW delivered the following performance as compared to lab-based molecular PCR tests:
- Overall performance of 84.6% positive agreement (sensitivity) and 98.5% negative agreement (specificity) in people seven days or less post-symptom onset at all Ct counts.
- Performance of 95.6% positive agreement (sensitivity) in people seven days or less post-symptom onset with Ct counts of 33 or below. These are people who are most likely to be infectious and spread the virus to others due to their lower Ct values.
Abbott also conducted multiple culture studies that consistently showed that Ct counts less than or equal to 28 are required to grow the virus in a lab. Other independent third-party studies have identified that higher Ct counts are correlated with a lack of infectiousness, and a rapid antigen test with high performance at a Ct count of 33 or below is able to detect the virus in people who are infectious.
Abbott continues to study the BinaxNOW COVID-19 Ag Card, including in asymptomatic people.
About the BinaxNOW COVID-19 Ag Card Home Test and NAVICA App
The BinaxNOW™ COVID-19 Ag Card Home Test is a lateral flow immunoassay intended for the qualitative detection of nucleocapsid protein antigen from SARS-CoV-2. This test is authorized for prescription home use with self-collected observed direct anterior nasal (nares) swab samples from individuals aged 15 years or older who are suspected of COVID-19 by their healthcare provider within the first seven days of symptom onset or adult collected nasal swab samples from individuals aged four years or older who are suspected of COVID-19 by their healthcare provider within the first seven days of symptom onset. The BinaxNOW COVID-19 Ag Card Home Test is to be performed only with the supervision of a telehealth proctor.
Along with BinaxNOW, Abbott is also offering a mobile app at no charge called NAVICA, which will allow people to display their results obtained through a healthcare provider or through the eMed at-home service when entering facilities requiring proof of testing. The NAVICA app is optional and an easy-to-use tool that allows people to store, access and display their results with organizations that accept the results so people can move about with greater confidence. The NAVICA app is supported by Apple and Android digital wallets and is available from public app stores in the U.S.
About Abbott
Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 107,000 colleagues serve people in more than 160 countries.
About eMed
eMed is democratizing healthcare with a digital point-of-care platform that provides fast, easy and affordable at-home healthcare testing, supervised and guided online by eMed Certified Guides. We utilize quantitative medicine to deliver prescribed tests and treatments directly to patients, driving better and more cost-effective results.
bioMérieux announces the CE marking of its molecular biology ARGENE® test for the simultaneous detection of SARS-CoV-2, influenza viruses A and B, and RSV and hMPV viruses
16 December 2020
Marcy l’Etoile, France – December 16, 2020 – bioMérieux, a world leader in the field of in vitro diagnostics, has announced the expansion of its ARGENE® range for the real-time PCR (RT-PCR) detection of SARS-CoV-2: the SARS-COV-2 RESPI R-GENE® test has received CE marking and is now commercially available.
This high-throughput test, which can be used on molecular biology platforms in hospital laboratories and private laboratories, allows the simultaneous (multiplex) detection of SARS-CoV-2 and influenza viruses A and B. In addition, it includes a cellular control to check the quality of the sample, providing an important clinical advantage in the context of the pandemic and large-scale sample collection at many different sites. In a single kit, this new test comes with a second RT-PCR analysis performed from the same extraction, for the detection of two other pathogens that often circulate at the same time and are particularly implicated in respiratory diseases affecting children and seniors: RSV (human respiratory syncytial virus) and hMPV (human metapneumovirus). hMPV is more rarely included in testing panels.
“Infections caused by respiratory viruses often have similar symptoms, but patient management may differ. Multiplex tests have a key role to play with the onset of winter and the flu season. Although the circulation of flu viruses is low to date, in light of the COVID-19 pandemic, it is even more important to detect other diseases associated with respiratory disease early on, especially for high-risk patient groups. This makes it possible to adapt clinical management and limit the circulation of these viruses,” explained François Lacoste, Executive VP, R&D.
The SARS-COV-2 RESPI R-GENE® test will be available in Europe and in countries that recognize the CE marking.
Genedrive notifies FDA of its intent to distribute the SARS-CoV-2 PCR test in the USA
16 December 2020
16 December 2020 -- Genedrive plc, the near patient molecular diagnostics company, announces that it notified the Food and Drug Association (FDA) in the United States of its intention to import and distribute its Genedrive 96 SARS-CoV-2 Kit prior to an Emergency Use Authorization (EUA) determination, as described in the guidance on Policy for Coronavirus Disease-2019 Tests During the Public Health Emergency, Section IV.C.2.
Notification was made on 25 November and acknowledged on 15 December. The current claims of the product cover high throughput testing on a variety of third-party RT-PCR platforms for upper respiratory track specimens.
David Budd, CEO of genedrive plc, said: “genedrive submitted its application to the FDA in May of this year but owing to the volume of applications received we are still waiting for EUA review. However, in order to support the Beckman Biomek system’s transition into clinical use and exploit commercial opportunities, the product needs to be commercially available in the United States to end users. We are confident in the performance claims of our assay and have generated independent evaluation data in the United States at non-automated sites and our automated Biomek installations which confirm our product claims.”
In light of the increasing numbers of COVID-19 cases throughout the US and the need to expand capacity for COVID-19 testing during the public health emergency, the FDA has stated that it does not object to a commercial manufacturer’s development and distribution of SARS-CoV-2 test kits for specimen testing for a reasonable period of time, where the test has been validated and while the manufacturer has made an Emergency Use Authorization request, where the manufacturer gives appropriate notification of validation to FDA, and where the manufacturer provides instructions for use of the test and posts data about the test’s performance characteristics on the manufacturer’s website.
The product will bear a labelling stating that “validation of this test has not been reviewed by FDA. Review under the EUA program is pending”.
Reference: https://www.genedrive.com/news/index.php
Abbott receives CE Mark for its COVID-19 IgG quantitative antibody blood test
15 December 2020 - SARS-CoV-2 IgG II Quant antibody test measures levels of IgG antibodies to help measure and understand a person's immune response. The test specifically identifies levels of IgG antibodies that attach to the virus' spike protein which can be helpful to evaluate a person's immune response to vaccines. CE Mark test will be available for use on Abbott's ARCHITECT® and Alinity i™ platforms. Abbott plans to submit its test for U.S. Food and Drug Administration (FDA) emergency use authorization soon.
ABBOTT PARK, Ill., Dec. 15, 2020 -- Abbott announced today it received CE Mark for its new quantitative SARS-CoV-2 IgG (Immunoglobulin G) lab-based serology test. IgG antibody testing that gives a quantitative result (measuring the amount of antibodies) provides important insights to people as they recover from COVID-19 and helps evaluate a person's immune response to a vaccine.
Countries around the world are preparing for the authorization and the distribution of COVID-19 vaccines. As these vaccines become available, healthcare professionals and researchers will need to assess how individuals and communities are responding.
"Testing will continue to help both identify those who are infected as well as determine whether people have had a natural or vaccine-induced immune response," said John Hackett, Ph.D., divisional vice president of Applied Research and Technology for Abbott's diagnostics business. "Quantitative antibody testing can help provide greater understanding of a person's immune response."
The evolution of serology testing during COVID-19
During the early months of the pandemic, Abbott launched its first COVID-19 IgG antibody blood test, which detects the nucleocapsid protein of the virus. The qualitative test continues to provide a better understanding of people's immune response to the virus, including potential duration of the recovery process. The new quantitative antibody test expands on this knowledge by determining both the presence and level (or titer) of antibodies present in the blood.
Abbott's scientists designed its quantitative assay to detect the spike protein of the virus, which plays an important part in how the virus enters the cells. As the body develops an immune response, antibodies develop and bind to the spike portion of the virus in order to block the protein and ultimately prevent infection.
Several vaccines are designed with the spike protein to trigger that same immune response. Research has also shown a correlation between rising IgG levels that target the spike protein, such as those in Abbott's quantitative test, and rising levels of neutralizing antibodies, or the specific antibodies that block infections. Studies are underway to understand the relationship between the levels of antibodies a person has and potential immunity from the virus.
As we continue to learn more about the virus, antibody tests may help:
- Determine and monitor a person's immune response to vaccines, including research to determine how long a response may last
- Assess whether a person's antibody levels are a result of the body's natural response to fighting the virus, versus a vaccine-induced response
- Evaluate an individual's level of antibodies to help determine eligibility and potency for convalescent plasma donations
The quantitative IgG antibody test is the latest in Abbott's broad portfolio of tests to support the global healthcare community in the fight against COVID-19. Abbott's COVID-19 test portfolio includes molecular, antigen and serology tests. These tests can help healthcare professionals detect the virus at all stages of its life cycle, including tests that are done in the lab as well as rapid tests done at the point of care.
About the SARS-CoV-2 IgG II Quant antibody test
Abbott's quantitative IgG antibody test is designed to detect levels of IgG antibodies that attach to the virus' spike protein on the virus surface in serum and plasma from individuals who are suspected to have had COVID-19, or in serum and plasma of subjects that may have been infected by SARS-CoV-2.
A study to determine the clinical performance of Abbott's SARS-CoV-2 IgG II Quant test on its Alinity i instrument found it had 99.60% specificity (ability to exclude false positives) and 99.35% sensitivity (ability to exclude false negatives) in patients tested 15 days or more after symptoms began.
The quantitative IgG test will be available on both the Abbott ARCHITECT and Alinity i platforms. Abbott is also developing a test and plans to submit for U.S. Food and Drug Administration (FDA) emergency use authorization soon.
About Abbott
Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 107,000 colleagues serve people in more than 160 countries.
EUROIMMUN Receives CE Mark for New PCR Test to Differentiate Between COVID-19 and Flu
14 December 2020 - Company expands testing portfolio for acute diagnostics of COVID-19
WALTHAM, Mass., December 14, 2020 – EUROIMMUN, a PerkinElmer, Inc. Company, today announced the launch of the CE marked EURORealTime SARS-CoV-2/Influenza A/B for direct detection of SARS-CoV-2, influenza virus type A and influenza virus type B. It expands the testing portfolio for acute COVID-19 diagnostics by supporting differential diagnostics between SARS-CoV-2 infections and the common flu. It is available in countries accepting the CE mark.
PCR technology is considered the gold standard for direct pathogen detection. The new EURORealTime test allows fast detection and differentiation of genetic material from SARS-CoV-2, influenza virus type A and influenza virus type B using throat swab samples of patients with acute symptoms, which can be indicative for COVID-19 or flu. Validation efforts revealed very high agreement of results obtained with the EURORealTime test and those obtained with reference PCR tests for SARS-CoV-2 and influenza A/B. No cross-reactions with other common respiratory pathogens were detected. The assay is compatible with common real-time PCR thermal cyclers, while the EURORealTime Analysis Software allows for reliable and standardized evaluation of the test results.
“As the flu season overlaps with the second wave of COVID-19, there is an increasing need to be able to quickly distinguish between SARS-CoV-2 and influenza infections. Individuals with these viral diseases can present with very similar symptoms which makes it difficult to differentiate between them. Here, direct pathogen detection plays a major role in rapid and correct identification of these infections as it is essential for proper subsequent patient management,” says Dr. Wolfgang Schlumberger, CEO of EUROIMMUN. “The combination of the three pathogens within this single multiparametric assay means saving valuable time and resources in the laboratories.”
The EURORealTime SARS-CoV-2/Influenza A/B assay adds to the Company’s broad product portfolio of COVID-19 diagnostics and is the second molecular assay for direct pathogen detection following the CE-marked and FDA-EUA approved EURORealTime SARS-CoV-2 assay. The EURORealTime SARS-CoV-2/Influenza A/B assay complements PerkinElmer’s PKamp™ Respiratory SARS-CoV-2 RT-PCR Panel that previously received the CE mark.
About PerkinElmer
PerkinElmer enables scientists, researchers and clinicians to address their most critical challenges across science and healthcare. With a mission focused on innovating for a healthier world, we deliver unique solutions to serve the diagnostics, life sciences, food and applied markets. We strategically partner with customers to enable earlier and more accurate insights supported by deep market knowledge and technical expertise. Our dedicated team of about 14,000 employees worldwide is passionate about helping customers work to create healthier families, improve the quality of life, and sustain the wellbeing and longevity of people globally. The Company reported revenue of approximately $2.9 billion in 2019, serves customers in 190 countries, and is a component of the S&P 500 index. Additional information is available through 1-877-PKI-NYSE, or at www.perkinelmer.com.
Roche launches laboratory SARS-CoV-2 antigen test to support high-volume testing of suspected COVID-19 patients
11 December 2020 - The Elecsys® SARS-CoV-2 Antigen test is an automated laboratory assay intended as an aid in the diagnosis of active SARS-CoV-2 infection. Roche will be able to ramp up to a double-digit million number of tests per month, by early 2021. The test is the latest addition to Roches comprehensive COVID-19 portfolio and can help in the management of patients for optimal care delivery.
Basel, 11 December 2020 -- Roche announced today that it has launched a high-throughput SARS-CoV-2 antigen test as an aid in the diagnosis of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) infections, in markets accepting the CE Mark. Roche has also filed for Emergency Use Authorisation (EUA) from the U.S. Food and Drug Administration.
The Elecsys® SARS-CoV-2 Antigen test is a highly accurate laboratory immunoassay for the in vitro qualitative detection of the nucleocapsid antigen of SARS‑CoV‑2. In clinical studies, the Elecsys SARS-CoV-2 Antigen test showed a 94.5% sensitivity across 200 PCR confirmed symptomatic individuals and a 99.9% specificity across 2747 PCR negative symptomatic and screening individuals. It is planned to ramp up production to have a double-digit million number of tests per month, in early 2021, depending on the demand of healthcare systems, globally. The test is performed by healthcare professionals and uses nasopharyngeal or oropharyngeal swab samples from patients with symptoms suggestive of COVID-19, or people with either known or suspected exposure to SARS-CoV-2. A widely available, laboratory-based automated antigen assay allows for cost and error reduction due to removal of manual handling as well as fast turn-around times and high test throughput.
“Healthcare systems remain under significant pressure to deliver robust testing options, with a sufficient number of tests available”, said Thomas Schinecker, CEO Roche Diagnostics. “The launch of our high-throughput antigen test will provide additional testing capacity to reliably support healthcare systems in diagnosing SARS-CoV-2 infection, as a supplement to PCR testing.”
About the Elecsys SARS-CoV-2 Antigen test
Roche’s Elecsys SARS-CoV-2 Antigen test is an immunoassay intended for the qualitative detection of SARS-CoV-2 present in the respiratory tract including nasopharynx and oropharynx. The Elecsys SARS-CoV-2 Antigen test is performed by healthcare professionals and could be used as an alternative or in conjunction with PCR testing. This is highly beneficial where reliable laboratory PCR testing is limited or not available. In symptomatic individuals, a positive result with the Elecsys SARS-CoV-2 Antigen test indicates an active SARS-CoV-2 infection with a likelihood of 94.5%. A negative result may require to be confirmed with a PCR test or repeated (antigen test) after one to two days, if other clinical indications point to a SARS-CoV-2 infection.
The Elecsys SARS-CoV-2 Antigen immunoassay runs on all cobas e immunochemistry analysers which are widely available around the world and allow for these test to be run alongside other COVID-19 infectious diseases diagnostic markers available from Roche, which run on the cobas e systems. These fully automated systems can provide test results in 18 minutes for a single test (excluding time for sample collection, transport, and preparation), with a throughput of up to 300 tests per hour from a single analyser, depending on the analyser.
About antigen testing
An antigen test detects proteins which are structural or functional components of a pathogen and are thus very specific to that pathogen. In this case, the test would provide a qualitative “yes/no” answer on the presence of the pathogen in the patient sample. If the target antigen is present in sufficient concentrations in the sample, it will bind to specific antibodies and generate a positive result, indicating an active infection.
In general, antigen tests have a high specificity, though are not as sensitive as PCR tests that amplify the target viral DNA or RNA sequence in order to generate a quantifiable signal to indicate the presence of the virus in a sample. Therefore, to make up for the potential decrease in sensitivity of an antigen test, negative results should be analysed together with additional patient factors, such as COVID-19 exposure history, clinical symptoms, additional test results to help guide the diagnosis and subsequent treatment of the patient.
| Detection of acute infections (SARS-CoV-2 PCR or Antigen) | Detection of immune response (SARS-CoV-2 Antibodies) |
|
| Laboratory setting | cobas® SARS-CoV-2 Test cobas® SARS-CoV-2 & Influenza A/B Test NEW: Elecsys® SARS-CoV-2 Antigen Test |
Elecsys® Anti-SARS-CoV-2 (N) immunoassay Elecsys® Anti-SARS-CoV-2 S Immunoassay |
| Point of Care setting (near patient) | SARS-CoV-2 Rapid Antigen Test cobas® Liat® SARS-CoV-2 Test |
SARS-CoV-2 Rapid Antibody Test |
About Roche’s response to the COVID-19 pandemic
As a leading healthcare company we are doing all we can to support countries in minimising the impact of COVID-19. We have developed a growing number of diagnostic solutions that help to detect and diagnose the infection in patients, as well as providing digital support to healthcare systems, and we continue to identify, develop and support potential therapies which can play a role in treating the disease.
We understand the impact of COVID-19 goes beyond those who contract it, which is why we are working with healthcare providers, laboratories, authorities and organisations to help make sure that patients continue to receive the tests, treatment and care they need during these challenging times. As we learn from the pandemic, we are partnering with governments and others to make healthcare stronger and more sustainable in the future.
Our diagnostics solutions:
Reliable, high-quality testing is essential to help healthcare systems overcome this pandemic. Our portfolio includes:
- a high-volume molecular test to detect SARS-CoV-2, the virus that causes COVID-19, (FDA Emergency Use Authorisation (EUA) and available in countries accepting the CE Mark)
- a SARS-CoV-2 laboratory-based antibody test, aimed at detecting the presence of antibodies in the blood targeting the nucleocapsid (FDA EUA and CE Mark)
- an IL-6 test to assist in identifying severe inflammatory response in patients with confirmed COVID-19 (FDA EUA and CE Mark)
- Roche v-TAC, which could help simplify the screening, diagnosis and monitoring of patients with respiratory compromise in the current COVID-19 pandemic
- a SARS-CoV-2 rapid antibody test to help determine at the point of care whether a person has been exposed to the virus (CE Mark)
- a rapid antigen test to support in the detection of SARS-CoV-2 at the point of care within 15 minutes (CE Mark)
- a high-volume molecular test to simultaneously detect and differentiate between SARS-CoV-2 and influenza A/B, as the symptoms are similar for both (FDA EUA and CE Mark)
- a second SARS-CoV-2 antibody test, aimed at measuring the spike protein to support vaccination development and complement our existing portfolio
- a point-of-care molecular PCR test that simultaneously detects and differentiates between SARS-CoV-2 and influenza A/B infections to support urgent triage and diagnosis (FDA EUA and CE Mark)
Our research into therapies:
Roche is committed to improving the treatment of COVID-19. We are actively involved in understanding the potential of our existing portfolio and are exploring the potential of our investigational molecules.
In August we signed a collaboration agreement with Regeneron on developing and manufacturing and significantly increasing global supply of an investigational antibody combination for COVID-19 if it proves safe and effective in clinical trials and regulatory approvals are granted. We are also partnering with Atea to jointly develop AT-527, an orally administered direct-acting antiviral (DAA) currently in Phase 2 clinical trials. If approved, Atea will distribute AT-527 in the United States and Roche will be responsible for global manufacturing and distribution outside the United States.
At the beginning of the pandemic, on 19 March on 19 March, we announced the initiation of COVACTA - a global Phase III randomised, double-blind, placebo-controlled clinical trial to evaluate the safety and efficacy of intravenous Actemra©/RoActemra© (tocilizumab) plus standard of care in hospitalised adult patients with severe COVID-19 pneumonia compared to placebo plus standard of care. On 29 July we announced that COVACTA did not meet its primary endpoint of improved clinical status in patients with COVID-19 associated pneumonia or the key secondary endpoint of reduced mortality.
Separately, we have studied Actemra©/RoActemra© in the EMPACTA study in COVID-19 associated hospitalised pneumonia in patients that are often underrepresented in clinical trials. On 18 September we announced that the phase III EMPACTA study showed Actemra/RoActemra plus standard of care reduced the likelihood of progression to mechanical ventilation or death in hospitalised patients with COVID-19 associated pneumonia compared to placebo plus standard of care. However, there was no statistical difference in mortality between patients who received Actemra/RoActemra or placebo.
Actemra©/RoActemra© is also being studied in combination with the investigational antiviral remdesivir in hospitalised patients with severe COVID-19 pneumonia in the REMDACTA trial in partnership with Gilead, announced 28 May. Actemra©/RoActemra© is not approved by any health authority for use in COVID-19 pneumonia. Roche has further initiated an internal early research programme focused on the development of medicines for COVID-19 and is engaged in multiple research collaborations.
In these exceptional times, Roche stands together with governments, healthcare providers and all those working to overcome the pandemic.
About Roche
Roche is a global pioneer in pharmaceuticals and diagnostics focused on advancing science to improve people’s lives. The combined strengths of pharmaceuticals and diagnostics under one roof have made Roche the leader in personalised healthcare – a strategy that aims to fit the right treatment to each patient in the best way possible.
Roche is the world’s largest biotech company, with truly differentiated medicines in oncology, immunology, infectious diseases, ophthalmology and diseases of the central nervous system. Roche is also the world leader in in vitro diagnostics and tissue-based cancer diagnostics, and a frontrunner in diabetes management.
Founded in 1896, Roche continues to search for better ways to prevent, diagnose and treat diseases and make a sustainable contribution to society. The company also aims to improve patient access to medical innovations by working with all relevant stakeholders. More than thirty medicines developed by Roche are included in the World Health Organization Model Lists of Essential Medicines, among them life-saving antibiotics, antimalarials and cancer medicines. Moreover, for the twelfth consecutive year, Roche has been recognised as one of the most sustainable companies in the Pharmaceuticals Industry by the Dow Jones Sustainability Indices (DJSI).
The Roche Group, headquartered in Basel, Switzerland, is active in over 100 countries and in 2019 employed about 98,000 people worldwide. In 2019, Roche invested CHF 11.7 billion in R&D and posted sales of CHF 61.5 billion. Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan. For more information, please visit www.roche.com.
Reference: https://www.roche.com/media/releases/med-cor-2020-12-11.htm
Direct from Saliva PCR Test for COVID-19 Enables Fast, Low-Cost Results for High-Frequency Surveillance Testing at Colleges and Universities
10 December 2020
CARLSBAD, Calif., Dec. 10, 2020 -- Thermo Fisher Scientific announced today the availability of a new direct from saliva PCR test for COVID-19 to enable widespread, high-frequency surveillance testing. The Applied Biosystems TaqCheck SARS-CoV-2 Fast PCR Assay uses raw saliva samples and simplifies lab workflows using instruments that are widely available globally to deliver reliable data quickly.
The company also introduced the Safe Campus Reopening Program to subsidize the cost of the test for U.S. colleges, universities and post-secondary institutions. Availability of this program coincides with recent guidance issued by the Centers for Disease Control and Prevention (CDC) that calls for expanded COVID-19 surveillance using PCR-based tests with turnaround times within 24-48 hours.
By performing the test directly from raw saliva and eliminating the need for equipment, materials, time and labor associated with nucleic acid extraction, the TaqCheck SARS-CoV-2 Fast PCR Assay helps labs meet the CDC turnaround time recommendations.
"Thermo Fisher scientists are continually working to answer the call as public and private institutions take proactive measures to protect their communities," said Mark Smedley, president of Genetic Sciences for Thermo Fisher Scientific. "The TaqCheck Fast PCR Assay breaks new ground and provides global communities access to affordable surveillance testing that is easy-to-implement and delivers trusted quality and reliability so they can manage the spread of COVID-19 and return to a sense of normalcy."
Direct from saliva PCR testing is already being implemented at the University of Illinois Urbana-Champaign (UIUC) to reduce the cost and complexity of on-campus testing. With its raw saliva direct to PCR protocol and comprehensive on-campus surveillance program, UIUC is currently processing more than 10,000 samples a day in as little as four hours.
UIUC is currently collaborating with Thermo Fisher to determine how the TaqCheck SARS-CoV-2 Fast PCR Assay could further improve UIUC's existing workflow. "The new assay produced highly correlative results with UIUC's current direct PCR testing and reduced thermocycling time by one-third," said Dr. Leyi Wang, clinical assistant professor who leads UIUC's COVID-19 data analysis and validation studies.
The TaqCheck Fast PCR Assay is ideal for institutions of higher learning with existing laboratories. Universities that do not have labs on campus can also benefit by partnering with third-party testing providers. These reference labs can leverage the assay's workflow to support significant increases in testing volume.
The TaqCheck SARS-CoV-2 Fast PCR Assay is available globally for research use only. Thermo Fisher plans to seek emergency use authorization (EUA) in the U.S. and CE-IVD in Europe in early 2021.
For more information on the TaqCheck SARS-CoV-2 Fast PCR Assay and Thermo Fisher's Safe Campus Reopening Program, please visit www.thermofisher.com/taqcheck.
About Thermo Fisher Scientific
Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $25 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, improving patient diagnostics and therapies or increasing productivity in their laboratories, we are here to support them. Our global team of more than 75,000 colleagues delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services and Patheon. For more information, please visit www.thermofisher.com.
New Quest Diagnostics Health Trends™ Survey Reveals COVID-19 Testing Hesitancy Among Americans, With 3 of 4 Avoiding a Test When They Believed They Needed One
9 December 2020 - Nationwide survey believed to be the first to reveal insights into U.S. consumer behaviors and attitudes toward COVID-19 testing and health effects since fall-winter COVID-19 wave began. Medical treatment delays and worsening chronic conditions during pandemic may lead to surge in non-COVID-19 health conditions, with nearly one-third (31%) of those living with a chronic health condition saying their health has gotten worse since pandemic began. Parents and women suffer disproportionate health impacts amid pandemic.
SECAUCUS, N.J., Dec. 9, 2020 -- A new Quest Diagnostics Health Trends™ study finds that three in four Americans who believed they needed a COVID-19 test (74%) chose not to get one, or delayed getting one, primarily due to concerns about exposure to the SARS-CoV-2 virus (30%).
The nationally representative survey was conducted online by The Harris Poll on behalf of Quest Diagnostics between November 10-12, 2020, among 2,050 U.S. adults. This survey is believed to be the first to evaluate attitudes about COVID-19's impact on medical care and testing since the recent fall-winter wave of COVID-19 cases began to sweep across the United States.
The findings suggest large numbers of Americans are putting off medical care they may need – including COVID-19 diagnostic lab tests as well as preventative and chronic care – due to fears and other barriers, with likely long-term consequences for patients and the U.S. healthcare system.
Among the key findings:
- Of those Americans who believed they needed a COVID-19 test, 74% chose not to get or delayed getting one. The primary reason was concern about exposure to the virus (30%); with others citing that they thought it was very unlikely they had COVID-19 (21%); concerns over having to quarantine while waiting for results or if they were positive (15%); and cost (15%). Lab testing for COVID-19 is an important tool in preventing COVID-19 disease spread, given that as many as 40% of infected individuals may lack symptoms and not know they are infected and able to pass the infection to others
- A larger proportion of Hispanic/Latinx adults (83%) vs. Whites (non-Hispanic) (72%) and Blacks (72%) chose to avoid or delayed getting a diagnostic COVID-19 test when they believed they needed one.
- Black Americans, who are overrepresented among America's essential workforce, who have been disproportionately affected by the pandemic and are more likely to be in essential jobs that put them at exposure risk, found greater access to testing even more important: specifically, 73% of Blacks compared to 55% of Whites feel greater access is "absolutely essential" or "very important" to slow the pandemic.
"Our Health Trends data show that while most Americans understand the vital role testing plays in helping to control the COVID-19 pandemic, people are scared of exposure to the virus. This fear keeps them from getting tested when they believe they needed it, and out of the doctor's office for routine care and treatment," said Harvey W. Kaufman, M.D., Senior Medical Director, Head of the Health Trends Research Program for Quest Diagnostics. "Those who are concerned about exposure should discuss their concerns with their healthcare provider or local health department, so that they can access a test, if appropriate, and other important health care services."
Delayed Health Care during Pandemic Could Lead to Surge of Chronic Disease and Non-COVID-19 Health Conditions and Emergencies
In the meantime, while they await a vaccine, Americans revealed deep concerns about undiagnosed and worsening chronic health conditions during the pandemic. Worries about exposure to the virus are at the top of the list of reasons why U.S. adults have avoided or delayed in-person health care (53%), but many of them also recognize that forgoing this care has now led to other health problems, like greater stress about a health condition (31%), delayed treatment (23%) or diagnosis (18%) and worsening symptoms (17%).
At the same time, Americans' reluctance to maintain routine or preventive medical visits due to the pandemic could lead to a wave of non-COVID-19 health conditions once the pandemic abates or a vaccine is distributed.
According to the findings:
- The majority of U.S. adults (60%) have skipped or delayed some in-person medical treatments or appointments during the COVID-19 pandemic, in particular, Hispanic/Latinx adults (67%) (compared to 59% White and 58% Black). About one in five Americans (22%) skipped or delayed blood work or lab testing specifically.
- Over a third of Americans do not plan to resume attending in-person medical treatments and appointments until the pandemic is under better control (39%) or until a vaccine is available (33%).
- One in two Americans (51%) said that only a severe illness or injury would motivate them to seek in-person medical care during the COVID-19 pandemic.
- Nearly one in three Americans who have a chronic health condition (31%) said their condition had gotten worse since the pandemic began and two in five Americans (41%) are somewhat/very concerned that they may currently have an undiagnosed health condition.
- Current attitudes toward delaying care are also supported by Quest Diagnostics lab data. According to other Health Trends™ research, the rate of cancer diagnoses across six common cancer types decreased by 46% between March 1 and April 18, 2020, during the COVID-19 pandemic. And the rate of diabetes (hemoglobin A1c) testing declined by as much as 66% during approximately the first two months of the pandemic, compared with the previous year.
Women and Parents Have Borne the Brunt of the Pandemic's Impact
More women than men say COVID-19 has negatively impacted their mental (49% of women vs. 36% of men), financial (42% vs. 37%) and physical health (33% vs. 26%).
Meanwhile, parents of children under 18 years of age are more likely to have delayed in-person medical treatment or appointments during the pandemic: 71% have delayed an appointment, compared to 54% of those who don't have children under age 18. Specifically, parents are more likely than those without children under age 18 to have delayed or skipped:
- An annual physical exam (31% vs. 22%)
- Blood work/lab testing (30% vs. 18%)
- Preventative vaccinations or screenings (24% vs. 12%)
Dr. Kaufman continued, "With a vaccine likely not making its way to the general public until spring at the earliest, the healthcare community needs to do a better job of helping Americans get back to routine care now. Early diagnosis can save lives and putting off preventative care and chronic disease treatment could make the difference between life and death. Chronic diseases take a toll on the body each day. Delays in diagnosis and treatment will cause, for many people, irreversible damage, require more aggressive and less effective treatments, and contribute to a higher death rate. As Benjamin Franklin advised, 'An ounce of prevention is worth a pound of cure.'"
Methodology
On behalf of Quest, The Harris Poll conducted an online survey of 2,050 adults 18 years and older across the United States from November 10-12, 2020. The survey sample included 337 Hispanic/Latinx, 265 Black and 1,278 White adults. Harris weighted figures for age by sex, region, education, household size, marital status and household income by race/ethnicity where necessary to make them representative of their actual proportions in the population. The Harris Poll is one of the longest running surveys in the U.S. tracking public opinion, motivations and social sentiment since 1963 that is now part of Harris Insights & Analytics, a global consulting and market research firm that delivers social intelligence for transformational times.
About Quest Diagnostics Health Trends™
Quest Diagnostics Health Trends™ is a series of scientific reports that provide insights into health topics, based on analysis of objective clinical laboratory data, to empower better patient care, population health management and public health policy. The reports are based on the Quest Diagnostics database of 48 billion de-identified laboratory test results, believed to be the largest of its kind in healthcare. Health Trends has yielded novel insights to aid the management of allergies and asthma, prescription drug monitoring, diabetes, Lyme disease, heart disease, influenza and workplace wellness. Quest Diagnostics also produces the Drug Testing Index (DTI)™, a series of reports on national workplace drug positivity trends based on the company's employer workplace drug testing data.
About COVID-19 testing at Quest Diagnostics
Quest Diagnostics is at the forefront of the response to the COVID-19 pandemic, working to broaden access to laboratory insights to help us all lead healthier lives. We provide both molecular diagnostic and antibody serology tests to aid in the diagnosis of COVID-19 and immune response. Through our team of dedicated phlebotomists, air fleet team, couriers and laboratory professionals, Quest Diagnostics works hard every day to help patients and communities across the United States access quality COVID-19 testing.
About Quest Diagnostics
Quest Diagnostics empowers people to take action to improve health outcomes. Derived from the world's largest database of clinical lab results, our diagnostic insights reveal new avenues to identify and treat disease, inspire healthy behaviors and improve health care management. Quest annually serves one in three adult Americans and half the physicians and hospitals in the United States, and our 47,000 employees understand that, in the right hands and with the right context, our diagnostic insights can inspire actions that transform lives. www.QuestDiagnostics.com
LabCorp Receives FDA Authorization to Make At-Home COVID-19 Collection Kits Available Through Retail
9 December 2020 - Pixel by LabCorp™ COVID-19 Test Home Collection Kit is first to receive FDA authorization for over-the-counter purchase
BURLINGTON, N.C., Dec. 9, 2020 -- LabCorp, a leading global life sciences company that is focused on advancing health and guiding patient care decisions, today announced that the U.S. Food and Drug Administration (FDA) granted Emergency Use Authorization (EUA) for the Pixel by LabCorp™ COVID-19 Test Home Collection Kit to become the first to be available over the counter without requiring a prescription. The kit is currently available through the Pixel by LabCorp website, and this approval will enable LabCorp to potentially distribute the kit through retail channels.
This authorization is the latest example of LabCorp’s commitment to increase access to COVID-19 testing. The kit allows consumers to self-collect their sample in the privacy of their own home, which helps minimize transmission of the virus. Users then send the sample for processing at LabCorp .
“With the first over-the-counter at-home collection kit ever authorized by the FDA for COVID-19, we are empowering people to learn about their health and make confident decisions,” said Dr. Brian Caveney, chief medical officer and president of LabCorp Diagnostics . “With this authorization, we can help more people get tested, reduce the spread of the virus and improve the health of our communities.”
Upon purchase, users register their Pixel by LabCorp COVID-19 collection kit at the Pixel by LabCorp website and follow the instructions included. Test results are securely delivered to the consumer via the Pixel by LabCorp portal. A healthcare provider will counsel consumers who test positive to assist with healthcare treatment and actions. The Pixel by LabCorp COVID-19 collection kit is not a substitute for visits to a healthcare professional and is for use in adults 18 and older.
Retailers interested in selling Pixel by LabCorp COVID-19 collection kits can contact the company at PixelPartners@LabCorp.com.
LabCorp’s COVID-19 PCR test has not been FDA cleared or approved, has been authorized by FDA under an Emergency Use Authorization (EUA), and has been authorized only for the detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens. The test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostic tests for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.
About LabCorp
LabCorp, an S&P 500 company, is a leading global life sciences company that is deeply integrated in guiding patient care, providing comprehensive clinical laboratory and end-to-end drug development services. With a mission to improve health and improve lives, LabCorp delivers world-class diagnostics solutions, brings innovative medicines to patients faster, and uses technology to improve the delivery of care. LabCorp reported revenue of more than $11.5 billion in 2019. To learn more about LabCorp , visit www.LabCorp.com.
Roche partners with Moderna to include SARS-CoV-2 antibody test in ongoing COVID-19 vaccine trials
9 December 2020 - Moderna’s vaccine triggers an antibody response to the SARS-CoV-2 spike protein. The Elecsys Anti-SARS-CoV-2 S test can quantitatively measure the level of antibodies against SARS-CoV-2 in vaccine trial participants and could help to establish correlation to protection from COVID-19. Emergency Use Authorisation by the US FDA for the Elecsys Ab test was granted on 25 Nov, 2020.
Basel, 9 December 2020 -- Roche today announced a partnership with Moderna Inc. to utilise the Elecsys® Anti-SARS-CoV-2 S antibody test in Moderna’s mRNA-1273 vaccine research trials. This will facilitate the quantitative measurement of SARS-CoV-2 antibodies and help to establish a correlation between vaccine-induced protection and levels of anti-receptor binding domain (RBD) antibodies. Significantly, Moderna’s vaccine triggers antibody response specifically to the RBD of the SARS-CoV-2 spike protein. This follows the recent announcement that Roche has received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) for the Elecsys® Anti-SARS-CoV-2 S antibody test.
“Roche values the collaboration with Moderna, which has already included the successful use of our qualitative Elecsys Anti-SARS-CoV-2 test, targeting the nucleocapsid protein, in an earlier part of the studies”, said Thomas Schinecker, CEO Roche Diagnostics. “We are pleased to see that our quantitative Elecsys SARS-CoV-2 S test, which targets the spike protein, is now also being used as part of the Moderna vaccine trials, which could ultimately help to end this pandemic.”
Measuring the quantitative levels of anti-RBD SARS-CoV-2 antibodies using Roche’s test will help Moderna to gain valuable insights into the correlation between protection from vaccination and antibody levels. This could play a role in assessing if, or when, an individual needs revaccination, or in helping to answer other clinically relevant questions.
To enhance our understanding of vaccines against SARS-CoV-2 there would be a benefit in knowing the starting levels of antibodies a person has, prior to vaccination, in order to evaluate any change in antibody levels that the vaccine induces. This is particularly relevant in the case of antibodies directed against the SARS-CoV-2 spike protein, since these antibodies have been shown to have potent antiviral activity and correlate to potential immunity. Measuring antibody levels can also play a role in establishing vaccine efficacy in the prevention of infection and/or the development of severe COVID-19.
This partnership with Moderna, started by using the Elecsys Anti-SARS-CoV-2 test for qualitative determination of anti-N SARS-CoV-2 antibodies. This has been part of Moderna’s vaccine trials for baselining and assessing natural infection in trial participants.
About potential SARS-COV-2 vaccines
Candidate vaccines, such as Moderna’s mRNA-1237, aim to induce an antibody response against the SARS-CoV-2 spike protein. Any potential vaccine for SARS-CoV-2 would work (amongst other mechanisms) by triggering the immune response to develop neutralising antibodies in the person receiving the vaccine. In doing so, the vaccine trains the body’s immune system to recognise and fight an exposure to SARS-CoV-2, in a controlled way, without being exposed to the actual virus.
About Elecsys Anti-SARS-CoV-2 S test
Elecsys® Anti-SARS-CoV-2 S is an immunoassay for the quantitative, in vitro determination of antibodies to SARS-CoV-2 in human serum and plasma. Through a blood sample, the test can measure the quantity of antibodies to the spike protein of the coronavirus. Specifically, the test targets antibodies which are directed against the particular region of the viral spike protein responsible for binding to the host cell receptor, which is required for the virus to enter the host cell.
The presence and level of such antibodies could signal whether a person has been already infected and potentially developed immunity to the virus.
This plays an important part in characterising a vaccine-induced immune response.2 The majority of current candidate vaccines aim to induce an antibody response against the spike protein.
About Elecsys Anti-SARS-CoV-2 test
Elecsys Anti-SARS-CoV-2 is an immunoassay for the qualitative, in vitro detection of antibodies (including IgG) to SARS-CoV-2. The test can detect antibodies to the coronavirus, which could signal whether a person has been already infected and potentially developed immunity to the virus. This test can also help in the determination of seroprevalence (i.e. the frequency of individuals with antibody to the virus), in a given population, as well as a complement test to Nucleic Acid Amplification Tests (NAAT) for the diagnosis of SARS-CoV-2 infection.
Hospitals and reference laboratories can run both the tests on Roche’s cobas e analysers which are widely available around the world. These fully-automated systems can provide SARS-CoV-2 test results in approximately 18 minutes, with a test throughput of up to 300 tests/hour, depending on the analyser.
About Roche’s response to the COVID-19 pandemic
As a leading healthcare company we are doing all we can to support countries in minimising the impact of COVID-19. We have developed a growing number of diagnostic solutions that help to detect and diagnose the infection in patients, as well as providing digital support to healthcare systems, and we continue to identify, develop and support potential therapies which can play a role in treating the disease.
We understand the impact of COVID-19 goes beyond those who contract it, which is why we are working with healthcare providers, laboratories, authorities and organisations to help make sure that patients continue to receive the tests, treatment and care they need during these challenging times. As we learn from the pandemic, we are partnering with governments and others to make healthcare stronger and more sustainable in the future.
Our diagnostics solutions:
Reliable, high-quality testing is essential to help healthcare systems overcome this pandemic. Our portfolio includes:
- a high-volume molecular test to detect SARS-CoV-2, the virus that causes COVID-19, (FDA Emergency Use Authorisation (EUA) and available in countries accepting the CE Mark)
- a SARS-CoV-2 laboratory-based antibody test, aimed at detecting the presence of antibodies in the blood targeting the nucleocapsid (FDA EUA and CE Mark)
- an IL-6 test to assist in identifying severe inflammatory response in patients with confirmed COVID-19 (FDA EUA and CE Mark)
- Roche v-TAC, which could help simplify the screening, diagnosis and monitoring of patients with respiratory compromise in the current COVID-19 pandemic
- a SARS-CoV-2 rapid antibody test to help determine at the point of care whether a person has been exposed to the virus (CE Mark)
- a rapid antigen test to support in the detection of SARS-CoV-2 at the point of care within 15 minutes (CE Mark)
- a high-volume molecular test to simultaneously detect and differentiate between SARS-CoV-2 and influenza A/B, as the symptoms are similar for both (FDA EUA and CE Mark)
- a second SARS-CoV-2 antibody test, aimed at measuring the spike protein to support vaccination development and complement our existing portfolio
- a point-of-care molecular PCR test that simultaneously detects and differentiates between SARS-CoV-2 and influenza A/B infections to support urgent triage and diagnosis (FDA EUA and CE Mark)
Our research into therapies:
Roche is committed to improving the treatment of COVID-19. We are actively involved in understanding the potential of our existing portfolio and are exploring the potential of our investigational molecules.
In August we signed a collaboration agreement with Regeneron on developing and manufacturing and significantly increasing global supply of an investigational antibody combination for COVID-19 if it proves safe and effective in clinical trials and regulatory approvals are granted. We are also partnering with Atea to jointly develop AT-527, an orally administered direct-acting antiviral (DAA) currently in Phase 2 clinical trials. If approved, Atea will distribute AT-527 in the United States and Roche will be responsible for global manufacturing and distribution outside the United States.
At the beginning of the pandemic, on 19 March on 19 March, we announced the initiation of COVACTA - a global Phase III randomised, double-blind, placebo-controlled clinical trial to evaluate the safety and efficacy of intravenous Actemra©/RoActemra© (tocilizumab) plus standard of care in hospitalised adult patients with severe COVID-19 pneumonia compared to placebo plus standard of care. On 29 July we announced that COVACTA did not meet its primary endpoint of improved clinical status in patients with COVID-19 associated pneumonia or the key secondary endpoint of reduced mortality.
Separately, we have studied Actemra©/RoActemra© in the EMPACTA study in COVID-19 associated hospitalised pneumonia in patients that are often underrepresented in clinical trials. On 18 September we announced that the phase III EMPACTA study showed Actemra/RoActemra plus standard of care reduced the likelihood of progression to mechanical ventilation or death in hospitalised patients with COVID-19 associated pneumonia compared to placebo plus standard of care. However, there was no statistical difference in mortality between patients who received Actemra/RoActemra or placebo.
Actemra©/RoActemra© is also being studied in combination with the investigational antiviral remdesivir in hospitalised patients with severe COVID-19 pneumonia in the REMDACTA trial in partnership with Gilead, announced 28 May. Actemra©/RoActemra© is not approved by any health authority for use in COVID-19 pneumonia. Roche has further initiated an internal early research programme focused on the development of medicines for COVID-19 and is engaged in multiple research collaborations.
In these exceptional times, Roche stands together with governments, healthcare providers and all those working to overcome the pandemic.
About Roche
Roche is a global pioneer in pharmaceuticals and diagnostics focused on advancing science to improve people’s lives. The combined strengths of pharmaceuticals and diagnostics under one roof have made Roche the leader in personalised healthcare – a strategy that aims to fit the right treatment to each patient in the best way possible.
Roche is the world’s largest biotech company, with truly differentiated medicines in oncology, immunology, infectious diseases, ophthalmology and diseases of the central nervous system. Roche is also the world leader in in vitro diagnostics and tissue-based cancer diagnostics, and a frontrunner in diabetes management.
Founded in 1896, Roche continues to search for better ways to prevent, diagnose and treat diseases and make a sustainable contribution to society. The company also aims to improve patient access to medical innovations by working with all relevant stakeholders. More than thirty medicines developed by Roche are included in the World Health Organization Model Lists of Essential Medicines, among them life-saving antibiotics, antimalarials and cancer medicines.
Moreover, for the twelfth consecutive year, Roche has been recognised as one of the most sustainable companies in the Pharmaceuticals Industry by the Dow Jones Sustainability Indices (DJSI).
The Roche Group, headquartered in Basel, Switzerland, is active in over 100 countries and in 2019 employed about 98,000 people worldwide. In 2019, Roche invested CHF 11.7 billion in R&D and posted sales of CHF 61.5 billion. Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan. For more information, please visit www.roche.com.
Reference: https://www.roche.com/media/releases/med-cor-2020-12-09.htm
Ro and Quest Diagnostics Partner to Offer Lab Testing Through Ro's Vertically Integrated Primary Care Platform
8 December 2020 - Quest’s industry-leading lab expertise will support Ro’s expansion in the treatment and management of chronic and complex conditions requiring diagnostic data
NEW YORK, NY and SECAUCUS, NJ, December 8, 2020 -- Ro, the healthcare technology company, and Quest Diagnostics, the nation’s leader in diagnostic information services, today announced a strategic partnership to add diagnostic capabilities and lab testing to Ro's vertically integrated primary care platform. The partnership will support Ro’s expansion in the treatment and management of chronic and complex medical conditions facilitated on its platform.
Quest Diagnostics is the first diagnostic services provider to collaborate with Ro to help patients manage chronic conditions through virtual and in-home care. As the leading provider of diagnostic information services, Quest provides thousands of laboratory screening and diagnostic test services and operates 2,200 patient service centers where individuals can provide lab samples across the United States.
This partnership complements Ro’s recent acquisition of Workpath, a software platform that enables on-demand, in-home care. The acquisition allows Ro to seamlessly integrate virtual and in-person care and send healthcare professionals to a patient’s home for blood draws, vaccinations and more. All diagnostic tests for Ro patients will be processed by Quest Diagnostics, and patients will be able to have blood draws performed in their home through Ro’s integration with Workpath or at a Quest Diagnostics facility.
Initial Quest Diagnostics services offered through Ro will focus on hormone testing, including total testosterone and PSA. The addition of diagnostic testing services is expected to dramatically expand the range of services Ro can provide, for example treatment for hypothyroidism, STIs, diabetes, and hyperlipidemia.
“Seventy percent of medical decisions are based on lab results, and many patients need ongoing diagnostic data and provider guidance to manage their conditions,” said Melynda Barnes, MD, SVP of Medical Affairs and Research of Ro. “This partnership permits physicians and patients on Ro’s platform to have access to these critical diagnostic services, allowing for the treatment of increasingly complex conditions through Ro, and encourages ongoing patient-provider engagement.”
“At Quest Diagnostics, we recognize that healthcare is becoming more and more consumer-driven,” said Cathy Doherty, senior vice president and group executive, clinical franchise solutions and marketing, Quest Diagnostics. "Ro has created a virtual care model that does what any good healthcare provider does but few health technology companies do well: foster intimacy and trust with each patient. Through our industry-first relationship, Quest will add quality diagnostic insights to the proven Ro model, so more people can access care for a broader array of medical conditions when and where they need it most.”
Ro patients will be able to access and discuss their lab results and treatment plan with their provider at any time. With this partnership, Ro seamlessly connects a patient’s doctor, pharmacy, and diagnostics, facilitating end-to-end care from diagnosis to the delivery of medication to ongoing care.
About Ro
Ro is the healthcare technology company building a patient-centric healthcare system. Ro’s vertically integrated primary care platform powers a personalized, end-to-end healthcare experience from diagnosis, to delivery of medication, to ongoing care. With a nationwide provider network, in-home care API, and proprietary pharmacy distribution centers, Ro seamlessly connects telehealth, diagnostics, and pharmacy services to provide high-quality, affordable healthcare without the need for insurance. Since 2017, Ro has facilitated more than five million digital healthcare visits in nearly every county in the United States, including 98% of primary care deserts. Visit Ro.co for more information.
About Quest Diagnostics
Quest Diagnostics empowers people to take action to improve health outcomes. Derived from the world's largest database of clinical lab results, our diagnostic insights reveal new avenues to identify and treat disease, inspire healthy behaviors and improve health care management. Quest annually serves one in three adult Americans and half the physicians and hospitals in the United States, and our 47,000 employees understand that, in the right hands and with the right context, our diagnostic insights can inspire actions that transform lives. www.QuestDiagnostics.com
Quest’s Commitment to Consumer Empowered Health
Quest Diagnostics has long been at the forefront of the movement for consumer empowerment in healthcare. The company was among the first diagnostic information services providers to offer free access to test results online and other channels. Its mobile app and patient portal, called MyQuest, provides millions of people a way to securely access and track their test results and other health data. The company's QuestDirect service provides dozens of tests for conditions ranging from heart health and sexually transmitted diseases. For added convenience, the company now offers at-home self-collection devices for tests including COVID-19 active infection, diabetes, and hormones. Through its collaborations with Safeway and Walmart, Quest Diagnostics operates approximately 200 patient service centers in retail store locations, for the utmost in convenient access. Quest Diagnostics also provides next generation sequencing and genotyping services for Ancestry.
Reference: https://newsroom.questdiagnostics.com/press-releases?item=137231
Thermo Fisher Scientific Gains CE Mark Certification for New OmniPATH Combi SARS-CoV-2 IgG ELISA Test
8 December 2020 - Quantifying IgG is critical component to test population-wide vaccination effectiveness
DARTFORD, UK, December 8, 2020 -- Thermo Fisher Scientific, the world leader in serving science, has secured CE Mark certification for the Thermo Scientific OmniPATH Combi SARS-CoV-2 IgG ELISA test. The test is intended for the quantitative measurement of immunoglobulin G (IgG) antibodies raised against the spike protein of the SARS-CoV-2 virus to aid clinicians in identifying patients with an immune response pre- and post-vaccination.
The ability to quantify IgG is a critical component to understanding an individual’s immune response to the SARS-CoV-2 virus, especially as we start to vaccinate the population. Having quantitative data on neutralizing antibodies will enable better understanding of a person’s immune response following exposure to the COVID-19 virus and support monitoring of the effectiveness of vaccines as they become available.
Dr. Sarah Walker, Professor of Medical Statistics and Epidemiology at the University of Oxford and Chief Investigator of the National COVID-19 infection survey said: “Using this test within the COVID-19 Infection Survey allows us to answer vital questions about the role of previous infection and varying levels of antibody response in protecting people from getting infected again in the future. As we follow individuals over the course of a year, we are repeatedly testing them for both virus and antibodies.”
Thermo Fisher joined forces with the University of Oxford to harness their academic research capabilities in identifying the spike protein. This, coupled with Thermo Fisher’s manufacturing capability and immunoassay expertise, enabled the development of both a 96 and a 384 microplate assay format. The 384-well microplate assay is compatible with a newly developed automation system, designed by Thermo Fisher and enables the Oxford Univeristy to deliver COVID-19 testing capacity of up to 50,000 tests per day.
“Thermo Fisher Scientific is proud to have developed and delivered this CE marked product in collaboration with Oxford University,” said Mark Stevenson, executive vice president and chief operating officer at Thermo Fisher Scientific. “Combining the academic research capabilities of world recognized scientists at Oxford University with Thermo Fisher’s Dartford UK development and manufacturing facility has expanded our serology portfolio for improved COVID-19 epidemiological studies.”
Thermo Fisher’s new fully automated testing platform is already in use by Oxford University to provide weekly UK-wide data to the Office of National Statistics as part of the national COVID-19 Infection Survey. In addition, the equipment further enhances Oxford’s capacity to accurately quantify a patient’s vaccine response as part of the ongoing Oxford coronavirus vaccine clinical trial.
This new OmniPATH Combi SARS-CoV-2 IgG ELISA test assay is an extension of Thermo Fisher’s COVID-19 antibody test portfolio. In October, the company launched the OmniPATH COVID-19 Total Antibody ELISA test for qualitative detection of total antibodies to SARS-CoV-2, including immunoglobulin M (IgM), immunoglobulin A (IgA) and IgG.
About Thermo Fisher Scientific
Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding
$25 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, improving patient diagnostics and therapies or increasing productivity in their laboratories, we are here to support them. Our global team of more than 75,000 colleagues delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services and Patheon. For more information, please visit www.thermofisher.com.
Reference: https://thermofisher.mediaroom.com/press-releases?item=123524
LGC's Anti-SARS-CoV-2 controls kit now CE Marked
8 December 2020
8 December 2020 -- LGC is pleased to announce that the ACCURUN® Anti-SARS-CoV-2 Reference Material Kit is now CE marked for in vitro diagnostic use (CE-IVD).
With this change in regulatory status, the new product name is ACCURUN Anti-SARS-CoV-2 Controls Kit. Bearing the CE mark and IVD symbol signifies that the ACCURUN Anti-SARS-CoV-2 Controls Kit meets extensive design control requirements.
ACCURUN controls are specifically formulated to exhibit low-positive reactivity in true patient-like matrices, to test assay performance near critical signal cutoff boundaries. The ACCURUN Anti-SARS-CoV-2 Controls Kit is offered in two configurations, one designed for IgG-specific assays and the other for total antibody tests. Both products are designed to measure day-to-day assay performance and contain positive materials for antibodies against the SARS-CoV-2 virus as well as complementary negative materials.
Michael Sweatt, Executive Vice President, Clinical Diagnostics, LGC, stated, “We remain steadfast in our mission to supply the diagnostic community with dependable infectious disease quality solutions, ensuring clinical laboratories have the tools necessary to be able to report accurate and reliable patient results – during the COVID-19 pandemic and beyond.”
To learn more about the ACCURUN Anti-SARS-CoV-2 Controls Kits as well as the complete line of SARS-CoV-2 Molecular & Serology Quality Solutions, please visit the SeraCare website.
Reference: https://www.lgcgroup.com/newsroom-and-blog/news-and-blog/anti-sars-cov-2-controls-kit-ce-marked/
QIAGEN to launch QuantiFERON SARS-CoV-2 for research into causes, spread and control of COVID-19 through T-cell response
7 December 2020 - T-cell response has the potential to give a clearer picture of immunity and course of illness. T-cell response to SARS-CoV-2 may decline less rapidly than antibodies. Potentially vital tool for research into immune response and vaccination efficacy.
Hilden, Germany and Germantown, Maryland, December 7, 2020 – QIAGEN N.V. announced today the launch of its QuantiFERON SARS-CoV-2 RUO solution that can detect T-cell responses of the human immune system to the pathogen that causes COVID-19, which could help researchers find out more about immunity levels and disease progression.
Studies suggest that T-cell response to SARS-CoV-2 declines much more slowly than antibody response, which presents several benefits to researchers who want to push beyond the existing detection of active infections to screen for potential courses of the illness and long-term immune responses to it. QIAGEN’s QuantiFERON SARS-CoV-2 Research Use Only (RUO) solution could be a valuable tool in this research.
There is also growing evidence that T-cell response gives a reliable indication of how severe the course of an illness triggered by SARS-CoV-2 will be in infected patients, and how immune those who have recovered remain months – possibly even years – after having been infected.
QuantiFERON SARS-CoV-2 RUO is a flexible, modular system designed to meet a wide range of research demands. It is based on QIAGEN’s easy-to-use QuantiFERON technology, pioneered in the QuantiFERON-TB Gold Plus test for latent tuberculosis and recognized worldwide for its ability to detect interferon gamma that T-cells release upon contact with certain pathogens.
QuantiFERON SARS-CoV-2 RUO is a crucial addition to QIAGEN’s growing COVID-19 portfolio that already provides sample-preparation technology, infection testing with polymerase chain reaction (PCR) technology, antibody and antigen tests, enzymes and automation solutions.
“Research suggests that testing T-cell response could provide valuable insights into the novel coronavirus and how our immune system responds to it,” said Thierry Bernard, CEO of QIAGEN. “The more we know about the novel coronavirus, the better equipped the world will be to stop the pandemic,” he said. “We are excited about our QuantiFERON technology potentially helping researchers understand illness pathways and also immune responses that are crucial for vaccine development and deployment.”
QuantiFERON SARS-CoV-2 RUO will initially comprise a Starter Set and a Monitor Direct package for separate or combined research use. Both are made up of the QuantiFERON blood collection tubes with their proprietary stimulation principle and the QuantiFERON detection system to measure the resulting interferon-gamma. They use a tried-and-tested combination of flexible blood collection workflow with innovative CD4/CD8 T-cell technology. An additional component of the QuantiFERON SARS-CoV-2 RUO solution is also being developed in partnership with TScan Therapeutics, a US-based biopharmaceutical company, target specific so-called immunodominant SARS-CoV-2 epitopes they have identified.
About QIAGEN
QIAGEN N.V., a Netherlands-based holding company, is the leading global provider of Sample to Insight solutions that enable customers to gain valuable molecular insights from samples containing the building blocks of life. Our sample technologies isolate and process DNA, RNA and proteins from blood, tissue and other materials. Assay technologies make these biomolecules visible and ready for analysis. Bioinformatics software and knowledge bases interpret data to report relevant, actionable insights. Automation solutions tie these together in seamless and cost-effective workflows. QIAGEN provides solutions to more than 500,000 customers around the world in Molecular Diagnostics (human healthcare) and Life Sciences (academia, pharma R&D and industrial applications, primarily forensics). As of September 30, 2020, QIAGEN employed more than 5,300 people in over 35 locations worldwide. Further information can be found at http://www.qiagen.com.
Reference: https://corporate.qiagen.com/newsroom/press-releases/2020/20201207_qfn_sars_cov_2
Roche receives FDA Emergency Use Authorization for new test to measure the level of SARS-CoV-2 antibodies
2 December 2020 - Elecsys® Anti-SARS-CoV-2 S test specifically detects antibodies against the SARS-CoV-2 spike protein. The spike protein is the target of many COVID-19 vaccines in development. This test may help identify recovering patients who could potentially be serum and plasma donors for developing treatments for COVID-19.
Basel, 2 December 2020 -- Roche today announced that its Elecsys® Anti-SARS-CoV-2 S antibody test has received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA). The serology (blood) test can be used to measure the level of antibodies in people who have been exposed to the SARS-CoV-2 virus. The EUA in the United States follows the launch of the Elecsys® Anti-SARS-CoV-2 S antibody test for markets accepting the CE Mark announced on 18 September.
The new test targets antibodies that are directed against the region of the novel coronavirus known as the spike protein, specifically the area that enables the virus to bind to a host cell receptor, which is required for the virus to enter the host cell. Many current candidate vaccines aim to induce an antibody response against the SARS-CoV-2 spike protein. Tests that quantify antibodies to the spike protein could be used to measure the level of that response and track that measurement over time. The test provides a numerical result describing the concentration of antibodies from 0.40-250 U/mL as well as a qualitative result.
“Since the start of this pandemic, our focus has been to bring effective diagnostic testing solutions to the fight against COVID-19,” said Thomas Schinecker, CEO of Roche Diagnostics. “Antibody tests like these will play a critical role in measuring a person’s vaccine-induced immune response”.
In addition to its role in helping to measure a patient’s immune response, the test may help guide the allocation of plasma donations from recovered COVID-19 patients to current patients by identifying donors that have antibodies to SARS-CoV-2 virus. Convalescent plasma therapy is an investigational procedure that separates and removes the plasma from a patient’s blood. This plasma is then replaced with plasma from a donor to give the ill patient antibodies to help fight the virus.
The laboratory-based Elecsys Anti-SARS-CoV-2 S test runs on Roche’s widely available cobas e analyzers and is the latest addition to Roche’s growing diagnostic portfolio to help healthcare systems combat COVID-19 through testing in the laboratory and at the point of care. Currently, this portfolio includes molecular, serology and digital solutions that help healthcare professionals diagnose COVID-19 and provide optimal patient care during the initial stages of infection and the recovery phase, as well as following the resolution of infection.
About SARS-CoV-2
Coronaviruses (CoV) are a large family of viruses that cause illness ranging from the common cold to more severe diseases such as Middle East Respiratory Syndrome (MERS-CoV) and Severe Acute Respiratory Syndrome (SARS-CoV). The novel coronavirus (SARS-CoV-2) is a new strain which has not previously been identified in humans.
Signs of infection include respiratory symptoms such as cough, shortness of breath, difficulty breathing and fever. In more severe cases, pneumonia, severe acute respiratory syndrome, kidney failure and death can occur.
About the Elecsys® Anti-SARS-CoV-2 S test
The Elecsys® Anti-SARS-CoV-2 S test is an immunoassay for the in vitro determination of antibodies to SARS-CoV-2. Through a blood sample, the test can measure antibodies to the spike protein of the coronavirus, which could signal whether a person has been already infected. The test has both a high negative percent agreement (NPA) of 99.98% (N=5991) and positive percent agreement (PPA) of 96.6% (N=233), 15 days or later after diagnosis with a PCR test. With this test, Roche also showed titer development over time for patient samples ranging >100 days following a reactive PCR result, with no samples showing a decline of titers below the reactive range. Additionally, across panels of potentially cross-reactive samples (N=1100) from endemic human coronaviruses, infectious respiratory diseases, other infectious diseases, auto-immune and liver related diseases, the test demonstrated zero cross-reactivity. This test has been authorized only for the presence of antibodies against SARS-CoV-2, not for any other viruses or pathogens.
Clinical laboratories can run these tests on Roche’s cobas e analyzers which are widely available around the world. These fully automated systems can provide antibody test results in approximately 18 minutes, with a test throughput of up to 300 tests/hour, depending on the analyzer.
About Roche’s response to the COVID-19 pandemic
To address the global COVID-19 healthcare crisis, Roche has developed a growing number of diagnostic solutions that help detect and diagnose the infection in patients, as well as providing digital support to healthcare systems. Roche also continues to identify, develop and support potential therapies that can play a role in treating the disease.
Reliable, high-quality testing is essential to help healthcare systems overcome this pandemic. Roche continues to work with healthcare providers, laboratories, authorities and organizations to help make sure that patients continue to receive the tests, treatment and care they need during these challenging times.
The Roche portfolio of COVID-19 solutions includes:
- a high-volume molecular test to detect SARS-CoV-2, the virus that causes COVID-19, (FDA Emergency Use Authorization (EUA) and available in countries accepting the CE Mark)
- a SARS-CoV-2 laboratory-based antibody test, aimed at detecting the presence of antibodies in the blood targeting the nucleocapsid (FDA EUA and CE Mark)
- an IL-6 test to assist in identifying severe inflammatory response in patients with confirmed COVID-19 (FDA EUA and CE Mark)
- a high-volume molecular test to simultaneously detect and differentiate between SARS-CoV-2 and influenza A/B, as the symptoms are similar for both (FDA EUA and CE Mark)
- a second SARS-CoV-2 antibody test, aimed at measuring antibody response to the spike protein, to help assess a patient’s immune response and support the development of convalescent plasma therapy
- a point-of-care molecular PCR test that simultaneously detects and differentiates between SARS-CoV-2 and influenza A/B infections to support urgent triage and diagnosis (FDA EUA and CE Mark)
About Roche
Roche is a global pioneer in pharmaceuticals and diagnostics focused on advancing science to improve people’s lives. The combined strengths of pharmaceuticals and diagnostics under one roof have made Roche the leader in personalised healthcare – a strategy that aims to fit the right treatment to each patient in the best way possible.
Roche is the world’s largest biotech company, with truly differentiated medicines in oncology, immunology, infectious diseases, ophthalmology and diseases of the central nervous system. Roche is also the world leader in in vitro diagnostics and tissue-based cancer diagnostics, and a frontrunner in diabetes management.
Founded in 1896, Roche continues to search for better ways to prevent, diagnose and treat diseases and make a sustainable contribution to society. The company also aims to improve patient access to medical innovations by working with all relevant stakeholders. More than thirty medicines developed by Roche are included in the World Health Organization Model Lists of Essential Medicines, among them life-saving antibiotics, antimalarials and cancer medicines. Moreover, for the twelfth consecutive year, Roche has been recognised as one of the most sustainable companies in the Pharmaceuticals Industry by the Dow Jones Sustainability Indices (DJSI).
The Roche Group, headquartered in Basel, Switzerland, is active in over 100 countries and in 2019 employed about 98,000 people worldwide. In 2019, Roche invested CHF 11.7 billion in R&D and posted sales of CHF 61.5 billion. Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan. For more information, please visit www.roche.com.
Reference: https://www.roche.com/media/releases/med-cor-2020-12-02.htm
Abbott's FreeStyle Libre 2 now approved for adults and children with diabetes in Canada, featuring unsurpassed 14-day accuracy and optional alarms
2 December 2020 - FreeStyle Libre 2 system continuously measures glucose data every minute with customizable, optional real-time alarms to alert users when their glucose is high or low without scanning. Now for children (ages 4 and older) and adults with diabetes, this latest technology sustains excellent performance for up to 14 days, providing trends, insights and actionable data on a reader or with the FreeStyle LibreLink mobile app – all at the same price as the current FreeStyle Libre system. Latest sensor-based glucose monitoring technology will be available in the coming months to the more than 3.7 million Canadians with diabetes.
ABBOTT PARK, Ill., Dec. 2, 2020 -- Abbott today announced its next-generation, sensor-based glucose monitoring technology, FreeStyle Libre 2, received approval by Health Canada for adults and children (4 and older) with diabetes. With new features such as optional, real-time alarms1 that measure glucose levels every minute, FreeStyle Libre 2 gives users the option to be alerted in real-time of critical events such as hypoglycemia (low glucose levels) or hyperglycemia (high glucose levels). The wearable technology, which eliminates the need for painful fingersticks, also provides people with diabetes with excellent accuracy and actionable information to better manage their condition, and will be priced at the same cost as the current FreeStyle Libre system.
"For the millions of Canadians with diabetes, Abbott's next-generation FreeStyle Libre 2 system expands on the life-changing capabilities of our original FreeStyle Libre system with enhanced accuracy, optional alarms and now available for children," said Marie-Flore Nabor, general manager of Abbott's diabetes care business in Canada. "This latest technology will transform the way diabetes is currently managed. The FreeStyle Libre 2 is designed to simplify this often complicated-to-manage condition and is accessible and affordable to people with diabetes in Canada."
How FreeStyle Libre 2 Works
As the world leader in sensor-based glucose monitoring, Abbott continues to transform how people with diabetes test their glucose levels. Using Bluetooth technology, the FreeStyle Libre 2 system automatically alerts users when their glucose is high or low without needing to scan the sensor.
The FreeStyle Libre 2 sensor is worn on the back of the upper arm for up to 14 days and measures glucose every minute to help users and their healthcare providers make informed treatment decisions. With a one-second scan using FreeStyle LibreLink, a smartphone app, or handheld reader, users can see their glucose reading, trend arrow and eight-hour history. Users can also share data with their physicians or family members via the LibreLinkUp mobile app.
Abbott′s FreeStyle Libre 2 system utilizes the same proprietary wired enzyme technology as the FreeStyle Libre system, which was the first to remove painful fingersticks and is associated with better glucose control, decreased time in hypoglycemia and hyperglycemia, more time in optimal glucose range, and improved HbA1C. A real-world study published in the British Medical Journal shows that the use of FreeStyle Libre system over one year is often associated with improved quality of life and that work absenteeism rate and diabetes-related hospital admissions decreased by two thirds.
"Adding an alarm to this glucose sensing technology is definitely a major step to help people with diabetes live more confidently with less fear of high or low glucose levels," said Dr. Bruce Perkins, M.D., Director, Leadership Sinai Centre for Diabetes and Clinician-Scientist, University of Toronto. "We have seen from research with similar technologies that this kind of innovation can improve glucose level control, and even prevent emergency room visits and hospitalizations. For kids and adults alike, it means less pain from fingersticks, much greater insight into patterns, and much more reassurance."
Abbott′s FreeStyle Libre 2 system will be available for people with diabetes ages 4 and up in Canada in the coming months.
As the #1 sensor-based glucose monitoring system used worldwide,6 Abbott's FreeStyle Libre portfolio has changed the lives of more than 2.5 million people across more than 50 countries. Abbott has also secured partial or full reimbursement for the FreeStyle Libre system in 37 countries, including Canada where residents of Ontario and Quebec who manage diabetes with insulin are covered. Other countries include France, Germany, Japan, the United Kingdom, and the U.S.
About Abbott
Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 107,000 colleagues serve people in more than 160 countries.
Charnwood Lighthouse Lab Goes Live Processing Thousands of COVID-19 Tests per Day with PerkinElmer Solutions
30 November 2020 - UK’s newest Lighthouse Lab boosts the country’s COVID-19 testing capacity, while generating hundreds of new local jobs
WALTHAM, Mass., November 30, 2020 – PerkinElmer, Inc., announced today the Lighthouse Lab in Charnwood, Loughborough, England is now processing COVID-19 testing samples as part of the Company’s collaboration with the Department of Health and Social Care (DHSC) in support of the UK Government’s NHS Test and Trace program.
The facility, operated by PerkinElmer Genomics, began processing samples today, and with its team of 400 scientists, researchers, technicians and operations personnel, has the capacity to test up to 50,000 samples daily by early 2021.
The Lighthouse Lab at Charnwood Campus is the result of a collaboration between the DHSC and PerkinElmer, which has been engaged to equip, staff, and manage the facility using PerkinElmer’s proprietary COVID-19 kits, diagnostic equipment, and industry leading workflow solutions.
Commenting on the launch of the Lighthouse Lab, PerkinElmer’s Managing Director for UK & Ireland, Miles Burrows, said: “PerkinElmer’s ability to draw on expertise from our operations across the globe has enabled us to rapidly build a facility that will apply our best-in-class technologies to efficiently test individuals and identify those carrying the virus. In addition to assisting the DHSC to ramp up the nation’s testing capacity, this lab has created hundreds of new jobs locally. This has allowed us to develop and deploy a team who are ready to play such an essential role in managing this pandemic.”
This experienced team will enable the facility to operate 24 hours per day. The Lighthouse Lab in Charnwood has created opportunities for graduates and those who are pursuing careers in the life sciences to start their careers at the forefront of delivering the UK’s national testing program.
Health Minister Lord Bethell said: “I am delighted the new Lighthouse Lab in Charnwood is now up and running. The lab is part of Britain’s largest ever network of diagnostic testing facilities and will support our strategy to stop the spread of the virus by helping us boost testing capacity and speed-up turnaround times.
“I’d like to thank everyone involved in the Charnwood lab who will play such an integral role in helping people get their test results as quickly as possible. The sooner test results are received, the sooner we can take swift action to trace the contacts of those people who test positive, and the sooner those who test negative can get back to normal life.”
Charnwood is the second Lighthouse Lab to be brought online by PerkinElmer on behalf of the DHSC. In October, the global diagnostics and life sciences leader opened the first of its COVID-19 testing operations in Newport, South Wales, which processes thousands of test samples per day.
Interim Executive Chair of the National Institute for Health Protection Baroness Dido Harding said: “Testing capacity for those with COVID-19 symptoms has increased almost five-fold in six months, from 100,000 a day at the end of April to 500,000 a day by the end of October, but we are not stopping there.
“Charnwood Lighthouse Lab is an important part of our growing network of labs that are working together to extend and improve testing across the whole country. I would like to congratulate everyone involved for their hard work in getting the lab up and running so quickly.”
In addition to creating and operating facilities for the Lighthouse Lab network, PerkinElmer also supplies testing capabilities, equipment and reagents to NHS Trusts across the UK.
Gosia Khrais, the director for Charnwood Campus, said: “I would like to welcome Department of Health and Social Care and PerkinElmer as new occupiers on the site. The addition of the DHSC and PerkinElmer to the stronghold of science-driven organizations here is fantastic news for Charnwood and our local economy. It would not have happened without an effort of a number of stakeholders, our local Council and MP, as well as of the committed design and construction team that delivered this fast-paced project on time.”
PerkinElmer is utilizing its chemagic™ 360 instruments and JANUS® G3 PCR+ Workstations in these UK labs to automate PerkinElmer’s RNA extraction and RT-PCR tests. This total workflow solution enables rapid sample processing at higher volumes, helping to decrease turnaround time. PerkinElmer’s OneSource® services and PerkinElmer Genomics operations enable this turnkey approach to provide sample testing in order to meet the Government’s immediate and future COVID-19 testing requirements.
About PerkinElmer
PerkinElmer enables scientists, researchers, and clinicians to address their most critical challenges across science and healthcare. With a mission focused on innovating for a healthier world, we deliver unique solutions to serve the diagnostics, life sciences, food, and applied markets. We strategically partner with customers to enable earlier and more accurate insights supported by deep market knowledge and technical expertise. Our dedicated team of about 13,000 employees worldwide is passionate about helping customers work to create healthier families, improve the quality of life, and sustain the wellbeing and longevity of people globally. The Company reported revenue of approximately $2.9 billion in 2019, serves customers in 190 countries, and is a component of the S&P 500 index. Additional information is available through 1-877-PKI-NYSE, or at www.perkinelmer.com.
LGC’s high-throughput PCR testing system for SARS-CoV-2 detection, submitted for Emergency Use Authorisation, capable of processing up to 35,000 tests per day
30 November 2020
30 November 2020 -- LGC’s high-throughput (HTP) RT-PCR testing system for SARS-CoV-2 has been submitted to the FDA for Emergency Use Authorisation (EUA). Testing labs can now leverage LGC’s unrivalled expertise in automated sample preparation and high-throughput RT-PCR workflows in a ready-to-deploy solution.
As the need for SARS-CoV-2 testing for both diagnostic and screening applications continues to grow, many organisations are looking to expand or create testing capacity. LGC’s high-throughput RT-PCR workflow can expand capacity by running up to 35,000 tests per day with one scalable testing system.
Mark Dearden, Managing Director, LGC Genomics, said, “We are grateful that the FDA is reviewing our SARS-CoV-2 testing system. LGC has been involved in the response to the COVID-19 pandemic since January. We know that large-scale and frequent testing is a key epidemiological response to help manage the spread of the virus and to assess positivity rates in communities. The benefits of being able to deliver large-scale testing capacity in tandem with rapid result turnaround time can’t be underestimated. Our Biosearch Technologies’ SARS-CoV-2 Real-Time and End-Point RT-PCR Test is intended to support our clients in meeting the surging demand for SARS-CoV-2 detection.”
Dearden continued, “Limited supplies of instruments, reagents and laboratory technicians have made it challenging to deliver high volumes of testing in a timely manner. The creation of new facilities and conversion of research labs into testing labs introduces the complexities of creating new, regulatory-compliant workflows. Our solution can enhance testing strategies and ramp up throughput of testing per day. If used widely, our ability to support large-scale testing could lead to enhanced management of virus response, which ultimately could unlock safe returns to work and get economies moving once again.”
LGC’s technology can be applied for a wide range of use cases, from businesses and academic institutions who wish to test their staff and students regularly, to public health institutions and governments wishing to conduct mass testing.
LGC has a proven track record in supporting the scientific and healthcare community with diagnostics for public health diseases as well as public health emergencies such as influenza, H1N1 (swine flu), Zika, and Ebola.
Strategic alliance between Grifols and the Egyptian government to boost plasma-derived medicines self-sufficiency in the Middle East and Africa
24 November 2020 - Grifols and the National Service Projects Organization (NSPO) have reached a strategic agreement to develop the local plasma-derived therapies market through the opening of 20 plasma centers and construction of production facilities in Egypt, including a plasma fractionation plant and a protein purification plants. The agreement is a unique collaborative opportunity that will strengthen Egypt’s healthcare system and self-sufficiency, while reinforcing Grifols’ international expansion in the Middle East and Africa. Grifols and NSPO will incorporate a new company (joint venture) which will be owned by Grifols and NSPO on a 49%-51% basis, respectively.
Barcelona, November 24, 2020 -- Grifols, one of the world’s leading producers of plasma-derived medicines with a more than 100-year track record of contributing to the health and well-being of people around the world, and the Government of Egypt, through the National Service Projects Organization (NSPO), have signed a strategic agreement (Master Joint Venture Agreement) to further develop the Egyptian plasma-derivatives market and promote its self-sufficiency. The operation will ensure national security needs and help strengthen the healthcare system in Egypt.
Under this joint venture, owned by NSPO (51%) and Grifols (49%), the parties will join their industrial expertise and financial efforts for the development, construction and operation of 20 plasma collection centers throughout Egypt (with an initial capacity to collect 600,000 liters of plasma per year); manufacturing facilities, including a fractionation plant (with a capacity to fractionate up to 1 million liters of plasma per year) and a purification and fill-and-finish plant; a warehouse and an analysis laboratory. The plasma centers and manufacturing installations are expected to be operational at the end of 2025.
Through this agreement, Grifols will become a strategic ally of the Egyptian government, while building on its commitment to help countries reach higher levels of self-sufficiency in the manufacture and procurement of plasma-derived therapies for patients who need them.
The transaction supports Grifols’ globally focused, long-term sustainable growth strategy, whose core objectives include increasing the company’s supply of plasma and reinforcing its global expansion.
The transaction will allow Grifols to bolster its presence in the Middle East and Africa after establishing a solid presence in the United States and Europe and making important inroads in China, all core areas of its growth plan.
For Víctor Grífols Deu, co-CEO of Grifols, “we are extremely pleased to take part in a strategic alliance that will contribute to developing the healthcare system of Egypt. In addition to marking an important step forward in our sustainable growth strategy, it fulfills our objective to continue helping countries achieve self-sufficiency in plasma-derived medicines, essential for patients who need them”.
Grifols’ leadership in the production of plasma-derived medicines, technical expertise and reputation in developing and managing plasma centers and manufacturing facilities have been key factors behind this strategic alliance.
About the strategic alliance
Under the agreement (Master Joint Venture Agreement), Grifols and NSPO will incorporate a new company which will be owned by Grifols and NSPO on a 49%-51% basis, respectively. The board of directors will comprise an equal number of members appointed by both parties. This notwithstanding, the agreement provides for a vast list of matters which will require unanimous consent of both shareholders in order to be approved.
The project will be carried out in stages over a 5-year time period and the total expected capital expenditure for the project is estimated to be USD 300 million and is to be disbursed by the shareholders according to their percentage ownership, on a need-be basis. An initial joint investment of USD 20 million will be made upon the incorporation of the joint venture in order to support immediate operations.
At a first stage, through a contract manufacturing agreement and whilst the manufacturing facilities are pending to be finalized and fully up and running, Grifols will secure the processing of the plasma collected in Egypt into plasma-derived products to serve Egyptian national needs in the short term.
The plasma-centers will initially enable the collection of around 600,000 liters of plasma per year and the plant will have a fractionation capacity of up to 1 million liters per year. The plasma centers and manufacturing facilities are expected to be operational at the end of 2025. For Grifols, this project will free-up plasma and manufacturing capacity, it will bring diversification to its plasma procurement sources and will create expansion opportunities in certain territories
As part of the recognized value to be contributed by Grifols into the joint venture it includes its industry expertise and experience, as well as its intellectual property. The subscription to specific complementary agreements (Consultancy and Services Agreement, Technology and Know-How License Agreement and Contract Manufacturing Agreement) will allow Grifols to provide with any needed support, guidance, training, engineering services, manufacturing services, know-how and technology to support the execution of the project, in exchange of fees and royalties agreed upon between the parties.
Grifols will assume full supervision and management of the operation’s quality and safety to guarantee the infrastructures and processes adhere to the strictest quality and safety standards. The installations are expected to be authorized by international regulatory agencies, such as the European Medicines Agency (EMA) or the International Quality Plasma Program (IQPP) of the Plasma Protein Therapeutics Association (PPTA), among others.
BGI’s Nucleic Acid Detection Kit for Bloodstream Infection Pathogens Obtains CE Mark
26 November 2020
26 November 2020 -- The Nucleic Acid Detection kit for Bloodstream Infection Pathogens with Combinatorial Probe-Anchor Synthesis Technology developed by BGI Patho-Genesis Pharmaceutical Technology Co. LTD, a holding subsidiary of BGI Genomics, has recently got CE Mark.
The kit was developed on basis of metagenomic sequencing for detecting nucleic acid of agnostic pathogens in plasma using combinatorial Probe-Anchor Synthesis technology, intending to identify the causative pathogens of bloodstream infection aiding clinical diagnosis and differential diagnosis in combination with clinical manifestation, examination and other laboratory findings.
The kit is to construct the total Nucleic Acid library directly from clinical samples for high-throughput sequencing. The sequenced data can be analyzed using the bioinformatic software dedicated for bloodstream infection and comparing with the curated microbial genome reference database, enabling to unbiased detection of pathogens including bacteria, fungi,
viruses and parasites. Because of its fast speed and high accuracy with wide coverage of microbial spectrum in a single test, it has been used widely in clinical practices for identifying the causative pathogens of bloodstream infection.
Bloodstream infection is a serious systemic infectious disease. Pathogens invade the blood circulatory system and release toxins and metabolites, causing systemic infection, poisoning and inflammatory responses frequently in form of bacteremia, septicemia, sepsis, catheter-related bloodstream infection, and bacterial endocarditis with high fatality rate. Rapid and timely diagnosis is very important for life-saving treatment. BGI new CE marked detection kit detects plasma samples from patients based on metagenomic sequencing without the need for prior culture of microorganism.
Beckman Coulter launches its semi-quantitative SARS-CoV-2 IgG II antibody test
23 November 2020 - Access SARS-CoV-2 IgG II test is a semi-quantitative assay that measures patient’s relative level of antibodies in response to a previous SARS-CoV-2 infection. Assay is an added tool to assess relative changes of IgG levels over time to demonstrate the durability of an immune response to the SARS-CoV-2 virus.
BREA, CALIF., Nov. 23, 2020 — Beckman Coulter, a clinical diagnostics leader, today launched its Access SARS-CoV-2 IgG II assay that measures a patient’s relative level of antibodies in response to a previous SARS-CoV-2 infection. The new capabilities of this assay enable clinicians to establish a baseline to evaluate an individual’s immune response to the SARS-CoV-2 virus based on a numerical value and assess relative changes of an individual’s immune response to the virus over time. The assay may also help researchers as they begin to understand the levels of IgG antibodies needed to be considered protective.
The organization is filing for Emergency Use Authorization of the assay with the U.S. Food and Drug Administration (FDA) and will immediately begin shipping assays to its customer base throughout the U.S. under Policy D. Beckman Coulter is also planning to make the assay available to markets accepting the CE Mark before the end of the year.
“Having a clearer picture of the immune response to SARS-CoV-2 plays an important role in the fight against COVID-19, especially before a vaccine is widely available,” said Shamiram R. Feinglass, M.D., MPH, chief medical officer Beckman Coulter. “While it's unknown how long antibodies persist following infection, and if the presence of antibodies confers protective immunity, having a quantifiable baseline is a critical step towards furthering the understanding of the adaptive immune response to SARS-CoV-2 in individuals over time.”
Access SARS-CoV-2 IgG II semi-quantitative assay provides a numerical result in Arbitrary Units (AU) from 2.00- 450 AU/mL as well as a qualitative result and offers the same high level of quality as Beckman Coulter’s Access SARS-CoV-2 IgG and IgM serology tests already on the market. The assays use the receptor-binding domain (RBD) of the spike protein. Beckman Coulter selected the RBD of the spike protein as it is critical for viral entry into human cells and has been shown to be the target for neutralizing antibodies in a surrogate model. This selection is also aligned with the multiple vaccines in development that target or include the RBD of the spike protein, with the goal of producing protective antibodies.
The Access SARS-CoV-2 IgG II semi-quantitative assay is the latest addition to Beckman Coulter’s full suite of testing solutions designed to provide valuable information to clinicians in their fight against COVID-19. The next product expected from the organization is an automated SARS-CoV-2 antigen test which is currently under development. While point of care (POC) antigen tests have a purpose in diagnosing COVID-19, they are difficult and resource intensive to scale to address high volume testing needs. Beckman Coulter’s antigen test is being designed to provide ultimate flexibility in scaling to address the needs of small, moderately complex laboratories that operate a desktop analyzer, to large laboratories that implement automated, high-throughput analyzers for mass testing.
About the Access SARS-CoV-2 IgG II assay
The Access SARS-CoV-2 IgG II assay is a semi-quantitative and qualitative immunoassay that measures IgG antibodies directed to the receptor-binding domain of the spike protein of the novel coronavirus in response to a previous infection. The assay then provides a numerical result ranging from 2.00-450/mL as well as a qualitative result for SARS-CoV-2 IgG antibodies.
The test has a confirmed 96.0% positive percent agreement (PPA, sensitivity) at 8-14 days post symptom onset and 99.9% negative percent agreement (NPA, specificity) evaluated in a study with 1,448 samples from donors in the U.S.A. and France collected prior to December 2019. With this high NPA rate, false positive results are extremely low to ensure accurate and reliable test results. It uses immobilized virus antigens on magnetic particles to capture IgG antibodies from patient serum or plasma samples and reveals them using labelled anti-IgG antibodies.
The Access SARS-CoV-2 IgG II assay can be used can be used in Random Access Mode (RAM) and seamlessly integrated into existing workflows without batch processing. Results of the new Access SARS-CoV-2 IgG II test are delivered quickly on Beckman Coulter’s award-winning immunoassay analyzers, including the DxI 800 high-throughput analyzer, which is capable of processing 200 samples per hour. For more information on Beckman Coulter’s full suite of testing solutions or its commitment to the fight against COVID-19, visit www.BeckmanCoulter.com/Coronavirus.
About Beckman Coulter
Beckman Coulter is committed to advancing healthcare for every person by applying the power of science, technology and the passion and creativity of our teams to enhance the diagnostic laboratory’s role in improving healthcare outcomes. Our diagnostic systems are used in complex biomedical testing, and are found in hospitals, reference laboratories and physician office settings around the globe. Beckman Coulter offers a unique combination of people, processes and solutions designed to elevate the performance of clinical laboratories and healthcare networks. We do this by accelerating care with a menu that matters, bringing the benefit of automation to all, delivering greater insights through clinical informatics and unlocking hidden value through performance partnership. An operating company of Danaher Corporation (NYSE: DHR) since 2011, Beckman Coulter is headquartered in Brea, Calif., and has more than 11,000 global associates working diligently to make the world a healthier place.
Genedrive HCV ID Kit demonstrates high clinical accuracy in India study
20 November 2020 - Hepatitis C virus testing kit reveals 100% sensitivity and specificity when compared to Abbott Real time HCV test
20 November 2020 -- Genedrive plc (AIM:GDR), the near patient molecular diagnostics company, announces the publication of the study data for the ‘Evaluation of the Point of Care Molecular Diagnostic Genedrive HCV ID Kit for the detection of HCV RNA in clinical samples’.
The study was led by Dr Ekta Gupta at ILBS, New Delhi, India. The objective of the study was to determine the diagnostic accuracy of the Genedrive HCV ID Kit, as a confirmatory test for seropositive hepatitis C virus (HCV) patients in Indian demographic settings.
The diagnostic accuracy of the Genedrive HCV ID Kit was evaluated by comparing the test with the Abbott Real time HCV test on the lab-based Abbott m2000 platform in an Indian demographic and across a range of different genotypes, to ensure suitability for introduction of the product to the Indian population. In India the circulation of HCV genotype is predominantly genotypes 3 and 1 with live infections of HCV estimated at between 6-12 million.
150 HCV RNA positive and 170 HCV RNA negative samples were tested using both methods. The comparison revealed 100% sensitivity (95% CI 97.9 – 100%) and 100% specificity (95% CI 97.9 – 100%). The overall diagnostic accuracy was 100% (95% CI 98.9 – 100%).
Overall, the study demonstrates that the Genedrive HCV ID Kit is suitable for use in India and can be used for decentralised testing of HCV thereby reducing the loss of patients to follow up.
David Budd, CEO of genedrive plc, said: “These excellent clinical results for our HCV assay further validate the applicability of the test for a decentralised setting. India is a key target market for our assay and we are excited about the commercial prospects in the region.”
Reference: https://www.genedrive.com/news/index.php
Aptima HIV-1 Quant Dx Assay Receives Additional FDA Approval for Use as an Aid in the Diagnosis of HIV Infection
20 November 2020 - First FDA-Approved Assay for Both Qualitative Diagnosis and Quantitative Viral Load Monitoring
MARLBOROUGH, Mass., 20 November 2020 -- Hologic, Inc. announced today that the U.S. Food and Drug Administration (FDA) has approved a diagnostic claim for its HIV-1 (human immunodeficiency virus type 1) viral load monitoring assay. The Aptima® HIV-1 Quant Dx assay is now the first dual-claim assay for both diagnosis and viral load monitoring in the United States.
The AptimaHIV-1 Quant Dx assay, which was approved in late 2016 for viral load monitoring, is a molecular diagnostic test that runs on the fully automated, sample-to-result Panther® system. The assay utilizes a dual target approach against highly conserved regions in the HIV genome that is designed to deliver reliable, consistent qualitative and quantitative results across HIV-1 groups and subtypes. The Aptima HIV-1 Quant Dx assay is also CE IVD-marked for both diagnostic and viral load monitoring claims.
“This is an exciting new claim for our highly sensitive and reliable HIV test because it has the potential to improve patient care,” said Kevin Thornal, president of Diagnostic Solutions at Hologic. “A simultaneous viral load measurement with diagnosis will allow healthcare providers to guide treatment choices for patients to begin therapy immediately. The dual claim will also benefit our clinical laboratory customers, who continuously seek to consolidate their testing as much as possible onto one automated platform.”
Starting treatment at the time of diagnosis is expected to reduce the risk of HIV transmission to others and to maximize prospects for long-term good health.
There are approximately 1.2 million people living in the US with HIV, with 38,000 new infections in 2018.
For more information about Hologic’s U.S. virology portfolio, please visit: http://usaptimavirology.com.
About the Panther and Panther Fusion Systems
The Panther molecular diagnostics system is a best-in-class, fully automated, sample-to-result platform that can be used in low-, medium- or high-throughput laboratories. With a small footprint, adaptable workflow options and consolidated testing menu, it combines women’s health, sexually transmitted infection and viral load testing, which can all be done simultaneously. The Panther Fusion system provides an expanded in vitro diagnostics menu, as well as Open AccessTM functionality to run laboratory developed tests. Hologic’s Panther and Panther Fusion systems now offer 18 FDA-cleared assays and 20 CE-marked assays that detect more than 20 pathogens. More than 2,250 Panther systems have been installed in clinical diagnostic laboratories around the world.
About Hologic
Hologic, Inc. is an innovative medical technology company primarily focused on improving women’s health and well-being through early detection and treatment. For more information on Hologic, visit www.hologic.com.
Siemens Healthineers is the First Leading Diagnostics Company Offering a Quantitative COVID-19 Test to Measure Neutralizing Antibodies
18 November 2020 - The Siemens Healthineers SARS-CoV-2 IgG Antibody Test, available under CE Mark, has proven to measure neutralizing antibodies. The company has submitted to the FDA under EUA. As SARS-CoV-2 vaccines become available, Siemens Healthineers is ready with fully automated antibody tests that can be used to help inform whether broad vaccination programs are working. Reliable antibody tests are a valuable tool to measure the effectiveness of vaccines.
TARRYTOWN, N.Y., November 18, 2020 – Siemens Healthineers announced today its SARS-CoV-2 IgG Antibody Test (sCOVG)1 has proven to measure neutralizing antibodies and has achieved CE Mark. The test is an enhanced version of the assay which became available globally this summer, including in the U.S. It demonstrates the ability to detect neutralizing antibodies and reports quantitative results measuring the amount of neutralizing antibodies present in a patient's blood sample. The company has submitted an application to FDA under Emergency Use Authorization.
Neutralizing antibodies are critical in the fight against COVID-19 because they defend cells from infection by the virus. A virus typically produces an immune response of many antibodies that act as an army to help fight off the virus; however, only a small subset of those antibodies are capable of neutralization—blocking the virus from infecting additional cells. Those neutralizing antibodies develop either in response to natural infection or to vaccination, then subsequently bind to the virus and block infection. To measure a vaccine’s effectiveness, it is critical to identify both the presence of these neutralizing antibodies as well as quantitatively assess the likely level needed to protect against future encounters with the virus. The Siemens Healthineers' antibody test will make learning this information possible as vaccines are rolled out and exposure to COVID-19 is tested against immunization and the level of immunity a vaccine provides.
"At the onset of the pandemic, the scientific community had to learn about COVID-19 and how our immune systems would respond. We targeted the spike protein for our antibody tests, anticipating antibodies to this protein would eventually prove to be neutralizing," said Deepak Nath, PhD, President of Laboratory Diagnostics at Siemens Healthineers. "Adequate data is available now to confirm the spike protein antibodies are indeed neutralizing, especially those against the spike receptor binding domain. Healthcare providers can feel confident that our test will help them determine whether a patient's immune system is producing the right antibodies to stop or prevent COVID-19 infection."
The Siemens Healthineers SARS-CoV-2 IgG antibody tests are available on one of the largest installed bases of automated immunoassay analyzers worldwide, and the largest in the U.S. This includes the Atellica® Solution and ADVIA Centaur® XP and XPT families of analyzers and the Dimension Vista® and Dimension® EXL™ systems.
Siemens Healthineers has distinguished itself as a provider of quality assays to aid the COVID-19 pandemic. In addition to antibody, antigen, and molecular SARS-CoV-2 tests, Siemens Healthineers offers a broad diagnostics portfolio to aid in the prognosis, treatment and follow-up of COVID-19 patients. The company’s broad and differentiated menu includes hematology, coagulation, cardiac, respiratory, inflammation and infectious disease panels. Blood gas and imaging solutions from Siemens Healthineers deliver actionable results that aid clinicians in caring for COVID-19 patients.
Reference: https://www.siemens-healthineers.com/press-room/press-releases/covid-19-igg-quantitative.html
bioMérieux announces the expansion of the CE marking of its molecular biology ARGENE® SARS-CoV-2 diagnostic test to include saliva specimens
16 November 2020
Marcy l’Etoile, France – November 16, 2020 – bioMérieux, a world leader in the field of in vitro diagnostics, has announced the expansion of its ARGENE® range for the detection of SARS-CoV-2. As a complement to nasopharyngeal swab specimens, the singleplex SARS-CoV-2 R-GENE® real-time PCR test may now be used on saliva and oropharyngeal (throat) swab specimens for the detection of the virus that causes COVID-19. This development helps optimize laboratory workflows.
The CE-marked SARS-CoV-2 R-GENE® test covers the above three sample types. This allows bioMérieux to address the recommendation issued by the French National Authority for Health (HAS) on September 18, 2020, which encourages the preferential use of saliva swabs to test symptomatic individuals for whom it is difficult or impossible to use nasopharyngeal swabs.
“True to its commitment to combat the COVID-19 pandemic, bioMérieux has taken into account the needs of laboratories. Expanding the use of the ARGENE® molecular test to include saliva swab specimens will make the test more acceptable to many patients, and will make it easier to perform,” said François Lacoste, Executive Vice President, R&D.
The expansion of the CE marking to include saliva and oropharyngeal swab specimens has been declared to the French National Agency of Medicines and Health Products Safety (ANSM).This new type of specimen is now mentioned in the list of tests authorized by the French Directorate General of Health.
Moreover, the Company will soon release a high-throughput test for the simultaneous (multiplex) detection of influenza viruses A and B and SARS-CoV-2, including a cellular control to check the quality of the sample. It will be available in Europe and in countries that recognize CE marking. This new test will be part of the same test kit for the detection of two other disease agents that often circulate during the winter months, RSV (human respiratory syncytial virus) and HMPV (human metapneumovirus).
About the ARGENE® SARS-COV-2 R-GENE® test
As for all tests in the ARGENE® range, the SARS-COV-2 R-GENE® test is an open assay, meaning that it may be performed by any laboratory using PCR technology on most commercially-available nucleic acid extraction and amplification platforms. Results are delivered in 4 to 5 hours, and a large number of patient samples may be processed simultaneously. The entire ARGENE® range for the detection of SARS-CoV-2 is produced in France at the bioMérieux site in Verniolle (Ariège).
QIAGEN launches NeuMoDx multiplex test to complete range of SARS-CoV-2 testing solutions in Europe and other markets
16 November 2020 - Fast and easy-to-use respiratory PCR test comes onto market as flu season gains pace in Northern Hemisphere. CE-IVD marking in Europe granted for NeuMoDx™ Flu A-B/RSV/SARS-CoV-2 Vantage Test, has also been submitted to FDA for Emergency Use Authorization. Test adds to QIAGEN’s growing portfolio of PCR testing solutions for COVID-19 testing. QIAGEN also expands sample type claim for NeuMoDx™ SARS-CoV-2 test to include saliva from a dedicated collection kit in Europe.
Germantown, Maryland, and Hilden, Germany, November 16, 2020 – QIAGEN N.V. today announced the European launch of the NeuMoDx™ Flu A-B/RSV/SARS-CoV-2 Vantage Test that will help healthcare professionals quickly identify and differentiate between patients with common seasonal respiratory infections and COVID-19.
With the Northern Hemisphere in the grip of flu season, this multiplex polymerase chain reaction (PCR) test detects and differentiates influenzas A and B, respiratory syncytial virus (RSV) and SARS-CoV-2 infections within 80 minutes. These viruses produce similar respiratory symptoms, making it essential to provide differential diagnosis among them for patient treatment and management decisions, especially in the COVID-19 pandemic.
QIAGEN has launched NeuMoDx™ Flu A-B/RSV/SARS-CoV-2 Vantage in the European Union and other markets after CE-IVD registration, and has submitted an Emergency Use Authorization (EUA) request to the FDA.
QIAGEN’s new respiratory test takes advantage of the NeuMoDx 96 and NeuMoDx 288 molecular systems’ automated three-step workflow. Coupled with additional system features – like processing capacity, true random access, and continuous loading of samples, reagents and consumables while the system is running – the NeuMoDx™ Flu A-B/RSV/SARS-CoV-2 Vantage test will be a powerful diagnostic tool for the flu season and COVID-19 pandemic.
In addition, QIAGEN has expanded specimen types that can be used on the existing NeuMoDx™ SARS-CoV-2 test. CE-IVD approval has been obtained for the use of saliva samples collected with the NeuMoDx™ Saliva Collection Kit, which includes a collection vial, stabilization tube and pipette.
This kit allows for less invasive sample collection compared to commonly used nasal swabs. It reduces the burden on the supply of the nasal collection devices and increases laboratory testing capacity. This claim extension for the saliva collection kit is also in review with the FDA. The singleplex test was granted an EUA in March.
“Both launch and label extension expand the capabilities of our NeuMoDx systems in detection of COVID-19,” said Thierry Bernard, Chief Executive Officer of QIAGEN. “They add to our growing NeuMoDx testing menu, which in 2020 included launches for HIV-1, TV/MG, Strep A/C/G, HPV, BK virus, and Influenza A-B/RSV. We will launch additional assays in 2021 and continue to increase the value of the platform for lab customers beyond the pandemic.
QIAGEN fully acquired NeuMoDx in September and made it one of its five growth drivers that make the company strong enough to continue to grow on a standalone basis – the others being Sample Prep, QIAcuity, QFT and the QIAstat-Dx. The NeuMoDx™ Flu A-B/RSV/ SARS-CoV-2 Vantage Assay strengthens QIAGEN’s footprint in PCR, the gold standard in coronavirus testing.
QIAGEN now is the only company to be able to offer fast singleplex and multiplex PCR tests as well as a fast syndromic solution (QIAstat-Dx), providing customers with a broad variety of PCR-based testing options. Furthermore, the portfolio includes RNA extraction kits and instruments as well as testing components and enzymes used by third parties for their own PCR test kits. In October, QIAGEN also launched QIAprep& which streamlines PCR workflows by integrating sample preparation and real-time PCR detection into a single kit. The product has initially been launched for research use only and is planned to gain EUA and CE-IVD registration soon.
Further information on QIAGEN’s response to the coronavirus outbreak can be found here. For more information on the NeuMoDx platform and NeuMoDx™ Flu A-B/RSV/SARS-CoV-2 Vantage Assay please visit http://qiagen.com/NeuMoDx
About QIAGEN
QIAGEN N.V., a Netherlands-based holding company, is the leading global provider of Sample to Insight solutions that enable customers to gain valuable molecular insights from samples containing the building blocks of life. Our sample technologies isolate and process DNA, RNA and proteins from blood, tissue and other materials. Assay technologies make these biomolecules visible and ready for analysis. Bioinformatics software and knowledge bases interpret data to report relevant, actionable insights. Automation solutions tie these together in seamless and cost-effective workflows. QIAGEN provides solutions to more than 500,000 customers around the world in Molecular Diagnostics (human healthcare) and Life Sciences (academia, pharma R&D and industrial applications, primarily forensics). As of September 30, 2020, QIAGEN employed more than 5,300 people in over 35 locations worldwide. Further information can be found at http://www.qiagen.com.
Reference: https://corporate.qiagen.com/newsroom/press-releases/2020/20201116_neumodx_ce_multiplex
PerkinElmer SARS-CoV-2 RT-PCR Assay Receives CE Mark for Saliva and Sample Pooling to Test Symptomatic and Asymptomatic Individuals
12 November 2020 - Non-invasive sample collection and batch processing to test symptomatic and asymptomatic individuals – a breakthrough in COVID-19 testing
WALTHAM, Mass., Nov. 12, 2020 -- PerkinElmer, Inc. announced today that its PerkinElmer® SARS-CoV-2 Real-time RT-PCR Assay received CE-IVD marking for the use of saliva as specimen type and the option to pool up to five specimens collected from individuals suspected of COVID-19 or asymptomatic individuals.
SARS-CoV-2 testing using saliva is less invasive, reduces the risk of exposure to healthcare workers involved in sample collection and need for frequent replacement of personal protective equipment.
Labs in countries accepting CE mark now have the option to accept saliva specimens and implement sample pooling using the PerkinElmer SARS-CoV-2 Real-time RT-PCR Assay. Sample pooling using saliva specimens is a critical advancement made possible by PerkinElmer’s chemistry and stringent manufacturing systems. The PerkinElmer SARS-CoV-2 Real-time RT-PCR Assay is built on the most sensitive SARS-CoV-2 test with the lowest limitation of detection in the market, according to the FDA’s reference panel comparative data.
The assay originally obtained its CE mark in the spring of 2020.
“To strike the right balance between keeping the world economy moving while ensuring safe practices, governments and private organizations are working tirelessly to increase the number of times individuals are tested for COVID-19,” said Masoud Toloue, Ph.D., Vice President & General Manager, Diagnostics, PerkinElmer. “We expect our newly released saliva-based collection and asymptomatic test solution will play a large role in this effort.”
PerkinElmer continues to work on the frontlines of improving COVID-19 testing. The Company’s comprehensive SARS-CoV-2 offerings span high throughput RNA extraction, RT-PCR, automation, ELISA, chemiluminescence, time-resolved fluorescence and lateral flow based serology testing.
About PerkinElmer
PerkinElmer enables scientists, researchers, and clinicians to address their most critical challenges across science and healthcare. With a mission focused on innovating for a healthier world, we deliver unique solutions to serve the diagnostics, life sciences, food, and applied markets. We strategically partner with customers to enable earlier and more accurate insights supported by deep market knowledge and technical expertise. Our dedicated team of about 13,000 employees worldwide is passionate about helping customers work to create healthier families, improve the quality of life, and sustain the wellbeing and longevity of people globally. The Company reported revenue of approximately $2.9 billion in 2019, serves customers in 190 countries, and is a component of the S&P 500 index. Additional information is available through 1-877-PKI-NYSE, or at www.perkinelmer.com
BGI Gets CE Mark for HPV Testing Products
12 November 2020
12 November 2020 -- BGI Europe A/S, A wholly-owned subsidiary of BGI Genomics Co., LTD., today announces that its HPV testing products: Human Papillomavirus (HPV) Typing Kit (Combinatorial Probe-Anchor Synthesis Sequencing Method), and related Nucleic Acid Extraction Kit has been CE marked.
The GLOBOCAN 2018 estimates there are about 500,000 new cases of cervical cancer each year, accounting for 3.2 percent of all new cancer cases, making it the fourth most common malignancy in terms of morbidity and mortality among women. Persistent high-risk human papillomavirus (HPV) infection is the leading cause of cervical cancer and precancerous lesions.
BGI CE marked Human Papillomavirus (HPV) Typing Kit (Combinatorial Probe-Anchor Synthesis Sequencing Method) together with its applicable nucleic acid extraction kit, used for the precise typing of 17 types of high-risk and medium-risk HPV such as HPV 16, 18, 31, etc. is conducive to the early diagnosis and treatment of HPV infection as well as the prevention and control of cervical cancer.
The CE certification of the HPV test will further enhance the company’s core competitiveness in the field of tumor detection in the global market, which will have a positive impact on the company’s tumor prevention and control business.
Reference: https://www.bgi.com/global/company/news/bgi-gets-ce-mark-for-hpv-testing-products/
QIAGEN launches portable digital SARS-CoV-2 antigen test that can accurately analyze over 30 samples per hour
11 November 2020 - QIAreach™ SARS-CoV-2 Antigen Test, developed in partnership with Ellume, is an important step towards decentralized mass screening by processing samples in 2–15 minutes. Digital results for dozens of samples per hour and the ability to process antibody tests in parallel, setting new standards in scalability and flexibility. Test submitted to FDA for Emergency Use Authorization for US, CE-IVD marking for European Union and other markets expected by year’s end.
Hilden, Germany, and Germantown, Maryland, November 11, 2020 – QIAGEN has started commercialization of a portable digital test in the United States that can be used by laboratories to detect SARS-CoV-2 antigens in people with active infections in 2-15 minutes. A point of care (POC) claim will be added and EUA amended later this year.
The QIAreach™ SARS-CoV-2 Antigen Test, developed in partnership with the Australian digital diagnostics company Ellume, sets new standards in scalability, validation and flexibility by processing more than 30 swab samples per hour, providing digital test results that do not require subjective interpretation, and allowing antibody tests to run simultaneously with antigen tests. This flexibility will be particularly valuable when vaccines are introduced.
QIAGEN has begun marketing and distributing QIAreach™ SARS-CoV-2 Antigen Test in the United States after applying for FDA emergency use authorization (EUA) for symptomatic patients. CE-IVD registration for European Union and other markets is expected as early as by the end of the year.
“As existing approaches often lack scalability and accuracy, antigen testing is playing an increasingly important role in national testing strategies as a complementary tool to PCR, the gold-standard for detecting active COVID-19 infections,” said Thierry Bernard, Chief Executive Officer of QIAGEN. “QIAreach SARS-CoV Antigen is a fast, digital and easy to use test that makes use of sensitive nanoparticle technology from Ellume. In as little as two minutes it allows objective reading of test results that provide clear qualitative interpretation. And it addresses the growing need for higher throughput testing for SARS-CoV-2 antigen by processing up to eight tests per hub simultaneously.”
Testing of clinical samples have shown the QIAreach™ SARS-CoV-2 Antigen Test to have a sensitivity of 90% and a specificity of 100%. It is the second QIAGEN COVID-19 test to make use of the digital eHub and eStick system made by its partner Ellume. QIAGEN in August announced the QIAreach™ Anti-SARS-CoV-2 Antibody Test – and both tests can run on the digital platform interchangeably.
The portable system provides a true walkaway solution with random access and does not require maintenance or calibration. It contains a rechargeable battery for eight hours of remote use and can fully connect to laboratory information management systems (LIMS) with an optional use software. The eHub will also run the QIAreach QuantiFERON®-TB test, a novel test for the detection of latent tuberculosis infections in low resource and high burden settings that is currently in development.
QIAreach™ SARS-CoV-2 Antigen Test uses the rugged and portable eHub to analyze eight eSticks with nasopharangeal-swab samples from symptomatic people at once, each test running independently of the others. The easy-to-use eStick uses nanoparticle fluorescent detection technology to flag the SARS-CoV-2 nucleocapsid protein, an antigen present on the inside of the virus. The device can detect strong positive cases in as little as two minutes and negative cases in 15 minutes.
For more information on QIAreach™ SARS-CoV-2 Antigen Test please visit https://go.qiagen.com/QIAreach-SARS-CoV2-Antigen-Test-LearnMore. Further information on QIAGEN’s response to the coronavirus outbreak can be found here.
About QIAGEN
QIAGEN N.V., a Netherlands-based holding company, is the leading global provider of Sample to Insight solutions that enable customers to gain valuable molecular insights from samples containing the building blocks of life. Our sample technologies isolate and process DNA, RNA and proteins from blood, tissue and other materials. Assay technologies make these biomolecules visible and ready for analysis. Bioinformatics software and knowledge bases interpret data to report relevant, actionable insights. Automation solutions tie these together in seamless and cost-effective workflows. QIAGEN provides solutions to more than 500,000 customers around the world in Molecular Diagnostics (human healthcare) and Life Sciences (academia, pharma R&D and industrial applications, primarily forensics). As of September 30, 2020, QIAGEN employed more than 5,300 people in over 35 locations worldwide. Further information can be found at http://www.qiagen.com.
About Ellume
Ellume is an Australian-based digital diagnostics company that develops, manufactures and commercializes high-performance, connected products for health professionals and consumers. Our focus is on the detection of common illnesses which affect the global population and our products differ from conventional diagnostics through performance, digital connectivity, actionability and simplicity. Ellume has developed novel detection technology powered by our unique quantum dot nanoparticle, which integrates optics, electronics, biologics and software into an intuitive and high-performance digital platform. Further information can be found at www.ellumehealth.com
Reference: https://corporate.qiagen.com/newsroom/press-releases/2020/20201111_qiareach_antigen_eua
BD Announces Canadian Government Order of More Than 7 Million Portable, Rapid Point-of-Care Antigen Tests to Detect SARS-CoV-2 in 15 minutes
10 November 2020
MISSISSAUGA, ON, Nov. 10, 2020 -- BD (Becton, Dickinson and Company), a leading global medical technology company, today announced its rapid, point-of-care, SARS-CoV-2 antigen test for use on the BD Veritor™ Plus System has been authorized for use by Health Canada under Interim Order. This authorization has been accompanied by an order from the Canadian government for 7.6 million tests through March 2021 to support Canada's planning for an advanced COVID-19 testing strategy.
"The Government of Canada continues to work diligently to provide Canadians with access to effective and efficient COVID-19 testing solutions," said Minister of Public Services and Procurement Anita Anand. "This new agreement with BD is critical to assisting the provinces and territories in their respective efforts to reduce the spread of the virus. We will continue to support Canadians through the COVID-19 pandemic."
The new test delivers results in approximately 15 minutes on an easy-to-use, portable instrument, which is a critical improvement in turnaround time for COVID-19 diagnostics, because it provides real-time results and enables decision-making while the patient is still onsite. This test is designed to be performed at the point-of-care, reducing the burden on testing laboratories. The test uses a mid-nasal swab to collect patient samples, which is less invasive for the patient than nasopharyngeal sample collection.
"As the demands for SARS-CoV-2 testing are increasing in Canada, we are excited to bring another testing solution to the Canadian market," said Greg Miziolek, president of BD-Canada. "The ability to perform SARS-CoV-2 testing at the point-of-care and deliver results while the patient waits will be truly impactful to help relieve some of the pressures on the testing labs and quickly identify affected patients. We applaud the federal government for their proactive approach in planning for future needs with a centralized order for antigen detection tests. We look forward to partnering with Canada's provincial health authorities to optimize the deployment of the BD Veritor™ Plus System to meet regional and local public health needs."
The test, which received Health Canada authorization in early October, has been available in the United States since July through an Emergency Use Authorization from the U.S. Food and Drug Administration (FDA).
The test uses the BD Veritor™ Plus System, which is already in use in Canada to detect Influenza A+B, Respiratory Syncytial Virus (RSV), and Group A Strep. The BD Veritor™ Plus System, which has a slightly larger footprint than a mobile phone, offers an easy-to-use workflow that makes it an ideal solution for point-of-care settings. It also offers customers traceability and reporting capabilities through the optional BD Synapsys™ informatics solution.
BD has also been supporting SARS-CoV-2 molecular testing (RT-PCR) in Canadian labs on the BD MAX™ System.
For Product Enquiries and How to Order:
Individuals interested in placing an order or learning more about the BD Veritor™ System for Rapid Detection of SARS-CoV-2 should visit: https://go.bd.com/BDVeritorinCanada.html
About the BD Veritor™ System for Rapid Detection of SARS-CoV-2 Assay
The BD Veritor™ System for Rapid Detection of SARS-CoV-2 assay has been authorized by Health Canada under Interim Order. This test is only authorized for the duration of the Interim Order Respecting the Importation and Sale of Medical Devices for Use in Relation to COVID-19, unless the authorization is terminated or revoked sooner. The SARS-CoV-2 antigen assay has been authorized only for the detection of proteins from SARS-CoV-2, not for any other viruses or pathogens. The BD Veritor™ System for Rapid Detection of SARS-CoV-2 Assay is not authorized for use by consumers or for at-home use.
About BD
BD is one of the largest global medical technology companies in the world and is advancing the world of health by improving medical discovery, diagnostics and the delivery of care. The company supports the heroes on the frontlines of health care by developing innovative technology, services and solutions that help advance both clinical therapy for patients and clinical process for health care providers. BD and its 65,000 employees have a passion and commitment to help enhance the safety and efficiency of clinicians' care delivery process, enable laboratory scientists to accurately detect disease and advance researchers' capabilities to develop the next generation of diagnostics and therapeutics. BD has a presence in virtually every country and partners with organizations around the world to address some of the most challenging global health issues. By working in close collaboration with customers, BD can help enhance outcomes, lower costs, increase efficiencies, improve safety and expand access to health care. For more information on BD, please visit bd.com/en-ca.
LGC signs pre-let for new R&D facility at Oxford Technology Park
10 November 2020
10 November 2020 -- The Native Antigen Company, one of the world’s leading suppliers of infectious disease antigens and antibodies, has signed a pre-let for a new purpose-built R&D and manufacturing facility at the Oxford Technology Park. It follows the acquisition of The Native Antigen Company in July 2020 by LGC.
This new 49,000 sq ft two-storey building, which will be ready by the summer 2021, will accommodate a mixture of bespoke laboratory, office and logistics operations.
The Native Antigen Company’s building will be constructed alongside the landmark three storey 30,000 sq ft lab-enabled office building fronting Langford Lane and the Oxford London airport, offering suites from 4,000 sq ft for occupation summer 2021.
These new buildings will join the Premier Inn hotel and Beefeater restaurant opened in January 2020 and will be quickly followed by the next phase of flexible hi-tech buildings suitable for lab, R&D and light manufacturing.
“The site presents a perfect opportunity to expand our operations”, comments Nick Roesen, COO of The Native Antigen Company. “The location is right for us and was made very attractive with the ability to design the interior space to suit our business requirements. We are also excited about being part of a new science community at the Oxford Technology Park.”
“We are thrilled to be working with The Native Antigen Company and will enjoy growing the community around them.” remarks Angus Bates, Director at Hill Street Holdings, owners of the Oxford Technology Park. “Oxford is such an amazing place and we have been overwhelmed by the scale of demand for what we are building. Our approach is to build flexible spaces with the power, data and construction technology to cater for any form of requirement from science and technology companies. We have great plans for the next phases including smaller ‘grow on’ units as well as more large buildings.”
Bidwells and Benedicts are the letting agents for the Oxford Technology Park. Further information at https://oxfordtechnologypark.com/
Reference: https://www.lgcgroup.com/newsroom-and-blog/news-and-blog/new-facility-site-in-oxford/
Beckman Coulter launches its SARS-CoV-2 IgM antibody test in countries accepting CE Mark and will begin shipping to diagnostics labs
10 November 2020 - Assay has 99.9% specificity and 100% sensitivity at >18 days post symptom onset and positive PCR1 and confirmed 96.9% positive predictive value when disease incidence is as low as 3%. Beckman Coulter developed separate SARS-CoV-2 Immunoglobulin M (IgM) and SARS-CoV-2 Immunoglobulin G (IgG) antibody assays to better help clinicians determine a patient’s immune status in response to a recent or past infection. Additional COVID-19 testing solutions coming to market to guide clinical and public health decision making include a SARS-CoV-2 antigen and quantitative IgG assay.
HIGH WYCOMBE, ENGLAND, Nov. 10, 2020 — Beckman Coulter, a clinical diagnostics leader, today announced the launch of its Access SARS-CoV-2 Immunoglobulin M (IgM) assay in countries accepting the CE Mark. The new IgM antibody test demonstrated 99.9% specificity with 1,400 negative samples and 100% sensitivity at >18 days post symptom onset and positive PCR. Beckman Coulter’s IgM assay is part of a full suite of testing solutions the company is developing to inform clinical and public health decision making during the COVID-19 pandemic. Beckman Coulter is also developing a SARS-CoV-2 antigen test and quantitative IgG assay. Beckman Coulter’s antibody assays and its other planned SARS-CoV-2 offerings run on the organisation’s award-winning immunoassay analysers, including the DxI 800 high-throughput analyser, which is capable of processing 200 samples per hour.
“Our new SARS-CoV-2 IgM assay provides information about an individual’s immune status with a positive predictive value of 96.9% in a population with disease incidence as low as 3%,” said Julie Sawyer Montgomery, president of Beckman Coulter. “As COVID-19 outbreaks continue to grow in intensity in many of our communities, highly accurate tests such as this are critical for providing reliable information for both individual health decisions as well as population-based immunity monitoring.”
The full suite of testing solutions, including the IgM and IgG assays currently available and the antigen and quantitative IgG assay under development, provide valuable information in clinical decision making for patients suffering from COVID-19. The company developed separate SARS-CoV-2 IgM and SARS-CoV-2 IgG antibody assays to help clinicians determine a patient’s immune status in response to a recent or past infection. The Beckman Coulter IgM assay detects antibodies that may emerge earlier in the course of infection and then dissipate, while the IgG test detects antibodies associated with the longer-term immune response. Both IgM and IgG assays can identify antibodies in asymptomatic individuals. Since each person’s seroconversion process is different, the two tests can be used together to provide the most accurate view of their immune response.
Rob Young, UK General Manager for Beckman Coulter, added: “This latest addition to our already extensive offering, which spans serological, antigen, and other diagnostic solutions, brings greater visibility to help monitor the progression of COVID-19 in patients. We continue to innovate and provide a multitude of high-quality tests in high volumes to help clinicians identify patients with the virus and support efforts in fighting the disease.”
Around the world, diagnostic labs are under immense pressure to be more efficient when it comes to meeting testing demands. Beckman Coulter’s assays can be performed in automated or high-throughput immunoassay formats. The Access SARS-CoV-2 IgM test can also be run on Beckman Coulter’s Access 2 analyser, a compact, table-top analyser enabling high-quality serology testing to be carried out in small hospitals and clinics. Additionally, this test seamlessly integrates into laboratory workflows, making it easy to add serology testing to routine blood tests performed during inpatient and wellness testing.
About the Access SARS-CoV-2 IgM assay
The Access SARS-CoV-2 IgM Assay is a qualitative immunoassay that detects IgM antibodies. The test has confirmed 100% sensitivity at >18 days post symptom onset and post positive PCR and 99.9% specificity. The assay utilises an immunocapture format to bind patient IgM antibodies on the magnetic particle solid phase and a recombinant SARS-CoV-2 protein - enzyme conjugate to detect anti-SARS-CoV-2 IgM. The Access SARS-CoV-2 IgM assay can be used in Random Access Mode (RAM), which means that the antibody tests can be run along with other immunoassay tests. The assay can also be used with a variety of Beckman Coulter analysers, including the high-throughput DxI 800 designed for large labs, the DxI 600 for mid-sized labs and the DxC 600i and Access 2 analysers for smaller labs and healthcare clinics.
About Beckman Coulter
Beckman Coulter is committed to advancing healthcare for every person by applying the power of science, technology and the passion and creativity of our teams to enhance the diagnostic laboratory’s role in improving healthcare outcomes. Our diagnostic systems are used in complex biomedical testing, and are found in hospitals, reference laboratories and physician office settings around the globe. Beckman Coulter offers a unique combination of people, processes and solutions designed to elevate the performance of clinical laboratories and healthcare networks. We do this by accelerating care with a menu that matters, bringing the benefit of automation to all, delivering greater insights through clinical informatics and unlocking hidden value through performance partnership. An operating company of Danaher Corporation since 2011, Beckman Coulter is headquartered in Brea, Calif., and has more than 11,000 global associates working diligently to make the world a healthier place.
EUROIMMUN Launches Quantitative ELISA to Measure SARS-CoV-2 Antibodies Against Viral S1 Protein
9 November 2020 - Underscores importance of serological testing using the S1 subunit for worldwide seroprevalence and vaccine development
WALTHAM, Mass., Nov. 9, 2020 -- PerkinElmer, Inc., a global leader committed to innovating for a healthier world, announced today that EUROIMMUN, a PerkinElmer company, has launched the Anti-SARS-CoV-2 QuantiVacTM ELISA (IgG) to quantify IgG antibodies against the SARS-CoV-2 S1 antigen. The assay is available for countries accepting the CE mark, and the Company plans to file a request for this product with the U.S. Food and Drug Administration for Emergency Use Authorization (EUA).
This quantitative test kit applies a recombinant S1 subunit of the SARS-CoV-2 spike protein, enabling detection of IgG antibodies. These antibodies have been the focus of vaccine development programs as well as discussions about possible immunity in previously infected individuals. With this new ELISA assay, EUROIMMUN is providing a product to support careful evaluation of an important antibody subgroup enabling standard curve-based quantification of the anti-S1 IgG antibody concentration.
“The global research and medical community is focused on having an effective SARS-CoV-2 vaccine available as soon as possible, but to do so, it’s clear that the quantitative measurement of antibodies in clinical studies will play a huge part,“ said Dr. Wolfgang Schlumberger, CEO of EUROIMMUN. “The EUROIMMUN assays, especially the S1-based tests, are important tools for pharmaceutical laboratories conducting clinical trials. Our assays can help to identify individuals who have been exposed to SARS-CoV-2 and may play a critical role in accurate evaluation of antibody status before and after infection, in antibody therapies or in vaccination programs.”
The QuantiVac ELISA assay adds to the Company’s broad product portfolio of COVID-19 diagnostics and is based on the CE-marked and FDA EUA-approved semi quantitative/qualitative Anti-SARS-CoV-2 ELISA (IgG).
EUROIMMUN has increased its ELISA production for COVID-19 diagnostics to more than three million tests per week and can supply large numbers of dried blood spot collection sets for upcoming seroprevalence and vaccination development studies. Large international reference laboratories have implemented EUROIMMUN SARS-CoV-2 assays, and the tests are being applied in an increasing number of epidemiological studies worldwide.
About PerkinElmer
PerkinElmer enables scientists, researchers and clinicians to address their most critical challenges across science and healthcare. With a mission focused on innovating for a healthier world, we deliver unique solutions to serve the diagnostics, life sciences, food and applied markets. We strategically partner with customers to enable earlier and more accurate insights supported by deep market knowledge and technical expertise. Our dedicated team of about 13,000 employees worldwide is passionate about helping customers work to create healthier families, improve the quality of life, and sustain the wellbeing and longevity of people globally. The Company reported revenue of approximately $2.9 billion in 2019, serves customers in 190 countries, and is a component of the S&P 500 index. Additional information is available through 1-877-PKI-NYSE, or at www.perkinelmer.com.
Sysmex Presents Academic Report with a View to Creating a Simple Method of Diagnosing Alzheimer’s Disease Using Blood - CTAD
9 November 2020 - The content presented at the 13th clinical trials on Alzheimer’s disease (CTAD) Conference
9 November 2020 -- Sysmex Corporation (HQ: Kobe, Japan; Chairman and CEO: Hisashi Ietsugu; "Sysmex") and Eisai Co., Ltd. (HQ: Tokyo, Japan; CEO: Haruto Naito; "Eisai") announced that the most recent data from the project to develop a method of diagnosing Alzheimer’s disease (AD) using blood plasma was presented at the 13th Clinical Trials on Alzheimer's Disease (CTAD) conference, held virtually from November 4 to 7, 2020. Sysmex demonstrated on behalf of the two companies the performance of the amyloid beta (Aβ) in plasma measured on Sysmex's HISCLTM fully automated immunoassay analyzers in predicting amyloid pathology as defined by amyloid positron emission tomography (PET) imaging on the centiloid scale.
The total number of those living with dementia across the world is projected to reach 82 million in 2030 and 152 million in 2050, with the total global societal cost of dementia stemming from direct medical and social care costs and lower productivity being estimated to reach 2 trillion USD in 2030. In Japan, the number of those with dementia is thought to have reached approximately 4.62 million in 2012 and is projected to grow to 7.30 million in 2025, with the total societal cost of this disease being estimated to be equivalent to 4.1% of the gross domestic product (GDP) in 2025 (25.8 trillion yen). Of these sufferers, those living with AD are thought to account for more than 60% of those living with dementia.
It is conceivable that AD is a disease that results in synaptic dysfunction and neuronal cell death due to tau deposition in neurons triggered by Aβ aggregation on the outside of neurons. These brain changes cause cognitive impairment and psychological and behavioral symptoms, suggesting that the Aβ aggregation and accumulation inside the brain is caused by AD before the presence of cognitive impairment appears, thus, it is believed that early diagnosis and early intervention is more effective in therapies targeting Aβ. Currently, amyloid PET and Aβ ratio in cerebrospinal fluid (CSF) are used for detecting amyloid aggregates in the brain, but this puts significant burden on patients in terms of access, costs, and their physical wellbeing.
Sysmex and Eisai are working to create new diagnostic technologies for the prevention and treatment of dementia. Accordingly, the overarching aim is to contribute to the advancement of healthcare and improve the quality of life for those living with the disease and their families.
About the collaboration between Sysmex and Eisai
In February 2016, Sysmex and Eisai signed a comprehensive non-exclusive agreement aimed at the development of new diagnostic tests in the field of dementia. By leveraging each other’s technologies and knowledge, the objective has been to discover next-generation diagnostic reagents that will enable early diagnosis of dementia, selection of the most appropriate treatment options, and regular monitoring of the effects of such treatments. At the 12th CTAD held in December 2019, the two companies reported on the performance of the plasma Aβ ratio measured on a fully automated immunoassay system HISCL in predicting the amyloid PET scan results (sensitivity: 73%, specificity: 71% [AUC = 0.74]), thus demonstrating the potential to predict amyloid pathology in the brain using the plasma Aβ ratio.* This finding was expected to lead to the development of a simple method of diagnosing Alzheimer's disease using blood.
RECOVERY trial data monitoring committee recommends continuing evaluation of REGN-COV2 in all hospitalized patients
5 November 2020
5 November 2020 -- Regeneron announced today an update from the independent data monitoring committee (DMC) for the United Kingdom-based RECOVERY trial evaluating REGN-COV2 in hospitalized patients with COVID-19. The DMC reviewed available safety and efficacy data for the 15,545 total patients randomized, including the 325 patients who were in the arm randomized to receive either REGN-COV2 or control. The DMC advised that, in the light of these data and the available external information, they saw no cogent reason to modify the protocol or intake to the study and recommended continuing recruitment of eligible patients to all study arms.
The DMC letter is available here: https://www.recoverytrial.net/for-site-staff/site-set-up-1/data-monitoring-committee-correspondence.
About the Trial
The RECOVERY trial is conducted by the registered clinical trials units in the Nuffield Department of Population Health in partnership with the Nuffield Department of Medicine. The trial is supported by a grant to the University of Oxford from UK Research and Innovation/National Institute for Health Research (NIHR) and by core funding provided by NIHR Oxford Biomedical Research Centre, Wellcome, the Bill and Melinda Gates Foundation, the Department for International Development, Health Data Research UK, the Medical Research Council Population Health Research Unit and NIHR Clinical Trials Unit Support Funding.
The trial involves many thousands of doctors, nurses, pharmacists, and research administrators at 176 hospitals across the whole of the UK, supported by staff at the NIHR Clinical Research Network, NHS DigiTrials, Public Health England, Department of Health & Social Care, the Intensive Care National Audit & Research Centre, Public Health Scotland, the Secure Anonymised Information Linkage at University of Swansea, and the NHS in England, Scotland, Wales and Northern Ireland.
REGN-COV2's development and manufacturing has been funded in part with federal funds from the Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response at the U.S. Department of Health and Human Services under OT number: HHSO100201700020C. Regeneron has partnered with Roche to increase the global supply of REGN-COV2 beginning in 2021. If REGN-COV2 proves safe and effective in clinical trials and regulatory approvals are granted, Regeneron will manufacture and distribute it in the U.S. and Roche will develop, manufacture and distribute it outside the U.S.
BD Receives Order from Dutch Ministry of Health for More than Nine Million 15-minute COVID-19 Antigen Tests
2 November 2020 - The first shipment of 1.2 million SARS-CoV-2 Assays for use on the BD Veritor™ Plus System to be delivered in The Netherlands by mid-November
THE HAGUE, NETHERLANDS and FRANKLIN LAKES, N.J., Nov. 2, 2020 -- BD (Becton, Dickinson and Company), a leading global medical technology company, today announced the receipt of an order from the Dutch Ministry of Health for 9.2 million of its rapid, point-of-care, SARS-CoV-2 antigen tests for use on the BD Veritor™ Plus System, which detects SARS-CoV-2 in symptomatic patients in approximately 15 minutes. The first 1.2 million units will be delivered by mid-November.
This is the first government contract in Europe for this test, which was CE marked to the IVD Directive (98/79/EC) in September. The Dutch Ministry of Health increased its initial order by 8 million assays to improve testing capacity. BD expects the order to be fulfilled by June 2021.
"We're proud to be working with the Dutch Ministry of Health to expand rapid testing for SARS-CoV-2. This test will be critical to aid rapid diagnosis and decision making," says Fernand Goldblat, vice president and general manager, Integrated Diagnostic Solutions, Europe at BD. "This rapid game-changing test is the latest effort in BD's comprehensive response to address the world's critical health needs during the global pandemic."
The BD Veritor™ Plus System is a portable, easy-to-use device that makes it an ideal solution for point-of-care settings. The BD Veritor™ Plus System is already in use across Europe to detect Influenza A+B, Respiratory Syncytial Virus (RSV), and Group A Strep. The SARS-CoV-2 assay has been available in the United States since July through an Emergency Use Authorization by the U.S. Food and Drug Administration (FDA).
For Product Enquiries and How to Order:
All BD SARS-CoV-2 diagnostic products have regulatory authorizations in the markets where they are sold. European customers interested in BD diagnostic solutions for SARS-CoV-2 should visit bd.com/VeritorSystem-EU or contact BD's local customer service.
About BD Veritor™ System for Rapid Detection of SARS-CoV-2 Assay
The BD Veritor™ Plus System for Rapid Detection of SARS-CoV-2 Assay has been CE marked to the IVD Directive (98/79/EC), but has not been cleared or approved by FDA. The test has been authorized by FDA under an Emergency Use Authorization (EUA) for use by authorized laboratories. The test has been authorized only for the detection of proteins from SARS-CoV-2, not for any other viruses or pathogens; and, the test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner. The BD Veritor™ Plus System for Rapid Detection of SARS-CoV-2 Assay is not authorized for use by consumers or for at-home use.
About BD
BD is one of the largest global medical technology companies in the world and is advancing the world of health by improving medical discovery, diagnostics and the delivery of care. The company supports the heroes on the frontlines of health care by developing innovative technology, services and solutions that help advance both clinical therapy for patients and clinical process for health care providers. BD and its 65,000 employees have a passion and commitment to help enhance the safety and efficiency of clinicians' care delivery process, enable laboratory scientists to accurately detect disease and advance researchers' capabilities to develop the next generation of diagnostics and therapeutics. BD has a presence in virtually every country and partners with organizations around the world to address some of the most challenging global health issues. By working in close collaboration with customers, BD can help enhance outcomes, lower costs, increase efficiencies, improve safety and expand access to health care.
Hologic Awarded U.S. Government Contract to Expand COVID-19 Test Production Capacity
30 October 2020 - $119 Million Contract Will Support Scale Up to 13 Million Tests Per Month for U.S. Market
MARLBOROUGH, Mass., 30 October 2020 -- Hologic, Inc. announced today that it has been awarded a $119 million contract from the United States government to expand its production capacity for COVID-19 molecular tests. The contract will support capital and labor investments enabling Hologic to provide 13 million COVID-19 tests per month for the U.S. market by January of 2022.
Hologic’s Panther Fusion® SARS-CoV-2 Assay and Aptima® SARS-CoV-2 Assay received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration in March 2020 and May 2020, respectively. The tests run on the Company’s fully automated Panther Fusion® and Panther® systems, which provide initial results in approximately three hours and process more than 1,000 tests in 24 hours. More than 2,000 of these systems have been installed in clinical diagnostic laboratories around the world, including in all 50 U.S. states.
“Hologic has already made significant investments in our test production capacity, which have resulted in our contributing tens of millions of COVID tests to the United States supply,” said Kevin Thornal, president of the Diagnostic Solutions Division at Hologic. “Our manufacturing teams continue to innovate to increase our contribution, and we are very pleased to partner with the federal government to further our ability to meet the ongoing public health need.”
The Department of Defense Joint Rapid Acquisition Cell collaborated with the Department of the Air Force’s Acquisition COVID-19 Task Force and the Biomedical Advanced Research and Development Authority (BARDA), part of the HHS Office of the Assistant Secretary for Preparedness and Response, to award the contract with BARDA funding. BARDA is also separately supporting development of Hologic’s COVID-19 assays.
About the Panther and Panther Fusion Systems
The Panther molecular diagnostics system is a best-in-class, fully automated, sample-to-result platform that can be used in low-, medium- or high-throughput laboratories. With a small footprint, adaptable workflow options and consolidated testing menu, it combines women’s health, sexually transmitted infections and viral testing, which can all be done simultaneously. In addition, patient samples can be loaded onto the Panther system as they arrive in the laboratory, a capability known as “random access” that improves efficiency and workflow. Overall, the instrument’s high throughput and quick turnaround time enable more patients to get results sooner.
The Panther Fusion system adds PCR (polymerase chain reaction) chemistry and provides an expanded in vitro diagnostics menu, as well as Open Access functionality to run laboratory developed tests. Together, the Panther and Panther Fusion systems now offer 16 FDA-cleared assays and 20 CE-marked assays that detect more than 20 pathogens.
About Hologic
Hologic, Inc. is an innovative medical technology company primarily focused on improving women’s health and well-being through early detection and treatment. For more information on Hologic, visit www.hologic.com.
PerkinElmer COVID-19 Test Kit Receives FDA Emergency Use Authorization for Sample Pooling
29 October 2020 - Latest testing strategy to increase the sample processing efficiency
WALTHAM, Mass., Oct. 29, 2020 -- PerkinElmer, Inc. announced today that the U.S. Food and Drug Administration (FDA) has issued Emergency Use Authorization (EUA) to allow sample pooling with PerkinElmer® New Coronavirus Nucleic Acid Detection Kit to increase the number of individuals who can be tested without increasing resources. This validation of batch testing using the industry’s most sensitive assay to date according to the FDA Reference Panel leverages its proven ability to detect low amounts of viral genetic material.
Laboratories certified under the Clinical Laboratory Improvement Amendments (CLIA) can now use PerkinElmer’s real-time RT-PCR in vitro diagnostic assay for COVID-19 to pool multiple samples together using the resources needed for a single test. If a pooled test is negative, all the individual samples are considered negative. If the pooled test is positive, each of the individual samples in that pool should be tested again separately to determine which of the samples are positive. For sample pooling to be effective, screening using a highly sensitive test is integral.
From comparative data released by the FDA, the PerkinElmer New Coronavirus Nucleic Acid Detection Kit has the lowest Limit of Detection (LoD) among the authorized COVID-19 molecular diagnostic tests reported, deeming it the most sensitive assay that can detect 3-fold less viral material in samples compared to the assay in second place, and over 90-fold times less viral material in samples compared to the industry average.
“The FDA has recognized that there is great interest in sample pooling to test for COVID-19,” said Masoud Toloue, Ph.D., Vice President and General Manager, Diagnostics, PerkinElmer. “The ability to pool samples using a highly sensitive RT-PCR test offers diagnostic labs an efficient and accurate way to increase testing capacity.”
PerkinElmer has been on the front lines of improving COVID-19 test turnaround times enabled by increasing production capacity of viral RNA extraction, RT-PCR tests and live streaming availability status to meet evolving public health needs.
PerkinElmer is actively working with specialty and reference diagnostic labs, clinics, hospitals, pharmaceutical and biopharmaceutical labs, academia, and governmental and research institutes to battle the pandemic. PerkinElmer’s comprehensive SARS-CoV-2 offerings span high throughput RNA extraction, RT-PCR, automation, ELISA, chemiluminescence, time-resolved fluorescence and lateral flow based serology testing.
About PerkinElmer
PerkinElmer enables scientists, researchers, and clinicians to address their most critical challenges across science and healthcare. With a mission focused on innovating for a healthier world, we deliver unique solutions to serve the diagnostics, life sciences, food, and applied markets. We strategically partner with customers to enable earlier and more accurate insights supported by deep market knowledge and technical expertise. Our dedicated team of about 13,000 employees worldwide is passionate about helping customers work to create healthier families, improve the quality of life, and sustain the wellbeing and longevity of people globally. The Company reported revenue of approximately $2.9 billion in 2019, serves customers in 190 countries, and is a component of the S&P 500 index. Additional information is available through 1-877-PKI-NYSE, or at www.perkinelmer.com
Merck Collaborates with Mammoth Biosciences to Scale New SARS-CoV-2 Test
29 October 2020 - Life Science business to serve as contract manufacturer for Mammoth’s new DETECTR BOOST™ SARS-CoV-2 Reagent Kit — a high-throughput Covid-19 test to be made available in the United States. Mammoth recently secured funding from the National Institute of Health’s RADx program to scale its CRISPR-based testing workflow. Once approved, new test will help laboratories increase testing capacity and decrease turnaround time for results.
Darmstadt, Germany, October 29, 2020 — Merck, a leading science and technology company, today announced a collaboration with Mammoth Biosciences Inc., of South San Francisco, California, USA, for the development, scale-up and commercial production of Mammoth’s CRISPR-based SARS CoV-2 diagnostic test. Mammoth’s high-throughput systems will be compatible with both nasal swab and saliva samples and are targeting approximately 1,500 tests per 8-hour shift with minimal user interaction. Mammoth Biosciences plans to submit the assay for FDA Emergency Use Authorization later this year.
“This collaboration will allow us to help Mammoth with the development and production of their new SARS-CoV-2 test, which, once approved by the FDA, will increase testing capacity here in the U.S. at the scale needed to combat this pandemic,” said Jean-Charles Wirth, head of Applied Solutions, Life Science, at Merck. “Merck is helping to advance the future of testing at scale. This is an important step in detecting Covid-19 quickly.”
The Life Science business of Merck will serve as the contract manufacturer of the DETECTR BOOST™ SARS-CoV-2 Reagent Kit, which will use standard, automated liquid handling equipment to allow rapid processing of patient samples. With this new test, Clinical Laboratory Improvement Amendments labs in the U.S. will be able to significantly improve capacity to regularly perform testing. According to Mammoth, the new test is expected to use a CRISPR-based workflow that reduces the time required for testing while maintaining the gold standard accuracy of Polymerase Chain Reaction expected by lab operators.
“Leveraging the proven manufacturing and product leadership of the Life Science business of Merck is critical to Mammoth delivering a CRISPR-based diagnostic solution to labs,” said Janice Chen, Ph.D., co-founder and chief technology officer of Mammoth Biosciences. “We have the opportunity to make a tremendous positive impact on the pandemic by enabling the further scale-up of our nation’s testing capacity.”
Mammoth recently secured funding from the National Institute of Health’s RADx program to scale its CRISPR-based testing workflow.
The Applied Solutions business unit, part of the Life Science business of Merck, offers a broad range of products and services for clinical and diagnostic testing laboratories as well as the food and beverage industry. It provides technologies that streamline processes, lower costs and deliver consistent, reliable results. The production will take place at the business’ Life Science Center in St. Louis, Missouri, USA.
Merck is committed to the fight against Covid-19. The company’s products are being used by scientists around the world to develop more than 50 vaccine candidates, more than 35 testing solutions and more than 20 monoclonal antibodies, plasma products and antivirals to combat the virus.
About Merck
Merck, a leading science and technology company, operates across healthcare, life science and performance materials. Around 57,000 employees work to make a positive difference to millions of people’s lives every day by creating more joyful and sustainable ways to live. From advancing gene editing technologies and discovering unique ways to treat the most challenging diseases to enabling the intelligence of devices – the company is everywhere. In 2019, Merck generated sales of €16.2 billion in 66 countries.
Scientific exploration and responsible entrepreneurship have been key to Merck’s technological and scientific advances. This is how Merck has thrived since its founding in 1668. The founding family remains the majority owner of the publicly listed company. Merck holds the global rights to the Merck name and brand. The only exceptions are the United States and Canada, where the business sectors of Merck operate as EMD Serono in healthcare, MilliporeSigma in life science and EMD Performance Materials.
Reference: https://www.merckmillipore.com/DE/de/20201028_185118
PerkinElmer Launches Industry First No-Wash Immunoassay For Phospho Ubiquitin Ser65 to Help Drive Neuroscience Disease and Therapeutics Research Forward
26 October 2020 - New kit provides highly sensitive and efficient approach for studying mitophagy impairment in conditions such as Parkinson’s and Alzheimer’s
WALTHAM, Mass., October 26, 2020 – PerkinElmer, Inc., a global leader committed to innovating for a healthier world, today launched the life science industry’s first no wash Ubiquitin phosphorylation at Serine 65 immunoassay for studying defective mitophagy biological mechanisms that have been broadly associated with diseases such as Parkinson’s and Alzheimer’s. The new PerkinElmer Cisbio HTRF® Phospho-Ubiquitin (Ser65) Cellular Kit takes analysis efficiency and accuracy to the next level compared to existing techniques such as Western blot and is aimed at helping scientists discover new therapeutic candidates earlier in the disease cycle.
The innovative assay leverages TR-FRET technology to bring high sensitivity across a wide range of analytes and greater study specificity to the Phospho-Ubiquitin (Ser65) intersection point that has been shown to play a key role in mitophagy dysfunction and breakdowns in the complex network between neurons and glial cells which can lead to neurodegenerative disease.
Efficient and streamlined workflows and accelerated data delivery are also provided by the immunoassay’s mix and read method approach and compatibility with microplate readers such as PerkinElmer’s VictorTM Nivo® or EnVision® systems. Analysis can also be automated and run in high throughput formats.
“With over 70 Million people around the world living with Alzheimer’s and Parkinson’s and the sheer complexity of how neurodegenerative disease develops in the brain, it is critical that scientists have the tools they need to help unlock promising avenues of study such as modulating mitophagy impairment,” said Alan Fletcher, VP and GM of Life Sciences, PerkinElmer. “With this new immunoassay, researchers now have a more efficient and effective way to study a key biomarker which could lead to exciting new therapeutic candidates.”
The new PerkinElmer Cisbio HTRF Phospho-Ubiquitin (Ser65) Cellular Kit, joins PerkinElmer’s range of immunoassay kits and reagents for neuroscience applications across HTRF, Alpha, LANCE® and DELFIA®. For more information please visit: https://learn.cisbio.com/lp/guide-neurodegenerative-diseases-and-neuroinflammation-pathways; https://uk.cisbio.eu/dd/by-universe/neuroscience
About PerkinElmer
PerkinElmer enables scientists, researchers and clinicians to address their most critical challenges across science and healthcare. With a mission focused on innovating for a healthier world, we deliver unique solutions to serve the diagnostics, life sciences, food and applied markets. We strategically partner with customers to enable earlier and more accurate insights supported by deep market knowledge and technical expertise. Our dedicated team of about 13,000 employees worldwide is passionate about helping customers work to create healthier families, improve the quality of life, and sustain the wellbeing and longevity of people globally. The Company reported revenue of approximately $2.9 billion in 2019, serves customers in 190 countries, and is a component of the S&P 500 index. Additional information is available through 1-877-PKI-NYSE, or at www.perkinelmer.com.
Point-of-care solution to detect SARS-CoV-2 in saliva
22 October 2020
22 October 2020 -- genedrive plc, the near patient molecular diagnostics company, announces it has completed the assay design for the Company’s Point-of-Care (“POC”) solution for COVID-19 testing and is now generating very promising analytical data aligned to market requirements.
The Genedrive® SARS-CoV-2 Kit is being designed to detect SARS-CoV-2, the virus causing COVID-19, amplified directly from a saliva sample without the need to extract viral RNA. This expands the potential use areas of the product and importantly, allows for rapid testing to be performed while a patient is present. When running on the Genedrive® POC device the chemistry is detecting a positive SAR-CoV-2 sample in approximately 15 minutes, with fully negative samples taking just over 20 minutes to resolve. The limit of detection is in line with the UK’s MHRA Target Product Profile sensitivity requirements.
The Genedrive SARS-CoV-2 POC Kit follows a similar workflow that has already been validated in the Company’s Genedrive® HCV-ID Kit which received WHO pre-qualification earlier this year.
The Company is targeting the end of the calendar year for completion of preliminary product evaluations, with full release of the final CE Marked system in Q1 2021 allowing for thorough clinical testing requirements. Additionally, the Company is working to progress to a version 2 of the product, which would accept a similar freeze-dried PCR bead format previously developed for the high throughput Genedrive® 96 SARS-CoV-2 Kit. This will allow for lower production costs and highly scalable manufacturing capacity.
David Budd, Chief Executive Officer of genedrive plc, said: “Rapid testing for current infection is a cornerstone to any track and trace programme, to quickly accessing current infection, to limiting infection, and to giving assurance to people concerned about their status. We believe the Genedrive® POC solution can contribute significantly to the ongoing management of this global health crisis.”
Reference: https://www.genedrive.com/news/index.php
Complete molecular solution for SARS-COV-2
21 October 2020
21 October 2020 -- Launch Diagnostics has increased its molecular diagnostic solution for SARS-CoV-2 with the addition of the Bosphore Novel Coronavirus (2019-nCoV) Detection kit v4 which is capable of detecting three different genes of SARS-CoV-2 in a single mix and the Bosphore SARS-CoV/Flu/RSV Panel kit.
Both assays are compatible with many open system platforms.
The GenomEra is a sample to answer instrument and the GenomEra SARS-CoV-2 assay; requires no sample extraction and with a run time of only 70 minutes .
To complete the molecular portfolio, AmpliRun and AmpiRun Total molecular controls from Vircell are external quality controls for nucleic acid detection.
Reference: https://www.launchdiagnostics.com/complete-molecular-solution-for-sars-cov-2/
CerTest Biotec and BD Announce CE Mark for Combination COVID-19, Influenza, RSV Test on BD MAX™ Molecular Diagnostic System
21 October 2020
ZARAGOZA, Spain and FRANKLIN LAKES, N.J., Oct. 21, 2020 -- CerTest Biotec, along with BD (Becton, Dickinson and Company), a leading global medical technology company, today announced that the VIASURE SARS-CoV-2 (N1 + N2) Real Time PCR Detection Kit adapted for the BD MAX™ System has been CE marked to the IVD Directive (98/79/EC).
This kit allows BD MAX™ System users to run a single module that tests concurrently for COVID-19 and Influenza (Flu) and Respiratory Syncytial Virus (RSV).
"The new CerTest kit will provide rapid COVID-19 diagnostic capabilities that can be run individually or combined with detection of Flu A, Flu B and RSV A and B," said Nelson Fernandes, managing director of CerTest Biotec. "As we enter flu season, the ability to test for both COVID-19 and Flu at the same time will speed diagnosis and, ultimately, treatment."
The BD MAX™ System, a molecular diagnostic platform, is widely used in hundreds of laboratories across Europe. Each unit can return results in two to three hours and is capable of analyzing hundreds of samples over a 24-hour period.
"Together with CerTest, we can offer our customers in Europe a complete solution for COVID-19 diagnostics during the winter season," said Nikos Pavlidis, vice president of Molecular Diagnostics and Women's Health for BD. "By leveraging our significant installed base and the versatility of the BD MAX System, this test will greatly enhance capacity for SARS-CoV-2 and Influenza testing, enabling clinicians to rapidly diagnose patients and help reduce the spread of COVID-19."
The CerTest tests snaps into the test-specific position on the BD MAX™ ExK™ TNA extraction strip, supplied by BD.
VIASURE SARS-CoV-2 (N1+N2) Real Time PCR Detection Kit for the BD MAX™ System and the VIASURE Flu A, Flu B & RSV Real Time PCR Detection Kit for the BD MAX™ System are sold through BD's network and are not available for sale in the United States. To locate an authorized BD representative or request information, visit: www.bd.com or www.certest.es
About CerTest
CerTest Biotec is a European company established in 2002 for the development and manufacturing of in vitro diagnostic medical devices.
Today, CerTest is a global company structured around 5 business units offering one of the widest portfolios for human In Vitro Diagnostic. The company bases its future on a strong technical knowledge and expertise in the detection of human diseases.
CerTest last generation laboratories, state-of-the-art technical equipment and skilled professionals are the keys for providing reliable solutions for the medical diagnostic professional.
About BD
BD is one of the largest global medical technology companies in the world and is advancing the world of health by improving medical discovery, diagnostics and the delivery of care. The company supports the heroes on the frontlines of health care by developing innovative technology, services and solutions that help advance both clinical therapy for patients and clinical process for health care providers. BD and its 65,000 employees have a passion and commitment to help enhance the safety and efficiency of clinicians' care delivery process, enable laboratory scientists to accurately detect disease and advance researchers' capabilities to develop the next generation of diagnostics and therapeutics. BD has a presence in virtually every country and partners with organizations around the world to address some of the most challenging global health issues. By working in close collaboration with customers, BD can help enhance outcomes, lower costs, increase efficiencies, improve safety and expand access to health care. For more information on BD, please visit bd.com.
PerkinElmer Immunoassay Helps NIH NCATS Team Identify Therapeutic Compounds Capable of Disrupting the SARS-CoV-2 Spike Protein/ACE2 Interaction
20 October 2020 - Findings shared on open data portal to help in global pursuit of drug repurposing candidates for COVID-19
WALTHAM, Mass., Oct. 20, 2020 -- PerkinElmer, Inc., a global leader committed to innovating for a healthier world, today announced that a research team at the National Center for Advancing Translational Sciences (NCATS), an arm of the National Institutes of Health (NIH), is working with PerkinElmer’s AlphaLISA® immunoassay to help support the global search for effective COVID-19 therapeutics.
The NCATS research project is focused on studying small molecule drug compounds that are already approved and in use as treatments but could potentially be repurposed for COVID-19.
The goal of the project is to quickly and reliably identify which small molecule compounds can best disrupt key proteins that bind together to allow for SARS-CoV-2 infection -- the S1 spike protein and the host ACE2 receptor.
Using PerkinElmer’s AlphaLISA assay, the NCATS team has been able to efficiently and accurately screen 3,384 molecular entities and narrow them down to a field of 25 quality therapeutic compounds or “hits”. The whole process, from assay development and optimization through screening, has been achieved in just a few months.
The AlphaLISA technology is a homogeneous (no-wash) assay that works by generating a light emission in response to a biomolecular interaction which results in proximity of the bead-binding complex. The platform can be used to detect and quantitate biomolecules of almost any size in both simple and complex sample types. Its bead-based, luminescent, signal amplification provides increased sensitivity, a wide dynamic range and potential assay miniaturization.
Speaking to the aim and contribution of the NCATS project, Dr. Quinlin Hanson, co-leader of the research effort and a Postdoctoral Fellow at NCATS said, “Our immediate goal was to develop a sensitive and robust assay platform that scientists could use as a template for screening small molecule compounds that might lead to further drug development. To share our learnings and support collaboration, we’ve posted our work on the NCATS Open Data Portal. Now our team will conduct additional testing on select molecules and make that information available to the scientific community as well when ready.”
Commenting on the importance of leveraging innovative approaches to help tackle COVID-19, Alan Fletcher, Vice President and General Manager, Life Sciences, PerkinElmer, added, “COVID-19 is inspiring research teams around the world to work in new ways -- both individually and collectively -- to tackle this universal health crisis. The research being done by the NCATS team around therapeutic compounds and the SARS-COV-2 spike protein is an important contribution to discovery efforts and we are delighted that our AlphaLISA technology is playing a role.”
The AlphaLISA technology is part of PerkinElmer’s testing and analysis portfolio that helps scientists around the globe fight COVID-19. From virus detection and therapeutic and vaccine discovery analysis to hand sanitizer testing, PerkinElmer’s innovations include research and diagnostics kits, assay platforms, instrumentation, automation solutions, informatics and custom services.
For more information, visit www.perkinelmer.com.
About PerkinElmer
PerkinElmer enables scientists, researchers and clinicians to address their most critical challenges across science and healthcare. With a mission focused on innovating for a healthier world, we deliver unique solutions to serve the diagnostics, life sciences, food and applied markets. We strategically partner with customers to enable earlier and more accurate insights supported by deep market knowledge and technical expertise. Our dedicated team of about 13,000 employees worldwide is passionate about helping customers work to create healthier families, improve the quality of life, and sustain the wellbeing and longevity of people globally. The Company reported revenue of approximately $2.9 billion in 2019, serves customers in 190 countries, and is a component of the S&P 500 index. Additional information is available through 1-877-PKI-NYSE, or at www.perkinelmer.com.
Thermo Fisher Scientific Increases Availability of COVID-19 Testing with Sample Collection Kit from Everlywell
19 October 2020
WALTHAM, Mass., Oct. 19, 2020 -- Thermo Fisher Scientific Inc., the world leader in serving science, announced it has received an expansion of its Emergency Use Authorization (EUA) for the TaqPath COVID-19 Combo Kit to include an additional sample collection method provided by Everlywell, a leading digital health testing company. The TaqPath test is authorized for use with the Everlywell COVID-19 Test Home Collection Kit, which enables individuals to self-collect nasal swab specimens when determined by a healthcare provider to be appropriate based on results of a COVID-19 questionnaire.
Samples collected using the Everlywell self-collection kit may be processed by CLIA-certified laboratories running Thermo Fisher's TaqMan SARS-CoV-2 RNase P Assay Kit, and the results obtained through the Everlywell online platform. This more convenient home-collection sample processing experience is expected to increase access to highly accurate PCR-based testing and complement other defensive measures including good hygiene, social distancing and wearing a mask.
"As part of our commitment to keep our workplaces safe and healthy, Thermo Fisher launched its own pilot program to provide at-home collection kits and online access to test results for more than 10,000 colleagues across the country," said Mark Stevenson, executive vice president and chief operating officer at Thermo Fisher Scientific. "Now, leveraging Everlywell's capabilities, we can expand our own use and offer other organizations the confidence to move forward with return-to-workplace strategies that reduce the risk of spreading the virus."
Julia Cheek, chief executive officer and founder of Everlywell, said, "Everlywell is a leader in at-home collection laboratory testing, providing access to dozens of essential lab tests through our digital platform. Joining forces with Thermo Fisher, one of the world's foremost life sciences and diagnostic companies, will expand our COVID-19 testing infrastructure and help keep workplaces, schools, and organizations safe over the coming months."
She added, "Accurate, convenient diagnostic testing is foundational to our country's efforts to reduce the spread of the virus. We are proud to support Thermo Fisher in these efforts."
About Thermo Fisher Scientific
Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $25 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, improving patient diagnostics and therapies or increasing productivity in their laboratories, we are here to support them. Our global team of more than 75,000 colleagues delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services and Patheon. For more information, please visit www.thermofisher.com.
LabCorp Launches Quantitative Antibody Test to Assess Effectiveness of COVID-19 Vaccines in Clinical Trials
19 October 2020 - Quantitative Test is Used to Assess Immune Response and to Support Other Scientific Research
BURLINGTON, N.C., Oct. 19, 2020 -- LabCorp, a leading global life sciences company that is focused on advancing health and guiding patient care, today announced a test that provides a quantitative measurement of an individual’s SARS-CoV-2 IgG antibodies. LabCorp’s Cov2Quant™ IgG test, which is available only for use in clinical trials and research, was developed to specifically detect and quantify antibodies to SARS-CoV-2, the virus that causes COVID-19. The level of antibodies is an important indicator of the strength of a person’s immune response, which can help determine the effectiveness of vaccines and therapies. Other COVID-19 antibody tests available in the market are qualitative and detect the presence of antibodies, but do not provide information on the individual’s antibody levels.
Pharmaceutical companies will be able to use the test to help evaluate the performance of vaccine candidates in clinical trials. While the level of antibodies needed to be considered immune to SARS-CoV-2 is yet to be determined, ongoing vaccine trials and research should help answer this question. The test is also currently being utilized by the Centers for Disease Control and Prevention (CDC) for SARS-CoV-2 seroprevalence studies to understand the level of antibodies produced through natural exposure and infection with the virus.
“Medical science and technology are the best ways to mitigate COVID-19, and our development of this quantitative assay is an important step in helping to bring effective treatments and vaccines to patients,” said Dr. Paul Kirchgraber, CEO of LabCorp’s drug development business unit, Covance. “LabCorp’s quantitative antibody test represents a significant advancement by giving scientists and researchers a more precise, detailed picture of the level of immune response. This will aid the scientific community as it works to characterize the immune response to SARS-CoV-2.”
The Cov2Quant IgG test is a continuation of LabCorp’s innovations and commitment to help physicians, health systems and patients manage the pandemic. Others include: the first commercially available COVID-19 RT-PCR test (March 5); first FDA Emergency Use Authorization (EUA) for at-home collection (April 20); first online consumer-initiated antibody testing (May 5); first digital service for physician-initiated patient collection (LabCorp At Home, July 7); first FDA EUA for asymptomatic testing and matrixed pool testing (July 24); first combined test for multiple respiratory infections including COVID-19 and flu (September 8); and first FDA EUA for a heat extraction method that improves test efficiency and throughput and for the use of matrixed pooling on samples collected by individuals outside of a healthcare setting (October 2).
LabCorp has performed more than 17 million molecular tests since first making the COVID-19 test available in March and is now able to process 210,000 tests per day, with plans to increase capacity further. The company also has performed 3 million COVID-19 antibody tests with the capacity to perform 300,000 per day.
About LabCorp
LabCorp, an S&P 500 company, is a leading global life sciences company that is deeply integrated in guiding patient care, providing comprehensive clinical laboratory and end-to-end drug development services. With a mission to improve health and improve lives, LabCorp delivers world-class diagnostics solutions, brings innovative medicines to patients faster, and uses technology to improve the delivery of care. LabCorp reported revenue of more than $11.5 billion in 2019.
To learn more about LabCorp, visit www.LabCorp.com, and to learn more about LabCorp’s drug development business, Covance, visit www.Covance.com.
BD Announces Assay for Immune Assessment of COVID-19 Patients Now Available in Europe
16 October 2020 - BD Multitest™ 6-Color TBNK Reagent with BD Trucount™ Tubes brings time-tested immune assessment solution to European clinicians treating COVID-19 patients
EYSINS, Switzerland, Oct. 16, 2020 – BD (Becton, Dickinson and Company), a leading global medical technology company, today announced the CE mark and European availability of a product for assessing immune function in COVID-19 patients.
The BD Multitest™ 6-Color TBNK Reagent with BD Trucount™ Tubes has been CE marked with expanded clinical application for the identification and enumeration of T-cell subtypes in COVID-19 patients, an innovation in helping clinicians better understand patient immune response to COVID-19 disease. Data from the first global wave of COVID-19 have shown that patients typically exhibit a remarkable decrease of CD4 and/or CD8 lymphocyte counts with increasing disease severity.
Accurate counts of T-cell subsets may be critical in informing the clinical course of action because T-cells are essential for viral killing and antibody response. The BD Multitest™ 6-Color TBNK Reagent with BD Trucount™ Tubes leverages time-tested technology for immune assessment and enables clinicians to go beyond the complete blood count (CBC) to better understand the underlying mechanisms for severity in COVID-19 patients, especially those with co-morbidities. This test has been used for more than a decade to assess immune function in HIV patients and may now also help clinicians better understand COVID-19 patient immune response, and when used in conjunction with clinical findings and laboratory testing, inform patient treatment plans and prioritize precious resources.
“The availability of this product with the expanded clinical application in COVID-19 patients is an important step in helping clinicians better understand how patient immune systems are responding to COVID-19 infection,” said Puneet Sarin, worldwide president, Biosciences at BD, “BD is a trusted partner in immunology research and clinical care with a long history helping clinicians and patients better understand immune function to make patient care decisions. Bringing this expertise to clinicians treating COVID-19 patients presents a great opportunity to enable deeper immune assessment of patients, which could lead to improved uses of precious resources within a hospital while helping get patients on the right clinical path.”
The BD Multitest™ 6-Color TBNK Reagent with BD Trucount™ Tubes is used in conjunction with the BD FACSLyric™ and BD FACSCanto™ II Clinical Flow Cytometers and the BD FACSLyric™/BD FACSDuet™ Sample-to-Answer Solution, which enables automated processing of samples, removing any unnecessary exposure to lab personnel.
About the BD Multitest™ 6-Color TBNK Reagent with BD Trucount™ Tubes
The BD Multitest™ 6-Color TBNK Reagent with BD Trucount™ Tubes is CE marked and is only available in the EU for COVID-19 Clinical Application.
The BD Multitest™ 6-Color TBNK Reagent with optional BD Trucount™ Tubes is a 6-color direct immunofluorescence reagent for use with a suitably equipped BD flow cytometer to identify and determine the percentages and absolute counts of T, B and natural killer (NK) cells, as well as the CD4 and CD8 subpopulations of T cells in peripheral blood. The BD Multitest™ 6-Color TBNK Reagent with BD Trucount™ Tubes can be used with the BD FACS™ Loader and the BD FACS™ Universal Loader.
Clinical Application
Determining counts of CD3+CD4+ and/or CD3+CD8+ lymphocytes may be useful in the immunological assessment of SARS-CoV-2 infected individuals with COVID-19 disease. Individuals with COVID-19 disease typically exhibit a decrease of CD3+CD4+ and/or CD3+CD8+ lymphocyte counts with increasing disease severity. For more information, visit www.bdbiosciences.com/Covid19-Tcell.
About BD
BD is one of the largest global medical technology companies in the world and is advancing the world of health™ by improving medical discovery, diagnostics and the delivery of care. The company supports the heroes on the frontlines of health care by developing innovative technology, services and solutions that help advance both clinical therapy for patients and clinical process for health care providers. BD and its 65,000 employees have a passion and commitment to help enhance the safety and efficiency of clinicians' care delivery process, enable laboratory scientists to accurately detect disease and advance researchers' capabilities to develop the next generation of diagnostics and therapeutics. BD has a presence in virtually every country and partners with organizations around the world to address some of the most challenging global health issues. By working in close collaboration with customers, BD can help enhance outcomes, lower costs, increase efficiencies, improve safety and expand access to health care. For more information on BD, please visit bd.com.
LGC’s multi-allergen reference material kit awarded ISO 17034 accreditation
16 October 2020
16 October 2020 -- LGC is delighted that the production of its first ever multi-allergen reference material kit containing five common allergens (milk, egg, almond, hazelnut, walnut), traceable to the SI (International System of Units), has been confirmed within the scope of its ISO 17034 accreditation.
The reference material kit, announced recently and produced by the LGC’s NML Reference Materials team, in collaboration with the University of Manchester and Romer Labs, is a world first. It will help scientists and industry by supporting method development to determine ‘true’ allergen content, and assist laboratories in monitoring the performance of methods on a day-to day basis.
Gill Holcombe, Head of the Reference Material Production Team, LGC said, “We are delighted that the RM kit is recognised by ISO accreditation. It is a fact that not many allergen RMs have this accreditation and this is confirmation that the kit has been prepared according to very exacting requirements. We hope this will ultimately improve the safety of food products for allergen sufferers.”
Gill Holcombe continued, “I am grateful to the Food Standards Agency and BEIS for funding the research that contributed to development of the RM. Food allergy is a serious and growing problem, with up to 2 million people in the UK estimated to be affected. In the absence of a currently accepted cure, these individuals must avoid eating problem foods throughout their life. This can be difficult to achieve in practice, as allergens can sometimes find their way into foods unintentionally, e.g. through use of common utensils and processing lines. Even very small quantities (as little as 1/100 of a gram) of a food such as peanut can cause an unwanted reaction in a person with peanut allergy”.
ISO 17034:2016 covers the production of all reference materials, including certified reference materials. It is intended as part of the general quality assurance procedures of the reference material producer.
The reference material kit consists of:
- five well-characterised individual common allergen foods (skimmed milk powder, egg white powder, almond, hazelnut and walnut flours),
- chocolate paste with all five added allergen food ingredients (fortified at 10 mg/kg as protein) and
- chocolate paste with no added allergen food ingredients (blank).
The Allergen RM kit is available to purchase from LGC Standards (reference LGC746-KT).
The allergen foods are also available for purchase as individual items. Click here for detailed statements of measurement for the allergen foods in the kit. The statement of measurement of the RM kit gives a wealth of detail on the composition of the RM, ELISA responses and conversion factors.
Siemens Healthineers Launches Rapid Antigen Test for the Detection of SARS-CoV-2
14 October 2020 - The CLINITEST Rapid COVID-19 Antigen Test helps identify infected individuals in 15 minutes so they can isolate sooner and avoid spreading COVID-19. Easy-to-use test, which doesn't require specialized laboratory personnel or instruments, offers flexibility to test in locations that benefit from immediate results. Test to be launched in CE mark countries; plans to submit to FDA for Emergency Use Authorization.
Erlangen, Germany, Oct 14, 2020 -- As society continues to navigate through the COVID-19 pandemic, there is a critical public health need to get ahead of the spread with a fast and simple testing for all. To address this need Siemens Healthineers is launching a rapid and easy-to-use antigen test for the detection of SARS-CoV-2, the virus that causes COVID-19. The CLINITEST Rapid COVID-19 Antigen Test1 is a point-of-care cassette test that does not require laboratory instruments or specialized lab personnel to administer, and it delivers results in 15 minutes.
The CE marked test which has been developed and tested by a Siemens Healthineers partner demonstrated 96.72 % sensitivity and 99.22 % specificity based on a clinical study of 317 subjects. The study was performed using operators with varied credentials at six diverse sites including a hospital, a community clinic, a college campus, and an oncology unit. Siemens Healthineers intends to meet such testing demand as the pandemic evolves. There are plans to submit the test for FDA Emergency Use Authorization.
“There is a great public need for reliable tests that can quickly identify contagious individuals and help to minimize the spread of COVID-19, especially in high-traffic areas and where people commonly congregate,” said Christoph Pedain, PhD, Head of Point of Care Diagnostics at Siemens Healthineers. “With quality at the forefront of decision makers’ criteria to determine test reliability, it was critical the clinical study for this test assesses variable clinical conditions that can be expected when implementing a rapid antigen test. This rapid antigen test makes testing available to more people across a wider variety of settings—particularly in locations that need to test people quickly such as airports or that have limited access to laboratory resources such as schools.”
The CLINITEST Rapid COVID-19 Antigen Test is easy to administer for healthcare professionals and delivers results quickly using the nasopharyngeal swab method. Once a sample is collected, the swab is inserted into a tube with special liquid to extract the target molecule. This liquid is then dispensed onto a test cassette and, in 15 minutes, a positive or negative result is clearly indicated.
In addition to the CLINITEST Rapid COVID-19 Antigen Test, Siemens Healthineers offers an extensive diagnostics portfolio to aid in the prognosis, treatment and follow up of COVID-19 patients. This test adds to the 15 critical assays Siemens Healthineers offers to detect severe symptoms and better manage critical COVID-19 patients. The company’s broad and differentiated menu includes antibody and molecular SARS-CoV-2 tests, and hematology, coagulation, cardiac, respiratory, inflammation and infectious disease panels. Blood gas and imaging solutions from Siemens Healthineers deliver actionable results that aid clinicians in caring for COVID-19 patients.
About Siemens Healthineers AG
Siemens Healthineers AG is shaping the future of Healthcare. As a leading medical technology company headquartered in Erlangen, Germany, Siemens Healthineers enables healthcare providers worldwide through its regional companies to increase value by empowering them on their journey towards expanding precision medicine, transforming care delivery, improving the patient experience, and digitalizing healthcare. Siemens Healthineers is continuously developing its product and service portfolio, with AI-supported applications and digital offerings that play an increasingly important role in the next generation of medical technology. These new applications will enhance the company’s foundation in in-vitro diagnostic, image-guided therapy, and in-vivo diagnostics. Siemens Healthineers also provides a range of services and solutions to enhance healthcare providers ability to provide high-quality, efficient care to patients. In fiscal 2019, which ended on September 30, 2019, Siemens Healthineers, which has approximately 52,000 employees worldwide, generated revenue of €14.5 billion and adjusted profit of €2.5 billion. Further information is available at www.siemens-healthineers.com.
Reference: https://www.siemens-healthineers.com/press-room/press-releases/covid-19-poc-rapid-antigentest.html
Roche to launch laboratory SARS-CoV-2 antigen test to support high-volume testing of suspected COVID-19 patients
13 October 2020 - The Elecsys® SARS-CoV-2 Antigen test is an automated laboratory assay intended as an aid in the diagnosis of SARS-CoV-2 infection. This new solution will run on all Roche cobas e immunochemistry analysers which are widely available around the world, thus helping to increase testing capacity. In combination with other COVID-19 diagnostic tests, the Elecsys SARS-CoV-2 Antigen test can help in the management of patients for optimal care delivery.
Basel, 13 October 2020 -- Roche announced today that it intends to launch a high-volume SARS-CoV-2 Antigen test as an aid in the diagnosis of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) infection. The test is planned to be made available at the end of 2020 for markets accepting the CE Mark. Roche also intends to file for Emergency Use Authorisation (EUA) from the U.S. Food and Drug Administration (FDA).
The Elecsys® SARS-CoV-2 Antigen test is a highly accurate laboratory immunoassay for the in vitro qualitative detection of the nucleocapsid antigen of SARS-CoV-2. The test is performed by healthcare professionals and uses nasopharyngeal or oropharyngeal swab samples from patients with signs and symptoms suggestive of COVID-19, or people with either known or suspected exposure to SARS-CoV-2.
The Elecsys SARS-CoV-2 Antigen immunoassay runs on all cobas e immunochemistry analysers which are widely available around the world. These fully automated systems can provide test results in 18 minutes for a single test (excluding time for sample collection, transport, and preparation), with a throughput of up to 300 tests per hour from a single analyser, depending on the analyser. A laboratory based automated antigen assay allows for cost and error reduction due to removal of manual handling as well as fast turn-around times and high test throughput.
Thomas Schinecker, CEO Roche Diagnostics, stated, “We are aware that governments and healthcare systems are under intense pressure to increase SARS-CoV-2 testing capacity to effectively manage the spread of the virus. A high-volume antigen test is a valuable addition to the testing portfolio for helping diagnose SARS-CoV-2 infection. Being able to quickly and correctly identify if someone has a SARS-CoV-2 infection is critical to informing patient management decisions and containing the spread of COVID-19. Roche remains committed to supporting governments, healthcare professionals and patients to fight this pandemic with the help of our diagnostics solutions.”
The test will be another addition to the comprehensive Roche diagnostic portfolio of solutions to help healthcare systems combat COVID-19 through testing in the laboratory and at the point of care. These solutions include both tests to detect an acute SARS-CoV-2 infection and tests measuring the body’s immune response upon infection or vaccination.
About the Elecsys SARS-CoV-2 Antigen test
Roche’s Elecsys SARS-CoV-2 Antigen test is an immunoassay intended for the qualitative detection of a specific antigen of SARS-CoV-2 present in the respiratory tract including nasopharynx and oropharynx. The Elecsys SARS-CoV-2 Antigen test is performed by healthcare professionals and could be used as an alternative or in conjunction with PCR testing. This is highly beneficial where reliable laboratory PCR testing is not available or where there are challenges in testing capacity. A positive result with the Elecsys SARS-CoV-2 Antigen test most likely indicates an active SARS-CoV-2 infection. A negative result may require to be confirmed with a PCR test or repeated (antigen test) after one to two days, if other clinical indications point to a SARS-CoV-2 infection. Performance evaluations around sensitivity and specificity of the test are ongoing and will be shared at the time of launch.
About antigen testing
An antigen test detects proteins which are structural or functional components of a pathogen and are thus very specific to that pathogen. In this case, the test would provide a qualitative “yes/no” answer on the presence of the pathogen in the patient sample. If the target antigen is present in sufficient concentrations in the sample, it will bind to specific antibodies and generate a positive result.
In general, antigen tests have a high specificity, though are not as sensitive as PCR tests that amplify the target viral DNA or RNA sequence in order to generate a quantifiable signal to indicate the presence of the virus in a sample. Therefore, to make up for the potential decrease in sensitivity of an antigen test, negative results should be analysed together with additional patient factors, such as COVID-19 exposure history, clinical symptoms, additional test results to help guide the diagnosis and subsequent treatment of the patient.
About Roche’s response to the COVID-19 pandemic
As a leading healthcare company we are doing all we can to support countries in minimising the impact of COVID-19. We have developed a growing number of diagnostic solutions that help to manage, detect and diagnose current and/or previous infection in patients, as well as providing digital support to healthcare systems. We continue to identify, develop and support potential therapies which can play a role in treating the disease.
We understand the impact of COVID-19 goes beyond those who contract it, which is why we are working with healthcare providers, laboratories, authorities and organisations to help make sure that patients continue to receive the tests, treatment and care they need during these challenging times. As we learn from the pandemic, we are partnering with governments and others to make healthcare stronger and more sustainable in the future.
Our diagnostics solutions:
Reliable, high-quality testing is essential to help healthcare systems overcome this pandemic. Our portfolio includes:
- a high-volume molecular test to detect SARS-CoV-2, the virus that causes COVID-19, (FDA Emergency Use Authorisation (EUA) and available in countries accepting the CE Mark)
- a SARS-CoV-2 laboratory-based qualitative antibody test, aimed at detecting the presence of antibodies in the blood targeting the nucleocapsid protein (FDA EUA and CE Mark)
- an IL-6 test to assist in identifying severe inflammatory response in patients with confirmed COVID-19 (FDA EUA and CE Mark)
- Roche v-TAC, which could help simplify the screening, diagnosis and monitoring of patients with respiratory compromise in the current COVID-19 pandemic
- a SARS-CoV-2 rapid antibody test to help determine at the point of care whether a person has been exposed to the virus (CE Mark)
- a rapid antigen test to support in the detection of SARS-CoV-2 at the point of care within 15 minutes (CE Mark)
- a high-volume molecular test to simultaneously detect and differentiate between SARS-CoV-2 and influenza A/B, as the symptoms are similar for both (FDA EUA and CE Mark)
- a second SARS-CoV-2 antibody test, aimed at measuring the spike protein to support vaccination development and complement our existing portfolio (CE Mark)
Our research into therapies:
Roche is committed to improving the treatment of COVID-19. We are actively involved in understanding the potential of our existing portfolio and are exploring the potential of our investigational molecules.
Specifically, on 19 March, we announced the initiation of COVACTA - a global Phase III randomised, double-blind, placebo-controlled clinical trial to evaluate the safety and efficacy of intravenous Actemra©/RoActemra© (tocilizumab) plus standard of care in hospitalised adult patients with severe COVID-19 pneumonia compared to placebo plus standard of care. On 29 July we announced that COVACTA did not meet its primary endpoint of improved clinical status in patients with COVID-19 associated pneumonia or the key secondary endpoint of reduced mortality.
Separately, we have studied Actemra©/RoActemra© in the EMPACTA study in COVID-19 associated hospitalised pneumonia in patients that are often underrepresented in clinical trials. On 18 September we announced that the phase III EMPACTA study showed Actemra/RoActemra plus standard of care reduced the likelihood of progression to mechanical ventilation or death in hospitalised patients with COVID-19 associated pneumonia compared to placebo plus standard of care. However, there was no statistical difference in mortality between patients who received Actemra/RoActemra or placebo.
Actemra©/RoActemra© is also being studied in combination with the investigational antiviral remdesivir in hospitalised patients with severe COVID-19 pneumonia in the REMDACTA trial in partnership with Gilead, announced 28 May. Actemra©/RoActemra© is not approved by any health authority for use in COVID-19 pneumonia. Roche has further initiated an internal early research programme focused on the development of medicines for COVID-19 and is engaged in multiple research collaborations.
In August we signed a collaboration agreement with Regeneron on developing and manufacturing and significantly increasing global supply of an investigational antibody combination for COVID-19 if it proves safe and effective in clinical trials and regulatory approvals are granted.
In these exceptional times, Roche stands together with governments, healthcare providers and all those working to overcome the pandemic.
About Roche
Roche is a global pioneer in pharmaceuticals and diagnostics focused on advancing science to improve people’s lives. The combined strengths of pharmaceuticals and diagnostics under one roof have made Roche the leader in personalised healthcare – a strategy that aims to fit the right treatment to each patient in the best way possible.
Roche is the world’s largest biotech company, with truly differentiated medicines in oncology, immunology, infectious diseases, ophthalmology and diseases of the central nervous system. Roche is also the world leader in in vitro diagnostics and tissue-based cancer diagnostics, and a frontrunner in diabetes management.
Founded in 1896, Roche continues to search for better ways to prevent, diagnose and treat diseases and make a sustainable contribution to society. The company also aims to improve patient access to medical innovations by working with all relevant stakeholders. More than thirty medicines developed by Roche are included in the World Health Organization Model Lists of Essential Medicines, among them life-saving antibiotics, antimalarials and cancer medicines. Moreover, for the eleventh consecutive year, Roche has been recognised as one of the most sustainable companies in the Pharmaceuticals Industry by the Dow Jones Sustainability Indices (DJSI).
The Roche Group, headquartered in Basel, Switzerland, is active in over 100 countries and in 2019 employed about 98,000 people worldwide. In 2019, Roche invested CHF 11.7 billion in R&D and posted sales of CHF 61.5 billion. Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan. For more information, please visit www.roche.com.
Reference: https://www.roche.com/media/releases/med-cor-2020-10-13.htm
BioGX Announces FDA Emergency Use Authorization Submission of Extraction-Free Direct RT-PCR Test for COVID-19
12 October 2020 - World’s Simplest High-Throughput RT-PCR Test for COVID-19 has the potential to increase testing capacity by millions per week
Birmingham, AL, October 12, 2020 – BioGX, a molecular diagnostics solutions company, announced FDA Emergency Use Authorization (EUA) submission of an extraction-free, direct sample addition RT-PCR test for detection of SARS-CoV-2 viral RNA in patients suspected of COVID-19.
The Xfree™ COVID-19 Direct RT-PCR test (“Xfree COVID-19”) is a complete test in a single vial, lyophilized in the trusted BioGX Sample-Ready™ format. The user would simply Just Add Water™, the patient sample, and run the test on a validated real-time PCR instrument.
“Xfree is a breakthrough in COVID-19 RT-PCR testing. Direct addition of patient samples without any pre-processing or extraction not only overcomes critical reagents supply issues, but also significantly shortens the results turnaround time. The fast and simple workflow is designed to help laboratories increase their testing capacity without adding expert personnel or new automation”, said Shazi Iqbal, Ph.D., CEO of BioGX.
“We believe Xfree is a game-changer. Xfree converts the most ubiquitous real-time PCR instruments into high throughput Sample-to-Answer machines – potentially augmenting the COVID-19 PCR testing capacity by millions”, said Michael Vickery, Ph.D., EVP & CSO of BioGX.
Xfree™ COVID-19 clinical performance study by direct, extraction-free testing of 77 patient samples demonstrated 98% Positive Percent Agreement (PPA) and 100% Negative Percent Agreement (NPA) when compared to the highly sensitive extraction-based BD-BioGX SARS-CoV-2 BD MAX™ test (FDA-EUA). Comparison with extracted viral RNA using QIAamp® DSP Viral RNA extraction kit (CDC EUA method) demonstrated 100% PPA and 100% NPA for Xfree™ COVID-19.
A single 96-well plate instrument can generate up to 1,500 test results every 24 hours, while a 384-well plate instrument can generate up to 6,000 test results. “Our current production capacity for the Xfree COVID-19 is nearly 2 million tests per week and can readily scale to 4 million per week. With efficient and early planning, we were able to secure long-term supply of critical raw materials to avoid any potential supply disruptions”, said Shahin Iqbal, Ph.D., SVP of Global Operations.
The Xfree™ COVID-19 test is validated for use on QuantStudio™ 5 and CFX Touch™ real-time PCR instruments with the most common specimen types – nasopharyngeal and oropharyngeal (throat) swabs with collections in UTM, UVT, VTM and saline. In addition to extraction-free direct testing, Xfree™ the world with no refrigeration required. Customers can request information on Xfree™ COVID-19 by contacting BioGX at covid19@biogx.com.
About BioGX
BioGX is a leading global provider of lyophilized real-time PCR reagents for molecular diagnostics. BioGX, Inc., headquartered in Birmingham, Alabama, and its wholly owned subsidiary BioGX B.V., based in Amsterdam, The Netherlands, (collectively “BioGX”), operates in a cGMP compliant environment certified to ISO 13485 medical device development and manufacturing standards. The proprietary Sample-Ready™ technology is at the core of all product offerings for Clinical, Food Safety, Pharma QC and Water Quality molecular testing. BioGX B.V.’s 50+ molecular diagnostic products are marketed and sold in several countries through its Global Distribution Network.
Abbott receives FDA Emergency Use Authorization for its COVID-19 IgM antibody blood test
12 October 2020 - Data demonstrates highly reliable test results with 99.56% specificity and 95.00% sensitivity for patients tested 15 days after symptom onset. Availability of the new IgM blood test on the ARCHITECT® and Alinity™ platforms is part of Abbott's effort to offer tests across the disease progression of COVID-19. Abbott's IgM test will give a more complete picture of where patients are in their recovery.
ABBOTT PARK, Ill., Oct. 12, 2020 -- Abbott announced today that the U.S. Food and Drug Administration (FDA) issued Emergency Use Authorization (EUA) for the company's AdviseDx SARS-CoV-2 IgM (Immunoglobulin M) lab-based serology test for use on the ARCHITECT® and Alinity™ platforms. IgM antibody testing can play an important role in understanding if someone has developed antibodies in response to the virus, indicating a recent or prior infection.
The new IgM antibody test is Abbott's latest test to support in the fight against COVID-19. Since the start of the pandemic, Abbott has received emergency use authorization for seven tests, including molecular tests, a rapid antigen test and an IgG antibody test.
"Abbott has developed tests to detect the virus at each stage of infection so doctors and their patients are equipped with knowledge of how they are responding to the virus and progressing through recovery," said Robert B. Ford, president and chief executive officer, Abbott. "Antibody tests will continue to play an important role to better understand the virus, the prevalence of COVID-19 in an area and where a patient may be in their recovery."
Understanding a person's immune response with antibody tests
While molecular tests detect whether someone has the virus, antibody tests determine if someone had a previous infection by detecting antibodies, such as IgM and IgG.
Abbott first developed an IgG blood test, which often is the antibody that is longer-lasting in the body after infection. This test has been widely adopted and continues to play a key role in understanding if someone has recovered from the virus, as well as contact tracing and epidemiological studies.
The IgM antibody, in comparison, is most useful for determining a recent infection as these antibodies become undetectable weeks to months following infection. Having this more complete picture of where a patient is in their recovery can help healthcare providers determine if treatment, isolation or follow-up visits are needed.
Similar to Abbott's IgG blood test, the IgM test has demonstrated high reliability in both Abbott's research and external virology laboratory studies. Abbott's data demonstrated 99.56% specificity and 95.00% sensitivity for patients tested 15 days after symptom onset.
The IgM test is now available on Abbott's ARCHITECT and Alinity platforms.
About Abbott
Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 107,000 colleagues serve people in more than 160 countries.
Thermo Fisher Scientific Further Expands COVID-19 Test Portfolio with Two New Antibody Tests
12 October 2020
WALTHAM, Mass., Oct. 12, 2020 -- Thermo Fisher Scientific Inc., the world leader in serving science, today introduced two new SARS-CoV-2 antibody tests: the Thermo Scientific OmniPATH COVID-19 Total Antibody ELISA test, and the Thermo Scientific EliA SARS-CoV-2-Sp1 IgG test. These new tests for detecting COVID-19 antibodies expand the company's leading response to the pandemic, which ranges from molecular diagnostic tests and sample collection products, to personal protective equipment, to support of therapy and vaccine development and manufacturing.
"Thermo Fisher is committed to providing a range of innovative solutions, including new serology tests that complement our PCR-based tests," said Marc N. Casper, chairman, president and chief executive officer of Thermo Fisher Scientific. "The addition of COVID-19 antibody tests to our broad portfolio further enables our support of the pandemic response on multiple fronts."
OmniPATH COVID-19 Total Antibody ELISA test
The OmniPATH COVID-19 Total Antibody ELISA test, developed in conjunction with the Mayo Clinic and WuXi Diagnostics as previously announced, has been granted Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) for qualitative detection of total antibodies to SARS-CoV-2, including immunoglobulin M (IgM), immunoglobulin A (IgA) and immunoglobulin G (IgG).
EliA SARS-CoV-2-Sp1 IgG test
The EliA SARS-CoV-2-Sp1 IgG test is commercially available in accordance with the FDA's "Policy for Coronavirus Disease-2019 Tests During the Public Health Emergency (Revised)". The EUA is currently under review by the FDA. The EliA test is designed for automated processing of up to 60 results per hour on the Thermo Scientific Phadia 250 instrument. The EliA test is quantitative within markets that accept the CE mark and semi-quantitative in the U.S. Individual IgM and IgA EliA tests are also available now for research use only.
Both of these new antibody tests are designed to meet the need for open ELISA and automated workflows. This flexibility enables laboratories to run the tests at customizable speed and throughput while using automated instruments already in place, minimizing initial costs and reducing the time needed to begin testing. Additionally, these tests are now available in Europe and countries accepting the CE Mark.
About Thermo Fisher Scientific
Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $25 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, improving patient diagnostics and therapies or increasing productivity in their laboratories, we are here to support them. Our global team of more than 75,000 colleagues delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services and Patheon. For more information, please visit www.thermofisher.com.
Grifols underlines the importance of plasma in its Annual General Shareholders’ Meeting
9 October 2020 - The company makes a public appeal on the critical role of plasma and the need to increase donations in support of International Plasma Awareness Week, promoted by the Plasma Protein Therapeutic Association (PPTA). Grifols’ co-CEOs outline the company’s main non-financial performance indicators and ongoing efforts to combat COVID-19. Shareholders endorse the company’s management in 2019, which led to an upturn in revenues (13.6%) and net profits (4.8%) to EUR 5,100 million and EUR 625 million, respectively. Grifols continued to promote innovation and capital investments in 2019 as core drivers of its long-term and sustainable growth strategy, allocating a total of EUR 661 million toward. The company optimized its financial structure, lowering its average cost of debt and extending maturities following an effective refinancing process that was closed at the end of 2019.
Barcelona, October 9, 2020 -- Grifols, a global healthcare company dedicated to enhancing the health and well-being of patients worldwide through the development of life-saving plasma-derived medicines, clinical diagnostics and pharmaceutical specialties for hospital use, and a pioneer in the research and development of therapeutic alternatives that drive scientific and social progress, celebrated its telematic Annual General Shareholders’ Meeting on second call.
Due to the healthcare crisis generated by COVID-19 and supported by law, the 2020 General Shareholders Meeting was held exclusively by telematic means, without the physical presence of shareholders or their representatives, through remote connection and direct broadcasting, reaching a high participation.
Grifols’ General Shareholders’ Meeting related to the 2019 financial year was represented by 448 shareholders, who hold 313.608.974 Class A shares and represent 73.6% of stock capital with voting rights. The votes delegated to the Board represented 78.3% of quorum and 57.6% of share capital, confirming shareholders’ support of the Group’s management and business plan.
More than EUR 3,150 million allocated to innovation and capital investments over the last five years
Grifols’ revenues grew by 13.6% in 2019 to EUR 5,099 million, while its net profit increased by 4.8% to EUR 625 million. Both results highlight Grifols’ progress toward its long-term and sustainable growth strategy, which led to sales increases in its main divisions in all regions of operation.
Grifols’ operations in 2019 aimed to reinforce factors crucial to advancing its corporate growth plan, such as strategic investments to increase its access to plasma; efforts to strength the company’s global presence; optimization of its financial structure; and a renewed focus on innovation and capital investments as key drivers of its growth.
The strategic alliance with Shanghai RAAS, announced in 2019 and closed in 2020, has enabled Grifols to boost its commercial presence in China, one of the world’s fastest-growing markets for plasma-derived products and transfusion diagnostic solutions. In addition, the company also closed a transaction with GC Pharma (Green Cross Group) to acquire different assets in Canada, henceforth becoming the only large-scale manufacturer of plasma products in this country. Both transactions have significantly advanced Grifols’ international expansion efforts.
Another important achievement in 2019 was the optimization of Grifols’ financial structure. The company finalized a debt financing process, leading to a lower average cost of debt and longer maturities. The process was well accepted by the market and completed in record time. Grifols also reinforced its liquidity position in 2020 after signing an upsize of its multicurrency revolving credit facility. As of June 30, 2020, the company’s liquidity position stands at EUR 1,900 million. The optimization and reduction of debt levels remains a priority for Grifols' financial management.
In 2019, Grifols continued to promote innovation and capital investments as key drivers of its long-term and sustainable growth strategy, allocating a total of EUR 661 million. Over the last five years, the company has allotted more than EUR 3,150 million to these core areas.
In terms of R+D+i highlights in 2019, Grifols completed its AMBAR (Alzheimer Management By Albumin Replacement) clinical trial, designed to evaluate the efficacy and safety of plasma replacement therapy. This is a procedure combining periodic extractions of plasma through plasmapheresis with albumin and immunoglobulin infusions. As presented in several international conferences, AMBAR’s findings demonstrate a significant slowdown in disease progression in patients with mild to moderate Alzheimer’s. These positive results encourage Grifols to continue its research efforts on discovering the potential benefits of plasma protein replacement therapies.
Grifols also announced an agreement to acquire the remaining capital of Alkahest, Inc. for USD 146 million to promote the research and development of innovative therapies based on the human plasma proteome to treat age-related diseases.
Alkahest currently has four candidates in six phase-2 clinical trials, including therapies to treat neurogenerative disorders, cognitive decline, neuromuscular and ophthalmological diseases. Alkahest has developed a map of the human plasma proteome, facilitating the identification of plasma proteins and their recombinant analogues as potential therapeutic solutions.
More than EUR 1,200 million allocated to dividends over the last 5 years
Grifols shareholders approved the allocation of EUR 250 million to dividends (approximately EUR 0.36 gross per share) in 2019. This amount includes the preferred dividend of EUR 0.01 gross per share of each Class B share.
The dividend was distributed in two payments: one already paid in December 2019 for EUR 0.20 gross per share and a second payment of EUR 0.16 gross per share, which will be distributed from October 28, 2020 onwards.
The company maintains its pay-out of 40% of the group’s consolidated net profits. Grifols remains firmly committed to creating value for its shareholders, distributing more than EUR 1,200 million in dividends over the last five years.
Non-financial information and sustainability
Grifols’ non-financial and corporate sustainability performance indicators in 2019 were presented during the General Shareholders’ Meeting. This information forms part of the Integrated Annual Report (IAR), submitted by the company and approved by the Board of Directors reflecting on the company’s long-standing commitment to transparency.
This publication aims to offer Grifols’ main stakeholders a clear and comprehensive view of its social, environmental and economic performance and progress toward the objectives included in its Corporate Social Responsibility Policy.
The non-financial information contained in the IAR was prepared in alignment with Global Reporting Initiative (GRI) information requirements and recommendations, and verified by an external independent firm.
Research efforts in the fight against COVID-19
Grifols’ ongoing efforts to combat COVID-19 were also disclosed during the General Shareholders’ Meeting. The company is currently leading efforts in two of the three potential disease treatments for COVID-19. At the same time, it has joined efforts with other global authorities to increase the rate of diagnosis, which is vital to battling highly infectious diseases like COVID-19.
In terms of potential treatments, Grifols is leading the development of an anti-SARS-CoV-2 hyperimmune immunoglobulin using plasma from recovered COVID-19 donors. Following the approval of scientific protocols by the FDA and National Institute of Allergy and Infectious Diseases (NIAID), a multicenter, randomized and double-blind clinical trial will assess the safety and efficacy of this hyperimmune immunoglobulin, produced in Grifols’ Clayton plant (North Carolina, USA) among other manufacturers.
In parallel, the company is promoting and supporting several researchers and healthcare entities in the U.S., Spain and Germany in clinical trials using inactivated convalescent plasma, as well as other plasma-derived specialty products such as immunoglobulin, alpha-1 and antithrombin III.
With regard to diagnostic solutions, Grifols has developed a specific Transcription-Mediated Amplification (TMA) molecular test to detect the SARS-CoV-2 virus in plasma, blood and respiratory samples. This test offers the same or even greater sensitivity than other molecular tests including PCR- (polymerase chain reaction) based diagnostics.
An appeal on the importance of plasma in support of the PPTA’s International Plasma Awareness Week
Within the framework of Grifols’ efforts to combat COVID-19 and discover the therapeutic potential of plasma to treat this infectious viral disease, the company made a global appeal on the strategic importance of plasma to ensure the health and quality of lives of thousands of people worldwide. Similarly, Grifols added its voice to the plea made by the Plasma Protein Therapeutic Association (PPTA), urging global healthcare authorities to take decisive action to increase the volume of plasma donations.
Plasma plays an essential role in global healthcare. Therefore, Grifols recognizes the generosity and commitment of all plasma donors in making plasma-derived therapies possible.
Approval of agenda items
Key agenda items ratified by the shareholders include:
- Approval of individual and consolidated annual accounts
- Re-election of Víctor Grífols Deu, Thomas Glanzmann and Steve F. Mayer as members of the Board of Directors and approval of the appointment of James Costos
- Appointment and re-election of auditors
- Approval of the Annual Compensation of the Board in an advisory capacity
AMSP partners with bioMérieux to facilitate supply of high-quality COVID-19 diagnostics
8 October 2020
8 October 2020 -- bioMérieux and the Africa Medical Supplies Platform (AMSP), have announced a new partnership to facilitate the supply of high-quality diagnostic solutions from the bioMérieux Pandemic Response Portfolio to African Union Member States.
The AMSP portal is an online marketplace that enables the supply of COVID-19-related critical diagnostics and medical equipment and consumables in Africa and the Caribbean Community (CARICOM). It was developed under the leadership of the African Union Special Envoy, Strive Masiyiwa and powered by Janngo, on behalf of the Africa Centres for Disease Control and Prevention (Africa CDC). The platform was developed in partnership with African Export-Import Bank (Afreximbank) and the United Nations Economic Commission for Africa (ECA).
This partnership with bioMérieux aims to respond to supply shortages experienced by African Union Member States by guaranteeing efficient, uninterrupted and rapid access to bioMérieux high-quality diagnostic solutions dedicated to the COVID-19 pandemic.
Under the partnership, a portfolio of high-quality diagnostic solutions (molecular testing and serology testing) for COVID-19 from bioMérieux will be available at very competitive prices to each of the 55 African Union Member States.
“To effectively respond to the COVID-19 pandemic, Africa needs continuous and predictable supply of diagnostics and medical consumables, and the AMSP was created to close the supply gap. Through AMSP we are building partnerships and exploring all markets, and we are delighted to have bioMérieux join this very important partnership,” said Dr John Nkengasong, Director of Africa CDC.
“We are very proud of this collaboration with AMSP, as it is part of our public health efforts which consist of allowing low and middle-income countries to have access to high quality diagnostics solutions in an ethical and equitable manner. It overall contributes to a better health for patients and communities in these countries at an affordable cost,” said Mr. Sindé Chekete, Vice-President, bioMérieux Africa.
“With the AMSP, Africa is leading the way to ensure all of our governments get access to test kits and other urgent medical supplies they need, at fair prices. We have been working relentlessly to expand choice & quality of supplies and that is why this partnership with bioMérieux is very important to us,” said African Union Special Envoy, Strive Masiyiwa.
“As a global leader pioneering diagnostics, bioMérieux’s commitment to fight infectious diseases for almost 60 years is highly commendable and we are very proud to partner with them through the AMSP. They are joining world class healthcare manufacturers in our fight against the pandemic in Africa,” concluded Fatoumata Bâ, Founder & Executive Chair of Janngo and Managing Partner of Janngo Capital.
Abbott releases ID NOW™ COVID-19 interim clinical study results from 1,003 people to provide the facts on clinical performance and to support public health
7 October 2020 - Data show ID NOW performance of 95.0% sensitivity and 97.9% specificity within seven days of symptom onset. ID NOW is the most studied COVID-19 test available; interim post-authorization study evaluated 1,003 people. To date, Abbott has shipped more than 12 million ID NOW tests to all 50 states and provided more than 30 million rapid and lab-based COVID-19 tests in the U.S. since March.
ABBOTT PARK, Ill., Oct. 7, 2020 -- In a continuing effort to provide the facts about ID NOW to support public health interests, Abbott is sharing new interim clinical data results on its ID NOW COVID-19 rapid test. The results confirm the data submitted to the U.S. Food and Drug Administration (FDA) in March for Emergency Use Authorization (EUA) and the interim results that Abbott shared in its May 21 press release. The data also speak to the important role played by reliable point-of-care testing that is available in convenient and accessible locations where people can get immediate results.
"We recognize there is a lot of discussion about testing and ID NOW, and we want to make sure the public has the facts and real-world data," said Robert B. Ford, president and chief executive officer, Abbott. "The facts we're seeing from one of the largest clinical studies of any COVID-19 test, conducted at some of the nation's leading academic centers, show that ID NOW delivers effective, consistent and reliable performance."
"In the beginning of the pandemic, the scientific community had to rely on samples and modeling to predict test performance," said John Hackett, Ph.D., divisional vice president of Applied Research and Technology for Abbott's diagnostics business. "But now we have a significant body of real-world, clinical data that support the critical role ID NOW is playing in identifying infection rapidly in places where people show up for care."
"Tests are taken at a moment in time and they detect the virus once there's enough viral material in a person to be able to detect it," continued Dr. Hackett. "While there's no perfect test, to fight a pandemic, we need a combination of gold standard lab-based PCR and accurate, reliable rapid tests like ID NOW to help reduce risk in society and slow the spread of the virus."
Post-Authorization Study Data
Abbott has completed an interim analysis of its ID NOW post-authorization study. A total of 1,003 people were evaluated across two care environments: urgent care clinics (acute care) and hospitals and nursing homes (in-patient care). In these two care environments, the ID NOW delivered the following agreement to lab-based molecular PCR tests:
- Overall performance of 93.3% positive agreement (sensitivity) and 98.4% negative agreement (specificity). Further, in the 161 patients with high viral titers (Ct <33), and therefore most likely to transmit virus, ID NOW showed performance of 97.0% positive agreement (sensitivity).
- Performance of 95.0% positive agreement (sensitivity) and 97.9% negative agreement (specificity) in subjects within seven days post symptom onset. Further, in the 129 patients with high viral titers (Ct <33), and therefore most likely to transmit virus,
ID NOW showed performance of 98.4% positive agreement (sensitivity). - Performance of 94.6% positive agreement (sensitivity) and 97.6% negative agreement (specificity) in symptomatic subjects. Further, in the 136 patients with high viral titers (Ct <33), and therefore most likely to transmit virus, ID NOW showed performance of 97.8% positive agreement (sensitivity).
Updates to May 21 Interim Data (Previous Studies)
In addition to the post-authorization data, Abbott is providing an update to three studies that were covered in its May 21 interim study press release:
- Multi-Site Urgent Care. In a completed analysis from a multi-site urgent care clinical setting of 430 symptomatic patients with two or more symptoms, including 53 PCR positive subjects, ID NOW demonstrated performance of 96.2% in positive agreement (sensitivity) and 99.5% negative agreement (specificity) compared to lab-based molecular PCR tests.
- Everett Clinic. In a completed study at The Everett Clinic in Washington of 974 people, including 23 PCR positive subjects, in partnership with Yuan-Po Tu, M.D., ID NOW demonstrated 91.3% positive agreement (sensitivity) and 100% negative agreement (specificity) compared to lab-based molecular PCR tests.
- In-patient. In an in-patient care study (hospitals and nursing homes), a total of 518 symptomatic patients were evaluated, including 94 PCR positive subjects. ID NOW demonstrated 79.8% positive agreement (sensitivity) and 94.3% negative agreement (specificity) compared to lab-based molecular PCR tests.
- In the 494 subjects who reported days from symptom onset, the median number of days from symptom onset was 10 days with 71.1% of people presenting >7 days post symptom onset. In 45 patients with high viral titers (Ct <33), and therefore more likely to transmit virus, ID NOW showed performance of 100% positive agreement (sensitivity).
- In a further analysis of this data, the subset of 143 symptomatic patients within seven days of symptom onset were evaluated, of which 30 were PCR positive. ID NOW demonstrated 86.7% positive agreement (sensitivity) and 96.5% negative agreement (specificity) compared to lab-based molecular PCR testing.
Cycle times (Ct) are the number of times a PCR instrument must cycle through to amplify enough genetic material to be detected. So, the greater amount of virus present (viral load), the fewer cycles required to detect the virus. A person is more likely to be contagious the higher their viral load (and the lower their Ct count). The Centers for Disease Control and Prevention (CDC) shares available data on its website indicating that at a Ct of 33 and above, replication competent virus has not been reliably recovered and infectiousness is unlikely.
These findings are also consistent with a study published in the Annals of Internal Medicine, where researchers from Johns Hopkins found that even the most sensitive lab-based molecular tests can have false negatives when viral load levels are ramping down, near the end of the infection cycle, when viral load decreases and patients may no longer be infectious.
Abbott's Research Continues
Abbott has continued to study ID NOW in a variety of settings in people who are at different stages of infection with more than 1,000 people, making it the most studied rapid COVID-19 test on the market today. Abbott has shared this data with the FDA throughout the research process and will continue doing so.
About Abbott
Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 107,000 colleagues serve people in more than 160 countries.
Hologic Panther Platform and HIV-1 Quant Assay Used in “HIV Cure” Research
7 October 2020 - Two published studies demonstrate automated detection of viral loads as low as one copy per milliliter
Marlborough, Massachusetts, October 7, 2020 – Two studies in the current issue of the Journal of Clinical Microbiology demonstrated the utility of Hologic’s Panther® platform and Aptima® HIV-1 Quant assay in research related to potentially curing HIV-infected individuals. Hologic scientists collaborated on the studies1,2 with researchers at Vitalant Research Institute, the University of California, San Francisco, the University of California, San Diego, and the University of Pittsburgh.
There is an intense international research effort to discover strategies to effectively cure HIV-infected individuals by eliminating the virus, so that they can discontinue medication permanently. To achieve this, scientists need a way to confirm that HIV has been eliminated.
“This is a promising field of research, but measuring very low levels of virus in patients’ blood has presented a major challenge,” said Andrew Worlock, Ph.D., senior director of R&D at Hologic. “We developed a way to take advantage of the flexibility of our Panther instrument and the high sensitivity of our Aptima HIV-1 Quant assay to measure single copy levels of virus in large volumes of plasma, and to do it quickly and inexpensively.” Methods used in the studies are for research use only, and are not for use in diagnostic procedures.
The Panther molecular diagnostics system is a fully automated, high-volume platform that can process approximately 1,000 tests in a 24-hour period. It is used in clinical diagnostic laboratories to run tests for sexually transmitted diseases and respiratory infections – including SARS-CoV-2/COVID-19 – and to monitor viral loads in HIV-, HCV- or HBV-infected individuals. The Aptima HIV-1 Quant assay is performed on a blood sample and will quantitate viral loads down to 30 copies/milliliter (ml).
In the new studies, the investigators described an approach in which samples were run in replicate, meaning multiple aliquots were run from the same tube loaded on the Panther system. The results of individual replicates were then combined to give the result for a sample. With this approach, the researchers demonstrated that they could detect HIV-1 RNA in all antiretroviral therapy-suppressed participants when 45 replicate 0.5 ml aliquots of plasma were tested. When nine replicates were tested, 100% of participants with an HIV concentration in the range of five copies/ml were positive, and 70% were positive with concentrations as low as one copy/ml.
“By running replicates of plasma samples on the automated Panther system, we succeeded in quantifying HIV viral loads in individuals well below the detection limits typically achieved with viral load assays used for clinical diagnosis and monitoring,” said Michael Busch, Ph.D., from Vitalant Research Institute and UCSF, the senior author of one of the studies. “It really opens the door to automating quantitation of viral loads that were previously only detectable using highly laborious, ultrasensitive HIV RNA assays that required manual processes including ultracentrifugation of large volumes of plasma. This new approach should help lead to progress in evaluating promising new interventions in the HIV cure research field.”
About the Panther System
The Panther molecular diagnostics system is a best-in-class, fully automated, sample-to-result platform that can be used in low-, medium- or high-throughput laboratories. With a small footprint, adaptable workflow options and consolidated testing menu, it combines women’s health, sexually transmitted infections and viral load testing, which can all be done simultaneously. More than 2,000 Panther systems have been installed in clinical diagnostic laboratories around the world.
About Hologic
Hologic, Inc. is an innovative medical technology company primarily focused on improving women’s health and well-being through early detection and treatment. For more information on Hologic, visit www.hologic.com.
Vela Diagnostics Launches Test Kits to Differentiate Between Flu, RSV and SARS-CoV-2
5 October 2020 - The ViroKey™ Flu A/B & RSV RT-PCR Extension Kit is available for ordering now
Singapore, October 5 2020 – Vela Diagnostics announced today the release of the ViroKey™ Flu A/B & RSV RT-PCR Extension Kit for research use (RUO). This extension kit is intended for use with Vela Diagnostics’ automated PCR workflow with the ViroKey™ SARS-CoV-2 RT-PCR Test v2.0 which tests for the SARS-CoV-2 virus.
The concurrent use of ViroKey™ Flu A/B & RSV RT-PCR Extension Kit with ViroKey™ SARS-CoV-2 RT-PCR Test v2.0 allows the differentiation of four virus types – Influenza A, Influenza B, Respiratory Syncytial Virus (RSV) and SARS-CoV-2 – in nasopharyngeal and oropharyngeal swabs.
The ViroKey™ SARS-CoV-2 RT-PCR Test v2.0 has garnered Emergency Use Authorization (EUA) from the U.S. FDA, CE-IVD and Australian Therapeutic Goods Administration (TGA) approvals, as well as Provisional Authorisation from the Health Sciences Authority in Singapore.
The automated workflow comprises of the Sentosa™ SX101 instrument and the Sentosa™ SA201 RT-PCR instrument, or the ABI 7500 Fast Dx. This workflow enables minimal hands-on time and tests for up to 46 samples and two controls per run with a turnaround time expected at 4.5 hours.
“The release of our Flu and RSV extension test kit is timely. It is a challenge to differentiate between Flu, RSV and SARS-CoV-2 simply based on symptoms alone, and with the flu season expected in the coming month, this solution will aid in the research of those respiratory viruses,” said Sam Dajani, CEO and Chairman of the Board.
About Vela Diagnostics
Vela Diagnostics is a leading provider for integrated IVD system solutions, from sample to result. VELA’s test solutions utilize the automated Sentosa™ platform, providing the unique ability to leverage one system for NGS and PCR testing in infectious disease and oncology.
All Sentosa™ products listed above are by Vela Diagnostics. For more information, visit www.veladx.com.
QIAGEN to complement COVID-19 testing portfolio with novel kit that simplifies and accelerates PCR analysis for research applications
5 October 2020 - Innovative QIAprep& technology integrates sample preparation and detection steps in one single kit. Streamlined workflow with sample prep under two minutes cuts costs, plastic usage and time to result to under one hour. Compatible with standard lab automation equipment, any assay and transport media.
Hilden, Germany, and Germantown, Maryland, October 5, 2020 – QIAGEN today announced plans to launch a novel straightforward approach to viral RNA epidemiology that will significantly simplify and accelerate PCR analysis and remove key testing bottlenecks for SARS-CoV-2 and other RNA viruses.
QIAGEN’s innovative QIAprep& Viral RNA UM Kit combines a liquid-based sample preparation step completed in only two minutes with real-time PCR detection in a streamlined workflow that can be automated with standard lab equipment for any throughput, any assay and any reaction need from single to multiplex testing. The kit, which uses the most common transport media such as Universal Transport Media (UTMTM) as the starting material, includes both sample extraction components and optimized PCR reagents for only one procedure.
The streamlined workflow takes under one hour to deliver a result, compared to approximately three hours for standard extraction-based quantitative PCR processes and can handle up to 2,600 samples per eight-hour shift per cycler. As a result, labs can significantly accelerate the time to result and the frequency of viral testing. With only three small pipette tips needed per sample, the kit keeps plastic usage to a minimum, while providing significant cost savings by reducing reagent use and labor utilization.
Initial studies run by select public health research institutions have shown that the level of detection of the new QIAprep& Viral RNA UM Kit, when used with their assay, is similar to or better than regular PCR workflows, and that performance compares to standard public health protocols of the U.S. Centers of Disease Control (CDC), the World Health Organization (WHO) and others that use the gold standard for sample extraction.
“We are excited to launch the first integrated liquid-based sample preparation and amplification method for testing of viral RNA with any assay, including SARS-CoV-2,” said Dr. Thomas Schweins, Senior Vice President of the Life Sciences Business Area at QIAGEN. “Unlike other products, QIAprep& does not eliminate the sample preparation step at the expense of performance. Instead, it streamlines the gold standard in sample preparation set by QIAGEN to a process completed in under two minutes to enable an immediate, fast real-time PCR run on any cycler that delivers results in under one hour. We are planning to ramp up the production capacities later in 2020 to levels that ensure a guaranteed supply and address effectively the challenge of long PCR turnaround times that are slowing down the frequency of testing.”
The QIAprep& workflow is simple, swift and straightforward, consisting of only three steps: an aliquot is taken from a primary sample (nasopharyngeal, oropharyngeal or nasal swab) in transport media and added to a sample preparation buffer that is optimized to prepare the viral RNA template without degradation. This is next combined with the RT-qPCR reaction mix, which provides reliable and sensitive results for RNA viruses in UTM. The sample then undergoes a routine real-time PCR in a cycler using any assay. The output is finally interpreted, delivering a test result in under one hour from start to finish – including incubation and hands-on time.
“QIAprep& makes the most of our expertise in both sample preparation and PCR,” said Thierry Bernard, Chief Executive Officer of QIAGEN. “PCR is the gold standard for detection of SARS-CoV-2 and other RNA viruses, and QIAprep& makes it faster – without compromising performance. The launch of this new product will complement our efforts to build the broadest portfolio of COVID-19 testing solutions that addresses the varying needs for clinical and research applications in the fight against the pandemic.”
QIAGEN has been adding PCR tests on the QIAstat-Dx and NeuMoDx systems that differentiate COVID-19 from other respiratory infections, delivering research gene panels integrated with bioinformatics for analysis of the SARS-CoV-2 virus on any sequencer and scaling up production capacity for sample preparation kits and reagents sold to other companies for their own COVID-19 tests. QIAGEN is also developing novel easy-to-use solutions for antibody and antigen testing running on a portable device that provides highly accurate results in less than 15 minutes.
About QIAGEN
QIAGEN N.V., a Netherlands-based holding company, is the leading global provider of Sample to Insight solutions that enable customers to gain valuable molecular insights from samples containing the building blocks of life. Our sample technologies isolate and process DNA, RNA and proteins from blood, tissue and other materials. Assay technologies make these biomolecules visible and ready for analysis. Bioinformatics software and knowledge bases interpret data to report relevant, actionable insights. Automation solutions tie these together in seamless and cost-effective workflows. QIAGEN provides solutions to more than 500,000 customers around the world in Molecular Diagnostics (human healthcare) and Life Sciences (academia, pharma R&D and industrial applications, primarily forensics). As of June 30, 2020, QIAGEN employed more than 5,200 people in over 35 locations worldwide. Further information can be found at www.qiagen.com.
Reference: https://corporate.qiagen.com/newsroom/press-releases/2020/20201005_qiaprepandamp
CLEAR Adds LabCorp COVID-19 Test Results to “Health Pass” Mobile App
5 October 2020 - Eases the Ability to Safely Travel, Enter Workplaces, and Attend Public Events
NEW YORK & BURLINGTON, N.C., Oct. 5, 2020 -- CLEAR, the secure identity company, and LabCorp, a leading global life sciences company that is focused on advancing health and guiding patient care decisions, today announced a partnership to enable users of CLEAR’s Health Pass mobile app to securely link their LabCorp test results using their LabCorp Patient™ account. The partnership brings together LabCorp’s advanced testing capabilities, including its COVID-19 tests, with CLEAR’s safe and secure Health Pass technology.
Health Pass securely connects a person’s digital identity with their COVID-19-related information to help ease access into public spaces and restore peace of mind. To leverage the new combined offering, eligible Health Pass users must first provide consent, then log in to their LabCorp Patient account through the CLEAR app to link their accounts. In communicating an individual’s health status, Health Pass only displays a comprehensive red or green signal to employers and venue operators — never sharing or providing access to a user’s private health details.
Health Pass is already being used across multiple industries, including the National Hockey League’s Stanley Cup Playoffs, and allows users to easily share their COVID-19-related health information. The app links a user with real-time health surveys, temperature checks through integrated CLEAR hardware, and will now provide users the ability to access test results performed by LabCorp. LabCorp has performed over 15 million COVID-19 diagnostic tests which are available to individuals through healthcare providers, pharmacies, employer programs and to patients directly through Pixel by LabCorpTM.
“We are enabling people to securely share their LabCorp health information in convenient ways so they can return to work, travel, and enter public venues safely and with confidence,” said Adam Schechter, chairman and CEO of LabCorp. “We are excited to combine science and technology in ways that can improve how people live and work.”
“We are thrilled to join forces with LabCorp to help our partners create safer environments for their employees and communities,” said CLEAR CEO Caryn Seidman-Becker. “Health Pass is helping thousands of people return to their jobs and routines, and now this partnership will advance users’ safety by creating a discreet, secure way to share their test results when they enter public settings and workplaces.”
How It Works: Health Pass and LabCorp Make it Easy to Create Safer Environments
Enroll, verify and you are good to go.
- Enroll: Download the CLEAR app from Google Play or the Apple App Store and enroll in Health Pass for free by creating a CLEAR account and verifying your identity.
- Connect to Tests: Link your CLEAR and LabCorp Patient accounts to securely and privately include your latest COVID-19 results as part of your Health Pass.
- Verify Identity: Before you enter a building or venue that is using Health Pass to securely screen visitors before entry, open the CLEAR app and snap a selfie to prove you are you.
- On-Site Touchless Access: Approach a CLEAR pod where you can use your face or a QR code to share your verified status and check your temperature to gain touchless access. The employer or venue only receives confirmation that you have satisfied their requirements for access with the equivalent of a red light or green light signal and never has access to your private health details.
About Clear
CLEAR is a leader in biometric identity and access, with more than 5 million users and 50+ locations across the United States. CLEAR already links identity with different information sets, including: credit cards, tickets to the game, reservations, frequent flyer numbers, flight manifests, health care identification, driver’s licenses and passports. CLEAR’s data security framework meets the highest standards for performance and for protecting sensitive information — FISMA High- and SAFETY Act-certified by the Department of Homeland Security. CLEAR never sells an individual’s information. To learn more, visit www.clearme.com.
About LabCorp
LabCorp, an S&P 500 company, is a leading global life sciences company that is deeply integrated in guiding patient care, providing comprehensive clinical laboratory and end-to-end drug development services. With a mission to improve health and improve lives, LabCorp delivers world-class diagnostics solutions, brings innovative medicines to patients faster, and uses technology to improve the delivery of care. LabCorp reported revenue of more than $11.5 billion in 2019. To learn more about LabCorp, visit www.LabCorp.com, and to learn more about LabCorp’s drug development business, Covance, visit www.Covance.com.
Quest Diagnostics Launches Three New Combined COVID-19 and Respiratory Virus Tests
30 September 2020 - Nearly 20 Viral and Bacterial Infections Can Be Identified from a Single Swab, Reducing Time to Diagnose and Treat
SECAUCUS, N.J., Sept. 30, 2020 -- Healthcare providers across the United States can now access three different test options from Quest Diagnostics to aid the diagnosis of COVID-19 and differentiate it from other seasonal respiratory infections, including influenza (flu).
Each test is designed to use a single specimen, promoting faster test ordering, reporting and diagnosis, as compared to ordering multiple tests, for potentially improved patient care. The tests may also help reduce demand for specimen collection devices amid supply constraints.
According to the Centers for Disease Control and Prevention, this fall and winter could be one of the most complicated times in the history of public health due to the potential spread of seasonal respiratory viruses with the SARS-COV-2 virus that causes COVID-19. Some symptoms of COVID-19 and seasonal respiratory viruses, including flu, are similar, and diagnostic testing can help determine the virus causing this illness. Because of the COVID-19 pandemic, reducing the spread of respiratory illnesses, like flu, this fall and winter is more important than ever.
The new test options include the cobas® SARS-CoV-2 & Influenza A/B, an automated high throughput multiplex real-time RT-PCR assay from Roche. The U.S. Food and Drug Administration (FDA) granted Emergency Use Authorization (EUA) for the test earlier this month. The test is intended for simultaneous qualitative detection and differentiation of SARSCoV-2, the virus that causes COVID-19, and/or influenza A or B virus RNA from individuals suspected of respiratory viral infection consistent with COVID-19 by their healthcare provider.
The test may be performed on healthcare provider-collected nasal and nasopharyngeal swab specimens and self-collected nasal swab specimens (collected in a healthcare setting with instruction by a healthcare provider). Nasal swabs include anterior nares swabs, which involve collecting a specimen from the lower nostril.
Two additional test panels from Quest Diagnostics, the Respiratory Viral Panel (RVP) test and the Respiratory Pathogen Panel (RPP), now include testing for SARS-CoV-2 using the company's SARS-CoV-2 RT-PCR test, which was granted FDA EUA in March 2020 to aid the diagnosis of SARS-CoV-2. With the addition of SARS-CoV-2, the RVP panel can aid the identification of up to a dozen viruses and subtypes and the RPP panel can aid the identification of 18 viral targets and two bacterial targets. Each respiratory panel test also only requires a single nasopharyngeal specimen.
"With a perfect storm of COVID-19, influenza and seasonal respiratory viruses circulating over the Fall and Winter months, laboratory testing that can reliably identify the virus causing disease will be critical to mobilizing effective patient care and public health response," said Jay G. Wohlgemuth, M.D., Senior Vice President and Chief Medical Officer, Quest Diagnostics. "Our goal is to give providers multiple tools to care for patients as quickly and effectively as possible, using a minimum of specimen collection materials amid continuing supply constraints."
Patients suspected of having or confirmed to have active SARS-CoV-2 infection or COVID-19 disease may not visit Quest patient service centers, which are not equipped to collect the necessary respiratory specimens for molecular SARS-CoV-2 diagnostic testing. Patients who believe they may have COVID-19, Influenza or other respiratory virus infections are strongly encouraged to contact their healthcare provider.
About Our COVID-19 Testing
Quest Diagnostics is at the forefront of the response to the COVID-19 pandemic, working to broaden access to laboratory insights to help us all lead healthier lives. We provide both molecular diagnostic and antibody serology tests to aid in the diagnosis of COVID-19 and the immune response to the virus. Our COVID-19 test services are based on tests that have received FDA emergency use authorization and which also meet our high standards for quality. We are providing these test services under the Public Readiness and Emergency Preparedness Act. We provide data on COVID-19 testing to various federal and state public health authorities, including the Centers for Disease Control and Prevention, and participate in studies with government and private institutions, aiding COVID-19 public health response and research. Through our team of dedicated phlebotomists, air fleet team, couriers and laboratory professionals, Quest Diagnostics works hard every day to help patients and communities across the United States access quality COVID-19 testing.
About Quest Diagnostics
Quest Diagnostics empowers people to take action to improve health outcomes. Derived from the world's largest database of clinical lab results, our diagnostic insights reveal new avenues to identify and treat disease, inspire healthy behaviors and improve health care management. Quest annually serves one in three adult Americans and half the physicians and hospitals in the United States, and our 47,000 employees understand that, in the right hands and with the right context, our diagnostic insights can inspire actions that transform lives. www.QuestDiagnostics.com
PerkinElmer EONIS Screening Test Receives CE-IVD Clearance
30 September 2020 - RT-PCR Newborn Screening Assay for SMA, SCID and XLA to be Integrated into Company’s Sample-to-Result Workflow
WALTHAM, Mass., September 30, 2020 – PerkinElmer, Inc., a global leader committed to innovating for a healthier world, today announced that the Company’s EONIS™ screening assay for newborns that simultaneously tests for SMA (spinal muscular atrophy), SCID (severe combined immunodeficiency) and XLA (X-linked agammaglobulinemia) has received CE-IVD approval. This IVD RT-PCR assay integrates into PerkinElmer’s entire newborn screening workflow to provide labs with a complete, single source solution encompassing everything from sample to solution.
SMA is one of the most common lethal recessive genetic conditions and is associated with significant motor disability, respiratory issues and nutritional compromise. SCID, known more commonly as “Bubble Boy” disease, is a rare condition, caused by a severe defect in the immune system that makes it difficult or impossible to fight off infections. XLA, most common in males, is a rare genetic disorder that affects the body's ability to fight infection. All three diseases can be fatal if not detected at birth before symptoms appear, making early screening imperative to identify affected children so that the proper care can be conducted.
The design of the EONIS assay enables automation with JANUS Liquid Handlers to further streamline the workflow of high-throughput laboratories without compromising the sample traceability from punch to result. The traceable dried blood spot workflow consists of five main elements to detect SMA, SCID and XLA: sample collection, punching, DNA extraction, amplification and data analysis utilizing dedicated analysis software.
“The global availability of this CE-marked assay for SMA, SCID and XLA will have a profound impact. It will help save lives and dramatically improve clinical outcomes for children by ensuring treatment can be given earlier to those who need it,” said Petra Furu, GM, Reproductive Health, PerkinElmer. “The integration of this assay with our complete workflow solution is a prime example of how PerkinElmer is providing laboratories with the innovative tools needed to run a reliable, and yet, cost-effective screening program.”
PerkinElmer’s comprehensive newborn screening portfolio includes tests for more than 50 conditions known to have positive outcomes when detection and diagnosis occur early with newborn screening. To learn more about PerkinElmer’s newborn screening platforms, please visit newbornscreening.perkinelmer.com.
About PerkinElmer
PerkinElmer enables scientists, researchers, and clinicians to address their most critical challenges across science and healthcare. With a mission focused on innovating for a healthier world, we deliver unique solutions to serve the diagnostics, life sciences, food, and applied markets. We strategically partner with customers to enable earlier and more accurate insights supported by deep market knowledge and technical expertise. Our dedicated team of about 13,000 employees worldwide is passionate about helping customers work to create healthier families, improve the quality of life, and sustain the wellbeing and longevity of people globally. The Company reported revenue of approximately $2.9 billion in 2019, serves customers in 190 countries, and is a component of the S&P 500 index. Additional information is available through 1-877-PKI-NYSE, or at www.perkinelmer.com.
LGC releases SARS-CoV-2 & influenza multiplexed molecular quality solutions
29 September 2020
29 September 2020 -- LGC’s SeraCare has expanded its line of SARS-CoV-2 quality solutions to include products designed for use with multiplexed molecular assays that can detect SARS-CoV-2, influenza A/B and respiratory syncytial virus (RSV).
AccuPlex™ SARS-CoV-2, Flu A/B and RSV Verification Panel is optimised for assay verification at installation by documenting test performance along the assay’s range, enabling laboratories to establish lower limits of detection, perform assay comparisons, and evaluate staff proficiency. AccuPlex SARS-CoV-2, Flu A/B and RSV Reference Material Kit is designed to measure day-to-day performance of the assay, providing both a positive and a negative reference solution.
Michael Sweatt, Executive Vice President, LGC Clinical Diagnostics Division, stated, “The upcoming flu season will present clinicians and laboratorians with diagnostic challenges, while we remain in the throes of the COVID-19 pandemic. Patients presenting with symptoms, common to both the flu and SARS-CoV-2 symptomatic infections, will need to be stratified in order to enact the appropriate treatment and containment strategy. Aligned with LGC’s corporate philosophy of ‘Science for a Safer World’, we strive to continuously improve and expand upon our ability to support global public health efforts by providing valuable tools such as these multiplexed quality solutions in response to the ever changing needs of infectious disease diagnostics.”
LGC's proprietary AccuPlex technology mimics wild-type pathogenic viruses, but is safe, non-infectious, and replication deficient. These materials serve as true, full-process controls that challenge the entire molecular test procedure, making them the preferred alternative to infectious materials.
To learn more about the AccuPlex SARS-CoV-2, Flu A/B and RSV multiplexed materials as well as the complete line of SARS-CoV-2 Molecular & Serology Quality Solutions, please visit the SeraCare website.
Cepheid Receives Emergency Use Authorization For SARS-CoV-2, Flu A, Flu B and RSV Combination Test
29 September 2020 - Challenged by Similar Clinical Presentations, Accurate Detection & Differentiation of all 4 Viruses is Critical for Clinicians This Flu Season
SUNNYVALE, Calif., Sept. 29, 2020 -- Cepheid today announced it has received Emergency Use Authorization (EUA) from the U.S. Food & Drug Administration (FDA) for Xpert® Xpress SARS-CoV-2/Flu/RSV, a rapid molecular diagnostic test for qualitative detection of the viruses causing COVID-19, Flu A, Flu B, and RSV infections from a single patient sample. The four-in-one test is designed for use on any of Cepheid's over 26,000 GeneXpert® Systems placed worldwide, with results delivered in approximately 36 minutes.
"Things may get complicated this respiratory season as clinicians encounter a range of viral infections with symptoms overlapping with COVID-19, including Flu A, Flu B, and respiratory syncytial virus," said Dr. David Persing, MD, Ph.D., Chief Medical and Technology Officer at Cepheid. "The ability to run a single, highly sensitive test that detects all four viruses in a syndromic panel provides actionable results and helps to alleviate pressure on our healthcare system."
Cepheid's previously announced capacity expansion program, supported by parent company Danaher Corporation, was designed in part to address anticipated demand for Xpert Xpress SARS-CoV-2/Flu/RSV. Cepheid expects the first impact of the program in the fourth quarter of 2020 with additional capacity ramping through 2021.
"The dramatic impact of SARS-CoV-2 has been felt by us all, and we understand that a reliable supply of SARS-CoV-2 tests is critical to the communities our healthcare institutions serve — for the coming Flu season and beyond," said Cepheid President Warren Kocmond. "Another goal of the capacity expansion program is to ensure supply continuity of not only our 4-Plex combination test for SARS-CoV-2, Flu A&B and RSV, but the entire portfolio of critical tests Cepheid supplies — including tests for tuberculosis, MRSA, C. difficile, CT/NG, Strep A, and many more."
GeneXpert System – Reference Lab Quality Tests Anywhere They Are Needed
The GeneXpert System was built for simple, reference lab quality PCR testing – on location at medical centers and hospitals or closer to patient in health clinics and nursing homes. At the core of every GeneXpert System is the module (or testing bay) where a test cartridge is loaded onto the machine. Our GeneXpert Systems are configured with a varying number of modules, or test bays, to meet the volume requirements of any setting. Smaller GeneXpert Systems are configured with 2 or 4 modules — meaning up to four different tests can be run at one time. Our largest GeneXpert System is configured with up to 80 modules — meaning as many as 80 tests can operate independently at any given time with a capacity of about 2,000 tests per day*.
About Cepheid
Based in Sunnyvale, Calif., Cepheid is a leading molecular diagnostics company that is an operating company within Danaher Corporation's (NYSE: DHR) Diagnostics platform. Cepheid is dedicated to improving healthcare by developing, manufacturing, and marketing accurate yet easy-to-use molecular systems and tests. By automating highly complex and time-consuming manual procedures, the company's solutions deliver a better way for institutions of any size to perform sophisticated molecular diagnostic testing for organisms and genetic-based diseases. Through its strong molecular biology capabilities, the company is focusing on those applications where accurate, rapid, and actionable test results are needed most, such as managing infectious diseases and cancer. For more information, visit http://www.cepheid.com.
About Emergency Use Authorization Status
This test has not been FDA cleared or approved. It has been authorized by the FDA under an EUA for use by authorized laboratories. The test has been authorized only for the simultaneous qualitative detection and differentiation of nucleic acid from SARS-CoV-2, influenza A virus, influenza B virus, and RSV and not for any other viruses or pathogens. The test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostic tests for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.
Sysmex Applies for Manufacturing and Marketing Approval for a SARS-CoV-2 Antigen Detection Reagent
29 September 2020 - Detecting SARS-COV-2 antigens using fully automated immunoassay systems HISCLTM-5000 / HISCLTM-800
September 29, 2020 -- Sysmex Corporation (HQ: Kobe, Japan; Chairman and CEO: Hisashi Ietsugu) announced today that it applied for in vitro diagnostic approval for manufacturing and marketing of a reagent for detecting antigens of SARS-CoV-2 (the "Reagent"), which causes coronavirus disease 2019 (COVID-19), in conjunction with its fully automated immunoassay systems HISCLTM-5000 / HISCLTM-800 to the Pharmaceuticals and Medical Devices Agency (PMDA).
The Reagent detects SARS-CoV-2 antigens present in nasopharyngeal swabs. When used in conjunction with Sysmex's fully automated immunoassay systems HISCLTM-5000 / HISCLTM-800, which use chemiluminescence enzyme immunoassay (CLEIA) as their measurement principles, it not only performs measurement with high sensitivity but also improves testing efficiency by delivering rapid test results in 17 minutes from the start of testing and processing 200 tests per hour (with HISCLTM-5000). Additionally, SARS-CoV-2 present in samples is deactivated after nasopharyngeal swab collection by using a sample extraction solution (sold separately), thus reducing the infection risk to medical professionals.
To prepare for the surge in testing demand anticipated after manufacturing and marketing approval, we are working to reinforce supply systems for a stable supply of the Reagent and fully automated immunoassay systems.
We are also considering expanding the scope of sample types to reduce both the physical burden on patients and the infection risk to medical professionals at the time of sampling.
Sysmex will remain committed to the establishment of diagnosis/treatment methods for COVID-19 by way of diverse testing techniques, including PCR tests, antigen tests, antibody tests, and cytokine tests, as well as existing ones such as hematology and coagulation tests.
BioGX launches CE-IVD Marked COVID-19, Influenza A/B, RSV Combo RT-PCR Test for the BD MAX™ System
29 September 2020
Amsterdam, The Netherlands, 29 September 2020 – BioGX BV, the European subsidiary of Birmingham, Alabama based BioGX, announced availability of a CE-IVD marked test for simultaneous detection of SARS-CoV-2, Influenza A, Influenza B and Respiratory Syncytial Virus RNA in a patient sample using the BD MAX™ System.
The test is offered in BioGX’s trusted, easy to use Sample-Ready™ format where all required reagents for real-time PCR are lyophilized in a single tube. BioGX provided tube snaps into a test-specific position on the BD MAX™ total nucleic acid extraction cartridge enabling Sample-to-Answer molecular testing. BioGX kits can be shipped anywhere in the world with no refrigeration required.
“We are very pleased with the reliability and performance of this complex respiratory panel. The simultaneous detection of COVID-19, Flu A, Flu B and RSV during Flu season would help further augment the BD MAX™ testing capacity by over 50,000 tests per week”, said Shazi Iqbal, Ph.D., CEO of BioGX.
The BioGX multiplex COVID-19, Flu A, Flu B and RSV test is intended for qualitative detection of RNA specific to SARS-CoV-2, Influenza A, Influenza B, and Respiratory Syncytial Virus A/B that may be present in Pharyngeal and Nasopharyngeal swab collections in transport media and saline, obtained from individuals at risk of respiratory viral infections.
The BD MAX™ System, commercialized by BD (Becton, Dickinson and Company), is a fully integrated and automated molecular diagnostic platform already in use at thousands of laboratories worldwide.
The BioGX COVID-19, FluA, Flu B, RSV test is marketed and sold through BioGX BV’s Global Distribution Network as CE-IVD marked for In Vitro Diagnostic Use. The test is not available for sale or use in the U.S.A. To locate an authorized distributor or request information, contact BioGX at info@biogx.com.
About BioGX B.V.
BioGX B.V., based in Amsterdam, The Netherlands is a provider of molecular diagnostics reagents for infectious disease testing. It is a wholly owned subsidiary of BioGX, with corporate headquarters located in Birmingham, Alabama.
About BioGX
BioGX is a leading global provider of lyophilized real-time PCR reagents for molecular diagnostics. BioGX, Inc., headquartered in Birmingham, Alabama, and its wholly owned subsidiary BioGX B.V., based in Amsterdam, The Netherlands, (collectively “BioGX”), operates in a cGMP compliant environment certified to International Standard ISO 13485. The company applies its proprietary Sample-Ready™ lyophilized technology to offer products and contract services across a variety of real-time PCR platforms. The Sample-Ready™ technology is at the core of all product offerings for Clinical, Food Safety, Pharma and Water Quality molecular testing. BioGX B.V.’s 50+ molecular diagnostic products are marketed and sold in several countries through its Global Distribution Network.
Hologic Granted FDA Emergency Use Authorization for Asymptomatic COVID-19 Testing with Panther Fusion SARS-CoV-2 Assay
28 September 2020 - Testing of Pooled Samples Also Authorized; New Claims Expected to Help Limit Spread of COVID-19, Open Economy and Schools
MARLBOROUGH, Mass., 28 September 2020 -- Hologic, Inc. announced today that its Panther Fusion® SARS-CoV-2 assay has received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) for testing of individuals without symptoms or other reasons to suspect COVID-19 infection.
Hologic’s assay is the first widely available, high-throughput molecular diagnostic test specifically authorized for screening asymptomatic people. This availability is expected to play a key role in identifying early infection in exposed individuals, as well as reopening schools, workplaces and the economy in general.
The U.S. Centers for Disease Control and Prevention (CDC) recently issued guidance recommending COVID-19 tests for people who have had recent contact with infected individuals, a key strategy for limiting the spread of the virus.
“Accurately identifying individuals early in the course of infection - so they can quarantine before passing on the virus - is critical to stemming the spread of this pandemic,” said Kevin Thornal, president of the Diagnostic Solutions Division at Hologic. “The high accuracy of molecular testing has made it the gold standard for infectious disease detection, and recent data demonstrate that Hologic’s molecular coronavirus tests are among the most sensitive available.”
A recent report published by the FDA compared more than 50 COVID-19 tests and demonstrated that Hologic’s assays are the most analytically sensitive of the fully automated, high-throughput molecular tests on the market. High analytical sensitivity is one of the key characteristics for tests to be used effectively in asymptomatic screening and pooling workflows.
The asymptomatic screening claim was authorized based on available analytical data as well as Hologic’s commitment to submit results from an ongoing clinical evaluation that is underway with several laboratory partners.
Hologic is also pursuing an EUA for asymptomatic testing for its Aptima® SARS-CoV-2 assay, another molecular diagnostic test for COVID-19.
Sample Pooling Protocol
In addition, the FDA authorized the company’s pooling protocol, which was previously disclosed on August 11, 2020, for symptomatic testing with the Panther Fusion SARS-CoV-2 assay. Hologic’s pooling protocol enables clinical laboratories to combine up to five patient samples into a single tube for processing. A negative result means that all five individuals have tested negative for SARS-CoV-2. In cases of a positive result, all five samples are re-tested individually to determine which patient or patients are infected. A high level of analytical sensitivity is especially important when testing pooled samples.
The Panther Fusion SARS-CoV-2 test runs on Hologic’s fully automated Panther® Fusion system, which can provide initial results in approximately three hours and process more than 1,000 coronavirus tests in 24 hours.
About the Panther and Panther Fusion Systems
The Panther molecular diagnostics system is a best-in-class, fully automated, sample-to-result platform that can be used in low, medium or high-throughput laboratories. With a small footprint, adaptable workflow options and consolidated testing menu, it combines women’s health, sexually transmitted infection and viral load testing, which can all be done simultaneously. The Panther Fusion system provides an expanded in vitro diagnostics menu, as well as Open Access™ functionality to run laboratory developed tests. Hologic’s Panther and Panther Fusion systems now offer 16 FDA-cleared assays and 20 CE-marked assays that detect more than 20 pathogens. More than 2,000 Panther systems have been installed in clinical diagnostic laboratories around the world.
About COVID-19
For more information about the novel coronavirus, visit: https://www.cdc.gov/coronavirus/2019-ncov/summary.html.
About Hologic
Hologic, Inc. is an innovative medical technology company primarily focused on improving women’s health and well-being through early detection and treatment. For more information on Hologic, visit www.hologic.com.
Abbott's FreeStyle® Libre 3 system receives CE Mark - features world's smallest, thinnest sensor with best-in-class performance at the same low cost for people with diabetes
28 September 2020 - The FreeStyle Libre 3 system automatically delivers real-time, up-to-the-minute glucose readings, unsurpassed 14-day accuracy and optional glucose alarms directly to smartphones for people with diabetes. With the smallest and thinnest wearable glucose sensor (about the size of two stacked U.S. pennies), FreeStyle Libre 3 users can view their glucose levels discreetly and conveniently, anytime. Building on the proven FreeStyle Libre 2 sensor performance with a new sensor design at the same affordable price as previous versions, the FreeStyle Libre 3 system is the latest innovation of Abbott's world-leading continuous glucose monitoring technology.
ABBOTT PARK, Ill., Sept. 28, 2020 -- Abbott, the worldwide leader in continuous glucose monitoring (CGM) technology, announced today it has secured CE Mark (Conformité Européenne) for its next-generation FreeStyle Libre 3 system, which is now approved for use by people living with diabetes in Europe. The FreeStyle Libre 3 technology provides continuous, real-time glucose readings automatically delivered to smartphones every minute, offering unsurpassed 14-day accuracy in the smallest and thinnest sensor design at the same affordable price as previous versions of the device.
"Abbott won't stop innovating when there's room to raise the bar. We've done that again with FreeStyle Libre 3, the smallest sensor that delivers life-changing benefits and best-in-class accuracy," said Jared Watkin, senior vice president, Diabetes Care, Abbott. "People living with diabetes are at the center of our design process, and we made our next-generation technology even more discreet for a better user experience to make managing diabetes as easy and seamless as possible."
With a 14-day wear time, the FreeStyle Libre 3 system includes the longest-lasting, self-applied CGM sensor available. The sensor is easy to apply with a one-piece applicator and is worn on the back of the upper arm, eliminating the need for painful fingersticks to view glucose levels.
To allow as many people as possible living with diabetes to access and benefit from the significant advancements of the technology, Abbott's FreeStyle Libre 3 system will be priced the same as previous generations of the device.
"Since we launched the first disposable glucose sensor in 2014, we've always believed all people with diabetes should have access to high-quality, accurate and affordable diabetes technologies," said Watkin. "That's why Abbott disrupted the traditional notion that CGMs have to sacrifice quality or accuracy for affordability, and we built our FreeStyle Libre family of products to deliver unparalleled results at a lower cost than any other CGM available."
The FreeStyle Libre 3 system fits seamlessly into the lives of people with diabetes. In addition to the sensor, the system includes the FreeStyle Libre 3 mobile app, which is designed to enable users to capture and view their real-time glucose levels, glucose history and trend arrows showing how their glucose is changing with just a glance at their smartphone.
Abbott designed its next-generation FreeStyle Libre 3 system to be more sustainable for the environment with a smaller and more discreet sensor, reducing the total volume by more than 70%. With a 41% reduction in plastic use and 43% reduction in carton paper, the new sensor design aligns with the company's continued commitment to sustainability.
Abbott is launching the FreeStyle Libre 3 system in Europe in the coming months. The FreeStyle Libre portfolio has been clinically proven to improve glucose control, increase time in target glucose range, decrease time in hyperglycemia (high glucose levels) and hypoglycemia (low glucose levels), and lower HbA1c (average glucose levels over a three-month period) – all factors contributing to better health outcomes. Data also show use of the FreeStyle Libre system reduces diabetes-related hospital admissions and work absentee rates to help improve quality of life.
As the #1 sensor-based glucose monitoring system used in the U.S. and worldwide, Abbott's FreeStyle Libre portfolio has changed the lives of more than 2 million people across more than 50 countries by providing breakthrough technology that is accessible and affordable. Abbott has secured partial or full reimbursement for the FreeStyle Libre system in 37 countries, including Canada, France, Germany, Japan, the United Kingdom and the U.S.
About Abbott
Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 107,000 colleagues serve people in more than 160 countries.
BGI Genomics receives CE mark for its SARS-CoV-2 & Influenza A/B test
25 September 2020
25 September 2020 -- BGI Genomics, today announced that two multiplex tests for SARS-CoV-2 and Influenza A/B produced by its subsidiary BGI PathoGenesis Pharmaceutical Technology Co., Ltd, have received CE mark.
Real-time Fluorescent RT-PCR kit for detecting SARS-CoV-2(ORF1ab), Influenza A Virus and Influenza B Virus, together with Multiplex Real-time Fluorescent RT-PCR kit for detecting SARS-CoV-2(ORF1ab and N), Influenza A Virus and Influenza B are multiplex reverse transcription polymerase chain reaction assay intended for the simultaneous qualitative detection and differentiation of SARS-CoV-2, Influenza A virus, and Influenza B virus in throat swabs samples.
The clinical symptoms of influenza A virus, influenza B virus are similar to COVID-19. Rapid detection and precise differential identification of causative pathogen play an important role in pandemic control and prevention. The new multiplex tests which detect three viruses in a single reaction at one time, can help the rapid triage of testing populations.
These new tests are a key additional step in BGI’s fighting against the COVID-19 pandemic, which has already included: Providing COVID-19 Local Laboratory Solutions; Supplying Real-Time Fluorescent RT-PCR kit for 2019-nCoV and Antibody Detection Kit (ELISA) for COVID-19. The newly released tests also provide a sensitive nucleic-acid-based solution for evaluating the infection situation of SARS-CoV-2 and Influenza A/B in specimens from patients during the upcoming season of influenza in mist of COVID-19 pandemic.
Reference: https://www.bgi.com/global/company/news/bgi-genomics-receives-ce-mark/
LGC COVID-19 antibody assay processes up to 40,000 tests per day in UK
23 September 2020
23 September 2020 -- LGC’s Immunogenicity Centre of Excellence has successfully developed a COVID-19 antibody assay that is suitable for both serum and dried blood sampling. LGC’s new assay can analyse up to 40,000 samples per day using serum or capillary blood collected remotely with Neoteryx’s Mitra® microsampling device.
Individuals can be tested for SARS-CoV-2 antibodies by visiting a blood draw centre to provide a serum sample via phlebotomy, or by collecting their own blood sample at home using the Mitra device and a simple fingerstick method. The Mitra blood samples can be posted through the regular mail to LGC’s Centre of Excellence laboratory for testing, where sample data are processed and reported using the company’s custom LIMS system. The assay that LGC developed for SARS-CoV-2 antibody testing achieves specificity of (95% CI) 100% (98.7-100.0) and sensitivity of (95% CI) 98.0% (87.0-99.0) for samples taken 21 days post positive PCR test. Sample results can be reported within 24 hours of sample receipt.
Why is precise detection of SARS-CoV-2 antibodies so important? Antibody tests are critical to understanding how widely the novel coronavirus has spread and how immunity against COVID-19 illness develops. Antibodies play a key role in the immune system’s defense against disease and reinfection. Unlike nasal/oral swab tests that detect an active viral infection, serology tests detect antibodies that develop after a person has recovered from an infection.
“A real value of remote blood sampling with the Mitra® device for testing in LGC’s outstanding lab is that people don’t have to leave home to learn if they have developed SARS-CoV-2 antibodies,” said James Rudge, PhD, Technical Director, Neoteryx. “Our Mitra is designed with volumetric absorptive microsampling, or VAMS® technology, which enables virtually anyone to collect a few drops of blood on the device with scientific precision.”
“Our assay is suitable for partnering with employers for back to work testing using the self-sampling Mitra® device, and therefore does not require a phlebotomist to take the blood sample in a healthcare setting,” commented Michael van der Merwe, Commercial Director, LGC. “The assay can also support patient stratification for clinical trials and COVID-19 vaccine development. As well as qualitative data, we can also provide semi-quantitative data on the level of antibodies present indicating the magnitude of the immune response.”
Reference: https://www.lgcgroup.com/newsroom-and-blog/news-and-blog/lgc-and-neoteryx-covid-antibody-assay/
Vela Diagnostics’ SARS-CoV-2 RT-PCR Test v2.0 Authorized for Emergency Use in the U.S.
22 September 2020 - Vela Diagnostics’ automated COVID-19 detection kit receives Emergency Use Authorization from the FDA
Fairfield, New Jersey, September 22 2020 – Vela Diagnostics announced today that the ViroKey™ SARS-CoV-2 RT-PCR Test v2.0 has obtained the Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA). This automated probe-based reverse transcription PCR test detects SARS-CoV-2, the coronavirus responsible for COVID-19, in nasopharyngeal and oropharyngeal swabs. With the EUA, laboratories in the United States certified under the Clinical Laboratory Improvement Amendments will now be able to use the test for COVID-19 detection.
“Receiving the EUA for our automated COVID-19 detection kit will enable us to better assist laboratory and healthcare personnel in managing the pandemic in the U.S.,” said Sam Dajani, CEO and Chairman of the Board.
The ViroKey™ SARS-CoV-2 RT-PCR Test v2.0 is an automated probe-based reverse transcription PCR test optimized for a workflow consisting of Vela Diagnostics’ Sentosa® SX101 and the Sentosa® SA201 instrument (or ABI 7500 Fast Dx). The automated test enables high throughput testing of up to 46 samples in a single run, with reduced hands-on time.
Besides receiving EUA from the FDA, the ViroKey™ SARS-CoV-2 RT-PCR Test v2.0 has also received the CE mark and Provisional Authorisation from the Singapore Health Sciences Authority.
About Vela Diagnostics
Vela Diagnostics is a leading provider for integrated IVD system solutions, from sample to result. VELA’s test solutions utilize the automated Sentosa® platform, providing the unique ability to leverage one system for NGS and PCR testing in infectious disease and oncology.
The First Direct Oral Anticoagulant Test Authorized for Clinical Use on Automated Hemostasis Systems
22 September 2020
Bedford, MA, September 22, 2020 -- Instrumentation Laboratory (IL) announced today that the US Food and Drug Administration (FDA) granted De Novo marketing authorization for the HemosIL® Liquid Anti-Xa test kit to measure apixaban. This is the first direct oral anticoagulant (DOAC) test for automated Hemostasis analyzers authorized by the FDA.
The FDA indication for HemosIL Liquid Anti-Xa has been expanded from the current quantitative determination of unfractionated heparin and low molecular-weight heparin, to include apixaban measurement, when used with HemosIL Apixaban Calibrators. The test is intended to measure apixaban concentrations in patients on apixaban therapy in the following situations where measurement of apixaban levels could be useful to have as additional information: patients at risk for major bleeding and patients experiencing a bleeding episode.
"DOACs are essential treatment for hundreds of thousands of patients around the world. Providing a means for clinicians to assess appropriate patients who take apixaban is an important step in enhancing care," said Remo Tazzi, Director, Worldwide Marketing at IL. "We are very proud to add another milestone "first" to our 60-year history of innovation in in vitro diagnostics."
Fully validated for use on the ACL TOP® Family and ACL TOP Family 50 Series Hemostasis Testing Systems, HemosIL Liquid Anti-Xa assay for apixaban measurement delivers an automated result with excellent linearity, limit of detection, precision and accuracy, for reliable results and enhanced patient management.
The HemosIL Liquid Anti-Xa assay is not a stand-alone test and the results should be used in conjunction with other clinical and laboratory findings. Apixaban is a direct factor Xa (FXa) inhibitor, developed by Pfizer Inc. and Bristol-Myers Squibb Company, and is sold under the trademark Eliquis.
Instrumentation Laboratory (www.instrumentationlaboratory.com), founded in 1959, is a worldwide developer, manufacturer and distributor of in vitro diagnostic instruments, related reagents and controls for use primarily in hospitals and independent clinical laboratories. Based in Bedford, MA, USA, IL operates Technology Centers there, as well as in Orangeburg, NY, USA, San Diego, CA, USA, and Munich, Germany. IL is a company of Werfen, based in Barcelona (Spain). IL Acute Care Diagnostics product offerings include the new GEM® Premier™ ChemSTAT system with Intelligent Quality Management (iQM®), GEM Premier 5000 system with iQM2, GEM Premier 4000 and 3500 analyzers with iQM, GEMweb® Plus Custom Connectivity, ROTEM® viscoelastic testing systems, Hemochron™ systems, VerifyNow™ platelet-function testing system, and Avoximeter™ CO-Oximeters. The IL Hemostasis portfolio includes new ACL TOP® Family 50 Series and ACL TOP Family of Hemostasis Testing Systems, fully automated, high-productivity analyzers, HemoCell™ Specialized Lab Automation and HemoHub™ Intelligent Data Manager. IL also offers the ACL AcuStar®, ACL Elite®, and other Hemostasis analyzers, along with the comprehensive HemosIL® line of reagents.
The Instrumentation Laboratory logo, GEM, Premier, GEM Premier ChemSTAT, ChemSTAT, GEMweb, iQM, HemosIL, ACL, ACL TOP, ACL Elite, ACL AcuStar, ReadiPlasTin, RecombiPlasTin, SynthASil, SynthAFax, ROTEM, Hemochron, VerifyNow and Avoximeter are trademarks of Instrumentation Laboratory Company and/or one of its subsidiaries or parent companies, and may be registered in the United States Patent and Trademark Office and in other jurisdictions. All other product names, company names, marks, logos, and symbols are trademarks of their respective owners.
Walmart, Quest Diagnostics and DroneUp pilot drone COVID-19 at-home self-collection kit delivery in north Las Vegas
22 September 2020 - Qualified residents in close proximity to North Las Vegas Walmart may be able to receive at-home self-collection kits by drone delivery
NORTH LAS VEGAS, NV – Sept. 22 – Walmart, Quest Diagnostics, and DroneUp today announced a pilot program to provide drone delivery of COVID-19 at-home self-collection kits to single-family homes in the North Las Vegas-area. Drone deliveries will launch from the North Las Vegas Walmart, located at 1807 West Craig Road, to single-family homes within a 1-mile radius of the store. Learnings from this pilot will help determine what roles drones can play in pandemic response, health care delivery and retail.
The drone delivery pilot will be available while supplies last every day from 8:30 a.m. to 3:30 p.m., weather and visibility permitting. Once delivered, patients will perform a self-administered nasal swab in the privacy of their home. Patients will ship the sample to a Quest Diagnostics lab using a provided pre-paid shipping envelope for processing at the lab and will receive their COVID-19 test results through the secure Quest Diagnostics MyQuest online portal or app.
“Walmart has been serving the North Las Vegas community throughout the pandemic with drive-thru testing sites, and we wanted to provide another way to access testing that provides convenience and leverages technology while learning how drones could impact the delivery of healthcare in the future,” said Amanda Jenkins, Vice President of Operation Support and Implementation, Walmart U.S. Health and Wellness “We are grateful to our Quest and DroneUp partners, and our pharmacists and associates, for their support in launching the pilot as we continue to work together during the pandemic.”
To be eligible for drone delivery, patients must live within the 1-mile radius of the North Las Vegas Walmart store and request a drone delivery appointment through www.GetDroneTest.com. There is no delivery cost for patients who qualify to receive an at-home self-collection kit through this pilot program. Patients must also meet CDC and state and local guidelines for testing and must be 18 years of age or older. Patients can visit www.GetDroneTest.com for more information and to determine if they are eligible.
The kit includes a device for anterior nares (nasal) swab collection, which is the same kit Quest recently made available through its QuestDirect Active Infection Test. The specimen is then forwarded to a Quest Diagnostics laboratory for testing. Test results are available in an easy-to-read report on MyQuest, the company's secure patient portal accessible on a smartphone, tablet, or desktop.
“Quest Diagnostics is proud to partner with Walmart and DroneUp on this innovative pilot program to examine how drones could deliver health care to patients who are unable to leave their home, or live in remote locations,” said Dan Haemmerle, General Manager of Extended Care at Quest Diagnostics. “We will take the learnings from this pilot and enhance the ways we deliver health care services to the patients we serve.”
“Collaborating to deliver self-collection kits offers further investment into solutions that will advance safe and effective drone delivery,” said Tom Walker, Founder & CEO of DroneUp. “We are honored to partner with Walmart and Quest to pioneer these deliveries and equally as proud to serve our communities.”
About Walmart
Walmart Inc. helps people around the world save money and live better – anytime and anywhere – in retail stores, online, and through their mobile devices. Each week, over 265 million customers and members visit approximately 11,500 stores under 56 banners in 27 countries and eCommerce websites. With fiscal year 2020 revenue at $524 billion, Walmart employs 2.2 million associates worldwide. Walmart continues to be a leader in sustainability, corporate philanthropy and employment opportunity. Additional information about Walmart can be found by visiting http://corporate.walmart.com, on Facebook at http://facebook.com/walmart and on Twitter at http://twitter.com/walmart.
About Quest Diagnostics
Quest Diagnostics empowers people to take action to improve health outcomes. Derived from the world's largest database of clinical lab results, our diagnostic insights reveal new avenues to identify and treat disease, inspire healthy behaviors and improve health care management. Quest annually serves one in three adult Americans and half the physicians and hospitals in the United States, and our 47,000 employees understand that, in the right hands and with the right context, our diagnostic insights can inspire actions that transform lives. www.QuestDiagnostics.com.
About DroneUp
DroneUp is the leading complete drone services provider, transforming businesses and government organizations with drone technology solutions. DroneUp’s diverse suite of products includes flight services, data analysis, drone program development, regulatory consulting, training, equipment, and Part 107 drone delivery. Recognized as a UAS industry pioneer with patented mobile app technology and a commitment to research and development, DroneUp further fuels invention and application across private and public sectors. With our people, services, and innovative solutions, DroneUp delivers on operational challenges with efficiency, reliability, and safety. For more information: https://www.droneup.com.
Roche launches new quantitative antibody test to measure SARS-CoV-2 antibodies, to support the evaluation of vaccines
18 September 2020 - The new Elecsys Anti-SARS-CoV-2 S test can quantitatively measure the level of antibodies against SARS-CoV-2 in patients who have been exposed to the virus. The test targets antibodies against the spike protein. This is the focus of vaccines in development and convalescent plasma therapy. Using the Elecsys Anti-SARS-COV-2 S antibody test, together with the Elecsys Anti-SARS-CoV-2 test launched in May, can help to more effectively determine the percentage of a population who already have antibodies against SARS-COV-2.
Basel, 18 September 2020 -- Roche today announced the launch of its Elecsys® Anti-SARS-CoV-2 S antibody test for markets accepting the CE Mark. Roche has filed for Emergency Use Authorisation (EUA) from the U.S. Food and Drug Administration (FDA).
The Elecsys Anti-SARS-CoV-2 serology test can be used to quantitatively measure antibodies in people who have been exposed to the Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) and can play an important part in characterising a vaccine-induced immune response. Specifically, the test targets antibodies which are directed against the particular region of the viral spike protein responsible for binding to the host cell receptor, which is required for the virus to enter the host cell. The majority of current candidate vaccines aim to induce an antibody response against the spike protein.
“As the possibility of an effective SARS-CoV-2 vaccine becomes a reality, quantitative measurement of antibodies will be crucial in the evaluation of any potential vaccine. The new quantitative Elecsys antibody test can play a pivotal role in vaccine clinical trials as well as helping clinicians assess patients immune response. This will be instrumental in protecting people most vulnerable to the virus, as well as in overcoming COVID-19 for society in general.” said Thomas Schinecker, CEO Roche Diagnostics. "This new test, the twelfth in the Roche SARS-CoV-2 testing portfolio, is another essential addition to support healthcare systems and patients as we jointly fight COVID-19.”
Before a vaccine is administered it is important to know the starting level of antibodies a person has, in order to evaluate any change in antibody levels that the vaccine induces, especially the development of antibodies directed against the SARS-CoV-2 spike protein. These antibodies have been shown to have potent antiviral activity and correlate to potential immunity. Measuring antibody levels could also be vital in establishing vaccine efficacy in the prevention of infection and/or the development of severe COVID-19.
Alongside its importance to vaccine design and efficacy evaluations, the Elecsys Anti-SARS-CoV-2 S serology test can be used to determine antibody levels in plasmapheresis donations. Performing a combination of the Elecsys Anti-SARS-CoV-2 S and Elecsys Anti-SARS-CoV-2 tests can also help to more effectively define what percentage of a given population has developed antibodies (seroprevalence) against SARS-COV-2, especially in low to moderate seroprevalence settings. Knowing a given population’s seroprevalence is important in understanding how to contain the spread of the virus, as well as how to safely ease lockdown restrictions.
The test is the latest addition to the comprehensive Roche diagnostic portfolio to help healthcare systems combat COVID-19 through testing in the laboratory and at the point of care. Currently, this portfolio includes molecular, serology and digital solutions which help diagnose and manage COVID-19 during the initial stages of infection, during the recovery phase, as well as following the resolution of infection.
About SARS-CoV-2
Coronaviruses (CoV) are a large family of viruses that cause illness ranging from the common cold to more severe diseases such as Middle East Respiratory Syndrome (MERS-CoV) and Severe Acute Respiratory Syndrome (SARS-CoV). The novel coronavirus (SARS-CoV-2) is a new strain which has not previously been identified in humans.
Signs of infection include respiratory symptoms such as cough, shortness of breath, difficulty breathing, and fever. In more severe cases, pneumonia, severe acute respiratory syndrome, kidney failure and death can occur.
About potential SARS-COV-2 vaccines
As of 3 September 2020, 47 candidate vaccines are in clinical evaluation and 3 vaccines have been approved for early or limited use, while at least 91 preclinical vaccines are under active investigation. All candidate vaccines in Phase III or approved for limited / early use aim to induce an antibody response against the SARS-CoV-2 spike protein. Any potential vaccine for SARS-CoV-2 would work (amongst other mechanisms) by triggering the immune response to develop neutralising antibodies, in the person receiving the vaccine. In doing so, the vaccine trains the body’s immune system to recognize and fight an exposure to SARS-CoV-2, in a controlled way, without being exposed to the actual virus.
About Elecsys Anti-SARS-CoV-2 S and Elecsys Anti-SARS-CoV-2 serology tests
The Elecsys® Anti-SARS-CoV-2 S is an immunoassay for the quantitative, in vitro determination of antibodies to SARS-CoV-2 in human serum and plasma. Through a blood sample, the test can measure the quantity of antibodies to the spike protein of the coronavirus, which could signal whether a person has been already infected and potentially developed immunity to the virus. This can also be used to determine antibody levels in plasmapheresis donations. Plasmapheresis is a procedure which separates and removes the plasma from a patient’s blood. This plasma is then replaced with plasma from a donor. It is assumed that plasma from a donor who has already had SARS-CoV-2 will have direct antiviral properties for the donor recipient.6 This is being explored as an adjunctive treatment for the management of COVID-19.6 The test has both a high clinical specificity of 99.98% (N=5991) and sensitivity of 98.8% (N=1423), 14 days or later after diagnosis with PCR. Additionally, across panels of potentially cross-reactive samples (N=1100) from endemic human coronaviruses, infectious respiratory diseases, other infectious diseases, auto-immune and liver related diseases, the test demonstrated zero cross-reactivity.
Hospitals and reference laboratories can run the test on Roche’s cobas e analyzers which are widely available around the world. These fully-automated systems can provide SARS-CoV-2 test results in approximately 18 minutes, with a test throughput of up to 300 tests/hour, depending on the analyzer.
About Roche response to COVID-19 section
The COVID-19 pandemic continues to evolve globally with varying developments from country to country and we are partnering with healthcare providers, laboratories, authorities and organisations to help make sure that patients receive the tests, treatment and care they need. This new test is an additional step in Roche’s fight against the COVID-19 pandemic, which has already included:
- Launching COVID-19 diagnostic tests for active infection and the detection of antibodies in patients who have been exposed to the virus,
- Investigating treatments from our existing portfolio to better understand their potential to treat patients with COVID-19,
- Increasing manufacturing and supply chain capacity to meet product demand across our portfolio within the wider context of COVID-19 treatment,
- Ensuring the supply of our existing medicines and diagnostics to patients around the world under exceptional conditions.
Reliable, high-quality testing is essential to help healthcare systems overcome this pandemic. On 13 March we received FDA Emergency Use Authorisation for a high-volume molecular test to detect SARS-CoV-2, the virus that causes COVID-19, which is also available in countries accepting the CE Mark. On 3 May, Roche announced that its COVID-19 antibody test, aimed at detecting the presence of antibodies in the blood, also received FDA Emergency Use Authorisation and is available in markets accepting the CE mark. Also in June we received an FDA EUA for the Elecsys® IL-6 test to assist in identifying severe inflammatory response in patients with confirmed COVID-19, as well as launching Roche v-TAC, which could help simplify the screening, diagnosis and monitoring of patients with respiratory compromise in the current COVID-19 pandemic. In July, we added a Rapid Antibody Test, with SD Biosensor as distribution partner, to our portfolio, that allows the detection of antibodies against Covid-19 at the point of care. Roche is working closely with governments and health authorities around the world, and has significantly increased production to help ensure availability of tests globally.
We are actively involved in understanding the potential of our existing portfolio and are researching options for the future. Roche has an ongoing clinical trial program evaluating the role of Actemra©/RoActemra© (tocilizumab) in COVID-19 pneumonia. On 29 July we announced that the COVACTA trial did not meet its primary endpoint of improved clinical status in patients with COVID-19 associated pneumonia, or the key secondary endpoint of reduced patient mortality. The study was the first global, randomised, double-blind, placebo-controlled phase III trial investigating Actemra/RoActemra in this setting. Roche remains committed to continuing the Actemra/RoActemra clinical trial programme in COVID-19 to further explore Actemra/RoActemra in other treatment settings, including in combination with an antiviral. In addition to COVACTA, Roche has initiated several studies to further investigate Actemra/RoActemra as a potential treatment for patients with COVID-19 associated pneumonia, including two phase III clinical trials, REMDACTA and EMPACTA, as well as the phase II MARIPOSA trial. Roche has further initiated an internal early research programme focused on the development of medicines for COVID-19 and is engaged in multiple research collaborations. On 19 August, we announced a partnership with Regeneron to develop, manufacture and distribute REGN-COV2, Regeneron’s investigational antiviral antibody combination, to people around the globe.
In these exceptional times, Roche stands together with governments, healthcare providers and all those working to overcome the pandemic.
About Roche
Roche is a global pioneer in pharmaceuticals and diagnostics focused on advancing science to improve people’s lives. The combined strengths of pharmaceuticals and diagnostics under one roof have made Roche the leader in personalised healthcare – a strategy that aims to fit the right treatment to each patient in the best way possible.
Roche is the world’s largest biotech company, with truly differentiated medicines in oncology, immunology, infectious diseases, ophthalmology and diseases of the central nervous system. Roche is also the world leader in in vitro diagnostics and tissue-based cancer diagnostics, and a frontrunner in diabetes management.
Founded in 1896, Roche continues to search for better ways to prevent, diagnose and treat diseases and make a sustainable contribution to society. The company also aims to improve patient access to medical innovations by working with all relevant stakeholders. More than thirty medicines developed by Roche are included in the World Health Organization Model Lists of Essential Medicines, among them life-saving antibiotics, antimalarials and cancer medicines. Moreover, for the eleventh consecutive year, Roche has been recognised as one of the most sustainable companies in the Pharmaceuticals Industry by the Dow Jones Sustainability Indices (DJSI).
The Roche Group, headquartered in Basel, Switzerland, is active in over 100 countries and in 2019 employed about 98,000 people worldwide. In 2019, Roche invested CHF 11.7 billion in R&D and posted sales of CHF 61.5 billion. Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan. For more information, please visit www.roche.com.
Reference: https://www.roche.com/media/releases/med-cor-2020-09-18b.htm
Quest Diagnostics Now Offers Two Consumer-Initiated and Physician-Ordered COVID-19 Diagnostic Test Options for Active COVID-19 Infection Through QuestDirect™
17 September 2020 - QuestDirect™ Active Infection allows individuals to collect a specimen at home or by drive-thru at more than 500 Walmart Neighborhood Market locations. Results are interpreted by a physician via telecare and provided digitally through the MyQuest™ patient portal so individuals may share results securely online with friends, family and physicians.
SECAUCUS, N.J., Sept. 17, 2020 -- Individuals can now purchase a test to diagnose COVID-19 online, without visiting a doctor's office, through QuestDirect, the consumer-initiated testing business of Quest Diagnostics, the world's leading provider of diagnostic information services. The QuestDirect COVID-19 Active Infection test can be purchased online with specimen collection available in two ways: at-home or at one of more than 500 Walmart Neighborhood Market drive-thru pharmacy locations across the United States.
"Accessible, high-quality COVID-19 diagnostic testing is essential to containing the spread of COVID-19," said Jay Wohlgemuth, M.D., Senior Vice President and Chief Medical Officer for Quest Diagnostics. "With our new QuestDirect COVID-19 Active Infection self-collection kit, anyone can access a high-quality COVID-19 test with access to interpretation and referral into care from a physician. Additionally, individuals can receive a self-collection kit either at home or at a nearby Walmart drive thru location, for the ultimate in speed, safety and convenience."
The new test uses the gold standard of COVID-19 diagnostic testing – highly sensitive molecular diagnostic technologies that have received emergency use authorization from the FDA to aid the detection of the RNA of SARS-COV-2, the virus that causes COVID-19. The test is appropriate for individuals who seek access to COVID-19 diagnostic testing, due to COVID-19-like symptoms or exposure to someone with COVID-19.
The kit includes a device for anterior nares (nasal) swab collection, a comparatively noninvasive specimen collection technique that involves inserting a swab into one nostril in the front of the nose.
Easy-to-Order Process with Two Access Options
After an individual purchases the test online, a licensed physician with an independent national network of physicians providing clinical oversight for QuestDirect services, will promptly review the order and, if deemed appropriate, order the test.
Unlike other consumer-initiated COVID-19 diagnostic tests, Quest provides two options for specimen collection:
- A specimen collection kit is mailed to the individual's home. The individual may then submit the specimen in the kit via FedEx overnight to a Quest Diagnostics laboratory for testing.
- An individual may also opt to purchase the kit online and take it to one of more than 500 Walmart drive-thru pharmacy window locations in the United States for observed collection. At these Walmart locations, a trained pharmacist will observe the collection process and the specimen will be picked-up from a secure drop box and delivered to a Quest laboratory for testing.
Test results are available in an easy-to-read report on MyQuest, the company's secure patient portal accessible on a smartphone, tablet, or desktop.
Physicians are available post-test via telehealth to help consumers with interpretation of the result and referral into appropriate care.
The new service complements the QuestDirect™ COVID-19 Antibody Test, which was launched in April 2020.
MyQuest™ Patient Portal Makes it Easy to Share Test Results
As areas of the country continue to reopen, and people are spending more time together in person, consumers are looking to learn that the people they spend time with pose a reduced risk for spreading COVID. Like all QuestDirect test results, the QuestDirect COVID-19 Active Infection test results are sent directly to Quest's patient portal, MyQuest, where they can be downloaded and/or shared with friends, or directly imported into a consumer's MyCircle – an online platform that securely links the results across authorized individuals, such as caregivers and dependents.
Additionally, through MyQuest, patients can share their QuestDirect COVID-19 Active Infection test results in combination with other test results performed by Quest with their physician, in order to provide a more comprehensive view of their state of health.
About Our Commitment to Consumer Empowered Health
Quest Diagnostics has long been at the forefront of the movement for consumer empowerment in healthcare. The company was among the first diagnostic information services providers to offer free access to test results online and other channels. Its mobile app and patient portal, called MyQuest, provides millions of people a way to securely access and track their test results and other health data. The company's QuestDirect service provides dozens of tests for conditions ranging from heart health and sexually transmitted diseases. For added convenience, the company now offers at-home self-collection devices for tests including COVID-19 active infection, diabetes, and hormones. Through its collaborations with Safeway and Walmart, Quest Diagnostics operates approximately 200 patient service centers in retail store locations, for the utmost in convenient access. Quest Diagnostics also provides next generation sequencing and genotyping services for Ancestry.
About COVID-19 Testing by Quest Diagnostics
Quest Diagnostics is at the forefront of the response to the COVID-19 pandemic, working to broaden access to laboratory insights to help us all lead healthier lives. We provide both molecular diagnostic and antibody serology tests to aid in the diagnosis of COVID-19 and immune response. Our COVID-19 test services are based on tests that have received FDA emergency use authorization and which also meet our high standards for quality. We are providing these test services under the Public Readiness and Emergency Preparedness Act. We provide data on COVID-19 testing to various federal and state public health authorities, including the Centers for Disease Control and Prevention, and participate in studies with government and private institutions, aiding COVID-19 public health response and research. Through our team of dedicated phlebotomists, air fleet team, couriers and laboratory professionals, Quest Diagnostics works hard every day to help patients and communities across the United States access quality COVID-19 testing.
About Quest Diagnostics
Quest Diagnostics empowers people to take action to improve health outcomes. Derived from the world's largest database of clinical lab results, our diagnostic insights reveal new avenues to identify and treat disease, inspire healthy behaviors and improve health care management. Quest annually serves one in three adult Americans and half the physicians and hospitals in the United States, and our 47,000 employees understand that, in the right hands and with the right context, our diagnostic insights can inspire actions that transform lives. www.QuestDiagnostics.com
QIAGEN fully acquires NeuMoDx Molecular, Inc., rounding out portfolio of PCR-based diagnostic automation systems
17 September 2020 - Transaction strengthens QIAGEN’s leadership position in automated molecular testing. QIAGEN acquires remaining 80.1% stake in NeuMoDx Molecular, Inc. for $248 million. Medium- and high-throughput NeuMoDx automation solutions based on PCR testing technology to now be integrated into QIAGEN’s portfolio on a global basis. Menu of test solutions for infectious diseases – which already includes COVID-19 – to be expanded, especially in the U.S.
Hilden, Germany and Ann Arbor, Michigan, September 17, 2020 – QIAGEN N.V. today announced the acquisition of the remaining 80.1% of diagnostics instruments company NeuMoDx Molecular, Inc. for $248 million in cash. The move rounds out QIAGEN’s portfolio of automated molecular testing solutions based on the proven PCR technology.
The transaction was completed after QIAGEN received U.S. regulatory clearance for the full acquisition. In 2018, QIAGEN had purchased a 19.9% stake in NeuMoDx along with the right to acquire the remaining NeuMoDx stake at a price of $234 million. The final payment price for this remaining stake includes customary purchase price adjustments for cash, indebtedness and transaction costs. Also as part of the 2018 agreement, QIAGEN has distributed the high-throughput NeuMoDx™ 288 and the medium-throughput NeuMoDx™ 96 platforms in Europe and other markets outside the U.S.
“NeuMoDx’s automated molecular testing platforms offer a unique combination of speed, flexibility, throughput and ease of use for molecular diagnostics assays, including laboratory-developed tests,” said Thierry Bernard, Chief Executive Officer of QIAGEN. “NeuMoDx has built an unparalleled platform that has demonstrated superior value during the coronavirus pandemic. This will expand QIAGEN’s portfolio of automated testing solutions and provide another driver for future growth.”
“NeuMoDx devices offer labs with medium to high throughput exactly what they need,” Bernard added. “Labs want compact systems with true random access, fast turnaround time, full automation and comprehensive menus. The full integration of the NeuMoDx systems will allow QIAGEN to address laboratory needs in almost any setting for molecular diagnostics. We are excited to be able to build on NeuMoDx’s success and will jointly work on expanding our product portfolio and global distribution.”
“Becoming a part of QIAGEN allows us to take our successes at NeuMoDx to the next level,” said Jeff Williams, Chairman and Chief Executive Officer of NeuMoDx Molecular. “We have built a broad testing portfolio and created strong customer enthusiasm around the world with our device’s unique combination of speed, flexibility, throughput and ease of use. This transaction is a testament to the achievements of the entire NeuMoDx team and we are excited to finally become a full part of the QIAGEN family.”
As rapid, integrated PCR-based devices, NeuMoDx™ 288 and NeuMoDx™ 96 already offer 13 CE-IVD-marked assays for different infectious diseases in Europe. These include a dedicated COVID-19 test, which has also received FDA Emergency Use Authorization for the U.S. market, complementing the FDA-approved GBS assay (group B Streptococcus). A new multiplex test for influenza, respiratory syncytial virus (RSV) and the SARS-CoV-2 virus is scheduled for launch in the fourth quarter of 2020.
The NeuMoDx devices have features that set them apart from other lab-based PCR diagnostics systems: they have the fastest fully automated turnaround time, delivering insights in an hour rather than their competitors’ three hours; they allow clinical molecular diagnostic laboratories to process ever-larger volumes and deliver ever-faster insights into many infectious diseases including COVID-19; their flexibility and efficiency is driving a growing menu of in vitro diagnostic (IVD) tests and enables the devices to process commercial and laboratory-developed tests (LDTs – IVD tests made by clinical labs for in-house use).
About NeuMoDx
NeuMoDx Molecular designs and develops revolutionary molecular diagnostic solutions for hospital and clinical reference laboratories. The company’s patented, ‘sample-to-result’ platform offers market-leading ease of use, true continuous random-access, and rapid turnaround time while achieving optimal operational and clinical performance for our customers and the patients they serve. For more information visit www.neumodx.com.
About QIAGEN
QIAGEN N.V., a Netherlands-based holding company, is the leading global provider of Sample to Insight solutions that enable customers to gain valuable molecular insights from samples containing the building blocks of life. Our sample technologies isolate and process DNA, RNA and proteins from blood, tissue and other materials. Assay technologies make these biomolecules visible and ready for analysis. Bioinformatics software and knowledge bases interpret data to report relevant, actionable insights. Automation solutions tie these together in seamless and cost-effective workflows. QIAGEN provides solutions to more than 500,000 customers around the world in Molecular Diagnostics (human healthcare) and Life Sciences (academia, pharma R&D and industrial applications, primarily forensics). As of June 30, 2020, QIAGEN employed more than 5,200 people in over 35 locations worldwide. Further information can be found at www.qiagen.com.
Reference: https://corporate.qiagen.com/newsroom/press-releases/2020/20200917_neumodx
Abbott introduces Libre Sense Glucose Sport Biosensor in Europe, world's first glucose biosensor designed for athletes
17 September 2020 - Abbott's Libre Sense Glucose Sport Biosensor, with CE Mark, is built upon the company's world-leading continuous glucose monitoring technology. Abbott is collaborating with sports performance technology company Supersapiens to advance this first-of-its-kind product. As part of an observational trial, two cycling teams leading into the world's largest annual sporting event, the Tour de France, trained with Abbott's Libre Sense biosensor to track the correlation between glucose levels and their athletic performance.
ABBOTT PARK, Ill., Sept. 17, 2020 -- Abbott is introducing the world's first glucose sport biosensor, Libre Sense Glucose Sport Biosensor, which is designed for athletes to continuously measure glucose to better understand the correlation between their glucose levels and their athletic performance. The Libre Sense biosensor is based on Abbott's world-leading FreeStyle Libre continuous glucose monitoring technology, which was originally developed for people living with diabetes. Based on that technology, this is the first personal-use product that allows for use beyond diabetes.
Abbott's Libre Sense Glucose Sport Biosensor, with CE Mark (Conformité Européenne), is a consumer over-the-counter product that provides glucose monitoring via a mobile app to athletes (ages 16 years and older) performing sports such as cycling, running, and swimming, to understand the efficacy of their nutrition choices on training and competition. Tracking and understanding glucose levels enable athletes to fuel appropriately through nutrition to help avoid fatigue from low glucose and to know when to replenish during training and competition to maintain peak performance.
"FreeStyle Libre changed the way millions of people manage their diabetes to get and stay healthier, and now with Libre Sense we're bringing that same proven technology to empower athletes to help them reach their athletic performance goals," said Jared Watkin, senior vice president, Diabetes Care, Abbott. "This is just the beginning – our breakthrough sensing technology has the potential to go beyond glucose and provide a lens into what's happening in the human body that could provide meaningful insights into other conditions, treatments, and ultimately improve health."
Proper nutrition at the right intervals allows athletes to maintain a stable glucose level during endurance activities, which is important for managing overall energy and avoiding muscle fatigue. A study published in the American College of Sports Medicine showed that an athlete who understands the effects of their nutritional intake will have a better chance at improving their performance during exercise. In addition, research has shown that understanding real-time glucose levels can guide nutritional intake to help improve muscle recovery and athletic performance.
To obtain glucose readings from Abbott's Libre Sense Glucose Sport Biosensor, athletes will wear the small round biosensor (approximately the size of a two Euro coin) on the back of their upper arm. The biosensor will provide real-time glucose values and can be worn for up to 14 days. The user will automatically receive streaming glucose data, via Bluetooth® wireless technology, every minute designed to work with compatible mobile apps and wrist readers.
Working together with sports technology companies for distribution, Abbott's Libre Sense Glucose Sport Biosensor is designed to be compatible with these companies' mobile apps and other accessory devices. Abbott's first non-exclusive collaboration is with Supersapiens, an Atlanta-based sports technology company that is focused on improving athletic performance. Their mission is to provide athletes with actionable and personalized insights on real-time biometric data, starting with glucose.
"With Abbott's Libre Sense, for the first time, an athlete will have access to glucose data to help give them insight into their body's fuel level at all times, fundamentally changing the way athletes think about energy management," said Phil Southerland, founder of Supersapiens and former professional cyclist. "By combining Abbott's proven track record in glucose sensing technology along with Supersapiens' app and personalized analytics, athletes will be primed to sustain peak performance."
Supersapiens has partnered with some of the top teams at the Tour de France, the largest annual sporting event in the world, who are utilizing the energy management system and have worn the Libre Sense biosensor in training as part of an observational trial. Through this experience, the athletes were able to track their glucose data to help inform them of fueling strategies to prepare them for the race.
Abbott's Libre Sense Glucose Sport Biosensor will be available in the coming weeks directly through the Supersapiens website. The product will initially be made available across eight European countries: Austria, France, Germany, Ireland, Italy, Luxembourg, Switzerland and the United Kingdom.
About Abbott Libre Sense Glucose Sport System
The Abbott Libre Sense Glucose Sport Biosensor is intended for athletes to measure glucose. Athletes are defined as individuals who perform exercise with the purpose of improving wellness and performance. When used with a compatible product, the biosensor allows athletes to correlate their glucose levels and their athletic performance. The biosensor is not intended for use in the diagnosis, treatment, or monitoring of a disease.
About Abbott
Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 107,000 colleagues serve people in more than 160 countries.
Thermo Fisher Scientific Further Expands Laboratory Plastics Production to Support COVID-19 Testing, Therapies and Vaccines
15 September 2020
WALTHAM, Mass. , Sept. 15, 2020 -- Thermo Fisher Scientific Inc., the world leader in serving science, today announced it is investing more than $140 million to further expand its laboratory plastics consumables production to support significant global demand for COVID-19 testing, as well as development and manufacturing of therapies and vaccines.
"Early in the pandemic, we quickly joined forces with governments, public health agencies and industry to increase capacity across our laboratory plastics production facilities and address the growing COVID-19 threat," said Fred Lowery, senior vice president and president of Life Sciences Solutions and Laboratory Products at Thermo Fisher Scientific. "However, demand quickly exceeded those early expansion projects, so we began a series of additional expansions to meet the growing needs of our customers. These investments, along with many others across the company, will ensure that our customers have the supplies they need to continue meeting the unprecedented demands of the COVID-19 response."
The rapid increase in production related to COVID-19 testing, and development and manufacturing of therapies and vaccines, has created historic demand for laboratory plastics, including pipette and automation tips, storage tubes and plates, transfer pipettes, and packaging vials and bottles. To support these needs, Thermo Fisher is creating more than 1,000 jobs across manufacturing sites globally, increasing automation capabilities and optimizing warehouse and sterilization capacity to improve supply chain agility.
Among the Thermo Fisher sites currently being expanded are Rochester, N.Y.; Petaluma, Calif.; Monterrey and Tijuana, Mexico; and Joensuu, Finland.
Thermo Fisher offers an extensive range of laboratory plastics, including Thermo Scientific Nalgene and Nunc plasticware and the Thermo Scientific Manual and Electronic Pipetting Systems. From bottles, beakers, funnels and tubes to pipettes, tips and diagnostic plates, Thermo Fisher consumables support critical COVID-19 work globally and include sample collection vials for diagnostic test kits, pipettes for test processing, lab essentials for research into therapies and vaccines, lab plastics to support clinical and epidemiological studies, and materials for vaccine production and biobanking.
For more information about the Thermo Scientific range of laboratory plastic consumables, please visit www.thermofisher.com/backtothelab.
About Thermo Fisher Scientific
Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $25 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, improving patient diagnostics and therapies or increasing productivity in their laboratories, we are here to support them. Our global team of more than 75,000 colleagues delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services and Patheon. For more information, please visit www.thermofisher.com.
Siemens Healthineers Collaboration with CDC Will Define Threshold for Neutralizing Antibody Sufficient to Confer Immunity
15 September 2020 - The collaboration will standardize SARS-CoV-2 assays by defining concentrations of antibodies to specific viral proteins to confer neutralization that could one day be extrapolated to thresholds considered sufficient to confer immunity. Standardization across manufacturers is also expected to improve patient care by enabling long-term antibody level comparison.
15 September 2020 -- Siemens Healthineers announced today a collaboration with the U.S. Centers for Disease Control and Prevention (CDC) and the JRC (Joint Research Centre) of the European Commission on a research project to develop a novel process for standardizing SARS-CoV-2 assays.
Antibody tests differ among test manufacturers and currently cannot be analytically compared because they target different SARS-CoV-2 proteins. These include the spike protein, S1/S2, S1 RBD, and N protein, which are found in different parts of the SARS-CoV-2 virus. As the pandemic has evolved, antibody test results have progressed from qualitative positive/negative results to more recent assays capable of numerical measurements that gauge the level of IgG antibodies in a patient’s blood sample.
The reportable numerical patient results of the current semi-quantitative assays are expressed in units that are not actual concentrations of antibodies, but rather the antibody activity to the virus. Because comparing test results across manufacturers has not been possible, establishing immunity associated with these tests has been challenging.
Siemens Healthineers' collaboration with the CDC and the JRC will develop a novel process for standardizing SARS-CoV-2 assays by anchoring each protein to a neutralization antibody titer—a level of antibody present to block virus from entering cells in laboratory experiments. The thresholds displayed in the standardized unit of measure for IgG—arising either from natural infection or vaccination—may likely contribute to a standardized interpretation of immunity through test results.
"One barrier to antibody test adoption is we don't currently have an established process to determine immunity," said Deepak Nath, PhD, President of Laboratory Diagnostics, Siemens Healthineers. "Different SARS-CoV-2 antibody targets produce different levels of neutralization. Our R&D team recognized that if you could define a level at which neutralization is conferred for different targets, you could create a common ground to standardize assays—not just on antibody production, but their ability to provide immunity. Our collaboration with the CDC and JRC will develop the framework that all antibody test manufacturers would be expected to adopt moving forward for greater benefit to patient care as the pandemic evolves."
Developing a standardized process will define which concentration confers neutralization for different manufacturers’ antigen targets. Each manufacturer currently standardizes their assays independently with internal standards that are not linked to a common reference. The results of this collaborative research project will support the JRC's production of a reference material. This reference material with assigned concentrations of antibody specific to each viral protein will allow manufacturers to refer to standardized values.
With an international standard established and adopted by manufacturers, clinicians would be positioned to track their patients' antibody concentrations, regardless of the test method or manufacturer used. This capability is expected to improve patient care by enabling long-term antibody level comparison—clinical information that is important for verifying natural immunity acquired by patient’s infection with the virus, as well as for determining the effectiveness of vaccines.
About Siemens Healthineers AG
Siemens Healthineers AG is shaping the future of Healthcare. As a leading medical technology company headquartered in Erlangen, Germany, Siemens Healthineers enables healthcare providers worldwide through its regional companies to increase value by empowering them on their journey towards expanding precision medicine, transforming care delivery, improving the patient experience, and digitalizing healthcare. Siemens Healthineers is continuously developing its product and service portfolio, with AI-supported applications and digital offerings that play an increasingly important role in the next generation of medical technology. These new applications will enhance the company’s foundation in in-vitro diagnostic, image-guided therapy, and in-vivo diagnostics. Siemens Healthineers also provides a range of services and solutions to enhance healthcare providers ability to provide high-quality, efficient care to patients. In fiscal 2019, which ended on September 30, 2019, Siemens Healthineers, which has approximately 52,000 employees worldwide, generated revenue of €14.5 billion and adjusted profit of €2.5 billion. Further information is available at www.siemens-healthineers.com.
Reference: https://www.siemens-healthineers.com/press-room/press-releases/covid-19-cdc.html
Aptima® HIV-1 Quant Dx Assay Awarded WHO Prequalification for Dried Blood Spot Samples
14 September 2020
MARLBOROUGH, Mass., September 14, 2020 -- Hologic, Inc. announced today that its CE-marked Aptima® HIV-1 Quant Dx assay has been awarded World Health Organization (WHO) prequalification for testing of dried blood spot (DBS) samples.
The Aptima® HIV-1 Quant Dx assay can be used with DBS samples to monitor viral load and disease progression among HIV-1 infected individuals, and to aid in the diagnosis of HIV-1 infected infants under 18 months. It is the first and only dual-claim assay for both viral load and early infant diagnosis (EID).
DBS sampling improves access to HIV diagnostic testing and care, particularly among HIV-infected populations living in remote areas. DBS samples are more stable and easily transportable compared to liquid whole blood or plasma samples. A finger stick or heel prick produces an adequate sample that is dried on a specially designed card. The DBS samples do not require refrigeration and when stored properly can withstand extreme conditions, including excess heat and humidity.
This additional approval is notable for the African market, where DBS is the primary sample type in several countries, and is expected to enable countries to expand their use of the Aptima® HIV-1 Quant Dx assay, the leading assay under Hologic’s Global Access Initiative (GAI). The GAI launched in 2018 and offers customers a single, all-inclusive pricing structure with no upfront cost or capital expenditure. Qualified products include molecular assays for HIV, Hepatitis B and C, and human papillomavirus (HPV), as well as the ThinPrep® Pap test for cervical cancer screening.
“With 25 million people infected with HIV in sub-Saharan Africa, there continues to be an urgent need for access to cost-effective and quality diagnostic testing,” said Joao Malagueira, vice president, Europe South, Middle East and Africa. “The ability to test DBS samples underlines Hologic’s commitment to promote simple, scalable and sustainable solutions for countries that need it most. The new product extension will ultimately enhance patient care and allow for partner governments to mitigate the burden of disease and respond to broader health needs.”
Despite substantial progress toward the UNAIDS 95-95-95 targets, there continue to be gaps across the HIV testing and treatment cascade, with 15.7 million people living with HIV who have an unsuppressed viral load globally. In addition, children and infants continue to be affected by the epidemic. In 2019, only 60% of infants born to pregnant women living with HIV received the recommended HIV test within two months of birth. About 86% of the estimated 160,000 children newly infected with HIV in 2018 were in sub-Saharan Africa.
The DBS sample type is the second approval Hologic has received from the WHO, following prequalification of the Aptima® HIV-1 Quant Dx assay for in vitro diagnostic use with plasma samples in December 2017.
About Hologic’s Global Access Initiative
The Hologic Global Access Initiative is a partnership with the Clinton Health Access Initiative, Inc. (CHAI) and MedAccess (backed by the UK government) to mitigate the burden of viral diseases in areas with high prevalence by providing greater access to testing using the Panther® system. Together with these organizations, Hologic delivers a pricing structure that allows eligible countries to procure testing with an all-inclusive ceiling price of $12 per patient test, with no requirement for capital expenditure. The test result price is inclusive of all necessary reagents and consumables, instrument placement, service and maintenance, freight and logistics, and replacement tests.
About Hologic
Hologic, Inc. is an innovative medical technology company primarily focused on improving women’s health and well-being through early detection and treatment. For more information on Hologic, visit www.hologic.com.
Genomic Leaders Collaborate to Create Australia’s First National COVID-19 Tracking System
14 September 2020
MELBOURNE, Australia, 14 September 2020 -- Illumina announced today that the Australian public health laboratories will aim to sequence the virus genomes of all positive COVID-19 tests in Australia and track COVID-19 using genomics across the country, rather than state by state, under a ground-breaking initiative spearheaded by Australia’s public health laboratory organisations and leading industry partners.
The Communicable Disease Genomics Network (CDGN) and Illumina are collaborating to track COVID-19 using next-generation genomic sequencing technology, which enables real-time data sharing and integration to better understand the transmission and spread of the virus. Coordinated by the CDGN, this will be the first national implementation of pathogen surveillance and a critical step forward in Australia’s pandemic response.
The Australian Government has provided a AUD $3.3M Medical Research Future Fund (MRFF) grant through The University of New South Wales (UNSW) Sydney’s School of Medical Sciences. As part of the research project, Illumina has further contributed more than AUD $2M worth of its genomic sequencing systems and related consumables.
UNSW Conjoint Professor Bill Rawlinson, Senior Medical Virologist, said the research project will address the urgent need for national implementation of COVID-19 genomics in Australia.
“This research will provide us with a better understanding of the behaviour, spread and evolution of COVID-19, thanks to the precision of next-generation sequencing technology. The project will enable us to measure the impact of using this technology not only for the COVID-19 pandemic, but also for future responses,” Prof. Rawlinson said.
Illumina’s systems are expected to be delivered next week to the Doherty Institute, Westmead Hospital, UNSW at the Prince Of Wales Hospital and Queensland Health Forensic and Scientific Services, expanding the capacity of the four major public health laboratories in New South Wales, Victoria and Queensland to sequence pathogens, including COVID-19 samples.
The Medical Research Future Fund grant will also help to build support in other jurisdictional public health laboratories and, with the added support of State and Territory Governments, will aim to sequence virus genomes of all positive COVID-19 tests in Australia.
“This is a leading global example that will demonstrate the unique value of genomics surveillance in understanding and helping to control the COVID-19 pandemic and Illumina is thrilled to be an instrumental partner of this effort,” Dr Phil Febbo, Illumina’s Chief Medical Officer, said. “The program will allow sharing of vital pathogen data with the use of bioinformatics across states and territories assuring that the sequencing of viral and other pathogens is not limited to this pandemic but will continue to expand in both academic research and the public health systems going forward.”
Pathogen genomics can reveal information that would otherwise be missed, including rapid insights into the behaviour, spread and evolution of COVID-19. This project will have an immediate application in the investigation of outbreaks, including identification of emerging outbreaks and transmission events as part of efforts to reduce community transmission.
Other benefits of genomics include the ability to identify mutations of COVID-19 in the Australian population to inform the design of treatments and vaccines, and the capacity to precisely identify persistent infection versus reinfection or inactive infection. This holds particular significance to healthcare workers and can help protect the capacity of the frontline workforce and vulnerable patients.
“The CDGN has been working to establish a nationally integrated pathogen genomics initiative that will facilitate the rapid implementation of this project, ensuring national access and consistency in genomics analyses. Information on the national transmission of the virus that causes COVID-19 will be important to informing future public health responses in Australia,” said University of Melbourne Professor Ben Howden, Co-chair of the CDGN and Director of the Microbiological Diagnostics Unit Public Health Laboratory at the Doherty Institute.
About Illumina
Illumina is improving human health by unlocking the power of the genome. Our focus on innovation has established us as the global leader in DNA sequencing and array-based technologies, serving customers in the research, clinical, and applied markets. Our products are used for applications in the life sciences, oncology, reproductive health, agriculture, and other emerging segments. To learn more, visit www.illumina.com and follow @illumina.
About the Peter Doherty Institute for Infection and Immunity
Finding solutions to prevent, treat and cure infectious diseases and understanding the complexities of the immune system requires innovative approaches and concentrated effort. This is why The University of Melbourne – a world leader in education, teaching and research excellence – and The Royal Melbourne Hospital – an internationally renowned institution providing outstanding care, treatment and medical research – have partnered to create the Peter Doherty Institute for Infection and Immunity (Doherty Institute); a centre of excellence where leading scientists and clinicians collaborate to improve human health globally.
About UNSW Sydney
UNSW aims to improve and transform lives through excellence in research, outstanding education and a commitment to advancing a just society. The University is one of the leading research and teaching-intensive universities in the world, known for innovative, pioneering research and high quality education with a global impact. The University offers an extensive range of undergraduate, postgraduate and research programs that attract students from across Australia and around the world. Visit www.unsw.edu.au and follow @unsw
RECOVERY COVID-19 Phase 3 trial to evaluate Regeneron's REGN-COV2 investigational antibody cocktail in the UK
14 September 2020 - One of the world's largest efforts to find effective COVID-19 treatments will evaluate the impact of REGN-COV2 on mortality, hospital stays, and the need for ventilation
TARRYTOWN, N.Y. and OXFORD, England, Sept. 14, 2020 -- Regeneron Pharmaceuticals, Inc. and the University of Oxford today announced that RECOVERY (Randomised Evaluation of COVid-19 thERapY), one of the world's largest randomized clinical trials of potential COVID-19 treatments, will evaluate Regeneron's investigational anti-viral antibody cocktail, REGN-COV2. The Phase 3 open-label trial in patients hospitalized with COVID-19 will compare the effects of adding REGN-COV2 to the usual standard-of-care versus standard-of-care on its own.
Peter Horby, Professor of Emerging Infectious Diseases and Global Health, Nuffield Department of Medicine, University of Oxford and chief investigator of the trial, said "We have already discovered that one treatment, dexamethasone, benefits COVID-19 patients, but the death rate remains too high so we must keep searching for others. The RECOVERY trial was specifically designed so that when promising investigational drugs such as REGN-COV2 became available they can be tested quickly. We are looking forward to seeing whether REGN-COV2 is safe and effective in the context of a large-scale randomized clinical trial; this is the only way to be certain about whether it works as a treatment for COVID-19."
"The world urgently needs new medicines to combat COVID-19, and well-designed trials to evaluate new treatment options will quickly help us learn which are most effective," said George D. Yancopoulos, M.D., Ph.D., President and Chief Scientific Officer of Regeneron. "REGN-COV2 was specifically designed by Regeneron scientists to target the virus that causes COVID-19. RECOVERY will be the fourth late-stage randomized clinical trial evaluating REGN-COV2 and will add to our knowledge about how this novel antibody cocktail may help hospitalized patients in need."
REGN-COV2 is the first specifically designed COVID-19 therapy being evaluated by RECOVERY. It was selected in part based on its emerging safety profile in humans, pre-clinical data showing it could protect against viral escape mutations, and prevention and treatment studies in non-human primates showing it reduced the amount of virus and associated damage in the lungs. REGN-COV2 is currently being studied in two Phase 2/3 clinical trials for the treatment of COVID-19 and in a Phase 3 trial for the prevention of COVID-19 in household contacts of infected individuals.
Martin Landray, Professor of Medicine & Epidemiology, Nuffield Department of Population Health, University of Oxford, added, "Throughout the COVID-19 pandemic we have seen the power of randomized trials to provide rigorous assessment of potential treatments. Up to now, we have largely been studying whether existing drugs can be re-purposed to tackle this new disease, but we now have the opportunity to rigorously assess the impact of a drug specifically designed to target this coronavirus. There are good reasons to be excited about this new development – RECOVERY will provide a robust assessment of the effect of this lab-manufactured monoclonal antibody combination treatment in hospitalized patients.
"We are very grateful to the patients who have already taken part in the trial and to those who will participate in this next phase of RECOVERY. We would not be able to find the best treatments without their support and that of the thousands of hospital and research staff who are working with us."
The open-label RECOVERY trial will assess the impact of adding REGN-COV2 to the usual standard-of-care on all-cause mortality 28 days after randomization. Other endpoints include the impact on hospital stay and the need for ventilation. It is anticipated that at least 2,000 patients will be randomly allocated to receive REGN-COV2 plus usual standard-of-care, and results will be compared with at least 2,000 patients who receive standard-of-care on its own. Usual standard-of-care varies by local hospital.
The trial is being coordinated by researchers at the University of Oxford, which acts as the sponsor for the research, working with clinical teams at 176 hospital sites across the UK.
About the Trial
The RECOVERY trial is conducted by the registered clinical trials units in the Nuffield Department of Population Health in partnership with the Nuffield Department of Medicine. The trial is supported by a grant to the University of Oxford from UK Research and Innovation/National Institute for Health Research (NIHR) and by core funding provided by NIHR Oxford Biomedical Research Centre, Wellcome, the Bill and Melinda Gates Foundation, the Department for International Development, Health Data Research UK, the Medical Research Council Population Health Research Unit and NIHR Clinical Trials Unit Support Funding.
The trial involves many thousands of doctors, nurses, pharmacists, and research administrators at 176 hospitals across the whole of the UK, supported by staff at the NIHR Clinical Research Network, NHS DigiTrials, Public Health England, Department of Health & Social Care, the Intensive Care National Audit & Research Centre, Public Health Scotland, the Secure Anonymised Information Linkage at University of Swansea, and the NHS in England, Scotland, Wales and Northern Ireland.
The inclusion of convalescent plasma in the RECOVERY trial was announced in June. The trial will compare adding convalescent plasma (plasma taken from patients who have recovered from COVID-19) to usual standard-of-care versus standard-of-care on its own.
About REGN-COV2
REGN-COV2 comprises two monoclonal antibodies (REGN10933 and REGN10987) and was designed specifically by Regeneron scientists to block infectivity of SARS-CoV-2, the virus that causes COVID-19. They evaluated thousands of fully-human antibodies produced by the company's VelocImmune® mice, which have been genetically modified to have a human immune system, as well as antibodies identified from humans who have recovered from COVID-19. The two potent, virus-neutralizing antibodies that form REGN-COV2 bind non-competitively to the critical receptor binding domain of the virus's spike protein, which diminishes the ability of mutant viruses to escape treatment and protects against spike variants that have arisen in the human population, as detailed in Science.
An Independent Data Monitoring Committee is monitoring all Regeneron-led REGN-COV2 Phase 2 and 3 trials, and all trials continue to enroll patients.
REGN-COV2's development and manufacturing has been funded in part by the Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response at the U.S. Department of Health and Human Services under OT number: HHSO100201700020C. Regeneron has recently partnered with Roche to increase the global supply of REGN-COV2. If REGN-COV2 proves safe and effective in clinical trials and regulatory approvals are granted, Regeneron will manufacture and distribute it in the U.S. and Roche will develop, manufacture and distribute it outside the U.S.
About Regeneron
Regeneron is a leading biotechnology company that invents life-transforming medicines for people with serious diseases. Founded and led for over 30 years by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to seven FDA-approved treatments and numerous product candidates in development, all of which were homegrown in our laboratories. Our medicines and pipeline are designed to help patients with eye diseases, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, pain, infectious diseases and rare diseases.
Regeneron is accelerating and improving the traditional drug development process through our proprietary VelociSuite technologies, such as VelocImmune®, which uses unique genetically-humanized mice to produce optimized fully-human antibodies and bispecific antibodies, and through ambitious research initiatives such as the Regeneron Genetics Center, which is conducting one of the largest genetics sequencing efforts in the world.
False Positive Test Cases in Sweden Explained
9 September 2020
9 September 2020 -- Last month, Sweden’s Public Health Agency announced that two laboratories discovered an RT- PCR kit for SARS-CoV-2 detection had returned around 3,700 false-positive results. The agency expressed concerns that the kits from BGI Genomics could not distinguish between very low levels of the virus and a negative result.
Lars Engstrand, director and professor at Karolinska Institutet/Science for Life Laboratory in Sweden, performed an analysis of the BGI RT- PCR kit for SARS-CoV-2. When asked about the possibility of false-positive results, he explained in an interview that the rate of positive detection can be linked to test sensitivity.
“This test is very sensitive, and this means that you want to catch all the positive cases in the population…” Professor Engstrand said. “When you have many cases, this kit is very good. It will not miss any positive cases. This means that you can rely on the results, but you also have a chance to get ‘false positive.’ But when the situation changes, and you have a very low number of infected individuals in society, as we have now, then you can lower the sensitivity and be sure that you pick up the right positive cases so you have not so many false positive cases. This is the situation now and we have now changed the threshold or the sensitivity of the test, so now it works perfectly fine in Sweden. We can rely on the test today.”
According to Reuters, “The Swedish labs that evaluate the tests have adjusted their methodology. The agency could not say how many tests had been done using the kit but only a minority of cases appeared to be involved, when the virus is at very low levels.”
Decisions made about the threshold may affect the interpretation of the results, which changes in accordance with the situation. Professor Engstrand explains: “With all tests, it’s a balance if you want to have high sensitivity or not. And in the beginning of the pandemic in Sweden, that was good. Now we don’t need that high sensitivity. We can actually be more precise and don’t risk to catch the false-positive cases. And today we have the situation with this kit.” Despite the special situation of COVID-19, “no test is 100 percent specific or sensitive,” he added. “That means every test has this kind of balance. You have to find out what this balance should be. And this is what we’ve done now in Sweden, for this test.”
Professor Engstrand also assured the public that “this test has been used in many, many countries. And in our hands today, it works perfectly fine. We can validate with other kits and other labs and we have 100 percent agreement between the answers.”
In a response to Sweden’s concern, BGI Genomics stated that the “high positive rate” was due to the amount of virus inside asymptomatic patients, and different countries and regions define asymptomatic patients differently. Different strategies have been implemented around the world. As a country with high population density, China prefers to implement stringent rules, conduct thorough tests, and set high sensitivity to avoid any blind spots and possible infections.
Reference: https://www.bgi.com/global/company/news/false-positive-test-cases-in-sweden-explained/
FBI Approves Thermo Fisher Scientific's Rapid DNA Solution for National DNA Index System
8 September 2020 - Applied Biosystems RapidHIT ID System plays key role in arrestee testing and investigative lead generation
SOUTH SAN FRANCISCO, Calif., Sept. 8, 2020 -- The U.S. Federal Bureau of Investigation (FBI) has approved Thermo Fisher Scientific's Applied Biosystems RapidHIT ID System for use by accredited forensic DNA laboratories to process DNA reference samples and search resulting profiles against the U.S. National DNA Index System (NDIS) CODIS database without manual interpretation and review.
The RapidHIT ID System is a fully automated, sample-to-answer genetic analyzer, allowing for analysis of DNA reference samples in as little as 90 minutes. This frees up DNA analyst time for more complex cases and quickly provides actionable information to help solve crimes faster. Faster turnaround time means law enforcement can more efficiently catch repeat offenders, exonerate the innocent, reduce costs to the criminal justice system and make communities safer.
NDIS approval of the RapidHIT ID System by the FBI paves the way for the technology to be used in booking stations for fast DNA processing. Previously, data generated from the RapidHIT ID System required review and interpretation from a qualified DNA analyst. Now, the system can perform automated review for the vast majority of resulting profiles. Pilot studies have been conducted by the FBI and participating agencies, enabling wider implementation in booking stations nationwide in the near future.
In a multi-site study of over 1,100 buccal samples, the RapidHIT ID System performance was proven suitable for single source reference samples and shown to be comparable to traditional laboratory results. Agencies participating in the study included the Louisiana State Police Crime Laboratory, Arizona Department of Public Safety, Alameda County Sheriff's Office Crime Laboratory, Florida Department of Law Enforcement, and Miami-Dade Police Department Forensic Services Bureau.
"NDIS approval of the RapidHIT ID system is a crucial step in supporting the FBI's vision of producing a DNA profile – and searching CODIS – while a qualifying arrestee is in police custody," said Martin Guillet, vice president and general manager for the Human Identification business at Thermo Fisher Scientific. "We remain committed to the standards of quality and integrity set forth by the forensics community, and to partnering with the law enforcement community to ensure booking station implementation is a success."
The NDIS-approved Rapid DNA system comprises the Applied Biosystems RapidHIT ID instrument, GlobalFiler Express typing kit, RapidHIT ID ACE GlobalFiler Express sample cartridge, RapidHIT ID System Software version 1.3, and RapidHIT ID Expert System software version 1.0.
Learn more at www.thermofisher.com/rapidDNA
About Thermo Fisher Scientific
Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $25 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, improving patient diagnostics and therapies or increasing productivity in their laboratories, we are here to support them. Our global team of more than 75,000 colleagues delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services and Patheon. For more information, please visit www.thermofisher.com.
Roche receives FDA clearance for BK virus quantitative test on cobas 6800/8800 Systems to support better care for transplant patients
8 September 2020 - Immunocompromised transplant patients are at risk of major complications when infected with BK virus. cobas BKV test addresses critical need for hospitals and laboratories to have standardised and comparable results across institutions. New Breakthrough Device test expands Roche molecular test menu for transplant patients, enabling simultaneous testing of BK virus with Cytomegalovirus and Epstein-Barr virus.
Basel, 8 September 2020 -- Roche today announced U.S. Food and Drug Administration (FDA) 510k clearance for the cobas® BKV Test on the cobas® 6800 and 8800 Systems. The test was previously granted FDA Breakthrough Device designation demonstrating the improved treatment or diagnosis of life-threatening diseases or conditions for transplant patients. The test provides standardised, high-quality results that can help healthcare professionals better assess the risk of complications caused by the BK virus in transplant patients and identify effective treatment options.
BK virus (BKV) is a member of the polyomavirus family that can cause severe transplant-associated complications. Infection can occur without symptoms and happen early in life. After primary infection, the virus can remain inactive, only to possibly reactivate in immunocompromised individuals such as transplant recipients.
“Our diagnostic tests can help clinicians greatly improve patient treatment plans and make quick adjustments for personalised healthcare,” said Thomas Schinecker, CEO Roche Diagnostics. “This FDA clearance allows Roche to offer healthcare professionals a transplant testing portfolio that includes Cytomegalovirus, Epstein-Barr virus and BK virus so they can simultaneously monitor and improve care for transplant patients who are at risk for these common infections or viral reactivations which can cause further illness or death.”
The cobas BKV Test is a polymerase chain reaction (PCR) viral load test that runs on the fully automated and widely available cobas® 6800 and cobas® 8800 Systems. Along with the previously approved cobas® EBV and CMV Tests, the cobas BKV Test has been calibrated to the World Health Organization (WHO) International Standard. This means that test results are reported in international units, making it possible for laboratories anywhere in the U.S. to obtain comparable results when measuring levels of BKV DNA.
About the cobas BKV Test
The cobas BKV Test was previously granted Breakthrough Device Designation by the FDA, together with the cobas EBV Test.
The cobas BKV Test is a real-time polymerase chain reaction (PCR) test with dual-target technology that provides quantitative accuracy and guards against the risk of sequence variations that may be present in the BK virus. The cobas BKV Test has robust coverage with a limit of detection of 21.5 IU/mL and an expanded linear range from 21.5 IU/mL to 1E+08 IU/mL in EDTA plasma.
The test offers an alternative to lab-developed tests (LDTs) or Analyte Specific Reagent (ASR) combinations, potentially minimising variability and complexity in testing, reducing workload and alleviating risk for laboratories. The test supports the goal of result standardisation across institutions by providing reproducible, high-quality results for clinical decision-making.
The fully automated cobas BKV Test and the cobas CMV and cobas EBV Tests can run on the cobas 6800/8800 Systems simultaneously, providing absolute automation with proven performance and flexibility, leading to time savings and increased efficiency.
About BK polyomavirus
BK polyomavirus (BKV) is a member of the polyomavirus family that can cause transplant-associated complications including nephropathy in kidney transplantation and hemorrhagic cystitis in hematopoietic stem cell transplantation. Infection can occur early in life, often with no symptoms. After primary infection, the virus can remain inactive throughout life, only to possibly reactivate in immunocompromised individuals, such as patients who receive solid-organ transplants. For kidney transplant patients, BKV infection is considered the most common viral complication, causing polyomavirus nephropathy (PVN) in up to 10 percent of kidney transplant recipients, and about 50 percent of PVN-affected patients will experience transplant graft failure. BKV is also associated with hemorrhagic cystitis after allogeneic hematopoietic stem cell transplantation.
About the cobas 6800/8800 Systems
When every moment matters, the fully automated cobas 6800/8800 Systems offer the fastest time to results with the highest throughput and the longest walk-away time available among automated molecular platforms. The systems provide up to 96 results in about three hours and 384 results for the cobas 6800 System and 1,056 results for the cobas 8800 System in an eight hour shift.
Both systems make it possible for labs to perform up to three tests in the same run with no pre-sorting required. The systems also enable up to eight hours (cobas 6800 System) and four hours (cobas 8800 System) of walk-away time with minimal user interaction.*
These real-time PCR systems serve the areas of infectious disease, donor screening, sexual health, transplant, respiratory and antimicrobial stewardship.
Through an ever-increasing worldwide install base of cobas 6800/8800 Systems, labs are quickly and easily processing millions of tests per month to meet the changing demands of their communities, their customers, and the patients relying on the results of each assay. Globally, labs know and trust that a Roche assay guarantees high precision, accuracy, and traceability to World Health Organization standards.
Today, rapid advancements in healthcare technology, a shortage of skilled workers, industry-wide consolidation, and the proven need to be ready for the next outbreak have health systems looking to lay a reliable foundation for the future. With proven performance, absolute automation, and unmatched flexibility delivering unparalleled throughput 24/7—cobas 6800/8800 Systems are designed to ensure a lab’s long-term sustainability and success … now, more than ever.
About Roche
Roche is a global pioneer in pharmaceuticals and diagnostics focused on advancing science to improve people’s lives. The combined strengths of pharmaceuticals and diagnostics under one roof have made Roche the leader in personalised healthcare – a strategy that aims to fit the right treatment to each patient in the best way possible.
Roche is the world’s largest biotech company, with truly differentiated medicines in oncology, immunology, infectious diseases, ophthalmology and diseases of the central nervous system. Roche is also the world leader in in vitro diagnostics and tissue-based cancer diagnostics, and a frontrunner in diabetes management.
Founded in 1896, Roche continues to search for better ways to prevent, diagnose and treat diseases and make a sustainable contribution to society. The company also aims to improve patient access to medical innovations by working with all relevant stakeholders. More than thirty medicines developed by Roche are included in the World Health Organization Model Lists of Essential Medicines, among them life-saving antibiotics, antimalarials and cancer medicines. Moreover, for the eleventh consecutive year, Roche has been recognised as one of the most sustainable companies in the Pharmaceuticals Industry by the Dow Jones Sustainability Indices (DJSI).
The Roche Group, headquartered in Basel, Switzerland, is active in over 100 countries and in 2019 employed about 98,000 people worldwide. In 2019, Roche invested CHF 11.7 billion in R&D and posted sales of CHF 61.5 billion. Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan. For more information, please visit www.roche.com.
Reference: https://www.roche.com/media/releases/med-cor-2020-09-08.htm
LabCorp Launches First Combined Test for Covid-19, Flu and RSV in Time for Flu Season
8 September 2020 - Single Test Detects Multiple Respiratory Infections Including COVID-19 and Flu to Inform Treatment Options. At-Home Use Through Pixel by LabCorp™ Pending FDA Authorization.
BURLINGTON, N.C., Sep. 8, 2020 -- LabCorp, a leading global life sciences company that is deeply integrated in guiding patient care, today announced the launch of the first testing method to simultaneously detect COVID-19, influenza A / B, and respiratory syncytial virus (RSV). The single-panel test, which detects multiple types of infections, can help doctors diagnose patients and make decisions about treatment options. The test is available to patients through doctors, hospitals, and other authorized healthcare providers nationwide. LabCorp has also submitted an application to the U.S. Food and Drug Administration (FDA) to offer the combined test through its Pixel by LabCorp™ at-home test collection kit, which would offer added convenience and accessibility.
“The U.S. is facing the most challenging health crisis in a century and is about to enter flu season, which has the potential to put additional strain on our healthcare system and cost lives,” said Dr. Brian Caveney, chief medical officer and president of LabCorp Diagnostics. “Individuals infected with COVID-19, influenza A / B, or RSV, often experience similar symptoms of cough, fever, chest tightness, and body aches, providing a potential surge of patients seeking testing. Leveraging our scientific and technological expertise to simultaneously test for four major respiratory viruses, including COVID-19, will provide doctors a simple, efficient way to diagnose their patients.”
LabCorp’s COVID-19, influenza A / B, and RSV testing method is part of the company’s continued commitment to meet the demand for diagnostic testing as the country addresses the overlap of the COVID-19 health crisis and flu season. Between October 1, 2019, and April 4, 2020, the Centers for Disease Control and Prevention estimated that there were 39 to 56 million flu illnesses, resulting in 18 to 26 million medical visits. A significant flu and RSV season this year could put an added strain on the healthcare system, as people experience similar symptoms – fever, cough, and aches, for example – with COVID-19 and respiratory viruses.
Pending authorization by the FDA, the Pixel by LabCorp at-home test will be another convenient option for individuals to determine if they have the flu, COVID-19, or RSV. Thousands of people have used the company’s COVID-19 Pixel by LabCorp at-home test kit, with 95 percent of users being very satisfied or satisfied with their experience. The Pixel by LabCorp at-home test uses a short swab that is easily inserted into the individual’s lower nostril, reducing the discomfort associated with much longer swabs.
In addition to its novel respiratory flu test, LabCorp offers a suite of readily accessible prevention-to-detection solutions for COVID-19 and flu that doctors, healthcare providers, individuals, employers, and students can access. The company has performed over 13 million molecular tests since March, using several sample collection methods, including simple nasal swabs and nasopharyngeal swabs. For more information, individuals can speak to their doctor, healthcare provider or visit LabCorp's COVID-19 website.
About LabCorp
LabCorp, an S&P 500 company, is a leading global life sciences company that is deeply integrated in guiding patient care, providing comprehensive clinical laboratory and end-to-end drug development services. With a mission to improve health and improve lives, LabCorp delivers world-class diagnostics solutions, brings innovative medicines to patients faster, and uses technology to improve the delivery of care. LabCorp reported revenue of more than $11.5 billion in 2019. To learn more about LabCorp, visit www.LabCorp.com, and to learn more about LabCorp’s drug development business, Covance, visit www.Covance.com.
QIAGEN to launch rapid portable test that can analyze over 30 samples per hour for SARS-CoV-2 antigen
8 September 2020 - Combination of speed and scale is an important step towards decentralized mass testing for coronavirus that has so far been elusive. Access Anti-SARS-CoV-2 Antigen Test, developed in collaboration with Ellume, is easy to use and provides accurate results in less than 15 minutes. Complements QIAGEN’s antibody and PCR tests to provide full range of COVID-19 testing solutions. Each Digital eHub device with capacity for up to 8 eSticks can simultaneously run QIAGEN Access Antigen and Antibody tests.
Hilden, Germany, and Germantown, Maryland, September 08, 2020 – QIAGEN today announced plans to launch a rapid portable test that can detect SARS-CoV-2 antigens in people with active infections in less than 15 minutes and process on average around 30 swab samples per hour using a small digital detection system.
The Access Anti-SARS-CoV-2 Antigen Test, which is expected to become available in the fourth quarter of 2020, is designed for environments that require a high volume of fast and accurate test results. The portable test offers a new combination of speed and scale that marks an important step towards decentralized mass testing that health authorities all over the world have been urgently seeking.
The Access Anti-SARS-CoV-2 Antigen Test extends the partnership with Ellume, an Australian digital diagnostics company. It is the second QIAGEN COVID-19 test to make use of Ellume’s digital eHub and eStick system. QIAGEN in August announced the Access Anti-SARS-CoV-2 Antibody Test that uses the same devices.
Two versions of the Antigen Test are scheduled for US launch in the fourth quarter – one for labs and one for point-of-care (POC) use. QIAGEN will apply for FDA Emergency Use Authorization and seek CE-IVD registration in Europe. A CLIA Waiver in the US would allow the POC version to be used in settings like airports or stadiums.
Feasibility tests have shown the Access Antigen Test to have a sensitivity of at least 90% and a specificity of 100%.
“The Access Antigen Test is fast, easy to use and cost-effective and will be a valuable tool to address the so far unmet high-volume testing needs for SARS-CoV-2 antigens in situations where time is of the essence,” said Thierry Bernard, Chief Executive Officer of QIAGEN. “It will deliver highly accurate results and will complement the gold-standard PCR tests used for detection of active COVID-19 infection. PCR tests offer a high level of diagnostic accuracy but are time-consuming and lab-bound.”
The Access Anti-SARS-CoV-2 Antigen Test uses the QIAGEN eHub that was launched in August, a rugged portable machine, to analyze nasal-swab samples from up to eight symptomatic people at once. The easy-to-use eStick uses nanoparticle fluorescent detection technology to flag the SARS-CoV-2 nucleocapsid protein, an antigen present on the surface of the virus. The device delivers negative results in 15 minutes – and in as little as three minutes in the case of a strong positive.
This means one eHub can process on average about 30 tests per hour with the possibility for one user to operate more than one eHub. As Access Anti-SARS-CoV-2 Antibody test, released late August, also uses the device, lab professionals will be able to run tests to detect both previous and active infections on one device at the same time – with each testing slot operating independently of the others. Knowledge of past and present infections is essential to understanding and inhibiting the spread of the disease.
The Antibody Test strengthens QIAGEN’s robust COVID-19 testing portfolio that addresses customer needs from fundamental research to diagnostics. The Access Anti-SARS-CoV-2 Antigen Test and the Access Anti-SARS-CoV-2 Antibody Test run on the eHub platform that QIAGEN is using for Access QuantiFERON-TB. This is a new solution still in development that will help low-resource and high-burden regions diagnose latent tuberculosis infection.
QIAGEN employees are addressing the urgent demand for testing solutions needed in the global response to the coronavirus pandemic. They are massively ramping up production capacity and building the most comprehensive portfolio of solutions for COVID-19 testing.
These include viral RNA extraction for use on QIAGEN’s QIAcube, QIAsymphony and EZ1 platforms as well as third-party instruments; a range of PCR tests on the QIAstat-Dx and NeuMoDx systems that enable COVID-19 detection while analyzing samples at the same time for other respiratory infections; and the Access Anti-SARS-CoV2-Antbody Test for detection of immune response in people who have been exposed to the virus in the past.
QIAGEN also provides universal next-generation sequencing (NGS) solutions for research use with any sequencer, in particular gene panels integrated with bioinformatics for analysis of the SARS-CoV-2 virus And QIAGEN is also providing reagents sold to other companies for use in their own COVID-19 tests.
QIAGEN products are being used for the development of vaccines against COVID-19. QIAGEN expects that the availability of vaccines will drive ongoing demand for testing as the immune response in the population will have to be assessed and monitored.
Further information on QIAGEN’s response to the coronavirus outbreak can be found here.
About QIAGEN
QIAGEN N.V., a Netherlands-based holding company, is the leading global provider of Sample to Insight solutions that enable customers to gain valuable molecular insights from samples containing the building blocks of life. Our sample technologies isolate and process DNA, RNA and proteins from blood, tissue and other materials. Assay technologies make these biomolecules visible and ready for analysis. Bioinformatics software and knowledge bases interpret data to report relevant, actionable insights. Automation solutions tie these together in seamless and cost-effective workflows. QIAGEN provides solutions to more than 500,000 customers around the world in Molecular Diagnostics (human healthcare) and Life Sciences (academia, pharma R&D and industrial applications, primarily forensics). As of June 30, 2020, QIAGEN employed more than 5,200 people in over 35 locations worldwide. Further information can be found at http://www.qiagen.com.
Reference: https://corporate.qiagen.com/newsroom/press-releases/2020/20200908_access_antigen
Roche receives FDA Emergency Use Authorization for the cobas SARS-CoV-2 & Influenza A/B Test for use on the cobas 6800/8800 Systems
4 September 2020 - First commercial test for fully automated high throughput systems to detect and differentiate SARS-CoV-2, influenza A virus and/or influenza B virus with a single sample. As COVID-19 and influenza infections can hardly be differentiated based on symptoms, healthcare professionals can confidently provide the right diagnosis and best course of treatment for patients. Test for use on high-throughput cobas 6800/8800 Systems will continue to support high volume testing. This test is also available in markets accepting the CE mark.
Basel, 04 September 2020 -- Roche today announced that the cobas® SARS-CoV-2 & Influenza A/B Test for use on the cobas® 6800/8800 Systems has received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA). This test is intended for the simultaneous qualitative detection and differentiation of SARS-CoV-2, Influenza A and Influenza B in patients suspected by their healthcare provider of having respiratory viral infection consistent with COVID-19. Additionally, it is available in markets accepting the CE mark.
“With the approaching flu season, this new test is particularly important as SARS-CoV-2 and influenza infections can hardly be differentiated by symptoms alone. Now, with a single test, healthcare professionals can confidently provide the right diagnosis and most effective treatment plan for their patients,” said Thomas Schinecker, CEO of Roche Diagnostics. “As a leader in diagnostics testing solutions, this launch demonstrates our ongoing commitment to stop the spread of serious infectious diseases by increasing access to accurate, reliable and efficient testing options.”
Roche’s widely-available, fully-automated cobas 6800/8800 Systems, which are used to perform the SARS-CoV-2 & Influenza A/B Test, offer the fastest time to results with the highest throughput and the longest walk-away time available among automated molecular platforms. The systems provide up to 96 results in about 3 hours and 384 results for the cobas 6800 System and 1,056 results for the cobas 8800 System in an 8-hour shift. Roche is committed to delivering as many tests as possible within the limits of supply.
The test is another key addition to the comprehensive Roche diagnostic portfolio to help healthcare providers combat COVID-19 and make informed decisions for optimised patient care. Currently, this portfolio includes molecular, serology and digital solutions, which help during the initial stages of infection, during the recovery phase, as well as following the resolution of infection.
About cobas SARS-CoV-2 & Influenza A/B Test
The cobas SARS-CoV-2 & Influenza A/B Test is a multiplex reverse transcription polymerase chain reaction (RT-PCR) assay intended for the simultaneous qualitative detection and differentiation of SARS-CoV-2, Influenza A virus, and Influenza B virus in nasal or nasopharyngeal swab samples collected from individuals suspected of a respiratory infection, and is not intended for the detection of Influenza C virus. Under FDA EUA, the test can be taken by individuals suspected of a respiratory viral infection like COVID-19 by their healthcare provider. The test runs on the cobas 6800/8800 Systems and has a full-process negative control, positive control and internal control. Multiplexing will increase lab efficiency and save resources in the labs.
Negative results do not preclude infection from SARS-CoV-2 or Influenza virus and should not be used as the sole basis of treatment or other patient management decisions. Negative results must be combined with clinical observations, patient history and epidemiological information.
The cobas SARS-CoV-2 & Influenza A/B Test is intended for use by trained clinical laboratory personnel specifically instructed and trained in the techniques of real-time PCR and in vitro diagnostic procedures. In the United States, the cobas SARS-CoV-2 & Influenza A/B Test for use on the cobas® 6800 and cobas® 8800 Systems is only for use under the FDA’s Emergency Use Authorization.
About SARS-CoV-2 (coronavirus)
Coronaviruses (CoV) are a large family of viruses that cause illness ranging from the common cold to more severe diseases such as Middle East Respiratory Syndrome (MERS-CoV) and Severe Acute Respiratory Syndrome (SARS-CoV). The novel coronavirus (SARS-CoV-2) is a new strain which has not previously been identified in humans.
Signs of infection include respiratory symptoms such as cough, shortness of breath, difficulty breathing, and fever. In more severe cases, pneumonia, severe acute respiratory syndrome, kidney failure and death can occur.
To control the spread of the infection, the World Health Organisation (WHO) recommends regular hand washing, covering mouth and nose when coughing and sneezing, and avoiding close contact with anyone showing symptoms of respiratory illness.
About Roche’s response to the COVID-19 pandemic
The COVID-19 pandemic continues to evolve globally with varying developments from country to country and we are partnering with healthcare providers, laboratories, authorities and organisations to help make sure that patients receive the tests, treatment and care they need. This new test is an additional step in Roche’s fight against the COVID-19 pandemic, which has already included:
- Launching COVID-19 diagnostic tests for active infection and the detection of antibodies in patients who have been exposed to the virus,
- Investigating treatments from our existing portfolio to better understand their potential to treat patients with COVID-19,
- Increasing manufacturing and supply chain capacity to meet product demand across our portfolio within the wider context of COVID-19 treatment, and
- Ensuring the supply of our existing medicines and diagnostics to patients around the world under exceptional conditions.
Reliable, high-quality testing is essential to help healthcare systems overcome this pandemic. On 13 March we received FDA Emergency Use Authorisation for a high-volume molecular test to detect SARS-CoV-2, the virus that causes COVID-19, which is also available in countries accepting the CE Mark. On 3 May, Roche announced that its COVID-19 antibody test, aimed at detecting the presence of antibodies in the blood, also received FDA Emergency Use Authorisation and is available in markets accepting the CE mark. Also in June we received an FDA EUA for the Elecsys® IL-6 test to assist in identifying severe inflammatory response in patients with confirmed COVID-19, as well as launching Roche v-TAC, which could help simplify the screening, diagnosis and monitoring of patients with respiratory compromise in the current COVID-19 pandemic. In July, we added a Rapid Antibody Test, with SD Biosensor as distribution partner, to our portfolio, that allows the detection of antibodies against Covid-19 at the point of care. On 1 September we announced that we will launch a SARS-CoV-2 Rapid Antigen Test, in late September, for markets accepting the CE Mark. We also intend to file for Emergency Use Authorisation (EUA) to the U.S. Food and Drug Administration (FDA). The SARS-CoV-2 Rapid Antigen Test is for use in point of care settings for both symptomatic and asymptomatic people.
Roche is working closely with governments and health authorities around the world, and has significantly increased production to help ensure availability of tests globally.
We are actively involved in understanding the potential of our existing portfolio and are researching options for the future. Roche has an ongoing clinical trial program evaluating the role of Actemra©/RoActemra© (tocilizumab) in COVID-19 pneumonia. On 29 July we announced that the COVACTA trial did not meet its primary endpoint of improved clinical status in patients with COVID-19 associated pneumonia, or the key secondary endpoint of reduced patient mortality. The study was the first global, randomised, double-blind, placebo-controlled phase III trial investigating Actemra/RoActemra in this setting. Roche remains committed to continuing the Actemra/RoActemra clinical trial programme in COVID-19 to further explore Actemra/RoActemra in other treatment settings, including in combination with an antiviral. In addition to COVACTA, Roche has initiated several studies to further investigate Actemra/RoActemra as a potential treatment for patients with COVID-19 associated pneumonia, including two phase III clinical trials, REMDACTA and EMPACTA, as well as the phase II MARIPOSA trial. Roche has further initiated an internal early research programme focused on the development of medicines for COVID-19 and is engaged in multiple research collaborations. On 19 August, we announced a partnership with Regeneron to develop, manufacture and distribute REGN-COV2, Regeneron’s investigational antiviral antibody combination, to people around the globe.
In these exceptional times, Roche stands together with governments, healthcare providers and all those working to overcome the pandemic.
About Influenza A and B (flu)
Influenza is an acute respiratory illness caused by infection with the influenza virus. Influenza viruses consist of three types: Influenza A, Influenza B, and Influenza C. In the U.S., Influenza A/H1N1, A/H3N2 and Influenza B are the predominant seasonal viruses. Influenza A and B viruses are among the leading causes of respiratory infections, estimated to affect 5-10% of adults and 20-30% of children every year worldwide. Influenza is primarily spread by breathing in infected droplets formed when a person with the flu sneezes, coughs, or talks. Symptoms include fever, cough, headache, fatigue, muscle pain, sore throat, and runny nose. Elderly people, young children and people with weakened immune systems or chronic medical conditions can be at high risk for serious disease. Each year, approximately 3 to 5 million people develop severe illness and 290,000 to 650,000 people die from the flu.
About the cobas 6800/8800 Systems
When every moment matters, the fully automated cobas 6800/8800 Systems offer the fastest time to results with the highest throughput and the longest walk-away time available among automated molecular platforms. With proven performance, absolute automation and unmatched flexibility delivering unparalleled throughput 24/7— cobas 6800/8800 Systems are designed to ensure a lab’s long-term sustainability and success … now, more than ever.
About Roche
Roche is a global pioneer in pharmaceuticals and diagnostics focused on advancing science to improve people’s lives. The combined strengths of pharmaceuticals and diagnostics under one roof have made Roche the leader in personalised healthcare – a strategy that aims to fit the right treatment to each patient in the best way possible.
Roche is the world’s largest biotech company, with truly differentiated medicines in oncology, immunology, infectious diseases, ophthalmology and diseases of the central nervous system. Roche is also the world leader in in vitro diagnostics and tissue-based cancer diagnostics, and a frontrunner in diabetes management.
Founded in 1896, Roche continues to search for better ways to prevent, diagnose and treat diseases and make a sustainable contribution to society. The company also aims to improve patient access to medical innovations by working with all relevant stakeholders. More than thirty medicines developed by Roche are included in the World Health Organization Model Lists of Essential Medicines, among them life-saving antibiotics, antimalarials and cancer medicines. Moreover, for the eleventh consecutive year, Roche has been recognised as one of the most sustainable companies in the Pharmaceuticals Industry by the Dow Jones Sustainability Indices (DJSI).
The Roche Group, headquartered in Basel, Switzerland, is active in over 100 countries and in 2019 employed about 98,000 people worldwide. In 2019, Roche invested CHF 11.7 billion in R&D and posted sales of CHF 61.5 billion. Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan. For more information, please visit www.roche.com.
Reference: https://www.roche.com/media/releases/med-cor-2020-09-04.htm
Merck Supports Eijkman Institute to Expedite Covid-19 Vaccine Development Research
3 September 2020 - Eijkman Institute for Molecular Biology developing Covid-19 vaccine based on local strain virus strain. Institute to receive research instruments and materials to advance production.
Jakarta, Indonesia, September 3, 2020 — Merck, a leading science and technology company, today announced the donation of research instruments and materials worth IDR 1.2 billion (€ 74,000) to support the efforts of Eijkman Institute for Molecular Biology, Indonesia, in its efforts to accelerate vaccine development research. The institute is developing a Covid-19 vaccine based on a local virus strain, in collaboration with several local research institutions.
“Merck supplies critical products and services and provides solutions for scientists to identify and characterize viruses and develop vaccines and therapies – work that is especially important as vaccine developers race to fight Covid-19,” said Christopher Thomas, president director at Merck in Indonesia. “Eijkman Institute’s work is promising and we are committed to supporting them.”
Merck is donating reagents and consumables to make viral transport medium, which are tubes that store patients’ swab test samples, allowing them to be safely transported from swab sampling locations (i.e., clinics, hospitals, health centers) to testing labs. The company is also donating RiOs™ Essential water purification systems, which produce high-quality type-3 pure water by integrating pre-treatment and high-performance reverse osmosis membranes.
"The utmost priority in combating Covid-19 is accelerating the discovery of Covid-19 vaccine to protect people and breaking the chain of infection in Indonesia,” said Professor Amin Soebandrio, chairman of Eijkman Institute for Molecular Biology. “Prevention is certainly better than cure. Global partners and qualified state-of-the-art research instruments will greatly help in expediting this vaccine research. We are grateful for Merck’s support in donating instruments and materials to help us in developing Indonesia’s Covid-19 vaccine."
Eijkman Institute’s research has progressed to the generation of sub-unit protein as the chosen platform. In general, vaccine manufacturing can take years to finish, but the institute is racing to generate the vaccine seed in only a year. It is estimated that the vaccine will be made available for further processes including clinical trials in Indonesia by early 2021.
About Merck
Merck, a leading science and technology company, operates across healthcare, life science and performance materials. Around 57,000 employees work to make a positive difference to millions of people’s lives every day by creating more joyful and sustainable ways to live. From advancing gene editing technologies and discovering unique ways to treat the most challenging diseases to enabling the intelligence of devices – the company is everywhere. In 2019, Merck generated sales of €16.2 billion in 66 countries.
Scientific exploration and responsible entrepreneurship have been key to Merck’s technological and scientific advances. This is how Merck has thrived since its founding in 1668. The founding family remains the majority owner of the publicly listed company. Merck holds the global rights to the Merck name and brand. The only exceptions are the United States and Canada, where the business sectors of Merck operate as EMD Serono in healthcare, MilliporeSigma in life science, and EMD Performance Materials.
Reference: https://www.merckmillipore.com/DE/de/20200902_133550
Chlamydia and Gonorrhea Positivity Surges in Women Ages 18-30 Years, Finds Quest Diagnostics Health Trends Study
3 September 2020 - Analysis of 18 million de-identified lab tests also reveals shift in positivity rate toward older women, with more females "aging out" of annual screening guidelines that end at age 25
SECAUCUS, N.J., Sept. 3, 2020 -- The rate at which women 18-30 years of age tested positive for the two most common reportable sexually transmitted infections grew by double digits between 2010 and 2017, finds an analysis of nearly 18 million de-identified test results from Quest Diagnostics.
The new Health Trends® study from Quest Diagnostics is believed to be one of the largest to examine rates of clinical laboratory test results for Chlamydia trachomatis (chlamydia) and Neisseria gonorrhoeae (gonorrhea) on a national scale. The study examined 17,794,680 co-testing laboratory results for both infections from females aged 12–30 years tested at Quest Diagnostics during 2010–2017.
The study is available in the American Journal of Preventive Medicine (AJPM) online ahead of print here.
In addition to showing sharp increases in the positivity rates of chlamydia and gonorrhea, the study also found that the positivity rates of both infections shifted toward older ages over the eight-year study period. This observed shifts in age-based risk is significant because it raises the prospect that current medical guidelines for screening are not aligned with the sexual behaviors of, and associated risk of infection in, women in the United States.
Guidelines from the Centers for Disease Control and Prevention (CDC) and the U.S. Preventive Services Task Force (USPSTF) recommend annual screening for both infections in all sexually active women younger than 25 years of age. Screening in women 25 years of age and older is recommended only for those with certain risk factors, such as a new or multiple sexual partners or inconsistent condom use.
Yet, according to the study, the positivity rate for chlamydia for 27-year-old women in 2017 (3.5%) was the same as the positivity rate for 24-year-old women in 2010. A similar dynamic was observed for gonorrhea infections, with the positivity rate in 30-year-olds in 2017 (0.5%) identical to that found in 23-year-olds in 2010.
Overall, the peak age of positivity for both infections increased by one to two years and, in test results at the farthest distribution, by 3 to 7 years for chlamydia and gonorrhea respectively, over the eight-year study period.
Infections with chlamydia and gonorrhea often lack symptoms and, left untreated, may result in pelvic inflammatory disease and infertility.
"Our Health Trends data shows that sexually transmitted infections do not discriminate by age," said lead researcher Harvey W. Kaufman, M.D., Senior Medical Director and Director, Health Trends Research Program at Quest Diagnostics. "When a sexually transmitted infection goes undetected and untreated, the result can be long-term health problems such as infertility and unknowing transmission of the infection to others. Sexual behaviors have changed in the United States, and guidelines need to reflect that women may be spending longer periods of time being sexually active and with more partners prior to childbearing than in the past."
Among the key findings:
- The annual chlamydia positivity rate increased by 18 percent overall (4.9% in 2010 to 5.8% in 2017), while annual gonorrhea positivity increased by 33 percent overall (0.7% in 2010 to 0.9% in 2017).
- Although women ages 18-24 were more likely to test positive for either infection, women 25-30 years of age experienced a higher increase over the 8-year period. Among women 25-30 years of age, the positivity rate increased by 50 percent (from 2.2% in 2010 to 3.3% in 2017), compared to women in the 18-24 age group, at 21 percent (6.1% to 7.4%).
- Among the youngest (12-17) age group, the positivity rate declined 17 percent for chlamydia (8.9% in 2010 to 7.4% in 2017) and 14 percent for gonorrhea (1.33% in 2010 to 1.17% in 2017).
"Our analysis raises the possibility that some women in the United States are prematurely aging out of access to annual screening, given current guidelines," said co-author Damian P. Alagia, III, M.D., Senior Medical Director of Woman's Health for Quest Diagnostics. "As such, women over the age of 24 years can only access testing if they are symptomatic or labeled 'high risk' by their healthcare provider following a potentially uncomfortable dialogue about their sexual behavior. Given changing sexual mores, a more thoughtful and inclusive population screening approach supporting screening access for women above the age of 24 years is overdue."
The study, "Chlamydia and Gonorrhea: Shifting Age-Based Positivity among Young Females, 2010-2017," is available at: https://www.sciencedirect.com/science/article/pii/S0749379720302713#!
Approximately 1,760,000 cases of chlamydia and 583,000 cases of gonorrhea infections were reported to the Centers for Disease Control and Prevention in 2018.
About Quest Diagnostics
Quest Diagnostics empowers people to take action to improve health outcomes. Derived from the world's largest database of clinical lab results, our diagnostic insights reveal new avenues to identify and treat disease, inspire healthy behaviors and improve health care management. Quest annually serves one in three adult Americans and half the physicians and hospitals in the United States, and our 47,000 employees understand that, in the right hands and with the right context, our diagnostic insights can inspire actions that transform lives. www.QuestDiagnostics.com.
Roche receives FDA approval for first HIV-1/HIV-2 Qualitative Test on the cobas 6800/8800 Systems in the fight against HIV/AIDS
1 September 2020 - Detects, confirms and differentiates HIV-1 and HIV-2 infections providing clinicians with critical diagnostic data for personalised management of patients with HIV - from appropriate counseling on disease differences to targeted therapy. Supports rapid molecular detection of acute HIV infection, which is critical in curbing further disease transmission. Combines confirmatory HIV testing and HIV-1/HIV-2 differentiation into one single test.
Basel, 1 September 2020 -- Roche today announced U.S. Food and Drug Administration (FDA) approval for the cobas® HIV-1/HIV-2 Qualitative Test for use on the fully automated cobas® 6800/8800 Systems in the U.S. The test provides healthcare professionals with a single result to confirm HIV diagnosis and differentiate HIV-1 and HIV-2, an important distinction needed to identify appropriate treatment options.
“Roche is committed to improving diagnostic technologies in the fight against HIV/AIDS,” said Thomas Schinecker, CEO Roche Diagnostics. “Being able to reliably determine a person’s HIV status and accurately diagnose which HIV type they may have is crucial for patients and healthcare providers in preventing further community transmission and selecting an individual’s best treatment options.”
Studies show that 50% of new HIV infections may be transmitted during the acute period, between three days and three weeks from the time of infection. Current serology-based testing methods rely on the ability to detect an antibody or antigen response. As a result, they can fail to identify an infection if the person is tested prior to having a detectable antibody or antigen response, which can take several weeks to generate. The higher sensitivity of PCR technology, which is used with the cobas HIV-1/HIV-2 Qualitative Test, can reduce this time-to-detection period by one week or more. This significant reduction in time to detection is critical to improve personalised healthcare while curbing further disease transmission.
About the cobas HIV-1/HIV-2 Qualitative Test
cobas HIV-1/HIV-2 Qualitative for use on the cobas 6800/8800 Systems is an in vitro nucleic acid amplification test for the qualitative detection and differentiation of human immunodeficiency virus type 1 (HIV-1) and type 2 (HIV-2) RNA in human serum and plasma.
The test is intended to be used as an aid in diagnosis of HIV-1/HIV-2 infection. Detection of HIV-1 or HIV-2 nucleic acid is indicative of HIV-1 or HIV-2 infection, respectively. The presence of HIV-1 or HIV-2 nucleic acid in the plasma or serum of individuals without antibodies to HIV-1 or HIV-2 is indicative of acute or primary infection. cobas HIV-1/HIV-2 Qualitative may also be used as an additional test to confirm the presence of HIV-1 or HIV-2 infection in an individual with specimens reactive for HIV-1 or HIV-2 antibodies or antigens. The assay may also be used as an aid in the diagnosis of infection with HIV-1 and/or HIV-2 in pediatric subjects and pregnant women.
About HIV-1 and HIV-2 in the U.S.
The U.S. Centers for Disease Control and Prevention (CDC) estimated in 2018 that 1.2 million people were living with HIV in the United States. Among them, more than 160,000 people did not know their HIV status, and only 53 percent were virally suppressed having low amounts of virus circulating in their blood. During this same year, 37,968 people became newly infected with HIV.
Human immunodeficiency virus (HIV) is categorized into two types, HIV-1 and HIV-2. Worldwide, most HIV infections are HIV-1, whereas HIV-2 largely has been confined to persons in or from West Africa. However, HIV-2 has been steadily increasing in the U.S. due to immigration. HIV-1 and HIV-2 have the same routes of transmission, and both can cause acquired immunodeficiency syndrome (AIDS); however, it is important to differentiate HIV-2 infections from HIV-1 infections because they require different clinical management.
About the cobas 6800/8800 Systems
When every moment matters, the fully automated cobas 6800/8800 Systems offer the fastest time to results with the highest throughput and the longest walk-away time available among automated molecular platforms. With proven performance, absolute automation and unmatched flexibility delivering unparalleled throughput 24/7 — cobas 6800/8800 Systems are designed to ensure a lab’s long-term sustainability and success … now, more than ever.
About Roche
Roche is a global pioneer in pharmaceuticals and diagnostics focused on advancing science to improve people’s lives. The combined strengths of pharmaceuticals and diagnostics under one roof have made Roche the leader in personalised healthcare – a strategy that aims to fit the right treatment to each patient in the best way possible.
Roche is the world’s largest biotech company, with truly differentiated medicines in oncology, immunology, infectious diseases, ophthalmology and diseases of the central nervous system. Roche is also the world leader in in vitro diagnostics and tissue-based cancer diagnostics, and a frontrunner in diabetes management.
Founded in 1896, Roche continues to search for better ways to prevent, diagnose and treat diseases and make a sustainable contribution to society. The company also aims to improve patient access to medical innovations by working with all relevant stakeholders. More than thirty medicines developed by Roche are included in the World Health Organization Model Lists of Essential Medicines, among them life-saving antibiotics, antimalarials and cancer medicines. Moreover, for the eleventh consecutive year, Roche has been recognised as one of the most sustainable companies in the Pharmaceuticals Industry by the Dow Jones Sustainability Indices (DJSI).
The Roche Group, headquartered in Basel, Switzerland, is active in over 100 countries and in 2019 employed about 98,000 people worldwide. In 2019, Roche invested CHF 11.7 billion in R&D and posted sales of CHF 61.5 billion. Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan. For more information, please visit www.roche.com.
Reference: https://www.roche.com/media/releases/med-cor-2020-09-01.htm
Abbott's FreeStyle® Libre 2 iCGM system now available to medicare beneficiaries
1 September 2020 - U.S. Centers for Medicare & Medicaid Services (CMS) reimbursement expands access of the FreeStyle Libre 2 system to Medicare patients to better manage their diabetes. The FreeStyle Libre 2 technology is the only integrated continuous glucose monitoring (iCGM) system available that continuously measures glucose data every minute without the need for painful fingersticks. Widely available in the U.S., the FreeStyle Libre 2 system is priced 70% lower than other available continuous glucose monitoring devices.
ABBOTT PARK, Ill., Sept. 1, 2020 -- Abbott, the worldwide leader in continuous glucose monitoring (CGM), announced today its next-generation FreeStyle® Libre 2 integrated continuous glucose monitoring (iCGM) system is now available to Medicare patients. Having met the codes for therapeutic CGM systems used for coverage by the U.S. Centers for Medicare & Medicaid Services (CMS), the FreeStyle Libre 2 system is now accessible to all Medicare patients with diabetes who meet the eligibility criteria.
"Abbott designed the FreeStyle Libre portfolio for performance, access and affordability to make it broadly available to people with diabetes who need it," said Jared Watkin, senior vice president, Diabetes Care, Abbott. "By securing reimbursement, Abbott is making sure our latest life-changing technology can get to everyone who needs it, whether they're children, adults or seniors eligible for Medicare."
The FreeStyle Libre 2 system includes a sensor that is the easiest to apply and is worn on the back of the upper arm for up to 14 days, measuring glucose every minute. With a one-second scan using a handheld reader over the sensor, the system provides users with a real-time glucose reading, trend arrow and eight-hour history to help them and their healthcare providers make more informed treatment decisions.
The FreeStyle Libre 2 system includes optional real-time alarms and measures glucose levels every minute, meeting the highest level of accuracy standards over 14 days, including superior day one6 accuracy compared to the other iCGM and excellent accuracy and alarm performance at low end glucose levels. With a 14-day wear time, the FreeStyle Libre 2 system is the longest-lasting, self-applied iCGM sensor currently available, eliminating the need for fingersticks – and priced at a third of the cost of other CGM systems.
The pandemic is changing the way healthcare is delivered with greater acceptance of telehealth and medical technologies with remote monitoring capabilities such as CGMs. For instance, during the public health emergency, CMS is giving healthcare professionals more flexibility to prescribe CGMs to those who qualify. Additionally, the U.S. Food and Drug Administration (FDA) is allowing the FreeStyle Libre system to be used in hospital settings during the pandemic, making Abbott's diabetes technology more easily accessible.
As the #1 sensor-based glucose monitoring system used in the U.S. and worldwide, Abbott's FreeStyle Libre portfolio has changed the lives of more than 2 million people across more than 50 countries by providing breakthrough technology that is accessible and affordable. Abbott has secured partial or full reimbursement for the FreeStyle Libre portfolio in 37 countries, including Canada, France, Germany, Japan, the United Kingdom and the U.S. For more information, visit www.freestylelibre.us.
Indications and Important Safety Information
The FreeStyle Libre 2 Flash Glucose Monitoring System is a continuous glucose monitoring (CGM) device with real time alarms capability indicated for the management of diabetes in persons age 4 and older.
WARNINGS/LIMITATIONS:
The System must not be used with automated insulin dosing (AID) systems, including closed loop and insulin suspend systems. Remove the sensor before MRI, CT scan, X-ray, or diathermy treatment. Do not take high doses of vitamin C (more than 500 mg per day), as this may falsely raise your Sensor readings. Failure to use the System according to the instructions for use may result in missing a severe low blood glucose or high blood glucose event and/or making a treatment decision that may result in injury. If glucose alarms and readings from the System do not match symptoms or expectations, use a fingerstick blood glucose value to make diabetes treatment decisions. Seek medical attention when appropriate and contact Abbott Toll Free (855-632-8658) or visit www.freestylelibre.us for detailed indications for use and safety information.
About Abbott
Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 107,000 colleagues serve people in more than 160 countries.
Noninvasive detection of Helicobacter pylori – reliable and safe for the patient
31 August 2020 - Helicobacter pylori can cause serious diseases. The symptoms of a Helicobacter infection vary widely in their form and expression. Detection is therefore critical for diagnosis and treatment. Identifying an infection is easy and safe using the noninvasive Helicobacter assays from R-Biopharm.
31 August 2020 -- Helicobacter pylori is a widespread bacterium that causes gastritis, dyspepsia, and gastric ulcers, among other things. In many cases, the latter can develop into stomach cancer. Prevalence rises with increasing age and varies depending on region and genetic predisposition. It is believed that nearly half of the world’s adult population is infected with the bacterium.
Immunoassays like the RIDA®QUICK Helicobacter immunochromatographic rapid test and the RIDASCREEN® Helicobacter enzyme immunoassay can detect a Helicobacter pylori infection extremely quickly via analysis of human stool samples. Both tests can be used for patients of any age and without any additional preparation. The tests can also be used after eradication therapy to verify the success of treatment.
A small stool sample from the patient is all that is needed to detect Helicobacter pylori. This noninvasive sample collection is patient-friendly, inexpensive, and less prone to failure than invasive and semi-invasive methods and has comparable sensitivity and specificity. It is suitable especially for patients in whom a biopsy is not indicated or whose compliance is not guaranteed (children).
In a study, the French National Reference Center for Campylobacters and Helicobacters (CNRCH) tested the clinical performance of RIDA®QUICK Helicobacter and RIDASCREEN® Helicobacter using 132 prepared samples from patients who had been previously tested for Helicobacter pylori using invasive methods (PCR and biopsy culture).
All 94 negative patients in both reference procedures correctly tested negative in the two stool antigen tests (RIDA®QUICK und RIDASCREEN®). Of the 38 PCR-positive samples, both antigen tests correctly identified 3 samples as positive that tested negative in the culture versus positive in the PCR.
The sensitivity of both test methods is highly comparable to the detection of Helicobacter pylori using a PCR or biopsy culture.
The results from RIDA®QUICK Helicobacter were quick and easy to analyze and the chromatography of the stool samples proceeded smoothly in all the tests conducted. Thus, RIDA®QUICK Helicobacter and RIDASCREEN® Helicobacter demonstrate very good test performance and high diagnostic certainty compared to the invasive applications.
Reference: https://clinical.r-biopharm.com/news/noninvasive-detection-of-helicobacter-pylori/
Roche announces FDA approval of FoundationOne Liquid CDx, a comprehensive pan-tumour liquid biopsy test
28 August 2020 - FoundationOne Liquid CDx analyses more than 300 cancer-related genes and multiple genomic signatures to help inform treatment decisions for all solid tumour cancers. Using a simple blood draw, the test allows more patients with advanced cancer to benefit from the insights of comprehensive genomic profiling, for example when a tissue biopsy is not possible or recommended. FoundationOne Liquid CDx adds to Foundation Medicine’s genomic testing portfolio supporting Roche’s mission to deliver truly personalised healthcare. Roche is committed to improve patient outcomes by providing multiple testing options that support decision-making during all lines of therapy. FoundationOne Liquid CDx is available to order, as of 28 August 2020, replacing Foundation Medicine’s currently available liquid biopsy test FoundationOne Liquid.
Basel, 28 August 2020 -- Roche today announced that the U.S. Food and Drug Administration (FDA) has approved FoundationOne®Liquid CDx, Foundation Medicine’s comprehensive pan-tumour liquid biopsy test for patients with solid tumours. FoundationOne Liquid CDx is a comprehensive genomic profiling (CGP) test that analyses more than 300 cancer-related genes and multiple genomic signatures to optimise patient care. Cancer is a disease of the genome, driven by genetic mutations within a tumour’s DNA. CGP is used to identify these unique mutations to determine how a tumour behaves and grows, and these insights can help physicians to determine a personalised treatment plan for each individual patient based on the specific mutations identified.
As well as approving FoundationOne Liquid CDx as a CGP test for patients with any solid tumour, the FDA approved the test for use as a companion diagnostic to identify patients who may benefit from treatment with certain prostate and lung cancer therapies, including Rubraca® (rucaparib), a poly (ADP-ribose) polymerase (PARP) inhibitor for treatment in patients with BRCA 1/2-mutant metastatic castration-resistant prostate cancer, and three first-line tyrosine kinase (TKI) inhibitors for the treatment of patients with non-small cell lung cancer. By incorporating multiple genes, including several companion diagnostic biomarkers, the test can help save time versus sequential biomarker testing.
“Many cancer patients are unable to have a tissue biopsy. FoundationOne Liquid CDx may provide a minimally-invasive option for patients who otherwise might not have benefitted from comprehensive genomic profiling,” said Levi Garraway, M.D., Ph.D., Roche’s Executive Vice President, Chief Medical Officer, Head of Global Product Development and Co-Founder of Foundation Medicine Inc. “The convenience of testing a blood sample may also enable more rapid treatment decisions, so that patients can feel reassured they are not losing time to fight their disease.”
FoundationOne Liquid CDx analyses circulating cell-free DNA from a patient’s blood sample and uses massively parallel sequencing to detect the four main classes of genomic alterations. The test is FDA-approved to report short variants in 311 genes including rearrangements and copy number losses in BRCA1 and BRCA2 genes. The results are delivered in an integrated report that identifies alterations matched to FDA-approved therapies. The report also delivers information about genomic signatures, including microsatellite instability and blood tumour mutational burden, as well as single gene alterations, including all NTRK fusions, to help inform the use of other therapies including immunotherapies, and provides relevant clinical trial information.
“With the acceleration towards precision therapy approaches, it is important that physicians have the highest quality tools that can provide an accurate picture of their patients’ cancers in a timely manner,” said Fortunato Ciardiello, M.D., Ph.D, Professor of Medical Oncology, Director of the Division of Medical Oncology at the Università della Campania Luigi Vanvitelli, Italy. “With the approval of FoundationOne Liquid CDx physicians have the choice of two high-quality, FDA-approved comprehensive genomic profiling tests, enabling them to select the most optimal option for their patients.”
The FDA approval of FoundationOne Liquid CDx was based on analytical and clinical validation studies including more than 7,500 samples and 30,000 unique variants across more than 30 cancer types. Evaluation of the platform using multiple validation methods across a broad range of tumour types demonstrated high sensitivity and specificity, even at the low allele frequencies often observed in clinical blood samples.
FoundationOne Liquid CDx is the latest addition to Foundation Medicine’s portfolio of high-quality CGP tests and the second of the company’s CGP tests to receive FDA approval. FoundationOne®CDx, Foundation Medicine’s tissue-based genomic test for patients with solid tumours received FDA approval in 2017. Together, these high-quality genomic profiling tests offer physicians important options for detecting specific genomic alterations that help guide efficient, personalised treatment decisions, while reducing the time and sample needed when testing for multiple biomarkers one at a time. FoundationOne Liquid CDx can also provide complementary insights to tissue-based testing regarding tumour heterogeneity (the differences between cancer cells), and clonal evolution (how tumours evolve over time).
About FoundationOne®Liquid CDx
FoundationOne Liquid CDx is a qualitative next-generation sequencing based in vitro diagnostic test for prescription use only that uses targeted high throughput hybridisation-based capture technology to analyse 324 genes utilising circulating cell-free DNA (cfDNA) isolated from plasma derived from anti-coagulated peripheral whole blood of advanced cancer patients. The test is FDA-approved to report short variants in 311 genes, including rearrangements and copy number losses in BRCA1 and BRCA2, and is a companion diagnostic to identify patients who may benefit from treatment with specific targeted therapies (listed in Table 1 of the Intended Use) in accordance with the approved therapeutic product labeling. Additional genomic findings may be reported and are not prescriptive or conclusive for labeled use of any specific therapeutic product. Use of the test does not guarantee a patient will be matched to a treatment. A negative result does not rule out the presence of an alteration. Patients who are negative for companion diagnostic mutations should be reflexed to tumour tissue testing and mutation status confirmed using an FDA-approved tumour tissue test, if available. For the complete label, including companion diagnostic indications and complete risk information, please visit www.F1LCDxLabel.com.
About Roche
Roche is a global pioneer in pharmaceuticals and diagnostics focused on advancing science to improve people’s lives. The combined strengths of pharmaceuticals and diagnostics under one roof have made Roche the leader in personalised healthcare – a strategy that aims to fit the right treatment to each patient in the best way possible.
Roche is the world’s largest biotech company, with truly differentiated medicines in oncology, immunology, infectious diseases, ophthalmology and diseases of the central nervous system. Roche is also the world leader in in vitro diagnostics and tissue-based cancer diagnostics, and a frontrunner in diabetes management.
Founded in 1896, Roche continues to search for better ways to prevent, diagnose and treat diseases and make a sustainable contribution to society. The company also aims to improve patient access to medical innovations by working with all relevant stakeholders. More than thirty medicines developed by Roche are included in the World Health Organization Model Lists of Essential Medicines, among them life-saving antibiotics, antimalarials and cancer medicines. Moreover, for the eleventh consecutive year, Roche has been recognised as one of the most sustainable companies in the Pharmaceuticals Industry by the Dow Jones Sustainability Indices (DJSI).
The Roche Group, headquartered in Basel, Switzerland, is active in over 100 countries and in 2019 employed about 98,000 people worldwide. In 2019, Roche invested CHF 11.7 billion in R&D and posted sales of CHF 61.5 billion. Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan. For more information, please visit www.roche.com.
Reference: https://www.roche.com/media/releases/med-cor-2020-08-28.htm
Thermo Fisher Scientific Officially Opens New Site for Manufacturing COVID-19 Sample Collection Products
28 August 2020 - New facility in Lenexa, Kansas built in six weeks to rapidly expand production of viral transport media
LENEXA, Kan., Aug. 28, 2020 -- Thermo Fisher Scientific Inc., the world leader in serving science, officially cut the ribbon on its new $40 million facility in Lenexa, Kansas dedicated to viral transport media (VTM) production. The company is also announcing that the site will continue to expand to meet expected sustained demand for COVID-19 testing. The facility has created more than 300 new full-time jobs and added 120,000 square feet of manufacturing capacity.
In early May, Thermo Fisher received a contract from the U.S. government to provide a significant quantity of highly specialized VTM for COVID-19 sample collection. VTM is dispensed into plastic tubes that are used to safely collect and transport clinical specimens containing viruses. This ensures that the sample collected from a COVID-19 nose swab maintains viability while it is shipped to a lab for testing. Thermo Fisher has responded quickly to meet increased demand for VTM by ramping up production in Lenexa from 50,000 units per week to now more than 8 million per week since the new facility began production in early July.
"Thermo Fisher is proud to support virtually every aspect of the global COVID-19 response and our colleagues in Lenexa have played a key role in those efforts," said Gianluca Pettiti, senior vice president and president of the company's Specialty Diagnostics business. "Thanks to their hard work, Lenexa significantly increased production of VTM units. The team has worked with unrelenting intensity to build out and open a new site in just about six weeks. They understood the urgent national need, accepted the challenge and have delivered for the American people."
Company executives and government leaders, including Governor Laura Kelly, U.S. Senator Jerry Moran and Lenexa City Mayor Michael Boehm, will attend the ribbon cutting and ground-breaking ceremony on August 28. The site will allow for social distancing for the 200 guests expected in attendance.
"Widespread testing is a necessary component to keep the American economy running safely," said U.S. Senator Jerry Moran. "Thermo Fisher has stepped up to produce additional test tubes to help meet the national demand for COVID-19 testing and has created 300 new jobs by expanding its manufacturing base in Lenexa. Kansans never fail to do their part in our country's time of need, and this is no different. Thermo Fisher's ability to manufacture test tubes and significantly increase production is important for making certain Americans can feel secure in their health and safely return to work."
"I'm grateful to the team at Thermo Fisher for the many ways they've stepped up for the health and safety of people in Kansas and across the country," Governor Laura Kelly said. "This facility will do important work innovating and supporting the tools we have to fight this pandemic. I applaud Thermo Fisher's commitment to this critical endeavor."
To ensure accuracy of COVID-19 test results, VTM must be manufactured and dispensed into tubes in an aseptic environment. The new facility is dedicated to accelerating production and ensuring quality control by utilizing the proven blueprint for high-quality VTM production that has been developed in Lenexa. In addition to supporting America's pandemic response, the products will be used for collection and sampling for flu and other viruses.
About Thermo Fisher Scientific
Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $25 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, improving patient diagnostics and therapies or increasing productivity in their laboratories, we are here to support them. Our global team of more than 75,000 colleagues delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services and Patheon. For more information, please visit www.thermofisher.com.
Abbott's fast, $5, 15-minute, easy-to-use COVID-19 Antigen test receives FDA Emergency Use Authorization; mobile app displays test results to help our return to daily life; ramping producton to 50 mil
26 August 2020 - Abbott's BinaxNOW™ COVID-19 Ag Card is a rapid, reliable, highly portable, and affordable tool for detecting active coronavirus infections at massive scale. Test delivers results in just 15 minutes with no instrumentation, using proven lateral flow technology with demonstrated sensitivity of 97.1% and specificity of 98.5% in clinical study. Abbott to offer a no-charge complementary phone app, which allows people to display their BinaxNOW test results when asked by organizations where people gather, such as workplaces and schools. Company will ship tens of millions of tests in September, ramping to 50 million tests a month at the beginning of October.
ABBOTT PARK, Ill., Aug. 26, 2020 -- Abbott announced today that the U.S. Food and Drug Administration (FDA) has issued Emergency Use Authorization (EUA) for its BinaxNOW™ COVID-19 Ag Card rapid test for detection of COVID-19 infection. Abbott will sell this test for $5. It is highly portable (about the size of a credit card), affordable and provides results in 15 minutes. BinaxNOW uses proven Abbott lateral flow technology, making it a reliable and familiar format for frequent mass testing through their healthcare provider. With no equipment required, the device will be an important tool to manage risk by quickly identifying infectious people so they don't spread the disease to others.
Abbott will also launch a complementary mobile app for iPhone and Android devices named NAVICA™. This first-of-its-kind app, available at no charge, will allow people who test negative to display a temporary digital health pass that is renewed each time a person is tested through their healthcare provider together with the date of the test result. Organizations will be able to view and verify the information on a mobile device to facilitate entry into facilities along with hand-washing, social distancing, enhanced cleaning and mask-wearing.
"We intentionally designed the BinaxNOW test and NAVICA app so we could offer a comprehensive testing solution to help Americans feel more confident about their health and lives," said Robert B. Ford, president and chief executive officer, Abbott. "BinaxNOW and the NAVICA app give us an affordable, easy-to-use, scalable test, and a complementary digital health tool to help us have a bit more normalcy in our daily lives."
In data submitted to the FDA from a clinical study conducted by Abbott with several leading U.S. research universities, the BinaxNOW COVID-19 Ag Card demonstrated sensitivity of 97.1% (positive percent agreement) and specificity of 98.5% (negative percent agreement) in patients suspected of COVID-19 by their healthcare provider within the first seven days of symptom onset.
"The massive scale of this test and app will allow tens of millions of people to have access to rapid and reliable testing," said Joseph Petrosino, Ph.D., professor and chairman, Molecular Virology and Microbiology, Baylor College of Medicine, whose labs have been leading efforts to provide COVID-19 testing for the college and Harris County. "With lab-based tests, you get excellent sensitivity but might have to wait days or longer to get the results. With a rapid antigen test, you get a result right away, getting infectious people off the streets and into quarantine so they don't spread the virus."
Under FDA EUA, the BinaxNOW COVID-19 Ag Card is for use by healthcare professionals and can be used in point-of-care settings that are qualified to have the test performed and are operating under a CLIA (Clinical Laboratory Improvement Amendments) Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation. Within these settings, the test can be performed by doctors, nurses, school nurses, medical assistants and technicians, pharmacists, employer occupational health specialists, and more with minimal training and a patient prescription.
"Our nation's frontline healthcare workers and clinical laboratory personnel have been under siege since the onset of this pandemic," said Charles Chiu, M.D., Ph.D., professor of Laboratory Medicine at University of California, San Francisco. "The availability of rapid testing for COVID-19 will help support overburdened laboratories, accelerate turnaround times and greatly expand access to people who need it."
Currently, AdvaMed (The Advanced Medical Technology Association) estimates that test manufacturers are shipping about 1 million tests per day. Abbott will ship tens of millions of tests in September, ramping to 50 million tests a month at the beginning of October. The company has invested hundreds of millions of dollars since April in two new U.S. facilities to manufacture BinaxNOW at massive scale.
The BinaxNOW COVID-19 Ag Card can be used as a first line of defense to identify people who are currently infected and who should isolate themselves to help prevent the spread of the disease. It is intended for the qualitative detection of nucleocapsid protein antigen from SARS-CoV-2 in nasal swabs from individuals suspected of COVID-19 by their healthcare provider within the first seven days of symptom onset.
As a near-person rapid antigen test, BinaxNOW was engineered for point-of-care settings, near-patient, and not for reference labs. Patient samples should be tested immediately and should not be diluted in viral transport media.
NAVICA mobile app will help facilitate return to daily activities
Abbott is also offering a mobile app at no charge that will allow people to display their results obtained through a healthcare provider when entering facilities requiring proof of testing. The NAVICA app is optional and an easy-to-use tool that allows people to store, access and display their results with organizations that accept the results so people can move about with greater confidence. The app is supported by Apple and Android digital wallets and will be available from public app stores in the U.S.
"While BinaxNOW is the hardware that makes knowing your COVID-19 status possible, the NAVICA app is the digital network that allows people to share that information with those who need to know," said Ford. "We're taking our know-how from our digitally-connected medical devices and applying it to our diagnostics at a time when people expect their health information to be digital and readily accessible."
If test results are negative, the app will display a digital health pass via a QR code, similar to an airline boarding pass. If test results are positive, people receive a message to quarantine and talk to their doctor. As they're required to do for all COVID-19 tests, healthcare providers in all settings will be required to report positive results to the CDC and other public health authorities, regardless of whether they use the app. The digital health pass is stored in the app temporarily and expires after the time period specified by organizations that accept the app.
The app's user interface is supported by a back-end digital infrastructure that is cloud-based, scalable and secure. It's been designed to support a very large number of users and enable access from anywhere. The app is not for contact tracing and only collects a person's first and last name, email address, phone number, zip code, date of birth and test results.
About the BinaxNOW COVID-19 Ag Card Test
The BinaxNOW COVID-19 Ag Card is an assay for the qualitative detection of specific antigens to COVID-19 in the human nasal cavity. A simple nasal swab is used to collect specimens from people suspected of having an active infection. No equipment is required to process samples or read test results. In addition, minimal chemical reagents are required, which lessens exposure to biohazardous materials and improves safety for those administering the test.
The BinaxNOW COVID-19 Ag Card is the sixth test that Abbott is launching in the U.S. to help fight the coronavirus pandemic. Abbott's tests are performed on its high-volume m2000™ and Alinity® m molecular laboratory systems; its ID NOW™ rapid molecular point-of-care platform; antibody tests for its high-throughput ARCHITECT® i1000SR and i2000SR and Alinity™ i laboratory instruments.
Abbott has provided more than 27 million COVID-19 tests in the U.S. to date, including 14 million detection tests and 13 million antibody tests.
About Abbott
Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 107,000 colleagues serve people in more than 160 countries.
Q BioMed Announces Initiation of GMP Production of Novel COVID-19 Therapeutic for Clinical Trial Program
26 August 2020 - COVID-19 clinical trial planned for Q1 2021 supported by Canadian Government. Proof of concept would validate platform for multiple indications and therapeutic alternatives in infectious diseases and others.
NEW YORK, August 26, 2020 -- Q BioMed Inc., a commercial stage biotech company, announced today that with its technology partner, Mannin Research, a GMP production contract has been initiated for MAN-19, a clinical grade therapeutic intended to treat complications caused by COVID-19. The Phase 1 clinical trial is slated to begin patient enrollment in February 2021.
The accelerated development of this novel virus-agnostic and host-directed therapeutic is being supported in part by funding from the Canadian and German governments under various R&D incentive and COVID-19 response initiatives.
More than 800,000 deaths have occurred worldwide as a result of COVID-19 as of August 25th 2020, and the number continues to climb rapidly. Clinicians have reported a range of physiological abnormalities in severely ill COVID-19 patients, including respiratory distress and vascular complications. Research also suggests that death rates are alarmingly high for patients requiring ventilator support, demonstrating the need for therapeutic interventions that can prevent the escalation of disease severity.
Human observational and genetic studies, as well as animal models of endothelial dysfunction collectively suggest that by targeting Tie2 receptor, MAN-19 may be effective in the treatment of a number of complications associated with viral infections such as COVID-19 and the seasonal flu.Therapeutics based on the Mannin platform have the potential to offer clinicians an intervention to rapidly stabilize the patient's vascular endothelium in hospital settings, such as the Intensive Care Unit (ICU), to prevent vascular leakage, pulmonary pathology, and acute respiratory distress syndrome (ARDS). Such an intervention could improve outcomes in the current COVID-19 pandemic around the world.
Q BioMed CEO Denis Corin stated, “This program is advancing very rapidly. We are very pleased with the input and support from government institutions and other industry stakeholders. There has been much talk of vaccines, but treatments are always going to be needed for people affected by these types of diseases, whether it's SARS-Cov-2 or another pathogen resulting in similar symptoms and complications. The Mannin Tie2 platform is designed to address life threatening complications from a number of infectious diseases, including future potential viral threats. With the support of regulators we expect this treatment to be in the clinic very early next year.”
About Mannin
Mannin is developing therapeutics with mechanism of action involving the Angiopoietin-Tie2 signaling pathway, which is a major regulator of vascular development, vessel remodelling, post-natal angiogenesis, and vessel permeability. Therefore, targeting this pathway has very broad therapeutic applications.
Mannin’s core R&D program is based on the Angiopoeitin-Tie2 Mechanism of Action. Mannin's small molecules and its biologic therapeutic target the endothelium of the patient, stabilizing endothelial barrier integrity by activating Tie2, which in turn reduces lung endothelial vascular leakage, inflammation and cell death that occurs during severe viral infection. This is a novel and promising therapeutic strategy as its mechanism of action is independent of viral replication, but instead focuses on endothelium of the host as the critical target for treatment intervention.
About Q BioMed Inc.
Q BioMed Inc. is a biotech acceleration and commercial stage company focused on licensing and acquiring undervalued biomedical assets in the healthcare sector. Q BioMed is dedicated to providing these target assets the strategic resources, developmental support, and expansion capital needed to ensure they meet their developmental potential, enabling them to provide products to patients in need.
Please visit http://www.QBioMed.com and sign up for regular updates.
Vela Diagnostics’ Automated COVID-19 Detection Test Approved for Use in Australia
26 August 2020
Singapore, August 26 2020– Vela Diagnostics announced today that the ViroKey™ SARS-CoV-2 RT-PCR Test v2.0 has been approved by the Australian Therapeutic Goods Administration (TGA) for in vitro diagnostic use.
The ViroKey™ SARS-CoV-2 RT-PCR Test v2.0 is a reverse transcription-polymerase chain reaction (RT-PCR) test that detects SARS-CoV-2 by targeting conserved regions on the SARS-CoV-2 genome, specifically the ORF1a and N genes. The automated test is optimized for a workflow consisting of the Sentosa™ SX101 instrument and works in conjunction with the Sentosa™ SA201 instrument or the ABI 7500 Fast Dx. The workflow tests up to 46 samples in a single run, with minimal hands-on time required.
“This timely approval from the TGA for our automated test will allow Vela Diagnostics to facilitate efficient testing for suspected COVID-19 patients in Australia,” said Sam Dajani, acting CEO and Chairman of the Board.
To date, the ViroKey™ SARS-CoV-2 RT-PCR Test v2.0 has received the CE mark for Europe and the provisional authorization from the Singapore Health Sciences Authority.
About Vela Diagnostics
Vela Diagnostics is a leading provider for integrated IVD system solutions, from sample to result. VELA’s test solutions utilize the automated Sentosa™ platform, providing the unique ability to leverage one system for NGS and PCR testing in infectious disease and oncology.
Workforce Drug Testing Positivity Climbed to Highest Rate in 16 Years, New Quest Diagnostics Drug Testing Index™ Analysis Finds
25 August 2020 - Marijuana positivity climbed by double digits across nearly all employee testing categories, while opiate and heroin positivity decline. Analysis of more than nine million workplace drug test results showed cocaine and methamphetamine positivity surges in Midwest.
SECAUCUS, N.J., Aug. 25, 2020 -- The rate of workforce drug positivity hit a sixteen-year high in 2019, according to a new analysis released today by Quest Diagnostics, the world's leading provider of diagnostic information services. Positivity rates in the combined U.S. workforce increased in urine drug tests, climbing to the highest level since 2003 (4.5%) and more than 28% percent higher than the thirty-year low of 3.5 percent recorded between 2010 and 2012.
In addition to overall increases in workforce drug positives, specific regions of the United States, particularly the Midwest, experienced dramatic increases in positivity for cocaine and methamphetamine as well as marijuana.
The new findings of the Quest Diagnostics Drug Testing Index™, which include an analysis of industry-specific data, were unveiled in advance of the Substance Abuse Program Administrators Association (SAPAA) virtual conference taking place on August 25, 2020.
For an interactive map with positivity rates and trend lines by three-digit zip code in the United States, visit DTIDrugMap.com.
The Quest Diagnostics findings generally align with other research. Drug deaths in the United States rose 5 percent in 2019, driven largely by methamphetamine, cocaine and fentanyl, following a decline in 2018. During the first few months of 2020, drug deaths increased about 13 percent compared with last year, attributable partly to social isolation and other disruptions caused by COVID-19.
"There is no question that before COVID-19, rates of workplace drug positivity were trending in the wrong direction, based on our Quest Diagnostics data, The enormous strain caused by COVID-19 may prove to be an accelerant on this disturbing trend," said Dr. Barry Sample, senior director of science and technology, Quest Diagnostics. "Organizations will need to consider the impact of COVID-19 not only on workplace safety but also as a health concern for their employees for some time to come."
Positivity rates for methamphetamine surged in the Midwest
Over the last five years, methamphetamine positivity in the general U.S. workforce testing increased nearly 12 percent (0.17% in 2015 versus 0.19% in 2019). The Midwest region experienced year-over-year increases, driven primarily by double-digit increases in the East North Central region during this period. Over the past five years, methamphetamine positivity in the Midwest increased nearly 78 percent (0.09% in 2015 versus 0.16% in 2019). Illinois (0.03% in 2015 versus 0.10% in 2019), Indiana (0.14% in 2015 versus 0.29% in 2019), Michigan (0.014% in 2015 versus 0.05 in 2019), and Ohio (0.04% in 2015 versus 0.11% in 2019) increased at least two-fold; while Wisconsin (0.05% in 2015 versus 0.09% in 2019) nearly doubled.
"While the national debate on drug misuse in the workforce has focused primarily on marijuana, increasing positivity rates for cocaine and methamphetamine are also cause for concern," said Dr. Sample. "Positivity by drug and region can be random and unpredictable. Our data is a reminder that it is important to remain vigilant about all drug misuse in the workforce.
Between 2019 and 2018. methamphetamine positivity inched up nearly 6 percent (0.18% in 2018 versus 0.19% in 2019) in general U.S. workforce tests and fell 6.3 percent (0.15% in 2018 versus 0.16% in 2019) in federally mandated, safety-sensitive testing. Methamphetamine positivity changed little in the general U.S. workforce (up 12 percent) and was flat in federally mandated, safety sensitive testing over five years.
The increased positivity rates for methamphetamine in urine test results were bolstered by similar patterns in other specimen types. Oral fluid methamphetamine positivity, which also assesses recent use, was up 4.3 percent since 2018 and up 69 percent since 2015; while methamphetamine positivity from hair tests, which gauges a pattern of drug use over time, was up 20 percent since 2018 and 60 percent since 2015.
"Testing with multiple specimen types can reveal a fuller understanding of patterns of misuse than one alone," said Dr. Sample. "Our data suggests that testing for methamphetamine with hair and oral fluid may be appropriate for employers with concerns about misuse of this particular drug to complement the standard urine drug screen."
Cocaine positivity increased in the Midwest and West
Cocaine positivity in the general U.S. workforce testing increased in the Midwest and West regions over the past five years. Cocaine positivity in the Midwest increased by 40 percent (0.20% in 2015 versus 0.28% in 2019) and in the West by 53 percent (0.15% in 2015 versus 0.23% in 2019). The Midwest was 20 percent less than the national rate in 2015 but 3.7 percent above the national rate in 2019, suggesting a surge in positivity in the region last year.
In the West, where cocaine positivity has been historically far lower, the cocaine positivity rate rose from 40 percent below the national rate in 2015 to 14.8 percent below in 2019. These increases in the West were primarily driven by increasing positivity in Colorado (0.19% in 2015 versus 0.30% in 2019), Nevada (0.13% in 2015 versus 0.22% in 2019), and Oregon (0.09% in 2015 versus 0.13% in 2019).
Opiate positivity declines throughout United States
In the general U.S. workforce, positivity for opiates in urine drug testing continues to decline across all opiate categories. Urine drug test positivity for opiates (primarily codeine and/or morphine) in the general U.S. workforce declined more than 19 percent (0.31% in 2018 versus 0.25% in 2019) and 49 percent over five years (0.49% in 2015 versus 0.25% in 2019). Among the more specific tests for other prescription opiates, the positivity for the semi-synthetic opiates (hydrocodone and/or hydromorphone) dropped 26 percent over the past year (0.50% in 2018 versus 0.37% in 2019) and more than 45 percent over five years (0.68% in 2015 versus 0.37% in 2019). Similarly, positivity for oxycodones (oxycodone and/or oxymorphone) declined 21 percent (0.43% in 2018 versus 0.34% in 2019) over the past year and nearly 55 percent over five years (0.75% in 2015 versus 0.34% in 2019).
Marijuana most commonly detected drug in U.S. workforce
Marijuana continues to top the list of the most commonly detected illicit substances across all workforce categories (general U.S. workforce; federally mandated, safety-sensitive workforce; and combined U.S. workforce, which includes the prior two populations) and specimen types (urine, oral fluid, and hair).
In the general U.S. workforce, marijuana positivity increased nearly 11 percent in urine testing (2.8% in 2018 versus 3.1% in 2019) and 29 percent since 2015 (2.4%). In the Midwest, marijuana positivity outpaced national increases in positivity in 2018 and 2019. Marijuana positivity increased in the Midwest by nearly 14 percent (2.9% in 2018 versus 3.3% in 2019). The West region also outpaced national positivity and saw double digit increases, as compared to the previous year, in 2017 through 2019. Marijuana positivity increased in the West by 24 percent (3.3% in 2018 versus 4.1% in 2019) and 78 percent since 2015 (2.3%).
"Marijuana continues to be an enduring presence in the U.S. workforce. Changing attitudes toward its use could pose heightened risks especially in safety-sensitive positions and those states exploring legalization," said Dr. Sample.
Positivity rates for heroin continue to decline in general U.S. and federally mandated, safety-sensitive workforce testing
Urine drug test results for the general U.S. workforce for heroin use, indicated by the presence of the 6-acetylmorphine (6-AM) metabolite, declined 33 percent (0.03% in 2018 versus 0.02% in 2019) and 50 percent decline since its peak in 2015 and 2016 (0.04%).
Positivity for 6-AM in the federally mandated, safety-sensitive workforce declined 15 percent between 2018 and 2019 (0.013% versus 0.011%), with a decrease of more than 45 percent since 2015 (0.02%).
Workforce positivity increases significantly in multiple industries
The Quest Diagnostics Drug Testing Index Industry Insights of general U.S. workforce positivity rates, based on more than 18 million urine drug test results (between 2015 and 2019), shows year-over-year increases in overall workplace drug positivity in 15 of the 17 sectors reported. The Retail Trade industry had the highest overall positivity rate (4.7% in 2015, 5.1% in 2016, 5.3% in 2017, 5.4% in 2018 and 5.5% in 2019) across all five years of the analysis. The Other Services (not including Public Administration) category, which includes services not listed in the other categories such as grantmaking, advocacy, and providing personal services, also had a 5.5% positivity rate in 2019. The Accommodations and Food Service category had the highest workforce positivity for marijuana, at 4.8%, a relative increase of 65 percent over five years (2.9% in 2015 versus 4.8% in 2019).
Workforce Drug Testing Webinar
Barry Sample, PhD, senior director of science and technology, for Quest Diagnostics will discuss the latest data and analysis from the Drug Testing Index via a webinar on Thursday, September 10, 2020 at 2:00 PM EDT. Click here to register and attend.
About the Quest Diagnostics Drug Testing Index™
The Quest Diagnostics Drug Testing Index™ (DTI) is a series of reports that provide insights into trends in workforce drug use, based on positivity results for de-identified laboratory testing performed by Quest Diagnostics for a range of illicit, legal and prescription drugs. It examines test results according to three categories of workers: federally mandated, safety-sensitive workers; the general workforce; and the combined U.S. workforce. Federally mandated, safety-sensitive workers include pilots, bus and truck drivers, and workers in nuclear power plants, for whom routine drug testing is mandated by the U.S. Department of Health and Human Services.
The strengths of the DTI analysis include its large, nationally representative sample size, longitudinal monitoring, a testing population that is generally reflective of the U.S. workforce and the quality of the company's drug testing services to confirm positive results. Limitations include analysis only of employers that perform drug testing with the company, and a lack of exact cross-specimen comparisons due to variations in substances for which employers test. Quest Diagnostics has analyzed annual workplace drug testing data since 1988 and publishes the findings as a public service.
In addition to workplace drug testing, Quest is a leader in clinician-ordered drug testing services through its Clinical Drug Monitoring program to aid the detection of potentially dangerous forms of prescription and illicit drug use. For more information on Quest's drug monitoring services for healthcare providers, visit QuestDrugMonitoring.com
About Quest Diagnostics
Quest Diagnostics empowers people to take action to improve health outcomes. Derived from the world's largest database of clinical lab results, our diagnostic insights reveal new avenues to identify and treat disease, inspire healthy behaviors and improve health care management. Quest annually serves one in three adult Americans and half the physicians and hospitals in the United States. Our 47,000 employees understand that, in the right hands and with the right context, our diagnostic insights can inspire actions that transform lives. www.QuestDiagnostics.com.
QIAGEN to launch easy-to-use digital test in the U.S. for rapid detection of SARS-CoV-2 antibodies following FDA emergency use authorization
24 August 2020 - Access Anti-SARS-CoV-2 is an easy-to-use 10-minute test on a portable device that provides highly accurate results on Total Ig antibodies (IgA, IgM, IgG). New test based on QIAGEN partner Ellume’s proprietary technology, addresses current test shortfalls in terms of automation and convenient read-out of results. Digital eHub and eStick system provides rapid qualitative serological in-vitro detection of total antibodies to SARS-CoV-2 in plasma and serum. U.S. launch set to start in late August 2020 after submission for FDA Emergency Use Authorization, European CE-IVD marking and commercialization start planned in coming weeks.
Germantown, Maryland, and Hilden, Germany, August 24, 2020 – QIAGEN N.V. today announced the U.S. launch of the new Access Anti-SARS-CoV-2 Total test, an easy-to-use digital test done on a portable device that provides results in about 10 minutes to detect antibodies in people exposed to the SARS-CoV-2 virus, which is the case of COVID-19.
The launch of this antibody test, which was developed in partnership with the Australian digital diagnostics company Ellume, comes after the submission by QIAGEN of this unique antibody test to the U.S. Food and Drug Administration (FDA) for Emergency Use Authorization (EUA). First shipments are planned for late August 2020. A CE-IVD marking for Europe and other markets is planned in the coming weeks.
The new serological test has been shown to have sensitivity of 100% (CI 88.43–100.00%) and specificity of 100% (CI 95.20–100.00%).
“Increased testing is the only way to gain visibility on the magnitude of the pandemic, which will ultimately lead to helping control it,” said Dr. Davide Manissero, M.D., Chief Medical Officer of QIAGEN. “As a trusted partner in the fight against COVID-19, QIAGEN has now added the Access Anti-SARS-CoV-2 to our portfolio as a smart solution for antibody testing that provides results with confidence. This is a rugged and portable platform that requires no hardware, can process a wide range of tests and provides fast results. We look forward to working with Ellume to discover and develop additional tests for this platform.”
The test is performed on the eHub, a small portable digital device that provides reliable results in 10 minutes. Each eHub can handle up to eight patient samples simultaneously and can perform up to 32 total tests per hour. The nanoparticle fluorescent detection technology uses serum or plasma from patient samples. The same platform is being used for QuantiFERON-TB Access, a new solution in development for diagnosis of latent tuberculosis (TB) infection in low-resource regions with a high TB disease burden.
Currently available rapid lateral flow antibody tests fall short when it comes to the automated and convenient read-out of results. Manual and visual result reporting, and potential pitfalls in read-out timing can lead of uncertain testing results. The Access Anti-SARS-CoV-2 eHub and digital eStick approach mitigates those risks, providing reliable results no matter when the results are read and also providing true walk-away capability to free up laboratory personnel.
Serological testing for antibodies is central to identifying people who have been recently infected by the virus or have been infected in the recent past, especially those who did not show any symptoms and therefore might not know of an infection. Understanding more about COVID-19 immunity in a population could help societies return faster to normal daily routines by helping to inform and guide public health measures, such as contact tracing and individual measures under clinical guidance. Antibody testing could also become fundamental in supporting vaccine development as well as guiding, planning, and assessing future SARS-CoV-2 immunization programs.
Access Anti-SARS-CoV-2 will complement QIAGEN’s array of COVID-19 testing solutions with a cost-effective way to detect immune responses in people who have been exposed to the virus.
QIAGEN employees around the world are fully mobilized to address the urgent demand for testing solutions needed in the global response to the coronavirus pandemic. QIAGEN’s initiatives focus on building the most comprehensive portfolio of solutions for COVID-19 testing. These include production of viral RNA extraction for use on QIAGEN’s QIAcube, QIAsymphony and EZ1 platforms as well as third-party instruments; building up a range of PCR tests on the QIAstat-Dx and NeuMoDx systems that enable COVID-19 detection while analyzing samples at the same time for other respiratory infections; QIAGEN is also providing universal next-generation sequencing (NGS) solutions for research use with any sequencer, in particular gene panels integrated with bioinformatics for analysis of the SARS-CoV-2 virus. QIAGEN is also scaling up production capacity for reagents sold to other companies for use in their own COVID-19 tests.
About QIAGEN
QIAGEN N.V., a Netherlands-based holding company, is the leading global provider of Sample to Insight solutions that enable customers to gain valuable molecular insights from samples containing the building blocks of life. Our sample technologies isolate and process DNA, RNA and proteins from blood, tissue and other materials. Assay technologies make these biomolecules visible and ready for analysis. Bioinformatics software and knowledge bases interpret data to report relevant, actionable insights. Automation solutions tie these together in seamless and cost-effective workflows. QIAGEN provides solutions to more than 500,000 customers around the world in Molecular Diagnostics (human healthcare) and Life Sciences (academia, pharma R&D and industrial applications, primarily forensics). As of June 30, 2020, QIAGEN employed more than 5,200 people in over 35 locations worldwide. Further information can be found at http://www.qiagen.com.
Reference: https://corporate.qiagen.com/newsroom/press-releases/2020/20200824_access_sars_cov_2
Trinity Biotech announces EUA submission for Covid-19 ELISA Antibody test
20 August 2020
DUBLIN, Ireland, August 20, 2020 -- Trinity Biotech plc, a leading developer and manufacturer of diagnostic products for the point-of-care and clinical laboratory markets announced that it has filed its submission for an Emergency Use Authorization (EUA) for its Covid-19 IgG ELISA antibody test with the FDA. This test will determine which individuals within the population have been exposed to the SARS-CoV-2 virus. The transfer of production to our facility in Jamestown, New York is complete, our manufacturing capability is very significant and the instrumentation platforms that perform ELISA testing are available in virtually every testing laboratory in the world.
The product demonstrates specificity in excess of 98% and sensitivity in excess of 95%, in samples of 14 days or more from symptom onset. EUA submission allows us to begin marketing the product immediately.
In addition, the Company is developing a rapid point-of-care Covid-19 test to detect antibodies to the virus that can be run in 12 minutes using one drop of blood procured by finger prick. This test will have utility similar to that outlined above for the ELISA antibody test. Once development and transfer to manufacturing of this rapid test is complete we intend to avail of the FDA’s EUA pathway to expedite its approval for sale in the USA.
This pipeline of Covid-19 products complements our existing Viral Transport Media (VTM) product, which is used in the Covid-19 sample collection process for PCR molecular testing. We have scaled up the manufacture of VTM to meet increased levels of demand over the past months and we expect demand to continue as Covid19 testing remains critical to the management of the pandemic.
Ronan O’Caoimh, Chief Executive Offer commented “We are very pleased to announce the submission of our Covid-19 ELISA antibody test for FDA Emergency Use Authorization (EUA). The test demonstrates both impressive specificity and sensitivity. Meanwhile, the ELISA testing platform with its excellent reputation for quality and widespread adoption makes it an ideal format for large scale antibody testing.”
About Trinity Biotech
Trinity Biotech develops, acquires, manufactures and markets diagnostic systems, including both reagents and instrumentation, for the point-of-care and clinical laboratory segments of the diagnostic market. The products are used to detect infectious diseases and to quantify the level of Haemoglobin A1c and other chemistry parameters in serum, plasma and whole blood. Trinity Biotech sells direct in the United States, Germany, France and the U.K. and through a network of international distributors and strategic partners in over 75 countries worldwide. For further information please see the Company's website: www.trinitybiotech.com.
QIAGEN announces new Chairman of Supervisory Board
21 August 2020 - Lawrence A. Rosen appointed by Supervisory Board as new Chairman with immediate effect. Appointment comes after Dr. Håkan Björklund decided to step down as Chairman of the Supervisory Board and as a Supervisory Board member.
Venlo, The Netherlands, August 21, 2020 – QIAGEN N.V. today announced a transition in the leadership of its Supervisory Board after an extraordinary meeting of the Supervisory Board and Managing Board.
Lawrence A. Rosen, a member of the QIAGEN Supervisory Board since 2013, was appointed by the Supervisory Board as the new Chairman with immediate effect. Mr. Rosen, a U.S. citizen who spent more than 20 years in senior leadership positions in Europe, also serves on the Supervisory Board of Lanxess AG. He was a member of the Board of Management and Chief Financial Officer of Deutsche Post DHL Group in Germany until September 2016. Prior to that, he served as Chief Financial Officer of Fresenius Medical Care AG & Co. KGaA in Germany from 2003 to 2009. Prior to that, he was Senior Vice President and Treasurer for Aventis SA in Strasbourg, France. Between 1984 and 2000, he held various positions at the Aventis predecessor companies Hoechst AG and American Hoechst / Hoechst Celanese Inc.
The appointment comes after Dr. Håkan Björklund decided to step down as Chairman and as a member of the Supervisory Board, and will not stand for re-election at the next Annual General Meeting planned for June 2021. Dr. Björklund was appointed as a new Supervisory Board member in March 2017 and as Chairman in June 2018. The number of Supervisory Directors has been reduced to six.
“As the leadership and composition of the Supervisory Board changes, and also in light of the recent outcome of the proposed acquisition by Thermo Fisher, the Supervisory Board wants to express its full commitment to QIAGEN pursuing a growth strategy focused on execution and greater value creation. We also look forward to working on a long-term basis with the Managing Board members. The contributions of QIAGEN to society have never been more critical due to the unprecedented magnitude of the coronavirus pandemic,” said Mr. Rosen. “On behalf of my colleagues in the Supervisory Board, I would like to thank Dr. Björklund for his contributions to QIAGEN during his time on the Board and wish him all the best in his future endeavors.”
“It has been a pleasure to be part of QIAGEN, a company having a critical role in modern molecular testing,” said Dr. Håkan Björklund. “I wish my colleagues on the Supervisory Board and Managing Board, and above all the more than 5,200 QIAGEN employees who are truly making a difference during this public health crisis, continued success in helping to improve the lives of people around the world.”
About QIAGEN
QIAGEN N.V., a Netherlands-based holding company, is the leading global provider of Sample to Insight solutions that enable customers to gain valuable molecular insights from samples containing the building blocks of life. Our sample technologies isolate and process DNA, RNA and proteins from blood, tissue and other materials. Assay technologies make these biomolecules visible and ready for analysis. Bioinformatics software and knowledge bases interpret data to report relevant, actionable insights. Automation solutions tie these together in seamless and cost-effective workflows. QIAGEN provides solutions to more than 500,000 customers around the world in Molecular Diagnostics (human healthcare) and Life Sciences (academia, pharma R&D and industrial applications, primarily forensics). As of June 30, 2020, QIAGEN employed more than 5,200 people in over 35 locations worldwide.
Reference: https://corporate.qiagen.com/newsroom/press-releases/2020/20200821_sb_chairman
Quidel to update packaging of point-of-care Sofia® SARS Antigen test for COVID-19 to include either nasal or nasopharyngeal swabs
19 August 2020
SAN DIEGO, 19 August 2020 -- Quidel Corporation (“Quidel”), a provider of rapid diagnostic testing solutions, cellular-based virology assays and molecular diagnostic systems, announced today that labeling for Quidel’s Emergency Use Authorization (EUA) for the Sofia® SARS Antigen FIA has been amended to include either nasal or nasopharyngeal swabs.
The new kit labeling, with the addition of a nasopharyngeal swab, allows Quidel to offer a second kit configuration to support the nasopharyngeal sample commonly performed in hospitals and helps alleviate some of the supply chain constraints around nasal swab-based kits. Quidel’s Sofia® SARS Antigen FIA has always been authorized for use with either nasal or nasopharyngeal swabs specimens. Due to customer preference, the Sofia SARS Antigen kit has been sold only with a nasal swab. A new kit configuration including nasopharyngeal swabs allows Quidel to increase its weekly delivery of the Sofia Antigen test.
“In our quest to do the most good during the novel coronavirus pandemic, offering our hospital customers another kit configuration with an NP collection device option allows us to work through some of the near-term nasal swab shortages we face to be able to ship more Sofia® SARS Antigen FIA kits and thereby enable more patients to be tested,” said Douglas Bryant, president and CEO of Quidel Corporation. “We strongly believe that frequent testing using an accurate point-of-care antigen test allows for more successful implementation of contact tracing and self-isolation programs, which are key to help reduce the spread of COVID-19.”
Quidel currently sells the Sofia® SARS Antigen FIA in the United States under Emergency Use Authorization (EUA) by the FDA.
About Quidel Corporation
Quidel Corporation serves to enhance the health and well-being of people around the globe through the development of diagnostic solutions that can lead to improved patient outcomes and provide economic benefits to the healthcare system. Marketed under the Sofia®, QuickVue®, D3® Direct Detection, Thyretain®, Triage® and InflammaDry® leading brand names, as well as under the new Solana®, AmpliVue®and Lyra® molecular diagnostic brands, Quidel’s products aid in the detection and diagnosis of many critical diseases and conditions, including, among others, COVID-19, influenza, respiratory syncytial virus, Strep A, lyme, herpes, pregnancy, thyroid disease and fecal occult blood. Quidel's Triage® system of tests comprises a comprehensive test menu that provides rapid, cost-effective treatment decisions at the point-of-care (POC), offering a diverse immunoassay menu in a variety of tests to provide diagnostic answers for quantitative BNP, CK-MB, d-dimer, myoglobin, troponin I and qualitative TOX Drug Screen. Quidel’s research and development engine is also developing a continuum of diagnostic solutions from advanced immunoassay to molecular diagnostic tests to further improve the quality of healthcare in physicians’ offices and hospital and reference laboratories. For more information about Quidel’s comprehensive product portfolio and to explore exciting employment opportunities, visit quidel.com.
Roche and Regeneron collaborate to significantly increase global supply of REGN-COV2 investigational antibody combination for COVID-19
19 August 2020 - REGN-COV2 is Regeneron’s two-antibody combination currently in late-stage clinical trials for the treatment and prevention of COVID-19 infection. The companies will collaborate on developing and manufacturing REGN-COV2. Regeneron will distribute REGN-COV2 in the U.S. and Roche will be responsible for distribution outside the U.S. Under this collaboration, the overall capacity of REGN-COV2 is expected to increase by at least three and a half times, substantially increasing the number of doses available to patients in the U.S. and around the world.
Basel, 19 August 2020 -- Roche and Regeneron announced today that they are joining forces in the fight against COVID-19 to develop, manufacture and distribute REGN-COV2, Regeneron’s investigational antiviral antibody combination, to people around the globe. REGN-COV2 could provide a much-needed treatment option for people already experiencing symptoms of COVID-19, and also has the potential to prevent infection in people exposed to the virus, thus slowing the spread of the global pandemic. This collaboration is expected to increase supply of REGN-COV2 to at least three and a half times the current capacity, with the potential for even further expansion.
REGN-COV2 is currently being studied in two Phase 2/3 clinical trials for the treatment of COVID-19 and in a Phase 3 trial for the prevention of COVID-19 in household contacts of infected individuals. If it proves safe and effective in clinical trials and regulatory approvals are granted, Regeneron will distribute and record sales for REGN-COV2 in the U.S. and Roche will be responsible for distribution outside the U.S.
“We are excited about the potential for one medicine to serve both as a treatment for those infected as well as protection for people exposed to the virus. REGN-COV2 could be a critical line of defense against the COVID-19 pandemic,” said Bill Anderson, Chief Executive Officer of Roche Pharmaceuticals. “We’re committing our manufacturing expertise and capacity, and our global distribution network to bring Regeneron’s potential antibody combination to as many people around the world as we possibly can.”
“Regeneron has progressed the REGN-COV2 research and development program at record speed and worked tirelessly to maximize our in-house manufacturing capacity,” said Leonard S. Schleifer, M.D., Ph.D., President and Chief Executive Officer of Regeneron. “This major collaboration with Roche provides important scale and global expertise to bring REGN-COV2 to many more patients in the United States and around the globe.”
Under the terms of the agreement, each company has committed to dedicate a certain manufacturing capacity to REGN-COV2 each year, and the collaborators have already begun the technology transfer process. Each company will bear its own distribution expenses in their designated territories. The collaborators will jointly fund and execute the ongoing Phase 3 prevention and Phase 1 healthy volunteers safety studies as well as additional global studies to evaluate further the potential for REGN-COV2 in treating or preventing COVID-19. Roche will be primarily responsible for securing regulatory approvals outside the U.S., following the initial European Medicines Agency (EMA) approval, and conducting any additional studies specifically required for approval by regulators outside the U.S.
About REGN-COV2
REGN-COV2 was designed specifically by Regeneron scientists to block infectivity of SARS-CoV-2, the virus that causes COVID-19. They evaluated thousands of fully-human antibodies produced by the company's proprietary VelocImmune® mice, which have been genetically-modified to have a human immune system, as well as antibodies identified from humans who have recovered from COVID-19. The two potent, virus-neutralizing antibodies that form REGN-COV2 bind non-competitively to the critical receptor binding domain of the virus's spike protein, which diminishes the ability of mutant viruses to escape treatment and protects against spike variants that have arisen in the human population, as detailed in recent Science publications.
REGN-COV2's development, manufacturing and clinical trials have been funded in part by the Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response at the U.S. Department of Health and Human Services under OT number: HHSO100201700020C.
About Roche’s response to the COVID-19 pandemic
The COVID-19 pandemic continues to evolve globally with varying developments from country to country and we are partnering with healthcare providers, laboratories, authorities and organisations to help make sure that patients receive the tests, treatment and care they need. This partnership is an additional step in Roche’s fight against the COVID-19 pandemic, which has already included:
- Launching COVID-19 diagnostic tests for active infection and the detection of antibodies in patients who have been exposed to the virus,
- Investigating treatments from our existing portfolio to better understand their potential to treat patients with COVID-19,
- Increasing manufacturing and supply chain capacity to meet product demand across our portfolio within the wider context of COVID-19 treatment, and
- Ensuring the supply of our existing medicines and diagnostics to patients around the world under exceptional conditions.
Reliable, high-quality testing is essential to help healthcare systems overcome this pandemic. On 13 March we received FDA Emergency Use Authorisation for a high-volume molecular test to detect SARS-CoV-2, the virus that causes COVID-19, which is also available in countries accepting the CE Mark. On 3 May, Roche announced that its COVID-19 antibody test, aimed at detecting the presence of antibodies in the blood, also received FDA Emergency Use Authorisation and is available in markets accepting the CE mark. Also in June we received an FDA EUA for the Elecsys® IL-6 test to assist in identifying severe inflammatory response in patients with confirmed COVID-19, as well as launching Roche v-TAC, which could help simplify the screening, diagnosis and monitoring of patients with respiratory compromise in the current COVID-19 pandemic. Roche is working closely with governments and health authorities around the world, and has significantly increased production to help ensure availability of tests globally.
We are actively involved in understanding the potential of our existing portfolio and are researching options for the future. Roche has an ongoing clinical trial program evaluating the role of Actemra©/RoActemra© (tocilizumab) in COVID-19 pneumonia. On 29 July we announced that the COVACTA trial did not meet its primary endpoint of improved clinical status in patients with COVID-19 associated pneumonia, or the key secondary endpoint of reduced patient mortality. The study was the first global, randomised, double-blind, placebo-controlled phase III trial investigating Actemra/RoActemra in this setting. Roche remains committed to continuing the Actemra/RoActemra clinical trial programme in COVID-19 to further explore Actemra/RoActemra in other treatment settings, including in combination with an antiviral. In addition to COVACTA, Roche has initiated several studies to further investigate Actemra/RoActemra as a potential treatment for patients with COVID-19 associated pneumonia, including two phase III clinical trials, REMDACTA and EMPACTA, as well as the phase II MARIPOSA trial. Roche has further initiated an internal early research programme focused on the development of medicines for COVID-19 and is engaged in multiple research collaborations.
In these exceptional times, Roche stands together with governments, healthcare providers and all those working to overcome the pandemic.
About Roche
Roche is a global pioneer in pharmaceuticals and diagnostics focused on advancing science to improve people’s lives. The combined strengths of pharmaceuticals and diagnostics under one roof have made Roche the leader in personalised healthcare – a strategy that aims to fit the right treatment to each patient in the best way possible.
Roche is the world’s largest biotech company, with truly differentiated medicines in oncology, immunology, infectious diseases, ophthalmology and diseases of the central nervous system. Roche is also the world leader in in vitro diagnostics and tissue-based cancer diagnostics, and a frontrunner in diabetes management.
Founded in 1896, Roche continues to search for better ways to prevent, diagnose and treat diseases and make a sustainable contribution to society. The company also aims to improve patient access to medical innovations by working with all relevant stakeholders. More than thirty medicines developed by Roche are included in the World Health Organization Model Lists of Essential Medicines, among them life-saving antibiotics, antimalarials and cancer medicines. Moreover, for the eleventh consecutive year, Roche has been recognised as one of the most sustainable companies in the Pharmaceuticals Industry by the Dow Jones Sustainability Indices (DJSI).
The Roche Group, headquartered in Basel, Switzerland, is active in over 100 countries and in 2019 employed about 98,000 people worldwide. In 2019, Roche invested CHF 11.7 billion in R&D and posted sales of CHF 61.5 billion. Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan. For more information, please visit www.roche.com.
Reference: https://www.roche.com/media/releases/med-cor-2020-08-19.htm
QIAGEN expands integrated coronavirus NGS and software solutions to accelerate COVID-19 research
18 August 2020 - QIAseq SARS-CoV-2 Primer Panel converts viral RNA samples into libraries ready for sequencing. QIAGEN Digital Insights solutions support COVID-19 drug, vaccine and epidemiology research.
Hilden, Germany, and Germantown, Maryland, August 18, 2020 – QIAGEN launched the innovative QIAseq SARS-CoV-2 Primer Panel for next-generation sequencing (NGS) of the novel coronavirus genome, along with integrated analysis and interpretation workflows for insights into the evolution and spread of the virus that causes COVID-19 disease. The new products are an expansion of QIAGEN’s broad offering of sample technologies, diagnostic tests and instruments, and research tools for use in the global effort to combat the COVID-19 pandemic.
“These solutions aim to accelerate research into COVID-19 prevention and treatment by enabling deeper, more holistic insights into the biology of SARS-CoV-2. The more we understand the novel coronavirus and its development, the better equipped the world will be to stop the pandemic,” said Thierry Bernard, Chief Executive Officer of QIAGEN. “We are partnering with leading institutes and companies to accelerate this vital research. Our new QIAseq SARS-CoV-2 Primer Panel and software pipeline will guide researchers into insights on the epidemiology, metatranscriptomics, immune response and pathways of the coronavirus – contributing to drug and vaccine development and public health strategies.”
QIAGEN’s new QIAseq SARS-CoV-2 Primer Panel provides optimized, single-day workflows to prepare libraries for sequencing as researchers use NGS to track viral genome changes in studying the epidemiology of virus outbreaks. The two-step process uses advanced QIAseq technologies to conduct reverse transcription and cDNA synthesis from a viral RNA sample, then generate libraries compatible with Illumina sequencing platforms. The workflow is faster and has lower-input requirements compared to hybrid capture solutions.
The panel is supported with software pipelines tailored to SARS-CoV-2 genome analysis using QIAGEN’s CLC Genomics Workbench. The optimized and configurable pipelines allow researchers to identify viral genome sequence variation across samples, and to visualize strain divergence across populations and geographies using phylogenetic approaches. QIAGEN also provides a complete Sample to Insight SARS-CoV-2 Whole Genome Sequencing Service covering all aspects of the workflow, from RNA isolation to NGS library preparation and data analysis.
The first independent study using the new QIAGEN workflows, an analysis of COVID-19 epidemiology in India, has been published in the Journal of Biosciences. The study used QIAGEN’s QIAamp Viral RNA Mini Kit for extraction of RNA. Researchers used the QIAseq SARS-CoV-2 Primer Panel for viral genome amplification in samples that did not generate sufficient NGS reads, converting the RNA to double-stranded cDNA and amplifying it, then generating libraries for sequencing on an Illumina instrument. The sequences were assembled and analyzed using QIAGEN CLC Genomics Workbench. The full study can be found at https://www.ias.ac.in/article/fulltext/jbsc/045/0076.
“We urgently need more research into the evolution of this virus. As we found in eastern India, mutations are emerging in the SARS-CoV-2 genome that might modulate viral transmission, replication efficiency and virulence in different regions of the world. Genomic research is required to improve understanding of transmission patterns, tracking of the outbreak and formulation of effective containment measures,” said Dr. Arindam Maitra, Associate Professor at the National Institute of Biomedical Genomics in India, one of the authors. “We found that a viral genome amplification method like the QIAseq SARS-CoV-2 Primer Panel was ideal for looking at low copy number, or high CT samples when compared to other methods.”
As a global leader in NGS solutions for evaluation of microbiomes and metagenomics, QIAGEN also offers a complete QIAseq workflow to expedite metatranscriptomics research and efficiently decipher the complex interplay between the SARS-CoV-2 virus, the host and its microbiota. A recently published study by Shah, S.J., et al. (2020) has illustrated the application of QIAseq FastSelect rRNA removal technology in facilitating SARS-CoV-2 metatranscriptomics, leading to a more comprehensive evaluation of co-infection rates in COVID-19 patients.
Since the start of the COVID-19 pandemic, QIAGEN’s initiatives focus on building the most comprehensive portfolio of solutions for COVID-19 testing. These include ramping up production of viral RNA extraction for use on QIAGEN’s QIAcube, QIAsymphony and EZ1 platforms as well as third-party instruments; building up a range of PCR tests on the QIAstat-Dx and NeuMoDx systems that enable COVID-19 detection while analyzing samples at the same time for other respiratory infections; and delivering universal next-generation sequencing (NGS) solutions for use with any sequencer, in particular gene panels like the QIAseq SARS-CoV-2, which are integrated with bioinformatics for analysis of the SARS-CoV-2 virus. QIAGEN is also scaling up production capacity for reagents sold to other companies for use in their own COVID-19 tests.
For an overview of QIAGEN’s coronavirus testing solutions, please visit http://www.qiagen.com/coronavirus.
To explore QIAGEN’s NGS-specific solutions for COVID-19 research, please visit https://go.qiagen.com/CoronavirusNGS
For details of QIAGEN’s SARS-CoV-2 Whole Genome Sequencing Service, please visit https://www.qiagen.com/applications/genomic-services/sars-cov-2-whole-genome-sequencing-services
About QIAGEN
QIAGEN N.V., a Netherlands-based holding company, is the leading global provider of Sample to Insight solutions that enable customers to gain valuable molecular insights from samples containing the building blocks of life. Our sample technologies isolate and process DNA, RNA and proteins from blood, tissue and other materials. Assay technologies make these biomolecules visible and ready for analysis. Bioinformatics software and knowledge bases interpret data to report relevant, actionable insights. Automation solutions tie these together in seamless and cost-effective workflows. QIAGEN provides solutions to more than 500,000 customers around the world in Molecular Diagnostics (human healthcare) and Life Sciences (academia, pharma R&D and industrial applications, primarily forensics). As of June 30, 2020, QIAGEN employed more than 5,200 people in over 35 locations worldwide. Further information can be found at http://www.qiagen.com.
Reference: https://corporate.qiagen.com/newsroom/press-releases/2020/20200818_qiaseq_sars_cov_2
PerkinElmer Launches Modular and Scalable explorer™ Workstations for High-throughput COVID-19 Detection
17 August 2020 - Enables Labs to Quickly Ramp up Testing Capacity and Generate Results Faster
WALTHAM, Mass., Aug. 17, 2020 -- PerkinElmer, Inc., a global leader committed to innovating for a healthier world, today announced the launch of a series of explorer™ workstations for SARS-CoV-2 testing capable of preparing and running up to 10,000 COVID-19 tests per day. These modular and scalable workstations enable laboratories to ramp up SARS-CoV-2 testing capacity quickly to generate results.
Currently many laboratories are unable to deliver COVID-19 testing results in a timely manner. Slow results and delayed responses can increase the risk of further spread of the disease.
PerkinElmer’s scalable and modular explorer automated workstations streamline testing workflows, speeding up SARS-CoV-2 RT-PCR and ELISA testing. The workstations help laboratories improve their efficiency, while eliminating errors. In addition, they reduce labor requirements by automating and standardizing disparate workflow steps. They also provide varying degrees of automation based on workload and staffing resources.
To better respond to the COVID-19 pandemic, laboratories need the ability to obtain all workflow components – from reagents to equipment, to consumables at the scale they need, when they need them. Today, PerkinElmer is able to deliver these workflow components globally.
“The global economy is reeling from this pandemic, and laboratories need to be able to rapidly scale their testing capacity up and down,” said Masoud Toloue, Ph.D., Vice President and General Manager, Diagnostics, PerkinElmer. “PerkinElmer is developing innovative solutions giving laboratories the flexibility they need to meet the ever-changing COVID-19 testing demand. The best-in-class explorer workstations enable laboratories to efficiently work through the COVID-19 pandemic.”
PerkinElmer has more than 20 years of experience in optimizing complete workflows (including reagents, equipment, and consumables) based on testing, throughput, and staffing requirements. The Company’s comprehensive SARS-CoV-2 offerings span high throughput RNA extraction, RT-PCR assays, automation, ELISA, and other laboratory solutions. Its ELISA offerings are available through EUROIMMUN, a PerkinElmer company.
About PerkinElmer
PerkinElmer enables scientists, researchers and clinicians to address their most critical challenges across science and healthcare. With a mission focused on innovating for a healthier world, we deliver unique solutions to serve the diagnostics, life sciences, food and applied markets. We strategically partner with customers to enable earlier and more accurate insights supported by deep market knowledge and technical expertise. Our dedicated team of about 13,000 employees worldwide is passionate about helping customers work to create healthier families, improve the quality of life, and sustain the wellbeing and longevity of people globally. The Company reported revenue of approximately $2.9 billion in 2019, serves customers in 190 countries, and is a component of the S&P 500 index. Additional information is available through 1-877-PKI-NYSE, or at www.perkinelmer.com.
Thermo Fisher Scientific Announces Results of Offer to Acquire QIAGEN, Lapse of Offer and Termination of Acquisition Agreement
13 August 2020
WALTHAM, Mass., Aug. 13, 2020 -- Thermo Fisher Scientific Inc., the world leader in serving science, today announced that its offer to acquire all of the ordinary shares of QIAGEN N.V. has lapsed.
Based on information provided by the settlement agents for the offer, Deutsche Bank Aktiengesellschaft and American Stock Transfer & Trust Company, 107,546,187 QIAGEN shares, representing 47.02% of the issued and outstanding ordinary shares of QIAGEN, were validly tendered into the offer by the end of the acceptance period at 24:00 hours (Frankfurt am Main local time) / 18:00 hours (New York local time) on August 10, 2020. Accordingly, the minimum acceptance threshold condition to the offer has not been satisfied, and the offer has lapsed in accordance with its terms.
Thermo Fisher has terminated the acquisition agreement with QIAGEN, and QIAGEN will pay to Thermo Fisher an expense reimbursement payment of USD 95 million in cash in accordance with the terms of the acquisition agreement.
Marc N. Casper, chairman, president and chief executive officer of Thermo Fisher Scientific, said, "Thermo Fisher is a disciplined acquirer with a strong track record of executing value-creating transactions. We remain extremely well-positioned to deliver on our proven growth strategy and continue to generate significant returns for our shareholders."
About Thermo Fisher
Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $25 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, improving patient diagnostics and therapies or increasing productivity in their laboratories, we are here to support them. Our global team of more than 75,000 colleagues delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services and Patheon. For more information, please visit www.thermofisher.com.
Philips launches Rapid Equipment Deployment Kit to COVID-19 response
13 August 2020 - New initiative can provide critical care patient monitoring anywhere, anytime to help meet the urgent challenges of ICU capacity. Helps mitigate the impact of natural disasters and pandemics like the ongoing COVID-19 outbreak.
Amsterdam, the Netherlands, 13 August 2020 – Royal Philips, a global leader in health technology, today introduced its Rapid Equipment Deployment Kit for ICU ramp-ups, allowing doctors, nurses, technicians and hospital staff to quickly support critical care patient monitoring capabilities during the COVID-19 pandemic. Currently successfully in use in the first health systems across the US, the Rapid Equipment Deployment Kit combines Philips advanced patient monitoring technology with predictive patient centric algorithms enabling care teams to quickly scale up critical care patient monitoring capabilities within a few hours. As health systems in the U.S. continue to experience surges in critical care and emergency care demand related to the COVID-19 crisis, the kit provides hospitals a way to quickly and easily expand their critical care capacity.
Innovative approach to help manage capacity surge in the ICU
The Philips Rapid Equipment Deployment Kit is a fully configured and ready-to-deploy ICU patient monitoring solution, which includes 20 ICU monitors, 20 measurement servers and one central management monitoring station. The kits are pre-built, pre-configured and pre-packed into sturdy cases that can elevate a hospital’s general care area to a critical care level in a matter of hours. Kits are complete with step-by-step instructions allowing the pre-configured system to be deployed by hospital staff, with remote technical and clinical support from Philips. Kits can be transferred from hospital to hospital as needed. Once a crisis/surge passes, the kits are disinfected, packed up and stored to have available in preparation for future emergencies.
“The current health crisis has demonstrated a clear need for us to deliver innovative solutions to our customers that provide a complete critical care monitoring solution with all of the equipment they require on demand. This eliminates the need to source and configure individual pieces of high-demand equipment during a crisis,” said Peter Ziese, General Manager of Monitoring Analytics at Philips. “To help ensure economical and more efficient use of hospital resources, the Rapid Equipment Deployment Kits provide the speed, flexibility and ease of implementation for advanced critical care patient monitoring that many of our customers must have during this most pressing time.”
Philips critical care patient monitoring solutions
In June, Philips announced it had received Emergency Use Authorization from the FDA for Philips’ IntelliVue Patient Monitors MX750/MX850 and its IntelliVue Active Displays AD75/AD85, for use in the US during the COVID-19 health emergency. These patient monitoring solutions support infection-control protocols and remotely provide critical patient information when caring for hospitalized COVID-19 patients. The MX750 and MX850 monitors are the latest additions to Philips’ portfolio of integrated patient monitoring solutions to help support improved clinical and operational workflows. Updated features, include enhancements to monitor and assess clinical and network device performance, and additional functionalities to strengthen cybersecurity. Visit Philips critical care patient monitoring for more information on the Rapid Equipment Deployment Kits in the US market and Philips full suite of critical care patient monitoring solutions.
Philips COVID-19 solutions portfolio
Philips has a comprehensive portfolio of services and solutions to help support the delivery of high-quality care to COVID-19 patients. Solutions include secure, connected and intelligent approaches to diagnosis, treatment and predictive monitoring in the hospital, plus screening, remote patient monitoring and care at home. With healthcare under more pressure than ever before, Philips’ telehealth and AI-enabled data analytics can help support workflows, facilitate remote collaboration and optimize resources. Philips’ COVID-19-related solutions are designed for rapid deployment and scalability. For more information on how Philips is addressing COVID-19 globally, please visit the Philips centralized COVID-19 hub.
About Royal Philips
Royal Philips is a leading health technology company focused on improving people's health and enabling better outcomes across the health continuum from healthy living and prevention, to diagnosis, treatment and home care. Philips leverages advanced technology and deep clinical and consumer insights to deliver integrated solutions. Headquartered in the Netherlands, the company is a leader in diagnostic imaging, image-guided therapy, patient monitoring and health informatics, as well as in consumer health and home care. Philips generated 2019 sales of EUR 19.5 billion and employs approximately 81,000 employees with sales and services in more than 100 countries. News about Philips can be found at www.philips.com/newscenter.
LabCorp Will Perform Antibody Test at No Charge to Accelerate COVID-19 Blood Plasma Donation
11 August 2020 - No Charge Program Uses High-Affinity Test to Detect SARS-CoV-2 Antibodies
BURLINGTON, N.C., Aug. 11, 2020 -- LabCorp, a leading global life sciences company that is deeply integrated in guiding patient care, today announced details of a no charge antibody testing program in response to federal health authorities’ request to increase donations of COVID-19 blood plasma. Plasma with COVID-19 antibodies may be helpful when treating patients with an active COVID-19 infection and is being evaluated as a possible treatment.
Beginning today for the next three months, LabCorp will perform the high-affinity antibody test at no charge to patients, insurance companies, or the government. When patients are receiving other medically necessary blood tests as part of a medically necessary exam or treatment, this program allows providers to add the SARS-CoV-2 Antibodies Test to the same order at no charge. The no-charge high-affinity antibody testing program will use only the Roche Elecsys® Anti-SARS-CoV-2 and does not apply to other COVID-19 antibody tests, such as the IgG test.
Patients will be able to access their results through the LabCorp Patient™ portal and through their doctor. Result data from the antibody testing program will also be reported to the CDC and state public health agencies to further support COVID-19 surveillance and response efforts.
Individuals who have tested positive for COVID-19 and have not experienced symptoms for at least two weeks, or who have been confirmed to have antibodies to the virus are likely candidates for plasma donation. Many people who have had COVID-19 do not experience symptoms and may be unaware they have antibodies that can help other patients. The antibody test performed by LabCorp can help determine if an individual has been exposed to the virus by detecting antibodies in the blood. Antibodies comprise part of the immune response to the virus.
Patients who test positive for COVID-19 antibodies are encouraged to donate their blood plasma. Donating plasma does not affect the donor’s immunity, as their body will continue to produce antibodies. More information can be found about plasma donation at TheFightIsInUs.org.
Adam Schechter, chairman and CEO of LabCorp, said: “Many people have antibodies and are unaware that they could potentially use them to help save lives. LabCorp is offering antibody tests at no charge through a patient’s doctor to make it easier for more people to know if they should consider giving plasma. If you have antibodies and donate your plasma, you are helping the fight against the pandemic.”
For more information on antibody tests and LabCorp’s diagnostic COVID-19 testing options, as well as information on how to get involved, go to our website. Patients interested in donating plasma should visit TheFightIsInUs.org. The website can help check eligibility criteria and connect patients directly to plasma and blood donation centers nearby.
For Healthcare Providers
Under this program, providers can order the high-affinity antibody test that is based on an in-solution double-antigen sandwich format and can detect antibodies to SARS-CoV-2, the virus that causes COVID-19. The test will be performed at no charge for the next three months. Antibodies could signal whether a person has already been infected and potentially developed immunity to the virus. LabCorp’s antibody test uses the Roche Elecsys® Anti-SARS-CoV-2 platform, has 99.8 percent specificity and shows no cross-reactivity to the common cold, HIV and other coronaviruses. This means it can lower the chance of false positives due to the detection of similar antibodies that may be present in an individual. The Anti-SARS-CoV-2 test detected antibodies with 100% sensitivity in samples taken 14 days after a PCR-confirmed infection. Please note, the no-charge antibody testing program includes the Roche Elecsys® Anti-SARS-CoV-2 and does not apply to specific antibody tests, such as the IgG test.
Emergency Use Authorization (EUA) Status
The Elecsys Anti-SARS-CoV-2 test has not been FDA cleared or approved. It has been authorized by FDA under an EUA for use by authorized laboratories. This test has been authorized only for detecting the presence of antibodies against SARS-CoV-2, not for any other viruses or pathogens. It is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.
About LabCorp
LabCorp (NYSE: LH), an S&P 500 company, is a leading global life sciences company that is deeply integrated in guiding patient care, providing comprehensive clinical laboratory and end-to-end drug development services. With a mission to improve health and improve lives, LabCorp delivers world-class diagnostics solutions, brings innovative medicines to patients faster, and uses technology to improve the delivery of care. LabCorp reported revenue of more than $11.5 billion in 2019. To learn more about LabCorp, visit www.LabCorp.com, and to learn more about LabCorp’s drug development business, Covance, visit www.Covance.com.
Hologic Launches Validated Pooling Protocol for COVID-19 Testing
11 August 2020 - In Time of Extraordinary Need, New Protocol Expected to Help Laboratories Deliver Greater Quantities of Highly Accurate Molecular Test Results and Reduce Turnaround Times
MARLBOROUGH, Mass., 11 August 2020 -- Hologic, Inc. announced today that it has validated use of its Aptima® and Panther Fusion® molecular diagnostic COVID-19 assays with pooled patient samples and completed an emergency use notification to the U.S. Food and Drug Administration (FDA) to make this workflow available to laboratory customers in the United States. By allowing samples from multiple individuals to be tested simultaneously, pooling is expected to help laboratories deliver increasing numbers of highly accurate molecular test results more quickly.
Hologic believes it is the first test manufacturer in the country to validate and launch a pooling workflow that ensures highly accurate detection of the SARS-CoV-2 virus. As described in the protocol, pooling is used most effectively in areas or populations of lower disease prevalence.
“By providing a pooling protocol, we are helping our lab customers meet the extraordinary demand for highly accurate molecular test results during this unprecedented time,” said Kevin Thornal, president, Diagnostic Solutions Division at Hologic. “Pooling will enable more samples to be tested each day, but at the same time, help test results get back to patients and their caregivers faster. I am very proud of the ingenuity and innovations that our Hologic teams continue to bring to fighting this pandemic.”
Hologic’s pooling protocol enables clinical laboratories to combine up to five patient samples into a single tube for processing. A negative result means that all five individuals have tested negative for SARS-CoV-2. In cases of a positive result, all five samples are re-tested individually to determine which patient or patients are infected.
The pooling workflow for the Aptima and Panther Fusion SARS-CoV-2 assays has not yet been reviewed by FDA. This workflow is being made available in accordance with Section IV.C. of FDA’s policy for diagnostic tests for Coronavirus disease – 2019 during the public health emergency at https://www.fda.gov/media/135659/download [fda.gov].
Hologic’s Aptima and Panther Fusion SARS-CoV-2 assays detect the genetic material of the virus and run on fully automated testing platforms that return initial results in approximately three hours. The Aptima SARS-CoV-2 test runs on Hologic’s Panther® system, and the Panther Fusion SARS-CoV-2 test runs on the Panther Fusion® system. More than 1,100 of these automated systems are installed in U.S. clinical laboratories. Each Panther and Panther Fusion system can process more than 1,000 SARS-CoV-2 tests in 24 hours. Hologic is currently producing an average of more than one and a half million COVID-19 tests per week.
This project has been funded in whole or in part with Federal funds from the Department of Health and Human Services; Office of the Assistant Secretary for Preparedness and Response; Biomedical Advanced Research and Development Authority, as part of an $8.9 million award under Contract No. 75A50120P00100.
About COVID-19
For more information about the novel coronavirus, visit: https://www.cdc.gov/coronavirus/2019-ncov/summary.html.
About Hologic
Hologic, Inc. is an innovative medical technology company primarily focused on improving women’s health and well-being through early detection and treatment. For more information on Hologic, visit www.hologic.com.
State of Maryland allows point-of-care testing for COVID-19; Quidel expands training program
10 August 2020
SAN DIEGO, 10 August 2020 -- Quidel Corporation (“Quidel”), a provider of rapid diagnostic testing solutions, cellular-based virology assays and molecular diagnostic systems, announced that the State of Maryland has allowed point-of-care testing for COVID-19.
The Maryland Department of Health has allowed point-of-care testing for COVID-19, stating:
“Any healthcare provider or healthcare facility, subject to certain terms and conditions, may perform COVID-19 point-of-care (POC) test analysis pursuant to Executive Order 20-03-23-02.” The order is effective August 10, 2020.
Under the new directive, Maryland residents who believe they should be tested can now contact their healthcare provider, who can order a “COVID-19 test for any individual who believes it necessary, regardless of symptoms.”
Quidel Expands Training Program
Separately, as part of its Nursing Home Program, and in collaboration with the U.S. Department of Health and Human Services (HHS), Quidel has expanded its Point-of-Care training protocol to help ensure that nursing home health care workers are appropriately trained in the use of the Sofia® 2 instrument and the Sofia® SARS Antigen FIA. Quidel now offers nursing home customers a multifaceted approach to training including: online self-guided step by step videos, live virtual training events, certificate programs, Virena® data management system connection and other support functions via Quidel’s dedicated nursing home site: togetheragain.quidel.com.
Quidel currently sells several different Sofia assays in the United States, including the Sofia® SARS Antigen FIA under FDA EUA and other FDA-cleared and CLIA-waived assays, including tests for Influenza A and B, Respiratory Syncytial Virus (RSV), Group A Strep, and a 15-minute finger-stick whole blood test for Lyme Disease. In addition, Quidel also markets Sofia® tests for Lyme Disease, Legionella, and S. pneumoniae in Europe.
About Quidel Corporation
Quidel Corporation serves to enhance the health and well-being of people around the globe through the development of diagnostic solutions that can lead to improved patient outcomes and provide economic benefits to the healthcare system. Marketed under the Sofia®, QuickVue®, D3® Direct Detection, Thyretain®, Triage® and InflammaDry® leading brand names, as well as under the new Solana®, AmpliVue®and Lyra® molecular diagnostic brands, Quidel’s products aid in the detection and diagnosis of many critical diseases and conditions, including, among others, COVID-19, influenza, respiratory syncytial virus, Strep A, lyme, herpes, pregnancy, thyroid disease and fecal occult blood. Quidel's Triage® system of tests comprises a comprehensive test menu that provides rapid, cost-effective treatment decisions at the point-of-care (POC), offering a diverse immunoassay menu in a variety of tests to provide diagnostic answers for quantitative BNP, CK-MB, d-dimer, myoglobin, troponin I and qualitative TOX Drug Screen. Quidel’s research and development engine is also developing a continuum of diagnostic solutions from advanced immunoassay to molecular diagnostic tests to further improve the quality of healthcare in physicians’ offices and hospital and reference laboratories. For more information about Quidel’s comprehensive product portfolio and to explore exciting employment opportunities, visit quidel.com.
Thermo Fisher Scientific Develops COVID-19 Antibody Assay Targeting Transplant Community
10 August 2020 - Powerful new solution provides more accurate COVID-19 antibody detection
WEST HILLS, Calif., Aug. 10, 2020 -- Thermo Fisher Scientific continues to expand its response to the COVID-19 pandemic, developing a new serological assay targeted towards transplant candidates and recipients that can detect antibodies directed against COVID-19 (SARS-CoV-2). The assay will be provided under the company's One Lambda brand representing leading in vitro diagnostic products for the transplant community. This novel antibody detection panel is part of Thermo Fisher's continued efforts to support transplant patients during the pandemic.
In collaboration with histocompatibility, infectious disease and nephrology laboratories at Emory University, Stanford University, University of Cincinnati and the University Health Network in Toronto, Thermo Fisher's transplant diagnostic business has developed the LABScreen COVID Plus Assay. The assay leverages the Luminex xMAP technology to detect multiple distinct antibodies and fragments, making it more specific than current assays and able to reduce false positives caused by infections with common coronavirus. In combination with HLA antibody detection, the LABScreen COVID Plus reagents can help provide a more complete picture of a patient's antibody profile.
The LABScreen COVID Plus Assay will be available for research use only by August 2020. Additionally, the assay will be submitted for Emergency Use Authorization (EUA).
"We approached Thermo Fisher's transplant diagnostic business because we believe their expertise with antibody assay development and commitment to the transplant community is critical to develop an assay for transplant patients that could both detect neutralizing antibodies and rule out false positives," said Dr. Howard Gebel, co-director of the Emory University Hospital HLA laboratory.
"A semi-quantitative multiplex assay that can simultaneously detect the response to spike, receptor-binding domain, nucleocapsid and other SARS-CoV-2 proteins will be a huge step forward towards fully characterizing the immune response to COVID-19," said Dr. Robert Bray, co-director of the Emory University Hospital HLA laboratory.
"We're proud of the role we play in responding to the pandemic, and this is one of many examples that demonstrate our ability and our commitment to fight COVID-19," said Nicole Brockway, president of the transplant diagnostic business for Thermo Fisher. "Transplant patients have unique needs compared to other COVID-19 patients, and with the support of Luminex and our research partners, we're delivering an innovative solution that's tailored to meet those needs."
As the global leader in transplant diagnostics for more than thirty-five years, Thermo Fisher's transplant diagnostics business is committed to improving the lives of patients worldwide by driving innovation and delivering quality products. The company's comprehensive product portfolio includes a broad range of antibody detection assays, post-transplant monitoring solutions including the novel Molecular Microscope Diagnostic System, HLA typing products, laboratory instrumentation and software, and industry-leading customer support.
Laboratories interested in the LABScreen COVID Plus Assay may visit www.onelambda.com for more information.
About Thermo Fisher Scientific
Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $25 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, improving patient diagnostics and therapies or increasing productivity in their laboratories, we are here to support them. Our global team of more than 75,000 colleagues delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services and Patheon. For more information, please visit www.thermofisher.com.
FDA issues Emergency Use Authorization to Vela Diagnostics' Coronavirus PCR test
6 August 2020 - The ViroKey™ SARS-CoV-2 RT-PCR Test receives Emergency Use Authorization from the FDA
Fairfield, New Jersey, August 6, 2020 – Vela Diagnostics announced that the manual version of its coronavirus PCR test has obtained Emergency Use Authorization from the U.S. Food and Drug Administration (FDA). By targeting conserved regions of the viral genome, the probe-based reverse transcription PCR test detects SARS-CoV-2, the coronavirus that causes COVID-19. The EUA allows the emergency use of FDA medical products in qualified labs, thus facilitating widespread access to the diagnostic test.
"RT-PCR is currently the gold standard for diagnosing SARS-CoV-2 infections. Given the escalating number of COVID-19 cases in the U.S., Vela Diagnostics is helping Americans get tested so as to detect and slow the spread of the virus,” said Sam Dajani, interim CEO and Chairman of the Board. “Our coronavirus test will assist healthcare professionals in managing the COVID-19 pandemic."
The ViroKey™ SARS-CoV-2 RT-PCR Test detects SARS-CoV-2 in nasopharyngeal and oropharyngeal swabs.The manual version of the ViroKey™ SARS-CoV-2 RT-PCR Test enables flexible sample processing and quick adoption of the test by laboratories with existing ABI 7500 Fast Dx instruments. For high throughput testing, Vela Diagnostics has also developed an automated version of the assay optimized for a workflow consisting of the Sentosa™ SX101 instrument, in conjunction with the Applied Biosystems 7500 Fast Dx Real-Time (ABI 7500 Fast Dx) PCR instrument or the Sentosa™ SA201 instrument.
In addition to being authorized by the FDA for emergency use, the ViroKey™ SARS-CoV-2 RT-PCR Test has also received the CE mark and provisional approval from the Singapore Health Sciences Authority.
About Vela Diagnostics
Vela Diagnostics is a leading provider for integrated IVD system solutions, from sample to result. VELA’s test solutions utilize the automated Sentosa™ platform, providing the unique ability to leverage one system for NGS and PCR testing in infectious disease and oncology.
Thermo Fisher Scientific's COVID-19 Response Continues to Expand with New High-Throughput Automated Testing Solution
5 August 2020
WALTHAM, Mass., Aug. 5, 2020 -- Thermo Fisher Scientific Inc., the world leader in serving science, today introduced a new highly automated, real-time PCR solution designed to analyze up to 6,000 samples in a single day to meet increasing global demand for COVID-19 testing. The high-throughput system enables laboratories to double or even triple their testing capacity to support global efforts to return communities back to work and school.
The Thermo Fisher Scientific Amplitude Solution is a molecular diagnostic testing system that leverages the company's Applied Biosystems QuantStudio 7 Flex Real-time PCR instruments along with liquid handling products from Tecan Group, a global leader in laboratory automation and liquid handling. The modular solution delivers test results in a four-step process requiring minimal hands-on time, laboratory space and staffing resources.
"Increased testing capability is an essential part of any community's plan to reopen schools and businesses," said Marc N. Casper, chairman, president and chief executive officer of Thermo Fisher Scientific. "Current approaches to scale up testing require substantial resources and personnel. This more automated, high-throughput solution will enable laboratories around the world to increase testing volumes and help the public get their test results faster."
The Amplitude Solution utilizes Thermo Fisher's Applied Biosystems TaqPath COVID-19 Combo Kit, a fast, highly sensitive multiplex diagnostic test that contains the assays and controls needed for the qualitative detection of nucleic acid from SARS-CoV-2, the virus that causes COVID-19. The company will submit this new end-to-end solution to the U.S. Food and Drug Administration for Emergency Use Authorization (EUA) and plans to secure additional authorizations globally.
The system also includes instruments from Tecan's Fluent Laboratory Workstation family, the highest-performance platform within its extensive portfolio of liquid-handling solutions for laboratory automation. The Fluent instruments will be supplied through Tecan's Partnering Business.
As part of this offering, Amplitude Solution customers will enter into a supply agreement with Thermo Fisher to secure an up-front, confirmed and reliable supply of reagents and consumables. Backed by dedicated, 24/7 customer support from Thermo Fisher, the end-to-end solution, including the reagents, consumables and test kits, is available from a single source.
The launch of the Amplitude Solution adds to the company's significant COVID-19 response. Since developing one of the first diagnostic tests to be granted EUA in the U.S., Thermo Fisher has expanded diagnostic testing to more than 50 countries globally and now has the capacity to produce more than 10 million COVID-19 test reactions per week to meet demand. The company has marshalled its leading scale and depth of capabilities in the fight against COVID-19, from collaborating with laboratory customers and governments to expand testing capacity, to quickly scaling production to meet demand for sample collection products, to supporting more than 200 vaccine and therapy development and manufacturing projects around the world.
For more information on the Amplitude Solution, please visit www.thermofisher.com/amplitude.
About Thermo Fisher Scientific
Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $25 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, improving patient diagnostics and therapies or increasing productivity in their laboratories, we are here to support them. Our global team of more than 75,000 colleagues delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services and Patheon. For more information, please visit www.thermofisher.com.
Roche announces FDA authorisation for the first Epstein-Barr virus quantitative test on the cobas 6800/8800 Systems to improve care for transplant patients
5 August 2020 - FDA granted de novo class II for cobas EBV test following the agency’s Breakthrough Device designation. Accurate monitoring of Epstein-Barr virus DNA levels is critical, as they are associated with a range of life threatening-diseases including cancer in transplant patients. Test meets World Health Organization standards for consistent result reporting among laboratories across the U.S., allowing for results to be easily comparable across hospitals and labs.
Basel, 5 August 2020 -- Roche today announced that the U.S. Food and Drug Administration (FDA) has authorised the cobas® EBV test. This is the first quantitative in vitro diagnostic test for Epstein-Barr virus (EBV) DNA in the United States. This authorisation gives healthcare professionals a key tool in monitoring transplant patients at risk for complications from infections or reactivations of EBV, by providing the ability to run a large number of patient tests for this virus in a short period of time.
“Monitoring of Epstein-Barr virus DNA can help prevent progression of life-threatening diseases, such as cancer in transplant patients,” said Thomas Schinecker, CEO Roche Diagnostics. “The EBV test helps set a new standard of care for patients, as healthcare professionals now can act early in the management of this virus with best-in-class monitoring tools and can make more informed decisions when treating patients.”
The cobas EBV test is a polymerase chain reaction (PCR) viral load test that runs on the fully automated and widely available cobas® 6800 and cobas® 8800 Systems. The test has been calibrated to the World Health Organization (WHO) International Standard. This means that test results are reported in international measures, making it possible for laboratories anywhere in the U.S. to obtain comparable results when measuring levels of EBV DNA.
The test was previously granted FDA Breakthrough Device designation, which enables an expedited review process for medical devices that provide improved treatment or diagnosis of life-threatening diseases or conditions.
About the cobas EBV test
The cobas EBV test is a real-time PCR (polymerase chain reaction) viral load test with dual target technology, which provides quantitative accuracy and guards against the risk of sequence variations that may be present in the Epstein-Barr virus. The cobas EBV test has robust coverage with a limit of detection of 18.8 IU/mL and an expanded linear range from 35 IU/mL to 1E+08 IU/mL in EDTA plasma.
The test offers an alternative to lab-developed tests (LDTs) or Assay Specific Reagents (ASR) combinations, potentially minimising variability and complexity in testing, reducing workload and alleviating risk for laboratories. The test supports the goal of result standardisation across institutions by providing reproducible, high-quality results for clinical decision-making.
The fully automated cobas EBV test can be run on the cobas 6800/8800 Systems providing absolute automation with proven performance and flexibility. Simultaneous testing with CMV or other virology tests leads to time savings and increased efficiency.
About Epstein-Barr virus (EBV)
Epstein-Barr virus is a member of the herpes virus family and has been associated with a range of cancers in transplant patients, such as post-transplant lymphoproliferative disorder (PTLD). Once infection with EBV occurs, the virus establishes as a latent form and can remain in the body. Most people harbor EBV with no long-term clinical ramifications.
EBV spreads most commonly through bodily fluids, primarily saliva. This does not always cause symptoms, but people with weakened immune systems, including transplant patients, are more likely to develop symptoms if EBV reactivates.
About the cobas 6800/8800 Systems
When every moment matters, the fully automated cobas 6800/8800 Systems offer the fastest time to results with the highest throughput and the longest walk-away time available among automated molecular platforms. The systems provide up to 96 results in about 3 hours and 384 results for the cobas 6800 System and 1,056 results for the cobas 8800 System in an 8-hour shift.*
Both systems make it possible for labs to perform up to three tests in the same run with no pre-sorting required. The systems also enable up to eight hours (cobas 6800 System) and four hours (cobas 8800 System) of walk-away time with minimal user interaction.
These real-time PCR systems serve the areas of infectious disease, donor screening, sexual health, transplant, respiratory and antimicrobial stewardship.
Through an ever-increasing worldwide install base of cobas 6800/8800 Systems, labs are quickly and easily processing millions of tests per month to meet the changing demands of their communities, their customers and the patients relying on the results of each assay. Globally, labs know and trust that a Roche assay guarantees high precision, accuracy and traceability to World Health Organization standards.
Today, rapid advancements in healthcare technology, a shortage of skilled workers, industry-wide consolidation, and the proven need to be ready for the next outbreak have health systems looking to lay a reliable foundation for the future. With proven performance, absolute automation and unmatched flexibility delivering unparalleled throughput 24/7—cobas 6800/8800 Systems are designed to ensure a lab’s long-term sustainability and success … now, more than ever.
About Roche
Roche is a global pioneer in pharmaceuticals and diagnostics focused on advancing science to improve people’s lives. The combined strengths of pharmaceuticals and diagnostics under one roof have made Roche the leader in personalised healthcare – a strategy that aims to fit the right treatment to each patient in the best way possible.
Roche is the world’s largest biotech company, with truly differentiated medicines in oncology, immunology, infectious diseases, ophthalmology and diseases of the central nervous system. Roche is also the world leader in in vitro diagnostics and tissue-based cancer diagnostics, and a frontrunner in diabetes management.
Founded in 1896, Roche continues to search for better ways to prevent, diagnose and treat diseases and make a sustainable contribution to society. The company also aims to improve patient access to medical innovations by working with all relevant stakeholders. More than thirty medicines developed by Roche are included in the World Health Organization Model Lists of Essential Medicines, among them life-saving antibiotics, antimalarials and cancer medicines. Moreover, for the eleventh consecutive year, Roche has been recognised as one of the most sustainable companies in the Pharmaceuticals Industry by the Dow Jones Sustainability Indices (DJSI).
The Roche Group, headquartered in Basel, Switzerland, is active in over 100 countries and in 2019 employed about 98,000 people worldwide. In 2019, Roche invested CHF 11.7 billion in R&D and posted sales of CHF 61.5 billion. Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan. For more information, please visit www.roche.com.
Reference: https://www.roche.com/media/releases/med-cor-2020-08-05b.htm
Beckman Coulter collaboration to automate high throughput SARS-CoV-2 PCR testing
4 August 2020
4 August 2020 -- genedrive plc, announces that it has entered into a collaboration with Beckman Coulter Life Sciences to fully automate the entire laboratory PCR testing process for COVID-19. The two companies are working to combine and validate the Genedrive® 96 SARS-CoV-2 Kit on the Biomek i7 automated workstation with saliva samples extracted using Beckman Coulter’s RNAdvance viral extraction chemistry.
The freeze-dried bead chemistry of the Genedrive® 96 SARS-CoV-2 test is ideally suited for use on high throughput robotic platforms like the Biomek i7. Stable at room temperature for 4 hours after unsealing, many Genedrive® 96 SARS-CoV-2 Kit 96-well plates can be left arrayed and open in the laboratory environment during the set-up process. The ready-to-go nature of the test bead also removes the fluid dispensing steps required in other assays, increasing the overall throughput of the Biomex i7 compared to using a liquid based test set-up. Accordingly, once validated, Beckman Coulter estimates that this new turnkey solution could process circa 1,000 PCR samples per Biomek installed during a standard 8-hour working day, using just a 0.5 full-time-equivalent in technician time for processing.
Genedrive has already completed initial evaluation of Beckman Coulter’s RNA extraction chemistry to confirm compatibility with the Genedrive® 96 SARS-CoV-2 test. Further work is ongoing to validate clinical saliva samples which are a very relevant sample type for applications such as high volume occupational screening. Beckman’s RNAdvance Viral XP has already been listed as an extraction method for swab samples for use with the Centers for Disease Control’s EUA-authorized COVID-19 test in FDA’s FAQ on testing for SARS-CoV-2.
Greg Milosevich, President at Beckman Coulter Life Sciences, said “The integration of Beckman Coulter Life Sciences’ and genedrive’s technologies produces a formidable workhorse solution for specialized laboratories looking to establish new or next level laboratory automation with labor cost reduction. Our ability to fully integrate the RNA extraction process on the Biomek while simultaneously preparing the plates for analysis is a critical step forward in advancing COVID testing workflows. Speed up the testing workflow, reduce labor time and costs. This is the goal of our collaboration with Genedrive and we are excited to be bringing this solution forward to the market.”
David Budd, Chief Executive Officer of genedrive plc, said ”We are very pleased to have the opportunity to work with Beckman Coulter in delivering an innovative high throughput COVID-19 PCR solution. It’s been our focus to work with a top tier, high throughput lab automation partner like Beckman to drive uptake of our test and further differentiate our unique capabilities in the market. The combination of our ready to use chemistry with robotics and on-board RNA extraction would give laboratories a unique and rapid workflow that can achieve impressive throughput and result turnaround times. We are both working to have the ongoing validation completed in approximately 6 weeks, with initial introduction in the USA at an already identified clinical laboratory.”
The integrated Genedrive/Beckman Coulter solution will be introduced in selected, relevant geographies subject to validation and any required regulatory approvals.
Reference: https://www.genedrive.com/news/index.php
Siemens Healthineers obtains first FDA EUA authorization for Semi-Quantitative SARS-CoV-2 IgG Antibody Test
4 August 2020 - The SARS-CoV-2 IgG Antibody Test offers the first EUA-authorized semi-quantitative assay to help clinicians assess the level of an individual‘s immune response. With this numerical result expressed as index value, clinicians will be better equipped to evaluate the duration and level of an individual’s immune response. The SARS-CoV-2 IgG antibody test offers 100% sensitivity and 99.9% specificity, which is critical for detecting adaptive immune response accurately. The test also attained the CE-mark and is now broadly available globally.
Erlangen, Germany, 4 August 2020 -- Siemens Healthineers announced today that it received FDA Emergency Use Authorization (EUA) for the SARS-CoV-2 IgG (COV2G) antibody test. This is the first antibody test authorized with a semi-quantitative detection claim and the fifth antibody test from the company to receive EUA that offers sensitivity and specificity of greater than 99 percent. The COV2G antibody test offers both a positive or negative result for IgG antibodies and reports a numerical result expressed as index value. The test also attained the CE-mark and is now broadly available globally.
A positive or negative result for IgG antibodies provides insight into an individual’s prior exposure to SARS-CoV-2 virus. Importantly, a semi-quantitative result enables clinicians to gauge the level of IgG antibodies in a patient’s blood sample. With this numerical value, clinicians can establish a baseline and be better equipped to assess changes of an individual’s immune response to the SARS-CoV-2 virus. Comparison of numerical results will help determine how SARS-CoV-2 antibodies develop in an individual and persist over time. A semi-quantitative result is necessary to accurately establish the level of IgG that may be protective, and Siemens Healthineer’s COV2G assay is well positioned to support this global pursuit.
When an individual is infected with the SARS-CoV-2 virus, unique antibodies will develop at different stages of the infection. Whereas the Siemens Healthineers SARS-CoV-2 Total antibody test detects antibodies to IgM and IgG that are present both early and later during the immune response, the COV2G antibody test specifically detects IgG antibodies that persist, and are the basis for an individual’s longer term immune response. The combination of these tests provides a complete picture of a patient’s serological status for the most accurate results throughout his or her contiuum of care.
“Our high-quality antibody test helps clinicians assess the level of a person‘s immune response, which is an important tool to have at this stage of the pandemic,” said Deepak Nath, PhD, President of Laboratory Diagnostics for Siemens Healthineers. “Siemens Healthineers offers a robust portfolio of reliable tests to help support patient care and fight COVID-19.”
Highly accurate antibody test results support key decision-making for individuals and communities. Antibody tests have multiple uses:
- As an adjunct to PCR tests to aid in clinical assessment
- To help determine prior exposure to the virus, by detecting antibodies that may neutralize the virus
- To potentially identify donors of convalescent plasma
- For epidemiological purposes including establishing prevalence of disease in populations
- To potentially help verify effectiveness of vaccines as they become available
Antibody tests from Siemens Healthineers are well-positioned to aid vaccine development efforts. The COV2G antibody test, and all SARS-CoV-2 antibody tests from Siemens Healthineers, detect antibodies to S1RBD. Multiple potential vaccines in development for SARS-CoV-2 include the spike protein, specifically S1RBD—a key protein on the surface of the SARS-CoV-2 virus—within their focus.
Among the considerations for accelerated vaccine approval, according to most recent FDA Guidance issued on June 30, 2020, validated serology testing in clinical trials may play a pivotal role in assessing surrogate endpoints such as immune response to a vaccine. This requires additional understanding of SARS-CoV-2 immunology and, specifically, vaccine immune responses that might be reasonably likely to predict protection against COVID-19 and post-marketing studies to affirm predicted efficacy. The COV2G test meets or exceeds FDA requirements.
The COV2G antibody test is available on an expansive installed base of analyzers installed in the U.S. and in countries that accept the CE mark worldwide. This includes the Atellica® Solution and ADVIA Centaur® XP and XPT families of analyzers. Comparable tests for Siemens Healthineers Dimension Vista® and Dimension® EXL™ systems also are being pursued.
Siemens Healthineers has distinguished itself during the pandemic as a provider of quality antibody tests. For example, in a recent head-to-head evaluation of four commercial antibody tests conducted by Public Health England, in partnership with the University of Oxford, Siemens Healthineers’ COV2T assay was the only test that met both sensitivity and specificity targets.
About Siemens Healthineers AG
Siemens Healthineers AG (listed in Frankfurt, Germany: SHL) is shaping the future of Healthcare. As a leading medical technology company headquartered in Erlangen, Germany, Siemens Healthineers enables healthcare providers worldwide through its regional companies to increase value by empowering them on their journey towards expanding precision medicine, transforming care delivery, improving the patient experience, and digitalizing healthcare. Siemens Healthineers is continuously developing its product and service portfolio, with AI-supported applications and digital offerings that play an increasingly important role in the next generation of medical technology. These new applications will enhance the company’s foundation in in-vitro diagnostic, image-guided therapy, and in-vivo diagnostics. Siemens Healthineers also provides a range of services and solutions to enhance healthcare providers ability to provide high-quality, efficient care to patients. In fiscal 2019, which ended on September 30, 2019, Siemens Healthineers, which has approximately 52,000 employees worldwide, generated revenue of €14.5 billion and adjusted profit of €2.5 billion. Further information is available at www.siemens-healthineers.com.
Reference: https://www.siemens-healthineers.com/press-room/press-releases/covid-19-antibody-igg.html
OIE Approves Registration of VetMAX African Swine Fever Virus Detection Kit in Diagnostics Manual
3 August 2020 - First African swine fever PCR test to be registered in OIE manual of testing
LISSIEU, France, August 3, 2020 — The World Organization for Animal Health (OIE) recently approved the registration of the Applied Biosystems VetMAX African Swine Fever Virus Detection Kit from Thermo Fisher Scientific in the OIE manual of diagnostic testing. It is the first African swine fever (ASF) kit to be registered by the OIE.
“The addition of our ASF detection kit to the OIE manual marks a key milestone in our effort to help our customers address the epidemic,” said Peter Vuong, General Manager AgriBusiness. “Veterinary authorities and labs now have access to a validated diagnostic tool that can quickly track infections and help countries take appropriate action against further spread of the ASF virus.”
ASF virus is rapidly spreading around the world, especially in Asia and Europe, wreaking havoc in domestic pig populations. Non-infected countries have stepped up their biosecurity efforts to ensure the virus does not cross their border. Diagnostics can play a critical role in both outbreaks and monitoring non-infected pig populations in non-infected countries.
Established ASF diagnostics
The VetMAX African Swine Fever Virus Detection Kit is listed in the OIE Register of diagnostic kits and has been validated as fit for purpose for the detection of the African swine fever virus from blood, serum and tissues of pigs and wild pigs (including wild boars). This is the result of a rigorous evaluation by a panel of third-party experts. The kit is sensitive and specific, detecting all ASF virus genotypes known to currently circulate. It allows for reliable and rapid screening during outbreaks as well as ongoing monitoring. The VetMAX African Swine Fever Virus PCR test has been validated as part of an entire workflow for ASF detection, from sample to answer including Applied Biosystems MagMAX CORE nucleic acid extraction kits and QuantStudio PCR instruments, and has proven useful in more than 1.5 million clinical ASF samples tested around the world. The kit is also the preferred detection technology in the current outbreak of ASF in China.
PCR-based testing identifies the virus by detecting its DNA, rather than antibodies that are generated against the virus. Thus, it provides detection of the virus earlier in the infection cycle compared to other diagnostic methods. The kit can detect virus DNA using serum, whole blood or tissue and allows users to test in pools of up to 10 samples while delivering fast results. Validations have been performed that show the test also works well on meat samples and nasal swabs.
For more information about the VetMAX African Swine Fever Virus Detection Kit, please visit www.thermofisher.com/animalhealth
About ASF
African Swine Fever Virus (ASFV) is a notifiable, highly contagious disease that can cause significant economic losses. The DNA virus can infect all Suidae (domestic and wild animals) but is not a human health threat. The virus is found in all body fluids and tissues of infected pigs. They usually become infected by direct contact with sick animals or by ingestion of infected products. ASFV is highly resistant in the environment. ASF disease is characterized by high fever, loss of appetite, hemorrhages in the skin and internal organs, and death can occur within two to 10 days. ASF cannot be differentiated from classical swine fever by either clinical or post-mortem examination.
About Thermo Fisher Scientific
Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $25 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, improving patient diagnostics and therapies or increasing productivity in their laboratories, we are here to support them. Our global team of more than 75,000 colleagues delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services and Patheon. For more information, please visit www.thermofisher.com.
Reference: https://thermofisher.mediaroom.com/press-releases?item=123477
Quest Diagnostics Completes Acquisition of Mid America Clinical Laboratories, Now Provides Professional Lab Management for Nearly 30 Hospitals of Community Health Network and Ascension St. Vincent in
3 August 2020
SECAUCUS, N.J. and INDIANAPOLIS, Aug. 3, 2020 -- Quest Diagnostics, the world's leading provider of diagnostic information services, today announced that it has completed its previously announced acquisition of its joint venture partners' interests in Mid America Clinical Laboratories ("MACL").
Quest now wholly owns MACL's laboratory in Indianapolis and approximately 50 patient service centers across Indiana. Quest also now provides professional lab management services for about 30 hospitals owned and operated by Community Health Network and Ascension St. Vincent in Indiana. Community Health Network and Ascension St. Vincent are formerly joint venture partners in MACL. In addition, AmeriPath, the specialty pathology business of Quest Diagnostics, will continue to provide services to these hospitals and broadly across Indiana.
With the completed transaction, patients and providers in Indiana now have direct access to a broader menu of innovative clinical laboratory and pathology services to patients and providers in Indiana.
About Quest Diagnostics
Quest Diagnostics empowers people to take action to improve health outcomes. Derived from the world's largest database of clinical lab results, our diagnostic insights reveal new avenues to identify and treat disease, inspire healthy behaviors and improve health care management. Quest Diagnostics annually serves one in three adult Americans and half the physicians and hospitals in the United States, and our 47,000 employees understand that, in the right hands and with the right context, our diagnostic insights can inspire actions that transform lives.
Members of the COVID R&D Alliance and Quantum Leap Healthcare Collaborative Enroll First Patients in I-SPY COVID Trial
3 August 2020 - I-SPY COVID will evaluate the impact of cenicriviroc, Otezla®, and Firazyr® on inflammatory response in COVID-19 patients. Additional candidates from COVID R&D member companies entering platform trials in coming weeks.
SAN FRANCISCO, CA Aug 3, 2020 – Today, members of the COVID R&D Alliance AbbVie, Inc., Amgen Inc., and Takeda Pharmaceutical Co. Ltd. announced the first patients enrolled in the I-SPY COVID Trial (Investigation of Serial Studies to Predict Your COVID Therapeutic Response with Biomarker Integration and Adaptive Learning) clinical trial. The I-SPY COVID Trial will evaluate the efficacy of cenicriviroc, a chemokine (CCR2 and CCR5) dual-receptor antagonist, Otezla® (apremilast), a PDE4 inhibitor, and Firazyr® (icatibant injection), a bradykinin B2 receptor antagonist in severely ill, hospitalized COVID-19 patients who require high-flow oxygen.
The I-SPY COVID Trial utilizes Quantum Leap Healthcare Collaborative's adaptive platform trial design, which is intended to increase trial efficiency by minimizing the number of participants and time required to evaluate potential treatments.
"Collaborative research efforts leveraging adaptive platform trials enable faster and more complete learning about what works for patients, and they are especially critical for addressing urgent public health threats like COVID-19,” said Dr. Mark McClellan, director of the Robert J. Margolis, Center for Health Policy at Duke University and former commissioner of the U.S. FDA and administrator of the Centers for Medicare and Medicaid Services. "Platform trials bring down the cost and increase the ease of executing well-powered, high quality studies, especially when multiple, potential therapies need to be evaluated quickly. The I-SPY COVID Trial is expanding a timely and effective platform trial strategy to evaluate promising treatments while maintaining an appropriate level of safety and statistical rigor necessary for regulatory evaluation.”
The study is a collaboration between members of the COVID R&D Alliance, Quantum Leap, and the U.S. Food and Drug Administration (FDA). AbbVie, Amgen, and Takeda are members of the COVID R&D Alliance (COVID R&D), a group of more than 20 of the world’s leading biopharmaceutical and life science companies working to speed the development of potential therapies, novel antibodies, and anti-viral therapies for COVID-19 and its related symptoms.
“Sick patients in hospitals cannot wait; options are urgently needed. I’m proud to partner with AbbVie and Amgen and the dozens of other companies who have joined the COVID R&D Alliance, to initiate critical platform trials like I-SPY COVID,” remarked Andy Plump, President of R&D at Takeda Pharmaceuticals and co-founder of the COVID R&D Alliance. “The world learned of COVID-19 only six months ago, and the speed at which the scientific community has joined forces to address the critically high unmet need is inspiring. Together, experts across our companies and industry can accelerate trials with promising, well-understood therapies that upon investigation, may show efficacy in this devastating disease.”
The therapies under investigation were selected based on their potential to impact the immune system response of COVID-19 patients who need respiratory support. Approximately 10-15 percent of patients afflicted by COVID-19 develop acute respiratory distress syndrome (ARDS), and up to 60 percent of those patients admitted to an ICU require ventilation for an average of two weeks. It is estimated that half of those patients will not survive. Based on the respective mechanisms of action, Otezla® may suppress inflammation resulting from an immune response, Firazyr® may ameliorate bradykinin-driven pulmonary edema, and cenicriviroc acts by blocking monocytes trafficking to tissues, features that may help to reduce or mitigate the severity of ARDS response in severely ill COVID-19 patients.
Dr. Laura Esserman, co-founder of Quantum Leap Healthcare Collaborative and lead investigator of the I-SPY Trials stated, “The level of cooperation among pharma companies in response to the pandemic is unprecedented. The COVID R&D Alliance stepped forward to streamline the process of identifying safe, scalable and potentially effective agents and joined with the I-SPY consortium to propel our efforts forward at record speed. We are excited to open the trial and work to reduce the devastating effects of the virus in severely ill COVID patients, and to do it now, when we need it most.”
I-SPY COVID is one of several platform studies being pursued by members of COVID R&D to test promising therapeutic candidates faster than any single company could do operating alone. Members are investigating marketed and late-stage therapies indicated for other disease states, which, based on their mechanisms of action may have a potential treatment effect in COVID-19 patients. The group is employing adaptive platform trial methodologies that enable the ability to test multiple therapies simultaneously and modify protocols in real-time based on outcomes observed.
In addition to designing and sponsoring several platform trials, the COVID R&D Alliance is:
- Evaluating more than 1,900 preclinical candidates against active controls to uncover which hold the greatest promise for COVID-19.
- Reviewing promising early-stage candidates that may show potential efficacy against COVID-19, and connecting them with potential funders from venture capital or pharmaceutical developers to enable rapid advancement.
- Working with TransCelerate’s DataCelerate® platform to enable real-time data sharing and real-world evidence to inform ongoing and future studies in COVID-19, so research communities benefit from learnings and avoid duplication.
- Operating as an interlocutor with governments, regulators, and non-governmental organizations to share insights and engage in other platform trials.
About the I-SPY COVID Trial
The I-SPY COVID Trial (Investigation of Serial Studies to Predict Your COVID Therapeutic Response with Biomarker Integration and Adaptive Learning) is an adaptive platform trial designed to increase trial efficiency by minimizing the number of participants and time required to evaluate experimental and/or repurposed drugs. The focus of the trial is to improve outcomes for severely-ill COVID-19 patients—those who require at least 6L of high-flow oxygen either by mask or nasal cannula, known as level 5 on the World Health Organization (WHO) COVID scale, an 8 point ordinal scale of clinical severity status. The primary endpoint of I-SPY COVID is time to achieve level 4 (or less) for at least 48 hours on the WHO COVID scale. Key secondary endpoints include duration of time on ventilator and mortality.
About the COVID R&D Alliance
Organized in March 2020, the COVID R&D Alliance is operating unconstrained by past models of development and is accelerating study candidates without regard to company affiliation. Members are sharing clinical trial data and real-world evidence, as well as crowd-sourcing early stage candidates to identify mechanisms and treatments that may be effective against COVID-19. Initial efforts by the group focus on advancing well understood therapies and late-stage investigational medicines for severely ill patients who need options. Future activities will expand to testing re-purposed molecules, early stage candidates, and therapeutic drug combinations.
Additional information on the COVID R&D Alliance is available at www.CovidRDAlliance.com.
About Cenicriviroc (CVC)
CVC is an oral, once-daily, potent immunomodulator that blocks two chemokine receptors, CCR2 and CCR5, which are intricately involved in the inflammatory and fibrogenic pathways in nonalcoholic steatohepatitis (NASH) known to cause liver damage including cirrhosis, liver cancer, or liver failure. These pathways have also been shown to be closely involved with the respiratory sequelae of COVID-19 and of related viral infections. Because of CVC’s unique mechanisms of action, the drug has been viewed as having a potential role in the treatment of COVID-19 patients, in addition to its potential in the management liver fibrosis due to NASH, including as a part of combination-treatment strategies. CVC has been studied in both NASH patients and in HIV+ patients, and is in Phase 3 development for NASH. CVC has been granted Fast Track status in adults with liver fibrosis due to NASH, the population at highest risk of progression to cirrhosis.
About Otezla® (apremilast)
OTEZLA® (apremilast) is an oral small-molecule inhibitor of phosphodiesterase 4 (PDE4) specific for cyclic adenosine monophosphate (cAMP). PDE4 inhibition results in increased intracellular cAMP levels, which is thought to indirectly modulate the production of inflammatory mediators. The specific mechanism(s) by which Otezla exerts its therapeutic action in patients is not well defined.
Otezla is currently approved for use in more than 45 countries as an oral treatment for inflammatory diseases including psoriasis, psoriatic arthritis and Behcet’s disease. By inhibiting PDE4, Otezla is thought to modulate the production of inflammatory cytokines and other mediators, which may prove helpful in inhibiting the inflammatory response associated with the signs, symptoms and pulmonary involvements observed in some COVID-19 patients. Amgen plans to collaborate with platform trials to investigate Otezla’s ability to prevent clinical deterioration in patients with COVID-19.
About Firazyr® (icatibant injection)
FIRAZYR® (icatibant injection) is a bradykinin B2 receptor antagonist indicated for the treatment of acute attacks of hereditary angioedema (HAE) in adults 18 years of age and older. Indication may vary by country. It is administered by subcutaneous injection. It is thought that icatibant may ameliorate bradykinin-driven pulmonary edema by blocking the bradykinin-2 receptors.
About AbbVie
AbbVie's mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, women's health, and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, YouTube, and LinkedIn.
Quidel receives preliminary contract leading to definitive agreement for $71 million unter NIH’s RADx-ATP program to accelerate the expansion of its manufacturing capacity for Sofia® SARS-COV-2 antige
31 July 2020
SAN DIEGO, 31 July 2020 -- Quidel Corporation (“Quidel”), a provider of rapid diagnostic testing solutions, cellular-based virology assays and molecular diagnostic systems, announced today that Quidel has entered into a preliminary letter contract with the National Institutes of Health (NIH) through its newly launched Rapid Acceleration of Diagnostics - Advanced Technology Platforms (RADx-ATP) initiative to support the expansion of its manufacturing capacity in San Diego for its diagnostic assays that test for SARS-CoV-2 Antigen using its Sofia® Fluorescence Immunoassay (FIA) platform. Quidel and the NIH endeavor to enter into a definitive agreement to support the initiative by mid-September.
The NIH RADx-ATP investment, subject to entering into the definitive agreement with key deliverables and identified milestones, would directly support the upgrade and addition of new manufacturing lines, thereby expanding capacity for test cassettes from approximately 84 million cassettes per year to in excess of 220 million cassettes per year. This investment would also support the outfitting of a larger distribution center that would be needed for the greatly expanded yield of rapid diagnostic assays, including not only those for COVID-19 diagnosis, but also for influenza, RSV, and other infectious diseases. The contract period would be for one year beginning on July 30, 2020.
Quidel is known for its production of fast, accurate, affordable rapid diagnostic products—and, importantly for their ease-of-use and CLIA waiver—making them especially well-suited for Point-of-Care applications. Sofia® is the name of Quidel’s best-selling instrumented system. Sofia and Sofia 2, its second-generation Analyzer, both employ a fluorescence-based, lateral flow immunochemistry design and state-of-the-art optics to provide an accurate, objective and automated result in 15 minutes or less. When needed, its Read Now or Batch Test Mode enables getting results for up to 50 patient specimens within one hour. The Sofia Analyzers also come connected to Virena®, Quidel’s data management system, which wirelessly provides aggregated, de-identified testing data in near real time to users of the system for laboratory management and to public health agencies, state and federal, for bio-surveillance.
Quidel currently sells several different Sofia assays in the United States, including the Sofia® SARS Antigen FIA under FDA EUA and other FDA-cleared and CLIA-waived assays, including tests for Influenza A and B, Respiratory Syncytial Virus (RSV), Group A Strep, and a 15-minute finger-stick whole blood test for Lyme Disease. In addition, Quidel also markets Sofia® tests for Lyme Disease, Legionella, and S. pneumoniae in Europe.
About Quidel Corporation
Quidel Corporation serves to enhance the health and well-being of people around the globe through the development of diagnostic solutions that can lead to improved patient outcomes and provide economic benefits to the healthcare system. Marketed under the Sofia®, QuickVue®, D3® Direct Detection, Thyretain®, Triage® and InflammaDry® leading brand names, as well as under the new Solana®, AmpliVue®and Lyra® molecular diagnostic brands, Quidel’s products aid in the detection and diagnosis of many critical diseases and conditions, including, among others, COVID-19, influenza, respiratory syncytial virus, Strep A, lyme, herpes, pregnancy, thyroid disease and fecal occult blood. Quidel's Triage® system of tests comprises a comprehensive test menu that provides rapid, cost-effective treatment decisions at the point-of-care (POC), offering a diverse immunoassay menu in a variety of tests to provide diagnostic answers for quantitative BNP, CK-MB, d-dimer, myoglobin, troponin I and qualitative TOX Drug Screen. Quidel’s research and development engine is also developing a continuum of diagnostic solutions from advanced immunoassay to molecular diagnostic tests to further improve the quality of healthcare in physicians’ offices and hospital and reference laboratories. For more information about Quidel’s comprehensive product portfolio and to explore exciting employment opportunities, visit quidel.com.
About the project:
This project is supported by the NIH Rapid Acceleration of Diagnostics - Advanced Technology Platforms (RADx-ATP) program and has been funded in whole or in part with Federal funds from the Office of the Director, National Institutes of Health, Department of Health and Human Services, under Contract No. 75N92020C00013.
LabCorp Working With Public Health Authorities on No-Charge Antibody Test Program to Accelerate COVID-19 Blood Plasma Donation
30 July 2020 - More details of the three-month program will be provided in the near future
BURLINGTON, N.C., Jul. 30, 2020 -- LabCorp, a leading global life sciences company that is deeply integrated in guiding patient care, today announced plans to create a program to offer total antibody testing at no charge through the patient’s doctor in support of increased blood plasma donations for use as a possible COVID-19 treatment.
LabCorp is proud to be part of The Fight Is In Us coalition to increase donations of blood plasma with COVID-19 antibodies. Blood plasma is being evaluated as a possible treatment for patients with an active COVID-19 infection. Public health authorities have asked for help with expanding the population of potential plasma donors, and LabCorp is seeking to meet that challenge by creating a program to offer total antibody testing at no charge through the patient’s doctor. Patients who are interested in donating blood plasma can speak with their doctor about the total antibody testing program during their next routine visit or treatment. LabCorp is currently working with public health authorities and the provider community on the details of the three-month program and will provide additional information in the near future.
About LabCorp
LabCorp (NYSE: LH), an S&P 500 company, is a leading global life sciences company that is deeply integrated in guiding patient care, providing comprehensive clinical laboratory and end-to-end drug development services. With a mission to improve health and improve lives, LabCorp delivers world-class diagnostics solutions, brings innovative medicines to patients faster, and uses technology to improve the delivery of care. LabCorp reported revenue of more than $11.5 billion in 2019. To learn more about LabCorp, visit www.LabCorp.com, and to learn more about LabCorp’s drug development business, Covance, visit www.Covance.com.
BD Announces $24 Million U.S. Government Investment to Support Scale Up of U.S. Manufacturing of COVID-19 Diagnostic Tests
30 July 2020 - Capital investments will enable U.S. manufacturing of 8 million BD Veritor™ brand SARS-CoV-2 tests per month
FRANKLIN LAKES, N.J., July 30, 2020 – BD (Becton, Dickinson and Company), a leading global medical technology company, today announced a $24 million investment from the U.S. Department of Defense in collaboration with the U.S. Department of Health and Human Services to support the scale up of U.S. manufacturing capabilities for BD Veritor™ Solution for Rapid Detection of SARS-CoV-2.
The additional capital equipment will bolster domestic production and increase total production capacity by 50 percent. These investments will enable global production of more than 12 million test kits per month by the end of February 2021.
“Making COVID-19 diagnostic tests widely available is critical to expanding rapid detection of COVID-19 infections, and mitigating the impact of the disease by identifying affected patients, quickly quarantining infectious individuals and tracing their contacts,” said Dave Hickey, president of Integrated Diagnostic Solutions for BD. “This investment will bolster our U.S. manufacturing capabilities helping us quickly scale our production of point-of-care COVID-19 tests to ensure we have a robust supply for our U.S. customers.”
BD announced that it had received FDA emergency use authorization for the BD Veritor™ Plus SARS-CoV-2 antigen assay on July 6, 2020 and plans to leverage its growing U.S. installed base of more than 25,000 BD Veritor™ Plus instruments to enable the deployment of the SARS-CoV-2 assay across the U.S. The easy-to-use design of the instrument, slightly larger than a cell phone, makes it ideal for use in a variety of clinical settings including hospitals, clinician offices, urgent care centers, and retail pharmacies, where it has already been used in influenza, group A strep and RSV testing for several years.
U.S. customers interested in BD diagnostic solutions for COVID-19 should visit BD.com/covid19 or contact IDS.Covidtests@bd.com.
About BD
BD is one of the largest global medical technology companies in the world and is advancing the world of health by improving medical discovery, diagnostics and the delivery of care. The company supports the heroes on the frontlines of health care by developing innovative technology, services and solutions that help advance both clinical therapy for patients and clinical process for health care providers. BD and its 65,000 employees have a passion and commitment to help enhance the safety and efficiency of clinicians' care delivery process, enable laboratory scientists to accurately detect disease and advance researchers' capabilities to develop the next generation of diagnostics and therapeutics. BD has a presence in virtually every country and partners with organizations around the world to address some of the most challenging global health issues. By working in close collaboration with customers, BD can help enhance outcomes, lower costs, increase efficiencies, improve safety and expand access to health care.
For more information on BD, please visit bd.com.
Roche provides an update on the phase III COVACTA trial of Actemra/RoActemra in hospitalised patients with severe COVID-19 associated pneumonia
29 July 2020 - COVACTA trial did not meet its primary endpoint of improved clinical status in patients with COVID-19 associated pneumonia, or the key secondary endpoint of reduced patient mortality. The study is the first global, randomised, double-blind, placebo-controlled phase III trial investigating Actemra/RoActemra in this setting. Roche remains committed to continuing the Actemra/RoActemra clinical trial programme in COVID-19 to further explore Actemra/RoActemra in other treatment settings, including in combination with an antiviral.
Basel, 29 July -- Roche today announced that the phase III COVACTA study of Actemra®/RoActemra® (tocilizumab) did not meet its primary endpoint of improved clinical status in hospitalised adult patients with severe COVID-19 associated pneumonia. In addition, the key secondary endpoints, which included the difference in patient mortality at week four, were not met; however, there was a positive trend in time to hospital discharge in patients treated with Actemra/RoActemra. The COVACTA study did not identify any new safety signals for Actemra/RoActemra. Further analysis of the trial results is needed to fully understand the data. The results will be submitted for publication in a peer-reviewed journal.
“People around the world are waiting for further effective treatment options for COVID-19 and we are disappointed that COVACTA did not demonstrate a benefit for patients in either clinical status or mortality at week four. We will continue to generate evidence to provide a more complete understanding of Actemra/RoActemra in COVID-19 associated pneumonia,” said Levi Garraway, M.D., Ph.D., Roche’s Chief Medical Officer and Head of Global Product Development. “We are grateful for the patients and physicians around the world who helped us to complete this study quickly during a public health crisis, while upholding the highest standards of scientific rigour. We will keep working to help combat the COVID-19 pandemic.”
The COVACTA trial was conducted in collaboration with the Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response at the United States Department of Health and Human Services.
COVACTA evaluated the safety and efficacy of intravenous Actemra/RoActemra added to standard-of-care treatment compared to treatment with placebo plus standard of care. The primary endpoint of clinical status in hospitalised adult patients with severe COVID-19 associated pneumonia was measured by a 7-category ordinal scale, which tracked patients’ clinical status based on the need for intensive care and/or ventilator use, as well as supplemental oxygen requirements. The COVACTA trial is the first global, randomised, double-blind, placebo-controlled phase III study to investigate Actemra/RoActemra in adult patients hospitalised with severe COVID-19 associated pneumonia, with study locations in the US, Canada and Europe.
Summary of Key COVACTA Clinical and Safety Findings
- Primary endpoint not met: The difference in clinical status between Actemra/RoActemra and placebo in patients assessed using a 7-category ordinal scale at week four was not statistically significant (p=0.36; odds ratio [95% CI] = 1.19 [0.81, 1.76], a statistically significant odds ratio greater than 1 would have favoured Actemra/RoActemra).
- There was no difference between Actemra/RoActemra and placebo in the percentage of patients that died by week four (Actemra/RoActemra = 19.7% and placebo = 19.4% with a difference [95% CI] of 0.3% [-7.6%, 8.2%], p=0.9410)
- Time to hospital discharge or ‘ready to discharge’ was shorter in patients treated with Actemra/RoActemra than in those treated with placebo. The median time to discharge or ‘ready to discharge’ for Actemra/RoActemra was 20 days and for placebo was 28 days (median time [95% CI]: Actemra/RoActemra = 20.0 [17.0, 27.0]; placebo = 28.0 [20.0, NE], p=0.0370). However, the difference cannot be considered statistically significant as the primary endpoint was not met.
- The difference in ventilator-free days between Actemra/RoActemra and placebo was not statistically significant (median of 22 days for Actemra/RoActemra and 16.5 days with placebo, difference in medians [95% CI] = 5.5 [-2.8, 13.0], p=0.3202).
- At week four, rates of infections were 38.3% and 40.6% in the Actemra/RoActemra and placebo arms, respectively, and the rates of serious infections were 21.0% and 25.9% in the Actemra/RoActemra and placebo arms, respectively. The COVACTA study did not identify any new safety signals for Actemra/RoActemra.
In addition to COVACTA, Roche has initiated several studies to further investigate Actemra/RoActemra as a potential treatment for patients with COVID-19 associated pneumonia, including two phase III clinical trials, REMDACTA and EMPACTA, as well as the phase II MARIPOSA trial. There are also a number of independent trials of Actemra/RoActemra in this setting. Actemra/RoActemra has not previously been studied in, nor approved for, COVID-19 associated pneumonia.
For more information on how Roche is responding to the global COVID-19 pandemic, please visit our COVID-19 response page.
About the COVACTA Trial
COVACTA is a global, randomised, double-blind, placebo-controlled phase III study (COVACTA, NCT04320615) evaluating the safety and efficacy of intravenous Actemra/RoActemra added to standard of care in adult patients hospitalised with severe COVID-19 associated pneumonia compared to placebo plus standard of care. The primary and secondary endpoints include clinical status, mortality, mechanical ventilation and intensive care unit (ICU) variables at week four. Patients will be followed for 60 days post randomisation.
About Actemra/RoActemra
Actemra/RoActemra was the first approved anti-IL-6 receptor biologic available in both intravenous (IV) and subcutaneous (SC) formulations for the treatment of adult patients with moderate-to-severe active rheumatoid arthritis (RA). Actemra/RoActemra can be used alone or with methotrexate (MTX) in adult RA patients who are intolerant to, or have failed to respond to, other disease-modifying anti-rheumatic drugs (DMARDs). In Europe, RoActemra IV and SC are also approved for use in adult patients with severe, active and progressive RA who previously have not been treated with MTX. Actemra/RoActemra IV and SC are approved globally for polyarticular juvenile idiopathic arthritis (pJIA) and in the US and Europe for systemic juvenile idiopathic arthritis (sJIA) in children two years of age and older. Actemra/RoActemra SC injection is also the first approved therapy for the treatment of giant cell arteritis (GCA) in more than 40 countries, including the US and Europe. In the US and Europe, Actemra/RoActemra IV injection is approved for the treatment of chimeric antigen receptor (CAR) T-cell-induced severe or life-threatening cytokine release syndrome (CRS) in people two years of age and older. Actemra/RoActemra was the first approved treatment for CRS in this setting. A prefilled auto-injector ACTPen has been approved in the US and Europe. In Japan, Actemra is also approved for the treatment of Castleman’s disease, adult Still's disease and Takayasu arteritis, in addition to the above mentioned indications. Actemra/RoActemra is part of a co-development agreement with Chugai Pharmaceutical Co., Ltd and has been approved in Japan since April 2005. Actemra/RoActemra is approved in more than 110 countries worldwide.
About Roche’s Response to the COVID-19 Pandemic
The COVID-19 pandemic continues to evolve globally, with varying developments from country to country. We are partnering with healthcare providers, laboratories, authorities and organisations to help ensure patients receive the tests, treatment and care that they need.
Reliable, high-quality testing is essential to help healthcare systems overcome this pandemic. On 12 March, we received FDA Emergency Use Authorisation (EUA) for a high-volume molecular test to detect SARS-CoV-2, the virus that causes COVID-19. It is also available in countries accepting the CE Mark. On 3 May, Roche announced that its COVID-19 antibody test, aimed at detecting the presence of antibodies in the blood, also received FDA EUA and is available in markets accepting the CE mark. Also in June, we received an FDA EUA for the Elecsys® IL-6 test to assist in identifying severe inflammatory response in patients with confirmed COVID-19, as well as launching Roche v-TAC, which could help simplify the screening, diagnosis and monitoring of patients with respiratory compromise in the current COVID-19 pandemic. Roche is working closely with governments and health authorities around the world, and has significantly increased production to help ensure availability of tests globally.
We are actively involved in understanding the potential of our existing portfolio for COVID-19 and are researching options for the future.
About Roche
Roche is a global pioneer in pharmaceuticals and diagnostics focused on advancing science to improve people’s lives. The combined strengths of pharmaceuticals and diagnostics under one roof have made Roche the leader in personalised healthcare – a strategy that aims to fit the right treatment to each patient in the best way possible.
Roche is the world’s largest biotech company, with truly differentiated medicines in oncology, immunology, infectious diseases, ophthalmology and diseases of the central nervous system. Roche is also the world leader in in vitro diagnostics and tissue-based cancer diagnostics, and a frontrunner in diabetes management.
Founded in 1896, Roche continues to search for better ways to prevent, diagnose and treat diseases and make a sustainable contribution to society. The company also aims to improve patient access to medical innovations by working with all relevant stakeholders. More than thirty medicines developed by Roche are included in the World Health Organization Model Lists of Essential Medicines, among them life-saving antibiotics, antimalarials and cancer medicines. Moreover, for the eleventh consecutive year, Roche has been recognised as one of the most sustainable companies in the Pharmaceuticals Industry by the Dow Jones Sustainability Indices (DJSI).
The Roche Group, headquartered in Basel, Switzerland, is active in over 100 countries and in 2019 employed about 98,000 people worldwide. In 2019, Roche invested CHF 11.7 billion in R&D and posted sales of CHF 61.5 billion. Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan. For more information, please visit www.roche.com.
Reference: https://www.roche.com/media/releases/med-cor-2020-07-29.htm
FDA Authorizes New Quest Diagnostics Lab Method Designed to Increase COVID-19 Molecular Diagnostics Capacity
29 July 2020 - Technique to increase COVID-19 molecular diagnostic testing capacity and provide faster test results reporting
SECAUCUS, N.J., July 29, 2020 -- Quest Diagnostics today announced that the U.S. Food and Drug Administration (FDA) has granted emergency use authorization (EUA) for a new laboratory technique that speeds the process of extracting viral RNA from specimens and will enable the company to expand its daily capacity of COVID-19 molecular diagnostic tests on behalf of patients in the United States.
"Laboratory innovation is key to optimizing testing capacity for COVID-19," said Steve Rusckowski, Chairman, Chief Executive and President, Quest Diagnostics. "We appreciate the collaboration of the FDA to bring this technique to several of our labs spanning the U.S. With more testing capacity, we expect to improve turnaround times for our customers and patients."
With the new FDA EUA, six of the company's laboratories in the U.S. may now run this new RNA extraction method, including on pooled specimens. Those laboratories are well situated geographically to address high testing demand in states where the virus has been surging. The labs are in San Juan Capistrano and Valencia, California; Lewisville, Texas; Lenexa, Kansas; Chantilly, Virginia; and Marlborough, Massachusetts.
Optimizing Capacity for Faster Testing
In its submission to the FDA, the company explained that "the method is needed to address availability of extraction supplies and increase testing capacity."
The company currently has the capacity to perform 135,000 COVID-19 molecular diagnostic tests a day. The new method is expected to add an additional 35,000 tests a day in overall capacity over the next several weeks. In addition, the company will be able to use specimen pooling with the new method to increase capacity even further.
Consequently, Quest now expects to have the capacity to perform 150,000 tests per day by next week and to continue to build additional capacity beyond that to 185,000 tests per day by Labor Day. Quest expects this innovation will help it to achieve average turnaround times of 1 day for "Priority 1" patients and 2-3 days for all other patients in coming weeks.
The new extraction technique may be used with the Quest Diagnostics SARS-CoV-2 RNA, Qualitative Real Time RT-PCR (Quest SARS-CoV-2 rRT-PCR), a proprietary test developed and validated by Quest Diagnostics for use on respiratory specimens from individuals suspected of COVID-19 by their healthcare provider. On July 17, the FDA granted an EUA for the test to be used with pooled specimens.
Quest Diagnostics is a leader in infectious disease testing services, with a broad menu of molecular, antibody, and other test services to aid diagnosis, treatment and monitoring. The new FDA EUA follows several others received by the company for its COVID-19 test innovations.
About Our COVID-19 Testing
Quest Diagnostics is at the forefront of the response to the COVID-19 pandemic, working to broaden access to laboratory insights to help us all lead healthier lives. We provide both molecular diagnostic and antibody serology tests to aid in the diagnosis of COVID-19 and immune response. Our COVID-19 test services are based on tests that have received FDA emergency use authorization and which also meet our high standards for quality. We are providing these test services under the Public Readiness and Emergency Preparedness Act. We provide data on COVID-19 testing to various federal and state public health authorities, including the Centers for Disease Control and Prevention, and participate in studies with government and private institutions, aiding COVID-19 public health response and research. Through our team of dedicated phlebotomists, air fleet team, couriers and laboratory professionals, Quest Diagnostics works hard every day to help patients and communities across the United States access quality COVID-19 testing.
About Quest Diagnostics
Quest Diagnostics empowers people to take action to improve health outcomes. Derived from the world's largest database of clinical lab results, our diagnostic insights reveal new avenues to identify and treat disease, inspire healthy behaviors and improve health care management. Quest annually serves one in three adult Americans and half the physicians and hospitals in the United States, and our 47,000 employees understand that, in the right hands and with the right context, our diagnostic insights can inspire actions that transform lives. www.QuestDiagnostics.com
LGC SeraCare SARS-CoV-2 Molecular Controls Kit now CE-Marked
28 July 2020
28 July 2020 -- LGC SeraCare is pleased to announce that the AccuPlex™ SARS-CoV-2 Reference Material Kit v2 is now CE-marked for in vitro diagnostic use (CE-IVD). With this change in regulatory status, the new product name is AccuPlex SARS-CoV-2 Molecular Controls Kit. Bearing the CE mark and IVD symbol signifies that the AccuPlex SARS-CoV-2 Molecular Controls Kit meets extensive design control requirements.
LGC SeraCare’s proprietary AccuPlex technology mimics wild-type pathogenic viruses, but is safe, non-infectious, and replication deficient. These materials serve as true, full-process controls that challenge the entire PCR test procedure, making them the preferred alternative to infectious materials. The AccuPlex SARS-CoV-2 Molecular Controls Kit is designed to measure day-to-day assay performance and contains positive materials directed against the published CDC and WHO consensus sequences and the S gene, and negative materials targeting the human RNase P gene.
Michael Sweatt, Executive Vice President, LGC SeraCare, stated, “Achieving this regulatory milestone for this SARS-CoV-2 control kit provides added value to our customers, especially throughout the European Union where this registration is sometimes required. We are committed to continuing to support the worldwide diagnostic community with dependable quality controls for infectious diseases, including COVID-19.”
To learn more about the AccuPlex SARS-CoV-2 Molecular Controls Kit as well as the complete line of SARS-CoV-2 Molecular & Serology Quality Solutions, please visit the LGC SeraCare website.
Grifols delivers first manufactured batches of its anti-SARS-CoV-2 hyperimmune globulin for clinical trials
28 July 2020 - The therapy, which provides passive immunity and could be used for both prevention and treatment, will undergo clinical trials this summer to evaluate its safety and efficacy. This is part of a collaboration agreement with U.S. government entities, including the Food and Drug Administration (FDA), the National Institutes of Health (NIH) and the Biomedical Advanced Research Development Authority (BARDA), among other healthcare agencies. In the past months Grifols has been collecting convalescent plasma in more than 245 Grifols U.S. donation centers from healthy recovered COVID-19 donors who have met the highest eligibility criteria.
Barcelona, Spain, July 28, 2020 -- Grifols, a global leader in the development of therapies with plasma-derived proteins with a track record of more than 100 years dedicated to enhancing people’s health and well-being, today announced it has delivered the first manufactured batches of its anti-SARS-CoV-2 hyperimmune globulin for clinical trials.
This medicine specifically targets SARS-CoV-2 by providing passive immunity to infected patients and boosting their immune system’s ability to fight the disease. The therapy, which could be used for both prevention and immediate treatment of COVID-19, will undergo clinical trials this summer to test its safety and efficacy.
The anti-SARS-CoV-2 hyperimmune globulin, which is derived from the blood plasma of healthy donors recovered from COVID-19, has the potential to be a highly specific, pure and safe medicine that delivers a high and consistent concentration of protective antibodies against the novel coronavirus.
As a medicine class, hyperimmune globulins have been increasingly used since the 1970s to prevent and treat common diseases including measles, rabies and tetanus. They are also a potential therapy option in response to future outbreaks of emerging viruses and other pathogens.
Since April, Grifols has moved quickly to collect COVID-19 convalescent plasma for its anti-SARS-CoV-2 hyperimmune globulin in more than 245 Grifols U.S. donation centers from donors who have met the highest eligibility criteria. Their plasma, rigorously tested and quality controlled, had high levels of anti-SARS-CoV-2 neutralizing antibodies.
The efforts form part of a collaboration agreement with U.S. government entities, including the Food and Drug Administration (FDA), the National Institutes of Health (NIH) and the Biomedical Advanced Research Development Authority (BARDA), among other healthcare agencies.
Previous experiences, particularly that with Ebola, have enabled the company to react rapidly to the challenge. During the Ebola outbreak in Liberia in 2014, Grifols collected convalescent plasma and designed and activated a plant in Clayton, North Carolina, especially equipped and staffed with personnel specialized in the production of plasma-derived medicines for infectious diseases.
“Grifols is grateful to all the plasma donors who through their generosity are now helping to develop a medicine, a hyperimmune globulin, whose concentrated antibodies will potentially provide others with passive immunity to overcome the disease,” said Victor Grifols Deu, co-CEO of Grifols.
Added Grifols co-CEO Raimon Grifols Roura: “All of us at Grifols are proud to devote our time, talent and energies to fight this health crisis.”
In addition to clinical trials in the U.S., Grifols is working on a European clinical trial of a hyperimmune globulin using convalescent plasma collected in Europe.
Grifols is the worldwide leader in the production and distribution of immunoglobulins and hyperimmune globulins, and is firmly committed to its mission of addressing the current and future needs of patients in the world.
Sysmex Launches Lab Assay Service for Research on Cytokines Related to the Novel Coronavirus (SARS-CoV-2)
27 July 2020 - Aiming to monitor the risk of increasing severity and treatment effects in clinical applications
27 July 2020 -- On July 1, 2020, Sysmex Corporation (HQ: Kobe, Japan; Chairman and CEO: Hisashi Ietsugu) began providing a lab assay service for research on cytokines,1which have been suggested as a useful indicator in monitoring the risk of increasing severity and treatment effects for the novel coronavirus (SARS-CoV-2), which causes the novel coronavirus disease COVID-19. Sysmex plans to continue conducting R&D with a view to expanding target parameters for lab assay and providing reagents for research.
The majority of patients suffer only light symptoms from COVID-19, the infection that occurs when SARS-CoV-2 enters the body. However, many asymptomatic carriers exist, and among otherpatientsthe disease can rapidly grow more severe. In preparation for a predicted resurgence of COVID-19, an urgent need exists for efforts to establish diagnostic tests that cover the time period spanningfromimmediately after infection through to treatment and recovery. This calls for a testing method that accommodates clinical applications, such as the confirmation of initial diagnosis, confirmed diagnosis, risk of increasing severity, and confirmation of treatment effect, and that satisfiesmeasurement parameters and measurement times (number of samples processed).
When a virus enters the body and attacks cells, those cells secrete immunoregulatory proteins called cytokines. By communicating the existence of the virus to immune cells, cytokines help immune cells to destroy cells infected by the virus. In some individuals, excessively active immune cells can begin attacking normal cells and tissues, which is known to injure the lungs and various other organs. In this process, large numbers of cytokines are released into the bloodstream in a phenomenon known as a cytokine storm. Cytokine storms are thought to be related to the increasing severity of COVID-19, and expectations are growing for the elucidation of this mechanism and the practical realization of clinical tests.
Against this backdrop, on July 1, 2020 Sysmex began providing “cytokine measurement for research,” a cytokine lab assay service for research using the chemiluminescence enzyme immunoassay method. Targeting research institutions, universities, medical institutions and pharmaceutical companies, we will provide data that can be used toconfirm testing methods suitable to such clinical applications as determiningthe risk of increasing severity and treatment effect, as well as data that can be usedfor vaccines, antiviral drugs and other drug discovery research. We will start by providing a lab assay service for research onthe six cytokines most relevant to COVID-19. We will gradually expand the parameters and continue development with a view to providing reagents for research.
Through the provision of a lab assay service for research that leverages its proprietary measurement platforms and the technologies it possesses, Sysmex will continue promoting R&D toward the practical realization of biomarkers with high clinical value, working with customers to help achieve advances in healthcare.
LabCorp Receives Authorization for COVID-19 Sample Pooling
25 July 2020 - New Method Aims to Improve Efficiency of COVID-19 Testing, Optimize Testing Supplies and Increase Overall Capacity
BURLINGTON, N.C.--(BUSINESS WIRE)--Jul. 25, 2020-- LabCorp (NYSE: LH), a leading global life sciences company that is deeply integrated in guiding patient care, today announced it received an Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) permitting diagnostic testing of groups of individuals for active COVID-19 infections utilizing matrixed pooled testing, a method that tests several patient samples at once.
LabCorp’s unique matrixed pooled strategy for COVID-19 provides an efficient testing approach for populations by allowing for larger groups of samples to be tested at one time. This methodology can quickly provide quality test results for individuals within the group, without requiring retesting in the majority of cases. Pooled testing may be used for populations at low risk of COVID-19, when testing demand exceeds laboratory capacity, or when testing reagents are in short supply.
“We believe science and technology are the best ways to beat the virus, and our matrixed pooled testing method is another way LabCorp is helping to respond to this health crisis,” said Brian Caveney, chief medical officer and president of LabCorp Diagnostics. “Pooling methods test groups of individuals efficiently and with high quality, while increasing our overall testing capacity. The demand for testing continues to increase and we are committed to finding innovative solutions to ensure testing is available.”
LabCorp’s matrixed pooled testing method involves testing up to five samples at once. If there is a positive sample in the pool, LabCorp can identify the individual positive sample in the pool using patterns detected by its robotic testing platform. Pooled testing can reduce the number of tests required in specific populations, optimize laboratory testing supplies, and increase testing capacity.
LabCorp received the EUA from the FDA on July 24 for the qualitative detection of nucleic acid from SARS-CoV-2 in upper and lower respiratory specimens from individuals suspected of COVID-19, using a matrix pooling strategy (i.e., group pooling strategy), containing up to five individual upper respiratory swab specimens (nasopharyngeal, mid-turbinate, anterior nares or oropharyngeal swabs) per pool and 25 specimens per matrix, where each specimen is collected under observation or by a healthcare provider using individual vials containing transport media. Negative results from pooled testing should not be treated as definitive. If a patient’s clinical signs and symptoms are inconsistent with a negative result or results are necessary for patient management, then the patient should be considered for individual testing. Specimens included in pools where the positive sample cannot be identified using the matrix must be tested individually prior to reporting a result. Specimens with low viral loads may not be detected in sample pools due to decreased sensitivity of pooled testing.
LabCorp’s COVID-19 molecular test has been authorized by the FDA under an EUA only for the detection of nucleic acid from SARS-CoV-2, and not for any other viruses or pathogens, and has not been FDA cleared or approved. The test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostic tests for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.
This EUA is effective until the declaration that circumstances exist justifying the authorization of the emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 is terminated under Section 564(b)(2) of the Act or the EUA is revoked under Section 564(g) of the Act.
About LabCorp
LabCorp (NYSE: LH), an S&P 500 company, is a leading global life sciences company that is deeply integrated in guiding patient care, providing comprehensive clinical laboratory and end-to-end drug development services. With a mission to improve health and improve lives, LabCorp delivers world-class diagnostics solutions, brings innovative medicines to patients faster, and uses technology to improve the delivery of care. LabCorp reported revenue of more than $11.5 billion in 2019. To learn more about LabCorp, visit www.LabCorp.com, and to learn more about LabCorp’s drug development business, Covance, visit www.Covance.com.
Grifols acquires 10% stake in Bloodbuy, cloud-based marketplace for blood products
23 July 2020 - Investment forms part of the company’s ongoing commitment to leading technologies and solutions that reinforce and complement its core businesses. Transaction will offer synergies to Grifols’ Bio Supplies Division and its Diagnostic Division’s leading transfusion medicine business.
Barcelona, Spain, July 23, 2020 -- Grifols, a leading global producer of plasma-derived medicines and a leader in the development of innovative diagnostic solutions, today announced it has acquired 10% of Bloodbuy (BloodSolutions, LLC), a cloud-based marketplace that facilitates buying and selling of blood components in the U.S.
Bloodbuy’s (www.bloodbuy.com) proprietary technology platform and computer-based algorithms enable regional blood-collection centers to expand their customer base across the U.S., while providing hospitals and other healthcare providers greater access to vital blood components in an efficient and efficacious manner connecting supply and demand.
Along with this equity investment, Grifols will obtain a seat on the Bloodbuy Board of Directors where it will be able to not only contribute to Bloodbuy’s growth but also closely analyze the blood-component-product marketplace, potentially allowing the company to make further investments in the digital healthcare space.
Bloodbuy’s platform allows participating healthcare providers to supplement their blood component needs on both a recurring and on-demand basis, ensuring hospitals can continue to provide the best care possible for their patients while providing blood-collection centers the ability to distribute their lifesaving products more broadly. The platform also reduces wastage costs of precious biological products while improving profitability.
“Grifols has always been interested in how digital technologies can disrupt the healthcare model to deliver better patient care more effectively,” said David Bell, Chief Innovation Officer of Grifols. “We believe Bloodbuy provides a unique opportunity to use technology to ensure critical blood components reach the patients who need them quickly and efficiently.”
“COVID-19 has created unprecedented challenges for our blood supply, both with respect to supply and demand shocks related to social distancing, suspension of elective procedures, and other necessary public health interventions,” said Chris Godfrey, Founder & CEO of Bloodbuy. “These externalities have had profoundly negative effects on blood product availability and utilization from region-to-region. Our online platform has played an integral role in connecting these geographies to create a digitally integrated network of blood centers and hospitals; so, we can easily redistribute available blood products and connect stakeholders around much-needed COVID-19 convalescent plasma.”
Bloodbuy’s cloud-based marketplace is available across the United States for all qualified hospitals, medical centers, integrated delivery networks, and blood collection centers. Bloodbuy’s current participants include some of the most prestigious medical institutions in the country, as well as nearly 30 independent blood collection centers. The recent COVID-19 crisis has spurred further adoption as hospitals and blood collection centers employ methods to reduce operational uncertainty in this unpredictable environment.
According to a recent U.S. Department of Health and Human Services report, nearly 23% of all hospitals surveyed were forced to cancel elective surgery for one or more days as a result of blood inventory shortages. Additionally, various studies have indicated some U.S. regions experience platelet wastage rates between 5% and 25% due to unpredictable supply and demand characteristics in local markets.
FDA Clears First Blood Test for Identifying a Novel Allergic Sensitization to Red Meat
23 July 2020 - Thermo Fisher Scientific's ImmunoCAP Specific IgE alpha-Gal Allergen Component test helps clinicians pinpoint a potentially fatal allergy often resulting from tick bites
PORTAGE, Mich., July 23, 2020 -- ImmunoCAP Specific IgE alpha-Gal Allergen Component test has been cleared by the U.S. Food & Drug Administration (FDA) for in vitro diagnostic use. Test results can aid specialists and other healthcare providers as they diagnose a patient's sensitization to the alpha-Gal carbohydrate found in mammalian (red) meat and assess his or her risk for an anaphylactic reaction.
According to the American Academy of Asthma, Allergy and Immunology, an allergy to alpha-Gal can cause patients to have a severe and potentially life-threatening reaction to galactose-alpha-1, 3-galactose that is found in most mammalian (red) meat. Unlike other food allergies, reactions from eating red meat may be delayed, occurring three to eight hours after eating. Symptoms range from hives and itching, to abdominal pain, nausea or vomiting. In severe cases the allergy can cause anaphylaxis which can be potentially fatal. The condition can appear in patients who have tolerated meat for many years, with researchers believing that sensitization to alpha-Gal may be the result of a bite from the lone star tick (Amblyomma americanum).
"Alpha-gal is dramatically different from other forms of food allergy," said Thomas Platts-Mills, MD, professor of medicine and microbiology at the University of Virginia School of Medicine and a leading researcher on the topic. "Previously healthy adults can suddenly develop potentially life-threatening reactions to red meats such as beef, pork and lamb. The delayed nature of the reactions adds to the difficulty that clinicians and patients have in identifying the cause of the symptoms. This unique set of circumstances makes an accurate diagnosis critical for managing this disease."
ImmunoCAP Specific IgE blood testing is the most widely used specific IgE blood test, and its use is documented in more than 6,000 peer-reviewed publications. The tests can help identify allergic sensitization to common environmental allergens – seasonal and perennial, outdoor and indoor– as well as common food allergens such as peanut, egg and milk. The ImmunoCAP Specific IgE Stinging Insect Allergen Component tests were recently cleared by the FDA to help improve the diagnosis of bee and wasp allergies. ImmunoCAP Specific IgE blood tests, which are available in most major U.S. laboratories, can be ordered for patients of any age regardless of skin condition, current medication, disease activity or pregnancy status.
"Sensitization to the alpha-Gal carbohydrate has been notoriously difficult to measure in patients," said Dr. Lakiea Wright, MD MAT MPH, Medical Director, US ImmunoDiagnostics at Thermo Fisher Scientific. "Skin prick testing to red meats such as beef, pork, or lamb often gives weak or negative results, which is why, based on clinical studies, quantification of IgE antibodies to alpha-Gal in the blood is the preferred diagnostic method. Information from these tests can help providers be more precise in their diagnosis and management recommendations."
For more information on testing for alpha-Gal allergy, symptoms and diagnosis, please visit allergyinsider.com.
About Thermo Fisher Scientific
Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $25 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, improving patient diagnostics and therapies or increasing productivity in their laboratories, we are here to support them. Our global team of more than 75,000 colleagues delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services and Patheon. For more information, please visit www.thermofisher.com.
QIAGEN announces publication of Supplemental Reasoned Position Statement for proposed acquisition by Thermo Fisher
22 July 2020
Venlo, the Netherlands, July 22, 2020 -- QIAGEN N.V. announced today the publication of its Supplemental Reasoned Position Statement in response to the amended Offer Document published by Thermo Fisher Scientific Inc on July 17, 2020. The Offer Document relates to the recommended offer by Thermo Fisher to fully acquire all issued ordinary shares in QIAGEN for an increased offer price of €43.00 per QIAGEN share in cash, as announced on July 16, 2020.
QIAGEN has published the Supplemental Reasoned Position Statement of the Managing Board and the Supervisory Board in accordance with Section 27 para. 3 in connection with Section 14 para. 3 of the German Securities Acquisition and Takeover Act (Wertpapiererwerbs- und Übernahmegesetz) and Section 18 para. 2 in connection with Annex G of the Dutch Public Offer Decree (Besluit openbare biedingen Wft).
The Supplemental Reasoned Position Statement, together with the Reasoned Position Statement already published on May 18, 2020, provides in detail the underlying financial and non-financial aspects and the overall circumstances which the Managing Board and Supervisory Board considered when reaffirming their unanimous recommendation of the offer and their unanimous recommendation that all QIAGEN shareholders accept and tender all of their QIAGEN shares in the offer prior to the end of the acceptance period on August 10, 2020. Each of the members of the Supervisory Board and Managing Board has tendered or will tender all of their QIAGEN shares in the offer.
The English and German version of the statement is published on QIAGEN’s website at http://www.qiagen.com/investors. Copies of the German version of the statement can also be obtained free of charge by contacting QIAGEN via e-mail at IR@qiagen.com or by telephone at +49 (0)2103 29 11709.
About QIAGEN
QIAGEN N.V., a Netherlands-based holding company, is the leading global provider of Sample to Insight solutions that enable customers to gain valuable molecular insights from samples containing the building blocks of life. Our sample technologies isolate and process DNA, RNA and proteins from blood, tissue and other materials. Assay technologies make these biomolecules visible and ready for analysis. Bioinformatics software and knowledge bases interpret data to report relevant, actionable insights. Automation solutions tie these together in seamless and cost-effective workflows. QIAGEN provides solutions to more than 500,000 customers around the world in Molecular Diagnostics (human healthcare) and Life Sciences (academia, pharma R&D and industrial applications, primarily forensics). As of June 30, 2020, QIAGEN employed approximately 5,200 people in over 35 locations worldwide. Further information can be found at http://www.qiagen.com.
Reference: https://corporate.qiagen.com/newsroom/press-releases/2020/20200722_supplemental_rps
BD receives FDA Approval for HPV Test with Extended Genotyping Capabilities
22 July 2020 - BD Onclarity™ HPV Assay is the only FDA-approved HPV assay to individually identify and report genotypes beyond 16, 18 and 45
FRANKLIN LAKES, N.J., July 22, 2020 -- BD (Becton, Dickinson and Company), a leading global medical technology company, today announced that it received approval for a pre-market approval (PMA) supplement from the U.S. Food and Drug Administration (FDA) for an expanded version of its BD Onclarity™ HPV Assay. The PMA supplement includes the expansion for genotype reporting beyond HPV genotypes 16, 18, and 45 to include types 31, 51, 52, 33/58, 35/39/68, and 56/59/66 genotypes making the BD Onclarity™ HPV Assay the only FDA-approved assay to individually identify and report these genotype results.
The value of extended genotyping for cervical cancer screening and triage has been reported from large clinical studies since 2015. Additionally, the need for expanded HPV genotyping for cervical screening has been recognized since 2016. In many cases, the reporting of HPV genotypes with the screening test result could improve risk stratification and support risk-based patient management. The April 2020 publication of the ASCCP risk-based management consensus guidelines anticipated that extended genotyping would be introduced soon.
"BD Onclarity™ extended genotyping is data-driven precision medicine at its best, helping us effectively and efficiently manage our patients,” said Mark H. Stoler, MD Professor Emeritus of Pathology, University of Virginia Health System. “Contemporary management of women with abnormal cervical cancer screening results demands an assessment of their risk of pre-cancer. An abundance of recent science clearly shows that knowing the HPV genotype of the patient provides excellent differential stratification of those risks.”
“It is well known that different HPV genotypes carry different risk of cervical cancer, and without the specific knowledge of the HPV genotype in a screening sample many women will be over-treated needlessly,” said Jesper Bonde, PhD, Senior Researcher and Molecular Pathology Laboratory Manager, Hvidovre Hospital, Denmark. “Screening strategies that employ HPV tests with simultaneous genotyping offer a simple way to improve cervical cancer screening to the benefit of the woman and health care providers by allowing risk stratification already on the screening sample.”
The reporting of HPV genotypes with the screening tests and surveillance tests will facilitate same-genotype persistence tracking and risk-based management. A recent systematic review by Bottari et al concluded that, “evaluation of the HPV genotype persistence may represent a valid option to monitor patients treated for CIN 2+ lesions, because relapses were detected only in patients with persistence of the same genotype detected at baseline.”
“With this FDA approval, BD can now offer laboratories, clinicians and patients access to critical information in screening for cervical cancer in the United States and other countries recognizing the PMA supplement or CE mark,” said Dave Hickey, president, Integrated Diagnostic Solutions at BD. “Our goal is to continue the global fight towards eliminating diseases and associated deaths due to cervical cancer with our comprehensive diagnostic solutions.”
About BD Onclarity™ HPV Assay
The BD Onclarity™ HPV Assay detects and identifies 14 high-risk human papillomavirus (HPV) types in a single analysis and provides genotyping information from specimens collected for cervical cancer screening purposes in the BD SurePath™ Collection Vial and in the Hologic PreservCyt® Solution (not approved in the United States). The assay is for use in accordance with clinical guidelines and within the scope of local regulatory authorizations as part of a comprehensive approach to cervical cancer screening. The BD Onclarity™ HPV Assay has FDA approval for clinical use in cytology-based screening with ASC-US triage, in co-testing paradigm, and in primary HPV screening. BD Onclarity™ HPV Assay has FDA approval for use in vaccinated women. As the previously vaccinated subpopulation ages, the screening population will progressively include women with reduced prevalence of HPV 16 and 18, increasing the value of extended genotype reporting in a mixed population of vaccinated and unvaccinated women. Visit bd.com to learn more.
About BD
BD is one of the largest global medical technology companies in the world and is advancing the world of health by improving medical discovery, diagnostics and the delivery of care. The company supports the heroes on the frontlines of healthcare by developing innovative technology, services and solutions that help advance both clinical therapy for patients and clinical process for healthcare providers. BD and its 65,000 employees have a passion and commitment to help enhance the safety and efficiency of clinicians' care delivery process, enable laboratory scientists to accurately detect disease and advance researchers' capabilities to develop the next generation of diagnostics and therapeutics. BD has a presence in virtually every country and partners with organizations around the world to address some of the most challenging global health issues. By working in close collaboration with customers, BD can help enhance outcomes, lower costs, increase efficiencies, improve safety and expand access to healthcare.
For more information on BD, please visit bd.com.
PerkinElmer Releases New Dried Blood Spot Based COVID-19 Serology Test
21 July 2020 - Fully automated kit detects human antibodies of immunoglobulin class IgG to help identify individuals with adaptive immune response
WALTHAM, Mass., 21 July 2020 -- PerkinElmer, Inc., a global leader committed to innovating for a healthier world, today announced the launch of a dry blood spot (DBS) based test for SARS-CoV-2 IgG using its GSP®/DELFIA® platform, enabling processing of up to 5,000 samples per day. The finger-prick sample collection device allows for both decentralized sample collection and high-throughput testing. The product is being marketed as a CE-IVD test, and the Company plans to apply for Emergency Use Authorization (EUA) with the U.S. Food and Drug Administration (FDA).
Serological tests detect antibodies that are formed after an immune reaction to the pathogen has taken place. These tests can determine if an individual has developed immunity to a virus. Researchers are still studying how long antibodies last and whether they are protective against the COVID-19 virus.
The DBS assay is run on PerkinElmer’s GSP® analyzer, a fully automated and high throughput system for large population testing. The GSP combined with the universal TRF (time resolved fluorescence) of the DELFIA platform screens more than 30 percent of all newborn babies worldwide, spanning 32 countries. The traceable DBS workflow consists of five main elements: sample collection, punching, measurement on the GSP analyzer, reagents, and software, to detect anti-SARS-CoV-2 IgG antibodies. The SARS-CoV-2 IgG assay can also be run with serum or plasma samples via the Company’s Victor2™D platform. With an install base of over 2,500 GSP and Victor2D instruments, the capability for laboratories to meet heightened demand for COVID-19 testing is robust.
“Dried blood spot samples have been used in large scale population screening programs for decades and can help alleviate the costs and logistical constraints associated with collecting, transporting and processing venous blood for SARS-CoV-2 antibody testing,” said Masoud Toloue, Ph.D., Vice President and General Manager, Diagnostics, PerkinElmer. “This CE-IVD marked assay enables decentralized collection, a much-needed tool in COVID-19 testing.”
PerkinElmer’s comprehensive SARS-COV-2 offerings span RT-PCR, high throughput RNA extraction, automation, ELISA and other laboratory solutions. This DBS based test follows the recently CE-Marked ELISAs for detection of IgG antibodies from EUROIMMUN, a PerkinElmer company.
About PerkinElmer
PerkinElmer enables scientists, researchers, and clinicians to address their most critical challenges across science and healthcare. With a mission focused on innovating for a healthier world, we deliver unique solutions to serve the diagnostics, life sciences, food, and applied markets. We strategically partner with customers to enable earlier and more accurate insights supported by deep market knowledge and technical expertise. Our dedicated team of about 13,000 employees worldwide is passionate about helping customers work to create healthier families, improve the quality of life, and sustain the wellbeing and longevity of people globally. The Company reported revenue of approximately $2.9 billion in 2019, serves customers in 190 countries, and is a component of the S&P 500 index. Additional information is available through 1-877-PKI-NYSE, or at www.perkinelmer.com.
Grifols to acquire Green Cross plasma fractionation facility in Montreal and a plasma collection organization in the U.S. for US$460 million
20 July 2020 - Grifols makes a significant investment to become the only large-scale commercial manufacturer of plasma products in Canada, with a fractionation capacity of 1.5 million liters/year. The operation aligns with Grifols’ commitment to helping countries reach self-sufficiency of life-sustaining plasma-derived medicines. The acquisition includes 11 collection centers in the United States.
Barcelona, Spain, July 20, 2020 -- Grifols, a global healthcare company and one of world’s top producers of plasma-derived medicines, today announced it has executed purchase arrangements with the South Korean-based GC Pharma (Group) whereby Grifols will acquire the Montreal-based plasma fractionation facility and two purification facilities, along with 11 U.S.-based plasma collection centers for a total amount of US$460 million.
The transaction is part of Grifols’ sustainable global growth strategy to expand plasma collection and fractionation capacity to ensure patients worldwide have safe and secure access to life-saving plasma-derived medicines. Most importantly, this strategic acquisition will strengthen Grifols’ presence in Canada, building on a legacy of partnership in Canada’s blood system.
For more than three decades, Grifols has been a fractionator of Canadian plasma under contract manufacturing services, providing trusted plasma-derived medicines for Canadian patients and their healthcare providers. Throughout these many years Grifols has gained firsthand knowledge of the Canadian healthcare system. This transaction further demonstrates Grifols’ commitment to supporting domestic self-sufficiency and security of plasma-protein-product supply.
According to Víctor Grífols Deu, co-CEO of Grifols, “This deal builds on our long-term vision and strategy of sustainable growth, and wholly aligns with our commitment to helping countries reach self-sufficiency of life-sustaining plasma-derived medicines, which are critical for patients who need them.”
Added Joel Abelson, President of Grifols’ Bioscience Commercial Division: “This transaction represents a unique opportunity for Grifols to intensify our global expansion and presence in North America. Canada is a market with one of the highest rates of plasma consumption per capita in the world and one with significant growth potential.”
As Grifols co-CEO Raimon Grífols Roura noted, “It has been a very meditated decision to invest in the midst of these unprecedented circumstances. This pandemic underscores the need to support robust and sustainable health infrastructures that, in case of other emergent pathogens in the future, will help ensure the availability of plasma medicines.”
No additional financing will be required for the acquisition. Upon completion of the transaction certain net worth, working capital and cash targets have been guaranteed. Once the facilities are fully licensed and approved, Grifols will become the only large-scale commercial manufacturer of plasma products in Canada, with a fractionation capacity of 1.5 million liters annually. Grifols plans to be ready to manufacture IVIG and Albumin in the facilities to supply the Canadian market starting in 2023.
As part of the transaction, by means of a plasma-supply agreement, Grifols has also committed to supplying certain output of plasma arising out of the Green Cross Collection Centers to GC Pharma (Group) for a 24-month period. The collection centers achieved a collection volume of 350,000 litres of plasma in 2019.
The completion of the transaction is subject to regulatory approvals and is expected to close prior to the end of 2020.
Grifols retained Osborne Clarke, S.L.P and Stikeman Elliott, L.L.P as legal advisors and Nomura Securities International, Inc. as a financial advisor.
BGI Genomics: Helping citizens in the fight against the pandemic
20 July 2020 - BGI Genomics: Helping Hong Kong citizens in the fight against the pandemic with daily inspection of more than 5,000 samples with strict confidentiality.
20 July 2020 -- The third wave of the new crown pneumonia epidemic broke out in Hong Kong recently. The daily number of confirmed cases continues to rise. Many of the cases are of unknown origin. Epidemic prevention and anti-epidemic situation are extremely severe. The Hong Kong government has introduced two private mainland organizations to conduct free new coronavirus tests for high-risk groups of more than 400,000 people in Hong Kong. One of these organizations is the Huasheng Diagnostic Center opened by BGI.
Wang Shihua, manager of BGI’s genetic laboratory in Hong Kong, said in an exclusive interview with our reporter that the current testing center cooperates with medical institutions and adopts automated testing methods. It can test about 5,000 samples per day and issue a test report in only half a day. At the same time, people’s privacy will be kept strictly confidential, hoping to help the Hong Kong government effectively control the epidemic as soon as possible.
Based on the anti-epidemic experience in Beijing, South Korea, and other places, as well as the recommendations of the World Health Organization, virus testing is currently the fastest and most effective way to locate and track cases including “invisible communicators” and cut off the local transmission chain. Recently, the epidemic situation in Hong Kong has changed drastically. Many Hong Kong citizens flocked to the border, hoping to return to the mainland to avoid the epidemic. Guangdong Province announced that from 10 am on July 17th, except for approved personnel, those entering Hong Kong from Hong Kong must hold a valid nucleic acid test negative certificate within 72 hours (3 days), and they will still be compulsory for 14 days after entry In quarantine, Hong Kong citizens’ demand for nucleic acid testing has increased rapidly.
Wang Shihua said that due to the rapid increase in the amount of testing, the original manual testing method was cumbersome and took 4 hours to produce the results, which could not meet the current huge testing needs. At the same time, to help high-risk community groups perform testing and screening, automated nucleic acid was introduced. The extraction instrument, coupled with the upgrade and transformation of the laboratory, only needs 5 to 6 chemists and can do about 5000 tests every day, which replaces nearly 10 times the manpower requirement. I believe that with the increase of automated nucleic acid extraction instruments in the future, The detection volume will increase exponentially.
Self-produced reagents are certified by WHO
In Hong Kong’s current medical system, Hong Kong usually uses foreign reagents. The cost is high and the supply is unstable. Taking German-made reagents as an example, each kit costs about 600 yuan. As for the remaining costs, including nucleic acid testing machines, laboratory quality control, and certification costs, most institutions still cost as high as 1,500 to 2,500 yuan per time.
Wang Shihua said that BGI has taken the lead in completing the research and development of the new coronavirus nucleic acid detection kit in early 2020 and quickly produced it. It has been supplied to more than 180 countries and regions around the world. It has been certified by different medical authorities such as the United States, Europe, and Japan. It has also been certified by the World Health Organization. The organization is included in the emergency use list (WHO EUL). BGI has been preparing to produce reagents locally in Hong Kong and hopes that 100% of the reagents will be produced in Hong Kong in the future to meet the growing demand for testing. I believe that the cost of each test can be reduced to less than 1,000 yuan.
Wang Shihua also pointed out that the inspection center collects throat samples for testing, instead of the deep throat saliva samples commonly used in Hong Kong, because Hong Kong’s methods are time-limited. “It can only be taken in the morning before brushing your teeth. We believe that in such a severe situation of the epidemic. It’s very inconvenient. The deep throat saliva collection bottle is 70ml. If 1,000 samples are to be collected, the inspection center will have to deal with 1,000 plastic bottles, which will cause huge work pressure and is not environmentally friendly.”
Privacy information is strictly confidential, so citizens do not need to worry
Regarding certain opposition groups intimidating citizens and stating: “If mainland institutions conduct nucleic acid tests, sensitive privacy information will be sent to the mainland.” In an attempt to create social panic and undermine Hong Kong’s anti-epidemic work, Wang Shihua said that under Hong Kong’s laws and regulations according to the requirements of the American Society of Pathology, the information received by the testing center generally only has a serial code, and at most only the name of the patient is known. No other personal information will be received. Except for the virus-positive samples, they will be sent to the Department of Health. Other samples will be destroyed and will not be sent back to the Mainland. The public need not worry.
Reference: https://www.bgi.com/global/company/news/bgi-help-hong-kong/
FDA Authorizes Quest Diagnostics COVID-19 Diagnostic Testing for Specimen Pooling for Emergency Use
18 July 2020 - First FDA authorization of laboratory technique for use in COVID-19 diagnostic testing. Company also receives new FDA emergency use authorizations for use of self-collection molecular diagnostic kit on the Hologic and Roche platforms, expanding use with healthcare provider supervision via telemedicine.
SECAUCUS, N.J., July 18, 2020 -- Quest Diagnostics, the world's leading provider of diagnostic information services, today announced that it has received emergency use authorization (EUA) from the U.S. Food and Drug Administration (FDA) to use specimen pooling with its proprietary molecular diagnostic test for COVID-19. Quest is the first lab provider to receive FDA authorization for the technique for COVID-19 testing in the United States.
In pooling, specimens must still be collected into individual vials, but then are combined into small batches or pools by the laboratory. A negative result for a batch means that all patients in that pool are considered negative (If a positive result occurs for the batch, each specimen is retested individually). The technique is an efficient way to evaluate patients in regions or populations with low rates of disease. Pooling is used routinely in blood banking to screen donated blood for a variety of viruses, among other applications.
With the new pooling EUA, the Quest Diagnostics SARS-CoV-2 RNA ("Quest SARS-CoV-2 rRT-PCR") test may be used with pooled upper respiratory specimens (nasopharyngeal, mid-turbinate, anterior nares or oropharyngeal swabs). In clinical data presented by Quest to the FDA, none of 3,091 total specimens from a population with a prevalence rate of 1-10 percent, if pooled, would have been incorrectly determined to be negative (95%CI 0.0-0.1%).
The company expects to deploy the technique at its laboratories in Chantilly, VA and Marlborough, Mass., by the end of next week with additional laboratories to follow.
"As COVID-19 continues to spread around the country, access to timely, quality laboratory testing is critical to patients and an effective public health response," said Steve Rusckowski, Chairman, CEO and President, Quest Diagnostics. "Pooled specimen testing is a proven technique that will help us to optimize testing capacity at this critical time for our country."
"We applaud FDA for taking this important step to empower Quest to increase capacity across our national laboratory network," said Jay G. Wohlgemuth, M.D., Senior Vice President and Chief Medical Officer, Quest Diagnostics. "Pooling will help expand testing capacity but it is not a magic bullet, and testing times will continue to be strained as long as soaring COVID-19 test demand outpaces capacity. Each of us can practice behaviors that will reduce COVID-19 infections in our communities, so our national healthcare system can better respond to this crisis."
On July 13, 2020, Quest issued a statement that soaring demand for COVID-19 molecular diagnostics is slowing turnaround times to report results.
FDA EUAs for Telemedicine Self-Collection
Yesterday, the FDA also granted three emergency use authorizations to Quest Diagnostics for the use of its Quest Diagnostics Self-Collection Kit with the Hologic Panther Fusion, Hologic Aptima and Roche cobas molecular platforms. The new EUAs expand the use of the self-collection kit beyond the EUA, granted on May 27th, for the use of the kit on the Quest SARS-CoV-2 rRT-PCR test. The company expects the new EUAs will allow it to use self-collection more broadly on behalf of clients and patients in the United States. Self-collected specimens that were not observed by a healthcare professional are not eligible for pooling.
New FDA EUAs Follows EUAs for Other Quest Innovations
Quest Diagnostics is a leader in infectious disease testing services, with a broad menu of molecular, antibody, and other test services to aid diagnosis, treatment and monitoring. The new FDA EUAs follow several others received by the company for its COVID-19 test innovations.
In March 2020, Quest received FDA EUA for The Quest Diagnostics SARS-CoV-2 RNA, Qualitative Real-Time RT-PCR ("Quest SARS-CoV-2 rRT-PCR"), a real-time RT-PCR test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in upper and lower respiratory specimens collected from individuals suspected of COVID-19 by their healthcare provider. In May 2020, the company received an FDA EUA to use the test nasal swab specimens that are self-collected at home or in a healthcare setting by individuals using an authorized home-collection kit when determined to be appropriate by a healthcare provider.
About Our COVID-19 Testing
Quest Diagnostics is at the forefront of the response to the COVID-19 pandemic, working to broaden access to laboratory insights to help us all lead healthier lives. We provide both molecular diagnostic and antibody serology tests to aid in the diagnosis of COVID-19 and immune response. Our COVID-19 test services are based on tests that have received FDA emergency use authorization and which also meet our high standards for quality. We are providing these test services under the Public Readiness and Emergency Preparedness Act. We provide data on COVID-19 testing to various federal and state public health authorities, including the Centers for Disease Control and Prevention, and participate in studies with government and private institutions, aiding COVID-19 public health response and research. Through our team of dedicated phlebotomists, air fleet team, couriers and laboratory professionals, Quest Diagnostics works hard every day to help patients and communities across the United States access quality COVID-19 testing.
For more information about the latest developments with our COVID-19 testing, visit: newsroom.questdiagnostics.com/COVIDTestingUpdates
About Quest Diagnostics
Quest Diagnostics empowers people to take action to improve health outcomes. Derived from the world's largest database of clinical lab results, our diagnostic insights reveal new avenues to identify and treat disease, inspire healthy behaviors and improve health care management. Quest annually serves one in three adult Americans and half the physicians and hospitals in the United States, and our 47,000 employees understand that, in the right hands and with the right context, our diagnostic insights can inspire actions that transform lives. www.QuestDiagnostics.com
Quidel’s Sofia® SARS Antigen FIA updates EUA performance data to 96.7% PPA versus PCR; product supports U.S. initiatives to expand access to COVID-19 testing in nursing homes; receives CE Mark for use
17 July 2020
SAN DIEGO, 17 July 2020 -- Quidel Corporation (“Quidel”), a provider of rapid diagnostic testing solutions, cellular-based virology assays and molecular diagnostic systems, announced today that Quidel has updated the performance data for its Sofia® SARS Antigen FIA test on its package insert to 96.7% using direct nasal swab specimens versus PCR as a result of further studies included in its amended Emergency Use Authorization (EUA) that were submitted to the U.S. Food and Drug Administration (FDA).
“The majority of PCR tests, including our Lyra® assay, have been shown to be effective in diagnosing COVID-19 within a specific window of SARS-CoV-2 exposure, generally within 5 days after the onset of patient symptoms. Further studies have validated that our Sofia® SARS Antigen FIA offers sensitivity that is comparable to PCR within this 5-day window, providing healthcare workers with confidence in their ability to accurately diagnose their patients,” said Douglas Bryant, president and chief executive officer of Quidel Corporation. “We expect that this test will continue to play a critical role as an effective first line of defense against COVID-19.”
Healthcare professionals can purchase the Sofia® SARS Antigen FIA in the United States through distribution representatives for Cardinal Health, Fisher Healthcare, Henry Schein, McKesson, or Medline.
Sofia® SARS Antigen FIA in Nursing Homes
The U.S. Department of Health and Human Services (HHS) has indicated its intent to purchase both Sofia® 2 instruments and the Sofia® SARS Antigen FIA for distribution and use in nursing homes. Under the proposed terms, HHS will purchase 2,000 Sofia® instruments and 750,000 Sofia® SARS Antigen FIA tests over the next few months to expand access to COVID-19 testing in nursing homes throughout the U.S.
Sofia® SARS Antigen FIA Receives CE Mark
Separately, the Sofia® SARS Antigen FIA received CE Mark for use with the Sofia® and Sofia® 2 instruments. The CE Mark allows Quidel to market and sell the Sofia® SARS Antigen FIA in Europe, as well as other countries that accept the CE Mark.
About Quidel Corporation
Quidel Corporation serves to enhance the health and well-being of people around the globe through the development of diagnostic solutions that can lead to improved patient outcomes and provide economic benefits to the healthcare system. Marketed under the Sofia®, QuickVue®, D3® Direct Detection, Thyretain®, Triage® and InflammaDry® leading brand names, as well as under the new Solana®, AmpliVue® and Lyra® molecular diagnostic brands, Quidel’s products aid in the detection and diagnosis of many critical diseases and conditions, including, among others, COVID-19, influenza, respiratory syncytial virus, Strep A, lyme, herpes, pregnancy, thyroid disease and fecal occult blood. Quidel's Triage® system of tests comprises a comprehensive test menu that provides rapid, cost-effective treatment decisions at the point-of-care (POC), offering a diverse immunoassay menu in a variety of tests to provide diagnostic answers for quantitative BNP, CK-MB, d-dimer, myoglobin, troponin I and qualitative TOX Drug Screen. Quidel’s research and development engine is also developing a continuum of diagnostic solutions from advanced immunoassay to molecular diagnostic tests to further improve the quality of healthcare in physicians’ offices and hospital and reference laboratories. For more information about Quidel’s comprehensive product portfolio and to explore exciting employment opportunities, visit quidel.com.
New Rapid Molecular Test For Tuberculosis Can Simultaneously Detect Resistance To First- And Second-Line Drugs
16 July 2020 - Xpert® MTB/XDR cartridge enables expanded drug-resistance profiling in less than 90 minutes. Used to empower clinicians to quickly prescribe treatment regimens for multidrug-resistant TB (MDR-TB) and extensively drug-resistant TB (XDR-TB), the test could help fill a critical gap that is currently jeopardizing global TB targets.
GENEVA and SUNNYVALE, Calif., July 16, 2020 -- The Foundation for Innovative New Diagnostics (FIND) and Cepheid, Inc, announced today the launch of the new Xpert® MTB/XDR test, which enables expanded drug-resistance tuberculosis (TB) profiling in less than 90 minutes. Xpert MTB/XDR can be used to empower clinicians to quickly prescribe treatment regimens for extensively drug-resistant TB (XDR-TB).
Able to detect TB that is resistant to multiple first- and second-line TB drugs, the test could help fill a critical gap that is currently jeopardizing global TB elimination targets. By contrast, current methods for identifying drug-resistance profiles for XDR-TB are very complex to perform, can take up to 16 weeks to deliver results, and as a result are often completely unavailable to patients.
XDR-TB is the most complicated form of TB, with the worst outcomes. Mortality has been reported as high as 41% in some cohorts. The scientific community has been focused on coordinating innovation to improve both diagnosis and treatment of XDR-TB for years. The World Health Organization (WHO) recommends rapid molecular testing and detection of drug-resistant TB as an essential condition for the implementation of new treatment regimens.
"An ordinary TB diagnosis is awful, but XDR-TB is the worst nightmare of every TB doctor and every patient," said Catharina Boehme, CEO of FIND. "Recent treatment advances are already making a huge impact, but for the best chances of survival, patients need to be able to start on treatment as soon as possible – and the only way for that to happen is through rapid diagnosis. By providing test results in just a few hours, the Xpert MTB/XDR test will save lives."
Xpert MTB/XDR leverages Cepheid's new 10-colour technology, which enables the detection of multiple mutations across several genes, from a single sample. Xpert MTB/XDR can detect resistance to isoniazid, ethionamide, fluoroquinolones, amikacin, kanamycin and capreomycin. Access to testing that can reliably identify resistance towards isoniazid as well as to fluoroquinolones and amikacin will help enable clinicians to quickly select the most appropriate MDR-TB treatment for each individual patient.
"Rapid testing of resistance to isoniazid and fluoroquinolones is a critical step towards ensuring those who are ill with drug-resistant TB, and in particular XDR-TB, can access treatment and care early – in line with the latest WHO guidelines on the treatment of drug-resistant TB," said Tereza Kasaeva, Director of the WHO Global TB Programme. "WHO is looking forward to receiving all relevant data on the GeneXpert MTB/XDR cartridge from Cepheid and partners to rapidly proceed with an evaluation of the new test."
The test runs on Cepheid GeneXpert® systems equipped with 10-colour multiplexing modules. GeneXpert 10-colour modules are capable of processing the already widely used Xpert MTB/RIF and Xpert MTB/RIF Ultra tests for diagnosis of TB and rifampicin resistance.
"This test is the first to leverage 10-colour homogeneous detection within the GeneXpert system," said Dr David H Persing, Executive Vice President and Chief Medical and Technology Officer at Cepheid. "In partnership with Dr David Alland and his team at Rutgers University as well as FIND, we have demonstrated the ability to detect a wide array of TB drug resistance mutations directly from clinical specimens with a high level of accuracy comparable with standard testing."
A study conducted by Cepheid showed promising results for the detection of mutations associated with first- and second-line drug resistance, while preliminary data from independent analytical and clinical evaluation studies conducted by FIND indicate that the test's sensitivity (ability to correctly identify drug-resistance) and specificity (ability to correctly identify drug-susceptibility) is comparable with current standard tests (culture-based phenotypic drug-susceptibility testing) and sequencing, and that the test meets the performance characteristics defined by the high-priority target product profiles for new TB diagnostics.
Data from the FIND evaluations will form part of the dossier now being prepared for WHO review at the end of this year. If the test is recommended for use by WHO, countries could include it in their national policies and accelerate its scale up – particularly in high-burden TB countries such as India and China.
"Reflex testing of MDR-TB patients, to rapidly and accurately diagnose XDR-TB within 2 hours and minimum expertise needed, has the potential to be the cornerstone in the rapid initiation of tailored treatment," said Camilla Rodrigues, Consultant Microbiologist, Chairperson Infection Control Committee, P.D. Hinduja Hospital, Mumbai.
"It is great to have the Xpert MTB/XDR test that can be deployed in the peripheral laboratories and greatly improve access to diagnosis of drug-resistant TB and selection of the most appropriate treatment regimens," said Lucica Ditiu, Executive Director of the Stop TB Partnership. "We should all work together to ensure that this and any other new TB diagnostics are fast-tracked from development, to WHO recommendation, to scale up and use by countries."
FIND is now working with Cepheid and WHO to support the rollout of the test.
About FIND
FIND is a global non-profit organization that drives innovation in the development and delivery of diagnostics to combat major diseases affecting the world's poorest populations. Our work bridges R&D to access, overcoming scientific barriers to technology development; generating evidence for regulators and policy-makers; addressing market failures; and enabling accelerated uptake and access to diagnostics in low- and middle-income countries (LMICs). Since 2003, we have been instrumental in the development of 24 new diagnostic tools used in 150 LMICs. Over 50 million FIND-supported products have been provided to our target markets since the start of 2015. A WHO Collaborating Centre, we work with more than 200 academic, industry, governmental, and civil society partners worldwide, on over 70 active projects that cross six priority disease areas. FIND is committed to a future in which diagnostics underpin treatment decisions and provide the foundation for disease surveillance, control and prevention. For more information, please visit www.finddx.org
About Cepheid
Based in Sunnyvale, Calif., Cepheid is a leading molecular diagnostics company that is an operating company within Danaher Corporation's (NYSE: DHR) Diagnostics platform. Cepheid is dedicated to improving healthcare by developing, manufacturing, and marketing accurate yet easy-to-use molecular systems and tests. By automating highly complex and time-consuming manual procedures, the company's solutions deliver a better way for institutions of any size to perform sophisticated molecular diagnostic testing for organisms and genetic-based diseases. Through its strong molecular biology capabilities, the company is focusing on those applications where accurate, rapid, and actionable test results are needed most, such as managing infectious diseases and cancer. For more information, visit http://www.cepheid.com.
BIOFIRE® Respiratory Panel 2.1 plus with SARS-CoV-2 is CE marked
15 July 2020
15 July 2020 -- bioMérieux, a world leader in the field of in vitro diagnostics, today announced that the BIOFIRE® Respiratory Panel 2.1 plus (RP2.1plus) is CE marked. The BIOFIRE® Respiratory Panel 2.1 plus (RP2.1plus) tests for 23 pathogens (19 viruses, including SARS-CoV-2, and 4 bacteria) responsible for the most frequent respiratory tract infections. It will be commercially available in all countries that recognize CE marking from now on or shortly thereafter.
The BIOFIRE® RP2.1plus advances the existing BIOFIRE® Respiratory Panel 2 plus (RP2plus) by adding SARS-CoV-2 to the panel menu while maintaining an assay runtime of about 45 minutes. The BIOFIRE® RP2.1plus panel also includes an assay for the Middle East Respiratory Syndrome Coronavirus (MERS-CoV). This new panel allows healthcare providers to quickly identify patients with common respiratory pathogens and differentiate those with COVID-19, using one single test. The BIOFIRE® RP2.1plus runs on the fully automated BIOFIRE® FILMARRAY® 2.0 and BIOFIRE® FILMARRAY® TORCH systems and is extremely easy to use.
“The availability of BIOFIRE® RP2.1plus in all countries recognizing CE marking represents a global syndromic response to this unprecedented COVID-19 pandemic,” said Pierre Boulud, Chief Operating Officer, Executive Vice President, Clinical Operations at bioMérieux. “With increasing reagent production capacity and an installed base of more than 14 000 BIOFIRE® units throughout the world, BIOFIRE® RP2.1plus will play a key role now and in the upcoming respiratory season as healthcare providers face the regular group of respiratory pathogens as well as SARS-CoV-2”, he added.
The BIOFIRE® RP2.1plus Panel is part of a suite of products in response to the COVID - 19 pandemic. The ARGENE® SARS-CoV-2 R-GENE® was launched in March 2020, followed by the U.S. FDA EUA cleared BIOFIRE® RP2.1 panel and the VIDAS® anti-SARS- CoV-2 IgM and anti-SARS-CoV-2 IgG tests. These complementary tests help meet the varying needs of bioMérieux’s diverse customers and patients throughout the world.
Reference: https://www.biomerieux.com/en/biofirer-respiratory-panel-21-plus-sars-cov-2-ce-marked
LGC expands SARS-CoV-2 molecular solutions to full genome coverage
15 July 2020
15 July 2020 -- LGC continues to innovate its portfolio of products supporting SARS-CoV-2 diagnostics. Initially designed to target the published CDC and WHO consensus sequences, the new AccuPlex™ SARS-CoV-2 Verification Panel and Reference Material Kit are now available with full SARS-CoV-2 viral genome coverage. This expansion allows for compatibility with any SARS-CoV-2 assay target, while maintaining the safety features and performance monitoring advantages of AccuPlex technology.
LGC’s proprietary AccuPlex technology mimics wild-type pathogenic viruses, but is safe, non-infectious, and replication deficient. These materials serve as true, full-process, quality solutions that challenge the entire PCR test procedure, making them the preferred alternative to infectious materials. Together, the AccuPlex SARS-CoV-2 Verification Panel and AccuPlex SARS-CoV-2 Reference Material Kit offer an ideal solution for clinical laboratories looking for a safe, effective tool to verify and monitor SARS-CoV-2 molecular assay performance.
Michael Sweatt, Executive Vice President, LGC SeraCare, stated, “We are proud to continue to expand our SARS-CoV-2 product offering to adapt to the evolving needs of the diagnostic community. Our full genome AccuPlex products are just the latest innovations in our line of SARS-CoV-2 molecular and serology quality solutions designed to support early detection of infection and antibody surveillance efforts throughout the ongoing COVID-19 pandemic.”
To learn more about the full genome AccuPlex SARS-CoV-2 Verification Panel and Reference Material Kit as well as the complete line of SARS-CoV-2 Quality Solutions, please visit the LGC SeraCare website.
Vela Diagnostics receives CE-IVD approval and Provisional Authorisation from the Health Sciences Authority in Singapore for automated COVID-19 detection test
13 July 2020
Singapore, July 13, 2020 – Vela Diagnostics announced today that an automated version of its COVID-19 detection test, the ViroKey™ SARS-CoV-2 RT-PCR Test v2.0, has received the CE mark for in vitro diagnostic use as well as Provisional Authorisation from the Health Sciences Authority in Singapore.
The ViroKey™ SARS-CoV-2 RT-PCR Test v2.0 is a probe-based reverse transcription PCR Test that detects SARS-CoV-2 by targeting conserved regions of the SARS-CoV-2 genome, specifically the ORF1a and N genes. The automated test is optimized for a workflow consisting of the Sentosa™ SX101 instrument, in conjunction with the Sentosa™ SA201 instrument or the ABI 7500 Fast Dx. The automated workflow enables high throughput testing with significantly reduced hands-on time. Up to 48 tests, including controls, can be performed in a single run. “Receiving CE certification and Provisional Authorisation from the Health Sciences Authority in Singapore for our automated test facilitates efficient testing of SARS-CoV-2 in patients suspected of COVID-19 in Europe, Africa, Middle East and Asia, where there is an urgent need to identify individuals infected with SARS-CoV-2 for effective management of the global pandemic,” said Managing Director, Andreas Goertz.
In April this year, an earlier version of the test, the ViroKey™ SARS-CoV-2 RT-PCR Test, also received the CE mark and Provisional Authorisation from the Health Sciences Authority in Singapore.
About Vela Diagnostics
Vela Diagnostics is a leading provider for integrated IVD system solutions, from sample to result. VELA’s test solutions utilize the automated Sentosa™ platform, providing the unique ability to leverage one system for NGS and PCR testing in infectious disease and oncology.
SARS-CoV-2 antibody test from Siemens Healthineers evaluated against other leading antibody assays in Public Health England study
10 July 2020 - New SARS-CoV-2 total antibody tests are appraised by Public Health England (PHE), in partnership with the University of Oxford, in a new head-to-head evaluation of four commercial tests. The laboratory-based COV2T antibody test from Siemens Healthineers was the only assay found to meet both sensitivity and specificity requirements as set out in the MHRA’s TPP for enzyme immunoassays. The test identifies antibodies to a spike protein on the surface of the SARS-CoV-2 virus, also a focus of many vaccine studies.
Erlangen, 10 July 2020 -- Public Health England, in partnership with the University of Oxford, recently conducted a head-to-head evaluation of four commercial immunoassay tests available in the UK and used for the detection of SARS-CoV-2 antibodies.Siemens Healthineers’ laboratory-based total antibody test distinguished itself as the only assay tested found to meet both the sensitivity and specificity requirements set out within the Target Product Profile (TPP) for immunoassays by the UK Medicines and Healthcare products Regulatory Agency (MHRA). The test is broadly available globally.
The evaluation was commissioned by the Department of Health and Social Care (DHSC) and conducted by Public Health England, the clinical research team at the University of Oxford and Oxford University Hospitals NHS Foundation Trust. Several commercial antibody tests were appraised over a three-week period in May - June 2020, with a view to assessing respective performance metrics on precision, using a large, well-characterised sample set. Primary data included evaluation of the assays’ sensitivity and specificity, each of which is key to assessing the overall clinical performance of a test.
The SARS-CoV-2 total antibody test from Siemens Healthineers is CE marked and has FDA Emergency Use Authorization. The test detects the presence of both IgM and IgG antibodies in blood. This allows for the identification of patients who have developed an adaptive immune response, indicating prior exposure to COVID-19. Critically, the test identifies antibodies to a key protein on the surface of the SARS-CoV-2 virus – a spike protein, which binds the virus to human cells. Multiple potential vaccines in development for SARS-CoV-2 include the spike protein within their focus, raising the possibility that the Siemens Healthineers total antibody test could support the determination of the effectiveness of these vaccines in the future.
“High-quality antibody tests will be critical to successfully reopening economies across the globe. From the start, our mission has been to develop highly accurate tests for SARS-CoV-2 and now we have an external appraisal that confirms our test offers exceptional quality,” said Deepak Nath, PhD, President of Laboratory Diagnostics at Siemens Healthineers. “Laboratories worldwide can be confident that our assay delivers the sensitivity and specificity we promised.”
The role of Public Health England
Public Health England is an executive agency of the Department of Health and Social Care and is not a regulator. PHE evaluations confirm that the Siemens Healthineers SARS-CoV-2 total antibody test meets the Target Product Profile. The Siemens Healthineers SARS-CoV-2 total antibody test has received the CE mark before PHE testing. The CE mark confirms that the test meets EU regulatory standards and could already be lawfully placed on the market in the UK and other Member States. Siemens Healthineers announced on June 1 that it has received FDA Emergency Use Authorization in the United States.
Siemens Healthineers AG is shaping the future of Healthcare. As a leading medical technology company headquartered in Erlangen, Germany, Siemens Healthineers enables healthcare providers worldwide through its regional companies to increase value by empowering them on their journey towards expanding precision medicine, transforming care delivery, improving the patient experience, and digitalizing healthcare. Siemens Healthineers is continuously developing its product and service portfolio, with AI-supported applications and digital offerings that play an increasingly important role in the next generation of medical technology. These new applications will enhance the company’s foundation in in-vitro diagnostic, image-guided therapy, and in-vivo diagnostics. Siemens Healthineers also provides a range of services and solutions to enhance healthcare providers ability to provide high-quality, efficient care to patients. In fiscal 2019, which ended on September 30, 2019, Siemens Healthineers, which has approximately 52,000 employees worldwide, generated revenue of €14.5 billion and adjusted profit of €2.5 billion. Further information is available at www.siemens-healthineers.com.
Reference: https://www.siemens-healthineers.com/press-room/press-releases/covid-19-antibody-phe.html
Sonora Quest Collaborates with State and Healthcare Leaders to Significantly Expand COVID-19 Testing Capacity in Arizona
10 July 2020
PHOENIX, July 10, 2020 – Governor Doug Ducey announced today a strategic collaboration with Sonora Quest Laboratories, the market share leader in diagnostic laboratory testing in Arizona, the Arizona Department of Health Services (ADHS) and PerkinElmer, Inc., a global leader committed to innovating for a healthier world, with one goal: expand COVID-19 testing in Arizona. The collaboration will support the strategic plan to catapult Sonora Quest’s COVID-19 diagnostic testing capacity in a material way to meet and exceed the rising demand in Arizona.
“This partnership will enable Arizona to continue rapidly expanding testing across the state, helping ensure all Arizonans have access to affordable, available testing with speedy turnaround of results,” said Governor Ducey. “I’m grateful to Sonora Quest Laboratories, PerkinElmer and the Arizona Department of Health Services for their innovative solutions to help protect the health and safety of Arizonans."
Through this collaboration, the State of Arizona and Arizona Department of Health Services are providing Sonora Quest Laboratories $2 million toward the purchase of new processing equipment. Sonora Quest continues to be committed to investing time and resources for community testing, and is contributing an additional $6 million toward the expansion to increase access to health care for Arizonans.
Sonora Quest expects to reach the capacity to perform up to 35,000 diagnostic tests per day by the end of July, and up to 60,000 tests per day by the end of August. The dedicated project team at Sonora Quest will be working 24 hours a day to install, validate and deploy the new production lines, which will include chemagic™ 360 instruments, JANUS® G3 Primary Sample Reformatters and PCR+ Workstations, to automate PerkinElmer’s RNA extraction and RT-PCR testing. The breadth of PerkinElmer’s total workflow solutions will enable Sonora Quest to rapidly process samples at higher volumes, ultimately helping decrease turnaround time in testing.
“The goal is to have test results available within 24 hours for anyone tested,” said David A. Dexter, President & CEO, Sonora Quest Laboratories. “I wish to express my sincere thanks and appreciation to Dr. Cara Christ, Director of ADHS, and PerkinElmer for supporting Sonora Quest. Together, we are making a significant difference in the Arizona healthcare community to provide ample testing throughout this pandemic.”
“Despite the recent resurgence of COVID-19 cases in the United States and some testing locations experiencing capacity shortfalls, PerkinElmer has complete SARS-CoV-2 testing solutions available and ready for delivery. We are teaming with Sonora Quest to meet their increased testing volume requirements and will continue to build capacity to support broad-based testing globally,” said Masoud Toloue., Ph.D., Vice President & General Manager, Diagnostics, PerkinElmer.
Sonora Quest’s priority remains the health and safety of all the patients and communities they serve. These efforts continue to build upon outreach and actions to expand testing for all Arizonans, including the most vulnerable and underserved populations.
“We are excited to partner with Sonora Quest to expand COVID-19 testing in Arizona,” said Dr. Cara Christ, ADHS director. “Since the start of the pandemic, ADHS has worked with Sonora Quest and several other private laboratories across Arizona to increase access to testing and laboratory capacity. We will continue to work with all of our lab partners to find ways to make testing more available to everyone in our state.”
Patients who believe they may have active COVID-19 are strongly encouraged to contact their healthcare provider or locate an Arizona Testing Blitz site for sample collection at https://www.azdhs.gov/testingblitz. Patients suspected of having or confirmed to have active COVID-19 infection or disease should not visit a Sonora Quest Patient Service Center. Sonora Quest Patient Service Centers do not offer collection for diagnostic COVID-19 testing.
The collaboration between Sonora Quest and PerkinElmer is an expansion of its existing relationship, in which EUROIMMUN, a PerkinElmer company, provides tests to support Sonora Quest’s antibody testing.
For more information about the COVID-19 testing service, visit www.SonoraQuest.com/coronavirus.
About COVID-19 testing at Sonora Quest
Sonora Quest is the leader in infectious disease testing services in Arizona with a broad menu of molecular, antibody, and other test services to aid in diagnosis, treatment and monitoring. On March 20, 2020, the company introduced an RT-PCR test allowing for the detection of nucleic acid in respiratory specimens of patients meeting CDC's clinical criteria for COVID-19 testing. RT-PCR tests for COVID-19 are generally used to aid diagnosis during active disease. Sonora Quest has performed and reported results of more than 400,000 diagnostic COVID-19 tests. Ramping up its fight against COVID-19, Sonora Quest began offering antibody testing for COVID-19 using blood specimens on April 24, with a physician order. That was quickly followed by a direct-to-consumer offering through their My Lab ReQuest ™ solution starting May 8, giving patients the ability to order the antibody test without a doctor’s order or insurance.
About Sonora Quest Laboratories
Sonora Quest Laboratories, a joint venture between Banner Health and Quest Diagnostics (NYSE: DGX), is part of the nation’s largest integrated laboratory system with approximately 3,500 employees serving more than 26,000 patients every day throughout Arizona. Sonora Quest Laboratories is the market share leader in clinical laboratory testing in Arizona, performing nearly 90 million diagnostic tests per year. Sonora Quest Laboratories offers a local comprehensive test menu which encompasses routine, molecular, prescription drug monitoring, genetic/genomic, women’s health and pathology testing services. My Lab ReQuest provides consumers direct access to a diverse range of affordable screening tests that can be ordered online at SonoraQuest.com or in any of Sonora Quest’s 75 patient service centers across Arizona. Ninety-eight percent of all testing is performed at the primary testing facilities located in Phoenix, Tucson, Flagstaff, Prescott and Yuma. Sonora Quest Laboratories is accredited by the College of American Pathologists (CAP), which is the gold standard in laboratory accreditation, helping laboratories to maintain accuracy of test results and ensure accurate patient diagnosis. This accreditation ensures the highest standard of care for all laboratory patients as CAP inspectors examine laboratory staff.
About PerkinElmer
PerkinElmer enables scientists, researchers and clinicians to address their most critical challenges across science and healthcare. With a mission focused on innovating for a healthier world, we deliver unique solutions to serve the diagnostics, life sciences, food and applied markets. We strategically partner with customers to enable earlier and more accurate insights supported by deep market knowledge and technical expertise. Our dedicated team of about 13,000 employees worldwide is passionate about helping customers work to create healthier families, improve the quality of life, and sustain the wellbeing and longevity of people globally. The Company reported revenue of approximately $2.9 billion in 2019, serves customers in 190 countries, and is a component of the S&P 500 index. Additional information is available through 1-877-PKI-NYSE, or at www.perkinelmer.com.
LGC acquires The Native Antigen Company, strengthening its offer to the IVD sector
9 July 2020
9 July 2020 -- Today, LGC announced the acquisition of The Native Antigen Company (NAC), one of the world’s leading suppliers of high quality infectious disease antigens and antibodies.
NAC is a developer, manufacturer and supplier of critical reagents to the in vitro diagnostic (IVD), pharmaceutical and academic sectors. It offers a comprehensive portfolio of native and recombinant infectious disease antigens and related products including pathogen receptors, virus-like particles and antibodies for use in immunoassay applications, vaccine development and quality control solutions. NAC was one of the first companies globally to offer antigens for SARS-COV-2 and continues to play an important role in supporting the global response to the COVID-19 pandemic.
The acquisition strengthens LGC’s existing product offering to the IVD sector, which includes a range of quality assurance tools, immunoassay reagents and disease state plasma as well as probes and primers for molecular diagnostics.
Michael Sweatt, Executive Vice President and General Manager, Clinical Diagnostics, LGC, said, “NAC is a natural fit with our clinical diagnostics business and will enable us to provide an expanded portfolio of critical reagents to our customers. NAC’s focus on infectious disease is highly complementary with our existing offer to this segment comprising controls, reference materials, MDx tools and other components. We are excited to welcome our new colleagues into our organisation.”
“We are delighted to be joining LGC as an integral part of their fast growing clinical diagnostics business”, said Nick Roesen, COO of NAC, “even more so, we are excited to join such a well-respected organisation that shares our purpose and mission, and that will support our diagnostic customers by providing even more world-leading products and services.”
Formed in 2010, NAC is based in Oxford, UK and currently employs over 30 people. It maintains an ISO 9001 accreditation.
NAC’s portfolio includes more than 60 viral and infectious disease products, with strengths in Dengue, Cytomegalovirus, Zika, Chikungunya and Clostridium difficile (C. diff).
Reference: https://www.lgcgroup.com/newsroom-and-blog/news-and-blog/lgc-acquires-nac/
Dia.Pro launches four COVID-19 serology EIA kits
9 July 2020
9 July 2020 -- Dia.Pro Launch Diagnostics Limited is pleased to announce that Dia.Pro Diagnostic Bioprobes srl, has developed and launched four new EIA microplate kits for the detection of novel Coronavirus COVID-19 antibodies in human serum and plasma.
Dia.Pro is a specialist Italian diagnostic company which develops, manufactures & markets a wide range of high-quality & trusted IVD’s for infectious disease diagnostics,
There are two kits for the detection of IgG or IgM to COVID-19 nucleocapsid and spike antigens, a kit for IgG to COVID-19 spike 1 and 2 and a fourth module-based immunoassay for the confirmation and typing of IgG antibodies to COVID-19 major-antigens.
These kits have been developed and evaluated in Northern Italy and are CE marked. The assays are intended to be used to show antibody response and immune status following COVID-19 infection.
Key Points
- Four assays are currently available based on EIA, 96 well, microplate technology
- The Dia.Pro COVID-19 assays can be run manually or automated on an ELISA processor
- Method files are available for the Stratec Gemini, Dynex DS2 and Dynex DSX
- The confirmation assay is a modular system to individually detect antibodies against COVID-19 Spike protein 1, Spike protein 2 and Nucleocapsid
Reference: https://www.launchdiagnostics.com/dia-pro-launches-three-covid-19-serology-eia-kits/
HPV Test Misses Twice as Many Women Who Develop Cervical Cancer as Cotesting, Quest Diagnostics Health Trends™ Study Finds
8 July 2020 - Largest study of a nationally representative American population demonstrates cotesting outperforms HPV or Pap testing alone in detecting cancer and precancer in women 30 years and older
SECAUCUS, N.J., July 8, 2020 -- A Health Trends™ study from researchers at Quest Diagnostics and the University of Pittsburgh Medical Center (UPMC) provides new evidence that the HPV screening test is significantly less likely to detect cervical cancer and precancer than cotesting, a method which combines HPV and Pap (Papanicolaou test by liquid based cytology) testing using the same specimen.
The study is significant because it is the largest to date to assess the performance of guideline-recommended cervical cancer screening methods in a diverse population of American women in real-world care settings. It reveals stark differences in the performance of the various recommended methods in detecting cancer and precancers in women 30 years of age and older.
Published online today in the American Journal of Clinical Pathology, the peer-reviewed study assesses sensitivity rates of HPV alone, Pap alone and cotesting (HPV and Pap testing together) in detecting cancer and precancer of the cervix in nearly 19 million de-identified cotest results performed by Quest Diagnostics on behalf of 13.6 million women in the United States from 2010 to 2018. Of these cases, 1,259 were diagnosed with cervical cancer – twice the number of diagnosed cancer cases as the next largest study.v
"This Health Trends analysis of a notably large and diverse population firmly validates the critical role of cotesting as a cancer and precancer screening method for women 30 and older," said R. Marshall Austin, MD, PhD, Emeritus Professor of Pathology, University of Pittsburgh Medical Center (UPMC). "It should put to rest any notion that HPV alone achieves the same bar for quality cancer screening."
HPV testing identifies the genetic material of the human papillomavirus virus, which can cause cervical cancer, while Pap identifies cellular changes on the cervix that may be or become cancer. The United States Preventive Services Task Force (USPSTF) recommends screening in women 30-65 years of age every three years with Pap, every five years with cotesting or every five years with primary HPV testing.
Among the key findings:
- HPV and Pap testing alone fails to detect twice as many women who develop cervical cancer as cotesting. Of 1,615 cotests taken at any time prior to a cancer diagnosis, 86.9 percent were positive by cotesting, a non-detection rate (also known as false negative) of about 13.1 percent. By comparison, Pap and HPV testing alone had non-detection rates nearly twice as high: Pap at 26.4 percent and HPV at 28.4 percent.
- Cotesting detected significantly more women who developed biopsy-confirmed adenocarcinomas, a typically aggressive form of cervical cancer, identifying 82.3 percent of this cancer compared to only 61.2 percent by HPV and 59.7 percent by Pap.
- HPV testing fails to identify one in five women who develop cancer when performed within a year of cancer diagnosis. Among women screened within one year of a cancer diagnosis, the non-detection rate for HPV testing alone was 22.5 percent, nearly 1.5 times higher than Pap (14.9%) and four times higher than cotesting (5.9%).
- Cotesting detected more women who developed biopsy-confirmed precancers than HPV or Pap alone, identifying 95.6 percent of these precancers, compared to 92.6 percent by HPV and 77.9 percent by Pap.
According to a report published in January 2020 by the American Cancer Society, cervical cancer is the second leading cause of cancer death nationally in women 20-39 years of age, causing 10 premature deaths per week in this age group.
"While widespread screening has helped cut cervical cancer mortality by three fourths in the past 80 years, this disease is still far too common," said co-author Harvey W. Kaufman, M.D., Senior Medical Director and Director, Health Trends Research Program, Quest Diagnostics. "Because most cervical cancers develop in the absence of regular screening, ensuring women have access to the most reliable screening method, cotesting, when they are screened is an essential step in lowering mortality from this disease."
Health Trends study builds on prior research
The new findings confirm previous Quest Diagnostics research published in Cancer Cytopathology in 2015, a journal of the American Cancer Society, which found HPV-only cervical screening would not have detected approximately 19 percent of 526 women who developed confirmed cervical cancer. An analysis of data from Magee-Women's Hospital (MWH) of the University of Pittsburgh Medical Center (UPMC) reported a higher percent of positive Pap than HPV tests among 109 cotesting results within 12 months from cancer diagnosis, similar to the present Quest Diagnostics Health Trends study.
By comparison, analysis of a regional dataset from Kaiser Permanente Northern California (KPNC) also found that cotesting outperformed other methods, but the authors of that study concluded that "the contribution of cytology to screening is shown to be very small." The KPNC data were also limited in its ability to identify cytological abnormalities associated with confirmed adenocarcinomas, an aggressive cancer, as compared to the Quest and MWH data.
"It is important to reconcile the similar conclusions of Quest Diagnostics and Magee-Women's Hospital with the different findings of Kaiser Permanente in Northern California," said Lee H. Hilborne, MD, Professor of Pathology and Laboratory Medicine at UCLA, Senior Medical Director, Quest Diagnostics. "KPNC has an exemplary care model, but this very strength may limit the usefulness of KPNC data for drawing conclusions about the real-world care experience of most American women who receive care in less integrated practice settings."
"For women who may otherwise not be screened at all, there is no question that cytology or HPV primary are useful screening technologies," said Damian P. Alagia, III, MD, Senior Medical Director of Woman's Health for Quest Diagnostics. "Yet, that should not obscure the fact that cotesting is fundamentally the better screening option for women and is widely available in the U.S."
Study Strengths and Limitations
The strengths of the study include the large, longitudinal, nationally representative sample size and a study population believed to be reflective of adult women in the United States. The study period covers nine years (2010-2018). The study was limited only to women who sought medical care and were referred to laboratory services at Quest Diagnostics. The Quest Diagnostics Health Trends study was deemed exempt by the Western Institutional Review Board.
About Health Trends™
Quest Diagnostics Health Trends™ is a series of scientific reports that provide insights into health topics, based on analysis of objective clinical laboratory data, to empower better patient care, population health management and public health policy. The reports are based on the Quest Diagnostics database of more than 50 billion de-identified laboratory test results, believed to be the largest of its kind in healthcare. Health Trends has yielded novel insights to aid the management of allergies and asthma, prescription drug monitoring, diabetes, Lyme disease, heart disease, influenza and workplace wellness. Quest Diagnostics also produces the Drug Testing Index (DTI)™, a series of reports on national workplace drug positivity trends based on the company's employer workplace drug testing data. www.QuestDiagnostics.com/HealthTrends
About Quest Diagnostics
Quest Diagnostics empowers people to take action to improve health outcomes. Derived from the world's largest database of clinical lab results, our diagnostic insights reveal new avenues to identify and treat disease, inspire healthy behaviors and improve health care management. Quest annually serves one in three adult Americans and half the physicians and hospitals in the United States, and our 47,000 employees understand that, in the right hands and with the right context, our diagnostic insights can inspire actions that transform lives. www.QuestDiagnostics.com
Regeneron announces start of REGN-COV2 Phase 3 COVID-19 prevention trial in collaboration with National Institute of Allergy and Infectious Diseases (NIAID)
6 July 2020 - Anti-viral antibody cocktail REGN-COV2 is also in Phase 2/3 treatment trials following positive Phase 1 safety review
TARRYTOWN, N.Y., July 6, 2020 -- Regeneron Pharmaceuticals, Inc. today announced the initiation of late-stage clinical trials evaluating REGN-COV2, Regeneron's investigational double antibody cocktail for the treatment and prevention of COVID-19. A Phase 3 trial will evaluate REGN-COV2's ability to prevent infection among uninfected people who have had close exposure to a COVID-19 patient (such as the patient's housemate), and is being run jointly with the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH). REGN-COV2 has also moved into the Phase 2/3 portion of two adaptive Phase 1/2/3 trials testing the cocktail's ability to treat hospitalized and non-hospitalized (or "ambulatory") patients with COVID-19.
This clinical progress follows a positive review from the Independent Data Monitoring Committee of REGN-COV2 Phase 1 safety results in an initial cohort of 30 hospitalized and non-hospitalized patients with COVID-19.
The Phase 3 prevention trial is being conducted at approximately 100 sites and is expected to enroll 2,000 patients in the U.S.; the trial will assess SARS-CoV-2 infection status. The two Phase 2/3 treatment trials in hospitalized (estimated enrollment =1,850) and non-hospitalized (estimated enrollment =1,050) patients are planned to be conducted at approximately 150 sites in the U.S., Brazil, Mexico and Chile, and will evaluate virologic and clinical endpoints, with preliminary data expected later this summer. All trials are adaptively-designed, and the ultimate numbers of patients enrolled will depend on trial progress and insights from Phase 2 studies.
"We are running simultaneous adaptive trials in order to move as quickly as possible to provide a potential solution to prevent and treat COVID-19 infections, even in the midst of an ongoing global pandemic," said George D. Yancopoulos, M.D., Ph.D., Co-Founder, President and Chief Scientific Officer of Regeneron. "We are pleased to collaborate with NIAID to study REGN-COV2 in our quest to further prevent the spread of the virus with an anti-viral antibody cocktail that could be available much sooner than a vaccine."
About REGN-COV2
Regeneron scientists evaluated thousands of fully-human antibodies produced by the company's proprietary VelocImmune® mice, which have been genetically-modified to have a human immune system, as well as antibodies isolated from humans who have recovered from COVID-19. They selected the two most potent, non-competing and virus-neutralizing antibodies to create REGN-COV2 and have scaled up this dual-antibody cocktail for clinical use with the company's in-house VelociMab® and manufacturing capabilities. REGN-COV2's two antibodies bind non-competitively to the critical receptor binding domain of the virus's spike protein, which diminishes the ability of mutant viruses to escape treatment and protects against spike variants that have arisen in the human population, as detailed in recent Science publications. More recent research also demonstrates coverage against the now prevalent D614G variant.
Regeneron used the same 'rapid response' capabilities and cocktail approach to develop REGN-EB3, a novel triple antibody treatment for Ebola that is now under regulatory review by the FDA. REGN-COV2's development and manufacturing has been funded in part with federal funds from the BARDA under OT number: HHSO100201700020C.
About Regeneron
Regeneron (NASDAQ: REGN) is a leading biotechnology company that invents life-transforming medicines for people with serious diseases. Founded and led for over 30 years by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to seven FDA-approved treatments and numerous product candidates in development, all of which were homegrown in our laboratories. Our medicines and pipeline are designed to help patients with eye diseases, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, pain, infectious diseases and rare diseases.
Regeneron is accelerating and improving the traditional drug development process through our proprietary VelociSuite® technologies, such as VelocImmune® which uses unique genetically-humanized mice to produce optimized fully-human antibodies and bispecific antibodies, and through ambitious research initiatives such as the Regeneron Genetics Center, which is conducting one of the largest genetics sequencing efforts in the world.
BD Launches Portable, Rapid Point-of-Care Antigen Test to Detect SARS-CoV-2 in 15 minutes, Dramatically Expanding Access to COVID-19 Testing
6 July 2020 - Simple new assay leverages more than 25,000 BD Veritor™ instruments already used across the U.S. to immediately increase access to COVID-19 testing in frontline health care settings. BD will begin shipping the new test this week and expects to ramp-up manufacturing capacity to 2 million tests per week by the end of September. This is the company's third diagnostic test to receive Emergency Use Authorization by U.S. FDA for detecting COVID-19.
FRANKLIN LAKES, N.J., July 6, 2020 -- BD (Becton, Dickinson and Company), a leading global medical technology company, today announced that the U.S. Food and Drug Administration (FDA) granted Emergency Use Authorization (EUA) for a rapid, point-of-care, SARS-CoV-2 diagnostic test for use with its broadly available BD Veritor™ Plus System. The launch of this new assay that delivers results in 15 minutes on an easy-to-use, highly portable instrument is critical for improving access to COVID-19 diagnostics because it enables real-time results and decision making while the patient is still onsite.
The BD Veritor™ System, which is slightly larger than a cell phone, is currently in use at more than 25,000 hospitals, clinician offices, urgent care centers and retail pharmacies in all 50 U.S. states. Its one-button functionality, workflow flexibility, and ease-of-use make it an ideal solution for settings without laboratory personnel. It also offers customers real-time reporting capabilities through the BD Synapsys™ informatics solution providing them with the ability to easily report data for disease monitoring and surveillance purposes.
BD is leveraging its global manufacturing network and scale and expects to increase capacity to be able to produce 2 million tests per week by the end of September. The company already expects to produce up to 10 million tests from July through September.
"This will be a game-changer for frontline health care workers and their patients to be able to access a quick diagnostic test for COVID-19, offering results in real-time at convenient locations like retail pharmacies, urgent care centers and doctors' offices," said Dave Hickey, president of Integrated Diagnostic Solutions for BD. "Such tests will also help communities be more informed and better prepared to help prevent new spikes and additional waves of COVID-19 by enabling public health workers to quickly identify infectious individuals and trace their contacts. The highly portable, easy-to-use, point-of-care format of this test, large quantity of test kits available and existing, expansive footprint of BD Veritor™ Plus instruments will help bring widespread access to COVID-19 testing in the United States and around the world as additional country-specific regulatory requirements are met."
The launch of the BD Veritor™ Plus System for Rapid Detection of SARS-CoV-2 Assay is the latest effort in the company's comprehensive response to address critical health needs related to the global pandemic. The new immunoassay test joins a portfolio of three molecular solutions for COVID-19 testing that have been registered for use with the BD MAX™ Molecular System, including two with EUAs and two with CE mark. So far this year, the company has provided health care providers globally with approximately 48 million swabs for flu and COVID-19 testing, more than 2.85 million COVID-19 rapid molecular diagnostic tests on the BD MAX™ System, and millions of products used in the treatment of COVID-19 patients, including infusion