BioGX Receives FDA EUA for a Novel, High-Throughput, Direct Sample RT-PCR Test for COVID-19
1 July 2021
Birmingham, Alabama, July 01, 2021 – BioGX, a global provider of molecular diagnostic solutions, announced that the United States Food and Drug Administration has issued Emergency Use Authorization (EUA) for their breakthrough direct sample addition, Xfree™ COVID-19 test. Xfree COVID-19 is a complete test lyophilized in a single tube, for extraction-free, direct sample addition real-time RT-PCR testing. The Xfree COVID-19 test eliminates all upfront sample processing steps and enables clinical laboratories to generate high-throughput Sample-to-Answer results using widely available real-time PCR platforms.
Matthew Beckman, Ph.D., Director of Laboratory Services at GENETWORx said, “the staff at GENETWORx has been very pleased with the performance of the BioGX Xfree COVID-19 test. In our studies, we have determined that the BioGX Xfree test performs superior to ThermoFisher’s Taqpath and Quanta’s XLT-Script One-Step RT-PCR products for the SARS-CoV-2 testing as determined by head-to-head comparisons. BioGX test is very simple to use while providing increased quality assurance of well-by-well monitoring of the PCR reaction. The product also offers the consistency and platform flexibility to rapidly increase throughput without needing to invest in additional resources and new systems.”
“Our test not only enables laboratories of all sizes to perform high-performance cost-effective testing, but also provides robust strain coverage for all prevalent strains, including the rapidly spreading Delta variant”, said Shazi Iqbal, Ph.D., CEO of BioGX. “The FDA authorization of our Xfree chemistry paves the way for us to leverage our expansive menu of tests to create an Xfree line of point-of-care (POC) tests for respiratory and urinary tract infections”, he added.
The FDA has authorized the Xfree COVID-19 test with broad specimen coverage to include nasopharyngeal, anterior nasal, mid-turbinate, and oropharyngeal swab specimens, nasopharyngeal wash/aspirate and nasal aspirates. Additionally, the test is authorized to run with extracted samples offering options for the laboratory to adapt the test in any laboratory workflow. The test is already in use in several laboratories and costs $7-12 per sample depending on its use as direct sample addition or with extracted sample.
Xfree is a complete test in a single vial, lyophilized in the trusted BioGX Sample-Ready™ format. To perform the RT-PCR test, the user simply rehydrates the lyophilized test with molecular grade water, adds a patient sample, and runs the test on a validated real-time PCR instrument. The test can be shipped anywhere in the world without refrigeration.
Customers can request information on Xfree COVID-19 by contacting BioGX at Ph: +1.205.250.8055 or sales@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 Dallas, TX, 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’s 60+ multiplex real-time PCR products are marketed and sold in several countries through its Global Distribution Network.
For more information on BioGX, please visit BioGX.com.
Genedrive® COVID-19 Point of Care device update
1 July 2021
1 July 2021 -- genedrive plc, the near patient molecular diagnostics company, provides an update on the development of its Genedrive® COV19-ID Kit, a rapid Point of Care (PoC) molecular test for SARS-CoV-2 detection, designed for the Company’s Genedrive® instrument.
The Company has been developing a new, best-in-class PoC molecular workflow and assay for more than 9 months. The Company is pleased to release the product’s current performance specifications as it moves towards the stages of formal clinical qualification and regulatory filing. While acknowledging the longer than anticipated development time, the Company has overcome significant technical hurdles and also further improved performance specifications alongside evolving marketplace requirements. Key specifications of sensitivity, specificity, speed, ease of use, and scalability have all been improved or addressed.
The Genedrive® COV19-ID Kit detects the presence of SARS-CoV-2 virus in a nasal swab. The product has been designed to provide an ease of use appropriate for people inexperienced in molecular testing. Positive samples are detected as quickly as 9-10 minutes, with a negative result reported after 20 minutes if no signal is detected.
In contrast to many competitor products, the test targets two genes of the SARS-CoV-2 genome, and is shown to be inclusive of all current Variants of Concern (VoCs), including the Delta variant. The intent of a two-gene design is to provide additional robustness to new emerging VoCs in the future. The specificity of the test during design verification (30 positive and 30 negative contrived clinical samples*) was 100%, with a PCR comparable limit of detection of 10-20 copies per reaction.
The testing procedure does not require extraction of the virus from the patient’s sample. The Company has developed a proprietary lysis buffer that is used to resuspend patient swab material, while providing biosafety to users. Exact quantification of biosafety is currently being assessed in an independent UK Public Health England laboratory. A fully biosafe process would present additional or novel opportunities and use-cases for PoC COVID-19 testing.
The simple, 4-step workflow uses an ‘eye-dropper’ liquid transfer process familiar from lateral flow testing, and makes the system appropriate for use by those without previous molecular experience. The ease of use of the Genedrive COV19-ID test is demonstrated at:
https://www.genedrive.com/assays/in-development-covid19-id.php
Full clinical validation on patient specimens is required for regulatory registration and/or other emergency listings. The Company is optimistic that this can be completed successfully and is targeting CE marking at the end of September / early October, with prospective patient sample collection already underway. The Company is targeting initial product launch in Europe.
David Budd, CEO of genedrive plc, said: “We are pleased to have achieve significant milestones in the development of our Genedrive® COV19-ID Kit and we have a product in which we are extremely proud. Once formally validated, we believe we can make commercial in-roads by expanding the opportunities to get a quick and sensitive molecular test for SARS-CoV-2. The product to date demonstrates a suite of features that have significant competitive advantage: simplicity of workflow, an extraction free procedure, biosafety for the user, multi-gene targeting, rapid time to result, high sensitivity, and cost effectivness. Whether in highly vaccinated countries or not, COVID-19 is likely to be an illness that we live with in the long term, necessitating rapid and accurate testing for infection in a wide range of environments, including outside of healthcare settings. Our commercial activities are currently focused on engaging the appropriate commercial partners to be in place in the autumn as the levels of infection undoubtedly rise in many geographies.”
Reference: https://www.genedrive.com/news/index.php
ALM-Update: Rückläufige Testzahlen und Positivrate der SARS-CoV-2-PCR bei steigendem Anteil der Delta-Variante
29 June 2021
29 June 2021 -- Der „Sommertrend“ im SARS-CoV-2-Testgeschehen hält an: Weniger PCR-Untersuchungen mit sinkender Positivrate und gleichzeitig weitere Zunahme der Delta-Variante bei den Neuinfektionen.
Die wöchentlichen Zahlen der Akkreditieren Labore in der Medizin – ALM e.V. aus der KW 25 zeigen eine Positivrate der SARS-CoV-2-PCR-Befunde von noch 1,0 Prozent (KW 24: 1,5 Prozent), das entspricht 6.230 positiven Befunden von insgesamt 619.644 durchgeführten PCR-Untersuchungen. Im Verlauf ist das PCR-Testgeschehen erneut um 4,0 Prozent zurückgegangen.
Die Testkapazität liegt seit Wochen bei rund 2 Millionen PCR-Tests pro Woche, die Auslastung sinkt somit stetig und liegt aktuell bei 31 Prozent. „Es ist weiterhin wichtig, dass in der aktuellen Phase der Pandemie mit Ausbreitung der Delta-Variante die Kapazitäten vorgehalten werden, damit gegebenenfalls kurzfristig reagiert werden kann“, erklärt Dr. Michael Müller. Der 1. Vorsitzende des ALM e.V. betont: „Das erhält Sicherheit und Stabilität in der ärztlichen Diagnostik der SARS-CoV-2-Infektion.
Public service campaign from Quidel Corporation directed toward heightening awareness among summer camps of the dangers of Lyme disease
29 June 2021
SAN DIEGO, Calif., 29 June 2021 -- The opening of summer camps for the first time in two years is good news for children across America. Unfortunately, it’s also good news for deer ticks, which now have a whole new population to prey upon and to potentially spread infectious Lyme disease.
To help camp directors and counselors heighten their awareness of this issue, a public service campaign has been launched by Quidel Corporation, the nation’s leading developer of rapid Lyme disease testing. The campaign includes printed educational materials being sent to camps around the country; information shared on social media platforms; and other components all built around education, prevention and mindfulness of the dangers of Lyme disease.
“Lyme disease is one of the fastest-growing infectious diseases in the country, affecting as many as 476,000 Americans of all ages annually,” said Judi Tilghman, Ph.D., vice president of technology assessment at Quidel Corporation. “Lyme disease occurs when people are bitten by an infected deer tick. The spirochetes from the bacterium called Borrelia burgdorferi have the ability to burrow between bones, cells, joints and a person’s central nervous system and can lead to serious, life-threatening problems if not caught early. That’s why it is so important to take proper precautions, know the warning signs of Lyme disease, and test immediately if Lyme disease is suspected.”
The educational materials produced by Quidel and sent to summer camps remind camp directors that there are a number of things they can do to help protect both staff and campers and minimize the chance of catching Lyme disease. These include:
- “Tick proofing” the campsite by clearing brush and leaves and mowing the lawn regularly.
- Sticking to trails and avoid walking through low bushes or long grass when on hikes or simply out exploring.
- Wearing long pants, shirts, a hat and gloves when in wooded areas.
- Applying lavender oil or insect repellants on legs, arms and any bare skin before heading out.
- Upon returning to the campsite, everyone should check their entire body for ticks, including low-visibility areas such as the groin, underarms and the back of the neck.
- Showering right away using a washcloth to help remove unattached ticks.
- Putting all worn clothes in the dryer.
If a camper or staffer is suspected of having Lyme disease or displaying early symptoms, Quidel advises to get tested right away. As with all afflictions, the key is catching it early so effective treatment can begin as soon as possible. The Sofia® 2 Lyme FIA is the only POC test on the market. It is ideal for campsites because it can be performed right on-site by a nurse and provides indicative results within 15 minutes, as opposed to sending the test sample to an off-site lab and waiting days for results, which has historically been the norm (the longer the wait, the more time organisms have to spread and become systemic). It is also the only test that can get results from a simple finger prick of blood.
“The opening of summer camps is another positive indication of America slowly extricating itself from the coronavirus pandemic, and that’s something worthy of rejoicing,” said Dr. Tilghman. “Everyone wants to get outdoors and never more so than this year when so many of us have spent the past 15 months hunkered down in our own homes. We want all of our outdoor camps to have a wonderful summer this year but also to be smart by taking steps to avoid getting a tick bite in the first place and then testing immediately if there are signs that a camper or counselor may have contracted Lyme.”
Lyme disease is a bacterial infection that has been reported in every state in the United States and in over 80 countries. Summer is the height of Lyme disease season and can strike anyone at any age. There are more new cases of Lyme disease in the United States than hepatitis B, hepatitis C and the West Nile virus combined. Unlike a mosquito bite where people know immediately if they have been bitten, one of the challenges with Lyme disease is that symptoms usually will not appear for two to six weeks and may appear in a low-visibility area of the body such as in hair, an underarm or groin. At that point, typical symptoms include fever, headache, fatigue, joint pain, weakness in the limbs and often a characteristic skin rash with a bull's-eye pattern (only 50% of patients will see a rash).
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 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. 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.
Thermo Fisher Scientific Launches Collection Kit to Streamline Saliva Testing
29 June 2021 - Self-collection kit facilitates raw saliva collection to aid global SARS-CoV-2 research and surveillance efforts
CARLSBAD, Calif., June 29, 2021 -- As businesses, universities and schools reopen, SARS-CoV-2 virus surveillance is critical to the management of outbreaks and emerging new strains, including the Delta variant that now makes up 91 percent of new cases in the United Kingdom. To support large-scale research and surveillance programs, Thermo Fisher Scientific today introduced the Thermo Scientific SpeciMAX Saliva Collection Kit.
While most approved methods for SARS-CoV-2 saliva collection use specialized tubes and buffers for RNA stabilization and virus inactivation, researchers have found that this expensive approach may not always be required. The SpeciMAX Saliva Collection Kit is designed to provide a widely available, cost-effective solution for raw saliva collection to simplify saliva-based testing, which is necessary for SARS-CoV-2 mapping and epidemiological studies on a global scale. The easy-to-use self-collection kits facilitate clean saliva transfers, reduce risk of cross-contamination when paired with liquid handlers, and fit seamlessly into viral RNA extraction and direct-to-PCR downstream automation workflows for high throughput surveillance testing.
"As governments lift mask mandates and new, more transmissible strains gain dominance, increased SARS-CoV-2 surveillance is needed to quickly curb outbreaks before they spread," said Ellie Mahjubi, vice president and general manager of sample preparation, Thermo Fisher Scientific. "Effective surveillance largely depends on testing frequency and labs need a cost-effective solution for saliva collection that can work within current automation workflows. With SpeciMAX, labs will be able to capture raw saliva with minimal workflow disruption and minimal manual processing, enabling more efficient SARS-CoV-2 research and surveillance."
The individually packaged and barcoded kits require just 1 mL of saliva and include a convenient funnel and cap to secure the sample for processing. The standardized collection tube size can hold 6 mL sample volume yet requires less refrigeration, incubation, and storage space than other collection kits available on the market.
For more information, please visit www.thermofisher.com/specimaxsaliva.
About Thermo Fisher Scientific
Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $30 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 80,000 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 receives CE MARK for its Panbio™ Rapid Antigen Self-Test, opening access throughout Europe to fast, reliable COVID-19 testing
28 June 2021 - Panbio™ COVID-19 Antigen Self-Test is approved for sale directly to consumers and for use in adults and children with or without symptoms, enabling fast, convenient coronavirus testing. The self-test features a minimally invasive nasal swab and delivers results in as early as 15 minutes with no instrumentation, using proven Abbott lateral flow technology. In clinical evaluations with self-test users, the Panbio Self-Test correctly identified 95.2% of positive samples and 100% of negative samples. Abbott is the only diagnostics manufacturer to provide performance data on a rapid antigen test. Specific for use on children who are 15 years and younger, including infants. Together with vaccines and health protocols, frequent, regular screening of asymptomatic and symptomatic people can restore a sense of safety and stability as more people return to work, school, family gatherings and recreational activities.
ABBOTT PARK, Ill., June 28, 2021 -- Abbott announced today it has received CE Mark for its Panbio™ COVID-19 Antigen Self-Test for sale directly to consumers for use in the detection of the SARS-CoV-2 virus in adults and children with or without symptoms. This over-the-counter approval paves the way for critical access to fast, reliable self-testing throughout Europe to reduce the spread of infection as economies reopen and daily life activities resume.
Frequent rapid testing at work, school, home and other facilities makes it possible for people to know their infection status when it matters most – making mass screening an essential tool in the mitigation of COVID-19 as restrictions lift and vaccines roll out. According to a recent study published in JAMA, at least 50% of COVID-19 infections are estimated to have originated from exposure to asymptomatic individuals. 1
Abbott's Panbio COVID-19 Antigen Self-Test arms people with timely health information to help reduce further spread of infection. The test delivers results in 15 minutes, is easy to use and features a minimally invasive nasal swab for self-collection of specimens. The test can be used on symptomatic or asymptomatic adults and children, including infants with an adult's support.
"We need to remain vigilant in identifying and slowing the spread of the virus to be successful in winning the fight against COVID-19 even as vaccines roll out," said Andrea Wainer, executive vice president, Rapid and Molecular Diagnostics, Abbott. "With CE Mark approval for the Panbio Self-Test, we are able to quickly get these critical rapid tests into the European countries and communities that need them to sustain the reopening of local economies and enable a safer return to work, school, sports, travel and other activities."
Restoring freedom and peace of mind through frequent, regular rapid testing
Rapid antigen testing is less expensive than PCR testing allowing people to test more frequently. While vaccines continue to roll out, the best way to curb the spread of infection is to regularly test people as they return to work or school and attend events and sports or opt to travel.
The Panbio Self-Test is already authorized for use in Germany and France as part of national testing programs in schools, universities and workplaces to test staff and students and restore continuity of in-person classes and safety. Abbott is the only diagnostics manufacturer to provide performance data on a rapid antigen test specific for use on children who are 15 years and younger, including infants.
In the German state of Bavaria, kindergarten students and staff are provided access to Abbott Panbio self-test kits to screen at the start of the week to quickly identify any contagious individuals and reduce the spread of infection.
In France, the Ministry of Education supplied Panbio Self-Tests to schools and universities as part of an overall prevention and control strategy enabling students, teachers and staff to return to school facilities with confidence and peace of mind.
Globally, the large number of COVID-19 cases and fear of disease spread has resulted in restrictions on travel, increased workplace absenteeism and the inability of employers to bring their employees back to the office. To help ensure business continuity and safety, many governments and employers are using the Panbio™ COVID-19 Antigen Rapid Test Device, for professional use, to facilitate mass screenings in airports, for cross-border travel, sporting events and other activities where people congregate in order to reopen and sustain operations.
Since last August to date, Abbott has shipped 300 million Panbio COVID-19 Antigen Rapid tests for professional use across Europe, the Americas, Asia and Africa.
Panbio delivers reliable performance for adults and children
Panbio COVID-19 Antigen is one of the mostly widely studied and used rapid antigen tests in the world.
In clinical evaluations of Panbio Covid-19 Rapid Antigen, performed by healthcare professionals, the test correctly identified 98.1% of positive specimens and 99.8% of negative specimens. All samples were confirmed negative or positive by an approved RT-PCR test.
In clinical evaluations with self-test users, the test correctly identified 95.2% of positive samples and 100% of negative samples. All samples were confirmed positive or negative by the Panbio COVID-19 Antigen Rapid Test Device (Nasopharyngeal).
Bringing affordable, reliable tests closer to home for more people
With CE Mark, the availability of Panbio COVID-19 Antigen Self-Tests can be offered for sale direct-to-consumer, increasing access to fast, reliable testing for more people.
Available in packages to support a variety of testing needs, the Panbio Self-Test comes in one, four, and 10 count test kits for individual and family or friends testing; it also comes in larger quantities of 20 test kits to meet school and workplace screening needs.
Panbio COVID-19 Antigen Self-Test is available in countries outside of the U.S.
About Panbio COVID-19 Antigen Tests
Panbio COVID-19 Antigen Rapid Self-Test is a lateral flow assay for rapid, qualitative detection of SARS-CoV-2 virus. A nasal swab is used for collection of specimens from individuals. Test results are delivered in as early as 15 minutes with no instrumentation.
Negative results must be combined with clinical observations, patient history and epidemiological information. Negative results do not preclude COVID-19 infection and cannot be used as the sole basis for treatment or other management decisions.
The Panbio COVID-19 Antigen Rapid Test Device for professional use is CE-Marked and has received World Health Organization (WHO) Emergency Use Listing for use on asymptomatic individuals and for self-collection of samples using a nasal swab under the supervision of a healthcare professional.
The professional test has data to support use on children 15 years and younger, including infants. Abbott has updated its existing label for use to include performance data in children and has submitted the updated label to the WHO for EUL.
The Abbott Panbio COVID-19 Antigen Rapid Test Device and Panbio COVID-19 Antigen Self-Test are available in countries outside of the U.S. and subject to local regulatory and commercialization requirements.
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 109,000 colleagues serve people in more than 160 countries.
Roche’s Actemra/RoActemra receives U.S. FDA Emergency Use Authorization for the treatment of COVID-19 in hospitalised adults and children
25 June 2021 - The authorisation enables emergency use of Actemra/RoActemra for the treatment of COVID-19 in hospitalised adult and paediatric patients
Basel, 25 June 2021 -- Roche announced today that the U.S. Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) for intravenous Actemra/RoActemra® (tocilizumab) for the treatment of COVID-19 in hospitalised adults and paediatric patients (two years of age and older) who are receiving systemic corticosteroids and require supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO). The EUA is based on results from four randomised, controlled studies that evaluated Actemra/RoActemra for the treatment of COVID-19 in more than 5,500 hospitalised patients. The results of these studies suggest that Actemra/RoActemra may improve outcomes in patients receiving corticosteroids and requiring supplemental oxygen or breathing support.
“Even with the availability of vaccines and declines in deaths from COVID-19 in various parts of the world, we continue to see new hospitalisations from severe forms of the disease,” said Levi Garraway, M.D., Ph.D., Roche’s Chief Medical Officer and Head of Global Product Development. “We are pleased that Actemra/RoActemra is now authorised as an option that may help improve outcomes for adults and children hospitalised with COVID-19 in the United States.”
The four randomised, controlled studies included in the EUA submission investigated the safety and efficacy of Actemra/RoActemra in more than 5,500 hospitalised patients with COVID-19. The RECOVERY Actemra/RoActemra study was led by researchers in the United Kingdom and included more than 4,000 hospitalised COVID-19 patients. Roche-sponsored global trials included the placebo-controlled EMPACTA, COVACTA and REMDACTA studies. There have been no new safety signals identified for Actemra/RoActemra in any of these studies. The most common adverse reactions seen (incidence ≥ 3%) are constipation, anxiety, diarrhoea, insomnia, hypertension and nausea.
The U.S. FDA Letter of Authorisation and Fact Sheets for patients and health care professionals are available for download with the latest information on this EUA. For more information on how Roche is responding to the global COVID-19 pandemic, please visit our COVID-19 response page.
In these exceptional times, Roche stands together with society, governments, healthcare providers and all those working to overcome the pandemic.
About the Emergency Use Authorization (EUA) for Actemra/RoActemra
Actemra/RoActemra has not been approved by the U.S. FDA in this setting, but the U.S. FDA has made Actemra/RoActemra available under an emergency access mechanism called an EUA as a treatment for certain patients with COVID-19. There is limited information known about the safety or effectiveness of using Actemra/RoActemra to treat people in the hospital with COVID-19. The EUA is supported by a Secretary of Health and Human Services (HHS) declaration that circumstances exist to justify the emergency use of drugs and biological products during the COVID-19 pandemic. The authorisation is temporary and does not replace the formal review and approval process. Actemra/RoActemra is authorised under the EUA only for the duration of the declaration that circumstances exist justifying the authorisation of the emergency use of Actemra/RoActemra under Section 564(b)(1) of the Act, 21 U.S.C.§ 360bbb-3(b)(1), unless the authorisation is terminated or revoked sooner. Roche has existing distribution channels established to ship Actemra/RoActemra to hospitals across the United States.
About the Actemra/RoActemra COVID-19 Clinical Trial Programme
Roche’s clinical trial programme evaluated the safety and efficacy of Actemra/RoActemra in hospitalised patients with COVID-19. Actemra/RoActemra is not approved for this use in any country and there is limited information known about the safety or effectiveness of using Actemra to treat people in the hospital with COVID-19. COVACTA and EMPACTA were the first two global phase III, multicentre, randomised, placebo-controlled studies of Actemra/RoActemra in patients hospitalised with COVID-19 associated pneumonia. COVACTA 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 (HHS). EMPACTA aimed to address research questions about the safety and efficacy of Actemra in underserved populations by emphasising enrollment from minority patients often underrepresented in clinical trials. Both studies were published in the New England Journal of Medicine. Roche also partnered with Gilead Sciences, Inc., on REMDACTA, a phase III, randomised, double-blind, multicentre study to evaluate the safety and efficacy of Actemra/RoActemra plus Veklury® (remdesivir), versus placebo plus Veklury, in hospitalised patients with severe COVID-19 associated pneumonia.
About Actemra/RoActemra
Actemra/RoActemra was the first humanised interleukin-6 (IL-6) receptor antagonist approved for the treatment of adult patients with moderately to severely active rheumatoid arthritis (RA) who have used one or more disease-modifying antirheumatic drugs (DMARDs), such as methotrexate (MTX), that did not provide enough relief. The extensive Actemra/RoActemra RA IV clinical development programme included five phase III clinical studies and enrolled more than 4,000 people with RA in 41 countries. The Actemra/RoActemra RA subcutaneous clinical development programme included two phase III clinical studies and enrolled more than 1,800 people with RA in 33 countries. Actemra/RoActemra subcutaneous injection is also approved for the treatment of adult patients with giant cell arteritis (GCA), for the treatment of patients two years of age and older with active polyarticular juvenile idiopathic arthritis (PJIA) or active systemic juvenile idiopathic arthritis (SJIA), and for slowing the rate of decline in pulmonary function in adult patients with systemic sclerosis-associated interstitial lung disease (SSc-ILD). In addition, Actemra/RoActemra is also approved in the IV formulation for patients two years of age and older with active PJIA, SJIA or CAR T cell-induced cytokine release syndrome (CRS). Actemra/RoActemra is not approved for subcutaneous use in people with CRS. It is not known if Actemra is safe and effective in children with PJIA, SJIA or CRS under two years of age or in children with conditions other than PJIA, SJIA or CRS. Actemra is intended for use under the guidance of a healthcare practitioner.
About Roche’s response to the COVID-19 pandemic
As a leading healthcare company we are doing all we can to support countries in their fight against COVID-19 and minimising its impact. We have developed a growing number of diagnostic solutions that help to detect and diagnose the infection, as well as providing digital support to healthcare systems. We also continue to identify, develop and support potential therapies which can play a role in treating the disease.
The impact of COVID-19 goes beyond those who contract it. That is why we are working with healthcare providers, laboratories, authorities and organisations to help make sure patients continue to receive the tests, treatment and care they need during these challenging times. Building on a longstanding tradition of partnerships, we are working together with governments and others to make healthcare stronger and more sustainable in the future.
Reliable, high-quality testing is essential to help healthcare systems overcome this pandemic and Roche has so far launched 16 diagnostics solutions to help minimise the impact of COVID-19. As soon as the novel SARS-CoV-2 virus was sequenced in early 2020, we got to work. On 13 March 2020 we became the first company to receive U.S. Food and Drug Administration (FDA) Emergency Use Authorization (EUA) for a high-volume molecular test to detect the virus. Since then, we have continued to add a range of diagnostics solutions to our global portfolio to help in the fight against COVID-19. In addition to the gold standard PCR test, we have developed antigen tests to help diagnose the virus in settings where there is limited molecular laboratory infrastructure, rapid antigen where the virus can be detected on the spot, tests that can test for both flu and COVID-19 at the same time, both high throughput and at the point of care, and tests that can detect virus antibodies that can help monitor the spread of the virus and can also support in vaccine development. On 16 March 2021 the SARS-CoV-2 variant test was launched, designed to detect key spike mutations.
Aside from these tests we have also looked at how we can support care for patients who have COVID-19, receiving an U.S. 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, a digital algorithm that could help simplify the screening, diagnosis and monitoring of respiratory-compromised patients with COVID-19. Roche is working closely with governments and health authorities around the world, and has significantly increased production to support availability of tests globally.
Roche is actively involved in understanding the potential of the existing portfolio and is researching options for the future. In 2020, Roche entered into a number of new partnerships, including with Gilead, Regeneron and Atea, to develop, manufacture and distribute molecules that can potentially both treat and prevent COVID-19.
In October, Roche announced a partnership with Atea Pharmaceuticals to jointly develop the investigational compound AT-527. If approved, Atea will distribute AT-527 in the United States (US) and Roche will be responsible for global manufacturing and distribution outside the US. Atea’s compound has the potential to be the first oral antiviral to treat COVID-19 patients outside the hospital setting as well as in the hospital. Its anticipated formulation (pill) may help to facilitate access to a broad patient population.
In November, our partner Regeneron received U.S. FDA EUA for casirivimab and imdevimab, its investigational antiviral antibody combination, for the treatment of recently diagnosed patients with mild to moderate COVID-19 who are at high risk of progressing to severe COVID-19 and/or hospitalisation. The antibody cocktail has been studied in two phase I-III adaptive clinical trials for the treatment of COVID-19 and in a phase III trial for the prevention of the disease. As part of the global partnership with Regeneron, we are committing a significant amount of manufacturing capacity and are working to expand supply of this antibody combination beyond the US to as many people as possible.
In addition, we are exploring the potential of our investigational molecules and existing portfolio: For example, Roche has initiated three global phase III clinical trials investigating the safety and efficacy of Actemra/RoActemra in COVID-19 associated pneumonia (COVACTA, EMPACTA and REMDACTA). Roche will continue to monitor the evolving clinical evidence for Actemra/RoActemra in this setting.
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, as well as growing capabilities in the area of data-driven medical insights help Roche deliver truly personalised healthcare. Roche is working with partners across the healthcare sector to provide the best care for each person.
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. In recent years, Roche has invested in genomic profiling and real-world data partnerships and has become an industry-leading partner for medical insights.
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 2020 employed more than 100,000 people worldwide. In 2020, Roche invested CHF 12.2 billion in R&D and posted sales of CHF 58.3 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-2021-06-25.htm
Late-breaking data demonstrate Abbott's FreeStyle® Libre System supports health equity for millions of americans living with diabetes
25 June 2021 - Comparative data presented at the American Diabetes Association 81st Scientific Sessions show Abbott's diabetes technology delivers the same reductions of HbA1c and acute complications as the competitor systems while reaching a much wider, more diverse population. Priced at a third of the cost of other available continuous glucose monitoring systems, data suggests increasing use of FreeStyle Libre system could save Medicaid millions annually by reducing costly complications. The groundbreaking FreeStyle Libre portfolio has been extensively studied with real-world data from more than 1 million users and clinical evidence, showing it helps people with diabetes significantly improve their health and quality of life.
ABBOTT PARK, Ill., June 25, 2021 -- Abbott today announced late-breaking data that showed FreeStyle Libre, the world's leading continuous glucose monitoring (CGM) system, can support health equity through access to more affordable, life-changing technology for Americans living with diabetes, including those in underserved communities.
Presented at the American Diabetes Association® (ADA) 81st Scientific Sessions, the data demonstrate meaningful outcomes for people with diabetes using FreeStyle Libre system, including reductions in HbA1C levels, acute diabetes events and all-cause hospitalizations. Globally priced at a third of the cost of other CGMs, the FreeStyle Libre technology is widely available to people with diabetes, reaching more diverse and at-risk populations than other systems. Notable findings include:
- FreeStyle Libre users reflect the diverse population of people with type 1 and type 2 diabetes (Abstract 67-LB, Abstract 68-LB): In comparative real-world data for U.S.-only matched patient groups, the FreeStyle Libre system was shown to achieve the same health benefits, including reductions in HbA1C levels and acute complications (hypoglycemia and hyperglycemia), while being accessible to a greater population of people with diabetes compared to other competitor CGM systems. Demographic data from these studies show that FreeStyle Libre users more closely represent America's diverse type 1 and type 2 diabetes population, including older people, those living in rural areas, people of color and those with higher rates of comorbidities.
- Increased use of CGM could save Medicaid millions annually while reducing complications (Abstract 136-LB): Using a CGM compared to traditional blood glucose monitoring with fingersticks can reduce potentially harmful and expensive complications, leading to an overall cost savings for individuals living with type 1 and type 2 diabetes. Cost analysis data showed that increasing the population of FreeStyle Libre users by 10% could save the Medicaid budget $23 million in one year due to the reduction in complications.
"Abbott is helping to close the health disparity gap for the millions of people living with diabetes. We designed FreeStyle Libre system to be broadly accessible to all those who need it, no matter a person's income level, race or background," said Mahmood Kazemi, M.D., divisional vice president, global medical and scientific affairs and chief medical officer, Diabetes Care, Abbott. "This new data adds to the unparalleled clinical evidence and real-world data from more than 1 million users demonstrating the positive impacts — in both health and equity — that come from the significant cost-savings of Abbott's life-changing continuous glucose monitoring technology."
Supporting Health Equity
Despite technological advancements in diabetes care, health inequity is increasing across many underserved populations, including low-income families, individuals with disabilities, older adults and people of color. Individuals with diabetes span a diverse population and it is critical that everyone living with diabetes has access to affordable and easy-to-use CGM systems that work.
More than 75 million Americans rely on Medicaid. This often-overlooked population is twice as likely to be living with diabetes and CGM access is limited by many state Medicaid programs. The median percentage of Medicaid beneficiaries with HbA1c of more than 9% (indicating poor control of diabetes) is about 39%, more than double the corresponding national average of 16%.
"For millions of people living with diabetes, systemic disparities are limiting access to healthcare resources, diabetes education, care and technology," said James R. Gavin III, MD, PhD, clinical professor of medicine at Emory University and chief medical officer of Healing Our Village, Inc. in Atlanta. "By opening the vital gateway to access, including to technology to monitor glucose continuously, we can drive improved health outcomes, stabilize glucose levels and keep people out of the hospital."
To further address the health and economic disparities, Abbott committed $5 million over three years to support the ADA's Health Equity Now initiative that champions the right for all people with diabetes to access better care and the latest medical advances. This includes community initiatives and efforts to support low-income Americans – of which more than 75% are made up of people of color – with access to the latest technologies.
"The COVID-19 pandemic has brought increased attention to the significant health disparities faced by millions of people from low-income and underserved communities across America, and has put a spotlight on the additional challenges faced by the particularly underserved population with diabetes," said Tracey D. Brown, chief executive officer, American Diabetes Association.
"Access is at the center point of how we can bridge the inequity gap for people with diabetes. Everyone living with diabetes should be able to lead healthy, full lives and that begins with ensuring widespread access to the latest technologies, including continuous glucose monitoring technology."
About the FreeStyle Libre Portfolio:
Abbott's FreeStyle Libre portfolio, the world's leading continuous glucose monitoring system, has changed the lives of more than 3 million people across more than 50 countries by delivering breakthrough technology that is accessible and affordable. FreeStyle Libre provides glucose readings and trends every minute through a sensor that is worn on the back of the upper arm and scanned with a reader or phone, eliminating the need for fingerstick. Abbott has secured partial or full reimbursement for the FreeStyle Libre system in 38 countries, including France, Ireland, Japan, the United Kingdom, and the U.S.
INDICATIONS AND IMPORTANT SAFETY INFORMATION
FreeStyle Libre 14 day system: Failure to use FreeStyle Libre 14 day system as instructed in labeling may result in missing a severe low or high glucose event and/or making a treatment decision, resulting in injury. If readings do not match symptoms or expectations, use a fingerstick value from a blood glucose meter for treatment decisions. Seek medical attention when appropriate or contact Abbott at 855-632-8658 or https://www.FreeStyle.abbott/us-en/safetyinformation.html for safety info.
FreeStyle Libre 2 system: Failure to use FreeStyle Libre 2 system as instructed in labeling may result in missing a severe low or high glucose event and/or making a treatment decision, resulting in injury. If glucose alarms and readings do not match symptoms or expectations, use a fingerstick value from a blood glucose meter for treatment decisions. Seek medical attention when appropriate or contact Abbott at 855-632-8658 or https://www.FreeStyle.abbott/us-en/safetyinformation.html for safety info.
About Abbott:
Abbott has a clear focus on innovating for access and affordability, with the goal of improving the lives of more than a third of all the people on Earth each year through its 2030 Sustainability Plan. An important part of this work is advancing health equity, working side-by-side with the communities we serve to address health disparities and tackle barriers to health. This includes efforts across our business and in partnership with others to expand access to technology, quality care and nutrition, and to advance STEM and health education to inspire a diverse and innovative next generation. To learn more, please visit abbott.com/sustainability.
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 109,000 colleagues serve people in more than 160 countries.
BGI Gets CE Mark for EasyNAT SARS-CoV-2 RNA Test
25 June 2021 - BGI Genomics Co. LTD., announces that its EasyNAT SARS-CoV-2 RNA Test has been CE marked
25 June 2021 -- BGI Genomics Co. LTD., announces that its EasyNAT SARS-CoV-2 RNA Test has been CE marked. It is difficult to differentiate between SARS-CoV-2 and respiratory infections caused by other pathogens through clinical manifestations because of the similar early symptoms. The EasyNAT SARS-CoV-2 RNA Test uses self-driven microfluidic technology to provide rapid and accurate detection of SARS-CoV-2 nucleic acid.
The kit produced by BGI PathoGenesis Pharmaceutical Technology Co., Ltd., a subsidiary of BGI Genomics, is a qualitative in vitro nucleic acid amplification assay to detect SARS-CoV-2 in the specimen of anterior nasal swab from suspect people infected with the virus, like those clustering cases and those under investigation.
The kit especially provides convenience for non-professional laboratories and primary health care institutions to conduct accurate nucleic acid testing, and also expands the application of coronavirus nucleic acid testing.
Reference: https://www.bgi.com/global/company/news/bgi-gets-ce-mark-for-easynat-sars-cov-2-rna-test/
With Lyme disease on the rise nationwide, Quidel corporation urges early testing with its rapid point-of-care test
24 June 2021
SAN DIEGO, 24 June 2021 -- As America approaches the tail end of the COVID-19 pandemic, a quiet epidemic has emerged that has the potential to affect as many as 476,000 citizens before the year is out. The epidemic is Lyme disease, which is being identified in record numbers throughout the country.
Researchers at such institutions as Johns Hopkins, Colorado State University and SUNY Upstate Medical University in Syracuse are all reporting an increased spread of Lyme disease. And they are finding it not only in the woodlands of New England and other forested regions as typically expected but in frightening and unexpected numbers on the beaches in Northern California, throughout the southwest and southeast and other parts of the country where reported cases are on the rise.
One suspected reason for the uptick is the pandemic itself, which drove people to spend more time walking outdoors and now, with restrictions being lifted, are seeing these people hitting the road for open-air destinations throughout the country. To complicate matters, this past winter was one of the warmest on record; and lingering summer heat added weeks of outdoor activity to animals that carry ticks and which thrive in hot, humid conditions. Pests.org, which produces an annual 2021 Tick Forecast, projects that “most states will experience the warmer, wetter conditions that drive tick populations—and the prospect of tick-borne diseases—skyward.”
As the prevalence and fear of Lyme disease intensifies, one thing that all experts agree on is the need for testing immediately if there are signs that someone may have contracted Lyme disease. These signs may include fever, headache, fatigue, joint pain, weakness in the limbs and often a characteristic skin rash with a bull's-eye pattern.
For accurate and fast testing, more and more clinicians are turning to the Sofia® 2 Lyme FIA by Quidel. This revolutionary test provides the patient and physician with indicative results within 15 minutes, as opposed to days, which has historically been the norm (and during which time organisms can spread and become systemic). It can be performed in the privacy of a doctor’s office, local clinic or even by a nurse at a children’s summer camp; and it is the only test that can get results from a simple finger prick of blood.
“Not having to wait days for test results allows physicians and nurse practitioners to treat patients with positive results more rapidly while more quickly pursuing other diagnosis and treatment for those who test negative,” said Judi Tilghman, Ph.D., vice president of technology assessment at Quidel Corporation. “For patients with a positive finding for Lyme, early treatment is the key; and excellent outcomes are common thanks to fabulous antibiotics now available. But if left undiagnosed or untreated, Lyme disease can lead to unintended consequences including neurological defects, heart problems (such as an irregular heartbeat), eye inflammation, liver inflammation, Bell’s palsy, meningitis and severe fatigue.”
One fear that some researchers have is that some people experiencing symptoms of Lyme may have been reluctant to seek medical care over the past year, given their concerns about exposure to COVID at the doctor’s office or clinic. This could result in cases going undiagnosed and untreated, which makes Lyme disease much more serious and harder to treat later on.
“As with all afflictions, the key is catching it early so effective treatment can begin as soon as possible,” said Dr. Tilghman. “Lyme disease can affect people of any age or gender. People should not hesitate to get tested, and physicians should have their radar up for signs of Lyme disease in their patients. With the general population’s increased awareness of Lyme disease, along with increased clinical awareness in the importance of early testing for tick-borne infections, later stages of Lyme disease and the life-threatening effects that accompany them should never happen.”
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.
bioMérieux launches EPISEQ® SARS-COV-2, a cloud-based software application for the epidemiological surveillance of SARS-CoV-2 variants
24 June 2021 - bioMérieux, a world leader in the field of in vitro diagnostics, has launched EPISEQ® SARS-COV-2, a genomic software solution to support microbiology labs in identification and reporting from raw sequencing data related to SARS-CoV-2 variants
24 June 2021 -- Viral mutation is a naturally occurring phenomenon leading to the emergence of variants that can have different characteristics. Today, a number of SARS-CoV-2 variants are circulating worldwide. Some of these variants are under particular scrutiny because of their impact on the pandemic (increased infectiousness or severity of infection, possible vaccine escape). Genomic surveillance of mutant circulation is therefore essential for public health.
Launched worldwide, EPISEQ® SARS-COV-2 is a new application, intended to identify SARS-CoV-2 variants using samples from positive patients. Automatically updated each week, the platform identifies variants based on international nomenclatures* including any new variant of concern (VOC) as defined by the World Health Organization and the US Centers for Disease Control and Prevention.
EPISEQ® SARS-COV-2 is compatible with three major sequencing platforms (Illumina, Oxford Nanopore, Thermo Fisher) and easy to use by any microbiology lab without bioinformatics knowledge or computing resources.
The application permits the export of viral genome assemblies and mutations in order to facilitate reporting to national public health authorities and for epidemiology studies.
“Microbiologists today deal with extensive data sets and need to translate these into meaningful information that impacts clinical decisions and public health actions. EPISEQ® SARS-COV-2 responds entirely to that challenge. It enables the in-depth analysis of complex viral genetic sequencing data without any need for specific bioinformatics competencies or major hardware investments.” noted Mark Miller, Executive Vice President, Chief Medical Officer.
Drawing on its expertise in microbiology and informatics, bioMérieux has developed BIOMÉRIEUX EPISEQ®, a genomic cloud-based computing platform that supports laboratories in the utilization of next generation sequencing (NGS) technologies and interpretation of its outcome. Multiple NGS- and cloud-based software modules are being developed on this platform.
“bioMérieux’s strategy is to leverage the tremendous potential of diagnostics data to support the fight against infectious diseases. Hence, we decided earlier this year to draw on our broad and deep expertise in the fields of data science, software development and bioinformatics in order to develop an easy-to-use application to serve our customers using next generation sequencing to identify SARS-CoV-2 variants.” said Pierre Boulud, Chief Operating Officer, Clinical Operations.
ALM-Update: SARS-CoV-2-Neuinfektionen weiter rückläufig – Delta-Variante breitet sich weiter aus
23 June 2021
23 June 2021 -- Die aktuellen Zahlen der wöchentlichen ALM-Datenhebung zum SARS-CoV-2-Testgeschehen bestätigen den Trend der letzten Wochen: Die Zahl der mit COVID-19 infizierten Menschen sinkt stetig, gleichzeitig steigt der Anteil der Delta-Variante bei den Neuinfektionen deutlich an. Nach der aktuellen Datenanalyse der Akkreditierten Labore in der Medizin – ALM e.V. aus der 24. Kalenderwoche sank der Prozentsatz der positiven SARS-CoV-2-PCR-Befunde abermals – von 2,5 Prozent auf nun 1,5 Prozent. Von den 643.824 SARS-CoV-2-PCR-Befunden (Vorwoche: 715.763) fielen 9.691 positiv aus (Vorwoche: 17.579). Das entspricht einem Rückgang um 45 Prozent.
Weiterhin melden die an der Datenerhebung teilnehmenden 178 Labore aus dem ambulanten und stationären Bereich gleichbleibende Testkapazitäten. Diese würden zur Sicherstellung der SARS-CoV-2-Diagnostik für die Bürger*innen auch weiterhin aufrechterhalten. „Die Delta-Variante breitet sich ähnlich dynamisch aus wie die Alpha-Variante zu Jahresbeginn. Und deswegen ist bei aller Freude über die sinkende Inzidenz weiterhin Vorsicht geboten. Nur insgesamt und gemeinsam können wir als Gesellschaft durch weiterhin besonnenes Verhalten das weitere Infektionsgeschehen auf einem für uns günstigen niedrigen Niveau halten“, erklärt Dr. Michael Müller.
Hologic Receives European CE Mark for Molecular Assay to Quantify Human Cytomegalovirus
23 June 2021 - Aptima ® CMV Quant Assay is Hologic’s first test for transplant pathogen monitoring
MARLBOROUGH, Mass., 23 June 2021 -- Hologic, Inc. has received CE mark for its new Aptima® CMV Quant assay in Europe, the Company announced today. This assay, which quantifies the viral load of human cytomegalovirus (CMV), is intended for use to aid in the diagnosis and management of solid-organ transplant patients and hematopoietic stem cell transplant patients. This in vitro nucleic acid amplification test (NAAT) uses real-time transcription-mediated amplification (TMA) technology on the fully automated Panther® system and can be used with human plasma and whole blood samples.
“Immunocompromised patients are vulnerable to a range of infections, with CMV a frequent complication, and healthcare providers need to quantify and monitor CMV accurately,” said Jan Verstreken, group president, International. “Our Aptima CMV Quant assay is the first in a new line of Hologic assays for transplant patients and demonstrates our commitment to our laboratory partners to expand our molecular diagnostics business into new segments.”
Human CMV is a common DNA virus that belongs to the herpes family. Its prevalence in the population ranges from 45 to 100% worldwide. CMV infections are typically mild or asymptomatic in people with normal immune systems. However, in immunocompromised people such as transplant recipients, CMV is a common cause of morbidity and mortality. CMV, like other herpes viruses, may cause a lifelong latent infection that can sporadically reactivate. In transplant recipients, transfer of latent CMV in the graft or reactivation of latent CMV infection in the host may result in widespread viral replication and dissemination to multiple organs, which is often life-threatening.
As higher viral loads generally correlate to an increased risk of CMV disease, it is crucial that CMV levels are quantitated in transplant patients, in conjunction with monitoring clinical presentation and other laboratory markers. Recent guidelines recommend at least weekly monitoring of CMV viral load post-transplant to guide decisions about starting anti-CMV therapy as well as to monitor response to therapy. Quantitative nucleic acid amplification testing is the preferred method as it is both rapid and sensitive.
For more information on the Aptima assays, visit www.hologic.com.
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.
Thermo Fisher Scientific Launches CE-IVD-Marked Next-Generation TaqPath COVID-19 2.0 Test
22 June 2021 - Updated version of highly sensitive and accurate COVID-19 PCR kit accounts for known and future viral mutations
INCHINNAN, Scotland, June 22, 2021 -- Thermo Fisher Scientific, the world leader in serving science, today announced the launch of a new CE-IVD-marked COVID-19 test. The TaqPath COVID-19 Fast PCR Combo Kit 2.0. expands Thermo Fisher's menu of highly accurate tests that detect active SARS-CoV-2 infections.
The kit uses an advanced assay design which compensates for current and emerging variants by using eight total targets across three genomic regions of the virus. This approach helps to ensure the test provides accurate results even as the virus that causes COVID-19 continues to mutate.
"COVID-19 variants can be more transmissible and potentially impact efficacy of diagnostics, vaccines and therapies, threatening to reverse progress made in the past year," said Manoj Gandhi, M.D., Ph.D., senior medical director, genetic sciences for Thermo Fisher. "We are working to empower our customers to prepare for the next stage of the pandemic by future-proofing our test design against likely mutations and to provide continued confidence in their results."
The TaqPath COVID-19 Fast PCR Combo Kit 2.0 test assesses raw saliva directly with a turnaround time of two hours to enable widespread, high-frequency testing. The first generation TaqPath COVID-19 CE-IVD RT PCR Kit and the TaqPath COVID-19 Combo Kit, which use a different assay design, respectively, received initial CE-IVD certification and Emergency Use Authorization from the U.S. Food and Drug Administration (FDA) in March 2020.
For more information on the TaqPath platform, please visit: www.thermofisher.com/covid19evolved
About Thermo Fisher Scientific
Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $30 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 80,000 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.
Sysmex launches HISCL™-5000 and the HISCL™ SARS-CoV-2 Ag Assay Kit in EMEA
18 June 2021 - Sysmex Europe GmbH announces the launch of the HISCL™-5000 fully automated random-access immunochemistry analyser and the HISCL™ SARS-COV-2 Ag Assay Kit in the EMEA region
Norderstedt, Germany, 18 June 2021 – Sysmex Europe GmbH announces the launch of the HISCL™- 5000 fully automated random-access immunochemistry analyser and the HISCL™ SARS-CoV-2 Ag Assay Kit in the EMEA region. Sysmex supports healthcare workers in fighting the pandemic with a range of different testing solutions, depending on the different global regions. By launching HISCL™-5000 conjointly with the HISCL™ SARS-CoV-2 Ag Assay Kit, Sysmex aims to provide medium- and high-throughput clinical laboratories in EMEA with a diagnostic solution that can meet the growing demand for workflow consolidation and testing efficiency in the evolving pandemic situation. It is based on a fast and strong immunochemistry analyser that is easy to use and employs technology trusted by customers across the globe.
HISCL™-5000 – the instrument
The HISCL™-5000 helps manage results in only 17 minutes from the start of testing and meet the need for a smooth workflow in the laboratory. HISCL™-5000’s smart measurement technology using the CLEIA (chemiluminescent enzyme immunoassay) principle with the CDP-Star® substrate provides high sensitivity, while the effective reduction of background signals, thanks to the ‘bound-and-free’ washing separation, results in high specificity. Altogether, this technology helps deliver excellent results for peace of mind.
HISCL™ SARS-CoV-2 Ag Assay Kit
HISCL™ SARS-CoV-2 Ag Assay Kit in conjunction with the HISCL™-5000 analyser detects antigens of SARS-CoV-2 with a clinical sensitivity of 100% compared with RT-PCR (Ct <30) and a clinical specificity of overall 100% in comparison with RT-PCR results. The HISCL™ SARS CoV-2 Ag Assay Kit not only detects the virus in samples from nasopharyngeal and nasal swabs but also improves testing efficiency by delivering fast test results in just 17 minutes and making use of HISCL™-5000’s capability of processing up to 200 tests per hour.
The test aims to aid diagnosis of suspected SARS-CoV-2 infection. The HISCL™ SARS-CoV-2 Ag Assay Kit provides laboratories with a robust solution to deliver reliable and fast results while increasing their testing capacity, and so further assisting local healthcare systems in smoothing their SARS-CoV-2 testing workflow.
Product overview
Product name:
HISCL™ SARS-CoV-2 Ag Assay Kit (Item code: BC429960)
HISCL™ SARS-CoV-2 Ag Calibrator (Item code: AH270120
HISCL™ SARS-CoV-2 Ag Control (Item code: BK261298)
Manufactured by / marketed by: Sysmex Corporation / Sysmex Europe GmbH
Applicable instruments: HISCL™-5000 (Item code: AF022051)
Related products: Extract Solution (Item code: AD578612)
About Sysmex Europe GmbH
Sysmex supports healthcare professionals around the world in lighting the way with diagnostics by providing a broad range of medical diagnostics products and solutions. In the fields of haematology, urinalysis, haemostasis, life science, flow cytometry, essential healthcare and now immunochemistry, we combine highly dependable, multi-functional and easy-to-operate instruments, a variety of reagents and software, plus reliable service and support. Sysmex Europe GmbH, located near Hamburg, Germany, is a subsidiary of the Sysmex Corporation from Kobe, Japan. From our Hamburg offices, we serve our affiliates, distributors and customers throughout Europe, the Middle East, and Africa (EMEA). For more information, visit www.sysmexeurope.com.
BGI Australia Contributes to Safeguarding Queensland from COVID-19
17 June 2021
BRISBANE, 17th Jun, 2021 — Amid the growing concern from the emergence of the highly contagious COVID-19 Delta variant in Victoria, Queensland tightens border restrictions and sustains adequate local testing capacity to keep Queenslanders safe. BGI Australia is proud to be the supplier for Pathology Queensland’s testing equipment and kits, contributing to safeguarding the people living in Queensland.
BGI’s proprietary COVID-19 Testing Solution installed in the Pathology Queensland Infectious Diseases Lab (IDL) in Herston Health Precinct officially started operating in April by running saliva samples that are collected from across the river city. Within two weeks, the lab added nasopharyngeal and oropharyngeal samples to the list of sample types. The “BGI system” as dubbed by the lab staff, surpassed the 10,000 test milestone in less than a month. The integrated system is expected to handle 4,700 tests daily at maximum capacity, with a 24-hour
turnaround time from swab collection at a clinic or hospital, to reported result.
Dr. Ian Mackay, the IDL’s Senior Molecular Scientist said, “our approach is to establish a diverse portfolio of advanced technologies to best serve Queenslanders. We appreciate how quickly the BGI team respond to our ongoing technical needs and how efficiently the equipment and testing kits were supplied. We are handling approximately 1,100 tests per day as there’s no community transmission in the Brisbane region, but the number we process continues to grow and we are well placed to respond should any new clusters occur in Brisbane’s future.”
With a local team of technical specialists and engineers, BGI Australia offers strong support to customers across Australia. Dr. Bicheng Yang, Director of BGI Australia, said “This project is very special for us as Brisbane is our home city, where most of the team members are based, and we are located in the same building as IDL. This certainly will benefit response time and service to ensure that everything runs smoothly and sustains the highest quality to deliver reliable results for the tests.”
The efficient, safe and reliable BGI COVID-19 Testing Solution used in the IDL covers the full testing workflow from sample transfer, RNA extraction, pre-PCR preparation to Q-PCR (quantitative polymerase chain reaction) test. The Solution incorporates MGI’s innovative high-throughput automation systems – MGISTP-7000 for sample transfer and MGISP-960 for sample preparation, and BGI Genomics’ Q-PCR instruments and real-time fluorescent Q-PCR kits for detecting SARS-CoV-2. All the products are registered in the Australian Register of Therapeutic Goods (ARTG) and have been widely used over the past year across Australia under the Security Through Accelerated Testing Initiative.
The automation systems used in the workflow minimise the need for manual handling of the samples, minimise the labour required, and significantly shorten the time required to transfer and prepare the samples, thus improving the operational efficiency and testing throughput. The running time has been optimised to return test results within 12-24 hours after sample arrival at the IDL.
Integrating tube decapping, tube recapping, barcode identification, automated liquid transfer, and negative pressure protection, MGISTP-7000 can transfer 192 samples from swab sample tubes or plain tubes to 96-Well Microplates in 40 minutes. MGISP-960 is an automated workstation with a 96-channel pipettor head, used to extract nucleic acid, or the genetic material from the sample, and it can accommodate different sample batches to process 192 samples in 80 minutes or 32-96 samples in under 55 minutes.
About BGI Australia
BGI Australia, a subsidiary of the BGI Group (BGI), was founded in Brisbane in 2016. Supercharged with BGI’s world-leading proprietary genetic sequencing platform DNBseq™, best-in-class bioinformatic analysis capabilities and innovative healthcare solutions, BGI Australia is dedicated to facilitating cutting-edge research in healthcare, agriculture,
environment and other related areas. BGI Australia is continuously seeking collaborative opportunities in the region to pursue scientific excellence by incorporating existing resources to contribute to the vision of using genomics to benefit the whole of mankind.
MGI, a member of the BGI Group, is committed to enabling effective and affordable healthcare solutions for all. Based on proprietary technology, MGI produces sequencing devices, equipment, consumables and reagents to support life science research, diagnostic pathology, medicine and healthcare.
BGI Genomics, a member of the BGI Group, is the world’s leading provider of genomic sequencing and proteomic services, now serving customers in more than 100 countries.
About Pathology Queensland
The Pathology Queensland (PQ) Infectious Diseases Laboratory (IDL) is a high-throughput molecular laboratory operating in Herston, with surge capacity to assist other PQ laboratories across Queensland. After receiving, registering, and processing swabs, the IDL uses multiple PCR-based testing systems to specifically and sensitively test for SARS-CoV-2 RNA, employing multiple platforms for redundancy. The IDL returns results within 24 hours of receiving samples and has the capacity to conduct evaluation, verification and validation studies.
PQ (part of Queensland Health), provides diagnostic pathology services to all Hospital and Health Services (HHS) across metro, regional and remote Queensland, offering laboratory services in the disciplines of anatomical pathology, chemical pathology, haematology, immunology, microbiology and genomics. PQ also provides an invaluable service to Queenslanders by supporting a coordinated response to incidents and disasters.
Pathology Queensland
- has laboratories located within 35 Queensland Health hospital facilities, providing 24/7 service every day of the year
- employs approximately 2,000 staff including specialist pathologists, registrars, scientists, technicians, laboratory assistants, and operational and support staff, across Queensland
- supports more than 450 point-of-care testing devices, extending access to pathology results in remote locations and after hours with testing at the patient’s bedside
- is involved with 70 per cent of all medical decisions and in all cancer diagnoses
- works alongside clinicians to better understand diseases, enable earlier diagnosis, inform treatment options and monitor disease progression
- is critical to the delivery of positive patient outcomes and plays a key role in delivering on Queensland Health’s commitment to achieve good health and well-being for all Queenslanders
- provides specialised testing services for samples referred from public and private pathology providers within Queensland and from interstate.
ALM-Update: Weiter Zuversicht bei rückläufiger Neu-Infektionszahl
16 June 2021
16 June 2021 -- Fast die Hälfte der Bürger*innen hat die erste Impfung gegen Corona erhalten, mehr als jeder Vierte ist vollständig geimpft. Schon werden Stimmen nach der Abschaffung der Maskenpflicht laut. Die Akkreditierten Labore in der Medizin warnen vor allzu schneller Vernachlässigung aller Corona-Schutzmaßnahmen – insbesondere der AHA-Regeln – auch bei weiter sinkenden Neu-Infektionszahlen. Nach der aktuellen Datenanalyse der Akkreditierten Labore in der Medizin – ALM e.V. verstetigt sich der rückläufige Trend im SARS-CoV-2-Infektionsgeschehen weiter: So zeigen die Auswertungen der KW 23, dass der Prozentsatz der positiven SARS-CoV-2-PCR-Befunde abermals – von 3,2 Prozent auf nun 2,5 Prozent – gesunken ist. Insgesamt 17.593 positive SARS-CoV-2-PCR-Tests meldeten die in der KW 23 an der Datenerhebung teilnehmenden 178 Labore aus dem ambulanten und stationären Bereich (Vorwoche: 25.062). Das ist ein Rückgang um 30 Prozent.
Auch die Zahl der insgesamt durchgeführten SARS-CoV-2-PCR-Tests sank erwartungsgemäß weiter, von 771.916 in der KW 22 auf nun 715.920 Tests. Dass die hohe Testkapazität von rund 2 Millionen PCR-Tests bei sinkender Auslastung trotzdem erhalten bleibt, ist ein nicht zu vernachlässigender Sicherheitsfaktor und eine bewusste Entscheidung der Facharztlabore. „Wir wissen nicht, wie sich die Delta-Variante weiter in Deutschland ausbreitet und wie sie das Infektionsgeschehen dadurch beeinflussen und dieses sich insgesamt entwickeln wird. Vorsicht ist also geboten, darum bleiben wir weiter vorbereitet“, so Dr. Michael Müller.
REGEN-COV™ (casirivimab and imdevimab) Phase 3 recovery trial meets primary outcome, improving survival in hospitalized COVID-19 patients lacking an immune response to SARS-COV-2
16 June 2021 - UK RECOVERY investigators found REGEN-COV reduced risk of death by 20% in patients hospitalized with COVID-19 who had not mounted their own immune response (primary outcome for the primary analysis population). First trial to demonstrate that any antibody treatment improved survival in patients hospitalized with COVID-19. Regeneron will share new data with regulatory authorities immediately and request that the U.S. EUA be expanded to include appropriate hospitalized patients.
TARRYTOWN, N.Y., June 16, 2021 -- Regeneron Pharmaceuticals, Inc. today welcomed positive results from the largest trial assessing any monoclonal antibody treatment in patients hospitalized with severe COVID-19. The UK RECOVERY trial found that adding investigational REGEN-COV™ to usual care reduced the risk of death by 20% in patients who had not mounted a natural antibody response on their own against SARS-CoV-2, compared to usual care on its own.
"These results are very exciting. The hope was that by giving a combination of antibodies targeting the SARS-CoV-2 virus we would be able to reduce the worst manifestations of COVID-19," said Sir Peter Horby, Professor of Emerging Infectious Diseases in the Nuffield Department of Medicine, University of Oxford, and Joint Chief Investigator for the RECOVERY trial. "There was, however, great uncertainty about the value of antiviral therapies in late-stage COVID-19 disease. It is wonderful to learn that even in advanced COVID-19 disease, targeting the virus can reduce mortality in patients who have failed to mount an antibody response of their own."
RECOVERY is the first trial large enough to definitively determine whether REGEN-COV reduces mortality in patients hospitalized with severe COVID-19. Previous Phase 3 trials in non-hospitalized COVID-19 patients have shown that REGEN-COV reduced viral levels, shortened the time to resolution of symptoms and significantly reduced the risk of hospitalization or death. In a Phase 1/2 trial in hospitalized patients, REGEN-COV also rapidly reduced viral levels, with preliminary evidence suggesting that it lowered the risk of death or receiving mechanical ventilation, with the benefit driven by patients who entered the trial without having mounted a natural antibody response of their own (seronegative); and in the absence of REGEN-COV treatment, seronegative patients had higher mortality rates than patients who had already mounted their own immune response (seropositive).
Based on the above Phase 1/2 data, the independently-run RECOVERY trial prospectively focused on seronegative patients. Similar to the prior trial, patients in RECOVERY who received usual care alone had double the mortality rate at day 28 if they were seronegative (30%) compared to seropositive (15%); approximately one-third of hospitalized patients were seronegative (n=3,153), one-half were seropositive (n=5,272) and one-sixth had unknown serostatus (n=1,360). The mean age of patients for this comparison was 62 years, and more than 90% received corticosteroids across all groups.
The primary outcome of RECOVERY showed that adding REGEN-COV 8,000 mg to usual care reduced all-cause mortality by 20% in seronegative patients (primary analysis population), compared to usual care alone (24% of patients in the REGEN-COV group died versus 30% in the usual care group by day 28; rate ratio [RR]: 0.80; 95% confidence interval [CI]: 0.70-0.91; p=0.001). When combining the larger seropositive group (as well as those with unknown status) with the seronegative patients, there was no longer a significant effect on 28-day mortality (overall 20% of patients in the REGEN-COV group died, versus 21% in the usual care group; RR: 0.96; 95% CI: 0.86-1.03; p=0.17).
"Definitive Phase 3 trials have now demonstrated that REGEN-COV can alter the course of COVID-19 infection from prevention, to very early infection, all the way through to when patients are on a ventilator in the hospital," said George D. Yancopoulos, M.D., Ph.D., President and Chief Scientific Officer at Regeneron. "We are incredibly grateful to the RECOVERY team, participating investigators and patients for conducting this in-depth analysis, and hope that the results mean that even more patients may soon be able to benefit from this life-saving medicine. We intend to rapidly discuss these results with regulatory authorities, including in the U.S. where we will ask for our EUA to be expanded to include appropriate hospitalized patients."
Among seronegative patients in the RECOVERY trial, the median duration of hospital stay was 4 days shorter in the REGEN-COV group (13 days versus 17 days), and the proportion of patients discharged alive by day 28 was greater (64% versus 58%; RR: 1.19; 95% CI: 1.08-1.30). Among the seronegative patients not on invasive mechanical ventilation at baseline, the risk of progressing to the composite endpoint of invasive mechanical ventilation or death was lower among the REGEN-COV group than the usual care group (30% versus 37%; RR: 0.83; 95% CI: 0.75-0.92). No such benefits were seen in the overall trial population (combining patients with negative, positive, or unknown serostatus).
"The RECOVERY trial has shown that in patients who had not made their own antibodies against SARS-CoV-2, treating them with REGEN-COV antibodies dramatically reduced their risk of dying or being on a ventilator, and also shortened how many days they remained in the hospital," said David Weinreich, M.D., Executive Vice President, Global Clinical Development at Regeneron. "The trial was conducted at a time when most patients had not been fully vaccinated. These results provide hope to patients who have a poor immune response to either the vaccine or natural infection, as well as those who are exposed to variants for whom their existing antibodies might be sub-optimal."
Multiple analyses, including a recent publication in Cell, have shown that REGEN-COV retains potency against the main variants of concern circulating within the U.S.; consequently, REGEN-COV remains available for use in all 50 states. REGEN-COV retains potency against variants including P.1 (first identified in Brazil, now classified by the World Health Organization [WHO] as Gamma), B.1.351 (first identified in South Africa, now classified by the WHO as Beta) and B.1.162.2 (first identified in India, now classified by the WHO as Delta). The combined frequency of the P.1 and B.1.351 variants now exceeds 10% of new COVID-19 diagnoses across eight states (Arizona, California, Florida, Illinois, Indiana, Massachusetts, Oregon and Washington), and the prevalence of these and other variants continues to be closely monitored.
Today's data in hospitalized patients follow multiple positive Phase 3 results earlier this year from Regeneron-sponsored trials assessing the ability of REGEN-COV to treat outpatients already infected with SARS-COV-2 (including symptomatic outpatients and recently infected asymptomatic patients), and also to prevent infection in close contacts of infected individuals. REGEN-COV has not been approved by the U.S. Food and Drug Administration (FDA), but is currently authorized in the U.S. under an Emergency Use Authorization (EUA) to treat mild-to-moderate COVID-19 in adults and pediatric patients (12 years of age and older weighing ≥40 kg) with positive results of direct SARS-CoV-2 viral testing, and who are at high risk for progression to severe COVID-19, including hospitalization or death. This use is authorized only for the duration of the declaration that circumstances exist justifying the authorization of the emergency use under section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.
Regeneron is in discussions with the FDA to expand the current EUA to other populations, including the prevention and hospitalized patient settings. Later this summer, Regeneron expects to submit a full Biologics License Application (BLA) for REGEN-COV.
Regeneron is collaborating with Roche to increase global supply of REGEN-COV. 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.
The development and manufacturing of REGEN-COV have been funded in part with federal funds from the Biomedical Advanced Research and Development Authority (BARDA), part of the U.S. Department of Health and Human Services' Office of the Assistant Secretary for Preparedness and Response, under OT number: HHSO100201700020C.
About the Trial
The RECOVERY trial (Randomised Evaluation of COVid-19 thERapY) was conducted by the registered clinical trials units in the Nuffield Department of Population Health in partnership with the Nuffield Department of Medicine. The trial was 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.
Between September 18, 2020 and May 22, 2021, 9,785 patients hospitalized with COVID-19 were randomly allocated to receive usual care plus REGEN-COV (8,000 mg by intravenous infusion) or usual care alone as part of the RECOVERY trial. Usual care was determined by individual facilities and clinicians, and could include steroids and remdesivir. Follow-up is complete for 99% of participants.
The trial involved 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.
About the REGEN-COV Antibody Cocktail
REGEN-COV (casirivimab and imdevimab) is a cocktail of two monoclonal antibodies (also known as REGN10933 and REGN10987) that was designed specifically to block infectivity of SARS-CoV-2, the virus that causes COVID-19, using Regeneron's proprietary VelocImmune® and VelociSuite® technologies. 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.
Under an EUA, REGEN-COV is available throughout the U.S. – information on availability in your area is available from the Department of Health and Human Services and the National Infusion Center Association. REGEN-COV can be administered by intravenous infusion (as short as 20 minutes) or by subcutaneous injection (four injections), which is an alternative when intravenous infusion is not feasible and would lead to a delay in treatment. It is now authorized as a co-formulated single vial, or in individual vials to be administered together.
In the U.S., REGEN-COV is 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.
About Regeneron's VelocImmune Technology
Regeneron's VelocImmune technology utilizes a proprietary genetically engineered mouse platform endowed with a genetically humanized immune system to produce optimized fully human antibodies. When Regeneron's President and Chief Scientific Officer George D. Yancopoulos was a graduate student with his mentor Frederick W. Alt in 1985, they were the first to envision making such a genetically humanized mouse, and Regeneron has spent decades inventing and developing VelocImmune and related VelociSuite technologies. Dr. Yancopoulos and his team have used VelocImmune technology to create approximately a quarter of all original, FDA-approved fully human monoclonal antibodies currently available. This includes REGEN‑COV (casirivimab and imdevimab), Dupixent® (dupilumab), Libtayo® (cemiplimab-rwlc), Praluent® (alirocumab), Kevzara® (sarilumab), Evkeeza® (evinacumab-dgnb) and Inmazeb™ (atoltivimab, maftivimab and odesivimab-ebgn).
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 nine FDA-approved treatments and numerous product candidates in development, almost 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, hematologic conditions, 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.
Quidel receives amended Emergency Use Authorization for new Sofia® Q Rapid Antigen Test Device
11 June 2021 - Sofia® Q device features a miniaturized, AI-powered design. Quidel plans initial release to professional and point-of-care segments with a goal of expansion to serve telemedicine and home markets.
SAN DIEGO, 11 June 2021 -- Quidel Corporation (“Quidel”), a provider of rapid diagnostic testing solutions, cellular-based virology assays and molecular diagnostic systems, announced today that Quidel has received an amended Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) allowing the company to market Sofia® Q, its latest addition to the Sofia® and Sofia® 2 line of Fluorescent Immunoassay Analyzers (FIA). Sofia Q features a sleek, miniaturized design that reads the same Sofia® SARS Antigen FIA tests as Sofia and Sofia 2 - with equal accuracy. Sales of Sofia Q device will initially be limited to use with the Sofia® SARS Antigen FIA in the CLIA and CLIA-waived professional segments.
Sofia Q is the latest product in Quidel’s best-selling Sofia instrumentation portfolio. Sofia Q utilizes Sofia® fluorescent technology to provide an accurate, objective, and automated result in 15 minutes. Quidel’s innovative design allows the Sofia Q device to be paired with the downloadable Sofia Q mobile application, which guides the user through the workflow and interprets the test result using a proprietary AI model.
“Sofia Q is our latest powerful diagnostic instrument designed to democratize access to the many benefits of our Sofia SARS rapid antigen tests and, ultimately, our full portfolio of Sofia tests for influenza, RSV, Strep and other conditions,” said Douglas Bryant, president and chief executive officer of Quidel Corporation. “We designed Sofia Q to be very affordably priced and conducive to widespread adoption across the ever-expanding global point-of-care and telemedicine marketplace. In the future, we believe Sofia Q will be ideal to serve consumers at home, as well as in schools and workplaces.”
In addition to the Sofia Q, Quidel offers other rapid diagnostic instrumented systems, including Sofia 2, and Sofia. Quidel’s Sofia assays for rapid antigen COVID-19 diagnosis include Sofia® 2 SARS Antigen FIA and Sofia® 2 Flu + SARS Antigen FIA, currently under EUA by the FDA. Quidel offers other FDA-cleared and CLIA-waived tests including 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 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.
SYNLAB bleibt offizieller COVID-19-Testpartner der UEFA in der Saison 2021/2022 und für die UEFA EURO 2020
11 June 2021 - SYNLAB, Europas führender Anbieter medizinischer Diagnostikdienstleistungen, und aktueller Diagnostikdienstleister der UEFA, des Dachverbandes des europäischen Fußballs, führt in der kommenden Fußballsaison erneut PCR-Testungen auf SARS-CoV-2 für Turnierspiele der UEFA durch.
11 June 2021 -- Nach Vereinbarung mit der UEFA wird SYNLAB als offizieller "UEFA Laboratory Diagnostics Provider 2021/2022" die Umsetzung des strengen "Return to Play"-Protokolls unterstützen, um die bestmögliche Sicherheit für Teams, Offizielle und den Mitarbeiterstab zu schaffen. Mit der Verlängerung der Zusammenarbeit wird SYNLAB sein umfassendes europäisches Labornetzwerk nutzen, um alle 24 Teams, Offizielle und Mitarbeiter an allen 11 Spielorten während der UEFA EURO 2020 regelmäßig zu testen. SYNLAB hat im Laufe der Saison 2020/2021 mehr als 160.000 PCR-Tests für Turnierspiele der UEFA erfolgreich durchgeführt. SYNLAB und seine Partnerlabore werden weiterhin alle Beteiligten vor jedem Spiel mit der PCR oder einer medizinisch gleichwertigen Testmethode auf SARS-CoV-2 testen.
Sysmex Obtains IVDR Certification for LYNOAMP (TM) CK19 E, a Gene Amplification Detection Reagent
11 June 2021 - Prompt response to legislative changes in the european region that demand greater product safety
11 June 2021 -- Sysmex Corporation (HQ: Kobe, Japan; Chairman and CEO: Hisashi Ietsugu) announced that the Company obtains the EU’s In Vitro Diagnostic Medical Devices Regulation (IVDR) certification, a first for one of our products, for the gene amplification detection reagent LYNOAMP CK19 E, which uses the OSNATM method developed by Sysmex as the measurement principle, from TÜV SÜD Product Service GmbH on June 4, 2021.
In the European region, the IVDR went into effect on May 26, 2017 to further improve the quality and safety of in vitro diagnostic medical devices. Manufacturers of in vitro diagnostic instruments and reagents are required to obtain certification based on an examination by a notified body designated by the European regulatory authority and to display the CE mark accordingly, in order to market, sell, and distribute their products within the European Economic Area.
With the aim of stably supplying products and services to its customers, Sysmex has been working with its European subsidiaries to rapidly respond to these important revisions in regulations, and has been building a system to promptly obtain the CE mark in accordance with the IVDR. Sysmex has capitalized on its network with key opinion leaders (KOLs), built up through activities aimed at increasing the clinical value of cancer lymph node metastasis testing, and has established robust clinical evidence by acquiring basic data and documenting the results of joint research.
On June 4, 2021, Sysmex acquired IVDR certification in Europe from the notified body TÜV SÜD Product Service GmbH for LYNOAMP CK19 E, a gene amplification detection reagent for the European market, as a Class C in vitro diagnostic medical device.
Sysmex has identified the “provision of responsible products and services” as materiality and is reinforcing its system to ensure the stable delivery of products and services to customers around the globe. Going forward, Sysmex will continue to acquire IVDR certification for the IVD products that the company provides across Europe in catering to various fields, and to contribute to human health by stably providing high-quality, high-value-added products to customers around the world.
Product Overview
- Brand name:LYNOAMPTM CK19 E
- Classification:Class C
- Target market: Europe
- Approval obtained:June 4, 2021
- Intended purpose: LYNOAMP CK19 E is an in vitro diagnostic reagent kit for detection and quantification of CK19 mRNA in surgically removed lymph node(s) lysate of breast, colorectal and gastric cancer patients as an aid to diagnosing the size of metastasis and metastatic burden in the lymph node(s). LYNOAMP CK19 E is intended for use on the Sysmex Gene Amplification Detectors. It shall be used by healthcare professionals and properly trained personnel
USA Swimming Partners with BD to Provide COVID-19 Screening for the Olympic Trials and Other Competitive Swimming Events
11 June 2021
FRANKLIN LAKES, N.J., June 11, 2021 -- USA Swimming, the national governing body for the sport of swimming in the United States, and BD (Becton, Dickinson and Company), a leading global medical technology company, have partnered to provide COVID-19 testing at USA Swimming events.
Specifically, rapid antigen tests using the BD Veritor™ Plus System will be conducted at the U.S. Olympic Team Trials – Swimming as an additional safety measure beyond the polymerase chain reaction (PCR) testing that will also be a part of USA Swimming's COVID-19 mitigation efforts. These tests will also be utilized at 2021-2022 USA Swimming events where testing is required.
"USA Swimming has prioritized athlete health and safety during this competitive season, emphasizing COVID-19 risk mitigation procedures," USA Swimming Director of Sports Medicine and Science Keenan Robinson said. "BD's rapid antigen test, combined with a PCR test, will ensure accurate testing, helping keep everyone involved at USA Swimming safe and in the water."
BD Veritor™ Plus is a portable, rapid and easy-to-use point-of-care antigen test that detects SARS-CoV-2 — the novel coronavirus that causes COVID-19 — and provides results in just 15 minutes on a simple, digital display. The on-site testing will be administered for USA Swimming by Premier Medical Group USA, a third-party provider that manages end-to-end testing, which will help overcome challenges that accompany testing in non-medical locations.
"We're thrilled to be the official COVID-19 testing partner of USA Swimming and to play a part in keeping these athletes safe as they look to fulfill their Olympic dreams," said Dave Hickey, president of Life Sciences for BD. "We are focused on helping people safely return to the activities they love – including our nation's top swimmers. We hope this testing with the BD Veritor™ Plus System gives them peace of mind, so they can focus on being the first touch to the wall and achieving their dreams."
Testing at the U.S. Olympic Team Trials - Swimming
Throughout the course of the U.S. Olympic Team Trials – Swimming, more than 2,000 tests using the BD Veritor™ Plus System will be administered. The tests will also be administered at remaining 2021-2022 USA Swimming events, recognizing that COVID-19 testing remains critically important to managing personal and public health.
As an official sponsor of USA Swimming, BD's partnership is just one example of the company's work to help our country's athletes achieve their goals. Whether in the pool or open water, a portable, rapid, easy-to-use system like BD Veritor™ Plus provides reliable and fast COVID-19 test results.
A Global Leader in the Fight Against COVID
In addition to providing antigen- and molecular-based diagnostics, BD has been at the forefront of the COVID-19 response by providing injection devices for vaccine administration, innovative solutions for immunology research and devices that aid in therapeutics. USA Swimming is also committed to ensuring the health and safety of its athletes, coaches and members throughout the pandemic. As part of the Aquatics Coalition, a group of more than 30 water safety and competitive water sports organizations to guide a safer return to water, USA Swimming closely follows guidance from the U.S. Centers for Disease Control and Prevention (CDC) to minimize the risk of COVID-19 transmission in the pool or at its events.
About USA Swimming
As the National Governing Body for the sport of swimming in the United States, USA Swimming is a 400,000-member service organization that promotes the culture of swimming by creating opportunities for swimmers and coaches of all backgrounds to participate and advance in the sport through clubs, events and education. Our membership is comprised of swimmers from the age group level to the Olympic Team, as well as coaches and volunteers. USA Swimming is responsible for selecting and training teams for international competition including the Olympic Games and strives to serve the sport through its core objectives: Build the base, Promote the sport, Achieve competitive success. For more information, visit www.usaswimming.org.
About BD Veritor™ Plus System for Rapid Detection of SARS-CoV-2
The BD Veritor™ Plus System for Rapid Detection of SARS-CoV-2 Assay has not been cleared or approved by the U.S. Food and Drug Administration (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. For more information on the BD Veritor™ system, please visit bdveritor.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 70,000 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 releases clinical diagnostic quality solution for SARS-CoV-2 variant analysis
9 June 2021
9 June 2021 -- LGC's SeraCare has expanded its line of SARS-CoV-2 molecular quality solutions to include AccuPlex™ SARS-CoV-2 Variant Panel 1. The kit contains full SARS-CoV-2 genomic RNA with a focus on S-gene mutations in three prominent variants of concern (UK variant B.1.1.7, South Africa variant B.1.351, and Brazil variant P.1) with vials for each variant as well as wild type control and human RNase P negative control vials. This solution is compatible with multiple applications, including performance confirmation for existing SARS-CoV-2 molecular assays as well as SARS-CoV-2 variant genotyping or NGS assays.
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, quality control solutions that challenge the entire molecular test procedure, making them the preferred alternative to infectious materials.
Bharathi Anekella, Executive Vice President and General Manager, LGC Clinical Diagnostics, stated, “As vaccine deployment efforts are proving to be effective in slowing the spread of SARS-CoV-2, the diagnostic community focus has shifted towards monitoring and surveillance of emerging variants. AccuPlex recombinant material is an ideal tool to support IVD development and diagnostic quality control efforts and we are proud to use this technology to produce solutions for variant analysis to help us move beyond the COVID-19 pandemic.”
To learn more about AccuPlex SARS-CoV-2 Variant Panel 1, as well as the complete line of SARS-CoV-2 Quality Solutions, please visit the LGC SeraCare website.
Pixel by Labcorp® COVID-19 PCR Test Home Collection Kits Now Available Nationwide at Walgreens and Through On-Demand Delivery
8 June 2021 - Kit Available Without a Prescription in Stores and Delivered by DoorDash® and Instacart®
BURLINGTON, N.C. & DEERFIELD, Ill., Jun. 8, 2021 -- Labcorp, a leading global life sciences company today announced that Pixel by Labcorp® COVID-19 PCR Test Home Collection Kits are now in 6,000 Walgreens stores nationwide and through Walgreens collaborations with on-demand delivery services DoorDash and Instacart. The newly expanded availability and delivery option advances Walgreens and Labcorp’s efforts to increase COVID-19 testing access in communities across the U.S., especially in underserved areas.
“Labcorp’s continued collaboration with Walgreens to make the Pixel by Labcorp COVID-19 PCR Test Home Collection Kit more broadly available helps us support our communities in returning to the activities of our daily lives,” said Brian Caveney, M.D., chief medical officer and president of Labcorp Diagnostics. “The on-demand delivery option is especially useful for individuals who might show symptoms of COVID-19 infection and want to be tested without potentially infecting others. It would also be helpful for people who may not have the flexibility to leave their home but need access to testing.”
Customers will be able to purchase the Pixel by Labcorp COVID-19 PCR Test Home Collection Kit at the pharmacy counter without a prescription, or they can order it for delivery through DoorDash and Instacart. Additionally, the Pixel by Labcorp COVID-19 PCR Test Home Collection Kit is available on Pixel by Labcorp and Walgreens Find Care®, a digital health platform available on the Walgreens app and at Walgreens.com. The expanded availability of the collection kit will increase customers’ access to testing solutions when and how they need them—at home, in stores, or in-person at one of Walgreens conveniently located testing sites. As recently announced, parents and guardians can request the kits for use with children and adolescents ages 2-17 through the Pixel by Labcorp website.
Customers can self-administer the test collection using a nasal swab and send the sample back to Labcorp via prepaid FedEx Express overnight shipping. Test results will then be available via the Pixel by Labcorp website. If a COVID-19 test is positive, a Labcorp-verified health care staff member will contact the individual to discuss next steps. Pixel by Labcorp has contracted with a physician network to make independent physician services available for consultation.
The Pixel by Labcorp COVID-19 PCR Test Home Collection Kit has not been FDA-cleared or approved, but has been authorized for emergency use by the FDA
under an EUA, and has been authorized only for the detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens. Emergency use of this product 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 Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 360bbb-3(b)(1), unless the declaration is terminated or authorization is revoked sooner. In-store availability is limited and may vary by location.
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 improve lives. With more than 70,000 employees, we serve clients in more than 100 countries. Labcorp reported revenue of $14 billion in FY2020. Learn more about us at http://www.Labcorp.com.
Roche obtains CE mark for the SARS-CoV-2 Antigen Self Test Nasal allowing for rapid self testing of COVID-19 at home
8 June 2021 - The SARS-CoV-2 Antigen Self Test Nasal enables individuals to quickly and conveniently test themselves for COVID-19 at home using a simple nasal swab. An early version of the test has already been available as a home-test in a number of European markets under local special approval pathways since February 2021. The test will be widely available to individuals through pharmacies and other locations in accordance to local guidelines and testing strategies. The test works seamlessly with NAVIFY® Pass, Roche’s digital solution that allows individuals and healthcare providers to immediately store, display, and share their COVID-19 test results and vaccine status through a unique QR code.
Basel, 08 June 2021 -- Roche today announced it has received CE mark for its SARS-CoV-2 Antigen Self Test Nasal for at-home testing. The test will be available in countries accepting the CE mark through pharmacies and other locations, in packs of five tests.
An early version of the test has already been available as a home-test in a number of European markets under local special approval pathways since February 2021. With the CE Mark, the SARS-CoV-2 Antigen Self Test Nasal for rapid self testing of COVID-19 test has received official approval following the traditional registration pathway and can now also be used in markets that have not established regulatory exemption pathways.
By following simple instructions, individuals can perform the test at home using a nasal swab without special training or the supervision of a healthcare worker. The test provides results in as little as 15 minutes and can help people to conveniently check if they are likely to be infectious from the comfort of their home. In the case of children under 18 years of age, the test must be performed by an adult or under close adult supervision.
As societies begin to reopen and in line with local health regulations, the convenient test allows individuals planning to attend an event or gathering to use the test as a tool to confirm that they are not likely to be carriers of a substantial amount of the virus thus helping them make informed decisions and reduce the risk of transmission to others.
Complementary to the SARS-CoV-2 Antigen Self Test Nasal, Roche is offering NAVIFY® Pass. This digital solution allows individuals and healthcare professionals to remotely store, display, and share their COVID-19 test results and vaccine status through a personalised QR code. Having easy digital access to test results and vaccination status could potentially be used by both individuals and companies to facilitate access to locations with COVID-19 entry protocols, such as restaurants or entertainment venues, as well as to validate safety to travel.
“As the world prepares to reopen, high-quality, home-based testing will play an important role in the battle against the pandemic,” said Thomas Schinecker, CEO, Roche Diagnostics. “Regular self-testing at home can reduce pressure on healthcare systems. It can quickly identify people with the highest potential to be infectious so they can take immediate action to seek medical advice, manage their infection and protect others.”
This test is part of a partnership with SD Biosensor Inc., with whom Roche has also launched a SARS-CoV-2 Rapid Antibody Test in July 2020 and two SARS-CoV-2 Rapid Antigen Tests for professional use in September 2020 and February 2021. These tests will continue to play an important role in fighting this pandemic and remain available for healthcare professional testing.
In addition to diagnostic testing, preventive measures remain key to protecting yourself and others against SARS-CoV-2. It is recommended to continue wearing masks, socially distance and practice good hygiene, especially if you have symptoms or known contact with others who have tested positive for the virus.
Roche continues to expand its comprehensive COVID-19 portfolio to support healthcare systems in diagnosing SARS-CoV-2 infection.
About the SARS-CoV-2 Antigen Self Test Nasal for at-home patient self-testing
The SARS-CoV-2 Rapid Antigen Self Test Nasal is a rapid chromatographic immunoassay (lateral flow assay) for the detection of the nucleocapsid protein of SARS-CoV-2 in human nasal samples. Each test contains a unique QR code to enable individuals to share their test results and vaccine status using NAVIFY Pass, Roche’s digital solution. For more information on NAVIFY Pass, visit www.navifypass.com
The clinical performance of the test was measured by head to head comparison with Roche’s highly sensitive reverse transcriptase polymerase chain reaction (RT-PCR) test using nasopharyngeal swab samples as a comparator, the gold standard sampling and detection method for SARS-CoV-2 detection.1,2 Combined study results showed that the relative sensitivity of the SARS-CoV-2 Antigen Self Test Nasal was 91.1%.** The overall relative specificity was 99.6 %,3 which represents the ability of the test to correctly identify patients without the virus. In one comparative independent self testing study where patients followed written and illustrated instructions to sample, test and read-out the results themselves, the majority of study participants considered the procedures easy to perform.4
About antigen testing
An antigen test detects proteins which are structural or functional components of a pathogen and are very specific to that pathogen.5 In this case, the test would provide a qualitative “yes/no” answer on the presence of the antigen in the patient sample and can be offered as a rapid strip test that is performed at the point of care. If the target antigen (nucleocapsid protein) is present in sufficient concentrations in the sample, it will bind to specific antibodies and generate a visually detectable signal on the test strip, typically with results ready in 15 minutes. A rapid antigen test can reliably detect individuals with a high viral load allowing healthcare professionals to quickly identify those patients at the greatest risk of spreading the infection.6
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 2020 we received FDA Emergency Use Authorization 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 2020, Roche announced that its COVID-19 antibody test, aimed at detecting the presence of antibodies in the blood, also received FDA Emergency Use Authorization and is available in markets accepting the CE mark. Also in June of last year 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 of 2020, we added a Rapid Antibody Test, with SD Biosensor as manufacturing partner, to the portfolio that allows the detection of antibodies against COVID-19 at the point of care. In addition, we also launched a Rapid Antigen Test in September and a lab-based Antigen Test in December. Roche is working closely with governments and health authorities around the world, and has significantly increased production to help ensure availability of tests globally.
Roche is actively involved in understanding the potential of the existing portfolio and is 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 2020 Roche 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 2020, Roche announced a partnership with Regeneron to develop, manufacture and distribute REGN-COV2, Regeneron’s investigational antiviral antibody combination, to people around the globe. On 18 October 2020, Roche announced a collaboration with Atea Pharmaceuticals to develop a potential oral treatment for COVID-19 patients.
In these exceptional times, Roche stands together with governments, healthcare providers and all those working to overcome the pandemic.
About SD Biosensor
SD Biosensor is a global in-vitro diagnostic company focused on the development of immunoassay and molecular diagnostic products at the POC. Founded in 2010, SD Biosensor has continued to research and develop products that can aid in the fast and accurate diagnosis of patients across the testing journey. Through these innovative products, they are striving to become a leading global in vitro diagnostics company.
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, as well as growing capabilities in the area of data-driven medical insights help Roche deliver truly personalised healthcare. Roche is working with partners across the healthcare sector to provide the best care for each person.
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. In recent years, Roche has invested in genomic profiling and real-world data partnerships and has become an industry-leading partner for medical insights.
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 2020 employed more than 100,000 people worldwide. In 2020, Roche invested CHF 12.2 billion in R&D and posted sales of CHF 58.3 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-2021-06-08.htm
BD Hits 2 Billion Injection Device Milestone in Support of Global COVID-19 Vaccination Efforts
8 June 2021 - Company Now Supplying More Than 40 Countries for Pandemic Vaccination Campaigns
FRANKLIN LAKES, N.J., June 8, 2021 -- BD (Becton, Dickinson and Company), a leading global medical technology company, today announced that it has received pandemic orders for needles and syringes totaling 2 billion injection devices to support global COVID-19 vaccination efforts.
This new milestone reflects commitments to governments across the world, including the United States, Australia, Brazil, Canada, France, Germany, India, Philippines, Saudi Arabia, South Africa, Spain and the United Kingdom, among many others, as well as non-governmental organizations supporting vaccine deployment for developing countries. In total, BD is supporting pandemic orders for more than 40 countries, non-governmental organizations and other partners.
"Expanding vaccination efforts are bringing restored hope and a long-awaited return to normalcy in multiple countries around the world," said Rick Byrd, president of Medication Delivery Solutions for BD. "We are committed to continuing to support government partners and non-governmental organizations in these efforts to ensure health care providers on the front lines of this crisis have these much-needed injection devices to protect their patients from COVID-19."
BD has delivered more than 900 million injection devices around the world to date, with the remaining orders to be delivered between now and the end of 2022 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 government agencies and non-governmental organizations on the need to plan ahead to ensure supply availability and place orders for delivery in late 2022 and into the future.
As part of its efforts, BD continues to closely plan supply capabilities to help ensure maximum volumes can be dedicated to COVID-19 efforts, while minimizing disruption for routine health care, annual flu vaccinations and childhood immunization programs.
BD has also announced multiple capital investments to expand capacity for vaccination injection devices for COVID-19 and future pandemics. These include:
- Partnering with the U.S. government on a $70 million capital project to further expand BD's operations and manufacturing capacity in Nebraska. Once it is completed this summer, the federal government will have priority access to hundreds of millions of injection devices to support vaccination efforts for COVID-19 and future pandemics.
- Adding new manufacturing lines for injection devices in the company's Fraga, Spain manufacturing facility. When these lines ramp up now through 2022 it will increase output of these devices by nearly 500 million per year to support COVID-19 and other efforts, mainly for markets in Europe, Middle East and Africa, as well as for non-governmental organizations.
- Investing $1.2 billion over four years to expand and upgrade BD's manufacturing capacity and technology for pre-fillable syringes and advanced drug delivery systems to allow for continued growth of new injectable drugs and vaccines. This will also provide surge capacity for increased pre-fillable syringe demand during times of pandemic response.
For this critical role and commitment to support vaccination efforts globally, BD was recently recognized at the 2021 World Vaccine Congress' Vaccine Industry Excellence Awards as the "Best Production/Process Development." The award recognized BD for its ability to extend its capacity to provide disposable syringes and pre-fillable syringes required for COVID-19 vaccinations, as well as its range of solutions covering the entire vaccine development.
BD is the largest manufacturer of injection devices in the world, producing multiple billions of syringes and needles annually through its global manufacturing network. To learn more about BD's vaccination preparedness efforts, visit bd.com/vaccination.
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 70,000 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.
Thermo Fisher Scientific Launches Ion AmpliSeq SARS-CoV-2 Insight Research Assay for SARS-CoV-2 Surveillance
7 June 2021 - Panel enables early identification of new and known variants from a variety of sample types
CARLSBAD, Calif., June 7, 2021 -- Thermo Fisher Scientific today introduced the Ion AmpliSeq SARS-CoV-2 Insight Research Assay to improve SARS-CoV-2 surveillance. The assay is designed to enable early identification of new and known variants from samples that have lower viral loads. By sequencing more than 99 percent of the SARS-CoV-2 genome, the assay covers all potential serotypes.
The new Ion AmpliSeq SARS-CoV-2 Insight Research Assay broadens and improves local, regional and national surveillance efforts to discover emerging SARS-CoV-2 variants through highly sensitive next-generation sequencing (NGS). Combined with Thermo Fisher's NGS technology, the panel enables researchers to obtain epidemiological insights with rapid turn-around time, workflow automation and seamless informatics and data uploading to public SARS-CoV-2 data repositories.
"RNA viruses such as SARS-CoV-2 mutate at high rates in response to selective environmental pressures, requiring labs and vaccine developers to monitor mutations diligently," said Andy Felton, vice president of clinical next generation sequencing at Thermo Fisher. "Higher sensitivity next-generation sequencing assays are needed to identify mutations earlier in both symptomatic and asymptomatic individuals to help public health officials and labs globally track the spread of new and known variants for public health decisions and guidance locally."
Optimized to run on the Ion GeneStudio S5 System, the assay includes 237 amplicons specific to SARS-CoV-2, with the addition of variant-tolerant primers for emerging variants. The increased sensitivity of this assay will empower researchers to sequence the complete genome and discover new variants from a variety of sample types including nasophyrengeal and shallow nasal swabs, saliva and others, and with cycle threshold (Ct) values higher than 28, or as low as 50 viral copies.
"Our lab has been sequencing positive COVID-19 samples since the fall, and recently announced a partnership with the Centers for Disease Prevention (CDC) to enhance national surveillance of known and emerging variants," said Josh Arant, chief operating officer of MAKO Medical Labs. "Supporting the increased scale of our sequencing program, the new, highly sensitive assay allows us to quickly report back valuable insights on SARS-CoV-2 variants to inform public health professionals across the country."
"As one of the labs currently sequencing positive SARS-CoV-2 samples as part of the International Travel Testing Programme, we need precise and comprehensive sequencing technology that can help us understand which mutations are present in positive samples for effective monitoring of SARS-CoV-2 cross-border transmission," said Marco Loddo, Ph.D., BSc, co-founder and scientific director at Oncologica. "The new assay offers fast improvement on the sensitivity for lower titer samples, including those from asymptomatic individuals, and has been brilliant for the discovery of emerging variants of concern entering the UK."
For more information, visit www.thermofisher.com/sarscov2insight
Assay for Genexus System Coming Soon
To further expedite NGS analysis of SARS-CoV-2 and to help meet growing customer demand, Thermo Fisher has begun optimizing the Ion AmpliSeq SARS-CoV-2 Insight Research Assay for the Ion Torrent Genexus System. Launched in November 2019, the company's newest sequencing platform automates the entire targeted NGS workflow and can deliver specimen to report economically in just one day. Optimization and validation of the research assay on the Genexus System is now underway in collaboration with Thermo Fisher customers.
About Thermo Fisher Scientific
Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $30 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 80,000 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 authorizes lower 1,200 mg intravenous and subcutaneous dose of REGEN-COV™ (casirivimab and imdevimab) antibody cocktail to treat patients with COVID-19
4 June 2021 - EUA supported by pivotal Phase 3 data showing 1,200 mg dose reduced risk of hospitalization or death by 70%. Only antibody therapy currently available in all 50 states, including eight states with high rates of two variants of concern.
TARRYTOWN, N.Y., June 4, 2021 -- Regeneron Pharmaceuticals, Inc. today announced the U.S. Food and Drug Administration (FDA) updated the Emergency Use Authorization (EUA) for REGEN-COV™, lowering the dose to 1,200 mg (600 mg casirivimab and 600 mg imdevimab), which is half the dose originally authorized. As part of the updated EUA, REGEN-COV should be administered by intravenous (IV) infusion; subcutaneous (SC) injections are an alternative when IV infusion is not feasible and would lead to a delay in treatment.
"Despite increased use of vaccines, thousands of patients are still becoming infected in the U.S. every day, with many at high risk of serious complications from COVID-19. Unfortunately, to date only a fraction of patients eligible for antibody treatments have received them, which we hope will change based on this updated FDA authorization. REGEN-COV is readily available and supplied free of charge by the U.S. government," said George D. Yancopoulos, M.D., Ph.D., President and Chief Scientific Officer at Regeneron. "REGEN-COV has also demonstrated potency against the main variants of concern to date in vitro and is the only antibody therapy currently available across the U.S., including in states where variants first identified in Brazil and South Africa are circulating at a higher rate."
REGEN-COV is authorized for use under an EUA to treat mild-to-moderate COVID-19 in adults and pediatric patients (12 years of age and older weighing ≥40 kg) with positive results of direct SARS-CoV-2 viral testing, and who are at high risk for progression to severe COVID-19, including hospitalization or death. The Fact Sheet updates remove the previously authorized 2,400 mg IV REGEN-COV dose.
The updated FDA authorization is based on data from several trials, including a recently presented Phase 3 trial which showed REGEN-COV reduced the risk of hospitalization or death by 70% in high-risk non-hospitalized patients, and that the treatment effect was consistent between the 1,200 mg and 2,400 mg doses. The SC administration was authorized based on the totality of scientific evidence, incorporating clinical, viral load reduction and pharmacokinetic data.
In addition, in vitro research has shown that REGEN-COV retains potency against the main variants of concern circulating within the U.S., including the P.1 variant (first identified in Brazil, now classified by the World Health Organization [WHO] as Gamma) and the B.1.351 variant (first identified in South Africa, now classified by the WHO as Beta). Consequently, REGEN-COV remains available for use in all 50 states. The combined frequency of the P.1 and B.1.351 variants now exceeds 10% of new COVID-19 diagnoses across eight states (Arizona, California, Florida, Illinois, Indiana, Massachusetts, Oregon and Washington), and the prevalence of these and other variants continues to be closely monitored.
Overall, more than 9,000 people have received IV REGEN-COV in clinical trials in both hospitalized and non-hospitalized settings. In a pooled Phase 1/2/3 analysis of non-hospitalized patients, investigator-assessed infusion-related reactions (≥grade 2) were observed in 0.2% (10/4,026) of those who received REGEN-COV at the authorized dose or a higher dose. Rare anaphylactic reactions have been reported as part of the REGEN-COV clinical program. In trial participants who received study drug via SC injection, injection site reactions were observed in 12% of those treated with REGEN-COV (88/729) and 4% with placebo (10/240).
In May, the REGEN-COV Fact Sheet was updated to expand the definition of eligible patients under the EUA. Patients with certain medical conditions or other factors (for example, race or ethnicity) may be at high risk for progression to severe COVID-19 and are eligible to receive REGEN-COV if they become infected with SARS-CoV-2. Recently, the National Institutes of Health COVID-19 Treatment Guidelines Panel also strongly recommended the use of REGEN-COV in non-hospitalized COVID-19 patients ("outpatients") at high risk of clinical progression.
REGEN-COV has not been approved by FDA but has been authorized for emergency use. This use is authorized only for the duration of the declaration that circumstances exist justifying the authorization of the emergency use under section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.
Regeneron expects to submit a full Biologics License Application (BLA) for REGEN-COV in non-hospitalized outpatients with COVID-19 later this summer. In addition to outpatients, REGEN-COV is also being evaluated in prevention and certain hospitalized COVID-19 patient settings. In April 2021, Regeneron announced positive results from a Phase 3 trial evaluating REGEN-COV for the prevention of infection among household contacts of SARS-CoV-2 infected individuals. Regeneron has submitted these data to regulatory authorities to potentially expand the EUA for use in the prevention setting.
The development and manufacturing of REGEN-COV have been funded in part with federal funds from the Biomedical Advanced Research and Development Authority (BARDA), part of the U.S. Department of Health and Human Services' Office of the Assistant Secretary for Preparedness and Response, under OT number: HHSO100201700020C.
REGEN-COV Supply Update
The U.S. government will purchase all REGEN-COV doses delivered by June 30, 2021 and may accept additional doses through September 30, 2021 at its discretion, up to a maximum amount of 1.25 million doses. Regeneron expects to deliver at least 1 million REGEN-COV doses to the U.S. government in the second quarter. The specific quantity of doses delivered will be impacted by the timeliness of manufacturing operations. Additionally, Regeneron expects its second quarter 2021 GAAP and non-GAAP effective tax rates to be similar and approximately 17% and the company's full year effective tax rate guidance remains unchanged.
About the REGEN-COV Antibody Cocktail
REGEN-COV (casirivimab and imdevimab) is a cocktail of two monoclonal antibodies (also known as REGN10933 and REGN10987) that was designed specifically to block infectivity of SARS-CoV-2, the virus that causes COVID-19, using Regeneron's proprietary VelocImmune® and VelociSuite® technologies. 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.
Under this EUA, REGEN-COV is available throughout the U.S. – information on availability in your area is available from the Department of Health and Human Services and the National Infusion Center Association. REGEN-COV can be administered by IV infusion (as short as 20 minutes) or by SC injection (four injections), which is an alternative when IV infusion is not feasible and would lead to a delay in treatment. It is now authorized as a co-formulated single vial, or in individual vials to be administered together.
In the U.S., REGEN-COV is 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 REGEN-COV. 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 nine FDA-approved treatments and numerous product candidates in development, almost 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, hematologic conditions, 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.
Grifols to provide Korean Red Cross with Procleix Panther for blood screening, extending donor testing leadership in Asia
3 June 2021 - The 28 systems to be deployed across KRC’s three laboratory sites will test about 94% of the country’s blood donations. They will run the Procleix Ultrio Elite Assay, an advanced nucleic acid test (NAT) ensuring donation safety by detecting the potential presence of the most important infectious pathogens in a single, simultaneous test. Grifols has recently expanded its transfusion safety excellence in the region, with more countries entrusting it to safeguard their blood supplies.
Barcelona, Spain, June 3, 2021 -- Grifols, a global leader in the development of plasma-derived therapies and innovative diagnostic solutions, today announced it will provide the Korean Red Cross (KRC) with its industry-leading Procleix Panther System running nucleic acid testing (NAT) technology to help ensure the safety of South Korea’s blood supply.
As part of the KRC contract, Grifols will deliver 28 Procleix Panther Systems that will be deployed during the following months across the humanitarian organization’s three laboratory sites in South Korea. When fully operational, they will test about 94% of the country’s blood donations, which are needed mostly for transfusions.
The Procleix Panther Systems are known for their reliability, scalability and versatility, providing high throughput with a small footprint while streamlining laboratory workflow. They will feature the Procleix Ultrio Elite Assay, a high-specificity NAT designed to improve blood safety by detecting the potential existence of the most important infectious pathogens in a single, simultaneous test from human serum or plasma.
“Increasingly countries in the Asia-Pacific region are relying on the innovative, robust and efficient screening capabilities of the Procleix Panther System to protect their blood supplies,” said David Dew, President, Grifols Diagnostic Commercial Division. “The combination of Grifols quality, safety and cutting-edge technology is making an important difference in enhancing the health and well-being of patients.”
Grifols has steadily increased its transfusion safety leadership in Asia-Pacific, where it currently screens more than half of all blood donations, including 100% of those in Australia, Japan, Malaysia and New Zealand.
Grifols Korea, formed in 2020, is the company’s most recent affiliate in Asia-Pacific, where it has grown to 13 subsidiaries after first establishing its presence in the region in 2000. China, where Grifols has a strategic alliance with Shanghai RAAS, a leader in the country’s plasma-derivatives sector, is one of the company’s most important markets in sales of Procleix NAT solutions.
About the Procleix Panther System
The Procleix Panther System automates all aspects of NAT (Nucleic Acid Testing)-based blood screening on a single, integrated platform, and is capable of delivering the highest result throughput per square meter. It eliminates the need for batch processing and combines walk-away freedom with intuitive design for ease of use.
About Procleix NAT Solutions
Today, Procleix systems are used to screen more blood donations around the world than any other NAT blood screening products, and include tests for HIV, hepatitis viruses (A, B, C and E), West Nile virus, SARS-CoV-2*, Zika virus, Dengue virus, Babesia, and more.
About Procleix Ultrio Elite Assay
The Procleix Ultrio Elite Assay is a nucleic acid test (NAT) that uses magnetic-based target capture, Transcription-Mediated Amplification (TMA) and chemiluminescence to detect HIV-1, HIV-2, HBV and HCV in serum or plasma of donated blood. Because of the high sensitivity and specificity of the technology, detection of the targeted pathogens can be achieved within the early stages of infection, thereby helping to prevent infected blood or blood components from being transfused even when the donor does not exhibit symptoms and traditional serological screening techniques are not able to detect the presence of the pathogen or antibodies against it. The assay runs on the Procleix Panther System, a fully automated NAT instrument launched by Grifols in the EU market in 2012 and currently widely used in laboratories globally.
EBM-Ziffer zur Bestimmung des fetalen Rhesusfaktors D
28 May 2021
28 May 2021 -- Mit Gültigkeit zum 24. November 2020 hat der Gemeinsame Bundesausschluss (GBA) beschlossen, die Bestimmung des fetalen Rhesusfaktors D aus mütterlichem Blut in die Mutterschafts-Richtlinien aufzunehmen. Ab dem 01. Juli 2021 wird für die Leistung nach EBM mit der Ziffer 01869 vergütet.
Vor diesem Hintergrund bieten wir diese ab sofort in unserem SYNLAB Verbund an. Für die Betreuung von schwangeren Patientinnen bedeutet dies, dass bei jeder Rhesus D-negativen Einlings-Schwangerschaft die Bestimmung des fetalen Rhesusfaktors D aus dem mütterlichen Blut auch für Patientinnen der gesetzlichen Krankenversicherungen möglich ist.
Reference: https://www.synlab.de/human/news-artikel/ebm-ziffer-zur-bestimmung-des-fetalen-rhesusfaktors-d-1377
Welsh Lighthouse Laboratory Extends Contract with PerkinElmer for its COVID-19 Solutions
27 May 2021 - Company’s RT-PCR kits and workflow solutions will continue to safeguard capacity for NHS Test and Trace laboratory
WALTHAM, Mass., May 27, 2021 – PerkinElmer, Inc., a global leader committed to innovating for a healthier world, today announced that its contract to operate the NHS Test and Trace Newport Lighthouse laboratory has been extended through March 2022.
A collaboration between PerkinElmer and NHS Test and Trace, the COVID-19 Lighthouse laboratory in Newport, South Wales, plays a pivotal role in supporting the UK government’s efforts to tackle COVID-19. Since being brought online in October 2020, the laboratory has processed over two million samples. The contract extension will see the facility’s approximately 125 employees retained at the state-of-the-art facility, to maintain its capacity of delivering tens of thousands of tests daily.
As the nation transitions out of lockdown, the contract extension will ensure that PerkinElmer solutions and expertise will remain available and able to respond as needed. “Testing is essential so that individuals carrying the virus can be rapidly detected and virus levels within communities can be monitored,” said Chris Hughes, managing director UK & Ireland, PerkinElmer.
“The extension of the Newport Lighthouse laboratory’s contract will enable our specialist team to continue utilizing our best-in-class technologies to ensure that maximum capacity will always align with NHS Test and Trace’s testing strategy, while also being able to quickly respond to evolving public health needs.”
Health Minister Lord Bethell, said: “To help us face down this global pandemic, we have built the largest network of diagnostic testing facilities in British history, establishing the UK as a world-leader on testing. We have now conducted over 166 million tests to date – more than any other European country – and this would not have been possible without the work of our partners such as PerkinElmer. Regular testing is a centrepiece of our roadmap back to normal life and sites like the Newport Lighthouse Laboratory are playing a pivotal role in our cautious easing of restrictions and continued efforts to send this virus into retreat.”
PerkinElmer is utilizing its chemagic™ 360 instruments and JANUS® G3 PCR+ Workstations in 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 COVID-19 testing requirements.
PerkinElmer continues to work on the frontlines of improving COVID-19 testing globally. The Company’s comprehensive SARS-CoV-2 offerings span high throughput RNA extraction, RT-PCR assays, automated liquid handlers, integrated workstations, rapid antigen tests, and serology tests using ELISA, chemiluminescence, time-resolved fluorescence and lateral flow technologies.
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 $3.8 billion in 2020, 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's TaqPath COVID-19 CE-IVD RT-PCR Kit Now Available for the Incoming International Travel Quarantine Protocol Testing in the United Kingdom
27 May 2021 - Highly Sensitive and Accurate COVID-19 PCR Testing Kits Available to Increase Testing Availability
INCHINNAN, Scotland, May 27, 2021 -- Thermo Fisher Scientific, the world leader in serving science, today announced that its TaqPath COVID-19 CE-IVD RT PCR Kit has been independently validated as meeting the performance characteristics for the Day 2 and Day 8 COVID-19 quarantine protocol testing required for international travellers arriving in the United Kingdom.
The United Kingdom has instituted quarantine rules for travellers entering the country that vary depending on the country of departure, but most people will be legally required to quarantine for ten days upon arrival. On days two and eight of their isolation, those travellers are obliged to take a PCR test to monitor for an active SARS-CoV-2 infection. Thermo Fisher's TaqPath kit is now permitted to be used by laboratories and clinics in that surveillance.
"Quarantine and surveillance programs such as the one in the United Kingdom are important for helping curb the spread of SARS-CoV-2 and its variants as countries begin to reopen," said Claire Wallace, vice president, commercial EMEA, life sciences at Thermo Fisher Scientific. "Thermo Fisher's strong supply chain of highly accurate COVID-19 PCR tests has been fundamental in the symptomatic testing for SARS-CoV-2 in the United Kingdom since the pandemic started and we are excited that independent validation for this additional use will help to increase testing availability as the international travel season begins."
The TaqPathCOVID-19 CE-IVD RT PCR Kit is a fast, highly sensitive multiplex diagnostic solution that contains both the assays and controls needed for the real-time PCR detection of RNA from the SARS-CoV-2 virus. In the independent validation study, the kit was shown to have clinical sensitivity of 100% with 95% Confidence Interval [97.9-100.0%] and a clinical specificity of 100% with 95% Confidence Interval [98.6-100.0%]. The limit of detection was determined as to be 250 copies/mL.
The TaqPathCOVID-19 CE-IVD RT PCR Kit received initial CE-IVD approval in March 2020 and is compatible with most widely used real-time PCR instruments. For more information on the platform, please visit: https://www.thermofisher.com/covid19ceivd
About Thermo Fisher Scientific
Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $30 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 80,000 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.
ALM-Update: SARS-CoV-2-PCR-Tests bestätigen weiter rückläufiges Infektionsgeschehen
27 May 2021 - Weiter und helleres Licht am Ende des Tunnels für die Bürger*innen in der SARS-CoV-2-Pandemie – und gleichzeitig Ärger und Enttäuschung bei den Fachärzt*innen im Labor über aktuelle Beschlüsse zur Abwertung der SARS-CoV-2-PCR.
27 May 2021 -- Die aktuellen Zahlen der Akkreditieren Labore in der Medizin – ALM e.V. bestätigen: Die dritte Welle der SARS-CoV-2-Infektionen in Deutschland ist wohl gebrochen. Die Zahl der positiven SARS-CoV-2-PCR-Befunde fiel von 8,8 Prozent in der KW 19 auf 6 Prozent in der vergangenen Woche (KW 20). Insgesamt wurden laut Analyse des ALM e.V., an der 178 Labore aus dem ambulanten und stationären Bereich teilnehmen, 64.583 (Vorwoche: 82.176) positive SARS-CoV-2-PCR-Befunde erhoben – und dies bei gleichzeitig wieder steigender Zahl der insgesamt durchgeführten SARS-CoV-2-PCR-Tests um 15 Prozent (1.074.246 Tests in der KW 20 zu 933.064 in der KW 19).
Der starke Anstieg an Testungen ist wahrscheinlich auch auf das Screening von Schülern in manchen Bundesländern zurückzuführen. „Das darf uns nun alle weiterhin zuversichtlich für die kommenden Wochen und Monate stimmen und uns weiter im bisher eingeschlagenen Weg bestärken“, sagt Dr. Michael Müller. Doch gibt es auch Grund für Ärger und Unverständnis bei den Fachärzt*innen im Labor: „Erneut hat der Erweiterte Bewertungsausschuss die Kostenerstattung für die SARS-CoV-2-PCR-Testung willkürlich herabgesetzt – ohne Transparenz herzustellen, auf welcher Grundlage diese Entscheidung getroffen worden ist“, ärgert sich der 1. Vorsitzende des ALM e.V.
Marijuana Workforce Drug Test Positivity Continues Double-Digit Increases to Keep Overall Drug Positivity Rates at Historically High Levels, Finds Latest Quest Diagnostics Drug Testing Index™ Analysis
26 May 2021 - First Large-Scale National Analysis of Workforce Drug Testing During the COVID-19 Pandemic, Based on More Than 9 Million Drug Tests in 2020. Stark Differences in Positivity Between States that Permit Recreational Marijuana Use with Either Medical Use and No Legal Marijuana States. Marijuana Positivity Rate of Post-Accident Test Results Grew Faster Than Rate for Pre-Employment Testing.
SECAUCUS, N.J., May 26, 2021 -- The COVID-19 pandemic did not dampen workforce drug testing positivity for marijuana, which continued to increase last year in the general U.S. workforce, according to a new analysis released today by Quest Diagnostics (NYSE: DGX), the world's leading provider of diagnostic information services. This study is thought to be the first large-scale analysis of de-identified results of laboratory workforce drug tests performed during the COVID-19 pandemic.
The overall positivity rate in the combined U.S. workforce based on more than seven million urine drug tests collected between January and December 2020 was down only slightly in 2020 (4.4%) compared to 2019 (4.5%, a sixteen-year high). Positivity in the federally mandated, safety-sensitive workforce based on more than 2 million urine drug tests declined 8.3 percent (2.4% in 2019 versus 2.2% in 2020) but was still 10 percent higher than the 2016 rate (5 years prior). In the general U.S. workforce, positivity increased 3.8 percent (5.3% in 2019 versus 5.5% in 2020) and was 12.2 percent higher than in 2016.
As positivity for most drug categories, other than marijuana, declined or remained flat in the combined U.S. workforce over the past five years, amphetamines (which includes methamphetamine) persisted at 1.1 percent positive each year.
The new findings of the Quest Diagnostics Drug Testing Index™ were unveiled to coincide with the National Drug & Alcohol Screening Association (NDASA) 2021 Annual Conference taking place May 25-27 in St. Louis, MO.
"Driven largely by surging rates of marijuana general U.S. workforce positives and steady rates of amphetamines positives, the rate of drug positivity remained stubbornly high despite seismic shifts to the workplace caused by the COVID-19 pandemic," said Barry Sample, Ph.D., senior director of science and technology, Quest Diagnostics. "However, as we see upticks in hiring and many employees returning to the workplace, it is important that employers consider workforce drug testing as a way to keep the workplace, their customers and the community safe."
"Impairment, whether it be by drugs, alcohol, fatigue or stress, decreases the safety of the workforce," said Jenny Burke, senior director of impairment practice, National Safety Council. "The DTI results, reflecting decreases in many drug categories, occurred in a unique year. Even though these are down, we must continue to educate people about the impairing impacts of these substances. And, as states and the federal government consider changes to the legality of marijuana, we can't take for granted that they also understand the impairing impact of THC. The safety of people who share the roadways and workplaces with impaired people needs to be a priority."
For an interactive map with positivity rates and trend lines by three-digit zip code in the United States, visit DTIDrugMap.com.
Positivity down or flat for most drug categories, but increase for ecstasy
Urine drug test results in the general U.S. workforce declined in eight drug categories but stayed the same in two drug categories (excluding propoxyphene, which was withdrawn from the U.S. market a decade ago). Positivity for cocaine declined 18.5 percent (0.27% in 2019 versus 0.22% in 2020), the semi-synthetic opiates (hydrocodone/hydromorphone) declined 10.8 percent (0.37% in 2019 versus 0.33% in 2020), oxycodone group of opiates (oxycodone/oxymorphone) declined 14.7 percent (0.34% in 2019 versus 0.29% in 2020) and benzodiazepines declined 9.3 percent (0.43% in 2019 versus 0.39% in 2020). While the positivity for MDMA/MDA 3,4-Methylenedioxymethamphetamine (commonly known as ecstasy) increased by 25 percent (0.008% in 2019 versus 0.010% in 2020) and has demonstrated small, year-over-year increases, the positivity rate remains very low at 1 in every 10,000 (0.010%) tests.
Positivity rates declined in federally mandated, safety-sensitive workforce testing categories
Urine drug test results for the federally mandated, safety-sensitive workforce declined in all drug categories other than phencyclidine (PCP), which remained at 0.011 percent, same as in 2019. Of note, positivity for marijuana declined 10.2 percent (0.88% in 2019 versus 0.79% in 2020), cocaine declined 20 percent (0.25% in 2019 versus 0.20% in 2020), semi-synthetic opiates (hydrocodone/hydromorphone) declined 14.3 percent (0.35% in 2019 versus 0.30% in 2020) and the oxycodone group of opiates (oxycodone/oxymorphone) declined 19.2 percent (0.26% in 2019 versus 0.21% in 2020).
Marijuana continued double-digit year-over-year increases in the general U.S. workforce, with lower positivity rates in states with only medical marijuana use or no form of legalized marijuana use versus states with legalized recreational statutes
Marijuana positivity surged ahead in 2020 in the U.S. general workforce and across specimen types (urine, oral fluid, and hair). In the U.S. general workforce, marijuana positivity increased 16.1 percent in urine testing (3.1% in 2019 versus 3.6% in 2020), 35.2 percent in oral fluid testing (9.1% in 2019 versus 12.3% in 2020) and 22.5 percent in hair testing (7.1% in 2019 versus 8.7% in 2020).
The Drug Testing Index data also showed stark differences between states that have legalized recreational marijuana use versus states that have only legalized medical marijuana use or no form of legal marijuana use. Marijuana positivity surged in states with legal recreational use statutes 118.2 percent from 2012-2020 (2.2% in 2012 versus 4.8% in 2020). In states with only medical marijuana statutes, marijuana positivity increased 68.4 percent (1.9% in 2012 versus 3.2% in 2020). In states with no medical or recreational marijuana statutes, marijuana positives increased 57.9% percent (1.9% in 2012 versus 3.0% in 2020).
"Our data suggest that marijuana positivity has increased sharply nationwide since states began to legalize marijuana in 2012. However, it appears that states where medical marijuana use alone is legal are not experiencing much higher rates of increase than states where neither medical nor recreational use is legal," Dr. Sample said.
The positivity rate of post-accident test results grew faster than the rate of positivity for pre-employment testing
Between 2012, when the first state legalized recreational marijuana, and 2020, the gap between pre-employment and post-accident marijuana positivity increased each year. In the U.S. general workforce, in 2012, marijuana pre-employment positivity was 1.9 percent and post-accident positivity was 2.4 percent (a 26.3% difference). In 2020, pre-employment marijuana positivity was 3.7 percent and post-accident 6.4 percent (a 73% difference).
"The Drug Testing Index data shows states with recreational marijuana statutes have significantly higher positivity and the year-over-year differences between recreational states and states with medical and no legalization statutes has grown. In addition, while urine drug testing cannot determine whether an individual is under the influence or impaired at the time of test, our post-accident data suggests that marijuana use may play a role in those workplace incidents prompting a drug test," Dr. Sample said.
Cocaine positivity lowest since 2012 general U.S. workforce
Urine drug test positivity for cocaine in the general U.S. workforce dropped to the lowest level since 2012. Positivity for cocaine declined 18.5 percent (0.27% in 2019 versus 0.22% in 2020). Positivity for cocaine over the past five years declined 21.4 percent (0.28% in 2016 versus 0.22% in 2020).
Workforce positivity increased significantly in multiple industries
The Quest Diagnostics Drug Testing Index™ Industry Insights of general U.S. workforce positivity rates, based on more than 17 million urine drug test results between 2016 and 2020, shows year-over-year increases in overall workplace drug positivity in 6 of the 17 sectors reported. The Retail Trade industry had the highest overall positivity rates for all drug categories across all five years of the analysis (5.1% in 2016, 5.2% in 2017, 5.4% in 2018, 5.5% in 2019 and 6.2% in 2020). Accommodation and Food Services tied with Retail Trade for the highest positivity in 2020 alone (4.7% in 2016, 4.6% in 2017, 4.9% in 2018, 5.1% in 2019 and 6.2% in 2020). The Accommodations and Food Service category had the highest workforce positivity for marijuana at 6.3 percent, a relative increase of 96.9 percent over five years (3.2% in 2016 versus 6.3% in 2020).
Workforce Drug Testing Webinar
Barry Sample, PhD, senior director of science and technology, for Quest Diagnostics, will discuss the latest data from the Drug Testing Index and an analysis of workforce marijuana testing via webinar on Wednesday, June 16 at 12 pm EDT/11 am CDT. 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 rates of de-identified laboratory tests 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. Additionally, COVID-19 and regulatory changes may have also impacted hiring and the way in which employers tested – for example, in 2020 for the federally mandated safety-sensitive workforce, the percentage of specimens tested for pre-employment purposes declined while those for random tests increased. 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 50,000 employees understand that, in the right hands and with the right context, our diagnostic insights can inspire actions that transform lives. www.QuestDiagnostics.com.
BD Leverages Artificial Intelligence To Transform Microbiology Urine Testing
26 May 2021 - U.S. Launch of BD Kiestra™ Urine Culture Application Helps Accelerate Workflow and Drive Lab Efficiency
FRANKLIN LAKES, N.J., May 26, 2021 -- BD (Becton, Dickinson and Company), a leading global medical technology company, today announced the U.S. launch of a Urine Culture Application for use with the BD Kiestra™ lab automation incubation and imaging system that can transform the way microbiology labs approach urine culture analysis.
Designed using artificial intelligence (AI) and leveraging the quality of BD BBL™ plated media, the application uses digital imaging and software algorithms to determine the amount of growth on a urine culture plate from clean caught and catheterized samples. The BD Kiestra™ system's intelligent incubation and imaging device uses high-throughput robotics to perform time series imaging, coupled with machine learning so that plates with no significant growth can be released for disposal and plates with significant growth automatically go into a queue for clinician analysis.
In many labs, urine cultures make up a significant part of the daily workload — however, the majority of those samples have no growth or non-significant growth and don't require any additional work-up. Batch review of large volumes of plates with non-significant growth and release can help medical laboratorians focus their time and expertise on more clinically relevant tasks.
"The use of the Urine Culture Application to automatically organize specimens into meaningful worklists driven by user-defined expert rules for critical criteria such as 'high risk patients' or 'complex specimens' will help laboratories work more efficiently and better prioritize their efforts to focus on the most critical and complex specimens," said Cecilia Soriano, vice president and general manager for Microbiology at BD Integrated Diagnostic Solutions. "Reading plates is one of the laboratory tasks that requires the most skill and given the decrease of skilled technicians entering the workforce and the strain on resources created by the COVID-19 pandemic, it's that much more critical for labs to be able to be more efficient."
Powered by BD Synapsys™ informatics solution, the BD Kiestra™ Urine Culture application (UCA) may help improve lab efficiency and enhance quality by providing diagnostically relevant, standardized images for interpretation by laboratory staff. The new Urine Culture app can be used with both standalone BD Kiestra™ ReadA systems as well as track-based BD Kiestra™ laboratory automation solutions.
About the BD Kiestra™ Laboratory Automation Solutions
BD Kiestra™ lab automation solutions provide total lab automation for the clinical microbiology laboratory. These solutions are designed to enhance laboratory operations, increase financial efficiencies and advance laboratory operations. BD Kiestra™ lab automation offerings include scalable and modular microbiology workflow automation solutions, ranging from standalone units to fully automated track-based automation systems for mid- and high-volume labs. Learn more about BD Kiestra.
About BD Synapsys™ Informatics
BD Synapsys™ Informatics is the informatics platform for BD Integrated Diagnostic Solutions, including the BD Veritor™ Plus System and the BD MAX™ System, which have been granted Emergency Use Authorization by the U.S. Food and Drug Administration to perform SARS-CoV-2 diagnostic testing. BD Synapsys™ Informatics solution provides secure connectivity, integrated workflows, and on-demand actionable insights for laboratories and facilities with Clinical Laboratory Improvement Amendments (CLIA) waivers. BD Synapsys Informatics was among the first life science diagnostics informatics platforms to receive the Underwriters Laboratory Cybersecurity Assurance Program certification, an independent third-party evaluation that uses standardized, testable criteria for assessing software vulnerabilities and weaknesses. Learn more about BD Synapsys.
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 70,000 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.
Health Canada approves Quidel’s Sofia® SARS Antigen FIA Test for screening of asymptomatic populations with serial testing
24 May 2021
SAN DIEGO, 24 May 2021 -- Quidel Corporation (“Quidel”), a leading provider of rapid diagnostic testing solutions, cellular-based virology assays and molecular diagnostic systems, announced today that its Sofia® SARS Antigen FIA is the first rapid antigen test to receive authorization from Health Canada for serial testing for the detection of active coronavirus infection in both symptomatic and asymptomatic populations.
The Sofia SARS Antigen FIA is a lateral flow immunofluorescent sandwich assay that is used with the Sofia and Sofia 2 instrument intended for the qualitative detection of the nucleocapsid protein antigen from SARS-CoV-2 in nasal (NS) swab specimens directly from individuals who are suspected of COVID-19 by their healthcare provider within the first five days of the onset of symptoms, or serial testing of asymptomatic populations using the Sofia SARS Antigen FIA test, at a minimum every 3 days/72 hours.
The Sofia® SARS Antigen FIA shows excellent performance within the first five days of the onset of symptoms, with positive results agreeing with PCR 96.7% of the time, and negative results agreeing 100% of the time, delivering confidence to physicians, healthcare workers and other customers within the professional segment. This new intended use claim allows the Sofia® SARS Antigen FIA to be used among asymptomatic individuals throughout Canada provided that individuals test at least every three days, or 72 hours. Routine testing by rapid antigen tests has shown to be effective in diagnosing COVID-19.1
“Quidel is proud to bring our most innovative and sensitive COVID-19 testing technologies to the Canadian market and make our tests as widely available as possible,” said Douglas Bryant, president and CEO of Quidel Corporation. “Health Canada’s approval opens the door to true democratization of the benefits of serial testing for both individuals experiencing symptoms and screening of people who may not have symptoms but are actively shedding the virus. Broadscale application of our Sofia® rapid antigen test for COVID-19 screening across Canada will catch asymptomatic cases early and limit virus spread and is an important tool to get Canadians back to work and getting the economy fully open again.”
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.
Labcorp Study Suggests COVID-19 Antibodies Remain at Least 10 Months After Infection
24 May 2021 - Study of More Than 39,000 People Also Investigated Impact of Age, Sex on Antibody Endurance
BURLINGTON, N.C., May 24, 2021 -- Nearly 87% of naturally infected COVID-19 patients maintained antibodies to SARS-CoV-2 proteins for at least 10 months, according to a new Labcorp (NYSE: LH) analysis of specimens from 39,086 individuals.
The study, published May 24 in The Lancet-affiliated EClinicalMedicine, offers real-world evidence of the body’s response to the virus and the possibility of protection against future infection. It is the largest known COVID-19-related study by specimen volume of its kind, harnessing Labcorp’s robust testing infrastructure to enhance the public’s understanding of this potentially deadly virus.
“Our observational analysis provides an encouraging timeline for antibody development and sustainability among the U.S. population,” said David Alfego, PhD, Labcorp senior data scientist and the paper’s lead author. “We sincerely hope it sparks more research, helps unearth answers to complex questions and informs critical, post-pandemic planning.”
Alfego and a team of Labcorp scientists analyzed results from tests used to detect antibodies that guard against “spike” and nucleocapsid proteins on the SARS-CoV-2 virus. Their analysis included specimens collected from 39,086 individuals with COVID-19 and tested between March 2020 and January 2021.
By employing various techniques, Labcorp scientists were able to map rates of antibody positivity, as well as the correlation of a person’s age and sex on antibody status.
Notable findings include:
- While sample sizes varied each day after a positive COVID-19 test, the antibody positivity rate to the SARS-CoV-2 spike protein remained mostly stable for the U.S. population through 300 days after the initial test.
- The positivity rate of antibodies to the nucleocapsid protein—a coronavirus component that is more active during early infection—declined more rapidly than the rate of spike antibodies but remained above 60% through 10 months of testing.
- Individuals under the age of 65 showed a more sustained rate of positive antibody results, meaning those 65 and older may have increased difficulty maintaining antibodies for a prolonged period of time.
- There was no statistically significant difference in spike antibody positivity rates between males and females over time.
“This is good news for naturally infected individuals, and potentially for those who have been vaccinated,” said Brian Caveney, M.D., chief medical officer and president of Labcorp Diagnostics. “More research must be done to understand what type and level of antibodies suggest protection from reinfection. But the prolonged presence of certain antibodies is a promising sign as we continue thinking about safely emerging from the pandemic, as well as future vaccinations and the timing of booster shots.”
The research, another example of Labcorp’s significant involvement in the country’s COVID-19 response, can be accessed here.
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 $14 billion in FY2020. Learn more about us at www.Labcorp.com.
Meeting the healthcare needs of the community: COVID-19 testing in urgent care and other non-acute settings
21 May 2021
21 May 2021 -- Long before the pandemic began, people have been seeking more convenient and cost-effective healthcare than the traditional primary care or hospital care settings offer. COVID supercharged that need as the pandemic brought uncertainty about access combined with a fear of exposure to the virus. As a result, the opening in the traditional healthcare market has widened.
Urgent care centers, drop-in testing facilities, retail pharmacies and health clinics that recognize the need to evolve the traditional healthcare system have a long-term opportunity to retain this customer base. Providing comfort and care now gets patients in the door – but patients have the potential to be retained for years to come if these healthcare settings continue to expand and diversify their services and programs.
In particular, because of COVID, more people have become accustomed to the convenience and comfort of receiving laboratory quality testing care in alternative settings. This has created a new standard for developing and administering future tests and an opportunity to grow the existing customer base.
The pandemic has helped educate the public about the benefits of accessible, rapid antigen testing – including reliable and convenient results within 15 minutes. With COVID-19 now added to the list of contagious diseases to monitor whenever common symptoms arise, testing at a higher degree of accessibility has the potential to become a norm, whether it’s testing before a flight, or if showing general symptoms of a virus.
Given the accessibility of testing in alternative care settings, receiving a test result when respiratory symptoms set in can become as commonplace as treating a sprained ankle. The convenience and easy access of testing will be particularly useful for people who interact with the public every day, like teachers and students, flight attendants, manufacturing professionals – the list goes on. Sites can capitalize on this opportunity by offering not only COVID-19 testing, but also other common respiratory tract infections like Influenza, Group A Strep, and Respiratory Syncytial Virus.
BD, a long-time global leader in diagnostic testing, is supporting the effort to boost the use of rapid testing in a post-COVID world. With the BD Veritor TM Plus System, testing is easy to implement and use regularly, low cost, doesn’t require sophisticated lab equipment or highly trained medical professionals, can be performed in a CLIA waived point-of-care setting and, most importantly, can provide test results in as little as 15 minutes. Come flu season, BD’s combined assay takes about 15 minutes to run on the BD Veritor™ Plus System and distinguishes between SARS-CoV-2, influenza A and influenza B, by providing definitive positive or negative individual digital display readouts for all three. Having the ability to run a rapid combination test to distinguish between these viral infections can help save time and resources.
COVID-19 has changed many of the public’s expectations around testing and access to healthcare. And with that new mindset, there is an opportunity for non-acute care health providers, like urgent care centers, drop-in testing facilities, retail pharmacies and health clinics, to win the business of new patients who are looking for access, convenience and affordability for services like COVID-19 and flu testing in a non-acute setting today and for the long term.
LGC’s high-throughput PCR testing system for SARS-CoV-2 detection granted Emergency Use Authorisation
20 May 2021
20 May 2021 -- LGC’s high-throughput SARS-CoV-2 Real-Time and End-Point RT-PCR Test has been granted Emergency Use Authorisation (EUA) by the FDA. It is the highest throughput PCR testing system to be approved to date, with the capability of processing up to 35,000 tests per day.
The FDA’s authorisation enables qualified laboratories to address SARS-CoV-2 testing demands while providing significant economic advantage when compared to other technologies.
Mark Dearden, Managing Director, LGC, Biosearch Technologies, said, “This tool is a game-changer in our fight against COVID-19. It offers the gold standard of PCR testing but with economics to support routine diagnostics at scale.”
Dearden continued, “The benefits of large-scale PCR testing can’t be underestimated. We know that extensive and frequent testing is a key tool for tracking and managing the spread of the virus. Used in concert with other point-of-need testing and continued vaccine rollout, the LGC solution can enhance our ability to fight the pandemic.”
LGC’s testing system has been built to be flexible and scalable, allowing organisations to meet changing SARS-CoV-2 testing needs.
The company has been involved in the response to the COVID-19 pandemic since January 2020. It 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.
Gruppentests in Friesland: Masse und Klasse?
20 May 2021
20 May 2021 -- Das SYNLAB Labor in Varel bietet eine kostengünstige und sehr sensitive Corona Testmethode im 7er-Pooling Verfahren an. Dabei werden die Proben einer Gruppe von sieben Teilnehmern zusammengeführt und gemeinsam gemessen. In diesem neuen und von SYNLAB zum Patent angemeldeten Verfahren werden aufgrund von Prozessoptimierungen anstatt wie bisher Proben von fünf Teilnehmern, ohne einen nennenswerten Sensitivitätsverlust sieben Proben gemessen. Ist das Pool-Ergebnis negativ, sind alle Teilnehmer nicht mit SARS-CoV-2 infiziert, fällt das Pool-Ergebnis positiv aus, werden die Teilnehmer nachgetestet und der oder die mit SARS-CoV-2 infizierten Teilnehmer analysiert.
Besonders für Unternehmen und den Schutz der Mitarbeiter am Arbeitsplatz ist das neue Verfahren sehr geeignet.
Reference: https://www.synlab.de/human/news-artikel/gruppentests-in-friesland-masse-und-klasse-1373
Beckman Coulter launches a fully quantitative and automated COVID-19 IgG Test to assess antibody immune response levels
19 May 2021 - The availability of an International Standard (IS) for antibodies facilitates the standardization of SARS-CoV-2 serological methods. Access SARS-CoV-2 IgG (1st IS) measures the quantity of antibodies so physicians can determine an individual’s COVID-19 antibody immune response and aids in the monitoring of patients who were previously diagnosed, or suspected of having COVID-19. High-quality test has a PPA/sensitivity ≥15 days post-symptom onset of 100% and NPA/specificity of 99.8% and delivers results traceable to 1st WHO International Standard for anti-SARS-CoV-2, 20/136. Available to all customers in countries accepting the CE mark and to customers throughout the U.S. and Puerto Rico under FDA Policy D.
BREA, CALIF., MAY. 19, 2021 — Beckman Coulter, a global clinical diagnostics leader, today announced the launch of Access SARS-CoV-2 IgG (1st IS), a fully-quantitative lab-based Immunoglobulin G (IgG) serology test that measures the quantity of antibodies against the virus that causes COVID-19. The newest addition to its suite of COVID-19 solutions, this high-quality assay is traceable to the 1st WHO International Standard for anti-SARS-CoV-2, 20/136 and reports results directly aligned with BAU/mL (Binding Antibody Units) established by the World Health Organization. As the pandemic continues its global assault, even while vaccinations are being rolled out, serology testing is emerging as a test with public health and clinical utility for monitoring and responding to the COVID-19 pandemic and caring for patients.
“Serology testing has wide-ranging clinical utility currently, as well as in a post-vaccinated world. For example, according to the CDC, antibody testing may be useful to support a diagnosis of a previous COVID-19 illness,” said Shamiram R. Feinglass, M.D., MPH, chief medical officer for Danaher Diagnostics and Life Sciences. “With a quantitative assay such as the IgG (1st IS), physicians can now compare results to a standard and look across populations.”
The Clinical Utility of COVID-19 Serology Testing
Beckman Coulter launched its first COVID-19 IgG and IgM tests in 2020 during the initial outbreak. The tests were designed to qualitatively detect antibodies produced against the spike protein of the SARS-CoV-2 virus as they were strongly suspected to be neutralizing. Following the launch, the company delivered highly accurate IgG and IgM tests to provide reliable information for both individual health decisions as well as population-based immunity monitoring.
“With the launch of a fully quantitative COVID-19 IgG assay, we [can] determine seroprevalence in a population and also help determine the quantity of antibodies in individuals over time, which wasn’t possible before because we didn’t have standardization across quantitative serology tests,” said Dr. Bernard Cook, division head of chemistry and director of operations of the core automated laboratory, Henry Ford Hospital in Detroit. “Now, and in a post-vaccinated world, these assays are going to help physicians better understand the immune response of patients who develop COVID-19 infections, those who have post-acute sequelae of COVID-19 and in assessing response to vaccination to SARS-CoV-2.”
Access SARS-CoV-2 IgG (1st IS)
In a clinical study, Beckman Coulter’s Access SARS-CoV-2 IgG (1st IS) quantitative test showed a clinical performance of 100% Positive Percent Agreement/Sensitivity (exclusion of false negatives) and 99.8% Negative Percent Agreement/Specificity (exclusion of false positives) in patients tested >/=15 days or more post-symptom onset. “Laboratory testing remains a powerful tool in our fight against the pandemic,” said Chris Hagen, global vice president of the COVID-19 task force at Beckman Coulter. “The Access SARS-CoV-2 IgG (1st IS) assay may be used to inform clinicians about changes in antibody levels over time. This virus continues to evolve, which is why we are continually developing diagnostic solutions to help physicians save lives.”
Beckman Coulter has more than 16,000 immunoassay analyzers worldwide. Just like all of Beckman Coulter’s COVID-19 assays, the Access SARS-CoV-2 IgG (1st IS) test can be used in Random Access Mode (RAM) and seamlessly integrated into existing workflows without batch processing. Results of the new quantitative antibody test are delivered quickly on Beckman Coulter’s award-winning immunoassay analyzers, including the DxI 800 high-throughput analyzer, which is capable of processing up to 200 Access SARS-CoV-2 IgG (1st IS) samples per hour.
Access SARS-CoV-2 IgG (1st IS) can be immediately shipped to customers in countries accepting the CE mark and to customers throughout the U.S. and Puerto Rico under the U.S. Food and Drug Administration’s (FDA) Policy D. The company has filed for Emergency Use Authorization of the assay with FDA.
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.
BGI Gets CE Mark for Colorectal Cancer Testing Kit
19 May 2021
19 May 2021 -- BGI Genomics today announces that the DNA Methylation Detection Kit for Human SDC2, ADHFE1 and PPP2R5C Genes (Real-Time PCR) has been CE marked. The kit can detect the methylation of SDC2, ADHFE1 and PPP2R5C genes in human fecal samples.
According to the Global Cancer 2020 (GLOBOCAN) statistics, there are about 19.3 million new cases of colorectal cancer each year, accounting for 10.0 percent of all new cancer cases. About 935,000 colorectal cancer deaths occur each year, accounting for 9.4 percent of all cancer deaths.
Abnormality of DNA methylation modification is closely related to the occurrence and development of cancer. This newly CE marked kit detects abnormal methylation of SDC2, ADHFE1 and PPP2R5C genes in stool DNA, which are highly specific markers for colorectal cancer cells. The kit is intended to be used as a non-invasive test to aid diagnosis of patients who are recommended by clinicians to receive diagnostic colonoscopy.
Reference: https://www.bgi.com/global/company/news/bgi-gets-ce-mark-for-colorectal-cancer-testing-kit/
Labcorp to Expand Bioanalytical Services With Integrated Laboratory in Singapore
19 May 2021 - New Laboratory Grows Asia-Pacific Operations
BURLINGTON, N.C., May 19, 2021 — Labcorp, a leading global life sciences company, today announced the expansion of its drug development offering in the Asia-Pacific region with the addition of bioanalytical services in Singapore.
“Singapore is a crucial region for strengthening Labcorp’s extensive global presence, offering our clients—both in-region and international—a complementary site to support their bioanalytical studies,” said Stephane Sidobre, vice president and head of Labcorp’s Global Bioanalytical Services. “We are thrilled to expand services in this area and enhance the options available to those we serve. The new laboratory will provide expedited turnaround time for our clients and enhance Covance by Labcorp’s ability to deliver for the Asia-Pacific region.”
The new bioanalytical laboratory in Singapore will support the development of both small and large molecular entities while providing a complete range of regulated and non-regulated bioanalytical services. Bioanalytics is a quantitative measure of drugs and metabolites in biological samples such as blood, serum, tissue and plasma. The laboratory will offer Good Laboratory Practice and Good Clinical Practice-compliant bioanalysis, liquid chromatography-mass spectometry and immunochemistry platforms, as well as discovery and clinical biomarker analytical services. In addition, it will allow faster data turnaround for early phase trials in Asia-Pacific markets.
Construction and reconfiguration of the bioanalytical laboratory has commenced, and its opening is expected in late 2021.
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 improve lives. With more than 70,000 employees, we serve clients in more than 100 countries. Labcorp reported revenue of $14 billion in FY2020. Learn about Covance by Labcorp at www.Covance.com, and Labcorp at www.Labcorp.com.
Illumina Appoints Susan Tousi as Chief Commercial Officer and Dr. Alex Aravanis as Chief Technology Officer, Head of Research and Product Development
17 May 2021
SAN DIEGO, 17 May 2021 -- Illumina, Inc. today announced that it is appointing Susan Tousi as Chief Commercial Officer (CCO), and Dr. Alex Aravanis as Chief Technology Officer (CTO), Head of Research and Product Development.
“We’re fortunate to have Susan and Alex, two of the strongest leaders in the genomics industry, take on these large, important roles,” said Francis deSouza, Chief Executive Officer of Illumina. “Susan and Alex are talented and passionate executives with successful track records of creating a compelling vision, building great teams, delivering exceptional results, and championing our culture. In their new roles, they will help further accelerate our innovation roadmaps and expand our customer relationships globally.”
Susan has more than 25 years of technical and general management leadership at scale and has led Illumina’s global product development since 2012. Under her leadership, Illumina delivered an expansive portfolio of breakthrough, industry-leading products across sequencing platforms, microarrays, library prep and informatics, including HiSeq™ X, NovaSeq™ 6000, NextSeq™ 500/550/550Dx/1000/2000, iSeq™ 100, MiSeq™ Dx, the world’s first FDA-cleared/CE-IVD marked sequencer, the DNAflex library prep solutions, COVIDSeq™ Test, and TruSight™ Oncology 500. She led the successful acquisitions of Edico Genomics, BlueBee and Enancio, which brought DRAGEN’s™ accelerated Bio-IT platform to Illumina, and resulted in the launch of Illumina Connected Analytics. Prior to Illumina, Susan was Corporate Vice President and General Manager for Eastman Kodak’s Consumer Inkjet Systems, and before that, spent 10 years at Hewlett-Packard in technical and management roles. She has received numerous business, technology, and leadership awards, and was elected to the National Academy of Engineers in 2018. Susan holds an MBA from UCLA and an Honors BS in Engineering Science from Pennsylvania State University.
“I am excited to lead Illumina’s extraordinarily talented commercial team to empower our customers around the world with innovations that further unlock the power of the genome,” said Susan. “I look forward to strengthening relationships between Illumina’s research and development teams and our customers, boosting our offerings and benefiting all. I am deeply passionate about our products and inspired by the breathtaking technology and portfolio we have set up for the next decade. It will take our customers to an entirely new level of genomics innovation, and I cannot wait to continue scaling our strong commercial engine to deliver on this promise.”
For nearly 20 years Alex has led innovation spanning basic research and technology development to late-stage clinical development. He first joined Illumina in 2013 and led research to create the first distributed comprehensive genomic profiling assay for liquid biopsy and tumor tissue, the first exome-wide targeted RNA assays for tumor tissue, massively parallel single cell sequencing, and other sequencing platform technologies including semiconductor-based detection. In 2016, Alex co-founded and served as Chief Scientific Officer and Head of R&D at GRAIL, where he led teams developing a multi-cancer early detection test by combining high-intensity sequencing, data science and engineering, including powerful machine learning approaches such as neural networks. His team at GRAIL created one of the largest clinical study programs ever in genomic medicine. Alex returned to Illumina in June 2020 as CTO, leading the company’s research and technology development and the innovation engine for next-generation sequencing platforms and applications. Alex is an inventor on numerous patents and publications. He has an MD and a PhD in Electrical Engineering from Stanford University and a BS in Electrical Engineering from UC Berkeley.
“I am honored to lead Illumina’s powerful research and product teams at a time when the impact of sequencing is accelerating worldwide across areas including research, oncology, reproductive health, genetic disease diagnosis and pathogen surveillance. Illumina’s products and partnerships are helping move healthcare toward earlier detection, faster diagnosis and precision medicine,” said Alex. “Our technology and product roadmaps will continue to set the pace for innovation, cost reduction, and new insights for our customers. I look forward to hitting the gas pedal as we accelerate other technology breakthroughs and their translation to the clinic.”
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.
PerkinElmer to Acquire In-Vitro Diagnostics Company Immunodiagnostic Systems Holdings PLC
17 May 2021 - Endocrinology testing specialist expands PerkinElmer’s immunodiagnostics segment
WALTHAM, Mass., May 17, 2021 -- PerkinElmer, Inc. (“PerkinElmer”) and Immunodiagnostic Systems Holdings PLC (“IDS”) are pleased to announce that they have reached an agreement on the terms of a recommended all cash offer whereby PerkinElmer will acquire IDS for approximately $155 million (£110 Million). The transaction has a total enterprise value of approximately $124 million (£88 Million) and is expected to close early in the third quarter of 2021, subject to approvals from the shareholders of IDS, sanction by the High Court of Justice in England and Wales and other customary closing conditions for a public takeover in the United Kingdom.
Through this acquisition, PerkinElmer will be able to grow its overall Diagnostics business and specifically its immunodiagnostics segment. Moreover, the deal will enable PerkinElmer to combine its channel expertise and testing capabilities with IDS’s best-in-class chemiluminescence products in endocrinology, autoimmunity and infectious diseases to better serve customers around the world.
IDS’s portfolio and expertise will seamlessly integrate within EUROIMMUN, a PerkinElmer company since 2017. EUROIMMUN is a global leader in autoimmune testing and an emerging force in infectious disease, allergy and molecular genetic testing.
Wolfgang Schlumberger, CEO of EUROIMMUN, remarked, “This proposed transaction is highly valuable for both parties as the respective product lines are to a large extent complementary. The cooperation of our global distribution channels, the expansion of the immunoassay portfolio in closely related indication fields and IDS's fully automated random access chemiluminescence platform strengthens our presence in immunodiagnostics. Our customers will benefit from a broader range of assays and laboratory diagnostic workflows. We are excited about these new opportunities and we look forward to welcoming Immunodiagnostic Systems into the PerkinElmer family following the completion of the transaction.”
Headquartered in Boldon, the United Kingdom, IDS is a leading in-vitro diagnostic solution provider to the clinical laboratory market. IDS develops, manufactures, and markets innovative immunoassays and automated immunoanalyzer technologies to provide improved diagnostic outcomes for patients. IDS’s immunoassay portfolio is a combination of an endocrinology specialty testing menu and assay panels in complementary fields. IDS has approximately 300 global employees.
PerkinElmer's comprehensive global diagnostics portfolio includes solutions focused on: reproductive health; autoimmune, infectious disease and allergy testing; gene analyses; and genomics offerings for oncology and other molecular tests through its wide range of instruments, reagents, assay platforms and software offerings.
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 forecasts IDS’s business to be attractively positioned in markets that are projected to grow at a compound annual growth rate of high-single digits over the next few years.
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 $3.8 billion in 2020, 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.
About Immunodiagnostic Systems
IDS engages in the development, manufacture, and marketing of in-vitro diagnostic tests (IVD) to the clinical laboratory market. It operates through the following business units: Automated IVD Business, Manual IVD Business, and Licensing and Technology. The Automated IVD Business unit offers an analyzer which automates nearly all steps required for performing a test using their kits. The Manual IVD Business unit sells assay kits whereby the testing is performed by laboratory technicians. The Licensing and Technology unit monetizes the technology and know-how that the company owns through original equipment manufacturer partners. The company was founded in 1977 and is headquartered in Boldon, the United Kingdom.
Die ersten 3.000 Lolli-Tests sind ausgewertet
17 May 2021 - Dr. Hassan Jomaa, Ärztlicher Leiter des SYNLAB Standorts in Leverkusen: Von den ersten 3.000 Lolli-PCR-Pool-Tests waren 20 positiv. Dies liegt im erwarteten Bereich. Studien haben ergeben, dass bis zu ein Prozent der Tests positiv sein können.
17 May 2021 -- In Nordrhein-Westfalen werden seit dem 10.Mai 2021 landesweit Lolli-PCR-Tests im Poolingverfahren an Grund- und Förderschulen angeboten. Hierbei lutschen Schüler zwei Mal pro Woche morgens in der Schule an einem Wattetupfer (Lolli), die Tupfer werden dann mit jeweils 15 Teilnehmern gemeinsam kostengünstig im PCR-Poolingverfahren gemessen. Im Falle eines positiven Ergebnisses haben alle Schüler einen Wattetupfer (Lolli) für eine Nachtestung für zu Hause bekommen, der dann von den Eltern am nächsten Tag in die Schule gebracht wird.
Alle Informationsabläufe für die Lolli-PCR-Tests laufen einfach und zeitnah über die SYNLAB Access App.
In der Woche vor dem Start der Lolli-Tests hat SYNLAB auf einer Webseite die Materialen zur Probennahme, Anleitungen, Erklärvideos und Beratung über Online-Seminare für Lehrer, Schulsekretariate und Eltern zur Verfügung gestellt.
Dr. Hassan Jomaa: „Wir wollen mit den Lolli-Tests auch die Lehrer und Eltern unterstützen, damit es Stabilität im Unterricht gibt, Schulen oder Schulbereiche nicht wieder schließen müssen.“
Reference: https://www.synlab.de/human/news-artikel/die-ersten-3000-lolli-tests-sind-ausgewertet-1371
Quidels’s QuickVue® At-Home OTC COVID-19 Test now available for sale through Amazon
14 May 2021
SAN DIEGO, 14 May 2021 -- Quidel Corporation (“Quidel”), a leading provider of rapid diagnostic testing solutions, cellular-based virology assays and molecular diagnostic systems, announced today that its non-prescription QuickVue® At-Home OTC COVID-19 Test is now available in the United Statesto consumers for online order through e-commerce retailer Amazon.
“The ability to quickly order and receive the QuickVue® At-Home tests and screen for COVID-19 in the privacy of their homes will give greater peace of mind to countless American families seeking a return to normal,” said Douglas Bryant, president and CEO of Quidel Corporation.
The QuickVue® At-Home OTC COVID-19 Test allows consumers to easily perform the test themselves without a doctor’s prescription and get results in 10 minutes from nasal swab samples. The QuickVue® At-Home COVID-19 Test shows excellent performance, with positive results agreeing with PCR 83.5% of the time, and negative results agreeing 99.2% of the time, delivering confidence to individuals running the test and helping to prevent asymptomatic virus spread.
A 2-pack COVID test is currently available for sale on amazon.com for $24.95 with free shipping.
The QuickVue® At-Home OTC COVID-19 Test is only for use under the Food and Drug Administration’s Emergency Use Authorization. The QuickVue® At-Home OTC COVID-19 Test has not been FDA cleared or approved. The test has been authorized only for the detection of proteins from SARS-CoV-2, not for any other viruses or pathogens, and 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 Federal Food, Drug and Cosmetic Act, 21 U.S.C. § 360bbb-3(b)(1), unless the declaration is terminated or authorization is revoked sooner.
Visit http://www.quickvueathome.com for more information.
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.
Danaher announces appointment of A. Shane Sanders to Danaher board
13 May 2021
WASHINGTON, May 13, 2021 -- Danaher Corporation announced today that it has appointed A. Shane Sanders to its Board of Directors and to its Audit Committee. This addition expands the size of Danaher's Board from twelve to thirteen members.
Mr. Sanders is currently Senior Vice President of Business Transformation at Verizon Communications Inc. (NYSE: VZ). Since joining Verizon in 1997, he has served in a series of progressively more responsible leadership positions including as Senior Vice President of Corporate Finance from 2015 to 2020. Prior to joining Verizon, Mr. Sanders served in various finance roles at Hallmark Cards, Inc. and Safelite Glass Corporation, and began his career at Grant Thornton in 1984.
Mr. Sanders earned his B.S. in Accounting from Oklahoma City University and his M.B.A. from Rockhurst University, and he is a Certified Public Accountant.
Steven M. Rales, Chairman of the Board of Danaher Corporation, said "We are very pleased to welcome Shane to the Danaher Board of Directors. His extensive leadership experience in corporate finance over the last twenty-five years will be a tremendous asset to our Board and to Danaher as we strive to build sustainable, long-term shareholder value."
ABOUT DANAHER
Danaher is a global science and technology innovator committed to helping its customers solve complex challenges and improving quality of life around the world. Its family of world class brands has leadership positions in the demanding and attractive health care, environmental and applied end-markets. With more than 20 operating companies, Danaher's globally diverse team of approximately 69,000 associates is united by a common culture and operating system, the Danaher Business System, and its Shared Purpose, Helping Realize Life's Potential. For more information, please visit www.danaher.com.
BD Announces Industry-First CE Marked Assay for HPV Screening from At-Home Self-Collected Vaginal Samples
13 May 2021 - BD Onclarity™ HPV Assay CE Marked for Self-Collection; Available on BD Viper™ LT and BD COR™ Systems
FRANKLIN LAKES, N.J., May 13, 2021 -- BD (Becton, Dickinson and Company), a leading global medical technology company, today announced the industry's first self-collection claim for HPV screening has been CE marked to the IVD directive 98/79/EC.
The new claim allows laboratories and facilities to process self-collected samples via a BD diluent tube using the BD Onclarity™ HPV Assay on either the BD Viper™ LT or the BD COR™ System. The BD Viper™ LT is in use globally and the BD COR™ System, launched last year, is in use across Europe.
"The goal of cervical cancer screening is simple but critical: to detect pre-cancer before it develops into cancer," stated Dr. Jeff Andrews, vice president of Global Medical Affairs at BD. "Not only does self-collection afford women greater access to testing, but they may also feel confident that the reliability of HPV testing of self-collected samples is the same as if they went to a cliniciani."
At-home collection will help address the urgent public health challenge of reaching women who do not attend routine cervical cancer screening. Over half of all cervical cancers are diagnosed in women who have never been screened or have not been screened in the previous five yearsii, a situation that has been compounded by the recent global pandemic.
Persistent infection with HPV is the cause of virtually all cases of cervical canceriii. Current estimates indicate that every year in Europe, more than 61,000 women are diagnosed with cervical cancer and nearly 26,000 die from the disease,iv making cervical cancer the second-most common female cancer deaths in women aged 15 to 44 and the ninth-most frequent cancer among women overall.iii
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. The BD Onclarity™ HPV Assay includes genotype reporting beyond HPV genotypes 16, 18, and 45 to include types 31, 51, 52, 33/58, 35/39/68 and 56/59/66.
In late 2020, the World Health Organization (WHO) launched its Global Strategy to Accelerate the Elimination of Cervical Cancer, recognizing the potential for a three-pronged approach of vaccination, screening, and treatment to virtually eliminate cervical cancerv. The European Union has set a goal to introduce "organized population-based HPV-based screening and achieve 70% of screening coverage in the target age group, specifying HPV testing of self-samples for non-screened or underscreened women; and to manage 90% of screen-positive women" by 2030vi.
"Adding HPV self-sampling to any cervical cancer prevention effort is close to a silver bullet; it's simple, easy and safe for women, and equals doctor-collected samples in diagnostic quality," said Jesper Bonde, PhD, Senior Researcher and Molecular Pathology Laboratory Manager, Hvidovre Hospital, Denmarkvii. "HPV self-sampling makes screening accessible to women who don't participate in screening or have limited access to screening."
He further added that, "Combining HPV self-sampling with extended genotyping allows for focus on those women at highest risk while not overtreating those at very low risk. Screening strategies, including at-home self-collection, 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 both by allowing risk stratification directly on the screening sample."
Cervical cancer screening has been very effective at reducing morbidity and mortality from disease but participation in screening programs varies widely across the Europe ranging from 7.3% to complete coverageviii. Adding at-home collection as an option to screening programs has been demonstrated to increase participation.i
"There has been a considerable drop in cervical cancer screening due to COVID-19ix," said Brooke Story, president of Integrated Diagnostic Solutions at BD. "As a woman, I can say that a fear of exposure to COVID has impacted my own preventive health behavior, so I recognize both professionally and personally the value of having an easy, convenient and private self-collection process for HPV screening available."
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), as well as in the Cervical Brush Diluent tube (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 womenx. Visit bd.com and advancing-diagnostics.eu 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 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 70,000 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.
Pixel by Labcorp COVID-19 PCR Test Home Collection Kit Receives FDA Emergency Authorization for Ages 2-17
13 May 2021 - Labcorp Becomes First Major Commercial Lab to Offer a COVID-19 PCR Test Home Collection Kit for Children 2 Years and Older
BURLINGTON, N.C., May 13, 2021 -- Labcorp, a leading global life sciences company, today announced that the U.S. Food and Drug Administration (FDA) has granted Emergency Use Authorization (EUA) for its Pixel by Labcorp COVID-19 PCR Test Home Collection Kit for ages 2-17. The authorization expands the use of Pixel by Labcorp to children and adolescents 2 years of age and older when purchased by a parent or guardian.
“Expanding access of our Pixel by Labcorp COVID-19 Test Home Collection Kit to include younger populations fills an important need as people seek to resume life activities safely,” said Brian Caveney, M.D., chief medical officer and president of Labcorp Diagnostics. “This is welcome news as children and parents look forward to summer activities, camps, travel and the upcoming school year.”
Pixel by Labcorp COVID-19 PCR Home Collection Kit uses the same PCR test trusted by doctors and hospitals across the country. Individuals age 14-17 can self-collect with adult supervision, and children between the ages of 2 and 13 will need adult assistance to collect their sample.
Beginning in late May, parents and guardians can request a kit for children 2 years of age and older directly through www.pixel.labcorp.com. Once the request is received by Labcorp, a kit will be shipped to the individual’s home via FedEx. For adults 18 and over, the Pixel by Labcorp COVID-19 PCR Test Home Collection Kit is also available in over 6,000 pharmacies nationwide.
Labcorp offers its Pixel by Labcorp COVID-19 PCR Test Home Collection Kit for zero upfront costs when clinical guidelines are met. Visit Labcorp’s COVID-19 website to learn about the company’s testing and drug development offerings.
The Pixel by Labcorp COVID-19 PCR Test Home Collection Kit has not been FDA-cleared or approved, but has been authorized for emergency use by FDA under an EUA, and has been authorized only for the detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens. Emergency use of this product 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 Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 360bbb-3(b)(1), unless the declaration is terminated or authorization is 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 improve lives. With more than 70,000 employees, we serve clients in more than 100 countries. Labcorp reported revenue of $14.0 billion in FY2020. Learn more about us at www.Labcorp.com
QIAGEN Receives U.S. FDA Emergency Use Authorization for Fast and Easy-to-Use Digital Test to Detect SARS-CoV-2 Coronavirus Antibodies
12 May 2021 - U.S. authorization gives healthcare professionals access to portable rapid testing device that can monitor immune status in relation to COVID-19. Test based on QIAGEN partner Ellume’s proprietary eHub technology and helps ease testing shortfalls by using automation and providing easy-to-read results. eHub digital device can handle eight tests at once, all working independently of each other, can process up to 32 samples per hour, can eventually be used simultaneously with the antigen test.
GERMANTOWN, Md. & HILDEN, Germany, 12 May 2021 -- QIAGEN N.V. today announced it has received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) for the fast and easy-to-use QIAreach® Anti-SARS-CoV-2 Total Test.
The authorization means QIAGEN can start making its portable antibody testing device available to health-care professionals in the U.S. Each antibody test takes only about 10 minutes to identify whether a person carries antibodies to the SARS-CoV-2 virus as a result of prior infection. Individual test results are read on a digital eHub device that can process up to 32 tests per hour – and will eventually also run the antigen test.
The QIAreach Anti-SARS-CoV-2 Total Test is a serological test that has been shown to have a sensitivity of 93.85% (CI 84.99–98.30%) and a specificity of 97.83 %–%% (CI 95.00–99.29%). QIAGEN’s technology detects total antibodies (Total immunoglobulin) specific to SARS-CoV-2 immune response – while most other tests currently identify only selected antibodies.
The QIAreach Anti-SARS-CoV-2 Total Test was developed in partnership with Ellume, an Australian digital diagnostics company. It is the first of two QIAGEN COVID-19 tests to make use of Ellume’s digital eHub and eStick system: QIAGEN in early September 2020 presented the QIAreach SARS-CoV-2 Antigen Test to detect active SARS-CoV-2 infection, which has been submitted to the FDA for an EUA.
Research into the SARS-CoV-2 pandemic also requires the monitoring of the immune status of individuals. QIAGEN is the only company that has developed both an antibody and a T-cell test to track immune responses. In November, it also launched the QuantiFERON SARS-CoV-2 test (for research use only) that can detect T-cell responses in people who have had natural infection or vaccination.
“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,” said Davide Manissero, Chief Medical Officer of QIAGEN. “As societies are now returning to normal daily routines, understanding the COVID-19 immunity in a population can help guide public health measures.”
Traditional rapid lateral-flow antibody tests are hard to automate and results can be hard to read. The QIAreach Anti-SARS-CoV-2 Total Test generates easy-to-read results on the digital eHub platform. Each QIAreach eHub can handle up to eight samples on eight eSticks simultaneously, with each eStick test running independently. QIAGEN is using the same platform to develop QIAreach® QuantiFERON®-TB, a new testing solution for identifying latent tuberculosis (TB) infections in low-resource regions.
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 March 31, 2020, QIAGEN employed approximately 5,700 people in over 35 locations worldwide. Further information can be found at http://www.qiagen.com.
United and Abbott partner to make return to U.S. “Worry Free” for international travelers with Home-Testing kits
12 May 2021 - Newly issued guidance from the U.S. Centers for Disease Control and Prevention now accepts rapid, self-administered testing option that meet its criteria. United customers can depart the U.S. with the Abbott BinaxNOW™ Home Test in their carry-on bag and administer the test via the eMed digital health platform to re-enter the U.S.
CHICAGO and ABBOTT PARK, Ill., May 12, 2021 – United and Abbott today announced a first-of-its-kind collaboration to use Abbott’s BinaxNOW™ COVID-19 Home Test and Abbott’s NAVICA app to help make the international travel experience more seamless. Recently updated CDC guidelines permit travelers to self-administer a rapid antigen test under the real-time supervision of a telehealth service and use the verified negative test result to board an international flight to the U.S. if they test negative.
“We appreciate the private sector proactively helping travelers have access to easy, reliable COVID-19 test options,” said CDC Director Rochelle P. Walensky, MD, MPH. “Comprehensive testing that is easy, rapid, accurate and trusted is a fundamental strategy for preventing the spread of COVID-19.”
United customers can depart the United States with the BinaxNOW Home Test in their carry-on bag and administer the test via the eMed digital health platform while overseas, avoiding the need to find a testing center abroad. United is the only airline to offer end-to-end integration between a digital platform and a testing app with the integration between the United Travel Ready Center platform and Abbott’s NAVICA app which provides a seamless passenger experience when departing and re-entering the UnitedStates. Since the Travel-Ready Center launched in January, United customers have been able to easily access testing or vaccine requirements needed for travel destinations, upload completed testing results and vaccine records, as well as have them verified, all within the United app.
“We want to give our customers greater peace of mind that when they travel internationally, they’ll be able to return to the U.S quickly and safely,” said Toby Enqvist, chief customer officer at United. “The Abbott BinaxNOW Home Test meets CDC requirements and, along with our partners at Abbott, United is doubling down on our commitment to make international travel as safe and covenient as possible by offering an easy testing option when customers are ready to return to the United States.”
The BinaxNOW Home Test kit is lightweight, about the size of a day planner and fits easily into a passenger’s carry-on luggage, briefcase or purse. It is recommended that passengers travel with more than one BinaxNOW test in their possession in the event of an inconclusive test result.
“The BinaxNOW COVID-19 rapid test is the most studied and widely used rapid test in the United States today and with our partner United, we’re making testing even more broadly available as the country returns to international business and leisure travel,” said Andrea F. Wainer, executive vice president of Abbott’s rapid and molecular diagnostics business. “The CDC’s recent guidance also reinforces the importance of our NAVICA app, because airlines and other safety-conscious industries, such as workplaces and higher education, will need digital solutions that can be used to quickly and easily validate and verify test results.”
The BinaxNOW COVID-19 rapid test can help restore a sense of normalcy to everyday life by reuniting family members and loved ones, providing additional confidence while traveling, and making it easier to do international business. Authorized since August 2020, more than 200 million BinaxNOW tests have been distributed throughout the United States, where they’ve been used by K-12 schools, universities, nursing homes, and underserved communities and serve as a powerful tool to help prevent the virus from spreading.
The Abbott BinaxNOW™ Home Test meets the the CDC’s guidance due to the unique digital proctor experience through eMed, which provides observed sample collection, testing and digitally verified test results. Abbott’s recently authorized BinaxNOW™ Self Test for over-the-counter purchase is not eligible for travel purposes.
About United
United's shared purpose is "Connecting People. Uniting the World." For more information, visit united.com, follow @United on Twitter and Instagram or connect on Facebook. The common stock of UAL is traded on the Nasdaq under the symbol "UAL".
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 109,000 colleagues serve people in more than 160 countries.
Quest Diagnostics Expands Eligibility for $0 Out-of-Pocket COVID-19 Testing Through QuestDirect™ To Assist in Combatting the Pandemic and Help Support Safer Travel, Events and Gatherings Nationwide
11 May 2021 - Eligibility for $0 out-of-pocket COVID-19 testing expanded to include adults and minors regardless of symptoms or suspected exposure, consistent with updated government guidance on insurance coverage for COVID-19 testing. Observed self-collection available at 500 Walmart Neighborhood Market drive-through sites and other locations.
SECAUCUS, N.J., May 11, 2021 -- Quest Diagnostics, the world's leading provider of diagnostic information services, today unveiled several new enhancements to its COVID-19 testing services, with the goal to help combat COVID-19 while empowering more individuals and families to resume "back to life" activities with greater safety this spring, summer and beyond.
Starting today, adults can request access to the company's $0 out-of-pocket COVID-19 test option for themselves and children 4 years of age and older through QuestDirect™, the company's online consumer-initiated test platform. Eligibility for $0 out-of-pocket COVID-19 testing includes adults and minors regardless of symptoms or suspected exposure, consistent with updated government guidance on insurance coverage for COVID-19 testing.
An individual simply fills out a form online, which is quickly reviewed by an independent physician. If deemed eligible by the physician, the individual may then schedule an appointment for an observed self-collection at one of 500 Walmart Neighborhood Market locations and other sites. Same-day appointments may be available, with test results typically provided the next day.* QuestDirect is not available in Alaska, Arizona and Hawaii. The $0 out-of-pocket COVID-19 test option through QuestDirect is not available for asymptomatic individuals without known or suspected exposure for public health surveillance or employment purposes.
Quest is believed to be the first national laboratory provider to enable a patient to request access to COVID-19 diagnostic testing, regardless of symptoms or exposure, through a consumer-initiated testing site with broadly accessible observed self-collection at no cost to individuals. The test will be billed to commercial health plans and government payors. The expanded test option comes as governments and organizations seek ways to utilize testing to resume safer in-person customer interactions.
"As a leader in the nation's COVID-19 testing response, Quest Diagnostics is continually spearheading new innovations to broaden access to quality COVID-19 diagnostic insights," said Cathy Doherty, Senior Vice President and Group Executive – Clinical Franchise Solutions and Marketing, Quest Diagnostics. "As more people are vaccinated and the economy opens, greater flexibility and affordability in COVID-19 testing will help keep us all safer. We believe this option for COVID-19 testing will enable individuals and families to return to normal activities more safely and responsibly."
The $0 out-of-pocket option applies to molecular laboratory (PCR/NAAT) and rapid antigen testing, where available. While the vast majority of testing provided by Quest is molecular laboratory testing, the company has also begun to offer rapid antigen tests at approximately 30 patient service centers in New York, with plans to extend the capability to other states over time.
Quest has capacity to provide 300,000 COVID-19 molecular diagnostic tests a day from approximately two dozen laboratories across the United States. Since launching its services in early March 2020, the company has performed more than 40 million COVID-19 molecular diagnostic tests. Quest reports the vast majority of test results within a day.*
About Our Commitment to Empowering Consumer Health
Quest Diagnostics has long been at the forefront of the movement for consumer empowerment in healthcare. Our QuestDirect consumer-initiated test platform provides dozens of tests for conditions ranging from heart health to sexually transmitted diseases. We were among the first diagnostic information services providers to offer free access to test results online and other channels. Our 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.
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 50,000 employees understand that, in the right hands and with the right context, our diagnostic insights can inspire actions that transform lives. www.QuestDiagnostics.com.
bioMérieux announces the CE marking of the new generation semi-quantitative VIDAS® SARS-COV-2 IgG II serology test
7 May 2021 - bioMérieux, a world leader in the field of in vitro diagnostics, today announces CE marking of the new generation of IgG serology test with VIDAS® SARS-COV-2 IgG II to semi-quantitatively detect antibodies in people who have been exposed to the SARS-CoV-2 that causes the COVID-19 disease.
7 May 2021 -- In 2021, on top of the importance of detecting COVID-19 virus, the emergence of variant strains and expansion of vaccination have generated new public health challenges. In particular, obtaining quantitative serological information by measuring antibody levels might provide important insights to help evaluate a person’s immune response following either natural infection or vaccination.
VIDAS® SARS-COV-2 IgG II offers a semi-quantitative interpretation of the level of IgG antibodies directed against the Receptor-Binding Domain (RBD) of the Spike (S) viral protein. Indeed numerous vaccines for COVID-19 are available, mostly focusing on eliciting an immune response to the RBD / S viral protein. Following an internal evaluation with two of the more common vaccines (Pfizer–BioNTech Comirnaty and Moderna mRNA-1273), it was demonstrated that this new VIDAS® assay will detect anti-SARS-Cov-2 IgG antibodies post-vaccination. Additionally, we have documented correlation of the IgG level results with the WHO international standard.
“Building on three decades of experience in immunoassays, the VIDAS® SARS-COV-2 IgG II will support labs with a solution adapted to new medical needs linked to the evolution of the COVID-19 pandemic.” declared François Lacoste, Executive Vice President, R&D, bioMérieux.
Hospitals and private laboratories can run this new test on bioMérieux’s VIDAS® analyzers (MINI VIDAS®, VIDAS® and VIDAS® 3) which are widely available with more than 30,000 systems installed around the world.
“bioMérieux is committed to fight against the spread of COVID-19 with both molecular biology and immunoassay solutions. Our large VIDAS® installed base and easy-to-use platform will provide a wide access to this new antibody test.” said Pierre Boulud, Chief Operating Officer, Clinical Operations, bioMérieux.
Reference: https://www.biomerieux.com/en/press-release-10-May-2021
PerkinElmer to Donate 1 Million Rapid COVID-19 Antigen Tests to Combat the Pandemic’s Second Wave in India
6 May 2021 - Much-needed diagnostics supplies will help accelerate testing capabilities of hospitals and clinics across India
DELHI, India, May 6, 2021 – As India faces a second wave of COVID-19, PerkinElmer Inc., a global leader committed to innovating for a healthier world, will donate 1 million PerkinElmer® COVID-19 Antigen Tests to the Government of India (GoI) to help accelerate testing capabilities across the country. With the support of the US-India Strategic Partnership Forum (USISPF), PerkinElmer COVID-19 Antigen Test kits will be distributed to government hospitals and testing centers across 10 states of India.
“The second wave of COVID-19 in India has mobilized our teams around the world to help in whichever ways we can,” said Deepak Tripathi, CEO of Tulip Diagnostics, a PerkinElmer company. “We’re working around the clock to assist employees and customers across India through this incredibly challenging time, with the hope that by providing vital goods and services needed to create a seamless testing network, we can help stop the spread of this terrible disease.”
The PerkinElmer COVID-19 Antigen Test is a lateral flow immunoassay ideally suited for point-of-care (POC) and non-clinical settings. The CE marked assay may be used with nasal or nasopharyngeal swab specimens to screen or to aid in the diagnosis of both asymptomatic and symptomatic individuals, and it is capable of delivering a positive or negative result in as little as 15 minutes.
“Since the Company’s founding, PerkinElmer has been dedicated to making the world a better place to live, and today it is even more important that we continue this tradition,” said Shripad Joshi, president of PerkinElmer India & South-Asia. “Since the earliest days of the pandemic, we have focused on keeping employees safe and providing critical diagnostic supplies to over 1,000 organizations that needed them. The current crisis in India motivates us to extend beyond our own horizons and support our government to fasten up 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 $3.8 billion in 2020, 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.
About USISPF (US-India Strategic Partnership Forum)
As the only independent not-for-profit institution dedicated to strengthening the U.S.-India partnership in Washington, D.C. and in New Delhi, USISPF is the trusted partner for businesses, non-profit organizations, the diaspora, and the governments of India and the United States. The organization’s mission is to build, enable, advocate, facilitate, and guide partnerships between the two countries by providing a platform for all stakeholders to come together in new ways that will create meaningful opportunities with the power to change the lives of citizens in both countries.
Dr. Hassan Jomaa zur Lolli-PCR-Methode im Pooling-Verfahren (ZDF-Videobeitrag)
5 May 2021
5 May 2021 -- Ein Team von ZDF Frontal21 war in unserem Labor in Leverkusen zu Besuch und hat sich vom ärztlichen Leiter, Dr. Hassan Jomaa, die Lolli-PCR-Methode im Pooling-Verfahren erklären lassen. Gerade im Hinblick auf die „trügerische Sicherheit“ (ZDF) der Antigen-Schnelltests stellt die Lolli-PCR-Methode in Schulen oder Kitas die sichere Alternative dar.
Quidel forms retail collaboration with Walgreens for over-the-counter sale of QuickVue® At-Home OTC COVID-19 Tests
5 May 2021 - Agreement will make QuickVue® At-Home rapid antigen tests available without a prescription at 7,600 Walgreens locations nationwide and online at walgreens.com
SAN DIEGO, 5 May 2021 -- Quidel Corporation (“Quidel”), a leading provider of rapid diagnostic testing solutions, cellular-based virology assays and molecular diagnostic systems, announced today a retail collaboration with Walgreens to make Quidel’s non-prescription QuickVue® At-Home OTC COVID-19 Test available to consumers at 7,600 Walgreens locations across the United States and Puerto Rico. The shelf-stable packages, each containing two of the self-administered rapid antigen tests, can also be ordered online at Walgreens.com for store pick-up or same day delivery.
“This retail collaboration with Walgreens will expedite in-store availability and over-the-counter sales of our QuickVue At-Home OTC COVID-19 antigen tests to consumers nationwide,” said Douglas Bryant, president and CEO of Quidel Corporation. “The ability to pick up the QuickVue® At-Home tests at a trusted pharmacy like Walgreens and screen for COVID-19 in the privacy of their homes will give greater peace of mind to countless American families and give added confidence to schools and businesses seeking to fully reopen.”
The QuickVue® At-Home OTC COVID-19 Test allows consumers to easily perform the test themselves without a doctor’s prescription and get results in 10 minutes from nasal swab samples. The QuickVue® At-Home COVID-19 Test shows excellent performance, with positive results agreeing with PCR 83.5% of the time, and negative results agreeing 99.2% of the time, delivering confidence to individuals running the test and helping to prevent asymptomatic virus spread.
The QuickVue® At-Home OTC COVID-19 Test is only for use under the Food and Drug Administration’s Emergency Use Authorization. The QuickVue® At-Home OTC COVID-19 Test has not been FDA cleared or approved. The test has been authorized only for the detection of proteins from SARS-CoV-2, not for any other viruses or pathogens, and 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 Federal Food, Drug and Cosmetic Act, 21 U.S.C. § 360bbb-3(b)(1), unless the declaration is terminated or authorization is revoked sooner.
Visit http://www.quickvueathome.com for more information.
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.
EBTi and BGI Health Ethiopia PLC sign MoU in HPV Genotyping Pilot Project
4 May 2021
Addis Ababa, 4 May 2021 – The Ethiopian Biotechnology Institute (EBTi) and BGI Health Ethiopia PLC signed a memorandum of understanding (MoU) in HPV Genotyping Pilot Project and technological relations.
The MoU intends to collaborate to carry out the HPV genotyping pilot project and complete 2000 sample screenings collected from Ethiopia in the responsibility of the EBTi in close collaboration with the HPV consortium and then which will be Genotyped by BGI. After finding this HPV pilot project, both sides will establish a new model, including HPV screening, diagnosis, and treatment in Ethiopia. According to the MOU signed, in line with the completion of the Pilot Project BGI and EBTi will continue their collaboration for large-scale HPV screening tests and then establish a genomic center in Ethiopia, enhancing the national genomics testing capacity.
According to the agreement, the two parties will organize events to bring together experts and stakeholders for the implementation procedure and awareness-raising programs.
BGI Health Ethiopia PLC is one of the world’s leading test and research service Providers and also as a federal entity, EBTi has a national mandate to organize, lead and coordinate biotechnology and emerging technology researches and development across the country through partnerships with national and international institutions.
Dr. Hailu Dadi, Deputy Director-General of EBTi, and Mr. Chen Songheng, BGI Health Ethiopia, signed the MoU, April 27th, 2021.
Reference: https://www.bgi.com/global/company/news/ebti-and-bgi/
Beckman Coulter is first diagnostics company to offer workflow automation speficically for mid-volume laboratories
4 May 2021 - Labs processing ~2,000 to 5,000 tests a day can finally enjoy the benefits of Total Laboratory Automation (TLA) with a compact workflow-automation solution that fits needs
BREA, CALIF., MAY. 4, 2021 — Beckman Coulter, a clinical diagnostics leader, today announced the global launch of the DxA 5000 Fit, a workflow-automation solution designed to fit into medium-sized labs that run fewer than 5,000 tests a day.
The clinical laboratory has gone through trial by fire in 2020, where total testing was 245% of baseline volumes, with ~55% being SARS-CoV-2 molecular tests. According to the CDC, an estimated 41% of U.S. adults delayed or avoided medical care. Despite vaccines, many industry players suggest SARS-CoV-2 testing volumes won’t be impacted in the near term, and the demand for COVID-19-related testing will continue through 2021 and potentially into 2022. This means that testing-volume pressure on labs is going to continue.
Labs of all sizes are facing the same challenges: shortage of laboratory technologists and technicians, historic financial pressures on hospitals and health systems, and physically and mentally exhausted laboratory professionals; – a pre-pandemic problem that has since been exacerbated. However, the TLA solutions that cater to labs processing high-sample volumes are out of reach for smaller volume labs due to space requirements and infrastructure constraints.
The Right Fit for Mid-sized Labs
“When we look at automation for our labs it's a balancing act between system throughput capacity, test menu and footprint of the system,” said Afruj Ruf, managing director at Integrated Pathology Solutions LLP, Airedale NHS Foundation Trust. “At the Harrogate District Hospital site, we knew that a large automated system will be too large and excessive and a standalone system doesn't give us the streamlined workflow we want. What we needed was a compact automation system that reduced the number of steps, requiring minimum human intervention and generated a valid result at first pass so that our lab professionals are not moving samples around but performing the valuable scientific tasks they are trained for. From its compact footprint and minimizing manual work by 80%, to intelligent routing that makes sure our acute patients get their results faster than routine ones, the DxA 5000 Fit was just the right fit for us."
In a survey, lab directors and managers were asked to identify the key challenges hospital labs are facing. The results found that staffing (26 percent) and turnaround time (23 percent) were identified as top priorities. Automation plays a key role in helping to address many of these issues while enabling precious resources to focus on high-value, clinical tasks – this has proven particularly true during the COVID-19 pandemic.
“For large laboratories, TLA is a reality today. However, for medium-volume labs like ours that process fewer than 4,000 tests per day, comprehensive workflow-automation solutions haven’t been an option,” said Susan Enciso, System Supervisor of Chemistry, Excela Health. “Beckman Coulter’s DxA 5000 Fit solution is the right fit for us. It has a flexible design which is important in a lab like ours where space is a precious commodity; and reduces our manual process steps by up to 80%, helping us meet today’s unprecedented need for COVID-19 and routine tests.”
With the DxA 5000 Fit, mid-sized labs can enjoy the same benefits as larger-volume labs:
- Comprehensive workflow automation to reduce up to 80% of manual steps through pre-analytical, analytical and post-analytical automation, conserving precious human resources to do higher-value clinical work
- Intelligent routing with dynamically calculated route planning for rapid and consistent TAT, with STATs always prioritized to deliver results faster
- Flexible design that can be adapted to meet a mid-volume lab’s space and infrastructure constraints
“We chose the DxA 5000 Fit because it offers us end-to-end automation and will automate a lot of the pre- and post-analytical routine work our skilled technologists spend their time doing,” said Dr. Hervé Vermeulen, lab director at Centre Hospitalier de Calais. “We look forward to lower, more consistent TATs and significant efficiency gains from the industry’s most comprehensive pre-analytical sample-quality assessment combined with automated pre-analytical sample processing and connected chemistry and immunoassay analyzers.”
The DxA 5000 Fit is authorized for sale in the United States and most European and Asian countries.
“At Beckman Coulter, we believe that medium-size labs should be able to leverage the benefits of automation to address their challenges. Just because your lab is not processing a higher number of samples, doesn’t mean you have to sacrifice the benefits of intelligent laboratory automation and settle for a marginally automated workcell-plus solution,” said Dr. Peter Soltani, senior vice president & general manager, hematology, urinalysis & workflow information technology solutions at Beckman Coulter. “This is why we have launched DxA 5000 Fit, the first compact workflow automation solution that’s the right fit for mid-volume labs because automation should be for all labs.”
Learn more about Beckman Coulter’s family of automation solutions and the DxA 5000 Fit on our website at www.beckmancoulter.com/automation.
You can access the media package for DxA 5000 Fit, which contains product videos, articles and other assets at www.beckmancoulter.com/DxA5000Fit-Media.
Merck Partners with Topco Scientific Co. to Increase Greener Manufacturing Materials Usage
4 May 2021 - Provides IDR 3 billion worth of advanced laboratory tools, equipment, and expertise. Offers broad access to academics and company scientists to accelerate innovation in Indonesia. Includes mentoring and a workshop series to transfer knowledge and expertise to Universitas Indonesia scientists and scholars.
Taipei, Taiwan, May 4, 2021 — Merck, a leading science and technology company, today announced a partnership with Topco Scientific Co. (TSC), a leading semiconductor supplier in Taiwan, to increase the use of more sustainable materials for the electronics industry.
TSC will promote the biorenewable Cyrene™ solvent and ECOSURF™ and TERGITOL™ biodegradable greener surfactants from Merck’s portfolio to facilitate the green manufacturing transformation of the electronics industry in Taiwan. The partnership aims to increase workplace safety and decrease environmental impact and waste disposal, without compromising material quality.
“At Merck, scientific progress and responsible entrepreneurship go hand in hand, enabling us to create a sustainable future for everyone,” said Wesley Chen, general manager, Life Science, at Merck in Taiwan. “TSC’s extensive experience in green technology, combined with Merck’s success in developing industry-leading alternatives, will contribute to a greener electronics industry.”
Merck offers more than 1,100 greener alternative products to help customers reduce the environmental impact of their work—including more than 600 products that demonstrate one or more characteristics that align with the 12 Principles of Green Chemistry. Products under Merck’s 12 Principles Aligned category lower toxicity and waste, reduce energy consumption, or are biorenewable or biodegradable. These activities support the company’s commitment to integrate sustainability into all value chains by 2030, as outlined in its sustainability strategy.
In 2019, Merck added to its portfolio Cyrene™ solvent, a novel bio-based solvent with a lower toxicity rate than traditional fossil fuel-based solvents. In addition, the Merck solvent’s manufacturing process requires significantly less resource consumption, with 99 percent of the solvent decomposing into carbon dioxide and water after 28 days. Compared with traditional fossil-derived solvents — such as Dimethylformamide and N-Methyl-2-pyrrolidone, which are under increasing regulatory restrictions due to their toxicity — Cyrene™ solvent is distinctly safer and more sustainable and yields superior performance in some applications.
Merck’s portfolio also includes ECOSURF™ and TERGITOL™ biodegradable surfactants, which do not contain octylphenol ethoxylates or nonylphenol ethoxylates toxins and fully comply with the European Chemicals Agency’s REACH Regulations. More than 60 percent of biodegradable surfactants decompose in about 28 days. These products also decompose into environmentally friendly components, and its manufacturing process furthermore critically reduces water pollution.
“TSC has been deeply involved in the semiconductor industry for more than 30 years, providing customers with the best products and technologies. As green energy and sustainability become increasingly important, environmentally friendly materials and technology are at the forefront of TSC’s mission,” said Lee Zheng-Rong (李正榮), CEO of TSC. “Through this partnership, we hope to provide our customers with brand-new green options that are both high-quality and protect the sustainability of our environment.”
About the Corporate Responsibility Efforts of the Life Science Business of Merck
Through its Corporate Responsibility initiatives, the Life Science business of Merck harnesses the collective expertise, passion and energy of employees to minimize its environmental footprint and positively impact communities around the world. The Life Science business of Merck is uniquely positioned to solve the toughest problems in life science through its efforts aligned with strengths in research, innovation and collaboration with the global scientific community. This helps differentiate its business and provides a competitive edge for its customers, while accelerating access to health for people everywhere. The Life Science business of Merck demonstrates its commitment to Corporate Responsibility through extensive programs in three main areas: Greener Products and Solutions — which includes Design for Sustainability, Green Chemistry, Packaging and Recycling initiatives; Employee and Community Engagement and Sustainable Operations.
About Merck
Merck, a leading science and technology company, operates across healthcare, life science, and electronics. Around 58,000 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 2020, Merck generated sales of € 17.5 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 Electronics.
Reference: https://www.merckmillipore.com/DE/de/20210506_152326
Genedrive COVID-19 PCR test approved by Indian regulator
30 April 2021
30 April 2021 -- genedrive plc, the near patient molecular diagnostics company, announces that the Genedrive® 96 SARS-CoV-2 Kit has been formally approved by the Indian Council of Medical Research (“ICMR”). The Genedrive® 96 SARS-CoV-2 Kit achieved 100% sensitivity and 100% specificity in the performance evaluation conducted by the ICMR. The Company will now commence commercial activities in India through its existing distributor Divoc Health and will also be seeking additional routes to the market.
David Budd, CEO of genedrive plc, said: “We are very happy to achieve formal registration of our COVID PCR tests in India. Although the process took longer than anticipated, the performance data is excellent and will support the commercial process and customer engagement. Formal product approval is an excellent testament to our technology.”
The Genedrive® 96 SARS-CoV-2 Kit is a novel Polymerase Chain Reaction (“PCR”) assay designed to detect active SARS-CoV-2 infection in COVID-19 patients. genedrive’s proprietary “ready-to-go” solid PCR bead format eliminates the need for reagent preparation or cold temperature storage, making it a preferable solution for high temperature countries such as India. The format streamlines laboratory workflow, allowing a patient sample to be mixed with a single bead and then tested on a variety of third-party RT-PCR platforms. The test is validated for use on certain Biorad, ThermoFisher, and Roche PCR platforms.
Given the escalating infection rate in the country, this week India began to allow the import of certain COVID test kits with foreign registrations, including CE-Marking, without the need for ICMR approval. The country has also introduced pricing controls into the public market, setting a dynamic that does favour the provision of “basic” tests. The Company believes however that formal performance evaluation data and ICMR approval will contribute positively to commercial efforts and premium products such as gendrive’s can play a part in the need for COVID-19 testing.
Reference: https://www.genedrive.com/news/index.php
QIAGEN Announces EZ2 Connect Instrument Line for Automated Sample Processing in Research, Forensics and Diagnostics
29 April 2021 - Pioneering next-level sample processing with connectivity, simplicity, and unmatched flexibility. Building on the success of EZ1 technology, three versions offer application area tailored value. Integration with QIAsphere digital infrastructure allows for optimized lab productivity.
GERMANTOWN, Md. & HILDEN, Germany, 29 April 2021 -- QIAGEN N.V. today announced the upcoming launch of the EZ2 Connect product line, a next-level automated sample-processing platform whose simplicity, flexibility and speed will benefit biomedical research, forensics and clinical diagnostics.
The EZ2 Connect instruments use pre-filled cartridges and magnetic bead technology to process up to 24 samples in parallel in as little as 20 minutes, ensuring process safety and efficiency of nucleic acid extraction. The new platform builds on QIAGEN’s groundbreaking EZ1 instrument line, which set new standards in the automation of sample preparation and sample-data management and has seen more than 4,500 devices installed worldwide at the end of 2020.
“Expanding on the strength of our sample-processing portfolio, we are paving the way to a new era of laboratory automation,” said Thomas Schweins, Senior Vice President, Business Area Life Sciences of QIAGEN. ”The EZ2 Connect platform makes standardized and efficient nucleic acid purification accessible for any lab - without the need for specialized training or previous experience with automation platforms, while providing a new level of connectivity for ease-of-use and reliability of results.”
The EZ2 Connect platform has a broad range of application areas, and will be tailored to three different key versions. The EZ2 Connect for use in research and pharmaceutical laboratory and the EZ2 Connect Fx for use in forensics and human identification (HID) will be launched in July. The release of the EZ2 Connect MDx for use in molecular diagnostic workflows is planned for early 2022, with regulatory approval in the U.S., the European Union and other markets worldwide.
Addressing a wide range of sample types and applications for biomedical research, the EZ2 Connect comes with an elaborate kit portfolio. In-tip separation, onboard heating and reagent pipetting, as well as large volume capabilities enable an unprecedented level of benchtop automation. With new approaches for cell free circulating DNA (cfDNA) and nucleic acid extraction from a range of sample types such as FFPE, EZ2 Connect catalyzes analytical quality, a valuable tool for example in cancer research.
The EZ2 Connect Fx is tailored to Human ID and forensics customer requirements, ensuring performance, process safety and reliability. It was designed and developed on the experiences and user feedback of the EZ1’s exceptional success in the HID market and offers a failure-safe method to isolate DNA even from smallest traces with highest efficiency. Increased capacity, full traceability, and maximum sample integrity allow labs to stand ready 24/7.
The EZ2 Connect MDx will address the challenges of medium throughput clinical diagnostics labs: dealing with fluctuating numbers of sample, large variety of sample types and quality, and less experienced staff. A single-use cartridge per sample and easy push-button operation minimizes the risk of sampling errors.
The EZ2 Connect platform complements QIAGEN’s leading offering of automation solutions including the QIAcube Connect and the QIAsymphony. The QIAcube Connect platform allows for a seamless transfer of QIAGENs wide range of manual spin column protocols to flexible and medium throughput automation, with the dedicated QIAcube Connect MDx version for molecular diagnostics workflows.
At the end of 2020, more than 9,800 QIAcube platform had been cumulatively placed with customers worldwide. The QIAsymphony provides fully automated high throughput with features such as continuous loading and primary tube handling, and had a cumulative installed base of over 2,900 systems at the end of 2020.
The newly introduced EZ2 Connect platform allows for medium- to high-throughput sample processing, combining flexibility with maximum process safety in dedicated instrument versions tailored to the individual needs of QIAGEN’s diverse customer base.
The new versions also allow for connection to QIAsphere, a digital laboratory ecosystem that enables additional remote features like instrument management and real-time status reporting. As a result, EZ2 Connect enables optimization of workflows and greater lab productivity with the next level of daily lab routine automation.
For more information about the EZ2 Connect platform, please visit https://www.qiagen.com/us/clp/ez2-connect-updates or see the product video at https://www.youtube.com/watch?v=RL5ao-mLXdQ&ab_channel=QIAGEN
More information on QIAGEN can be found at www.qiagen.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 December 31, 2020, QIAGEN employed approximately 5,600 people in over 35 locations worldwide. Further information can be found at http://www.qiagen.com
Roche launches new ways to use their cardiovascular tests empowering clinicians to improve diagnosis and treatment of millions of people
28 April 2021 - Cardiovascular diseases are responsible for 17.9 million deaths every year, a third of all deaths globally. Roche announces five new intended uses for key cardiac biomarkers to help identify cardiovascular risk, better diagnose patients and support early treatment. Early diagnosis and treatment can contribute to saving or improving people's lives and could help healthcare systems save money.
Basel, 28 April 2021 -- Roche announced a series of five new intended uses for two key cardiac biomarkers using the Elecsys® technology: high sensitive cardiac troponin T (cTnT-hs) and N-terminal pro-brain natriuretic peptide test (NT-proBNP). These gold standard biomarkers have proven to be successful in supporting cardiovascular disease management and can help clinicians diagnose heart attacks (cTnT-hs) and better manage heart failure (NT-proBNP). Roche's introduction of five new intended uses for these existing, globally accepted diagnostic solutions means more people could benefit from improved cardiovascular diagnostics. By providing greater precision and certainty for clinicians, Roche can help them tackle the world's biggest killer: cardiovascular diseases.
“The five new solutions we launch this month add real value for clinicians by supporting cardiac risk identification and improving diagnosis. In turn, this will help them make early treatment decisions, improve people’s lives and reduce healthcare costs,” said Thomas Schinecker, CEO Roche Diagnostics. “As the market leader in cardiovascular testing Roche is committed to innovation in cardiovascular care and these new intended uses are the first of many solutions planned over the next decade that could help improve the lives of millions of people.”
One of the new intended uses for Elecsys® NT-proBNP supports healthcare professionals in identifying which people with type-2 diabetes (463 million worldwide) are at higher risk of developing cardiovascular disease. Early identification of people at risk means cardioprotective treatment can be started sooner, which could prevent 65% of hospitalisations or deaths. The second newly-launched intended use for NT-proBNP provides healthcare professionals with a biomarker-based solution that identifies people at risk of developing Atrial Fibrillation (AF), an abnormal heart rhythm that can lead to stroke, brain damage and death. More than 37 million people suffer from AF globally. NT-proBNP, in combination with a single lead (or higher) electrocardiogram, can help to successfully diagnose AF so therapy can be started to reduce the stroke risk.
Another important biomarker, Elecsys® cTnT-hs, now provides healthcare professionals with data to help predict heart attack risk and mortality in non-cardiac surgery patients. Every year, over 200 million adults undergo major non-cardiac surgery with 10 million suffering from major adverse cardiac events (MACE) that could be prevented through early and accurate diagnosis.
Both Elecsys® NT-proBNP and Elecsys® cTnT-hs can be run on all cobas e® analysers. They are among the first products certified under the new European In Vitro Diagnostics Regulation (IVDR) and available as of today in countries accepting CE mark. Availability in other countries is subject to local registration processes and timelines.
About Elecsys® NT-proBNP
Tests for NT-proBNP, a cardiac hormone that is released into the blood when the heart wall is stretched, are developed and marketed by Roche. NT-proBNP is an objective marker for the aid in diagnosis in individuals suspected of having congestive heart failure and detection of mild forms of cardiac dysfunction. This assay is further indicated for the risk stratification of patients with acute coronary syndrome and congestive heart failure, and it can also be used for monitoring the treatment in patients with left ventricular dysfunction.
Added intended uses for Elecsys® NT-proBNP
(1) Type-2 diabetes and heart failure
463 million people suffer from type-2 diabetes worldwide and are at higher risk of developing cardiovascular disease. The new intended use of Elecsys® NT-proBNP provides healthcare professionals with a precise biomarker that supports them to identify patients with high cardiovascular risk. This means that effective drug treatment can be started early so that cardioprotective treatment can be optimized. In PONTIAC-I it was shown that 65% of hospitalisations or death could be prevented.
(2) Atrial fibrillation
More than 37 million people suffer from Atrial Fibrillation (AF) and 25% of people over 40 years old develop AF in their lifetime. More than 450 million people aged 70 or above are considered high risk for this disease. Patients with AF are exposed to a fivefold risk of stroke and therefore brain damage or death. One of the key elements in reducing stroke is early detection of people at risk of Atrial Fibrillation by better identification methods. Our second launched intended use for Elecsys® NT-proBNP provides healthcare professionals with a biomarker based solution that identifies people at risk and, in combination with a single lead (or higher) ECG, can aid successful diagnosis so therapy can be started.
About Elecsys® cTnT-hs
The Elecsys cardiac Troponin T high-sensitivity (cTnT-hs) test from Roche, detects cardiac troponin which is the guideline recommended biomarker for the diagnosis of heart attack in clinical practice. In combination with an electrocardiogram (ECG), high-sensitive Troponin has become the gold standard for the diagnosis of heart attack. Using the accelerated ESC 0/1 hour algorithm with the Elecsys cTnT-hs assay, significantly accelerates “rule-in” and “rule-out” decision-making, thereby maximising the potential for effective treatment. At the same time, the faster decision-making may help to better manage the emergency room workload and related costs for healthcare systems.
Added intended uses for Elecsys® cTnT-hs in coronary artery disease
(3) Over 200 million adults globally undergo major non-cardiac surgery every year. Of these, over 10 million suffer from major adverse cardiac events (MACE) in the first 30 days after non-cardiac surgery and more than 80% of those are clinically asymptomatic. The new intended use for Elecsys® cTnT-hs provides healthcare professionals with a biomarker that helps to predict the perioperative risk of a heart attack and to a perioperative heart attack in non-cardiac surgeries to allow clinicians to tailor surgery and post-operative care accordingly.
(4) The second newly-launched intended use for Elecsys® cTnT-hs makes the biomarker serve as an aid in assessing the long-term risk of cardiovascular events (death, myocardial infarction, coronary revascularisation, heart failure or ischemic stroke) in asymptomatic individuals.
(5) Elecsys® cTnT-hs is the gold standard for triaging patients suspected of Acute Coronary Syndrome in Emergency Departments and Intensive Care Units The third launched intended use for this biomarker can help to improve early discharge and outpatient management of these patients.
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 2020 employed more than 100,000 people worldwide. In 2020, Roche invested CHF 12.2 billion in R&D and posted sales of CHF 58.3 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-2021-04-28b.htm
Elizabeth McCombs Appointed Chief Technology Officer at BD
28 April 2021 - John DeFord to join newly formed external Scientific Advisory Board
FRANKLIN LAKES, N.J., April 28, 2021 -- BD (Becton, Dickinson and Company), a leading global medical technology company, today announced the appointment of Elizabeth McCombs as executive vice president and chief technology officer, effective April 26, 2021, succeeding John DeFord.
McCombs, 45, will be responsible for continuing to drive the company's category innovation strategy and leading all research and development (R&D) activities, including executing the current innovation pipeline and developing the future product portfolio.
"Beth has been an influential leader since joining BD, leading R&D for the Medical Segment to achieve all key innovation and execution metrics with significant improvement over prior years," said Tom Polen, chairman, CEO and president of BD. "She has served as a highly impactful R&D sponsor for our top Medical segment priorities, while co-leading the segment portfolio strategy and growth acceleration initiatives. In addition, Beth has helped to prioritize and redirect investments toward high-growth spaces that will accelerate category innovation across the Medical Segment businesses, with a focus on smart connected devices."
McCombs, who brings more than 20 years of extensive experience in advanced medical device innovation to her new role, joined BD in 2019 as the senior vice president of R&D for the BD Medical Segment. She began her career at Johnson & Johnson (J&J) Ethicon Endo-Surgery and progressed through positions of increasing leadership responsibility, including director for the J&J Corporate Office of Science and Technology (COSAT), focused on external technology partnerships; R&D leader for the J&J Sports Medicine business; vice president of Surgical Innovation for the Ethicon franchise; and most recently, as vice president of R&D for Ethicon, while also leading China R&D and Industrial Design/Human Factors for all of J&J Medical Devices. Aside from her technical credentials, Beth has been recognized for her work driving inclusion and diversity efforts, including the support and mentorship of fellow female professionals.
"BD is making great strides in shifting our R&D portfolio toward high impact opportunities like smart connected devices, enabling new care settings, and improving diagnosis and treatment for chronic diseases," said McCombs. "We will continue to advance an insight-driven innovation strategy and accelerate external technology partnerships and investments to increase the velocity and value creation of the innovation funnel, and we are committed to deliver the best customer outcomes and return on investment."
McCombs holds both a Bachelor of Science and a Master of Science in Mechanical Engineering from the Massachusetts Institute of Technology, and a Master of Business Administration from the University of Pennsylvania's Wharton School of Business.
Scientific Advisory Board
BD also announced the creation of an external Scientific Advisory Board (SAB), which will be comprised of top medical key opinion leaders, science and technology experts and experienced innovation leaders. The SAB will meet to review BD's technology capabilities, innovation pipeline, tuck-in M&A opportunities and early-stage investments. The SAB will also advise BD's leadership on its growth prioritization as well as emerging trends in health care, science and technology, and the potential implications for BD.
John DeFord, following his retirement from BD on May 28, 2021, will be a founding member and co-chair of the SAB. DeFord brings 35 years of extensive industry experience to the SAB as well as in-depth knowledge of BD's R&D and business priorities. DeFord earned his bachelor's degree and master's degree in Electrical Engineering from Purdue University, where he also earned a doctorate in Electrical/Biomedical Engineering.
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 70,000 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.
Reference: https://news.bd.com/2021-04-28-Elizabeth-McCombs-Appointed-Chief-Technology-Officer-at-BD
Excellent performance of Genedrive® HCV ID Kit in large multi-centre study
23 April 2021
23 April 2021 -- genedrive plc, the near patient molecular diagnostics company, announces the publication of a large independent multi-centre study evaluating the real-world performance of the Genedrive® HCV ID Kit in low and middle income countries. The study yielded sensitivity specifications of 96.2-100%, and specificity specifications of 98.7-99.5 %, depending on the site or viral load. The results confirm that the Genedrive® HCV ID Kit is effective as intended in the diagnosis of HCV infection in resource limited settings. Importantly, the authors highlight a test fail rate of only 1.6 %, showing that the Genedrive® system performs to this high standard even though the system operators in the study had no previous experience in molecular testing.
The study, published in the journal Diagnostics (Lamoury et al, 2021, 11, 746) was conducted in Georgia and Cameroon, and enrolled 426 participants, which had very different demographic backgrounds. The participants in the Georgia trial were almost all intravenous drug users. Intravenous drug users are a key patient population for HCV infection. The Genedrive sensitivity and specificity results were obtained by comparison to testing with the Abbott RealTime HCV Assay. The publication can be accessed on line at https://www.mdpi.com/2075-4418/11/5/746. The study was conducted by The Foundation for Innovative New Diagnostics (FIND), with grant funding provided by Unitaid.
The study’s findings also corroborate other key performance capabilities of the Genedrive® HCV ID Kit, including the ability of the kit to identify all major HCV genotypes, the utility of requiring small volumes of plasma, and the lack of hazardous chemicals in the Genedrive kits construction, allowing for normal disposal processes versus competitor products that require heat incineration.
David Budd, Chief Executive Officer of genedrive plc, said: “This study is the first large scale, independent multi centre evaluation from low and middle income markets using the Genedrive HCV test. While the performance results are as expected and excellent, it is equally gratifying to see these achieved with operators with no previous experience in molecular testing. Moving testing from highly complex and automated central hospital settings towards more simple decentralised settings is a balance of technological complexity, cost, performance, and usability, which is not always an easy balance to achieve. This study is an excellent demonstration of real world performance and the ability of Genedrive to contribute to fighting HCV in resource limited settings.”
The Genedrive® HCV ID Kit allows for decentralised molecular testing of Hepatitis C (HCV) by PCR, providing results within 90 minutes direct from a small plasma sample (30 µl). This allows for testing to be done outside of a large hospital facility and indeed while a patient may be waiting for a result. The assay is performed on the Genedrive® platform, the only truly portable molecular diagnostics system designed for diagnosing HCV at the point of need.
Reference: https://www.genedrive.com/news/index.php
Labcorp Opens Automated Clinical Trial Kit Production Line at New European Operations Center
22 April 2021 - Faster Delivery, More Flexible Ordering, and Reduced Transportation Costs for Biopharma Clients and Investigator Sites in Europe, the Middle East, and Africa
BURLINGTON, N.C., April 22, 2021 — Labcorp®, a leading global life sciences company, today announced the opening of an automated clinical trial kit production line in Mechelen, Belgium, which doubles the automated production capacity of the company’s industry-leading central laboratory services unit. The central laboratory services unit is part of Labcorp’s Drug Development business, also known as Covance by Labcorp.
“In addition to supporting future growth and capacity needs, the enhanced capacity significantly strengthens our business continuity infrastructure,” said Jonathan DiVincenzo, president of the Clinical Trial Testing Solutions group at Covance by Labcorp. “This is good news for drug developers who are seeking faster, simpler, clinical trial testing and delivery without sacrificing quality.”
The new, automated line will be used to produce specimen collection kits for clinical trial investigator sites in Europe, the Middle East, and Africa. It is housed in Covance by Labcorp’s European Operations Center, a multi-use facility responsible for dry ice production and distribution, as well as study and logistics support.
“With approximately one-third of the biopharma pipeline focused on precision medicines, it’s critical that we find innovative ways to help our customers speed these transformational therapies to the patients who need them,” said Paul Kirchgraber, M.D., CEO of Labcorp Drug Development. “This new production line is a prime example of such innovation.”
Kit production will follow standard operating procedures used at the company’s Mechelen and Indianapolis, Ind. locations, offering the same high-quality kits already associated with Labcorp Drug Development. The new, Belgium-based line is expected to scale up production as the year progresses.
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 improve lives. With more than 70,000 employees, we serve clients in more than 100 countries. Labcorp reported revenue of $14 billion in FY2020. Learn about Covance by Labcorp at www.Covance.com.
Quidel signs retail distribution agreement to increase access to At-Home COVID-19 Testing
22 April 2021 - National distribution fulfillment agreement will make QuickVue® At-Home rapid antigen tests available to families, schools and workplaces for use without a prescription
SAN DIEGO, 22 April 2021 -- Quidel Corporation (“Quidel”), a leading provider of rapid diagnostic testing solutions, cellular-based virology assays and molecular diagnostic systems, announced today that it has completed a distribution and fulfillment agreement with McKesson Corporation, a global leader in healthcare supply chain management solutions and retail pharmacy, to expedite consumer access to Quidel’s non-prescription QuickVue® At-Home OTC COVID-19 Test.
The agreement with distribution leader McKesson will enable Quidel to continue to supply existing customers in the professional segment and also reach significant new markets as the company introduces its new over-the-counter COVID-19 antigen product for retail markets and testing for reopening schools, and for health departments, employers, entertainment centers, and many other locations. McKesson will be Quidel’s lead commercial partner in fulfilling QuickVue® At-Home OTC COVID-19 rapid antigen test orders to individuals and businesses with the following support:
- Access to multiple retailers, where McKesson will accelerate our product roll-out strategy.
- Availability to McKesson’s Health Mart franchise, allowing Quidel access to a network of over 5,000 independent pharmacies.
- E-commerce support; ability to rapidly introduce products across multiple e-commerce sites, such as Amazon, eBay, and Simply Medical, McKesson’s home health e-commerce site.
“We are pleased to partner with McKesson, expecting to leverage McKesson’s ability to sell and distribute QuickVue through online channels like Amazon, WalMart.com, and through retail pharmacies, including their network of independent Health Mart pharmacies, grocery outlets, as well as health systems and other medical providers,” said Douglas Bryant, president and CEO of Quidel Corporation. “This distribution agreement is intended to expedite broad availability of our QuickVue® At-Home OTC COVID-19 Test for families, schools and businesses and help Quidel meet our goal of democratizing access to affordable antigen testing. We are proud that the combined strength of our two companies working in partnership can truly advance individual and public health.”
The QuickVue® At-Home OTC COVID-19 Test received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) in March. The QuickVue® At-Home OTC COVID-19 Test allows consumers to easily perform the test themselves without a doctor’s prescription and get highly accurate results in 10 minutes or less from nasal swab samples. The QuickVue® At-Home OTC COVID-19 Test shows excellent performance, with positive results agreeing with PCR 83.5% of the time, and negative results agreeing 99.2% of the time, delivering confidence to individuals running the test and helping to prevent asymptomatic virus spread.
Shipping of the QuickVue® At-Home OTC COVID-19 Test is expected to begin early next week, and it will be available from McKesson and its customer outlets soon thereafter.
The QuickVue® At-Home OTC COVID-19 Test is only for use under the Food and Drug Administration’s Emergency Use Authorization. The QuickVue® At-Home OTC COVID-19 Test has not been FDA cleared or approved. The test has been authorized only for the detection of proteins from SARS-CoV-2, not for any other viruses or pathogens, and 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 Federal Food, Drug and Cosmetic Act, 21 U.S.C. § 360bbb-3(b)(1), unless the declaration is terminated or authorization is revoked sooner.
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.
Roche purchases shares in tender offer for GenMark Diagnostics, Inc.
22 April 2021
Basel, 22 April 2021 -- Roche and GenMark Diagnostics, Inc. today announced that Roche’s wholly owned subsidiary Geronimo Acquisition Corp. has accepted for payment all shares validly tendered and not validly withdrawn pursuant to its tender offer for all outstanding shares of common stock of GenMark Diagnostics, Inc. (NASDAQ: GNMK) at a price of USD 24.05 per share in cash. The tender offer expired at 12:00 midnight, Eastern Time, at the end of the day on 21 April 2021 and was not extended.
Roche has been advised by Citibank, N.A., the depositary for the tender offer, that a total of approximately 61,201,761 shares of GenMark’s common stock were validly tendered and not validly withdrawn in the tender offer (excluding shares tendered by notice of guaranteed delivery for which certificates have not yet been “received”), which represent approximately 82.89% of the total number of shares of GenMark’s common stock outstanding.
Later today, Roche intends to complete the acquisition of GenMark through a merger of Geronimo Acquisition Corp. with and into GenMark without a vote or meeting of GenMark’s stockholders. In the merger, all shares of GenMark not owned by GenMark, Roche or Roche’s wholly owned subsidiaries (other than shares as to which appraisal rights have been validly exercised under Delaware law) will be converted into the right to receive the same cash consideration per share, less any applicable withholding taxes, as was paid in the tender offer. Following completion of the merger, GenMark will become a wholly owned subsidiary of Roche, and GenMark’s shares will cease to be traded on the NASDAQ Stock Market.
“We are excited about this important milestone, as this acquisition will support our long-lasting commitment to help control antibiotic resistance and infectious diseases, which are a leading cause of death globally,” said Thomas Schinecker, CEO Roche Diagnostics. “The addition of GenMark Diagnostics’ proprietary multiplex technology, which is designed to detect multiple pathogens from a single patient sample, will broaden our best-in-class molecular diagnostics portfolio to help make lifesaving information available to healthcare providers quickly to improve patient outcomes.”
About GenMark Diagnostics
GenMark Diagnostics is a leading provider of multiplex molecular diagnostic solutions designed to enhance patient care, improve key quality metrics and reduce the total cost-of-care. Utilizing GenMark’s proprietary eSensor® detection technology, GenMark’s eSensor XT-8® and ePlex® systems are designed to support a broad range of molecular diagnostic sample-to-answer tests with compact, easy-to-use workstations and self-contained, disposable test cartridges. GenMark’s ePlex: The True Sample-to-Answer Solution™ is designed to optimize laboratory efficiency and address a broad range of infectious disease testing needs, including respiratory, bloodstream and gastrointestinal infections.
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 2020 employed more than 100,000 people worldwide. In 2020, Roche invested CHF 12.2 billion in R&D and posted sales of CHF 58.3 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.
All trademarks used or mentioned in this release are protected by law.
Reference: https://www.roche.com/media/releases/med-cor-2021-04-22.htm
QIAGEN, in partnership with DiaSorin, announces the launch of the new LIAISON® LymeDetect® Assay based on QuantiFERON technology in countries accepting CE Mark for early diagnosis of Lyme Borreliosis
21 April 2021 - The LIAISON® LymeDetect® assay is a solution for the early diagnosis of Lyme Borreliosis combining detection of IgG and IgM Antibodies and cellular immunity. The test is available in countries accepting the CE Mark and is designed to be run on the DiaSorin LIAISON® XL and LIAISON® XS platforms. In clinical studies, the assay showed, within 21 days from the first evidence of infection, a sensitivity of 74% versus that of existing, established methods at 49%, while also demonstrating a high diagnostic specificity of 100%. Under the development agreement, DiaSorin is responsible for commercialization of the new LIAISON LymeDetect, while QIAGEN and DiaSorin are jointly responsible for development and production of the solution.
HILDEN, Germany & SALUGGIA, Italy, 21 April 2021 -- QIAGEN N.V. and DiaSorin today announced the launch of the LIAISON® LymeDetect® Assay for markets accepting the CE Mark, as an aid to detect early Lyme Borreliosis infection (Lyme) on LIAISON® analyzer systems.
Lyme is a tick-borne illness caused by the Borrelia burgdorferi bacterium species, with different types of manifestations in the early phase: early-localized rash (the typical Erythema Migrans) and early-disseminated forms, where people may develop a different kind of rash, remain asymptomatic or have quite non-specific symptoms such as fever, chills, headache, fatigue, muscle and joint aches.
If the early infection is left untreated, Borrelia burgdorferi might spread to joints, the heart and the nervous system becoming a chronic illness and evolving into severe complications. Late stage symptoms can include severe headaches and neck stiffness, facial palsy, arthritis with severe joint pain and swelling, intermittent pain in tendons, muscles, joints, and bones, heart palpitations or an irregular heartbeat (Lyme carditis), inflammation of the brain and spinal cord and pain. These long term effects may persist after a successful treatment course.
Recent publications estimate that the total number of yearly cases in Western Europe could be as high as 230,000.
The current diagnostic routine for early disseminated Lyme diagnosis uses serological testing for IgG and IgM antibodies detection (B cell response), followed by a confirmation using Western Blot in case of positivity or equivocal results.
In the early stages of the infection, however, results can be unsatisfactory because patients often get tested at the onset of the disease, when visible signs of the tick bite or the presence of the tick itself are detected, but before the appearance of antibodies (IgG or IgM) against the pathogen. An undetected Lyme disease presents an increased risk of developing into a severe chronic disease. This presents a significant untapped diagnostic need.
DiaSorin and QIAGEN have been collaborating to provide a solution to this diagnostic gap which significantly improves the sensitivity of testing in the early phase of Lyme borreliosis. The new LIAISON® LymeDetect® solution combines both humoral (detection of IgG and IgM antibodies) and cellular immunity through a specific interferon-gamma release assay, stimulated by specific Lyme peptides using QuantiFERON® LymeDetect® technology, providing significantly improved sensitivity and earlier detection of the infection.
In clinical studies, the LIAISON® LymeDetect® Assay showed, within 21 days from the first evidence of infection, a sensitivity of to 74% versus that of existing alternative methods (ca. 49%). Moreover, the LIAISON® LymeDetect® Assay also demonstrated a high diagnostic specificity of 100%.
By providing a tool which significantly increases the sensitivity in the early stages of the disease, the LIAISON® LymeDetect® could help physicians identify and treat the disease earlier, minimizing the risk of late and chronic manifestation, with benefits for patients and a significant healthcare cost reduction, mainly due to shorter hospitalization and long-term care for late disease treatment.
DiaSorin and QIAGEN worked together to co-develop the new LIAISON® LymeDetect®, an innovative solution for diagnosing Lyme disease, designed to be run on the LIAISON® XL and LIAISON® XS platforms. Under the development agreement, DiaSorin is responsible for commercialization of the new LIAISON® LymeDetect, while QIAGEN and DiaSorin are jointly responsible for development and production of the solution.
“QIAGEN believes in expanding and maximizing the value of our QuantiFERON portfolio, led by the gold-standard QuantiFERON TB Gold-Plus Assay that forms the foundation of our collaboration with DiaSorin and the joint global marketing of our solution for use on the LIAISON family of analyzers,” said Thierry Bernard, Chief Executive Officer of QIAGEN. “The fight against Lyme disease is increasingly critical given the risks and symptoms and estimates that the number of ticks carrying the disease is on the rise worldwide. For this collaboration, we are taking a new approach with DiaSorin that builds on our unique strengths, in particular our capabilities to develop and gain approval for novel QuantiFERON-based tests and DiaSorin’s expertise with its current portfolio of solutions for this disease. We are eager to see the benefits of this partnership in improving outcomes for patients suffering from a disease with often debilitating consequences.”
“We are very proud of this new milestone reached in partnership with QIAGEN, because we think it is going to be a game-changer in the Lyme disease diagnosis space and a milestone in our Value Based Care strategy,” commented Carlo Rosa, Chief Executive Officer of DiaSorin Group. “The collaboration between our companies leverages on their QuantiFERON technology and our extensive installed base of LIAISON family analyzers and is positioning us both as leaders in the T-cell response market with a unique franchise for laboratories looking for an efficient way to detect asymptomatic infections and risks that cannot be detected in all situations with standard diagnostic technologies. This new solution, together with our already validated Lyme disease tests, will strengthen our role as a company committed to find solutions for diagnosing a disease so prevalent in specific regions and so difficult to detect at an early stage that causes painful and long-lasting consequences in the lives of affected patients.”
QIAGEN’s QuantiFERON-TB Gold Plus for latent tuberculosis is registered in more than 75 countries in North America, Europe, Asia, Africa and Latin America. QIAGEN’s QuantiFERON-TB Gold (QFT) and QFT-Plus tests are the gold standard blood tests for latent TB, with faster, less labor-intensive and more accurate insights than the century-old tuberculin skin test. The test can be automated on DiaSorin LIAISON® platforms. The QuantiFERON Product portfolio also includes tests for SARS-CoV-2 T-Cell immune response, CMV and QuantiFERON Monitor used for transplant applications. LymeDetect® is the newest expansion to this portfolio leveraging innovative CD4/CD8 T cell technology to enable immune response detection.
About DiaSorin
Headquartered in Italy and listed at the Italian Stock Exchange in the FTSE MIB Index, DiaSorin is a global leader in the In Vitro Diagnostic (IVD) field, with 26 companies, 4 branches, 5 manufacturing facilities and 5 research and development centers.
For over 50 years, the Company has been developing, producing and marketing reagent kits used by diagnostic laboratories worldwide.
The extensive diagnostic testing offer, made available through continuous investments in research, positions DiaSorin as the player with the broadest range of specialty tests available within the diagnostic market, and identifies the Group as the “Diagnostic Specialist”.
More info at www.diasoringroup.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 December 31, 2020, QIAGEN employed approximately 5,600 people in over 35 locations worldwide. Further information can be found at http://www.qiagen.com.
Labcorp Launches COVID-19 Test Kits for Small Businesses to Support Return to Work and Life Safely
20 April 2021 - Businesses Can Order Pixel by Labcorp® COVID-19 PCR Test Home Collection Kits Online or Through Labcorp Employer Services
BURLINGTON, N.C., Apr. 20, 2021 -- Labcorp, a leading global life sciences company, today announced the availability of the Pixel by Labcorp® COVID-19 PCR Test Home Collection Kit for small businesses, an initiative aimed at providing fast, convenient, and reliable testing for companies with as many as 120 employees. Labcorp Employer Services currently provides COVID-19 testing and vaccination services for larger organizations and communities.
The small business offering enables bulk purchasing, and is well-suited for restaurants, professional services offices, event planners and small venue owners. Bulk purchasing saves on shipping costs, and those savings are passed on to the small business. Kits can be purchased in multiples of six, with a maximum of 120 kits per order, at Pixel by Labcorp. Purchases are made with a credit card.
“By making it easier for employees to get tested, we are supporting communities and small businesses across the country,” said Brian Caveney, M.D., chief medical officer and president, Labcorp Diagnostics. “Pixel by Labcorp offers reliable, trusted, and convenient COVID-19 testing along with the information needed for small business owners to make confident decisions in the interests of their customers and employees. We’re thrilled to work with small businesses to provide easy access to the same high-quality PCR tests used by doctors and hospitals as we work to improve health and improve lives.”
The offering for small businesses is yet another example of the company’s commitment to expanding access to testing so people can safely return to work and everyday activities. As states continue to reopen, small businesses will need a convenient way to ensure the safety of their employees and patrons. Many of these businesses are not able to offer remote working environments for their employees. The small business offering through Pixel by Labcorp makes it easier than ever for restaurants, production companies, retailers, and other small businesses to safely operate in their local communities.
Upon receiving a Pixel by Labcorp COVID-19 PCR Test Home Collection Kit from their employer or an event organizer, individuals self-administer the test using a short nasal swab and send their sample back to Labcorp via prepaid FedEx Express overnight. Results are typically available within 1-2 days from when Labcorp
receives the sample. Once the test is processed by Labcorp, results are accessed securely by the employee via the Pixel by Labcorp website.
If a COVID-19 test is positive, a Labcorp-verified healthcare staff member will contact the individual directly by phone or mail to discuss next steps. Pixel by Labcorp has contracted with a physician network to provide independent physician services for consultation.
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 improve lives. With over 70,000 employees, we serve clients in more than 100 countries. Labcorp reported revenue of $14 billion in FY2020. Learn about Labcorp at www.Labcorp.com.
Illumina Remains Committed to GRAIL Acquisition to Accelerate Access to Breakthrough Multi-Cancer Early Detection Blood Test
20 April 2021
SAN DIEGO, 20 April 2021 -- Illumina, Inc., today announced that it disagrees with the European Commission’s Directorate-General for Competition’s decision to review Illumina’s acquisition of GRAIL, a company founded to accelerate early screening of cancer. Illumina will continue to work with the Directorate-General to bring the investigation to conclusion. Illumina remains committed to the transaction, the impact of which would accelerate the adoption of a multi-cancer early detection blood test.
“Reuniting GRAIL and Illumina will allow us to bring GRAIL’s breakthrough early detection multi-cancer test to patients across the world faster and consequently save lives,” said Francis deSouza, Chief Executive Officer of Illumina. “We do not believe that the European authorities have jurisdiction to review the GRAIL acquisition and look forward to resolving this matter expeditiously.”
Illumina originally founded GRAIL five years ago and the two companies do not compete in any way. In reuniting the two organizations, Illumina will leverage its global scale of manufacturing and clinical capabilities, as well as its global regulatory and reimbursement expertise, to bring early-stage, multi-cancer testing to patients more quickly and more affordably, resulting in more lives being saved.
Illumina strongly believes that acquiring GRAIL is in the best interest of patients, is procompetitive, and benefits the multi-cancer early detection field as a whole. Together with GRAIL, Illumina looks forward to changing the course of cancer detection and treatment.
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.
QIAGEN Launches artus Prep&Amp as CE-Marked SARS-CoV-2 Test Offering up to Threefold Increase in Daily Lab Testing Capacity
20 April 2021 - QIAGEN’s innovative Prep&Amp technology integrates sample preparation and detection in a single kit, enabling throughput of more than 670 tests per PCR cycler in an eight-hour shift. CE-IVD marking for Europe and other countries worldwide, EUA (Emergency Use Application) submission made in the U.S. Streamlined workflow cuts costs and plastic usage – offering time to result of about two hours.
HILDEN, Germany & GERMANTOWN, Md., 20 April 2021 -- QIAGEN today announced the launch of the artus® SARS-CoV-2 Prep&Amp UM Kit which uses a liquid based sample preparation technology to simplify and increase COVID-19 testing throughput. The artus® SARS-CoV-2 Prep&Amp UM Kit has been CE-IVD registered for use in the European Union and other markets and an application for Emergency Use Authorization (EUA) has been submitted to the FDA, allowing commercialization via notification in the US.
QIAGEN’s innovative artus® SARS-CoV-2 Prep&Amp UM Kit integrates a liquid-based sample preparation that takes no more than two minutes with the provided real-time PCR assay. The kit uses common transport media like Universal Transport Media (UTM™) as the starting material, and provide all reagents required for sample to result on suspected SARS-CoV-2 patient samples.
The streamlined workflow delivers results considerably faster than standard extraction-based Real-Time PCR processes – and can support up to 672 samples per cycler in an eight-hour shift. Additionally, due to the short workflow the quantity and volume of waste created is considerably lower.
The artus® SARS-CoV-2 Prep&Amp UM Kit is based on the same technology that was launched in October 2020 as QIAprep& for research applications. It has since proved its ability to detect the SARS-CoV-2 pathogen to be similar to regular PCR workflows.
“The launch of our artus® SARS-CoV-2 Prep&Amp test is an important step as it expands our portfolio of testing solutions for COVID-19,” said Jean-Pascal Viola, Senior Vice President, Head of the Molecular Diagnostics Business Area and Corporate Business Development at QIAGEN. “We continue to see the need for a large volume of PCR tests as COVID-19 cases continue around the world – and our novel technology will enable clinical labs to drastically increase testing capacity with existing infrastructure. It is also an exciting and versatile technology with additional potential applications.”
QIAGEN has one of the most comprehensive SARS-CoV-2 research and testing portfolios. It includes sample preparation innovations like artus® SARS-CoV-2 Prep&Amp, syndromic testing solution QIAstat-Dx, high throughput PCR with its NeuMoDx devices, QIAcuity digital PCR for wastewater testing applications, QIAreach digital antibody and antigen tests, and T-cell research solutions based on QIAGEN’s QuantiFERON IGRA technology. QIAGEN also has a range of products for NGS research into the SARS-CoV-2 virus and bioinformatic services and databases such as QDI (QIAGEN Digital Insights).
QIAGEN continues to add novel solutions to support laboratories combatting the pandemic and to provide experts with tools to learn more about the virus and drive forward research – as well as providing solutions that will be relevant beyond the current pandemic.
More information on artus® SARS-CoV-2 Prep&Amp UM Kit can be found here.
For an overview of QIAGEN’s coronavirus testing solutions, please visit http://www.qiagen.com/coronavirus.
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 December 31, 2020, QIAGEN employed approximately 5,600 people in over 35 locations worldwide. Further information can be found at http://www.qiagen.com.
Newly launched Chinese-operated COVID-19 testing lab rekindles hope for reviving Ethiopia’s passenger flight service
19 April 2021
ADDIS ABABA, April 17 — The Addis Ababa Bole International Airport, Africa’s busiest airport and the continent’s leading gateway, is aspiring to revive its COVID-19-affected passenger traffic with a newly launched Chinese operated state-of-the-art COVID-19 testing lab.
The newly launched high-end COVID-19 testing lab, Huo Yan Air Lab, which is inside the premises of Ethiopia’s international flight hub, is administered by the BGI Health Ethiopia, a subsidiary of China’s biotech giant, the BGI Genomics Co., Ltd.
The Ethiopian flag carrier, Ethiopian Airlines, expects the lab, equipped with cutting-edge technologies, to inject the much-needed momentum in terms of easing the pressure through the provision of timely and accurate COVID-19 testing.
“Having this facility in the airport will enable us to facilitate the testings easily available to our passengers as well as it will enable us to do it in a faster basis to address any requirement that might have for our passengers,” Acting Chief Operating Officer of Ethiopian Airlines Retta Melaku told Xinhua in a recent interview. “We believe this facilitation and convenience will enable our passengers to develop their confidence on flying from the Addis Ababa hub at the Bole International Airport.”
According to Retta, the facility is the outcome of the excellent partnership between Ethiopia’s flag carrier and the BGI Health Ethiopia towards ensuring the safety of passengers in line with all international requirements.
With the capacity of undertaking 1,000 COVID-19 tests a day, which could be further augmented to 5,000 tests per day with further expansion, the COVID-19 testing lab is the Chinese company’s first-ever high-end laboratory in the East African region.
The facility is said to be the continuation of the company’s growing portfolio in the African continent on the backdrop of similar other cutting-edge technology laboratories operating in other African countries, such as Togo, Gabon, Angola and Botswana.
Wanyue Wang, deputy general manager of BGI Health Ethiopia, said the short-term aspiration is to ensure the continuation of flight operation between Ethiopia and other countries by managing the COVID-19 pandemic through timely and accurate screening and diagnosis.
“We are delivering the result in as short as three hours. Now, transit passenger don’t need to come out of the terminal and go back in, they can just stay inside the transit area and wait for three hours and they can get their results and continue their journey for next destination,” she said.
The newly launched facility also enabled departing passengers in Addis Ababa with an option to undertake rapid as well as regular COVID-19 testing in a very short period of time.
The facility, which was initiated with the invitation and strong support of Ethiopian Airlines and was eventually approved by the Ethiopian Public Health Institution (EPHI), will undertake COVID-19 testing for all passengers on flights to the Chinese mainland.
Independently operated by the BGI Health Ethiopia, the high-end laboratory presently provides passengers with RT-PCR and IgM antibody tests for COVID-19.
The facility is said to the first laboratory invested and operated by a Chinese company in Africa to provide international passengers with COVID-19 testing services in an airport terminal.
In September 2020, the BGI Health Ethiopia inaugurated its first-ever COVID-19 test kit factory in the African continent on the outskirts of Ethiopia’s capital, Addis Ababa.
The company is presently providing its COVID-19 test kits to public and private diagnostic centers in Ethiopia, eventually contributing to the East African country’s fight against the COVID-19 pandemic, which has been commended by the Ethiopian government for saving the much-needed foreign currency that the Ethiopian government would otherwise have been spending in importing test kits.
Abbott begins shipping BinasNOW™ COVID-19 Ag Self Test to retailers today
19 April 2021 - BinaxNOW is the most studied and widely available rapid antigen test in the U.S. and initially will be available at CVS Pharmacy, Walgreens and Walmart without a prescription. Abbott to manufacture tens of millions of BinaxNOW Self Tests per month and can scale capacity upward based on demand. The BinaxNOW Self Test will be sold in 2-count packs for an MSRP of $23.99, making it the most affordable over-the-counter (OTC) COVID-19 rapid test available in the U.S.
ABBOTT PARK, Ill., April 19, 2021 -- Abbott announced today it began shipping its BinaxNOW™ COVID-19 Ag Self Test to retailers across the country. Consumers can expect the test to be available in the next few days online and in some stores. Broader nationwide availability is expected in the next two weeks as tests work their way through distribution channels.
The BinaxNOW Self Test initially will be available at CVS Pharmacy, Walgreens and Walmart as part of Abbott's commitment to get the country's most studied COVID-19 rapid test to as many Americans as possible. The test, which can be purchased over the counter without a prescription, will then roll out to other major food, drug and mass merchandisers in the weeks ahead.
"Over the past year, Abbott has developed high-quality rapid testing and invested in U.S. facilities to scale up manufacturing so we could bring affordable testing to Americans on a mass scale," said Robert B. Ford, president and chief executive officer, Abbott. "We're pleased to be working with the country's leading retailers to provide broad access to this affordable test so that it gets out into the communities that need it most."
Abbott will manufacture tens of millions of BinaxNOW Self Tests per month and can further scale capacity based on demand. Abbott can also work with retailers to prioritize distribution to areas of the country where the virus is surging as additional supply comes online.
The BinaxNOW Self Test will be sold in 2-count packs for an MSRP of $23.99, making it the most affordable OTC COVID-19 rapid test available in the U.S. Abbott is the only manufacturer in the U.S. that has Emergency Use Authorization (EUA) for a COVID-19 self test that can provide tests immediately at this scale.
"Let's not back down on testing, let's double down on it," said Thomas Quinn, M.D., professor of medicine and pathology at the Johns Hopkins School of Medicine. "As long as COVID remains unpredictable, there's an important role for the corner pharmacy and the central lab to tackle this virus in tandem, which gives this country the best chance to detect and screen for COVID-19."
The CDC advises that "a robust and responsive testing infrastructure is essential to our success in stopping the spread of SARS-CoV-2" and provides guidance on the important role both PCR tests and rapid antigen tests play in detecting infections and screening individuals. Abbott will continue bringing accessible testing options and lead the U.S. in supplying COVID-19 tests for use in labs, at the point of care, and now over the counter.
Proven testing technology now broadly available
On March 31, Abbott announced that it received FDA EUA for over-the-counter, non-prescription, symptomatic and asymptomatic use of its BinaxNOW™ COVID-19 Ag Self Test for detection of COVID-19 infection. This new indication allows individuals with or without symptoms to have access to this test without a prescription, bringing the country's most extensively studied and widely used rapid antigen test to nearly everyone in the U.S. The test will come in a two-count pack to meet serial (frequent) testing requirements.
The BinaxNOW Self Test uses the same technology as the existing BinaxNOW test that has been available since August 2020 but is now indicated by the FDA for serial symptomatic and asymptomatic testing, meaning that people should test themselves frequently. The test can be used on children as young as two years old when samples are collected by an adult and for all people aged 15 years or older.
Using the BinaxNOW Self Test will be simple, even for people who have never tested themselves. People will only need to perform a minimally invasive nasal swab (not the deep nasopharyngeal swab) and all materials required to perform the test (swab, test card, and reagent solution) will come in the box. With results in just 15 minutes, the BinaxNOW Self Test lets people who test positive immediately isolate so that they do not infect others, rather than waiting days for results from a lab or send-away at-home tests.
Abbott launched the BinaxNOW professional test nationwide in August 2020 and scaled up production at its new U.S. manufacturing facilities to produce 50 million tests per month. The U.S. Department of Health and Human Services (HHS) purchased the company's first 150 million tests, sending them to K-12 schools, nursing homes, historically black colleges and universities, and underserved communities, where they remain in use today and serve as a powerful tool to help prevent the virus from spreading.
Since its original authorization in August 2020, the BinaxNOW COVID-19 professional use test has gone on to be used by workplaces, additional universities and other organizations throughout the country.
BinaxNOW performance in the field
Today, BinaxNOW demonstrates 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. In our studies, it further shows performance of 95.6% positive agreement (sensitivity) in people seven days or less post-symptom onset with Ct counts of 33 or 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.
In a recent study published by Pilarowski et al. in the peer-reviewed journal Clinical Infectious Diseases, researchers in California assessed BinaxNOW in a community-based setting in people of all ages with and without symptoms. They demonstrated high sensitivity and specificity for BinaxNOW, including in asymptomatic people and in children. Among 102 people who were asymptomatic or whose symptom onset was greater than 7 days before testing, sensitivity for a Ct cutoff of 30 was 100% and specificity was 98.9%. As Ct counts increased to 35 (therefore reflecting less viral load) performance remained high in asymptomatic people of all ages, showing 97.5% sensitivity and 99.7% specificity.
As part of its Emergency Use Authorization for self-testing, Abbott has committed to complete a post-authorization study to determine serial testing performance in people without symptoms.
About BinaxNOW™ COVID-19 Ag Card Self Test
The BinaxNOW COVID-19 Ag Card Self Test is a lateral flow immunoassay intended for the qualitative detection of nucleocapsid protein antigen from SARS-CoV-2. This test is authorized for home use with self-collected direct anterior nasal (nares) swab samples from individuals aged 15 years or older or adult collected nasal swab samples from individuals aged two years or older with or without symptoms or other epidemiological reasons to suspect COVID-19 infection, when tested twice over three days with at least 36 hours between tests.
Individuals who test negative and continue to experience COVID-like symptoms should seek follow up care from their healthcare provider. Individuals who test positive should take precautions, isolate and seek follow-up care from their healthcare provider. BinaxNOW COVID-19 Ag Card Self Test is only for use under the Food and Drug Administration's Emergency Use Authorization.
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 109,000 colleagues serve people in more than 160 countries.
Corona-PCR-Tests mit neuer Lolli-Methode
16 April 2021
16 April 2021 -- SYNLAB startet ein medizinisches Pilotprojekt und testet in den nächsten Wochen Kinder und Jugendliche in Kindertagesstätten und Schulen in Deutschland. Es gibt aktuell keine zufriedenstellende Teststrategie für Kinder und Jugendliche, daher starten mehrere Gesundheitsämter und SYNLAB gemeinsam ein neues Verfahren. Bei den sogenannten Lolli-Tests lutschen Kinder und Jugendliche zweimal pro Woche 30 Sekunden lang jeweils an zwei Abstrich-Tupfern. Das ist eine für Kinder und Jugendliche einfache und gut tolerierte Probenentnahme. Die Proben werden im Poolingverfahren in SYNLAB-Laboren getestet. Im Fall eines positiven Ergebnisses innerhalb eines Pools erfolgt die Testung der weiteren Probe, die durch den zweiten Abstrich-Tupfer entnommen wurde.
Ziel ist es, Alternativen zu Antigentests zu entwickeln, die mit einer Sensitivität von häufig unter 60 % Infektionen übersehen. Mit dem Pilotprojekt will SYNLAB eine deutlich sensitivere und gleichzeitig kostengünstige Alternative zum Antigen-Schnelltestverfahren für Kinder und Jugendliche etablieren, um Infektionsketten schneller durchbrechen zu können und dadurch Kindertagesstätten und Schulen offen halten zu können.
Reference: https://www.synlab.de/human/news-artikel/corona-pcr-tests-mit-neuer-lolli-methode-1357
Siemens Healthineers completes acquisition of Varian, strengthening its position as a holistic partner in healthcare
15 April 2021 - Transformative combination accelerates the company’s impact on global healthcare and establishes a strong partner for customers and patients along the entire cancer care continuum and for many of the most threatening diseases. Varian becomes new business segment within Siemens Healthineers; important step in the implementation of its Strategy 2025. Synergies of at least EUR 300 million per annum expected to be achieved in fiscal year 2025.
15 April 2021 -- Siemens Healthineers AG today announced that it has successfully completed the acquisition of Varian Medical Systems, Inc. (“Varian”). The acquisition was previously announced on August 2, 2020.
“With Varian, Siemens Healthineers has the most comprehensive portfolio in the MedTech sector, which offers the company considerable potential for value creation. With a highly integrated approach, Siemens Healthineers will take the global fight against cancer to a new level,” said Prof. Dr. Ralf P. Thomas, Chairman of the Supervisory Board of Siemens Healthineers AG.
“With the completion of this transaction, we are now best-positioned to take two leaps together: a leap in cancer care and a leap in our impact on healthcare overall. Together, we are establishing a strong and trusted partner capable of supporting customers and patients along the entire cancer care continuum as well as through all major clinical pathways,” said Dr. Bernd Montag, CEO of Siemens Healthineers AG.
“Through the transformative combination of Varian and Siemens Healthineers, our united company will address the growing need for personalized, data-driven diagnosis and precision cancer care that enables us to fight back against globally increasing cancer rates,” said Chris Toth, CEO of Varian, a Siemens Healthineers company. “By bringing together our unique and highly complementary portfolios and capabilities, we will support oncology clinicians and patients in achieving better outcomes and move even closer to achieving our vision of a world without fear of cancer.”
The combined company is creating a unique, highly integrated portfolio of imaging, laboratory diagnostics, artificial intelligence and treatment for the global fight against cancer with significant potential for increased value creation. The acquisition aligns perfectly with the “Upgrading” phase of Siemens Healthineers strategy. With today’s closing of the acquisition, Varian is expected to positively contribute to Siemens Healthineers adjusted basic earnings per share1 within the first 12 months. Additionally, Siemens Healthineers aims for EBIT synergies of at least EUR 300 million per annum in fiscal year 2025.
Varian and Siemens Healthineers are building on the long-standing strategic partnership called “EnVision” to establish a comprehensive digital, diagnostic and therapeutic ecosystem that includes treatment management. With Varian, Siemens Healthineers will leverage AI-assisted analytics to advance the development and delivery of data-driven precision care and redefine cancer diagnosis, care delivery and post-treatment survivorship. Through early and accurate detection as well as more efficient diagnosis, increased treatment quality and access, Siemens Healthineers will support and accelerate Varian’s mission to reduce uncertainty for cancer patients and increase the level of cancer survivorship.
Siemens Healthineers completed the first phase of its Strategy 2025 at the end of fiscal year 2019, during which the company successfully implemented its IPO and launched important product innovations such as the AI-Rad Companions. With the start of fiscal year 2020, Siemens Healthineers has entered the second phase of its “Siemens Healthineers Strategy 2025.” This “Upgrading” phase will take Siemens Healthineers to the next level of profitable growth. With the acquisitions of Corindus and ECG Management Consultants, the company has already strengthened its offerings in adjacent growth areas. And, with Varian, Siemens Healthineers is well-positioned to grow in existing markets, enter adjacent fields and make new markets.
Varian’s common stock ceased trading on the New York Stock Exchange prior to the opening of trading today.
Reference: https://www.corporate.siemens-healthineers.com/press/releases/varian-closing
Thermo Fisher Scientific to Acquire PPD, Inc., a Leading Clinical Research Organization
15 April 2021 - Further expands service offering to pharma and biotech customers - Establishes Thermo Fisher as a global leader in the attractive and high growth clinical research services industry - Adds highly complementary services for the company's fastest growing end market - Offers both meaningful cost and revenue synergies which will further accelerate growth - Expected to be immediately and significantly accretive to Adjusted Earnings Per Share (EPS) after close
WALTHAM, Mass. and WILMINGTON, N.C., April 15, 2021 -- Thermo Fisher Scientific Inc. ("Thermo Fisher"), the world leader in serving science, and PPD, Inc. ("PPD"), a leading global provider of clinical research services to the pharma and biotech industry, today announced that their boards of directors have approved a definitive agreement under which Thermo Fisher will acquire PPD for $47.50 per share for a total cash purchase price of $17.4 billion plus the assumption of approximately $3.5 billion of net debt. This represents a premium of approximately 24% to the unaffected closing price of PPD's common stock on the Nasdaq as of Tuesday, April 13, 2021, or 32% to the 60-day VWAP inclusive of that date.
PPD provides a broad range of clinical research and laboratory services to enable customers to accelerate innovation and increase drug development productivity. A leader in the growing $50 billion clinical research services industry, PPD has more than 26,000 colleagues operating in nearly 50 countries. In 2020, the company generated revenue of $4.7 billion. Upon close of the transaction, PPD will become part of Thermo Fisher's Laboratory Products and Services Segment.
"Pharma and Biotech is our largest and fastest growing end market, and our customers value us as a strategic partner and an industry leader. The acquisition of PPD is a natural extension for Thermo Fisher and will enable us to provide these customers with important clinical research services and partner with them in new and exciting ways as they move a scientific idea to an approved medicine quickly, reliably and cost effectively," said Marc N. Casper, chairman, president and chief executive officer, Thermo Fisher Scientific. "Longer term, we plan to continue to invest in and connect the capabilities across the combined company to further help our customers accelerate innovation and drive productivity, while driving further value for our shareholders."
David Simmons, chairman and chief executive officer, PPD, said, "This is a very exciting announcement for our shareholders and will provide customers with an even better opportunity to bring meaningful innovation to the market faster and more efficiently. Thermo Fisher is a world-class company with a very similar culture and values and will provide a great foundation for our colleagues to continue to deliver for our customers and to develop their own skills and careers."
Casper added, "Both companies have complementary mission-driven cultures, and I can't wait to welcome PPD's colleagues from around the world to Thermo Fisher once the transaction is completed."
Benefits of the Transaction
Establishes Thermo Fisher as One of the Global Leaders in the Attractive, High Growth Clinical Research Services Industry
PPD serves a $50 billion industry forecasted to grow long-term in the mid-single digits, driven by scientific breakthroughs, the continued expected robust funding for drug discovery and the need for strategic suppliers for the pharma and biotech industry to help them bring safe and effective medicines to the patients that need them. PPD has invested significantly in its capabilities and is one of the leading global players providing services to both emerging biotech customers and to all of the top pharma companies in the world.
Combination Further Enhances Thermo Fisher's Value Proposition for Pharma and Biotech Customers by Adding Highly Complementary Services
Thermo Fisher is a leading supplier to the pharma and biotech industry, supporting research and development, clinical trials and production. PPD enhances Thermo Fisher's offering, bringing a proven drug development platform, excellent patient recruitment capabilities, strong laboratory services and a complementary reputation for excellent quality and service. These combined capabilities further enhance Thermo Fisher's value proposition to pharma and biotech customers and allow them to more efficiently access these services, which are key enablers of their success.
Creates Meaningful Benefits for Customers
In the near-term, Thermo Fisher's access to key decision makers in pharma and biotech companies will increase the opportunities for PPD to win additional work from existing and new customers as the pandemic has further highlighted the need for these customers to develop strategic relationships with their key suppliers. The combined company's extensive capabilities and knowledge in serving the pharma and biotech industry will enable new solutions for customers that create the potential to reduce the time and cost of the drug development process.
Delivers Attractive Financial Benefits
The transaction is expected to be immediately and significantly accretive to Thermo Fisher's adjusted EPS, adding $1.40 in the first 12 months after close. Thermo Fisher expects to realize total synergies of approximately $125 million by year three following close, consisting of approximately $75 million of cost synergies and approximately $50 million of adjusted operating income benefit from revenue-related synergies.
Approvals and Financing
The transaction, which is expected to be completed by the end of 2021, is subject to the satisfaction of customary closing conditions, including the receipt of applicable regulatory approvals.
In addition to board approval, shareholders holding in aggregate approximately 60% of the issued and outstanding shares of common stock of PPD have approved the transaction by written consent. No further action by other PPD shareholders is required to approve the transaction.
Thermo Fisher has obtained committed bridge financing with respect to a portion of the purchase price. To fund the transaction, Thermo Fisher intends to use proceeds from debt financing and cash on hand.
Advisors
Barclays Capital, Inc. and Morgan Stanley & Co. LLC are serving as financial advisors to Thermo Fisher, and Cravath, Swaine & Moore LLP and Arnold & Porter Kaye Scholer LLP are serving as legal counsel. For PPD, J.P. Morgan Securities LLC is serving as exclusive financial advisor, while Simpson, Thacher & Bartlett LLP is serving as legal counsel.
Conference Call and Webcast
Thermo Fisher will host a conference call and webcast at 8:30 a.m. Eastern Time today to provide more information on this announcement. The webcast and accompanying slides can be accessed in the Investors section of www.thermofisher.com. An audio archive of the call will be available in that section of the website until April 29, 2021.
ALM-Update: Corona-Maßnahmen konsequent beibehalten und die besorgniserregenden Varianten (B.1.1.7) mehr beachten
13 April 2021
13 April 2021 -- Eine weiterhin steigende Positivrate und die starke Verbreitung der Varianten – insbesondere der Variante B.1.1.7 – das zeigen die aktuellen Ergebnisse der Datenauswertung der Akkreditierten Labore in der Medizin – ALM e.V. Die Zahl der SARS-CoV-2-Neuinfektionen ist in der KW 14 (Ostern und Ferien) auf 128.063 (Vorwoche: 118.945) gestiegen. Die britische Variante B.1.1.7 wird bundesweit mittlerweile bei deutlich über 80 Prozent der diagnostizierten SARS-CoV-2-Fälle nachgewiesen. Die Positivrate stieg in der KW 14 auf 12,8 Prozent (Vorwoche: 11,3 Prozent). Insgesamt wurden 1.002.082 SARS-CoV-2-PCR-Tests angefordert (KW 13: 1.050.115). An der Auswertung des ALM e.V. nehmen 177 Labore (+ 1) aus dem ambulanten und stationären Bereich teil.
BD MAX™ Molecular Multi-Drug Resistant Tuberculosis Test To Be Included In WHO Updated Consolidated Guidelines On Tuberculosis
13 April 2021 - WHO Rapid Communication cites high accuracy for the detection of TB, rifampicin and isoniazid resistance on respiratory samples
FRANKLIN LAKES, N.J., April 13, 2021 -- BD (Becton, Dickinson and Company), a leading global medical technology company, today announced that its BD MAX™ Molecular Multi-Drug Resistant Tuberculosis (MDR-TB) Assay was included in the moderate complexity automated NAAT class of molecular diagnostic technologies that were recognized for high diagnostic accuracy for tuberculosis testing by the World Health Organization (WHO) in advance of an update to its guidelines for TB diagnostic tests.
Laboratorians and clinicians can use the BD MAX™ MDR-TB Assay to simultaneously detect bacteria that cause tuberculosis (TB) and determine if the bacteria contain mutations associated with resistance to two important first-line drugs, isoniazid (INH) and rifampicin (RIF), enhancing the information available to direct the optimal treatment for their patients.
"BD is keenly focused on the fight against antimicrobial resistance and we believe the BD MAX™ MDR-TB Assay will make a real impact on the detection of MDR-TB and better inform which treatment regimen to use for TB patients," said Dave Hickey, president of Life Sciences for BD. "This recognition by WHO is a significant milestone for this product and furthers BD's commitment in the fight to end TB. We look forward to WHO releasing its updated guidelines later this year."
The BD MAX™ MDR-TB Assay is an in vitro diagnostic device with CE mark available in Europe and other countries around the world. The PCR-based molecular diagnostic test is an integrated diagnostic test intended to help in the detection and diagnosis of TB, and INH and RIF resistance in a single assay.
Every year, about 10 million people develop TB and 1.4 million die from the disease. Until the global COVID-19 pandemic, TB was the leading cause of death from a single infectious agent. With proper detection and treatment, TB is curable. Multidrug-resistant TB (MDR-TB), defined as resistance to both isoniazid and rifampicin, remains a critical hurdle in the fight to eradicate tuberculosis as patients with this type of TB will not benefit from those key medicines and could spread the resistant forms of the disease to others.1 Additionally standard testing that only detects RIF resistance can miss cases of TB infection resistant to INH further delaying appropriate treatment and cure for those in need.
BD has a long history in TB diagnostics, having launched the first automated liquid culture system, the BD BACTEC™ MGIT™ Automated Mycobacterial Detection System for comprehensive testing for TB, drug susceptibility and monitoring patients' response to treatment. The BD MAX™ MDR-TB Assay complements this technology enabling clinicians to rapidly test for TB and multidrug resistance as a first-line test and then use the BD BACTEC™ MGIT™ System for broader drug susceptibility testing and patient monitoring.
BD offers a free on-demand webinar featuring Dr. Daniela Maria Cirillo, president of the European Society of Mycobacteriology and head of the Emerging Bacterial Pathogen Research unit at San Raffaele Scientific Institute in Milan. The webinar explores the importance of laboratory diagnostics to stop TB, as well as how the STOP TB Partnership and the ongoing work of the European Society of Mycobacteriology are working to help fight TB. View the on-demand webinar at labroots.com (https://www.labroots.com/webinar/importance-laboratory-diagnostics-fight-tuberculosis).
For more information on BD's role in TB diagnostics please visit: https://www.bd.com/en-us/company/global-health/infectious-diseases/tuberculosis. For more information on BD's molecular platform visit: https://advancing-diagnostics.eu/.
About BD MAX™ SYSTEM
The BD MAX™ System is a molecular diagnostic platform already in use at thousands of laboratories worldwide. The system is fully automated, reducing the opportunity for human error and increasing the speed to result, and can process 24 samples simultaneously, and up to several hundred samples per 24-hour period. Each unit is capable of performing assays for respiratory infections, enterics, hospital acquired infections, and sexually transmitted infections.
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 70,000 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.
FDA Authorizes New High-Throughput, Automated System for Leading COVID-19 Test
12 April 2021 - The Amplitude Solution with the TaqPath COVID-19 High-Throughput Combo Kit enables laboratories to rapidly scale high-sensitivity PCR testing capacity as schools and employers seek increased testing to support reopening strategies
WALTHAM, Mass., April 12, 2021 -- Thermo Fisher Scientific Inc., the world leader in serving science, today announced that the U.S. Food and Drug Administration (FDA) has granted Emergency Use Authorization (EUA) for the Thermo Fisher Scientific Amplitude Solution with the TaqPath COVID-19 High-Throughput Combo Kit.
The Amplitude Solution enables clinical and public health laboratories to scale gold standard PCR testing and process up to 8,000 samples in a single day with minimal staffing resources and a secured supply of kits, reagents and consumables to meet their testing needs. The Amplitude Solution has been implemented globally including labs in Europe and Japan.
"While COVID-19 cases globally may be decreasing in some areas as vaccines become more widely available, there continues to be a demand for frequent routine testing to control future outbreaks," said Mark Stevenson, executive vice president and chief operating officer of Thermo Fisher Scientific. "For population-wide testing programs, lab-based PCR is the best fitting technology, providing confidence in results, capacity to process thousands of samples a day, and consistent, reliable turnaround times. The Amplitude Solution can help support a systematic testing strategy by enabling labs to quickly scale their testing and begin processing high-volume samples, even with limited personnel."
The Amplitude Solution is a molecular diagnostic testing system that helps clinical labs expand testing capacity by combining Thermo Fisher's extraction and real-time PCR instruments with liquid handling products from Tecan Group. The modular system utilizes a high-throughput version of Thermo Fisher's Applied Biosystems TaqPath COVID-19 Combo Kit, which received EUA in March 2020, to process samples in four steps with minimal hands-on time and laboratory space requirements. The kit's multi-gene target design and updated interpretive software may help labs detect SARS-CoV-2 variants.
For more information on the Amplitude Solution, please visit www.thermofisher.com/amplitude.
Testing with the Amplitude Solution with the TaqPath COVID-19 High-Throughput Combo Kit is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. 263a, to perform high-complexity tests, or by similarly qualified non-U.S. laboratories.
The Amplitude Solution with the TaqPath COVID-19 High-Throughput Combo Kit has not been FDA cleared or approved and is only authorized for the duration of the EUA granted 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 Thermo Fisher Scientific
Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $30 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 80,000 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.
World's fastest marathoner Eliud Kipchoge uses Abbott's Libre Sense at NN Mission Marathon qualifier race for the Olympic Games
12 April 2021 - Abbott, Eliud Kipchoge and the NN Running Team collaborate in a partnership to track glucose levels during training and marathons. Kipchoge and NN Running Team members will wear Abbott's Libre Sense Glucose Sport Biosensor in upcoming competition at the NN Mission Marathon, the fastest way to the Tokyo Games. Built upon the company's world-leading continuous glucose monitoring technology, Abbott's Libre Sense is the world's first glucose biosensor designed for athletes to help sports performance.
ABBOTT PARK, Ill., April 12, 2021 -- Abbott announced today it is teaming up with Eliud Kipchoge, who is considered the world's fastest marathon runner, and the NN Running Team to support their athletic performance training program. Kipchoge and three NN Running Team members are training with Abbott's Libre Sense Glucose Sport Biosensor to monitor their glucose levels to help them achieve optimal athletic performance. The NN Mission Marathon, a qualifying race for the Olympic Games, in Enschede, the Netherlands on April 18, will be the first time Kipchoge and the NN Running Team will use Abbott's biosensor in a competitive marathon.
"Using Abbott's Libre Sense has transformed my training program. I am learning how my glucose levels relate to my running performance and have already started to see how quickly small adjustments can make a big difference," said Eliud Kipchoge, the world's fastest marathon runner. "I am honored to work on this project, which hopefully will help athletes around the world to better understand the relationship between nutrition and performance to help them improve."
Kipchoge is celebrated as the greatest marathon runner in history as a three-time Olympic medal winner and the first person in history to run a marathon in under two hours. To maintain elite performance, Kipchoge and the NN Running Team continually seek to innovate across all aspects of their training program, evaluating everything from race planning, nutrition and hydration to clothing and footwear. As the first product of its kind, Abbott's biosensor empowers the runners to tap into real-time molecular data to monitor their glucose levels and help them design personalized nutrition plans.
"We've utilized our breakthrough sensing technology to help world-class athletes like Eliud and everyday athletes alike live up to their optimal potential," said Duncan Williams, divisional vice president, Biosensor Technology, Abbott. "Libre Sense will help make glucose monitoring commonplace in athletic performance training and enable athletes to fuel their peak performance."
Abbott's Libre Sense, CE Marked in September 2020, is an over-the-counter product made available in Europe that is designed to provide continuous glucose monitoring via a mobile appiii and wrist readersiv to athletes. Athletes wear the small round biosensor (approximately the size of a two Euro coin) on the back of their upper arm. Worn for up to 14 days, the biosensor provides real-time glucose values through a mobile app developed by Supersapiens, a sports technology company focused on improving athletic performance. Abbott's biosensor and Supersapiens app are designed to help athletes understand the efficacy of their nutrition choices in training and competition.
Abbott is providing Kipchoge and the NN Running Team members with Abbott's biosensors for training, as well as collaborating to develop personalized insights into their athletic performance. Kipchoge and the NN Running Team will provide key learnings, share their experiences and educate athletes worldwide to better understand the link between nutrition and performance.
To prepare for the NN Mission Marathon, their last competitive marathon before the Olympic Games, Eliud and the NN Running Team have been training in Kenya using Libre Sense for the past month.
"After training with Abbott's biosensor, we've been able to quickly develop new insights into high-performance, endurance training nutrition and hydration. For example, we are exploring a shift in timing of pre-race and race-time carbohydrate fueling to net maximum benefits," said Valentijn Trouw, performance director of NN Running Team and Global Sports Communications. "Abbott's biosensor enables us to build personalized nutrition plans based on glucose data in order to deliver peak athletic performance and a competitive advantage. The NN Mission Marathon will be an excellent opportunity to show how important glucose insights can make a real difference in performance."
To see Kipchoge and the NN Running Teams training sessions in Kenya with the Abbott biosensor, click here.
About Abbott Libre Sense Glucose Sport System
The Abbott Libre Sense Glucose Sport Biosensor is intended for athletes (aged 16+ years) to measure glucose. Athletes are defined as individuals who perform exercise and train with the purpose of improving fueling and performance. 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.
The product is available across eight European countries: Austria, France, Germany, Ireland, Italy, Luxembourg, Switzerland and the United Kingdom.
For more information about Abbott's biosensor, visit LibreSense.com. For more information about the app, visit Supersapiens.com.
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 109,000 colleagues serve people in more than 160 countries.
Expediting the Diagnosis of Heart Attack with Atellica VTLi Patient-Side Analyzer for Industry First Fingerstick High-Sensitivity Troponin I at Point-of-Care
11 April 2021 - Expediting triage times for patients presenting with heart attack symptoms enhances patient care and helps against Emergency Department overcrowding – a patient safety issue and a world-wide public health problem that contributes to cardiac deaths. The Siemens Healthineers Atellica VTLi Patient-Side Analyzer is offering clinicians the first high-sensitivity troponin I test from a fingerstick sample. With the ability to aid in diagnosing a heart attack quickly and accurately in eight minutes, clinicians can improve outcomes for patients and healthcare providers.
11 April 2021 -- Siemens Healthineers announced today the company's Atellica VTLi Patient-Side Immunoassay Analyzer2 has obtained CE mark and is expected to be available later this spring. The Atellica VTLi analyzer provides lab standard, high-sensitivity cardiac troponin I (hs-cTnI) test results to clinicians in eight minutes using a patient's fingerstick blood sample. With this industry first technology, Siemens Healthineers is helping to improve the patient care paradigm with its disruptive technology, providing hs-cTnI results at the patient’s side to help clinicians properly diagnose and treat heart attacks with confidence.
“Siemens Healthineers is among the best-in-class with cardiac disease state solutions, immunoassays, and critical care diagnostics. Now we are raising the bar as the first company to offer a true point-of-care high-sensitivity cardiac troponin I test with results comparable to laboratory performance using just a fingerstick sample. Healthcare providers have been waiting decades for hs-cTnI at the point of care and now the wait is over. This new technology further expands Siemens Healthineers' broad cardiac portfolio throughout the entire patient care continuum,” said Christoph Pedain, PhD, Head of Point of Care Diagnostics, Siemens Healthineers.
Globally, millions of patients present annually to the emergency room with symptoms that may be related to a heart attack. Responsible for an estimated 31 percent of all deaths worldwide, cardiovascular disease is the leading cause of death.3 Fast triage for patients presenting with symptoms can help save lives. Clinicians primarily rely on the central laboratory for critical blood test results before they can make care decisions for their patients. This process can take an hour or more to get results. The substantial reduction in turnaround time achieved when introducing the wireless, handheld Atellica VTLi analyzer may offer clinicians a fast pathway to help diagnose and treat their patients, helping to accelerate care, improve patient outcomes, and reduce the strain felt in overcrowded EDs.
When a patient presents at the hospital with symptoms of a potential heart attack, securing favorable outcomes depends on the speedy availability of test results, and the confidence care providers have in them. “In today’s busy emergency departments across the globe, there is a demand by clinicians for the rapid measurement of cardiac troponin, using guideline-recommended, high-sensitivity assays, to quickly and accurately rule in and rule out myocardial injury and myocardial infarction in patients presenting with symptoms suggestive of ischemia," said Dr. Fred Apple, PhD, Medical Director of clinical laboratories, clinical chemistry, point-of-care testing, and clinical and forensic toxicology laboratories at Hennepin County Medical Center. "The Siemens Healthineers Atellica VTLi point-of-care assay technology, utilizing whole blood with result turn-around times in as fast as eight minutes, provides a high-sensitivity cardiac troponin I measurement that is equivalent to the diagnostic and analytical accuracy of instruments found in the central laboratory. I believe this POC system could easily integrate into existing hospital and clinic workflows, with the potential to impact patient care and clinical outcomes, with operational and financial efficiencies.”
The Atellica VTLi system has wireless capability that easily integrates and directly connects to data management systems, including the Siemens Healthineers POC Ecosystem Solution, and the laboratory and hospital information systems. Together, this offering provides the laboratory centralized control over decentralized point-of-care testing.
The Atellica VTLi immunoassay analyzer is the resulting innovation stemming from Siemens Healthineers' acquisition of Minicare BV, which was completed on July 2, 2019.
Reference: https://www.corporate.siemens-healthineers.com/press/releases/atellica-vtli
DiaSorin to acquire Luminex Corporation for USD 37.00 per share or approximately USD 1.8 billion
11 April 2021 - Provides access to proven Luminex multiplexing technology and molecular testing solution to be used in unique testing panels, generating critical mass in the molecular diagnostics space. Sets the ground for new partnerships and business development opportunities through life science offerings. Broadens DiaSorin’s presence in the U.S. Accelerates Luminex technology and solutions' penetration outside the U.S. by leveraging DiaSorin’s international commercial footprint. Creates significant value and is expected to be immediately accretive to DiaSorin earnings per share post closing.
Saluggia (Italy), April 11, 2021 -- DiaSorin S.p.A. today announced that its Board of Directors has unanimously approved and signed a definitive merger agreement for DiaSorin to acquire Luminex Corporation for a price of USD 37.00 per share in an all-cash transaction. This corresponds to a total equity value of approximately USD 1.8 billion on a fully diluted basis and an enterprise value of approximately USD 1.8 billion.
The cash consideration represents a c.23.1% premium to Luminex shareholders based on the unaffected closing stock price of Luminex on 24 February 2021 (the date prior to press rumors regarding a potential sale of the company) and a c.30.6% and c.47.5% premium, based on, respectively, the 30-day and 90-day volume-weighted average closing stock price before 24 February 2021.
Luminex develops, manufactures and sells proprietary biological testing technologies and products with leading applications throughout the Diagnostics and Life Science industries. Luminex is a leader in multiplexing technology, one of the fastest growing markets in the molecular space, with more than 900 active clients. With its first-class technology and extensive Life Science solutions supporting clinical and pharmaceutical research and development, Luminex is highly complementary to DiaSorin’s growing diagnostics segment.
The acquisition will broaden DiaSorin’s positioning in the molecular diagnostics space and strengthen its existing value proposition in line with its strategic priorities. Through the acquisition, DiaSorin will gain access to Luminex’s molecular diagnostics multiplexing technology and a portfolio that will strengthen its existing offering while expanding its presence in the U.S. The acquisition will also provide access to Luminex’s applications throughout the Life Science industry, supporting access to academic and scientific research to shape market intelligence on future market trends, engaging with biopharma companies to drive opportunities for long-term partnerships (e.g. vaccine development, biological drugs) and access to clinical multiplexing assays for future Value Based Care projects based on diagnostic algorithms, as defined at the 2019 DiaSorin Investor Day.
Following the acquisition, the combined entity will have combined 2020 revenues of approximately € 1.25 billion, adjusted EBITDA of approximately € 472 million, and positive Net Financial Position of approximately € 335 million.
Reference: https://www.luminexcorp.com/wp-content/uploads/2021/04/DiaSorin-to-acquire-Luminex-Corporation24.pdf
BGI’s Detection Kit for Neutralization Antibody of SARS-CoV-2 Obtains CE Mark
9 April 2021
9 April 2021 -- The Detection Kit for Neutralization Antibody of SARS-CoV-2 (Competitive ELISA) has recently got the CE Mark. It was developed by BGI PathoGenesis Pharmaceutical Technology Co., Ltd., a subsidiary of BGI Genomics.
The positive conversion rate of neutralizing antibody is one of the important indicators for clinical research and vaccine efficacy monitoring to evaluate the level of effective antibodies generated after vaccination. BGI‘s new CE marked kit can detect the neutralizing antibody of SARS-CoV-2 in human serum or plasma samples after inoculation, helping to evaluate the positive conversion rate of a COVID-19 vaccine and providing scientific data support for the monitoring and evaluation of vaccines, and helps continuously optimize vaccine clinical research data.
Last month, BGI’s Rapid Identification Kit for B.1.1.7 lineage and B.1.351 lineage of SARS-CoV-2 (Fluorescence RT-PCR), and the Detection Kit for six mutations in S gene of SARS-CoV-2 (ARMS-PCR) also got the CE Mark.
Hologic to Acquire Mobidiag, Innovator in Near-Patient, Acute Care Diagnostic Testing, for Approximately $795 Million
8 April 2021 - Transaction Will Accelerate Global Growth of Mobidiag’s Differentiated Molecular Platform, which Offers Ease of Use, Multiplex Capability and Rapid Turnaround Time
MARLBOROUGH, Mass., 8 April 2021 -- Hologic, Inc., a global leader in women's health, announced today that it has signed a definitive agreement to acquire Mobidiag Oy, a privately held, commercial-stage Finnish-French developer of innovative molecular diagnostic tests and instrumentation, for an enterprise value of approximately $795 million. This includes a cash payment of approximately $714 million (€600 million) for Mobidiag’s equity, and net debt of approximately $81 million.
“Acquiring Mobidiag will further strengthen our international and diagnostics businesses by enabling us to expand into the large, fast-growing acute care adjacency with a near-patient testing solution that offers ease of use, multiplex capability and rapid turnaround time,” said Jan Verstreken, group president, international at Hologic. “We believe that Mobidiag has developed a differentiated platform that addresses many of the historical challenges of multiplexed point-of-care molecular testing.”
“We are very excited to join Hologic’s diagnostic business,” said Tuomas Tenkanen, Mobidiag’s chief executive officer. “Hologic’s commercial expertise and scale will drive broader market adoption of our products, and their established U.S. regulatory and market development capabilities will accelerate the introduction of our products and maximize their potential in the United States.”
Mobidiag develops and markets PCR (polymerase chain reaction)-based tests for acute care conditions such as gastrointestinal and respiratory infections, antimicrobial resistance management, and healthcare associated infections. The Amplidiag and Novodiag platforms are automated instruments that deliver rapid turnaround times ranging from 50 minutes to two hours.
The Novodiag platform combines real-time PCR and microarray capabilities to provide high-level multiplexing. Multiplexing enables multiple pathogens to be identified in a single sample, streamlining workflows for laboratories and providing rapid results to physicians. For example, gastrointestinal infections commonly present with similar or identical symptoms but can be caused by more than 25 organisms. Highly multiplexed assays allow clinicians to identify which organism is responsible for an infection quickly, accurately and efficiently.
“One of our key goals is to use our strong cash flow to create a larger, faster growing company for a post-pandemic world,” said Steve MacMillan, Hologic’s chairman, president and chief executive officer. “Mobidiag provides an exceptional new growth platform, which will generate long-term value by enabling us to enter the acute care market, which is expected to roughly double in the next five years, with a differentiated, highly competitive solution.”
Mobidiag generated approximately $42 million (€35 million) of revenue in calendar 2020. Hologic intends to invest in assay development to drive growth of the Novodiag platform. As a result, the acquisition is expected to be approximately $0.10 dilutive to Hologic’s non-GAAP earnings per share in fiscal 2022, slightly dilutive in 2023, and accretive thereafter. Hologic expects to finance the transaction with cash on hand and borrowing on its existing line of credit.
The acquisition is expected to close early in the fourth quarter of fiscal 2021, subject to receipt of certain required regulatory approvals and other customary closing conditions.
About Hologic, Inc.
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.
Hologic and The Science of Sure are trademarks and/or registered trademarks of Hologic, Inc. and/or its subsidiaries in the United States and/or other countries.
About Mobidiag
Mobidiag is a commercial stage, fast-growing Finnish-French biotechnology company that develops and markets innovative molecular diagnostic solutions for gastrointestinal infections, antimicrobial resistance management, healthcare associated infections (HAIs), respiratory infections and sepsis. Based on well-established qPCR and microarray technologies, Mobidiag offers a broad range of tests and automated platforms. These include a comprehensive range of fast, reliable and cost-effective molecular diagnostic solutions for the detection of infectious diseases adapted to laboratories of all sizes. They allow detection of most clinically relevant bacteria, parasites, viruses and markers for antibiotic resistance.
Non-GAAP Financial Measures
This press release discusses non-GAAP diluted EPS, which is a non-GAAP financial measure. Hologic’s definition of non-GAAP diluted EPS may differ from similarly titled measures used by others. Hologic defines its non-GAAP EPS presented in this press release to primarily exclude the amortization of intangible assets, acquisition- and integration-related charges, and income taxes related to such adjustments.
Non-GAAP diluted EPS adjusts for specified items that may be non-cash, or can be highly variable or difficult to predict. In the context of forward-looking statements, the non-GAAP financial measures facilitate period-to-period comparisons by excluding the effects of events that have occurred in the past or may occur in the future and have accounting consequences that can mask underlying operational trends, such as acquisitions, restructurings, debt extinguishment and impairments.
This non-GAAP financial measure should be considered supplemental to, and not a substitute for, financial information prepared in accordance with GAAP. Because non-GAAP financial measures exclude the effect of items that will increase or decrease Hologic’s reported results of operations, management encourages investors to review Hologic’s consolidated financial statements and publicly filed reports in their entirety.
Future GAAP EPS may be affected by changes in ongoing assumptions and judgments, and may also be affected by non-recurring, unusual or unanticipated charges, expenses or gains, which are excluded in the calculation of Hologic’s non-GAAP EPS as described in this press release.
When Hologic provides its expectations for non-GAAP EPS on a forward-looking basis, a reconciliation of the differences between these non-GAAP expectations and the corresponding GAAP measures are not available without unreasonable effort because Hologic has not estimated the fair value of the assets and liabilities expected to be acquired in the transaction. Nor has Hologic determined the fair value of acquired intangible assets and related annual amortization expense that would be required to provide the corresponding GAAP measure. The variability of the items that have not yet been determined may have a significant, and potentially unpredictable, impact on Hologic’s future GAAP results.
QIAGEN erweitert Test-Portfolio um Antigen-Schnelltests für den deutschen Markt
8 April 2021 - QIAGEN-Initiative ermöglicht Unternehmen, mehr Arbeitskräfte in höherer Frequenz zu testen. Mehrere Millionen Tests pro Monat lieferbar. Zulassung für die Nutzung durch Fachpersonal erteilt. Zulassung für Selbsttestung ohne Fachpersonal für April erwartet.
Hilden, 8. April, 2021 – QIAGEN hat heute angekündigt, mehrere Millionen Antigen Schnelltests für Unternehmen in Deutschland ab sofort liefern zu können um die Wirtschaft bei ihrer Selbstverpflichtung zum Testen von Mitarbeitern im Kampf gegen SARS-CoV-2 unterstützen zu können.
QIAGEN aktiviert sein Fachwissen und seine Schlagkraft im Vertrieb von Diagnostika-Produkten und bezieht die zugelassenen und qualitativ hochwertigen Tests von dem deutschen Hersteller möLab GmbH, um ab dem 6. April die Coronavirus-Testkapazitäten von Unternehmen in Deutschland deutlich zu erweitern.
„Mit der Initiative möchten wir Unternehmen dabei unterstützen, ihren Mitarbeiterinnen und Mitarbeitern mindestens zwei Coronavirus-Tests pro Woche anbieten zu können,“ sagte Kai te Kaat, Vice President, Leiter Programmmanagement Life Sciences bei QIAGEN. „Für die erfolgreiche Umsetzung der Selbstverpflichtung der Spitzenverbände der Wirtschaft braucht es einen gemeinsamen Kraftakt. Wir freuen uns, einen weiteren Beitrag leisten zu können, dass Wirtschaft und Gesellschaft am Laufen bleiben.“
Der von QIAGEN vertriebene immunochromatographischer Schnelltest wird von medizinischem Fachpersonal durchgeführt und liefert innerhalb von 15 Minuten ein Ergebnis. Eine Zulassung zur Eigenanwendung für Laien wurde bereits beantragt und wird für April erwartet.
Der Test ist beim Bundesinstitut für Arzneimittel und Medizinprodukte gelistet und nutzt sowohl einen einfachen Nasen- als auch einen tieferen Nasen-Rachen-Abstrich. Er hat eine Sensitivität von 97,25 % und eine Spezifität von 99,9 % und wird vom Paul-Ehrlich-Institut in Deutschland empfohlen.
Zusätzliche Informationen zu QIAGENs Antigen-Schnelltest finden Sie hier.
Weitere Informationen zu QIAGENs Engagement im Kampf gegen das Coronavirus finden Sie hier.
Über QIAGEN
QIAGEN N.V., eine niederländische Holdinggesellschaft, ist der weltweit führende Anbieter von Komplettlösungen zur Gewinnung wertvoller molekularer Erkenntnisse aus biologischen Proben. Die Probentechnologien von QIAGEN ermöglichen die Aufreinigung und Verarbeitung von DNS, RNS und Proteinen aus Blut, Gewebe und anderen Stoffen. Testtechnologien machen diese Biomoleküle sichtbar und bereit zur Analyse. Bioinformatik-Lösungen und Wissensdatenbanken helfen bei der Interpretation von Daten zur Gewinnung relevanter und praktisch nutzbarer Erkenntnisse. Automationslösungen integrieren diese zu nahtlosen und kosteneffizienten molekularen Test-Workflows. QIAGEN stellt seine Lösungen mehr als 500.000 Kunden aus den Bereichen Molekulare Diagnostik (Gesundheitsfürsorge) und Life Sciences (akademische Forschung, pharmakologische F&E und industrielle Anwendungen, hauptsächlich Forensik) zur Verfügung. Zum 31. Dezember 2020 beschäftigte QIAGEN weltweit rund 5.600 Mitarbeiter an über 35 Standorten 1.200 hiervon am Standort in Hilden. Weitere Informationen über QIAGEN finden Sie unter http://www.qiagen.com.
ALM-Update: Auch über die Osterfeiertage, weiterhin deutliche Zunahme der Positivrate an SARS-CoV-2-PCR-Tests
7 April 2021
7 April 2021 -- Auch wenn das Bild der Coronatestungen über die Osterfeiertage gesondert betrachten werden sollte, setzt sich der Trend der vergangenen Wochen fort: Die Zahl der SARS-CoV-2-Neuinfektionen bleibt weiterhin hoch und die britische Variante B.1.1.7 hat sich durchgesetzt – ihr Anteil liegt bundesweit bei über 80 Prozent der diagnostizierten Fälle, regional teilweise noch deutlich darüber. Die Positivrate stieg in der KW 13 auf 11,3 Prozent (Vorwoche: 9,5). Dabei wurden in der Karwoche erwartungsgemäß weniger SARS-CoV-2-PCR-Tests angefordert. Im Vergleich zur Vorwoche ging die Zahl der PCR-Tests um rund 18 Prozent auf 1.050.115 zurück. Insgesamt wurden 118.945 Menschen positiv auf das Vorliegen einer Coronainfektion getestet (Vorwoche: 121.982). Das zeigt die Auswertung der Akkreditierten Labore in der Medizin – ALM e.V., an der 176 (+ 1) Labore aus dem ambulanten und stationären Bereich teilgenommen haben.
Grifols advances in the execution of its expansion plan with the acquisition of 7 plasma centers in the U.S.
7 April 2021 - The seven plasma centers acquired from Kedrion obtain roughly 240,000 liters of plasma per year. The USD 55 million transaction will be financed with Grifols’ own resources. Grifols’ acquisitions of plasma centers in 2021 provide the company with immediate access to approximately 1.4 million liters per year and move forward with the execution of its plasma expansion plan. This transaction is aligned with the plasma-supply expansion and diversification strategy of the company, an industry leader with the world’s largest network of plasma centers: 351 centers in the U.S. and Europe. The company remains firmly committed to further increasing its plasma supply to meet current and expected strong increases in demand for plasma-based therapies.
Barcelona, April 7, 2021 -- Grifols, a global leader in the development of plasma-derived medicines with a track record of more than 100 years dedicated to enhancing people’s health and well-being, closed the acquisition of seven U.S. plasma donation centers from Kedrion for USD 55.2 million. The operation received regulatory clearances and will be financed with Grifols’ own resources, without issuing debt.
Grifols will gain immediate access to the plasma obtained in these centers, which obtain approximately 240,000 liters per year. The seven newly acquired centers are authorized by the U.S. Food and Drug Administration (FDA) and European healthcare authorities.
This acquisition reflects Grifols’ commitment to enlarge its plasma supply through organic and inorganic growth.
Since January 2021, Grifols’ efforts to accelerate the execution of its strategic expansion plan have enabled it to instantly leverage approximately 1.4 million more liters of plasma yearly. At the same time, the company continues its efforts to open new centers.
In this regard, in March 2021, Grifols acquired 25 plasma centers from BPL Inc., which obtain approximately 1 million liters of plasma per year.
As part of its organic efforts, the company plans on opening between 15 and 20 new plasma centers in 2021. Additionally, Grifols will open several plasma centers in Egypt during the year1, following the strategic alliance signed with the Egyptian government in November 2020.
This most recent acquisition advances Grifols’ strategy to reinforce and diversify its access to plasma. An industry leader, the company boasts a robust network of 351 plasma centers, with 296 in the United States and 55 in Europe across Germany, Austria and, recently Hungary.
The transaction reinforces the company’s efforts to strengthen its plasma center network, which represents a significant competitive advantage. Grifols remains committed to increasing the availability of its life-enhancing plasma-derived products for patients who need them and doing its utmost to respond to expected strong demand.
bioMérieux announces the CE marking of 3 dengue immunoassays on VIDAS®
7 April 2021 - bioMérieux, a world leader in the field of in vitro diagnostics, announces the CE marking of its innovative and fully-automated assays to diagnose dengue infection: VIDAS® DENGUE NS1 Ag VIDAS® Anti-DENGUE IgM VIDAS® Anti-DENGUE IgG
7 April 2021 -- Dengue is a viral disease transmitted to humans by certain types of mosquitoes. With 100 to 400 million people affected each year, it is the most common arthropod-borne viral infection worldwide. The global incidence of this infection has grown over 8 fold during the last 20 years, with the greatest burden observed in Asia (75%) followed by Latin America and Africa.
Dengue often presents non-specifically and with fever, thereby leading to a high risk of misdiagnosis in the absence of laboratory confirmation, especially in countries where many other infectious diseases are circulating. “Presenting in different forms, from mild to life-threatening, a dengue diagnosis and optimal patient management both rely on rapid and reliable diagnostics. In line with our goal of addressing major global health issues, it is important for us to provide these easy, automated, and high-quality tests for diagnosing dengue virus infection.” said Mark Miller, Executive Vice President, Chief Medical Officer, bioMérieux.
Diagnostic testing for dengue relies on several laboratory methods, mainly manual, which each have their own advantages and limitations. If molecular assays are not available or the patient presents later during the course of the disease, serological methods are particularly well suited.
VIDAS® DENGUE NS1 Ag, Anti-DENGUE IgM and Anti-DENGUE IgG are the new automated assays intended as an aid in the diagnosis of dengue infection.
These VIDAS® DENGUE assays can be used independently to detect the viral antigen (NS1) and antibodies (IgM and IgG) produced by the host in response to the infection. These 3 serological tests are recommended by international guidelines.
Performed on the VIDAS® family platforms, VIDAS® DENGUE assays provide reliable results with improved quality compared to the existing manual methods. The performance level responds to the medical need for an early and accurate diagnosis of dengue.
The test process is fully automated, from sample identification to the result report. Based on the single test concept and the “load & go” system, the VIDAS® DENGUE panel is easy to use and accessible to all laboratories. Capitalizing on bioMérieux’s expertise in infectious diseases, VIDAS® DENGUE assays enable clear-cut results with no equivocal zone and an objective interpretation thanks to the automation.
“This new VIDAS® DENGUE solution is cost-effective and suitable for low- and middle-income countries where VIDAS® is widely available. It broadens our immunoassay offer against vector borne-diseases that will be further extended to chikungunya” said Pierre Boulud, Chief Operating Officer, Clinical Operations, bioMérieux.
Reference: https://www.biomerieux.com/en/biomerieux-announces-ce-marking-3-dengue-immunoassays-vidasr
QIAGEN Adds to COVID-19 Portfolio With New Ultra-Fast Sequencing Solution for High-Throughput Genomic Surveillance
6 April 2021 - QIAseq DIRECT SARS-CoV-2 Kit halves both library preparation times and plasticware use. Kit supports analysis of over 6,000 samples simultaneously on highest-throughput sequencers. Integrates with QIAGEN Digital Insights cloud solutions to support variant detection and reporting including clade and lineage annotations across sequencing platforms.
GERMANTOWN, Md. & HILDEN, Germany, 6 April 2021 -- QIAGEN N.V. today announced the launch of QIAseq DIRECT SARS-CoV-2 Kit, a viral genome enrichment and library preparation solution that significantly reduces library turnaround times and plastics use compared with ARTIC project protocols (primer-based approaches for next-generation sequencing (NGS)). The lab and bioinformatic protocols of the ARTIC network, an initiative funded by the Wellcome Trust, are considered the gold standard in NGS-based characterization of SARS-CoV-2 genomes.
High-throughput NGS is increasingly being used to conduct genomic surveillance and research on new and potentially dangerous COVID-19 variants that continue to emerge. These viral mutations have become an area of intense concern particularly with regard to vaccine efficacy. As a result, sequencing laboratories worldwide have come under intense pressure to provide results as quickly as possible.
QIAseq DIRECT SARS-CoV-2 supports sample multiplexing with up to 768 Dual Molecular Indices - unique markers tagged to molecules in a sample to eliminate errors from downstream analysis - in a library preparation workflow from extracted viral RNA that reduces turnaround time to as little as four hours. This also increases the amount of samples per sequencer to over 6,000 samples on the highest-throughput instruments. The kit also cuts plastics usage by 50%, drastically reduces hands-on time, requires no fragmentation or ligation reactions and can be readily automated with robotic liquid handlers. The viral enrichment approach delivers superior uniformity of coverage across the SARS-CoV-2 genome as well as deeper sequencing performance compared with the most widely used amplicon-based options.
“QIAseq DIRECT SARS-CoV-2 is a powerful solution that will increase the efficiency and output of NGS at a time when global expectations to perform could not be higher,” said Thomas Schweins, Senior Vice President of the Business Area Life Sciences of QIAGEN. “This kit is an important extension of our QIAseq range, that allows for more accurate detection and quantification of molecular variants, while drastically reducing the time and workflow steps needed for library preparation, increasing lab efficiency and throughput.”
An additional pressure point for laboratories is the analysis and interpretation of the large and rapidly collected viral datasets. The QIAseq DIRECT SARS-CoV-2 kit is supported by the new QIAGEN Digital Insights CoV-2 Insights Service, a cloud-based solution tailored to viral genome analysis, characterization and reporting. The service is designed for large-scale surveillance applications and is available globally. It offers Whole Genome Sequencing variant analysis, identification and standardized reporting of community-based standards essential for high-throughput genomic surveillance, as well as fast and easy set up.
QIAGEN has built up one of the most comprehensive SARS-CoV-2 research and testing portfolios. It includes sample preparation innovations like QIAprep&, syndromic testing solution QIAstat-Dx, high throughput PCR with NeuMoDx, QIAreach digital Antibody and Antigen tests and T-Cell research solutions based on QIAGEN’s QuantiFERON IGRA technology. The company continues to add novel solutions to support laboratories combatting the pandemic and to provide experts with tools to learn more about the virus and drive research forward.
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 December 31, 2020, QIAGEN employed approximately 5,600 people in over 35 locations worldwide. Further information can be found at http://www.qiagen.com.
Quest Diagnostics Sells Ownership Interest in Q² Solutions to IQVIA
1 April 2021
SECAUCUS, N.J. and RESEARCH TRIANGLE PARK, N.C., April 1, 2021 -- Quest Diagnostics, the world's leading provider of diagnostic information services, today announced the sale of its minority share in Q2 Solutions to IQVIA, a leading global provider of advanced analytics, technology solutions, and clinical research services to the life sciences industry, for $760 million in an all-cash transaction.
Q2 Solutions is a leading global clinical laboratory services organization that provides comprehensive testing, project management, supply chain, biorepository, biospecimen and consent tracking solutions for clinical trials. IQVIA and Quest established Q2 Solutions as a joint venture in 2015. IQVIA previously owned a 60 percent majority share and Quest Diagnostics owned a 40 percent minority share.
"Divesting from Q2 Solutions supports our vision to be focused on empowering better health with diagnostic information services," said Steve Rusckowski, Quest Diagnostics Chairman, CEO and President. "We are proud of our contributions to the growth of Q2 Solutions, and are confident that IQVIA has the strategic vision and agility to lead Q2 Solutions on the next phase of its journey as a global leader in central lab services."
Under a multi-year agreement, Quest will remain the strategic preferred laboratory provider for Q2 Solutions' clients, providing a range of complementary lab testing capabilities to augment Q2 Solutions' core offerings and extend its industry leading suite of services.
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 approximately 50,000 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 Test receives Emergency Use Authorization for screening use with serial tests
1 April 2021 - Easy-to-use test that provides results in 15 minutes is now available without a prescription
SAN DIEGO, 1 April 2021 -- 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 an Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA), allowing the company to market its Sofia® SARS Antigen FIA for the qualitative detection of the nucleocapsid protein antigen from SARS-CoV-2 from anterior nares swab specimens directly from individuals who are either suspected of COVID-19 by their healthcare provider within the first five days of the onset of symptoms, or are individuals without symptoms or other epidemiological reasons to suspect COVID-19 tested twice over two (or three) days with at least 24 hours (and no more than 36 hours) between tests. Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, that meet the requirements to perform moderate, high or waived complexity tests. This test is authorized for use at the Point of Care (POC), i.e., in patient care settings operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation.
The Sofia® SARS Antigen FIA shows excellent performance within the first five days of the onset of symptoms, with positive results agreeing with PCR 96.7% of the time, and negative results agreeing 100% of the time, delivering confidence to physicians, healthcare workers and other customers within the professional segment. This new intended use allows the Sofia® SARS Antigen FIA to be used among asymptomatic individuals and run without a prescription provided that individuals test twice within 24-36 hours. Routine testing by rapid antigen tests has shown to be effective in diagnosing COVID-19.1 As with all antigen tests, performance may decrease as days since symptom onset increases due to lower viral loads later in the patient’s disease course. Similarly, the inability to synchronize asymptomatic individuals with onset of infection may impact performance as specimens may be tested when viral loads are below the assay’s limit of detection. Clinical studies in asymptomatic patients undergoing serial testing are ongoing to establish the clinical performance.
“Quidel’s goal throughout this pandemic has been to develop the most innovative and sensitive testing technologies on the market and to make our COVID-19 tests as widely available as possible,” said Douglas Bryant, president and CEO of Quidel Corporation. “FDA’s authorization opens the door to true democratization of the benefits of serial testing for both individuals experiencing symptoms and screening of people who may not have symptoms but are actively shedding the virus. Broadscale application of our Sofia® rapid antigen test for COVID-19 screening will catch asymptomatic cases early and limit virus spread.”
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.
EUROIMMUN Launches SARS-CoV-2 NeutraLISA Assay to Determine the Neutralizing Capacity of Anti-SARS-CoV-2 Antibodies
1 April 2021 - CE marked assay based on well-established ELISA technology expands EUROIMMUN’s offerings for labs that seek to understand immune response to COVID-19
WALTHAM, Mass., April 1, 2021 – EUROIMMUN, a PerkinElmer, Inc. Company, today announced the launch of the SARS-CoV-2 NeutraLISA™ assay, a surrogate neutralization test intended for the detection of neutralizing antibodies against SARS-CoV-2, the pathogen causing COVID-19. The CE marked assay adds to the Company’s broad portfolio of COVID-19 diagnostics and is currently available in more than 30 countries that accept the CE mark.
In COVID-19, antibodies that target the viral receptor binding domain (RBD) in the S1 domain of the SARS-CoV-2 spike protein have been shown to exhibit a virus-neutralizing capacity, which predominately are IgG antibodies.
SARS-CoV-2 enters a human host cell through interaction of its RBD with the host cell ACE2 receptor. However, if the RBD is blocked by specific antibodies formed during immune response, the virus cannot continue to infect and proliferate within the human body. This is why many leading COVID-19 vaccine developments are also based on this protein domain.
The EUROIMMUN SARS-CoV-2 NeutraLISA imitates this natural process by determining the inhibitory effect of antibodies capable of hampering the interaction between biochemically produced RBD and ACE2. Unlike standard neutralization tests, which can be labor-intensive and require handling of the live virus in a specialized high-safety laboratory setting, the SARS-CoV-2-NeutraLISA assay is based on well-established ELISA technology and uses non-pathogenic viral proteins. As such, the assay can be processed in common lab settings either manually or automatically.
“In addition to disturbing or altogether inhibiting the pathogen from binding to a host cell, neutralizing antibodies may last for years in the human body and can potentially prevent SARS-CoV-2 infection and reinfection,” said Dr. Wolfgang Schlumberger, CEO of EUROIMMUN. “The SARS-CoV-2 NeutraLISA assay supplements EUROIMMUN’s existing CE-marked QuantiVac™ ELISA and SARS-CoV-2 Interferon-gamma Release Assay which is expected to be available with CE mark soon. In combination, the assays make a powerful trio to help evaluate the immune response to SARS-CoV-2 induced through natural infection or vaccination with S1/RBD-based vaccines from multiple angles.”
EUROIMMUN offers a comprehensive COVID-19 product portfolio, including real-time PCR tests, an antigen detection assay for acute diagnostics, multiple antibody tests and a dried blood spot solution to support assessment of the immune response. In addition, EUROIMMUN offers the Interferon-gamma Release Assay to evaluate specific T-cell response, currently available for research use only, and provides automation systems for small, medium and high sample throughput workflows.
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 $3.8 billion in 2020, 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 launches Plasma-SeqSensei™ liquid biopsy RUO kits in EMEA
1 April 2021 - Sysmex Europe GmbH, together with Sysmex Inostics GmbH, announced today that they will launch the Plasma-SeqSensei™ Liquid Biopsy Research Use Only (RUO) kits for colorectal cancer (CRC), non-small cell lung cancer (NSCLC), melanoma and thyroid cancer.
1 April 2021 -- Liquid biopsy detects material in body fluids to assess the extent of disease, most often used for the detection of cancerous material in plasma. Though several molecular techniques are used, next generation sequencing is considered to be the most important method to detect minute amounts of circulating tumour DNA (ctDNA). In contrast to tissue biopsy, which is not always obtainable and much more invasive, liquid biopsy is well-suited for clinical research purposes due to its less invasive nature, high concordance to tissue samples in many cancers and real-time information available.
Due to a unique technology developed at Johns Hopkins University, Plasma-SeqSensei™ kits can reduce sequencing errors by >100 fold after refining the previously published methods and therefore detect very small amounts of mutant DNA down to seven mutant molecules per sample. It solves one of the key weaknesses to date which has been the inability to detect very low levels on analyte, missing over 40% of the samples with metastatic disease.
Sysmex is launching four reagent kits with a highly convenient software to enable the use of this highly sensitive technology for RUO purposes in four different types of cancers, namely CRC, NSCLC, melanoma (skin cancer) and thyroid cancer. The liquid biopsy market is expected to grow rapidly by >40% per year to 1B USD over the next three to five years.
About Sysmex Inostics GmbH
Sysmex Inostics (President and CEO: Bhuwnesh Agrawal), a subsidiary of Sysmex Corporation, is a molecular diagnostic company that is a pioneer in blood-based cell-free tumour DNA (ctDNA) mutation detection in oncology utilising highly sensitive technologies such as BEAMing (digital PCR) and SafeSEQ (NGS). With more than 10 years’ experience in liquid biopsy, Sysmex Inostics is a trusted partner to leading pharmaceutical companies, advancing their efforts to bring the most effective personalized cancer therapies to global markets, from discovery through companion diagnostics.
LGC launches SARS-CoV-2 quality solution for antigen testing
1 April 2021
1 April 2021 -- LGC has released ACCURUN® SARS-CoV-2 Antigen Reference Material Kit, a new quality measurement tool to support SARS-CoV-2 antigen testing. It is formulated for use with test methods that detect the nucleocapsid (NP) protein of SARS-CoV-2 virus – the target for the majority of the SARS-CoV-2 antigen assays currently on the market.
The product comprises purified recombinant SARS-CoV-2 NP protein in simulated viral transport media. Offering both positive and negative materials, the kit is designed to support assay installation and monitoring of day-to-day assay performance, providing a complete quality solution for SARS-CoV-2 antigen testing.
Clinical laboratories are increasingly adopting antigen tests as a first line SARS-CoV-2 screening tool. While less accurate than amplification-based molecular tests, most antigen tests offer high specificity paired with a less complex, cost-effective design – making them more amendable to rapid, repeat testing of large populations in a point-of-care environment.
Bharathi Anekella, Executive Vice President and General Manager, LGC Clinical Diagnostics, stated, “We anticipate the demand for SARS-CoV-2 antigen testing to continue to be strong for the coming year, as it has become a preferred testing method for rapid large-scale screening, including back-to-work and back-to-school programs. Adding a quality solution like ACCURUN SARS-CoV-2 Antigen Reference Material Kit to the testing workflow offers a way to increase confidence in the results produced by these types of rapid diagnostics.”
To learn more about ACCURUN SARS-CoV-2 Antigen reference materials, as well as the complete line of SARS-CoV-2 Quality Solutions, please visit the SeraCare website.
Philips and NHS implement the first regional data integration hub for UK’s National COVID-19 Chest Imaging Database
31 March 2021 - Cheshire and Merseyside consortium (NHS) is the first region to have achieved this milestone for the UK’s National COVID-19 Chest Imaging Database (NCCID). The deployment of a single SMART box server has provided access to 15 years of imaging data across 2.5 million people in the region, the largest single data source for NCCID. Data integration capabilities as a result of this deployment will allow Cheshire and Merseyside to validate the use of AI technology across a variety of conditions.
Amsterdam, the Netherlands and Guildford, United Kingdom, 31 March 2021 – Royal Philips, today announced it has supported the NHS’ Cheshire and Merseyside consortium to become the first regional hub supplying the United Kingdom’s National COVID-19 Chest Imaging Database (NCCID). The NCCID is a centralized database containing X-Ray, CT and MRI images from hospital patients across the country. It aims to support a better understanding of the COVID-19 virus and develop AI-powered technology which will enable the best care for patients hospitalized with a severe infection. This first regional hub is integrating data across 13 NHS trusts in the consortium. The deployment of a single centralized and secure server has provided access to 15 years of imaging data across 2.5 million people in the region, the largest single data source for NCCID.
The Cheshire and Merseyside consortium engaged with Philips to help with enabling access to the entire region’s imaging data through a single hub. Philips’ advanced data integration solution for radiology, Philips Global worklist, was used to enable easy integration with the NCIDD’s secure central SMART Box server that will be required to support mass data collection, management and de-identification and can facilitate multiple trials/research projects simultaneously.
“One of the findings coming out of the end of this project will definitely be to focus on regional hubs that will be able to coordinate and better centralize the data, a hub just like Cheshire and Merseyside,” said Prof Mark-Halling Brown, Head of Scientific Computing at Royal Surrey NHS Foundation Trust. “It can take many months or even years to set up SMART boxes at individual trusts, so doing it regionally is the only way to scale up nationally."
“Most District General Hospitals average 250,000 to 350,000 imaging exams per year,” said Steve Sparks, Professional Services Manager Radiology Informatics at Philips UK&I. “With a single regional SMART box we have been able to gain access to the images from the 13 Trusts within the Cheshire and Merseyside consortium.”
Save Radiologists’ time, increase the safety and consistency of care
The NCCID database is developed in collaboration with NHSX, an organization driving the digital transformation of the NHS, The British Society of Thoracic Imaging (BSTI) and The Royal Surrey NHS Foundation Trust. The database is being used for the validation of AI products for use in the NHS, aiding the diagnosis and treatment of COVID-19 in the UK population. This data has the potential to enable quicker patient assessment when arriving at hospital’s emergency departments, save Radiologists’ time, increase the safety and consistency of care across the country, and ultimately save lives. It is being made available to researchers, clinicians, technology companies and all those wanting to investigate the disease and develop solutions that can support the COVID-19 patient care pathway.
The SMART box server technology will also enable Cheshire and Merseyside to participate in research into many areas requiring large volumes of clinical imaging data. The COVID-19 pandemic has highlighted the potential for medical imaging systems powered by AI. The NHS AI Lab, created last year within NHSX, is developing a National Medical Imaging Platformwith the purpose of creating a pipeline for patient data to be used within AI technology across conditions other than COVID-19. The NCCID is one workstream taken forward by the NHS AI Lab at NHSX, which will accelerate the safe, ethical, and effective adoption of AI in the healthcare sector. The power of large-scale data collection has already been demonstrated in various studies, including breast cancer screening studies such as OPTIMAM. Setting up regional hubs, such as the SMART box deployment in Cheshire and Merseyside, will aid the creation of these large-scale National databases and AI technology to help combat a variety of conditions.
Comprehensive portfolio for COVID-19 high-quality care
Philips has a comprehensive portfolio of products, services and solutions to support the delivery of high-quality care to COVID-19 patients worldwide. 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. 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.
About Royal Philips
Royal Philips is a leading health technology company focused on improving people's health and well-being, 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 2020 sales of EUR 19.5 billion and employs approximately 82,000 employees with sales and services in more than 100 countries. News about Philips can be found at www.philips.com/newscenter.
Abbott's BinaxNOW™ Rapid Antigen Self Test receives FDA Emergency Use Authorization for asymptotic, over-the-counter, non-prescription, multi-test use
31 March 2021 - FDA Emergency Use Authorization permits asymptomatic, non-prescription, over-the-counter self use for people with or without symptoms. The BinaxNOW COVID-19 Self Test is identical to the professional-use test, used since August 2020, bringing the most studied and widely used rapid antigen test to retail shelves across the country. BinaxNOW Self Test will be available nationwide and in large quantities at major food, drug and mass merchandiser retailers nationally and will be priced affordably, similar to common over-the-counter (OTC) tests. Together with vaccines, serial testing of asymptomatic people will help restore a sense of safety in everyday settings where people gather. Asymptomatic multi-test authorization also applies to BinaxNOW professional-use test.
ABBOTT PARK, Ill., March 31, 2021 -- Abbott announced today it has received U.S. Food and Drug Administration (FDA) Emergency Use Authorization (EUA) for over-the-counter, non-prescription, asymptomatic use of its BinaxNOW™ COVID-19 Ag Self Test for detection of COVID-19 infection. This new indication allows individuals with or without symptoms to have access to this test without a prescription. Abbott will begin shipping to major food, drug and mass merchandiser retailers in the coming weeks and expect the test to be available through some of their online store websites.
The test can be used on children as young as two years old when samples are collected by an adult and for all people aged 15 years or older, bringing the country's most extensively studied and widely used rapid antigen test to nearly everyone in the U.S. The test will come in a two-count box to meet serial (frequent) testing requirements.
Using the test will be simple, even for people who have never tested themselves. People will only need to perform a minimally invasive nasal swab (not the deep nasopharyngeal swab) and all materials required to perform the test (swab, test card, and reagent solution) will come in the box.
"We've now accomplished what we set out to do when we launched BinaxNOW, which is to bring an accurate, affordable and readily available test to the American people that they can have on hand, whether they want to test frequently or in certain circumstances," said Robert B. Ford, president and chief executive officer, Abbott. "Together with vaccines, the BinaxNOW Self Test will help Americans get back to doing what they want and need to do – like going to work and school or seeing friends and family – with greater confidence."
Abbott launched the BinaxNOW professional test nationwide in August 2020 and scaled up production at its new U.S. manufacturing facilities to produce 50 million tests per month. The U.S. Department of Health and Human Services (HHS) purchased the company's first 150 million tests, sending them to K-12 schools, nursing homes, historically black colleges and universities and underserved communities, where they remain in use today and serve as a powerful tool to help prevent the virus from spreading. Since its approval, BinaxNOW has also been used by workplaces, K-12 schools and universities and other organizations throughout the country.
The BinaxNOW Self Test is the same technology as the existing BinaxNOW test that has been available since August 2020 but is indicated by the FDA for serial asymptomatic testing, meaning that people should test themselves frequently.
The advantages of serial (frequent) testing with BinaxNOW
Serial testing makes it possible for people to know their infection status when it matters most. And because rapid antigen testing is less expensive, people can test themselves with greater regularity, which is important for those who may be concerned that they were recently exposed or may be attending a large event in close confines.
When combined with vaccines and other public health precautions, serial testing can restore a sense of safety and let Americans get back to celebrating life's big milestones or everyday moments, such as weddings, birthdays and graduation parties, traveling, dinner with friends, and countless other cherished moments that were once taken for granted.
With results in just 15 minutes, the BinaxNOW Self Test lets people who test positive immediately isolate so that they do not infect others, rather than waiting days for results from a lab or send-away at-home tests. BinaxNOW is proven to be high quality, with a complaint rate for the 150 million professional tests distributed to HHS of 0.0034% as of March 24. That is 1 out of every 29,511 tests, affirming Abbott's decades of leadership in infectious disease detection and commitment to studying real-world performance of its products.
Abbott to bring massive scale and experience to over-the-counter COVID-19 testing
Abbott's manufacturing scale and existing retail distribution partnerships with the nation's largest food, drug and mass merchandiser retailers are unmatched by any rapid-test maker. Abbott expects the BinaxNOW Self Test to be priced affordably – similar to common OTC tests – to make it more accessible and affordable for Americans to test themselves, whether regularly or for life's important moments.
Digitally verified results remain important in many settings
Abbott's earlier innovations in rapid testing remain as important as ever, especially for people who need to show digitally verified proof of a negative COVID-19 test before returning to work, school, travel, and congregate-care living environments.
As part of this authorization, the BinaxNOW COVID-19 Ag Card test for professional use will no longer require a prescription, meaning that states, workplaces, schools and other organizations no longer need to work through a medical provider to generate a prescription before the test can be administered. For congregate environments using the professional-use version of BinaxNOW, a CLIA certificate is still required.
Abbott continues to deploy its NAVICA system so that individuals can obtain digitally verified test results. Users can download the NAVICA app, take a BinaxNOW Home Test or BinaxNOW professional-use test at a NAVICA-enabled testing site, and display negative results through an encrypted NAVICA Pass. This solution supports organizations – such as employers, K-12 schools, universities, sports and entertainment venues, and nursing homes – to take ownership of their testing solutions and make informed decisions about who enters their facilities.
BinaxNOW performance in the field
Today, BinaxNOW demonstrates 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. In our studies, it further shows performance of 95.6% positive agreement (sensitivity) in people seven days or less post-symptom onset with Ct counts of 33 or 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.
In a recent study published by Pilarowski et al. in the peer-reviewed journal Clinical Infectious Diseases, researchers in California assessed BinaxNOW in a community-based setting in people of all ages with and without symptoms. They demonstrated high sensitivity and specificity for BinaxNOW, including in asymptomatic people and in children. Among 102 people who were asymptomatic or whose symptom onset was greater than 7 days before testing, sensitivity for a Ct cutoff of 30 was 100% and specificity was 98.9%. As Ct counts increased to 35 (therefore reflecting less viral load) performance remained high in asymptomatic people of all ages, showing 97.5% sensitivity and 99.7% specificity.
As part of its Emergency Use Authorization for self-testing, Abbott has committed to complete a post-authorization study to determine serial testing performance in people without symptoms.
About BinaxNOW™ COVID-19 Ag Card Self Test Card
The BinaxNOW COVID-19 Ag Card Self Test is a lateral flow immunoassay intended for the qualitative detection of nucleocapsid protein antigen from SARS-CoV-2. This test is authorized for home use with self-collected observed direct anterior nasal (nares) swab samples from individuals aged 15 years or older or adult collected nasal swab samples from individuals aged two years or older with or without symptoms or other epidemiological reasons to suspect COVID-19 infection, when tested twice over three days with at least 36 hours between tests.
Individuals who test negative and continue to experience COVID-like symptoms should seek follow up care from their healthcare provider. Individuals who test positive should take precautions, isolate and seek follow-up care from their healthcare provider. BinaxNOW COVID-19 Ag Card Self Test is only for use under the Food and Drug Administration's Emergency Use Authorization.
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 109,000 colleagues serve people in more than 160 countries.
Trinity Biotech Announces the Submission of TrinScreen™ HIV to the World Health Organisation for Approval
30 March 2021
DUBLIN, Ireland, March 30th, 2021 -- Trinity Biotech plc has submitted its new HIV screening product, TrinScreen™ HIV, to the World Health Organisation (WHO) for approval.
This product, once approved, will allow the Company to build on its strong presence in HIV testing in Africa, with the Company having been the main confirmatory test provider over many years with its UniGold™ HIV test.
It is expected that the WHO will take a number of months to consider the submission. The Company intends to use that time to prepare for automated manufacturing of the test at the Company’s facility in Ireland.
Test Overview
The product is designed to test for the presence of HIV antibodies from a finger stick sample of blood, in less than 12 minutes. The test has been designed to maximise assay sensitivity and ease of use in the field. A high assay sensitivity indicates the potential risk of a false negative result is very low - a critical parameter in screening programmes where the objective is to identify those with HIV infection. Ease of use in the field allows for broad dissemination of testing which is of critical importance in the African HIV testing market.
Performance Evaluation
As part of the WHO approval process the product has already undergone an evaluation sponsored by the WHO with 1,200 clinical samples at an independent laboratory. The results of this evaluation were excellent. In addition to this, the full submission for pre-qualification also includes the data from a multicentre clinical evaluation which concluded in Africa in 2020.
Comments
Commenting, Ronan O’Caoimh, Chief Executive Officer stated, “We are excited to have submitted our new HIV screening product, TrinScreen HIV, to the WHO for approval. The development of this product has been a strategic priority for Trinity Biotech over several years. It is very positive to see this project reach such a key milestone, especially given the challenges caused by COVID-19 to the clinical evaluation process. Trinity Biotech has already earned a strong reputation in the HIV testing market in Africa with our HIV confirmatory test, Uni-Gold HIV. We expect that on approval by the WHO of TrinScreen HIV, Trinity Biotech will be ideally positioned to take a significant share of the HIV screening market in Africa given the excellent clinical performance of the product and our existing strong reputation in the HIV testing market in Africa.”
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.
ALM-Update: SARS-CoV-2-Pandemie bleibt sehr dynamisch
30 March 2021
30 March 2021 -- Wie seit einigen Wochen beobachtet und vorhergesehen, nehmen die SARS-CoV-2-Neuinfektionen weiterhin deutlich zu – und der Anteil der britischen Variante B.1.1.7 ebenso, mancherorts liegt er bei deutlich über 80 Prozent der diagnostizierten Fälle. Für die Osterfeiertage bedeutet das: „Wir alle sollten uns und unsere Mitmenschen weiterhin diszipliniert vor Ansteckungen schützen“, sagt Dr. Michael Müller. Der 1. Vorsitzende des ALM e.V. rät weiterhin und besonders jetzt zur Beachtung der bekannten und auch gegenüber den Varianten wirksamen wesentlichen Maßnahmen: Kontaktreduzierung, Hygiene, Abstand halten, Maske tragen. Die Auswertung der Akkreditierten Labore in der Medizin – ALM e.V., an der 175 Labore aus dem ambulanten und stationären Bereich teilgenommen haben, zeigen für die KW 12 eine Positivrate von 9,5 Prozent (Vorwoche: 8,3 Prozent). Insgesamt fielen in der vergangenen Woche von den durchgeführten 1.279.394 (Vorwoche: 1.196.364) SARS-CoV-2-PCR-Tests 121.787 Tests positiv aus (Vorwoche: 98.762). Das ist eine Steigerung um 23 Prozent.
Reference: https://www.synlab.de/human/news-artikel/alm-update-sars-cov-2-pandemie-bleibt-sehr-dynamisch-1356
QIAGEN Receives FDA Emergency Use Authorization for NeuMoDx Multiplex Test Expanding COVID-19 Portfolio
29 March 2021 - NeuMoDx™ Flu A-B/RSV/SARS-CoV-2 Vantage Test receives Emergency Use Authorization by FDA. The 4-plex test utilizes the high-throughput, automated testing capabilities of the NeuMoDx systems, which has a growing and comprehensive assay menu for respiratory, blood-borne virus, transplant, and reproductive health disease areas. Test adds to QIAGEN’s expanding portfolio of PCR testing solutions for COVID-19 testing.
GERMANTOWN, Md. & HILDEN, Germany, 29 March 2021 -- QIAGEN N.V. today announced the Emergency Use Authorization by the U.S. FDA for the NeuMoDx™ Flu A-B/RSV/SARS-CoV-2 VantageAssay that will help healthcare professionals quickly identify and differentiate individuals suspected by a healthcare provider of respiratory viral infection consistent with COVID-19.
As restrictions are eased and social distancing measures are reduced, respiratory viral infections are likely to increase. Clinical signs and symptoms of respiratory viral infection due to SARS-CoV-2, influenza or RSV can be similar. This makes it essential to correctly identify them in order to treat and manage patients accordingly, especially in the COVID-19 pandemic. This polymerase chain reaction (PCR) multiplex test will be an important tool now and in upcoming winter seasons for simultaneous qualitative detection and differentiation of influenzas A and B, respiratory syncytial virus (RSV) and SARS-CoV-2 infections within 80 minutes.
QIAGEN launched the NeuMoDx™ Flu A-B/RSV/SARS-CoV-2 Vantage Test in the European Union and other markets that accept CE-IVD in November 2020 and will now begin commercialization of the test in the U.S.
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 VantageAssay will be a powerful diagnostic tool for the flu season and COVID-19 pandemic.
“The authorization of this new test will become a pivotal tool for the detection and differentiation of SARS-CoV-2 from influenza like illnesses, or ILls,” said Jean-Pascal Viola, Senior Vice President, Head of the Molecular Diagnostics Business Area and Corporate Business Development at QIAGEN. “This test will play an important role in differentiating between ILI’s while the burden of COVID-19 continues. With its ease of use and true random access, the NeuMoDx will help laboratories maintain throughput for this increased testing volume while continuing routine testing. Also, with the continued ramp up of our manufacturing capacity, the NeuMoDx will be ready to answer the needs of molecular diagnostic laboratories for 2021 and beyond.”
The new 4-plex test joins a growing menu of assays on the NeuMoDx platform, which includes tests for blood-borne viruses, sexual and reproductive health, transplant and immunocompromised disease areas. More tests are in development and expected to launch in the coming months, including VZV, adenovirus and others.
QIAGEN fully acquired NeuMoDx in September 2020 and made it one of its five growth drivers for the company to continue growing on a standalone basis – the others being Sample Prep, QIAcuity, QFT and QIAstat-Dx. The NeuMoDx™ Flu A-B/RSV/ SARS-CoV-2 VantageTest strengthens QIAGEN’s footprint in PCR, the gold standard in coronavirus testing.
QIAGEN has a broad portfolio of testing and research solutions for COVID-19, ranging from fast singleplex and multiplex PCR tests to fast syndromic solutions (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. QIAGEN’s COVID-19 portfolio also includes the QIAreach Antibody and Antigen tests, as well as SARS-CoV-2 T-Cell tests based on the QuantiFERON IGRA technology. In October 2020, the company also launched QIAprep& which streamlines PCR workflows by integrating sample preparation and real-time PCR detection into a single kit. QIAGEN also provides NGS solutions for research into mutations of COVID-19, dPCR solutions for wastewater testing and bioinformatics with QDI.
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 Test,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 December 31, 2020, QIAGEN employed more than 5,600 people in over 35 locations worldwide. Further information can be found at http://www.qiagen.com.
BGI Obtains CE Mark for Two SARS-CoV-2 Mutant Detection Kits
29 March 2021
29 March 2021 -- BGI Genomics Co. LTD., today announces that its Rapid Identification Kit for B.1.1.7 lineage and B.1.351 lineage of SARS-CoV-2 (Fluorescence RT-PCR*), and the Detection Kit for six mutations in S gene of SARS-CoV-2 (ARMS-PCR*) get the CE Mark.
The two kits developed by BGI PathoGenesis Pharmaceutical Technology Co., Ltd., a subsidiary of BGI Genomics, enable rapid identification and monitoring of new variants. The Rapid Identification Kit for B.1.1.7 lineage and B.1.351 lineage of SARS-CoV-2 (Fluorescence RT-PCR) can identify the B.1.1.7 and B.1.351 lineages, whereas the Detection Kit for 6 mutations in S gene of SARS-CoV-2 (AMRS-PCR) enables the identification of wild-type and mutant coronavirus virus strains by detecting spike protein mutations (N501Y, A570D, HV69-70del, K417N, K417T and E484K).
B.1.1.7, B.1.351 and B.1.1.28 variants have been found in many countries. They have N501Y mutations in the receptor-binding domain (RBD) of the spike protein on the surface of the virus, making it easier to bind to the angiotensin-converting enzyme 2 (ACE2) receptor on the human cell surface. The RBD mutations in these variants also include A570D, HV69-70del, K417N, K417T and E484K mutations.
Since the outbreak of COVID-19, the evolution of SARS-CoV-2 has been one of the focuses of public attention. These two CE marked kits will facilitate the rapid identification and global surveillance of new SARS-CoV-2 variants.
*RT-PCR: reverse transcriptase—polymerase chain reaction
*ARMS-PCR: amplification refractory mutation system—polymerase chain reaction
Augsburg: Corona-Tests mit neuer Lolli PCR-Methode
29 March 2021
29 March 2021 -- SYNLAB startet ein medizinisches Pilotprojekt und testet in den nächsten Wochen Kindertagesstätten und Grundschulen in Augsburg. Es gibt aktuell keine zufriedenstellende Teststrategie für Kinder, daher starten das Gesundheitsamt Augsburg und SYNLAB nach Ostern ein neues Verfahren. Bei den sogenannten Lolli-Tests lutschen Kinder zwei Mal pro Woche 30 Sekunden lang zu Hause an einem Abstrich-Tupfer. Das ist eine für Kinder einfache und nicht invasive Probenentnahme. Die Proben werden im Poolingverfahren im SYNLAB Labor in Augsburg getestet. Im Falles eines positiven Ergebnis innerhalb eines Pools erfolgt eine Testung der einzelnen Proben.
Ziel ist es Alternativen zu Antigentests zu entwickeln, die mit einer Sensitivität von häufig unter 60% Infektionen übersehen. Mit dem Pilotprojekt will SYNLAB eine deutlich sensitivere und gleichzeitig kostengünstige Alternative zum Antigen-Schnelltestverfahren für Kinder etablieren, damit Infektionsketten schneller durchbrechen und dabei unterstützen Kindertagesstätten und Grundschulen offen zu halten.
Reference: https://www.synlab.de/human/news-artikel/augsburg-corona-tests-mit-neuer-lolli-pcr-methode-1355
Labcorp Appoints Johnson & Johnson Executive Kathryn Wengel to the Board of Directors
26 March 2021 - Healthcare Veteran Brings Significant Global Industry Experience
BURLINGTON, N.C., Mar. 26, 2021-- Labcorp, a leading global life sciences company, today announced the appointment of Kathryn Wengel, current Executive Vice President and Chief Global Supply Chain Officer at Johnson & Johnson, as an independent member of Labcorp’s Board of Directors, effective immediately. In connection with this appointment, the Labcorp Board will expand from 9 to 10 directors.
“I am pleased to welcome a renowned healthcare industry veteran like Kathy to the Labcorp Board,” said Adam Schechter, chairman and CEO of Labcorp. “Kathy brings a wealth of experience managing complex healthcare organizations and developing globally diverse teams. We look forward to benefitting from her unique perspective as the Board works with management to advance Labcorp’s role in healthcare and improving the health and lives of patients around the world. Kathy’s appointment is also aligned with the Labcorp Board’s commitment to bring diverse perspectives to the boardroom that will best position us to deliver for our patients, customers, and shareholders."
Ms. Wengel brings significant healthcare and operations experience and global business expertise, with more than three decades of experience in leadership positions within Johnson & Johnson. She currently serves on Johnson & Johnson’s Executive Committee as Executive Vice President and Chief Supply Chain Officer. Ms. Wengel is responsible for all aspects of the development and implementation of Johnson & Johnson’s global Supply Chain, as well as its Quality & Compliance, Procurement, Environmental Health and Safety, Sustainability and Engineering & Property Services functions.
“I’ve long admired Labcorp for its innovation, leadership and commitment to patients and their health, as most recently demonstrated by the essential role the Company has played in combating the COVID-19 pandemic over the last year,” said Wengel. “I’m honored to join Labcorp’s board, and I look forward to working with Adam and the entire Labcorp team to deliver on its important mission and the best interests of patients, clients, and shareholders.”
As Executive Vice President, Chief Global Supply Chain Officer, Ms. Wengel leads a team of more than 56,000 people globally across Johnson & Johnson’s three business segments: Pharmaceuticals, Medical Devices and Consumer Health. Prior to this role, she served in a variety of leadership positions with increasing responsibilities since joining Johnson & Johnson in 1988. In 2009, she co-led the design of Johnson & Johnson’s enterprise Supply Chain and Quality operating model and subsequently served as the company’s first Chief Quality Officer. She also serves as an executive sponsor for both Johnson & Johnson’s Women’s Leadership and Inclusion Initiative and its Women in Science, Technology, Engineering, Math, Manufacturing and Design program.
In addition to her role at Johnson & Johnson, Ms. Wengel serves as Chairman of the Board of GS1 Global, an organization that sets and maintains standards regarding the exchange of critical business data for global commerce. Ms. Wengel is also a member of the Executive Committee of the National Association of Manufacturers (NAM) in the US. She also serves on the Executive Advisory Board for Gartner’s Supply Chain practice and is a member of Supply Chain 50. In 2019, Ms. Wengel was recognized with the Distinguished Service Award by the Council of Supply Management Professionals (CSCMP) and was inducted into the Supply Chain Hall of Fame.
Ms. Wengel holds a Bachelor of Science in Engineering, Civil Engineering & Operations from Princeton University.
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 improve lives. With over 70,000 employees, we serve clients in more than 100 countries. Labcorp (NYSE: LH) reported revenue of $14 billion in FY2020. Learn about Labcorp at www.Labcorp.com.
Roche commences tender offer for all shares of GenMark Diagnostics, Inc. for $24.05 per share in cash
25 March 2021
Basel, 25 March 2021 – Roche today announced that it has commenced a cash tender offer for all of the outstanding shares of common stock of GenMark Diagnostics, Inc. (NASDAQ: GNMK) at a price of $24.05 per share. The tender offer is being made pursuant to the previously announced merger agreement dated as of March 12, 2021 among Roche Holdings, Inc., an indirect wholly owned subsidiary of Roche Holding Ltd, Geronimo Acquisition Corp., a wholly owned subsidiary of Roche Holdings, Inc., and GenMark.
The tender offer period will expire at 12:00 midnight, Eastern Time, at the end of the day on Wednesday, April 21, 2021, unless the offer is extended.
Roche has filed a tender offer statement on Schedule TO with the United States Securities and Exchange Commission (SEC). Geronimo Acquisition Corp. is the acquirer in the tender offer. The Offer to Purchase contained within the Schedule TO sets out the terms and conditions of the tender offer.
GenMark has also filed a Solicitation/Recommendation Statement with the SEC on Schedule 14D-9, which includes the unanimous recommendation of the GenMark board of directors that GenMark stockholders tender their shares in the tender offer. Closing of the tender offer is conditioned upon customary closing conditions, including the expiration or termination of the applicable waiting period under the Hart-Scott-Rodino Antitrust Improvements Act, and there being validly tendered and not validly withdrawn a majority of the outstanding shares of GenMark common stock. The offer is not subject to any financing condition. Following successful completion of the tender offer, any shares not acquired in the tender offer will be acquired in a second step merger at the same price of $24.05 per share. The closing of the transaction is expected to take place in the second quarter of 2021.
The complete terms and conditions are set out in the Offer to Purchase, which was filed with the SEC today, March 25, 2021. GenMark stockholders may obtain copies of all of the offering documents, including the Offer to Purchase, free of charge at the SEC’s website (www.sec.gov) or by directing a request for the Solicitation/Recommendation Statement on Schedule 14D-9 to GenMark’s website at www.genmarkdx.com or the Offer to Purchase and the other related materials to MacKenzie Partners, Inc., the Information Agent for the offer, toll free at (800) 322-2885 (or please call (212) 929-5500 if you are located outside the U.S. or Canada) or via email at tenderoffer@mackenziepartners.com.
Before making any decision with respect to the Offer, investors are urged to read the Offer to Purchase and related documents, as well as the Solicitation/Recommendation Statement, because they contain important information about the Offer.
About GenMark Diagnostics
GenMark Diagnostics is a leading provider of multiplex molecular diagnostic solutions designed to enhance patient care, improve key quality metrics and reduce the total cost-of-care. Utilizing GenMark’s proprietary eSensor® detection technology, GenMark’s eSensor XT-8® and ePlex® systems are designed to support a broad range of molecular diagnostic sample-to-answer tests with compact, easy-to-use workstations and self-contained, disposable test cartridges. GenMark’s ePlex: The True Sample-to-Answer Solution™ is designed to optimize laboratory efficiency and address a broad range of infectious disease testing needs, including respiratory, bloodstream and gastrointestinal infections.
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 2020 employed more than 100,000 people worldwide. In 2020, Roche invested CHF 12.2 billion in R&D and posted sales of CHF 58.3 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-2021-03-25.htm
Thermo Fisher Scientific Completes FDA Listing and Launches the Applied Biosystems QuantStudio 5 Dx Real-Time PCR System for In Vitro Diagnostic Use
25 March 2021 - Innovative qPCR platform simplifies molecular diagnostic workflows for infectious disease, oncology and COVID-19 testing
CARLSBAD, Calif., March 25, 2021 -- Thermo Fisher Scientific today announced the completion of the U.S. Food and Drug Administration (FDA) listing for the Applied Biosystems QuantStudio 5 Dx Real-Time PCR System. The innovative product enables clinical laboratories and assay developers to meet testing demands and enhance their molecular diagnostics workflows.
Clinical diagnostic and hospital laboratories across the United States have ramped up PCR testing over the last year in response to the global COVID-19 pandemic. These laboratories are now seeking solutions to continue to screen for COVID-19 after emergency use authorizations (EUAs) for SARS-CoV-2 assays expire.
"The COVID-19 pandemic has increased testing demands for laboratories exponentially, with a significant portion of the testing globally conducted on Thermo Fisher PCR instruments," said Mark Smedley, president of Genetic Sciences for Thermo Fisher Scientific. "As our customers' testing requirements grow, we are continuously innovating to meet their needs with our molecular diagnostic products. With the launch of the IVD QuantStudio 5 Dx, we can continue to support our customers around the world."
The high-performing qPCR system's simplified, efficient workflow minimizes steps to deliver quality results in as little as 30 minutes. The system has high sensitivity and specificity and offers up to six channels for multiplexing. The cost-effective and complete solution, including simplified software, enhanced security and a simple-to-use interface, comes in a compact footprint that can fit in any lab.
"Thermo Fisher is a valued partner, supporting us in the development of clinical trial assays and companion diagnostics," said Michael Sloan, global vice president of commercial operations at Almac Diagnostic Services. "Thermo Fisher's QuantStudio qPCR systems offer a seamless integration into our assay development workflows. Both the QuantStudio Dx and QuantStudio 5 Dx offer the flexibility of customizable solutions and provide high-quality data output for molecular diagnostic testing."
The QuantStudio 5 Dx Real-Time PCR System is listed with the FDA, includes the CE-IVD Mark under the self-certification process in the European Union, and has been certified and approved by the National Medical Products Administration (NMPA) in China. The system is currently registered in more than 50 countries.
For more information, please visit www.thermofisher.com/quantstudio5dx.
About Thermo Fisher Scientific
Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $30 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 80,000 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 Procleix UltrioPlex E and Procleix Babesia assays receive CE mark
25 March 2021 - Procleix UltrioPlex E Assay enhances blood safety by detecting the presence of HIV-1, HIV-2, HBV, HCV, and HEV in a single, simultaneous test, improving overall laboratory efficiencies. Procleix Babesia Assay detects the Babesia pathogen responsible for one of the most frequent causes of non-viral transfusion-transmitted infections (TTI). The CE mark for these two assays is an important step forward for the Grifols Procleix portfolio and is another example of the company’s commitment to transfusion safety.
Barcelona, Spain, March 25, 2021 -- Grifols, a global leader in the development of plasma-derived therapies and in the development of innovative diagnostic solutions, today announced it has obtained the CE mark for its Procleix UltrioPlex E and Procleix Babesia assays.
The Procleix UltrioPlex E Assay is a nucleic acid test (NAT) designed to improve blood safety by detecting the presence of human immunodeficiency virus type 1 (HIV-1), HIV type 2 (HIV-2), hepatitis B virus (HBV), hepatitis C virus (HCV), and hepatitis E virus (HEV) in a single, simultaneous test from human serum or plasma. It was first commercially launched in August 2020 in Japan and represents a significant advance in streamlining a laboratory’s NAT testing operations by allowing for an increased screening of viruses from a single-donor specimen without the need for any additional equipment. The Procleix UltrioPlex E Assay also helps produce less waste with higher results throughput and greater walk-away time for laboratory staff when compared with running current screening solutions separately.
The Procleix Babesia Assay detects Babesia, a tick-borne parasite that infects the host’s red blood cells and is responsible for one of the most frequent causes of non-viral TTI. It is the first Procleix assay to use a whole blood specimen and, most importantly, target a parasite instead of a virus. The detection of ribosomal RNA, which is present in thousands of copies per parasite, allows equivalent sensitivity in individual samples and pooled lysates. Screening of donated whole blood to detect the presence of the four most common Babesia species is currently mandated in certain parts of the United States where the pathogen represents a serious threat to the safety of the blood supply.
“We are excited to announce the CE mark of two additional assays, as part of our Procleix portfolio for screening blood and plasma, demonstrating Grifols’ continued commitment to transfusion safety,” said David Dew, President, Grifols Diagnostic Commercial Division. “Certification of the Procleix UltrioPlex E and Procleix Babesia assays enhances the competitiveness of our Procleix portfolio and enables blood banks in Europe to increase transfusion safety.”
The Procleix UltrioPlex E and Procleix Babesia assays will be available in all markets accepting the CE mark after completion of any additional registration and notification requirement.
About Procleix UltrioPlex E Assay
The Procleix UltrioPlex E Assay is a nucleic acid test (NAT) that uses Transcription-Mediated Amplification (TMA) to detect the presence of specific nucleic acid sequences for HIV-1, HIV-2, HBV, HCV, and HEV in serum or plasma of donated blood. Because of the high sensitivity and specificity of the amplification technology, detection of the targeted pathogens can be achieved within the early stages of infection, thereby helping in preventing infected blood or blood components to be transfused even when the donor does not exhibit symptoms and traditional screening techniques are not able to detect the presence of the pathogen, or the antibodies against it. The assay runs on the Procleix Panther System, a fully automated NAT instrument launched by Grifols in the EU market in 2012, and currently widely adopted in laboratories globally.
About Procleix Babesia Assay
The Procleix Babesia Assay is a nucleic acid test (NAT) that uses Transcription-Mediated Amplification (TMA) to detect the presence of specific ribosomal RNA sequences of at least four clinically relevant species of Babesia parasites (B. microti, B. duncani, B. divergens, and B. venatorum) in whole blood specimens from blood donors. Because of the high sensitivity and specificity of the amplification technology, detection of the pathogen can be achieved within the early stages of infection, thereby helping in preventing infected blood or blood components to be transfused even when the donor does not exhibit symptoms and traditional screening techniques are not able to detect the presence of the pathogen, or the antibodies against it. The assay runs on the Procleix Panther System, a fully automated NAT instrument launched by Grifols in the EU market in 2012, and currently widely adopted in laboratories globally.
bioMérieux announces the CE marking of TB IGRA® test on VIDAS®
24 March 2021 - Today marks World Tuberculosis (TB) Day and bioMérieux, a world leader in the field of in vitro diagnostics, announces the CE marking of its innovative and fully-automated test VIDAS® TB IGRA (Interferon-Gamma Release Assay) to diagnose latent TB infection.
24 March 2021 -- Tuberculosis continues to be a major global health problem. With 10 million new active cases and 1.4 million related deaths worldwide in 2019, TB remains an important cause of mortality from a single infectious disease.
It is estimated that a fourth of the global population is infected with Mycobacterium tuberculosis, the bacteria responsible for TB disease. In most cases (90-95%), people with healthy immune systems can control the infection without developing the active disease: this is called “Latent Tuberculosis Infection” (LTBI). The remaining infected people (5-10%), will develop active TB disease (aTB), making them sick as well as infectious to others.
“Despite all efforts, tuberculosis has not been eradicated and remains a significant health problem for a large proportion of the world’s population, especially in low- and middle-income countries. Diagnosing people who have latent TB infection is an important tool for global TB control. Detecting and then following or treating people with latent TB infection can help in preventing their progression to active disease, which would make them sick and also infectious to others.” said Mark Miller, Executive Vice President and Chief Medical Officer, bioMérieux.
There is no single gold standard for diagnosing LTBI. Current diagnostic tools for LTBI include a detailed clinical history of exposure to TB, the tuberculin skin test (TST) or an IGRA test, which are indirect diagnostic methods based on the host immune response to the pathogen.
Despite their improved performances over TST, current IGRA tests are cumbersome, consist of many manual steps, and can negatively impact the lab workflow. There is a need for improved TB-IGRA tests having complete automation, standardization of each step, faster time to results, more accurate and reliable clinical performances and increased ease-of-use for any lab without specialized expertise.
VIDAS® TB-IGRA is the new fully automated assay intended as an aid in the diagnosis of infection with Mycobacterium tuberculosis.
Performed on the VIDAS® 3 platform, VIDAS® TB-IGRA provides reliable test results and improves current workflow compared to existing TB-IGRA solutions.
The complete test process is fully automated from sample to result interpretation, including the stimulation step. Only one whole blood sample tube is needed with no manual sample preparation. Thanks to this simplified “load & start” process, laboratories will now be able to easily manage TB-IGRA testing in-house and deliver faster results to clinicians without additional cost.
In addition to full automation, VIDAS® TB-IGRA demonstrated strong clinical performances. Clinical trials conducted on populations coming from different areas around the world demonstrated a better sensitivity in an active TB population compared to an existing test (97% vs 80,6%), a high specificity of 97.5% in populations at very low risk of being TB infected and a strong agreement with the comparative assay on populations at mixed risk levels of TB infection. Furthermore, significantly fewer indeterminate results (0,1% vs 1,3%) were observed.
“For more than 55 years, bioMérieux has been driven by a pioneering spirit and unrelenting commitment to improve public health worldwide. It is a great achievement for us to provide laboratories with a fully automated assay with high performances to detect latent tuberculosis. As we commemorate World Tuberculosis Day today, the launch of VIDAS® TB-IGRA reaffirms our commitment to help end tuberculosis by detecting infected individuals” declared Alexandre Mérieux, Chief Executive Officer, bioMérieux.
VIDAS® TB-IGRA will be gradually deployed in countries that recognize CE marking. Hospitals and private laboratories will be able to run the test on bioMérieux’s VIDAS® 3 system, which allows for higher automation and traceability. bioMérieux is planning a submission for FDA clearance in the near future.
Reference: https://www.biomerieux.com/en/biomerieux-announces-ce-marking-tb-igrar-test-vidasr
BGI Detection Kit for 6 Mutations in S Gene of SARS-CoV-2
24 March 2021
24 March 2021 -- Here in BGI, we work night and day looking for solutions, using cutting-edge technology and our team expertise to bring health to the people. In response to the new COVID-19 mutants, BGI monitors the emergence of additional SARS-CoV-2 variants of concern and develops a variety of identification kits for B.1.1.7, B.1.351, and P1.
Reference: https://www.bgi.com/global/company/news/6-mutations/
ALM-Update: SARS-CoV-2-Infektionen nehmen weiter deutlich zu
23 March 2021
23 March 2021 -- Die SARS-CoV-2-Neuinfektionen nehmen wieder deutlicher und schneller zu. Das bestätigen auch die Zahlen der Akkreditierten Labore in der Medizin – ALM e.V. aus der vergangenen Kalenderwoche. So zeigt die Auswertung der Daten der nun 175 Labore aus dem ambulanten und stationären Bereich eine erneut deutlich gestiegene Positivrate von 8,3 Prozent (Vorwoche 7,2 Prozent). Insgesamt fielen in der KW 11 von den durchgeführten 1.196.364 (Vorwoche: 1.090.422) SARS-CoV-2-PCR-Tests 98.762 positiv aus (Vorwoche: 77.646). „Neben dem forcierten Impfen und der konsequenten Umsetzung der Nationalen Teststrategie mit breiter und niedrigschwelliger Testung nach den RKI-Kriterien bleiben die bekannten allgemeinen Maßnahmen mit Kontaktreduktion, Abstand halten, Maske tragen, Lüften in Innenräumen und der Nutzung der Corona-Warn-App weiterhin das wirksame Mittel gegen die Ausbreitung von SARS-CoV-2. Jede und jeder von uns kann hier einen Beitrag leisten“, sagt Dr. Michael Müller, 1. Vorsitzender des ALM e.V.
Roche launches new high throughput configurations for cobas pro integrated solutions to increase testing efficiency
23 March 2021 - With eight new configurations, cobas pro® integrated solutions offers labs greater flexibility to ramp up their testing capacity to adapt to evolving testing needs. This will allow a greater number of patient samples to be processed faster. By consolidating up to four analytical units on a single platform, testing efficiency in high-volume labs is increased.
Basel, 23 March 2021 – Roche announced today the launch of eight new configurations for cobas pro integrated solutions, in countries accepting the CE mark. As a result, this analyser can deliver up to 4,400 tests per hour, doubling its previous testing capacity. This makes it the ideal choice for labs seeking greater flexibility in ramping up their testing capacity, to adapt to evolving clinical chemistry and immunochemistry testing needs.
Today, the importance of accurate and timely diagnostic testing can be felt across the globe. Growing testing demands put laboratories under significant pressure to increase their testing volumes and operational efficiency, with fewer resources. At the same time, clinicians and patients rely on accurate and timely results to make informed decisions. To overcome these challenges, labs require reliable diagnostic solutions that ensure simplified testing, allowing for earlier diagnosis and improved patient care.
“We are excited to release eight new high throughput configurations for cobas pro integrated solutions which have been designed to address the individual needs of healthcare professionals to maximise throughput and efficiency,” said Thomas Schinecker, CEO Roche Diagnostics. “By building on a system with proven reliability and performance, we continue to simplify laboratory operations so that patients can benefit from shorter time to results and faster treatment decisions.”
cobas pro integrated solutions now offers the possibility to add two additional analytical units of cobas c 503 and/or cobas e 801, consolidating up to four analytical units on a single platform and thus serving the needs of high throughput labs. Labs can now benefit from eight new configurations, allowing them to better tailor their instrumentation to their individual needs. As a result, cobas pro integrated solutions can deliver up to 4,400 tests per hour, doubling its previous testing capacity. Running more tests across a broad range of disease areas including cardiology, oncology and infectious diseases, enables labs to further extend their value for physicians and patients. Furthermore, by consolidating a greater number of samples on a single platform and offering the industry’s broadest clinical chemistry and immunochemistry assay menu of over 230 diagnostic tests, this analyser helps to simplify sample processing and laboratory workflows.
About cobas pro integrated solutions
Launched in 2018, cobas pro integrated solutions is a scalable and modular solution designed to achieve mid-to-high volume clinical chemistry and immunochemistry testing needs. It aims to increase efficiency with fast analytical units, intelligent sample routing, and short assay incubation times, with 93% of Roche immunoassays having reaction times of 18 minutes or less. This analyser features automated maintenance and cobas® AutoCal, an automated calibration procedure, to save hands-on time. Additionally, it incorporates cobas® SonicWash, an ultrasonic probe cleaning to ensure sample integrity.
cobas pro integrated solutions provides fully standardised results and operation to cobas® pure integrated solutions. Together, they deliver a seamless experience and the highest level of standardisation using the same reagents and assay menu, delivering consistent results and operation, and therefore allow for flexible staff assignment and minimal training needs. It makes these systems also ideal candidates for integrated health networks and lab chains.
cobas pro integrated solutions is fully compatible with the cobas® mobile solution, a tablet that integrates multiple Roche applications, allowing laboratory professionals to interact with the analyser from anywhere in the lab.
With cobas pro integrated solutions, the required sample volume per test has been reduced on average by 43% compared to previous generation systems. Additionally, the plastic generated per test result has been reduced by up to 78% due to smaller reagent pack sizes with a higher number of tests per pack.
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 2020 employed more than 100,000 people worldwide. In 2020, Roche invested CHF 12.2 billion in R&D and posted sales of CHF 58.3 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-2021-03-23b.htm
Thermo Fisher Scientific to Offer Integrated COVID-19 Testing to School Districts Nationwide
23 March 2021 - Increased testing capacity and an extensive network of testing laboratories combined with support from Color, a leading software and logistics provider, will enable safe, sustainable in-person instruction
WALTHAM, Mass., March 23, 2021 -- Thermo Fisher Scientific Inc., the world leader in serving science today announced the launch of a nationwide testing program designed to support U.S. efforts to return to in-person classroom instruction. This program, developed in partnership with Color Health, Inc., a California-based leader in distributed healthcare services, along with leading providers of laboratory testing, aims to support schools as the Biden Administration provides $10 billion in funding to conduct COVID-19 testing.
The Biden Administration has identified COVID-19 testing in schools as a critical proactive step in the recovery from the pandemic and has proposed a two-pronged strategy that includes both funding for states to administer testing programs and a soon-to-be-awarded federal hub and spoke based program to expand capacity for schools and underserved populations.
Since the start of the pandemic, Thermo Fisher has supported governments and laboratory partners with COVID-19 testing ramp-up, including equipping a network of labs with capacity to deliver accurate PCR-based individual and pooled testing. Testing programs for this initiative can include PCR-based testing as well as rapid antigen, depending on the school and/or district.
Thermo Fisher's partnership with Color draws on Color's experience serving school districts, major employers, universities, and public health departments to provide critical testing programs. Color's scaled easy-to-use school testing model will provide both convenient sample collection and a seamless result-reporting platform.
"The $10 billion allocation is a critical first step to returning students to school in April, and what happens next is even more critical – helping schools take advantage," said Mark Stevenson, executive vice president and chief operating officer of Thermo Fisher Scientific. "This program is possible because our industry has already established a strong testing infrastructure during the pandemic and now it's time to make that available where it's needed most urgently."
According to Othman Laraki, chief executive officer of Color, "As we have seen throughout the COVID-19 pandemic, one of the most daunting obstacles has been the ability to effectively address the logistical and accessibility challenges for the last mile of healthcare. This initiative allows us to link individuals in need of COVID-19 tests with available lab capacity near their school or home."
For more information on setting up a testing program for your school district, visit www.thermofisher.com/safeschools or email safeschools@thermofisher.com.
About Thermo Fisher Scientific
Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $30 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 80,000 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.
https://clinical.r-biopharm.com/news/quality-controls-for-sars-cov-2-rapid-tests-and-rt-pcr/
23 March 2021 - Lenco Diagnostic Laboratories among first to offer Beckman Coulter’s semi-quantitative antibody test; Lab expects clinicians will use assay to monitor patients’ COVID-19 recovery and assess immune response over time. Assay available to ship in the U.S. and countries accepting the CE Mark.
BREA, CALIF., MAR. 23, 2021 — Beckman Coulter, a clinical diagnostics leader, today announced that its Access SARS-CoV-2 IgG II antibody assay received U.S. Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration. The semi-quantitative assay measures a patient’s level of antibodies in response to a previous SARS-CoV-2 infection and provides a qualitative and numerical result of antibodies in arbitrary units (AU).
Lenco Diagnostic Laboratories, one of New York City’s largest privately-owned, full-service reference labs, is among the first to offer the test in its facilities across Brooklyn, NYC, and the tri-state metropolitan area. Lenco conducted an independent verification of the assay’s performance and is highly satisfied with the quality of the results.
“To help in the fight against COVID-19, it is important that we partner with a company that has the reputation, quality, and testing accuracy like Beckman Coulter in meeting the needs of the people of New York,” said Robert Boorstein, M.D., Ph.D., medical director, Lenco Diagnostics Laboratories. “This next step in COVID-19 antibody testing creates a pathway in helping us establish a quantitative baseline of different antibody levels and determine how a patient’s immune response to COVID-19 is affected over time. We expect that clinicians will find this assay useful for monitoring the progress of a patients’ COVID-19 recovery and assessing the immune response over time.”
The Access SARS-CoV-2 IgG II assay measures IgG antibodies directed to the receptor-binding domain of the spike protein of the coronavirus. The test has a confirmed 100% negative percent agreement (specificity) and a 98.9% positive percent agreement (sensitivity) at >/= 15 days post symptom onset. The Access SARS-CoV-2 IgG II assay can be used in Random Access Mode (RAM) and seamlessly integrates into existing workflows without batch processing.
“Effective and high-quality diagnostic solutions are essential in the fight against COVID-19,” said Shamiram R. Feinglass, MD, M.P.H, chief medical officer at Beckman Coulter. “Antibody assays like our Access SARS-CoV-2 IgG II test can help researchers quantitatively determine the levels of IgG antibodies and enable them to assess the relative changes of an individual’s immune response to the SARS-CoV-2 virus over time. This information is essential because it helps continually inform therapeutics and vaccine development.”
The Access SARS-CoV-2 IgG II antibody assay is now available in the U.S. and countries accepting the CE Mark. Results of the new test are delivered on Beckman Coulter’s award-winning immunoassay analyzers, including the DxI 800 high-throughput analyzer, capable of processing up to 4,800 samples per day. The IgG II antibody assay is the latest addition to Beckman Coulter’s full suite of testing solutions that provide clinicians valuable information in their fight against COVID-19. Beckman Coulter also recently launched an automated SARS-CoV-2 antigen test in the U.S. under Policy C of the FDA’s emergency use authorization (EUA) program. For more information on Beckman Coulter’s antibody assays, as well as its full suite of COVID-19 diagnostic solutions, 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 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.
Quality controls for SARS-CoV-2 rapid tests and RT-PCR
22 March 2021
22 March 2021 -- We complement our control reagent portfolio with new controls including SARS-CoV2 positive and negative controls, as well as all-encompassing validation and verification kits for respiratory and SARS-CoV-2 pathogens. Our portfolio includes control material for RT-PCR as well as for quick tests. These quality controls are cross-platform compatible, mimic patient samples and safe to use.
Microbix quality assessment products advantages:
- Liquid material is in ready to use aliquots and swabs
- Stable for up to two years
- Compatible with immunoassays and nucleic acid tests
- Commutable and cross-platform compatible
- ONBOARDx™ (RUO): designed to meet the instrument/device sample adequacy requirements if needed
- Special SARS-CoV-2 controls
PROCEEDx™
A sample that is used to ensure whether a device complies with its specification or imposed condition (fault insertion). Intended for use in internal processes.
REDx™
Ensures day-to-day consistency of an analytical process and assists in determining reliable patient test results.
ONBOARDx™
All-encompassing validation and verification kit for instrument/kit/assay qualification and operator training. Contains PROCEEDx™ material and is intended for use in internal processes.
Reference: https://clinical.r-biopharm.com/news/quality-controls-for-sars-cov-2-rapid-tests-and-rt-pcr/
BGI Rapid Identification Kits for SARS-CoV-2 Variants in Use in Angola
20 March 2021
On March 18, 2021, BGI announced the donation of 40,000 Rapid Identification Kits for SARS-CoV-2 variants to the Ministry of Health of Angola, to support the local fight against the pandemic. The kits arrived earlier this month in Luanda, the capital of Angola.
At the online ceremony, Silvia Lutucuta, the Minister of Health of Angola, said: “In the face of new challenges brought by the COVID-19 variants, BGI once again lent a helping hand and provided Identification Kits for SARS-CoV-2 variants to Angola. On behalf of the Angolan government, we express our heartfelt thanks.”
On July 16, 2020, the Angolan government commissioned BGI to build Huo-Yan Laboratories in four cities with a total daily testing capacity of 6,000 samples to fight against the pandemic. In the second half of 2020, four laboratories were opened successively. The 18 local laboratory experts were trained by BGI.
Angolan Minister of Health Silvia Lutucuta (top right), and Gong Tao, Chinese Ambassador to Angola (bottom left), attend the ceremony onsite in Angola. Li Ning, Vice President of BGI (top left, second from left) attended online.
Recently, three SARS-CoV-2 variants–the lineage B.1.1.7 first identified in England, and the lineages B.1.351 and P1 initially discovered in South Africa and Brazil have gained global attention.
In response to the new COVID-19 mutants, BGI monitors the emergence of additional SARS-CoV-2 variants of concern and develops a variety of identification kits for B.1.1.7, B.1.351, and P1. We have also developed a new NGS-based Genome Analysis Solution, which can detect mutations in new variants with high-quality genome sequencing results.
BGI provides a full range of COVID-19 nucleic acid detection kits, antibody detection kits and antigen detection kits together with identification kits. The series of product and applications can meet the clinical needs of various scenarios and contribute to the global COVID-19 prevention and control work.
Illumina Announces Board Changes
18 March 2021 - Jay Flatley to step down from the Board; John W. Thompson to be appointed new Chair
SAN DIEGO, 18 March 2021 -- Illumina, Inc. (the “Company”) today announced that Jay Flatley has decided to step down from the Board of Directors and John W. Thompson will be appointed as the Company’s new Chair of the Board. These changes will be effective as of the Company’s Annual Shareholder Meeting on May 26, 2021. This is part of a thoughtful, long-term succession planning process.
“It has been a tremendous honor to work with the Illumina team during the past 22 years to create an industry leader. Having witnessed the impact of our technology on patients’ lives and the passion of our employees, I am deeply grateful for my time at this incredible Company,” said Mr. Flatley. “I am excited about the future of Illumina – the potential for improving human health through our next-generation sequencing and technology remains enormous. Illumina has significant opportunities ahead and I am confident that John, Francis and the entire Illumina leadership team will continue the Company’s strong legacy of innovation and execution for long-term success.”
“It has been a privilege to work closely with Jay since I joined Illumina eight years ago. On behalf of our Board and the Company, I would like to thank Jay for his vision, partnership and dedication to continued growth and innovation. The entire Illumina team wishes Jay all the best as he embarks on his new chapter,” said Francis deSouza, Chief Executive Officer. “John’s extensive leadership and operating experience, his proven track record as the Chair of Microsoft’s Board, as well as his tenure as our Lead Independent Director, uniquely position him to serve as Illumina’s next Chair. He is an outstanding choice to lead our talented Board.”
“I am honored to be selected as Illumina’s next Chair of the Board,” said Mr. Thompson. “I look forward to working with Francis and the Board to support the next phase of Illumina’s evolution to benefit patients, employees, customers and shareholders.”
Mr. Flatley led Illumina as CEO from 1999 until mid-2016, served as Executive Chair from mid-2016 through 2019, and currently serves as Chair of the Board. Over the course of Mr. Flatley’s tenure, Illumina established its mission to “Unlock the Power of the Genome” and launched a myriad of products that made sequencing faster, more cost-effective and more accessible. As a pioneer of the genome sequencing market, Mr. Flatley spearheaded Illumina’s acquisition of Solexa and the underlying technology for the Company’s sequencing technology, transforming Illumina into the leading global provider of next-generation sequencing solutions.
Mr. Thompson has been a Director on Illumina’s Board since 2017. He brings extensive executive leadership experience having served in chief executive officer roles at Virtual Instruments and Symantec. He also brings 28 years of leadership experience at IBM where he held senior roles in sales, marketing, software development and served as General Manager of IBM Americas. He has served as Microsoft’s Chair of the Board since 2014 and as a director since 2012. He currently serves as a director on the boards of two privately held companies, Rubrik and Seismic Software. He has also served on the boards of Symantec, NIPSCO (Northern Indiana Public Service Company), Fortune Brands, Seagate Technologies, and United Parcel Service (UPS). Mr. Thompson is a member of the board of trustees for the Wetlands America Trust and was formerly a member of the national board of Teach for America.
Mr. Thompson received a bachelor’s degree in business administration from Florida A&M University and a master’s degree in management science from MIT’s Sloan School of Management. He has received honorary doctorate degrees from the University of Notre Dame, Mendoza College of Business and Florida A&M University.
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.
BIOFIRE® Respiratory 2.1 (RP2.1) Panel with SARS-CoV-2 obtains De Novo FDA Authorization
18 March 2021
Marcy l’Étoile, France, 18 March 2021 – bioMérieux, a world leader in the field of in vitro diagnostics, today announced that BioFire Diagnostics, its subsidiary specialized in molecular syndromic infectious disease testing, has received U.S. Food and Drug Administration (FDA) De Novo authorization for the BIOFIRE® RP2.1 Panel.
This panel allows for the detection of 22 viral and bacterial pathogens responsible for respiratory infections, including SARS-CoV-2 (the cause of COVID-19 disease). The panel is the first SARS-CoV-2 diagnostic test of any kind that has been granted De Novo status by U.S. FDA, having gone through the normal U.S. FDA review pathway outside of the Emergency Use Authorization (EUA) track.
This De Novo authorization will be concurrent with the revocation of the U.S. FDA EUA that was obtained on May 1st, 2020 for this panel. The BIOFIRE® RP2.1 Panel EUA and De Novo kits are identical with the exception of changes to the labeling.
The De Novo application was supported by a multicenter prospective clinical study in which the performance of the BIOFIRE® RP2.1 Panel SARS-CoV-2 assay was evaluated in over 500 specimens against a combined reference of three independent molecular SARS-CoV-2 assays, each with U.S. FDA EUA designation. The BIOFIRE® RP2.1 Panel SARS-CoV-2 assay demonstrated positive percent agreement (PPA) of 98.4% and negative percent agreement (NPA) of 98.9%.
Pierre Boulud, Chief Operating Officer, Clinical Operations of bioMérieux said: “The De Novo authorization of the BIOFIRE® RP2.1 Panel demonstrates how BioFire is dedicated to responding to a rapidly-evolving global pandemic with urgency and accuracy. This is the first U.S. FDA De Novo authorized Covid-19 test.”
The BIOFIRE® RP2.1 Panel allows healthcare providers to quickly identify common respiratory pathogens found in patients presenting with acute respiratory tract infection, using one simple test. The BIOFIRE® RP2.1 Panel yields results in approximately 45 minutes using nasopharyngeal swab (NPS) samples in transport media or saline. It runs on the fully automated BIOFIRE® FILMARRAY® 2.0 and BIOFIRE® Torch Systems with only 2 minutes of sample preparation time.
About bioMérieux's global response to COVID-19
bioMérieux provides several SARS-CoV-2 diagnostic solutions:
- ARGENE® SARS-CoV-2 R-GENE® and SARS-CoV-2 RESPI R-GENE®: these tests are available in certain international markets outside of the US and rely on real-time PCR technology and can be used with most commercially available amplification PCR-platforms. The SARS-CoV-2 RESPI R-GENE® allows the simultaneous (multiplex) detection of SARS-CoV-2, influenza viruses A and B and two other respiratory pathogens (RSV and hMPV).
- BIOFIRE® COVID-19 test: this fully automated SARS-CoV-2 test provides results from a patient sample in 45 minutes. It is suitable for use in emergency situations for critically ill patients. The BIOFIRE® COVID-19 test was developed with funding from the U.S. Department of Defense (DoD) and is produced in Utah (USA).
- BIOFIRE® Respiratory 2.1 plus Panel: this test is available in certain international markets outside of the US and includes the detection of MERS-Coronavirus in addition to the other pathogens of the BIOFIRE® RP2.1 Panel in approximately 45 minutes.
- BIOFIRE® Respiratory 2.1-EZ Panel: this panel identifies 19 pathogens associated with respiratory infections, including SARS-CoV-2 in approximately 45 minutes, and is used in point of care and near patient (e.g. CLIA-waived) settings. Available in the US only.
- EMAG® and easyMAG®: equipment and associated reagents are pivotal for the extraction of nucleic acids prior to the amplification and detection of specific gene sequences. These systems are in high demand as a means of preparing nucleic acids from clinical specimens.
- VIDAS® anti-SARS-CoV-2 IgM and anti-SARS-CoV-2 IgG: these two serology tests detect antibodies as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection.
Beckman Coulter Offers $4/High-throughput Antigen Test to Support U.S. Government Initiative to Expand COVID-19 Testing
18 March 2021 - Company ready to support the $12 billion expansion in COVID-19 testing as vaccinations increase. Company able to support testing for schools and underserved congregate settings, directly through existing and new coordinating centers by supplying 25 million tests per month. The test is specifically designed to support high-throughput automated testing screening.
BREA, CALIF., MAR. 18, 2021 — Beckman Coulter, a clinical diagnostics leader, today announced their commitment to support the U.S. government’s plan to invest more than $12 billion to expand COVID-19 testing with their high-throughput, high-quality lab antigen test, Access SARS-CoV-2 Ag*, ideal for mass screening testing.
Beckman Coulter announced in December that their $4 antigen test will be available to all customers and has a confirmed 93% positive predictive agreement (PPA) and 100% negative predictive agreement (NPA). Results can be delivered in as little as 30 minutes on Beckman Coulter’s immunoassay analyzers, including the DxI 800 high-throughput analyzer that can process up to 200 samples every 60 minutes.
“We support the U.S. government’s goal to expand screening because this is the right way to open up our schools, our economy and get people back to work in tandem with the massive vaccination drive that is underway,” said Julie Sawyer Montgomery, president of Beckman Coulter Diagnostics. “The key to saving lives while vaccines are being put into arms is still masking, social distancing, regular testing, tracing and isolation. Our antigen assay makes the regular testing part of this equation a reality by enabling institutions and communities to implement low-cost, frequent, mass COVID-19 testing with automation, ease of handling and speed to enable scalability.”
Beckman Coulter’s antigen test can be used for testing in high-risk settings, such as nursing homes, hospitals, universities and other group settings where repeat testing, coupled with relevant clinical information, could identify those with a SARS-CoV-2 infection to minimize transmission.
“We are offering our solution at $4 per test because it’s only with affordable and regular testing that we can address disparities and promote equity in COVID-19 testing, which is vital to address COVID-19-related health gaps and advance health equity among high-risk and underserved populations, including racial and ethnic minority groups and people living in rural areas,” said Shamiram R. Feinglass, M.D., MPH, chief medical officer for Beckman Coulter.
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. Only Beckman Coulter’s $4 SARS-CoV-2 antigen test makes large-scale, serial testing programs feasible and affordable.
“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 hundreds or thousands of people; the workflow breaks down with too many manual handling steps in the process,” said Dr. Feinglass. “Furthermore, a hospital is compelled to report positive results to the regulatory bodies, and some point of care tests require cumbersome manual recording of patient data into their EMR.”
Ideal for implementing as part of a large-scale community, workplace or school screening program, Access SARS CoV-2 Antigen test samples are collected with a nasopharyngeal or nasal swab and can be stored at room temperature for up to 24 hours and 48 hours refrigerated (2-8 degrees Celsius) with one freeze/thaw cycle.
The assay also provides ultimate flexibility in scaling to address the needs of small or low volume to moderately-sized laboratories that operate a desktop analyzer, to large laboratories with automated, high-throughput analyzers for mass testing. Whether on a desktop with an Access 2 or on a high-throughput analyzer like the DxI 800, results are immediately delivered electronically to physicians, patient portals and health agencies, allowing clinicians to initiate proper treatment quickly, isolate patients, and start tracing, helping to minimize the spread of COVID-19.
Learn more about Beckman Coulter’s affordable, reliable and designed for high-throughput antigen solution at www.beckmancoulter.com/accessantigen.
Beckman Coulter’s Suite of COVID-19 Testing Solutions
Beckman Coulter offers a menu that matters for COVID-19, including the $4 Access SAR-CoV-2 Antigen assay, as well as three antibody assays: Access SARS-CoV-2 IgM, Access SARS CoV-2 IgG and the semi-quantitative SARS-CoV-2 IgG II. Beckman Coulter is also developing a SARS-CoV-2 quantitative IgG assay based on WHO reference ranges.
The company also has an interleukin 6† (IL-6) assay, which can be used to aid physicians in identifying a severe inflammatory response and determining the risk of intubation with mechanical ventilation in COVID-19 patients. Beckman Coulter also offers a biomarker that measures monocyte distribution width (MDW), which can be used as an aid in the early detection of sepsis in adult patients presenting to the emergency department. Earlier this year, the company received government funding to develop a machine learning algorithm to help accurately predict and detect sepsis in COVID-19 patients leveraging its MDW test. Additionally, in mid-October, Beckman Coulter was awarded funding by for a multi-center clinical trial to validate the ability of MDW to aid in the rapid detection of Multisystem Inflammatory Syndrome in Children (MIS-C), a severe COVID-19 complication.
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, tabletop 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.
Quidel Corporation applauds Biden administration plan to expand COVID-19 testing
18 March 2021
SAN DIEGO, 18 March 2021 -- Quidel Corporation (“Quidel”), a provider of rapid diagnostic testing solutions, cellular-based virology assays and molecular diagnostic systems, today announced its support for the Biden Administration’s plan to expand COVID-19 testing in schools, underserved communities, rural areas and other settings that have been gravely impacted by the pandemic.
“Quidel applauds the Biden Administration’s urgent and comprehensive approach to bringing the benefits of rapid, routine and equitable coronavirus testing to America’s classrooms, underserved communities and rural areas,” said Douglas Bryant, president and CEO of Quidel Corporation. “Frequent testing has proven to be a critical tool for both empowering people to take charge of their own health and allowing large institutions, businesses, sports and entertainment venues and enumerable other aspects of society to reopen safely and remain so.”
“Our mission at Quidel has always been to democratize access to frequent, affordable and highly accurate COVID-19 testing, and we expect the Administration’s American Rescue Plan for testing will turbocharge efforts all across the diagnostics industry to get everyone screened so the virus and any variants can be stopped, tracked and traced in real time,” Mr. Bryant noted. “We are approaching the inflection point where frequent at-home, in-school and on-site testing of asymptomatic people at scale can give us greater peace of mind to see our families, dine out and travel.”
Quidel recently received Emergency Use Authorization (EUA) from the FDA for its QuickVue® At-Home COVID-19 Test, an easy-to-use test that provides results to symptomatic patients in ten minutes with a doctor’s prescription. The company is seeking an EUA for over-the-counter (OTC) sale of the QuickVue® At-Home COVID-19 Test to symptomatic and asymptomatic consumers without a prescription. Quidel is currently building out a new manufacturing facility in Carlsbad, CA dedicated to the production of Quidel’s popular QuickVue® line of products. The 128,000 square foot facility will be the company’s highest-volume production plant in the world and is expected to produce 600 million QuickVue® rapid antigen tests for the detection and diagnosis of COVID-19 infections.
Visit www.quickvueathome.com for more information.
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.
BD Statement On U.S. Government Plan To Invest $10 Billion In Covid-19 Testing In Schools
17 March 2021
FRANKLIN LAKES, N.J., March 17, 2021 – BD (Becton, Dickinson and Company), a leading global medical technology company, today issued the following statement regarding the U.S. government’s plan to invest $10 billion in COVID-19 testing in American schools:
Dave Hickey, president of Life Sciences for BD said, “Committing $10 billion for COVID-19 testing in America’s schools is a critical investment in getting all schools open and back to in-person learning.
“As a manufacturer of both PCR and antigen tests, BD understands the strengths of both approaches to testing. For testing programs administered by health care providers in schools, antigen tests are ideal because they are easy to use, low cost, don’t require sophisticated lab equipment or personnel, can be performed in a CLIA waiver point-of-care setting and most importantly, can provide a test result in 15 minutes when students are suspected of COVID-19, which allows for immediate isolation and other protective measures to minimize the spread of COVID-19.
“In addition, some antigen tests, like the one used on the BD Veritor™ Plus System provide additional benefits, including a definitive positive or negative digital readout and enabling data transfer to the cloud for ease of reporting test results to public health officials. The ease of use and immediate results provided by antigen tests would allow our educators to focus on teaching, not testing.”
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 70,000 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 launches cobas pure integrated solutions analyser to help simplify operations in small to medium sized labs
17 March 2021 - cobas® pure integrated solutions brings together three diagnostic technologies on a single platform to optimise space and resources in small to medium laboratory settings. With a footprint of just two square meters, this new analyser provides small to medium sized labs with access to more than 230 diagnostic tests across a wide-range of disease areas including infectious diseases, oncology and cardiology. Through automation of manual tasks, Roche’s new solution is designed to simplify workflows and improve the productivity of lab personnel whilst also supporting the delivery of better patient care.
Basel, 17 March 2021 – Roche announced today the launch of cobas pure integrated solutions in countries accepting the CE mark. This new compact analyser combines three technologies1 on a single platform helping to simplify daily operations in labs with limited space and resources.
Now more than ever, diagnostic laboratories have proven to be a critical component of our global healthcare system. Medical and laboratory professionals play a key role in delivering optimal patient care, yet they are under significant pressure to deliver accurate and timely results with less resources.
Built on the latest technology, cobas pure integrated solutions provides labs with an integrated system that focuses on the automation of manual tasks. This reduces the hands-on maintenance time of technicians to just 5 minutes per day which is 80% less than previous generation systems. This can help to improve the productivity of lab personnel whilst also supporting fast delivery of patient results and clinical decision-making.
With a footprint of just two square meters, cobas pure integrated solutions is up to 30% smaller in footprint than previous generation systems. It is able to perform up to 870 tests per hour whilst providing small to medium sized labs with access to the full clinical chemistry and immunochemistry assay menu from Roche which includes over 230 diagnostic tests across a wide-range of disease areas such as infectious diseases, oncology and cardiology. cobas pure integrated solutions will enable small to medium sized labs to make better use of their space and expand their offering of high medical value tests for the benefit of patients.
“During these challenging times, providing accurate and timely testing has never been more vital. Roche continues to invest heavily in laboratory innovation to help meet the changing demands of healthcare systems,” said Thomas Schinecker, CEO Roche Diagnostics. “With the launch of cobas pure integrated solutions, we seek to simplify complex workflows in small to medium sized labs so that laboratory professionals can focus on providing clinicians with the information they need to make reliable and timely clinical decisions for patients.”
Furthermore, to ensure simple and effective work across healthcare networks, cobas pure integrated solutions provides fully standardised results and operation to cobas® pro integrated solutions – Roche’s latest analyser designed for larger labs. Standardisation enables labs to do more work on fewer instruments, through consolidation of workflows, systems and reagents. This results in improved speed and accuracy of care as well as optimised patient management. In addition, cobas pure integrated solutions is fully compatible with the cobas® mobile solution, a tablet that integrates multiple Roche applications, allowing laboratory professionals to interact with the analyser from anywhere in the lab.
About the cobas pure integrated solutions
cobas pure integrated solutions is the newest member of the cobas family of systems and combines clinical chemistry, immunoassay and ISE diagnostic testing on a single platform for low to mid volume testing needs. In addition, cobas pure integrated solutions comes with a number of innovations including automated maintenance, automated calibration and completely ready to use reagents that help simplify the overall operation of the lab.
With cobas pure integrated solutions, the required sample volume per test has been reduced on average by 43% compared to previous generation systems. Additionally, the plastic generated per test result has been reduced by up to 78% due to smaller reagent pack sizes with higher number of tests per pack.
To learn more about cobas pure integrated solutions system, please visit: https://diagnostics.roche.com/global/en/products/systems/cobas-pure-integrated-solutions.html
To learn more about cobas pro integrated solutions, please visit: https://diagnostics.roche.com/global/en/products/systems/cobas-pro-integrated-solutions.html
To learn more about the cobas mobile solution, please visit: https://diagnostics.roche.com/global/en/products/instruments/cobas-mobile-solution.html
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 2020 employed more than 100,000 people worldwide. In 2020, Roche invested CHF 12.2 billion in R&D and posted sales of CHF 58.3 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-2021-03-17.htm
Vela Diagnostics receives CE-IVD approval for automated Flu A/B & RSV Extension Kit
17 March 2021 - The ViroKey™ Flu A/B & RSV RT-PCR Extension Kit is now CE certified
Singapore, Mar 17 2020 – Vela Diagnostics announced today that its ViroKey™ Flu A/B & RSV RT-PCR Extension Kit (for use only with ViroKey™ SARS-CoV-2 RT-PCR Test v2.0), has received the CE mark for in vitro diagnostic use.
The ViroKey™ Flu A/B & RSV RT-PCR Extension Kit detects Influenza A, Influenza B and RSV by targeting the matrix protein gene in the RNA of the respective viruses. The ViroKeyTM SARS-CoV-2 RT-PCR Test v2.0 detects SARS-CoV-2 by targeting conserved regions of the SARS-CoV-2 RNA—the ORF1a and N genes.
The tests are optimized on a workflow consisting of the Sentosa™ SX101 instrument for automated sample extraction and PCR setup, in conjunction with the Sentosa™ SA201 instrument. The automated workflow enables high throughput testing with significantly reduced hands-on time. Up to 46 samples (and two controls) can be tested—to detect up to four viruses—in a single run. The PCR is set up as two separate reactions; one to detect SARS-CoV-2, and the other for the Flu A/B and RSV triplex. This prevents masking of low positive results, resulting in higher sensitivity of detection.
“The flu season and the recent appearance of a new SARS-CoV-2 variant makes pandemic management all the more challenging, especially when these viral infections cause similar symptoms in patients. With the ViroKey™ Flu A/B & RSV RT-PCR Extension Kit, we can distinguish across the four viruses in patients with flu-like symptoms, thus enabling clinicians to prescribe the appropriate treatment protocol at the soonest,” said Managing Director, Andreas Goertz.
The ViroKeyTM SARS-CoV-2 RT-PCR Test v2.0 received the CE mark in July 2020.
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.
ALM-Update: SARS-CoV-2-PCR-Positivrate steigt wieder deutlich an
16 March 2021
16 March 2021 -- Deutlich steigende Zahlen an SARS-CoV-2-Infizierten und eine Bestätigung der erneut zunehmende Infektionsdynamik von COVID-19 ist durch die Analyse der Akkreditierten Labore in der Medizin – ALM e.V. aus der vergangenen Kalenderwoche erkennbar. So zeigt die Auswertung der Daten von nunmehr 173 (171) Laboren bei steigenden an SARS-CoV-2-PCR-Testzahlen (1.084.771; Vorwoche: 1.021.024) eine im Vergleich zur Vorwoche von 6,4 auf nun 7,2 Prozent gestiegene Positivrate. Insgesamt fielen 20 Prozent mehr SARS-CoV-2-PCR-Tests (77.660) positiv aus als in der Vorwoche (64.981). „Wir in den Laboren sind besorgt angesichts dieser Entwicklung, denn auch der Anteil der Varianten, insbesondere von B.1.1.7, nimmt weiter zu. Deswegen gilt unverändert und gerade jetzt: Wir sollten die Ergebnisse und die Situation ernst nehmen“, sagt Dr. Michael Müller, 1. Vorsitzender des ALM e.V. Nina Beikert, Vorständin im fachärztlichen Verband bestätigt: „Bis zu einer echten Entspannung wird es noch einige Zeit dauern. Wir sind deshalb auf ein gutes Konzept und wirksame Maßnahmen zur Pandemieeindämmung angewiesen.“
Roche launches SARS-CoV-2 variant test to help monitor emerging coronavirus mutations
16 March 2021 - The cobas SARS-CoV-2 Variant Set 1 Test is designed to detect key spike mutations in virus variants associated with increased human-to-human transmission. Accurate detection and differentiation of SARS-CoV-2 mutations can help assess the spread of circulating variants and monitor their potential impact on therapeutics, vaccines and public health interventions. Periodic assessments against emerging variants have shown that Roche’s current diagnostic tests for detecting active SARS-CoV-2 infections remain accurate and effective. The test runs on widely used high-throughput systems and is for research purposes only.
Basel, 16 March 2021 -- Roche today announced the launch of the cobas® SARS-CoV-2 Variant Set 1 Test to detect and differentiate mutations found in variants that originated in the UK (B.1.1.7), South Africa (B.1.351), and Brazil (P.1). This research use only laboratory test can be used to help scientists track mutation prevalence and to assess any potential impact on diagnostics, vaccines and therapeutics, providing crucial insight for healthcare systems in making appropriate measures to combat COVID-19.
Variants of B.1.1.7, B.1.351 and P.1 lineage gained prominence in late 2020, with each carrying a number of genomic mutations. Among them, mutations E484K, N501Y and del 69-70 are located in the spike protein, the region that enables the virus to attach to and enter the human cell. Studies have suggested that these mutations may be linked to increased disease transmissibility, and possibly decreased therapeutic and vaccine efficacy.
“Viruses naturally evolve over time. While most mutations do not have a clinical impact, some variants need to be tracked carefully as they seem to spread more easily and quickly,” said Thomas Schinecker, CEO Roche Diagnostics. “Continued surveillance is essential for public health. Our latest solution provides laboratories a fast and efficient way to investigate these variants found in infected individuals and the potential impact on existing therapies, vaccines and tests.”
The cobas SARS-CoV-2 Variant Set 1 Test runs on the widely available, high-volume cobas® 6800/8800 Systems. Pre-optimised assay design, ready-to-use test cassettes and predefined software parameters enable laboratories to reduce testing complexity and increase walkaway time.
It is important to note that Roche has confirmed its existing diagnostic tests to detect SARS-CoV-2 are not affected by known mutations and remain accurate and effective in detecting active infections. The company is conducting assessments on a regular basis and will continue to monitor as new variants arise.
About SARS-CoV-2 Variants B.1.1.7, B.1.351 and P.1
First reported in the UK in December 2020, B.1.1.7 variant has quickly become the dominant circulating variant and has since been found in countries worldwide.1 B.1.1.7 carries a large number of mutations, eight of which are accumulated in the spike region. Preliminary studies have suggested that two such spike mutations, N501Y and del 69-70, are associated with increased transmissibility of the disease.2,3 Another variant, B.1.351, which arose independently from B.1.1.7, was reported in South Africa in December 2020. In addition to having mutation N501Y, B.1.351 carries another spike mutation E484K, which appears to evade the body’s immune response, possibly diminishing vaccine efficacy.4 Variant P.1, a close relative to B.1.351, has several defining mutations including N501Y and E484K in the spike region. P.1 has been circulating in the Amazon region as of late 2020 and is thought to evade immunity generated after infection by other variants.
About cobas SARS-CoV-2 Variant Set 1 Test
cobas SARS-CoV-2 Variant Set 1 Nucleic Acid test for use with the cobas 6800/8800 Systems is an automated, multiplex, real-time reverse transcription polymerase chain reaction (RT-PCR) assay for the rapid in vitro qualitative detection and discrimination of select SARS-CoV-2 mutations E484K, N501Y and del 69-70. The test contains the respective primers and probes provided in the ready-made 384-test cassette. Automated data management is performed by the cobas 6800/8800 software, which assigns test results for all tests. Results can be reviewed directly on the system screen, and printed as a report. Roche is committed to providing additional variant tests as needed based on regular assessments of the infectious disease landscape.
About 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. Learn more now: www.cobas68008800.com.
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, 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 2020 employed more than 100,000 people worldwide. In 2020, Roche invested CHF 12.2 billion in R&D and posted sales of CHF 58.3 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-2021-03-16b.htm
Kostenlose Antigen-Schnelltests im Rahmen der neuen Coronavirus-Testverordnung
12 March 2021 - SYNLAB bietet Ihnen ab sofort an allen Laborstandorten kostenlose PoC-Antigen-Tests im Rahmen der neuen Coronavirus-Testverordnung an.
12 March 2021 -- Seit dem 08. März hat jeder Bürger mit Wohnsitz in Deutschland Anspruch auf einen Schnelltest pro Woche. Das Testergebnis liegt in der Regel innerhalb von 15 bis 30 Minuten vor. Die kostenlosen Tests richten sich nur an Personen, die keine SARS-CoV-2-Symptome vorweisen.
Zu jedem Antigen-Schnelltest erhalten Sie einen Befund, den Sie über unsere App abrufen können. Personen mit einem positiven Schnelltest-Ergebnis sind verpflichtet, anschließend einen PCR-Test machen zu lassen. Diesen Test können Sie ebenfalls über uns beauftragen.
Bitte vereinbaren Sie vorab einen Termin über unser Terminbuchungstool an einem unserer Standorte und bringen Sie Ihren Personalausweis mit.
Abbott announces its pandemic defense coalition: a global network of experts collaborator designed to help prevent future pandemics, currently searching for COVID-19 variants
11 March 2021 - The Abbott Pandemic Defense Coalition is a first-of-its-kind global scientific network dedicated to the early detection of, and rapid response to, future pandemic threats. The coalition builds on Abbott's decades of leadership in virus surveillance and helps to analyze virus samples for unknown diseases and detect mutations and variants including for COVID-19. Abbott is bringing together global collaborators specializing in identification of unknown diseases, surveillance, virus sample collection, testing and sequencing. Abbott will rapidly develop tests that can be used to help identify, isolate and contain outbreaks when potential new virus threats are identified.
ABBOTT PARK, Ill., March 11, 2021 -- Abbott today announced the formation of the Abbott Pandemic Defense Coalition, a first-of-its-kind global scientific and public health partnership dedicated to the early detection of, and rapid response to, future pandemic threats. By connecting global centers of excellence in laboratory testing, genetic sequencing and public health research, the program will identify new pathogens, analyze potential risk level, rapidly develop and deploy new diagnostic testing and assess public health impact in real time.
The coalition is designed to help the global scientific and health community identify new viral threats, take quick action when one is discovered, and help prevent future pandemics. The sequences of the viruses that are found will be published in a public database so that health officials and laboratories can work together to identify if it's a novel strain, or a virus that has previously been detected. This program expands upon the viral surveillance and discovery work that Abbott has performed over the last three decades.
"We cannot fight what we cannot see coming. This program establishes a global network of 'eyes on the ground' that are always looking for threats, which helps the global health community to stay one step ahead of the next viral threat, and allows us to utilize Abbott's expertise and technology to quickly develop tests to address them," said Gavin Cloherty, Ph.D., head of infectious disease research at Abbott. "The COVID-19 pandemic has demonstrated a clear need for advanced surveillance and viral sequencing – and the critically important role of testing. Understanding what pathogenic threats are emerging will help us test, diagnose and hopefully help prevent the next pandemic."
Abbott is helping look for COVID-19 variants and ensuring COVID-19 tests are effective
Abbott is playing an important role in helping to monitor for new variants or mutations to the virus that causes COVID-19. The company is collecting virus samples from around the world and looking for any changes (mutations) to the virus's genetic sequencing.
With decades of experience in viral surveillance, Abbott specifically designs its tests, including COVID-19 tests, with viral evolution in mind. As new strains are discovered, Abbott vigorously analyzes them so it can ensure its diagnostic tests can detect them. The coalition provides the network to collaborate with other leading institutions on this effort.
A global force of scientific experts focused on outsmarting viruses
The new Abbott Pandemic Defense Coalition consists of global collaborators specializing in virus identification, surveillance, sample collection, testing and data analytics. The process to identify potential new viral threats begins with physicians across the network identifying patients with unknown conditions that they cannot treat or diagnose. Next, patient samples are tested by our partners on a global scale, followed by genetic sequencing and analyses to spot trends and identify peculiarities that may indicate an emerging threat or outbreak. If a potential threat is discovered, Abbott will quickly develop diagnostic testing to assist in containment efforts.
Abbott's growing network of partners includes organizations in strategic geographic locations:
- Colombia/Wisconsin One-Health Consortium at the Universidad Nacional de Colombia, Medellin, Colombia
- Faculty of Medicine, Siriraj Hospital, Mahidol University, Bangkok, Thailand
- Institut de Recherche en Santé, de Surveillance Epidémiologique et de Formations (IRESSEF), Dakar, Senegal
- KRISP, Genomic Centre of the University of KwaZulu-Natal, Durban, South Africa
- Rush University System for Health, Chicago, U.S.
- The University of the West Indies, Mona Campus, Jamaica
- Universidade de São Paulo, São Paulo, Brazil
- YRG Care, Chennai, India
Abbott is in talks with additional non-governmental organizations, governments and research centers of excellence regarding participation and collaboration.
"In a sophisticated network like the Abbott Pandemic Defense Coalition, we have access to best-in-class science and technology that makes data collection, analysis and sharing efficient and effective," said Professor Souleymane Mboup, president of Institut de Recherche en Santé, de Surveillance Epidemiologique et de Formations (IRESSEF) of Dakar, Senegal. "The key here is collaboration; no single lab or organization in any one country would be able to conduct testing and analysis of this breadth and scale but connecting global centers of excellence makes it possible for us all to assist in identifying the next potential threats to public health."
A history of hunting viruses around the globe – and a future dedicated to further advancing this vital work
As a leader in blood screening and infectious disease testing, Abbott created its Global Viral Surveillance Program more than 25 years ago to monitor HIV and hepatitis viruses and identify mutations, which helps ensure the company's diagnostic tests remain up to date and enable researchers to proactively evaluate and solve infectious disease challenges. This surveillance program will now be a part of the Abbott Pandemic Defense Coalition.
Through its surveillance efforts, the company recently announced the discovery of a high prevalence of HIV Controllers – a group of people living with controlled HIV without antiretroviral medications in the Democratic Republic of Congo, which could hold the key to a cure. Abbott also announced the finding of a new strain of HIV in 2019.
And looking ahead, Abbott will focus on testing and digital solutions accessible to more people in more places for many of the world's most pressing health challenges, including infectious diseases. This work also is an important part of Abbott's 2030 sustainability strategy which includes a focus on transforming the care of infectious diseases. Across its business and through collaboration, Abbott will create new technologies to detect and monitor infectious diseases such as COVID-19, HIV, malaria and hepatitis, as well as tomorrow's pandemic threats.
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 109,000 colleagues serve people in more than 160 countries.
Roche awarded WHO prequalification for the HIV and HCV tests on the cobas 6800/8800 Systems
11 March 2021 - For patients living in areas with limited healthcare resources, WHO prequalification ensures access to the highest quality diagnostics. Access to broader reliable diagnostic solutions helps healthcare communities working to expedite and increase disease elimination programs. Roche’s Global Access Program provides innovative diagnostic solutions improving disease and patient management for those most in need.
Basel, 11 March 2021 -- Roche today announced that the cobas® HIV-1 and cobas® HCV Tests for use on the cobas® 6800/8800 Systems have been awarded World Health Organization (WHO) prequalification. WHO prequalification helps regulators and procurers in low and middle-income countries to identify products that meet high quality standards and are safe and suitable for their intended use. This is of benefit to healthcare professionals and patients, for whom quality assured IVDs are essential for effective diagnosis and monitoring of therapeutic efficiency. Increased access to diagnostic testing and monitoring for HIV and hepatitis C virus (HCV) provides broader reliable solutions to patients living in remote settings. Without accurate diagnosis, appropriate disease management may be delayed.
For people who can not easily access healthcare facilities, the ability to simplify blood collection and sample transportation on a stable device improves access to reliable diagnostics. The cobas HIV-1 Test can be used in conjunction with the first-of-its-kind cobas® Plasma Separation Card to process dried plasma spot samples collected in remote areas, where access to testing facilities can be difficult.
“We are focusing on improving patient and disease management where it is needed most. Sustainable solutions can help healthcare providers more efficiently work towards eliminating infections,” said Thomas Schinecker, CEO Roche Diagnostics. “Since we launched the Global Access Program in 2014, access to innovative diagnostics solutions has improved in countries with high disease burdens. There is still more work that needs to be done and with the WHO prequalification more people around the world will have access to high-quality diagnostics.”
Roche is committed to helping countries scale up HIV elimination programs and reach the WHO 2030 goals of 95% of people living with HIV knowing their HIV status; 95% of HIV-positive people on treatment; and 95% of people on treatment having suppressed viral loads. Roche also strives to help reach the 2030 hepatitis elimination targets of 90% reduction in new chronic hepatitis B and C cases; 65% reduction in hepatitis-related deaths and 80% of eligible people with chronic hepatitis B and C infections receiving treatment.
About the Global Access Program
In 2014, Roche announced the Global Access Program for increased access to HIV diagnostics. Roche partnered with national governments, local healthcare facilities, communities and international agencies, including UNAIDS, Clinton Health Access Initiative (CHAI), Unitaid, the U.S. President’s Emergency Plan for AIDS Relief (PEPFAR), Global Fund and Center for Disease Control and Prevention (CDC), to establish programs that would go beyond providing diagnostic tests.
Since its inception, the program has expanded substantially in menu and geographic footprint to provide increased access to diagnostics at affordable pricing for qualifying organizations in eligible countries with the highest disease burden. The Global Access Program includes diagnostic solutions for HIV, Mycobacterium tuberculosis (MTB), Hepatitis B and C (HBV and HCV), and Human Papillomavirus (HPV) to help towards implementation of elimination programs in efforts to eradicate disease and in line with the WHO 2030 elimination goals.
About the cobas Plasma Separation Card
According to the WHO, plasma is the preferred sample type for viral load diagnostic testing to ensure accurate results versus potential excessive quantification of the viral load result in whole blood. In the size of a simple credit card, the cobas Plasma Separation Card is a stable and easy-to-use sample collection device for HIV plasma viral load testing. By providing a small amount of a patient’s blood from a fingertip, this specially designed card simplifies blood collection and sample transportation - even in areas of extreme heat and humidity - as it is sent by post to the testing laboratory, no refrigeration required. The card is the only CE-marked plasma sample collection device which meets the WHO sensitivity standard of < 1000 cp/mL and fundamentally changes the way plasma samples are taken and processed allowing for reliable quantitative testing for determining HIV viral load.
About the cobas® 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® Systems are designed to ensure a lab’s long-term sustainability and success … now, more than ever.
Learn more now: http://diagnostics.roche.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 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 2020 employed more than 100,000 people worldwide. In 2020, Roche invested CHF 12.2 billion in R&D and posted sales of CHF 58.3 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-2021-03-11b.htm
Luminex Submits Joint SARS-CoV-2 and Flu/RSV Respiratory Panel to FDA for Emergency Use Authorization
10 March 2021
AUSTIN, Texas, March 10, 2021 -- Luminex Corporation today announced that it has submitted an Emergency Use Authorization application to the U.S. Food and Drug Administration for the company's new multi-analyte respiratory panel combining Flu A/B and respiratory syncytial virus (RSV) targets with the SARS-CoV-2 target. The ARIES® Flu A/B & RSV+SARS-CoV-2 Assay can be run on all Luminex ARIES® Systems. This submission represents completion of a key milestone in a Luminex funding award from the Biomedical Advanced Research and Development Authority (BARDA), which helped support the rapid development and validation of the assay.
Respiratory infections such as COVID-19 and influenza can be challenging to differentiate and diagnose because they often have overlapping symptoms. Luminex designed the combined assay to quickly deliver clear answers about these infections from a single test and, thereby, help clinical-care teams treat patients more effectively. The ARIES® Flu A/B & RSV+SARS-CoV-2 Assay can be run on six-unit and 12-unit ARIES® Systems with minimal hands-on time, producing results in approximately two hours. The ARIES® System is an FDA-cleared, sample-to-answer, automated molecular diagnostics platform designed for use in moderate and high complexity labs.
Importantly, the ARIES® Flu A/B & RSV+SARS-CoV-2 Assay is expected to detect new variants of the coronavirus. An in silico analysis of molecular probes used in the assay compared to SARS-CoV-2 sequences available in the GISAID database as of February 11, 2021, determined that key sequences still match and should yield a positive result. The analysis included variants originally detected in the United Kingdom (B.1.1.7), South Africa (B.1.351 or 20H/501Y.V2), Brazil (P.1 lineage or 20J/501Y.V3), and California (one of five reoccurring mutations that constitute the B.1.429 lineage and CAL20C).
"We are grateful to BARDA for supporting development of this important new assay, and are pleased to have fulfilled our commitment to file for EUA so quickly," said Nachum "Homi" Shamir, Chairman, President and CEO of Luminex. "It is critical to continue expanding the number of FDA-authorized assays that include SARS-CoV-2 detection for a broad range of clinical uses, and we're proud to have developed a single assay that provides answers about some of the most common respiratory infections – including SARS-CoV-2 - in just two hours."
BARDA is part of the US Department of Health and Human Services and is tasked with protecting the country against emerging infectious diseases and other threats. Through public-private partnerships, BARDA supports the development of vaccines, drugs, and diagnostics. Luminex developed the original ARIES® SARS-CoV-2 Assay with financial support from BARDA earlier this year.
Since the COVID-19 pandemic began, Luminex has expanded capacity for SARS-CoV-2 testing across its diagnostic platforms. The company previously launched the NxTAG CoV Extended Panel under an EUA from the FDA and an Authorization for Import or Sale with Conditions from Health Canada, and also received FDA EUA for its ARIES® SARS-CoV-2 Assay. It also received an EUA from the FDA for its xMAP® SARS-CoV-2 Multi-Antigen Immunoglobulin G (IgG) Assay, a serology test that can be run on any of Luminex's xMAP-based, high-throughput, gold-standard multiplex platforms.
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, Division of Research Innovation and Ventures under Contract No. 75A50121P00025.
About Luminex Corporation
At Luminex, our mission is to empower labs to obtain reliable, timely, and actionable answers, ultimately advancing health. We offer a wide range of solutions applicable in diverse markets including clinical diagnostics, pharmaceutical drug discovery, biomedical research, genomic and proteomic research, biodefense research, and food safety. We accelerate reliable answers while simplifying complexity and deliver certainty with a seamless experience. To learn more about Luminex, please visit us at luminexcorp.com. To learn more about Luminex's COVID-19 Testing and Research Solutions, please visit: https://www.luminexcorp.com/solutions/.
ALM-Update: SARS-CoV-2-PCR-Positivrate stagniert bei ca. 6,4 Prozent
10 March 2021
10 March 2021 -- Die aktuelle Datenauswertung der ALM zeigt, dass die AHA-Regeln weiterhin konsequent eingehalten werden müssen, was die positiven Schnell- und Selbsttests durch die PCR-Diagnostik bestätigen. Weiterhin leicht steigende Zahlen an in Anspruch genommenen SARS-CoV-2-PCR-Tests, eine Positivrate auf etwa gleichbleibendem Niveau und die erwartete weitere usAbreitung der Variante B.1.1.7. Das ist das Ergebnis der wöchentlichen Datenerhebung der Akkreditierten Labore in der
Medizin – ALM e.V., an der wieder 171 Labore der ambulanten und stationären Versorgung teilgenommen haben. Wegen des Feiertags in Berlin gingen die Zahlen erst im Laufe des heutigen Dienstags ein. In der KW 09 wurden insgesamt 1.020.839 SARS-CoV-2-PCR-Tests durchgeführt, 3 Prozent mehr als in der Woche zuvor (991.290). Die Positivrate blieb in der KW 09 auf annährend gleich hohem Niveau bei 6,4 Prozent (Vorwoche: 6,5 Prozent). Insgesamt fielen 64.979 (Vorwoche: 64.644) SARS-CoV-2-PCR-Tests positiv aus.
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Thermo Fisher Scientific Launches Customizable TaqMan SARS-CoV-2 Mutation Panel
10 March 2021 - Panel designed to provide surveillance of ongoing mutations of virus that causes COVID-19
CARLSBAD, Calif., March 10, 2021 -- Thermo Fisher Scientific, the world leader in serving science, today announced the launch of its Applied Biosystems TaqMan SARS-CoV-2 Mutation Panel, a customizable menu of 22 verified real-time PCR assays for identification of SARS-CoV-2 mutations. These assays enable surveillance of variants that are causing COVID-19 infections in specific regions globally and allow laboratories to choose which mutations to track.
SARS-CoV-2 has mutated countless times, with some variants potentially impacting efficacy of treatments and vaccines, stressing the importance of continued surveillance of viral changes. The TaqMan SARS-CoV-2 Mutation Panel is designed to be highly scalable, being able to run a few or hundreds of samples to identify one or many mutations. This provides laboratories with the ability to meet various levels of testing need with real-time PCR instruments they already use.
"With an evolving virus, having up to date, reliable and accurate information is critical in fighting back," said Mark Smedley, president of the genetic sciences business of Thermo Fisher Scientific. "With this panel, we're empowering researchers and clinicians by putting another tool in their hands to monitor changes in the virus so they can make informed and effective decisions for overall public health."
The TaqMan SARS-CoV-2 Mutation Panel provides results in about an hour and is based on gold standard TaqMan SNP genotyping assay technology, which can help to detect and distinguish mutations efficiently.
About Thermo Fisher Scientific
Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $30 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 80,000 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.
BD Announces Collaboration with ImageMover for Rapid Antigen Test Reporting
9 March 2021 - Reporting app helps facilitate SARS-CoV-2 testing and result reporting from BD Veritor™ Plus System
FRANKLIN LAKES, N.J., March 9, 2021 -- BD (Becton, Dickinson and Company), a leading global medical technology company, today announced an agreement with ImageMover, a software platform that automates and simplifies medical data collection and management, to offer a companion mobile app that enables more streamlined reporting of SARS-CoV-2 antigen testing results performed on the BD Veritor™ Plus System at everyday testing locations, such as schools and businesses. The ImageMover app is available immediately for BD Veritor™ Plus System customers.
COVID-19 testing in everyday settings presents challenges in managing test subject demographics and results. The ImageMover app enables organizations performing point-of-care testing to efficiently capture required demographic details of those being tested, upload COVID-19 test results, report results to appropriate stakeholders and automate reporting to federal and state agencies. While the BD Veritor™ Plus System has built-in functionality to allow for data sharing to electronic health records through the BD Synapsys™ Informatics platform, that functionality requires an information technology infrastructure common to diagnostic testing locations in health care facilities such as hospitals, doctor's offices and urgent care centers. The addition of the ImageMover app provides the benefits of seamless and secure data sharing for everyday locations that don't have a health care information technology platform in place.
"The ImageMover app helps resolve a major administrative reporting burden for 'return to normal' testing and further strengthens the advantages of using a digitally read test like the BD Veritor™ Plus System," said Dave Hickey, president of Life Sciences for BD. "From handheld portability to a simple workflow to a definitive digital readout of results that eliminates human subjectivity and now an automated reporting tool, the BD Veritor™ Plus System provides the simplicity needed for novice testers."
The ImageMover app coordinates with the BD Veritor™ Plus System to upload testing results for streamlined reporting and significantly reduced manual documentation. The app is compliant with patient privacy requirements under the Health Insurance Portability and Accountability Act of 1996 (HIPAA).
"ImageMover has pioneered a highly secure mobile solution for managing the end-to-end workflow for point-of-care COVID-19 test administration and result management," said Laura Brown, chief clinical officer at ImageMover. "Now, organizations without sophisticated information systems can more easily manage the data associated with testing from anywhere and across any care setting with the BD Veritor™ Plus System. With ImageMover, these non-acute organizations now have a solution that automatically submits test results to public health authorities. In addition, we securely share test subject results with the individuals directly. We are excited to partner with BD to increase access to a comprehensive testing solution for organizations struggling with point-of-care testing today."
For traditional acute care settings, the optional BD Synapsys™ Informatics solution will continue to deliver automated result reporting, provide streamlined CARES Act and other Health & Human Services-mandated reporting functionality, and offer analytics and reports to support clinical and operational decision-making.
The ImageMover app differs from BD's previously announced collaboration with Scanwell Health, which was created to develop a lateral flow antigen test to be paired with the Scanwell Health mobile app for at-home use. The Scanwell Health app is expected to provide step-by-step instructions on how to collect and transfer a nasal swab sample, perform the test and use the mobile device's camera to analyze and interpret results in the home. The ImageMover app still requires the use of the BD Veritor™ Plus System to read the results of the test, but it provides a more streamlined reporting tool for testing locations that don't have a health care IT infrastructure.
BD has been on the forefront of the COVID-19 response providing innovative solutions for immunology research, molecular- and antigen-based diagnostics, devices that aid in therapeutics and injection devices for vaccine administration. For more information about the BD Veritor™ Plus System, please visit bdveritor.com
About the BD Veritor™ Plus System for Rapid Detection of SARS-CoV-2 Assay
The BD Veritor™ Plus System for Rapid Detection of SARS-CoV-2 Assay has not been cleared or approved by FDA but has been authorized by FDA under an Emergency Use Authorization (EUA) for use by authorized laboratories. This product has been authorized only for the detection of proteins from SARSCoV-2, not for any other viruses or pathogens, and this product 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 declaration is terminated or authorization is revoked sooner.
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 70,000 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.
About ImageMover
ImageMover is a medical software company that innovates seamless point-of-care medical workflow software solutions for healthcare professionals and patients. The company's solutions employ an exclusive approach to securely capture and integrate medical data to simplify communication and enhance patient care. For more information, visit http://imagemovermd.com/ or email Info@ImageMoverMD.com.
PerkinElmer Launches Comprehensive Solutions for Detecting SARS-CoV-2 Mutations
9 March 2021 - Company expands SARS-CoV-2 assay portfolio with RT-PCR and next generation sequencing solutions to identify mutations associated with SARS-CoV-2 variants
WALTHAM, Mass., March 9, 2021 -- PerkinElmer, Inc. today announced the launch of two Research Use Only (RUO) solutions, PKamp™ VariantDetect™ SARS-CoV-2 RT-PCR Assay and Next Generation Sequencing-based NEXTFLEX® Variant-Seq™ SARS-CoV-2 Kit. Using nucleic acid extracted from samples that previously tested positive, laboratories can use these assays to identify genomic mutations reported in relation to SARS-CoV-2 variants.
Public health agencies such as the U.S. Food and Drug Administration (FDA) have alerted clinical laboratories and the healthcare community about SARS-CoV-2 viral mutations. Upon detecting a positive case using a first-tier diagnostic assay, second-tier assays such as the PerkinElmer PKamp VariantDetect and NEXTFLEX Variant-Seq kits provide further information about mutations in the sample. The PKamp VariantDetect SARS-CoV-2 RT-PCR assay can detect mutations associated with B.1.1.7, B.1.351 and P.1 variants, which are the predominant variant strains known today. The NEXTFLEX Variant-Seq SARS-CoV-2 WGS workflow can detect all SARS-CoV-2 genetic changes relative to the strain originally identified in Wuhan, China.
“While continuing to rely on gold-standard RT-PCR tests for COVID-19 diagnosis, we must understand emerging variants to effectively limit the spread of the virus,” said Masoud Toloue, Ph.D., senior vice president, diagnostics, PerkinElmer. “The second-tier assays made available today are the outcome of a product development engine primed to continue producing assays that will help labs outpace the virus.”
PerkinElmer continues to work on the frontlines of improving COVID-19 testing. The PerkinElmer® New Coronavirus Nucleic Acid Detection Kit is the most sensitive molecular test for COVID-19 on the market, according to comparative data released by a FDA Reference Panel, and can be used to test symptomatic or asymptomatic individuals, individually or in pools of up to five samples. The Company’s comprehensive SARS-CoV-2 offerings also include high throughput RNA extraction, RT-PCR, antigen testing, workflow 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 $3.8 billion in 2020, 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 on Creating a Simple Method of Diagnosing Alzheimer’s Disease Using Blood
8 March 2021 - Presenting the most recent data at the 15th international conference on Alzheimer’s & Parkinson’s diseases (AD/PD 2021)
8 March 2021 -- Sysmex Corporation (HQ: Kobe, Japan; Chairman and CEO: Hisashi Ietsugu; "Sysmex") will present the most recent data on using blood as a method of diagnosing Alzheimer’s disease at the 15th International Conference on Alzheimer’s & Parkinson’s Diseases (AD/PD 2021), held virtually from March 9 to 14, 2021. Sysmex is conducting this development in collaboration with Eisai Co., Ltd. (HQ: Tokyo, Japan; CEO: Haruo Naito; "Eisai").
In February 2016, Sysmex and Eisai signed a non-exclusive comprehensive agreement aimed at the creation of new diagnostics in the field of dementia. By leveraging each other’s technologies and knowhow, we aim to discover next-generation diagnostic drugs that will enable the early diagnosis, selection of treatment options, and regular monitoring of the effects of treatment for dementia. Sysmex and Eisai are pursuing joint development aimed at creating a simple method of diagnosing Alzheimer’s disease using blood. At AD/PD 2021, Sysmex will announce the most recent data regarding prediction of amyloid positivity by incorporating the APOE4 status into plasma Aβ ratio measurement on the HISCLTM automated immunoassay system.
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Asset in Development, Session Name |
Topic/Planned Date and Time (Eastern Standard Time) |
Presenter (Affiliation) |
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AD Diagnostics “Amyloid, Tau, and Synapse PET Imaging” |
A Fully Automated Plasma Aβ Assay Incorporating APOE4 Status Shows High Performance to Predict Amyloid Positivity Determined by Centiloids of Amyloid PET Session time: March 12 (Fri.) 10:00-12:00 Oral presentation: 11:15-11:30; live Q&A session: 16:30-17:00 |
Kazuto Yamashita (Sysmex) |
Sysmex is working to create new diagnostic technologies for the prevention and treatment of dementia. We aim to contribute to the advancement of healthcare and improve the quality of life for patients and their families.
Grifols fosters world’s first scientific journal specialized in blood plasma
8 March 2021 - Plasmatology aims to become the reference publication for plasma science, bringing together the discipline’s knowledge, research and scientific advances that until now lacked a specialized journal. The prestigious Publisher SAGE Publications, specializing in scientific journals, independently edits the new international, open access, peer-reviewed online publication, which debuts March 9.
Barcelona, Spain, March 8, 2021 -- Grifols, a global leader in plasma-derived therapies with a more than 100-year track record of contributing to the health and well-being of people, today announced it’s fostering the first scientific journal dedicated to the science of plasma, coinciding with the 70th anniversary of the international presentation of the plasmapheresis technique.
This procedure, which separates plasma from the other blood components that are then reinfused into the donor, was developed by Josep Antonio Grifols i Lucas in 1951 in Barcelona and today continues to be the gold standard for plasma collection globally.
Plasmatology, which begins publishing March 9, aspires to become the scientific reference in its field, featuring all relevant research related to plasma science, from basic research to clinical application.
The publication is edited independently, with its editorial committee and director answering only to the prestigious publisher SAGE Publications , a longtime publisher of respected scientific journals covering different medical disciplines, life sciences, engineering, the humanities and other areas.
The international, open access, peer-reviewed journal will publish manuscripts evaluated and vetted by independent experts. Researchers can send their work – original articles, case studies, technical essays, reviews, editorials and comments – to the editorial board for its consideration. All content will be indexed in PubMed Central, as well as other scientific data bases.
Grifols, as part of its longstanding commitment to the scientific community, will provide the journal with an educational grant during the next two years to establish the publication as a global source for the scientific knowledge and research accomplishments in plasma science.
According to Víctor Grifols Deu, co-CEO of Grífols, “At Grifols we’re celebrating the creation of Plasmatology and we believe without a doubt it will accelerate the knowledge and research of proprietary plasma therapeutics.”
Raimon Grifols Roura, co-CEO of Grifols, added: “In addition it’s particularly gratifying that the birth of the publication coincides with the 70th anniversary of the development of plasmapheresis by my uncle Josep Antoni Grifols i Lucas. The company’s commitment to research and scientific publishing forms part of his legacy.”
Abbott receives FDA EUA for laboratory PCR assay that detects and differentiates SARS-COV-2, FLU A, FLU B AND RSV in one test - and FDA EUA for asymptotic usage of alinity m COVID-19 test
5 March 2021 - Abbott's Alinity™ m Resp-4-Plex assay will allow healthcare workers to test for four viruses in one test, a critically important tool as flu presents with similar symptoms. The test helps save on much-needed testing supplies since it allows for testing for all four viruses with one swab. Assay will run on Abbott's most advanced molecular PCR platform, the Alinity m system, which provides fast results in high volumes. Abbott also received updated EUA for asymptomatic usage of its Alinity m SARS-CoV-2 assay.
ABBOTT PARK, Ill., March 5, 2021 -- Abbott today announced U.S. Food and Drug Administration (FDA) Emergency Use Authorization (EUA) for the company's Alinity™ m Resp-4-Plex molecular assay to detect and differentiate SARS-CoV-2, influenza A, influenza B and respiratory syncytial virus (RSV) in one test. This is an important tool because these viruses have similar symptoms but require different treatment approaches. This test is CE Marked and available in countries outside the U.S.
The Alinity m Resp-4-Plex test can be conducted with one swab specimen (anterior nasal or nasopharyngeal) collected by a healthcare provider or an anterior nasal swab specimen self-collected at a healthcare location from individuals suspected by their provider of respiratory viral infection consistent with COVID-19. Test will run on Abbott's Alinity m system — the company's most advanced high-volume laboratory molecular instrument. Alinity m uses Polymerase Chain Reaction (PCR) technology, which is known for its high sensitivity in detecting infectious diseases. To help fight the pandemic, Abbott has accelerated placements of the Alinity m system in hospital labs, academic centers and labs that are critical to patient care.
"Abbott has been developing and introducing tests that have been playing a critical role in fighting the pandemic. The need for a combination of testing methods in different settings has never been more clear," said Andrea Wainer, executive vice president, Rapid and Molecular Diagnostics, Abbott. "This newest test will allow for fast and efficient diagnosis and triage of patients who present with respiratory symptoms so they can be given the right care."
Advanced technology's role in the fight
The Alinity m Resp-4-Plex assay will be a critical tool in detecting these four prevalent respiratory viruses. The advanced technology of the Alinity m system provides automation and on-demand access, meaning an urgent test can be run at any time. This flexibility and efficiency allow for the testing of multiple diseases while still producing fast results in high volumes. This assay's ability to detect and differentiate these viruses simultaneously with only one swab will also ease the resource strain on collection devices, which have been in high demand throughout the COVID-19 pandemic.
Expanding Alinity m SARS-CoV-2 to asymptomatic cases
Abbott is also announcing that the EUA for the company's Alinity m SARS-CoV-2 test has been updated to include an asymptomatic claim – detecting COVID-19 in individuals who do not have symptoms. A recent study found that more than 60% of COVID-19 infections present as asymptomatic cases, which is why it's critical to catch those cases before they spread. With the recent update to the Alinity m SARS-CoV-2 test EUA, the assay can now be used to detect individuals who are infected with SARS-CoV-2, but do not have symptoms or other reason to suspect COVID-19 infection. The Alinity m SARS-CoV-2 test EUA was also updated to include a pooling claim, which allows up to five samples to be tested at the same time. The updated Alinity m SARS-CoV-2 test, Alinity m Resp-4-Plex assay, and Abbott's existing testing technologies will now all be available to support front-line healthcare workers.
About Alinity m
Assays available for use on the Alinity m system worldwide include: SARS-CoV-2, HCV (hepatitis C), HBV (hepatitis B), HIV-1 (human immunodeficiency virus type 1), STI (CT/NG/TV/MG) and HR HPV. The easy-to-use system will help to improve laboratory workflow and efficiency with its large capacity and fast turnaround time, being able to run up to 1,080 tests in a 24-hour period based on laboratory practice and workflow. Alinity m systems are designed to be more efficient – running more tests in less time and minimizing human errors – while continuing to provide quality results. The availability of the Alinity m system and tests varies by geography. More information is available at molecular.abbott.
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 109,000 colleagues serve people in more than 160 countries.
Illumina and R-Pharm Secure Registration for Two Complete IVD Sequencing Platforms in Russia
5 March 2021
SAN DIEGO, 5 March 2021 -- Illumina, Inc.’s NextSeq™ 550Dx platform and associated reagent kits received medical device registration in Russia, as have reagents for the MiSeq™Dx which was approved previously as a medical device. Both of these in vitro diagnostic (IVD)-ready solutions are available to customers and third-party developers to create diagnostic solutions using the technology. These registrations will catalyze the expansion of sequencing-based clinical diagnostics across the country.
Sequencing platforms, and the reagents that drive them, must be approved separately in Russia by the medical device regulatory agency, Roszdravnadzor. Illumina’s strategic partner in Russia and CIS, R-Pharm, led the regulatory process and this is the first approval of complete sets of sequencing instruments plus reagents.
“Having the two IVD-platforms available to assay developers to expand the clinical use of Next Generation Sequencing-based (NGS) molecular diagnostics will be a great boost to testing for genetic diseases and oncology in Russia,” said Paula Dowdy, Senior Vice President and General Manager of Illumina, Europe Middle East and Africa. “The NextSeq 550Dx is ideal for high throughput sequencing at large, federal hospitals, and the desktop MiSeqDx is well suited to the laboratory facilities of standard clinical centers.”
“These registrations are a significant step in bringing NGS technologies closer to patients, many of whom live near the smaller municipal and regional clinics. Bringing NGS diagnostics, with accurate and validated results, will be a huge benefit to patients,” said deputy Director General of the Dmitry Rogachev National Medical Research Center of Pediatric Hematology, Oncology and Immunology, Professor Mikhail Maschan.
Director of the Tomsk National Research Medical Center, correspondent member of the Russian Academy of Sciences, Vadim Stepanov, said: “Genetics and molecular biology are the core of clinical science because the majority of diseases originate from genetic mechanisms in cells, tissues and organs. Registration of Illumina’s products as medical devices allows to add the most modern technologies to clinical practice.”
“We are pleased that our partnership with Illumina, a global leader in human genome sequencing, will help Russian patients benefit from improved diagnosis and precision healthcare,” said Alexey Repik, R-Pharm Chairman of the Board.
About R-Pharm
R-Pharm Group introduces comprehensive solutions for the healthcare system and focuses on research, development, manufacturing and commercialization of pharmaceuticals, laboratory equipment and medical devices. R-Pharm's mission is to increase the accessibility of advanced diagnostics, preventative care and therapy methods in Russia and abroad. More than 4500 employees of the group in 70 branches and 30 countries of the world do their best to provide as many people as possible with the necessary means to improve and prolong their lives. To learn more, visit www.rpharm.com.
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.
BioGX Sample-Ready™ technology launches into Space yet again, aboard the International Space Station
4 March 2021
BIRMINGHAM, ALABAMA, 03 March 2021 – BioGX Sample-Ready™ lyophilized qPCR technology was selected by the NASA WetLab-2 program in 2016 to conduct genetic analysis in a microgravity environment aboard the International Space Station (ISS). Five years and several launches later, the collaboration is still going strong with a track record of success.
The International Space Station (ISS) is the world’s leading laboratory for cutting-edge research and innovation. “We are proud to be NASA’s partner in their quest for high-performing, innovative molecular chemistries. Our outer space innovations find their way in creating best in class molecular diagnostics solutions for any lab setting, here on earth” said Shazi Iqbal, Ph.D., CEO of BioGX.
BioGX support was essential for the successful launch of the latest One-Step Gene sampling tool for genetic analysis on the ISS. At the core of this technology is a microscopic probe for rapid and single-step purification of RNA from biological specimens using a pin interface with the Cepheid SmartCycler instrument that is currently on the ISS. The One-Step Gene Sampler was developed in a collaboration between Dr. Gergana G. Nestorova (Louisiana Tech University, Ruston, LA), Dr. Niel Crews (nou Systems Inc, Huntsville, AL), and the WetLab-2 team at NASA ARC. The latest batch of BioGX Sample-Ready™ lyophilized reagents and the One-Step Gene Sampler were launched on Space-X21 in December,2020 and are scheduled for testing this month.
“BioGX worked with us to develop a custom-designed lyophilized mixture for the reverse-transcription PCR experiment in orbit. The company provides our reagents in a ready-to-use format, customized in SmartCycler tubes that require only the addition of water before the actual genomic experiment in orbit. The reverse-transcription PCR reagents supplied by BioGX provide excellent sensitivity and reproducibility. Due to the constraints of performing experiments in space, the traditional liquid suspension format of PCR reagents is not appropriate for delivery to the ISS. Therefore, the lyophilization method developed by BioGX is essential for the preparation of PCR reagents for launch and storage in orbit.” said Dr. Gergana G. Nestorova of Louisiana Tech University, Ruston, LA.
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.
Luminex Receives FDA Emergency Use Authorization and CE Mark for Expanded NxTAG® Respiratory Panel Test Including SARS-CoV-2
4 March 2021 - Provides labs with high throughput, syndromic respiratory testing capabilities
AUSTIN, Texas, March 4, 2021 -- Luminex Corporation today announced that it has received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) for a new expanded version of its NxTAG® Respiratory Pathogen Panel (RPP) that includes the SARS-CoV-2 virus for high-throughput respiratory testing. The new test is a combination of the company's original NxTAG RPP, an FDA-cleared in vitro diagnostic for syndromic respiratory infection testing, and SARS-CoV-2.
Respiratory infections such as COVID-19 and influenza can be challenging to differentiate and diagnose because they often have overlapping symptoms. NxTAG RPP is a multiplex, high-throughput test designed to enable simultaneous detection of the most common respiratory pathogens for a fast, syndromic testing approach. Following the addition of the SARS-CoV-2 virus target, the panel now includes 19 viral and 2 bacterial targets, combining the most common respiratory pathogens in one panel to help facilitate the rapid identification of various individual and co-occurring infectious pathogens.
NxTAG RPP provides scalable throughput, allowing clinical labs to run up to 96 samples at a time—generating results in approximately four hours with minimal hands-on time. The test runs on Luminex's easy-to-use, compact MAGPIX® System and is designed for use in high-complexity molecular laboratories.
Importantly, the NxTAG RPP + SARS-CoV-2 Assay is expected to detect new variants of the coronavirus. An in silico analysis of molecular probes used in the assay compared to SARS-CoV-2 sequences available in the GISAID database as of February 11, 2021, determined that key sequences still match and should yield a positive result. The analysis included variants originally detected in the United Kingdom (B.1.1.7), South Africa (B.1.351 or 20H/501Y.V2), Brazil (P.1 lineage or 20J/501Y.V3), and California (one of five reoccurring mutations that constitute the B.1.429 lineage and CAL20C).
"Given the emergence of new respiratory pathogens and new variants of these pathogens, it will be increasingly challenging to identify and distinguish the presence and co-existence of SARS-CoV-2, influenza, and other common respiratory pathogens. As a highly accurate, low-cost, multiplex test, our NxTAG RPP + SARS-CoV-2 test delivers an ideal solution for this challenge," said Nachum "Homi" Shamir, Chairman, President and CEO of Luminex. "Clinical laboratories using the assay will be able to scale-up their testing for both COVID-19 and the flu with one high-capacity diagnostic platform that can provide much-needed information for appropriate patient treatment. This is especially important given that the symptoms for the flu, COVID-19, and other respiratory illnesses can be very similar, but their treatment may be very different."
A version of the assay, which also detects Legionella pneumophila and the 2009 H1N1 Flu A subtype, also just received a CE Mark, and was commercialized last month in Europe.
Since the COVID-19 pandemic began, Luminex has expanded capacity for SARS-CoV-2 testing across all of its molecular platforms. The company previously launched the NxTAG CoV Extended Panel under an EUA from the FDA and an Authorization for Import or Sale with Conditions from Health Canada, and also received FDA EUA for its ARIES® SARS-CoV-2 Assay. In August, the company announced it received an EUA from the FDA for its xMAP® SARS-CoV-2 Multi-Antigen Immunoglobulin G (IgG) Assay, a new serology test that can be run on any of Luminex's xMAP-based, high-throughput, gold-standard multiplex platforms. The test detects IgG antibodies, which are an important component of an adaptive immune response and typically reflect sustained immunity to a given pathogen.
The NxTAG CoV Extended Panel and the ARIES® SARS-CoV-2 Assay have each been funded with $642,450 of Federal funds, approximately 36% each of the expected overall cost of development, from the Department of Health and Human Services; Office of the Assistant Secretary for Preparedness and Response; Biomedical Advanced Research and Development Authority, Division of Research Innovation and Ventures under Contract Nos. 75A50120C00037 (NxTAG CoV Extended Panel) and 75A50120C00043 (ARIES® SARS-CoV-2 Assay). Luminex financed the remaining $1,118,663 of each program, constituting 64% each of the total program costs.
About Luminex Corporation
At Luminex, our mission is to empower labs to obtain reliable, timely, and actionable answers, ultimately advancing health. We offer a wide range of solutions applicable in diverse markets including clinical diagnostics, pharmaceutical drug discovery, biomedical research, genomic and proteomic research, biodefense research, and food safety. We accelerate reliable answers while simplifying complexity and deliver certainty with a seamless experience. To learn more about Luminex, please visit us at luminexcorp.com.
Der Corona-Selbsttest zum Gurgeln (logo! ZDF-Kindernachrichten)
4 March 2021
4 March 2021 -- logo-Reporterin Maral war zu Gast in der SYNLAB-Teststation in Augsburg um den Corona-Selbsttest mit Rachen-Spülwasser zum Gurgeln zu testen.
Zum Videobeitrag: https://www.zdf.de/kinder/logo/selbsttest-corona-maral-100.html
Antibiotic Induced Hearing Loss update new clinical guidance in the UK supports assay
3 March 2021
3 March 2021 -- genedrive plc, the near patient molecular diagnostics company, provides an update on its Antibiotic Induced Hearing Loss (“AIHL”) assay. As announced on the 3 December 2020, an 11 month implementation trial at Manchester University NHS Foundation Trust and and Liverpool Women’s Hospital successfully concluded in November 2020. The results of the study will be published in a peer reviewed journal. The study’s primary outcomes were very positive, showing genedrive’s utility as the world’s first rapid genetic test in an emergency care neonatal setting. In excess of 750 babies were tested and 160 hospital staff were trained to provide rapid testing in this critical care setting.
Since completion of the trial, there has been new clinical guidance in the UK on the importance of the management of specific genetic mutations and their role in hearing loss as a result of antibiotics (“ototoxicity”). Government and Society guidance are considered a key factor influencing the speed and extent of future adoption. The Company and Inspiration Healthcare Group plc (AIM: IHC), the distribution partner for the AIHL assay, believe this will lead to increased demand for the genedrive AIHL test in the UK. This new government guidance reminds healthcare professionals about the impact of antibiotic related ototoxicity and to consider the need for genetic testing prior to initiation of treatment. genedrive’s assay is the only commercial point of care test available for the testing of MT-RNR1, the most important mutation contributing to AIHL in infants.
The launch of the genedrive AIHL assay remains on track for summer 2021 and the Company is enthusiastic about both the commercial prospects and the clinical benefits of this novel test to prevent potential irreversible hearing loss and this test becoming a standard of care. The Company is executing initial stage key opinion leader engagement in the UK alongside Inspriration Healthcare in preparation for commercial launch.
David Budd, CEO of genedrive plc, said: “We had the privilege of working with Manchester University NHS Foundation Trust and Liverpool Women’s Hospital throughout 2020 on the first deployment globally of a point of care test system to screen for MT-RNR1 – a mitochondrial mutation closely associated with ototoxicity in infants. Despite the emergence of COVID-19, our clinical partners showed huge dedication in keeping this important project on-track, becoming the first in the world to generate valuable information on the utility of this approach in an emergency care setting. As we see updated guidance and greater awareness to the requirement for genetic testing, we only expect increased interest in our novel assay.”
Reference: https://www.genedrive.com/news/index.php
BGI Donates COVID-19 Testing Kits to Bosnia and Herzegovina
3 March 2021
3 March 2021 -- BGI on Tuesday held an online signing ceremony with the Ministry of Health and Social Welfare of the Republic of Srpska, Bosnia and Herzegovina, and its Public Health Institute, to donate 5,000 COVID-19 test kits and help fight against the local pandemic. The Mammoth Foundation provided full supports for this donation.
Dr. Alen Šeranić, the Minister of Health and Social Welfare of the Republic of Srpska, Bosnia and Herzegovina, Mr. Branislav Zeljković, the Director of the Public Health Institute, and Dr. Li Ning, Vice President of BGI, jointly signed the agreement of donation.
Dr. Nina Sajić, the advisor in the Cabinet of the Serbian member of the Presidency of Bosnia and Herzegovina, Mr. Xie Yu, Economic and Commercial Counsellor, Embassy of China to Bosnia and Herzegovina, Dr. Yin Ye, Chief Executive Officer of BGI Genomics and Mr. Wang Kai, Secretary-General of Mammoth Foundation attended the signing ceremony.
Dr. Yin Ye, CEO of BGI Genomics, said that BGI is proud to do its part in Bosnia and Herzegovina. BGI has a motto, “Omics for All”, and hopes to use its research and expertise to improve people’s welfare.
Dr. Seranic and Dr. Sajic, in their expression of appreciation and gratitude, said that BGI’s donation will be a strong support to the fight against the pandemic in the country. They expected to discuss cooperation further.
Mr. Xie Yu, Economic and Commercial Counsellor from the Embassy of China, praised the donation and said it is a reflection of friendship and mutual support between the peoples of the two countries.
Since the outbreak of the COVID-19 pandemic, the order of BGI’s testing kits have covered over 180 countries and regions. More than 80 Huo-Yan laboratories have been established. Besides, BGI joins forces with the Mammoth Foundation to donate COVID-19 test kits and equipment. It’s dedicated to making contributions in the global fight against the pandemic.
Reference: https://www.bgi.com/global/company/news/bgi-donates-covid-19-testing-kits-to-bosnia-and-herzegovina/
Quidel receives Emergency Use Authorization for QuickVue® At-Home COVID-19 Test
1 March 2021 - Easy-to-use at-home test provides results in ten minutes with a doctor’s prescription
SAN DIEGO, 1 March 2021 -- 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 an Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA), allowing the company to market its new QuickVue® At-Home COVID-19 Test for the qualitative detection of the nucleocapsid protein antigen from SARS-CoV-2. This test is authorized for prescription home use with self-collected (unobserved) anterior nares (NS) swab specimens directly from individuals aged 14 years and older who are suspected of COVID-19 by their healthcare provider within the first six days of the onset of symptoms. This test is also authorized for prescription home use with adult-collected anterior NS samples directly from individuals aged 8 years or older who are suspected of COVID-19 by their healthcare provider within the first six days of the onset of symptoms.
Quidel has provided rapid COVID-19 testing through doctors and health care providers throughout the pandemic, manufacturing and shipping millions of Sofia® tests last year. Now, Quidel’s QuickVue® At-Home COVID-19 Test will allow patients with a prescription to easily perform the test themselves and get results in 10 minutes. The QuickVue® At-Home COVID-19 Test shows excellent performance, with positive results agreeing with PCR 84.8% of the time, and negative results agreeing 99.1% of the time, delivering confidence to patients running the test and facilitating informed discussions with doctors.
“Quidel’s employees have truly risen to the challenge of the SARS pandemic. Our mission is to provide greater access to frequent, affordable and highly accurate diagnostic testing, and ultimately to enable individuals to take charge of their own health and help them make prudent decisions to protect themselves and their loved ones,” said Douglas Bryant, president and CEO of Quidel Corporation. “This is an important first step in a two-step process that, once additional ongoing studies are completed, will further expand access to frequent testing at home.”
The QuickVue® At-Home COVID-19 Test employs the same Quidel lateral flow technology used for decades by healthcare professionals and features the same SARS CoV-2 rapid antigen test strip and reagent solution that received an EUA from the FDA for use in professional settings in December 2020. Quidel’s contract with the National Institutes of Health’s Rapid Acceleration of Diagnostics initiative was expanded in late 2020 to include the QuickVue At-Home COVID-19 test, which expedited its emergency use authorization.
Quidel recently started the buildout of a new manufacturing facility in Carlsbad, CA. The 128,000 square foot facility is expected to be the company’s highest-volume production facility and begin operations in the second half of 2021, initially with a mission to produce more than 50 million QuickVue® rapid antigen tests per month, or 600 million tests per year at full capacity.
“The flexibility of our QuickVue® At-Home COVID-19 Test for meeting the urgent testing needs of individuals at home will save time and enable doctors and telemedicine providers to determine appropriate treatments without exposing their staff and other patients to heightened risk of infection,” Mr. Bryant noted. “We hope to bring the benefits of this technology to more broadly serve consumers, school systems, businesses and remote communities in the near future.”
Quidel’s QuickVue® brand launched in 1986 with visually read rapid diagnostics focusing on women’s health and respiratory diseases. In 1999, QuickVue® Influenza A+B was the first visually read rapid test approved by the FDA for professional use. 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. Today, QuickVue® is a market leading platform in the professional segment for visually diagnosing Influenza, respiratory syncytial virus, Strep A and a variety of other illnesses. Since the launch of the QuickVue® brand into the professional segment, more than 150 million QuickVue® diagnostic tests have been sold.
The QuickVue At-Home COVID-19 Test is intended for self-use and/or, as applicable for an adult lay user testing another person aged 8 years or older in a non-laboratory setting. The QuickVue At-Home COVID-19 Test is only for use under the Food and Drug Administration’s Emergency Use Authorization. The QuickVue® At-Home Covid-19 Test has not been FDA cleared or approved. The test has been authorized only for the detection of proteins from SARS-CoV-2, not for any other viruses or pathogens, and 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 Federal Food, Drug and Cosmetic Act, 21 U.S.C. § 360bbb-3(b)(1), unless the declaration is terminated or authorization is revoked sooner.
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.
Grifols acquires 25 U.S.-based plasma centers from BPL ensuring one million additional liters for fractionation
1 March 2021 - Grifols will immediately increase its plasma supply following the acquisition of these 25 plasma centers, which obtain a run-rate of 1 million liters of plasma per year. The USD 370 million transaction will be financed from Grifols’ own resources. This acquisition promotes the global expansion and plasma-supply diversification strategy of the company, an industry leader with 344 plasma centers worldwide: 289 in the U.S. following this transaction and 55 in Europe. Grifols remains committed to increasing its supply of plasma and plasma-derived therapies to ensure patients continue to receive the treatments and healthcare they need.
Barcelona, March 1, 2021 -- Grifols, a global leader in the development of plasma-derived therapies dedicated for more than 100 years to enhancing people’s health and well-being, finalized a USD 370 million transaction to acquire 25 U.S.-based plasma donation centers from BPL Plasma Inc., a subsidiary of Bio Products Laboratory Holdings Limited. The transaction has received the applicable regulatory clearances and will be financed with Grifols’ own resources, without issuing debt.
In accordance with the company’s strategic plan to advance its plasma-collection leadership, this transaction expands, reinforces and diversifies Grifols’ already-robust network of centers and capacity to supply life-enhancing plasma-derived medicines to patients.
In parallel, the transaction also builds on its network of plasma centers, which represents an important competitive advantage. Grifols remains committed to increasing the availability of its essential plasma-derived products to meet growing demand.
Grifols was able to limit its net plasma supply impact by roughly 15% in 2020 despite of COVID-19-related constraints. In 2021, the company is ready for a rebound in its plasma-collection levels in the wake of wider vaccination deployments and the ease of COVID-19 constraints. Grifols is also advancing on the execution of its expansion plan, comprising organic and inorganic growth.
As part of its organic efforts, the company plans to open between 15 and 20 new plasma centers in 2021. Thanks to its agile management, Grifols will open several plasma centers in Egypt in 2021, following the strategic alliance signed with the Egyptian government in November 2020.
Grifols now operates 344 plasma centers worldwide: 289 in the U.S. and 55 in Europe across Germany, Austria and, recently Hungary. The 25 centers acquired from BPL are authorized by the U.S. Food and Drug Administration (FDA) and the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA).
Grifols retained the legal services of Osborne Clarke, S.L.P. for this transaction.
Expanding its plasma supply to ensure patients’ access to treatments
Plasma-derived medicines are used to treat or prevent serious disorders or diseases in a range of therapeutic areas, including pulmonology, hematology, immunology and neurology.
Grifols is making every effort to increase its supply of plasma and plasma-based therapies to ensure patients continue to receive the treatments and healthcare they need. The company also joined global appeals to mobilize all qualified individuals to donate plasma, including both patients recovered from COVID-19 and those unaffected by the virus, given its critical role in the production of life-saving plasma-derived medicines.
Roche SARS-CoV-2 Rapid Antigen Test receives special approval for at-home patient self-testing using nasal swabs in Germany
26 February 2021 - Special approval from German Federal Institute for Drugs and Medical Devices (BfArM) enables home use of a SARS-CoV-2 Rapid Antigen Test using a simple nasal swab. The test will be widely available in pharmacies across Germany.
Basel, 26 February 2021 -- Roche today announced it has been granted special approval by the German Federal Institute for Drugs and Medical Devices (BfArM) to offer the SARS-CoV-2 Rapid Antigen Test using a simple nasal swab for patient self-testing in Germany.
The test is a reliable rapid test for the qualitative detection of a specific SARS-CoV-2 antigen in nasal swab samples.This rapid antigen test collects the sample from the front area of the nose instead of the nasopharynx, resulting in a simplified and more comfortable sampling procedure. By following simple instructions, patients can perform the test at home with results ready after only 15 minutes. The test will be made available in pharmacies and requires no prescription.
The German Federal Institute for Drugs and Medical Devices’ special approval of our test provides people in Germany with a reliable option to test themselves in the comfort of their own home,” said Thomas Schinecker, CEO Roche Diagnostics. “Regular self-testing at home can reduce pressure on healthcare systems. It can quickly identify people with the highest potential to be infectious so they can take immediate action to manage their infection, seek medical advice and protect others.”
This test is part of a partnership with SD Biosensor Inc., with whom Roche has also launched a SARS-CoV-2 Rapid Antibody Test in July and two SARS-CoV-2 Rapid Antigen Tests for professional use in September 2020 and February 2021. Those tests will continue to play an important role in this pandemic and remain available for healthcare professional testing.
Roche continues to expand its comprehensive COVID-19 portfolio to support healthcare systems in diagnosing SARS-CoV-2 infection.
About the SARS-CoV-2 Rapid Antigen Test for at-home patient self-testing
The SARS-CoV-2 Rapid Antigen Test for self testing is a rapid chromatographic immunoassay for the qualitative detection of the nucleocapsid protein of SARS-CoV-2 present in human nasal specimens. In a self-testing clinical study, the SARS-CoV-2 Rapid Antigen Test showed a sensitivity of 82.5% and a specificity of 100.0% when compared to RT-PCR testing. The relative sensitivity was 91.2% for samples with a high viral load ( Ct ≤30). Patients suspected of COVID-19 followed written and illustrated instructions to sample and test themselves. Most study participants considered the procedures easy to perform.
About antigen testing
An antigen test detects proteins which are structural or functional components of a pathogen and are very specific to that pathogen. In this case, the test would provide a qualitative “yes/no” answer on the presence of the antigen in the patient sample and can be offered as a rapid strip test that is performed at the point of care. If the target antigen (nucleocapsid protein) is present in sufficient concentrations in the sample, it will bind to specific antibodies and generate a visually detectable signal on the test strip, typically with results ready in 15 minutes. A rapid antigen test can reliably detect individuals with a high viral load allowing healthcare professionals to quickly identify those patients at the greatest risk of spreading the infection.
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 2020 we received FDA Emergency Use Authorization 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 2020, Roche announced that its COVID-19 antibody test, aimed at detecting the presence of antibodies in the blood, also received FDA Emergency Use Authorization and is available in markets accepting the CE mark. Also in June of last year 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 of 2020, we added a Rapid Antibody Test, with SD Biosensor as manufacturing partner, to the portfolio, that allows the detection of antibodies against COVID-19 at the point of care, a Rapid Antigen Test in September and a lab-based Antigen Test in December. Roche is working closely with governments and health authorities around the world, and has significantly increased production to help ensure availability of tests globally.
Roche is actively involved in understanding the potential of the existing portfolio and is 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 2020 Roche 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 2020, Roche announced a partnership with Regeneron to develop, manufacture and distribute REGN-COV2, Regeneron’s investigational antiviral antibody combination, to people around the globe. On 18 October 2020, Roche announced a collaboration with Atea Pharmaceuticals to develop a potential oral treatment for COVID-19 patients.
In these exceptional times, Roche stands together with governments, healthcare providers and all those working to overcome the pandemic.
About SD Biosensor
SD Biosensor is a global in-vitro diagnostic company focused on the development of immunoassay and molecular diagnostic products at the POC. Founded in 2010, SD Biosensor has continued to research and develop products that can aid in the fast and accurate diagnosis of patients across the testing journey. Through these innovative products, they are striving to become a leading global in vitro diagnostics company.
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 2020 employed more than 100,000 people worldwide. In 2020, Roche invested CHF 12.2 billion in R&D and posted sales of CHF 58.3 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-2021-02-26c.htm
Vela Diagnostics adds two SARS-CoV-2 assays for virus genotyping, and variant identification to its COVID-19 testing solutions
26 February 2021 - The ViroKey™ SQ FLEX SARS-CoV-2 Genotyping Assay and ViroKey™ SARS-CoV-2 ID RT-PCR Test are added to our COVID-19 portfolio offering
Singapore, February 26 2021 – Vela Diagnostics announced that it has added ViroKey™ SQ FLEX SARS-CoV-2 Genotyping Assay and ViroKey™ SARS-CoV-2 ID RT-PCR Test to its portfolio offering.
The ViroKey™ SQ FLEX SARS-CoV-2 Genotyping Assay (RUO) harnesses next-generation sequencing (NGS) technology to sequence the whole SARS-CoV-2 genome. The accompanying Sentosa™ SQ Reporter software calls out mutations and classifies them by lineage, thereby aiding in the research and understanding of the molecular epidemiology of the COVID-19 pandemic. According to WHO, whole-genome sequencing is essential for improving effectiveness/sensitivity of molecular diagnostics, serological assays, vaccine design and anti-viral therapy, and aiding investigation of transmission routes and outbreak clusters.
“We offer a highly automated workflow which requires less than 2 hours of hands-on time from sample to report generation. With this ease-of-use, laboratories can very quickly adopt an NGS solution that would become an important tool in this pandemic situation,” said Managing Director, Andreas Goertz.
The ViroKey™ SARS-CoV-2 ID RT-PCR Test (RUO) is able to quickly identify variants present in positive samples. Variants include the B.1.1.7 (UK), B.1.351 (South Africa) and P.1 (Brazil) lineages.
“Identification of variants that may cause more severe disease or be more contagious is critical in our global response to the pandemic. Such variants may lead to more cases of COVID-19, putting a strain on healthcare systems and potentially leading to more deaths. As such, they need to be identified promptly for measures to be taken,” says Vice President, Jim Mismas.
“With emerging variants, like the recent B.1.526 from New York, that may weaken vaccine effectiveness, the need for mutation identification becomes clear. We are now able to offer options for quick detection of known variants of concerns, and all future variants for better pandemic management,” says Director of Business Development, Scott Cassidy.
The variant identification test can be used in conjunction with the ViroKey™ SARS-CoV-2 RT-PCR Test v2.0, which has received FDA Emergency Use Authorization, CE-IVD and TGA approval, and HSA Provisional Authorization.
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 Completes Acquisition of Mesa Biotech
26 February
WALTHAM, Mass., Feb. 26, 2021 -- Thermo Fisher Scientific Inc., the world leader in serving science, today announced it has completed its previously announced acquisition of Mesa Biotech, Inc., a privately held point-of-care molecular diagnostic company.
"Mesa Biotech is an important part of our strategy to expand the benefits of molecular diagnostics at the point of care, starting with COVID-19 testing," said Mark Stevenson, executive vice president and chief operating officer of Thermo Fisher Scientific. "By combining Thermo Fisher's operational excellence, access to raw materials and existing distribution and sales channels with Mesa's innovative platform, we can rapidly scale manufacturing volume, drive cost efficiencies and bring much-needed diagnostics to market faster and at greater scale."
Mesa Biotech has developed the Accula System, an affordable, easy-to-use, point-of-care PCR-based testing platform for infectious disease diagnosis. The platform enables rapid, highly accurate testing at physician offices, pharmacies and other settings, providing results in 30 minutes. Beyond COVID-19 testing, Mesa Biotech's existing platform includes tests for flu, respiratory syncytial virus (RSV), and Strep A.
"The Accula System complements our existing offerings and immediately provides our clinical customers with more options and flexibility for COVID-19 testing. And, as the point-of-care diagnostic market expands globally, we're well-positioned to deliver a broader menu of tests to meet increasing demand," Stevenson continued.
The Accula Flu A/Flu B, RSV and Strep A tests have 510(k) clearance and Clinical Laboratory Improvements Amendments (CLIA) waivers from the U.S. Food and Drug Administration (FDA). The Flu A/Flu B and RSV assays have also received CE-IVD Mark approval. Additionally, the Accula System has received Emergency Use Authorization (EUA) from the FDA for SARS-CoV-2 in vitro diagnostic testing*.
Mesa Biotech will become part of the Life Sciences Solution Segment and is expected to add revenue of approximately $200 million in 2021.
About Thermo Fisher Scientific
Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $30 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 80,000 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.
EMA issues advice on casirivimab and imdevimab antibody cocktail for the treatment of mild-to-moderate COVID-19
26 February 2021 - CHMP has completed a review of available data for investigational antibody cocktail casirivimab and imdevimab (REGN-COV2) to be considered for the treatment of confirmed COVID-19. CHMP scientific opinion supports national decision making within EU states on the use of the antibodies before a formal authorisation is granted during a public health emergency. Roche and Regeneron are collaborating on developing and manufacturing casirivimab and imdevimab; Roche will be responsible for distribution in Europe and other countries outside the US.
Basel, 26 February 2021 -- Roche confirmed today that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a scientific opinion supporting the use of the investigational antibody cocktail, casirivimab and imdevimab, as a treatment option for patients with confirmed COVID-19 who do not require oxygen supplementation and who are at high risk of progressing to severe COVID-19.
The CHMP’s scientific opinion (under Article 5(3) of Regulation 726/2004) provides a harmonised, EU-level opinion on the efficacy, quality and safety of casirivimab and imdevimab. This review took place in parallel to the EMA’s ongoing rolling review process, which is used to speed up the formal marketing application assessment of a promising medicine during a public health emergency. Under Article 5(3), the CHMP assessed available data in patients with COVID-19, including data from the REGN-COV2 2067 trial, as well as supportive data from other settings.
“This advice by the CHMP regarding casirivimab and imdevimab is an important step towards addressing the COVID-19 pandemic in the EU,” said Levi Garraway, M.D., Ph.D., Chief Medical Officer and Head of Global Product Development. “Initial data showed that patients treated with this investigational antibody cocktail saw a reduction in both viral loads and medically-attended visits. Together with our partner Regeneron, we will continue working with the EMA, governments and other health authorities across the globe to bring this antibody cocktail to as many patients as possible.”
Roche and Regeneron are collaborating to develop, manufacture and distribute casirivimab and imdevimab, to people around the globe, with the aim of having more than two million doses available in 2021. Regeneron will be responsible for distributing the antibody cocktail in the US and Roche will be responsible for distribution outside the US, with the first Roche-manufactured doses already being distributed. Casirivimab and imdevimab could provide a much-needed treatment option for infected individuals already experiencing symptoms of COVID-19, and may be able to prevent infection in people exposed to the virus, and hopefully help slow the spread of the global pandemic.
The investigational antibody cocktail of casirivimab and imdevimab continues to be evaluated in clinical trials in multiple settings for COVID-19: in non-hospitalised and certain hospitalised patients, including the open-label RECOVERY trial of hospitalised patients in the UK, and a trial for the prevention of COVID-19 in household contacts of infected individuals. As of February 2021, approximately 23,000 people have participated in casirivimab and imdevimab clinical trials. Lower doses of casirivimab and imdevimab are also being studied with the aim of increasing the number of patients who could potentially be treated if the cocktail is approved.
In these exceptional times, Roche stands together with society, governments, healthcare providers and all those working to overcome the pandemic.
About the CHMP’s review under Article 5(3) of Regulation 726/2004
The intent of the Article 5(3) referral procedure is for the CHMP to develop a harmonised scientific opinion at the EU level on the quality, safety and efficacy of a medicine based on the currently available data. The scientific opinions can then be considered by EU member states when making decisions on the use of medicines at a national level before a formal authorisation is issued.
The review under Article 5(3) of Regulation 726/2004 was requested by the EMA’s Executive Director following preliminary discussions with the COVID-19 EMA pandemic task force (COVID-ETF), which brings together experts from across the European medicines regulatory network to advise on the development, authorisation and safety monitoring of medicines and vaccines for COVID-19.
About casirivimab and imdevimab
Casirivimab and imdevimab is a cocktail of two monoclonal antibodies (also known as REGN10933 and REGN10987, respectively) and was designed 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-neutralising antibodies that form casirivimab and imdevimab are believed to bind non-competitively to the critical receptor binding domain of the virus's spike protein, which is hypothesised to diminish the ability of mutant viruses to escape treatment and to protect against spike variants that may arise in the human population, as detailed in recent Science publications.
Casirivimab and imdevimab have not been approved by any health authority. In November 2020, the antibody cocktail was authorised by the U.S. Food and Drug Administration (FDA) under an Emergency Use Authorization (EUA) for the treatment of mild to moderate COVID-19 in adults and paediatric patients (12 years of age and older weighing at least 40 kg) with positive results of direct SARS-CoV-2 viral testing, and who are at high risk for progressing to severe COVID-19 and/or hospitalisation. The US EUA is temporary and does not take the place of the formal biologics license application (BLA) submission, review and approval process.
Casirivimab and imdevimab’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
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.
There have been/are a number of clinical trials with an external 3rd party as the sponsor exploring the efficacy and safety of Actemra (tocilizumab) for the treatment of COVID-19 associated pneumonia. COVACTA and EMPACTA, sponsored by Roche, are the first global phase III, multi-centre, randomised, placebo-controlled studies evaluating Actemra in this setting.
We continue to evaluate the data from the global COVACTA study, which did not meet its primary endpoint as announced on 29 July 2020, in conjunction with results from the global EMPACTA study of Actemra in COVID-19 pneumonia, which met its primary endpoint as announced on 17 September 2020, as well as additional data sources that are in the public domain to determine whether a population can be defined based on patient and disease characteristics in which Actemra on top of usual care may provide a favourable benefit risk profile.
Roche remains committed to continuing the Actemra clinical trial programme in COVID-19 to further explore Actemra in other treatment settings, including in combination with an antiviral.
In August 2020 we signed a collaboration agreement with Regeneron on developing, manufacturing and significantly increasing global supply of an investigational antibody cocktail for COVID-19 if it proves safe and effective in clinical trials and regulatory approvals are granted.
In October 2020 we signed an agreement with Atea to jointly develop AT-527, an orally administered direct-acting antiviral (DAA) currently in phase II clinical trials. AT-527 has the potential to be the first novel oral antiviral to treat COVID-19 patients outside the hospital setting, as well as in the hospital, and may also be used in post-exposure prophylactic settings.
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 2020 employed more than 100,000 people worldwide. In 2020, Roche invested CHF 12.2 billion in R&D and posted sales of CHF 58.3 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-2021-02-26b.htm
EMA issues advice on Regenerons's antibody cocktail (Casirivimab with Imdevimab) for certain COVID-19 patients
26 February 2021 - EU member states can utilize the positive CHMP opinion when making national decisions about use of the antibody cocktail, prior to a potential future EMA market authorization. Regeneron has collaborated with Roche to develop and manufacture the antibody cocktail; Roche is responsible ex-U.S. and has already begun distribution in the EU.
TARRYTOWN, N.Y., Feb. 26, 2021 -- Regeneron Pharmaceuticals, Inc. today announced the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion for the company's investigational COVID-19 antibody cocktail (casirivimab with imdevimab). The CHMP recommends that the antibody cocktail, known as REGEN-COVTM in the U.S., can be used to treat confirmed COVID-19 in patients who do not require supplemental oxygen and who are at high risk of progressing to severe COVID-19.
"Today's endorsement by the EU's leading scientific body for medicines helps bring our antibody cocktail one step closer to even more COVID-19 patients who could benefit from it," said George D. Yancopoulos, M.D., Ph.D., President and Chief Scientific Officer at Regeneron. "Our collaborator Roche is already in active discussions with a number of European countries following release of our data in non-hospitalized patients that showed the antibody cocktail significantly reduced virus levels within days of treatment, which was associated with significantly fewer medical visits. This is supported by preclinical data that show that our antibody cocktail effectively neutralizes emerging strains of the virus, which are becoming increasingly common in Europe and around the world."
The CHMP recommendation provides a harmonized, European Union (EU)-level opinion on the efficacy, quality and safety of the antibody cocktail, which can be used by EU member states when making decisions on the possible use of the antibody cocktail at a national level prior to a market authorization. Under Article 5(3) of Regulation EC 726/2004, the CHMP assessed available data in non-hospitalized patients ("outpatients") with COVID-19 as well as supportive data from other settings.
The CHMP's review took place in parallel to the EMA's ongoing rolling review process, which is used to speed up the formal marketing application assessment of a promising medicine during a public health emergency. Once finalized it will be the basis for an EU marketing authorization for the antibody cocktail. Regeneron, together with Roche, continues to work closely with the EMA as it undertakes its rolling review.
Regeneron is collaborating with Roche to increase global supply of the antibody cocktail. 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., with the first Roche-manufactured doses already being distributed. 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.
The development and manufacturing of REGEN-COV have been funded in part with federal funds from the Biomedical Advanced Research and Development Authority (BARDA), part of the U.S. Department of Health and Human Services, Office of the Assistant Secretary for Preparedness and Response, under OT number: HHSO100201700020C.
About the Antibody Cocktail
The antibody cocktail, known as REGEN-COV (casirivimab with imdevimab) in the U.S., consists of two monoclonal antibodies (also known as REGN10933 and REGN10987) 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, REGEN-COV received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (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., REGEN-COV is 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.
REGEN-COV continues to be evaluated in clinical trials in multiple settings for COVID-19: in non-hospitalized and certain 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. As of February 2021, approximately 23,000 people have participated in clinical trials involving REGEN-COV. Lower doses of REGEN-COV are also being studied with the aim of increasing the number of patients who could potentially be treated if the cocktail is approved.
REGEN-COV was invented using Regeneron's VelocImmune® technology that utilizes a proprietary genetically engineered mouse platform endowed with a genetically-humanized immune system to produce optimized fully-human antibodies. When Regeneron's co-Founder, President and Chief Scientific Officer George D. Yancopoulos was a graduate student with his mentor Frederick W. Alt in 1985, they were the first to envision making such a genetically humanized mouse, and Regeneron has spent decades inventing and developing VelocImmune® and related VelociSuite® technologies. Dr. Yancopoulos and his team have used VelocImmune technology to create multiple antibodies including Dupixent® (dupilumab), Libtayo® (cemiplimab-rwlc), Praluent® (alirocumab), Kevzara® (sarilumab), Evkeeza™ (evinacumab-dgnb) and Inmazeb™ (atoltivimab, maftivimab, and odesivimab-ebgn).
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 nine 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.
Corona-Test: Von der Probenentnahme bis zur Sequenzierung im Labor (Jena TV)
24 February 2021
24 February 2021 -- Dr. Martin Roskos, CMO der SYNLAB Holding Deutschland GmbH bietet einen Blick hinter die Kulissen des SYNLAB-Labors in Jena, das täglich hunderte Corona-Proben mit der PCR-Methode untersucht und die Viren in positiven Abstrichen auch sequenziert. In diesem Interview mit Jena TV erklärt Dr. Martin Roskos den Ablauf eines Corona PCR-Tests von der Probenentnahme bis zur Untersuchung und ggf. anschließenden Sequenzierung der Probe im Labor.
Quest Diagnostics Introduces New COVID-19 Semi-quantitative Serology Test Service
24 February 2021
SECAUCUS, N.J., Feb. 24, 2021 -- Quest Diagnostics, the world's leading provider of diagnostic information services, today introduced a new COVID-19 testing service that aids in providing insight into an individual's immune response as a result of a recent or prior infection with SARS-CoV-2, the virus that causes COVID-19, or to immune response observed in connection with COVID-19 vaccination.
As many as 40 percent of individuals infected with SARS-CoV-2 do not experience symptoms and may not realize they are or have been infected. Serology testing can inform if an individual's immune system has produced antibodies in response to infection, even in asymptomatic individuals, about two weeks following suspected infection. According to the U.S. Food and Drug Administration, serology tests can help to identify individuals who have "developed antibodies that may protect from future infection as well as identify those still at risk."
The new Quest Diagnostics test service provides a positive/negative result as well as a numerical result that may provide the basis for assessing relative changes in antibody blood levels. In addition, the new service can aid in assessing blood levels of antibodies produced to structural proteins of the SARS-CoV-2 spike protein. Because currently available vaccines in the United States contain mRNA that encodes the spike protein, the test may aid in indicating an immune response resulting from a recent or prior infection or vaccination. The test will not differentiate between immune response mounted in response to infection or vaccination.
"We believe that SARS CoV-2 semi-quantitative serology testing will be an important clinical tool to assess if an individual has mounted an immune response from recent or prior infection or from vaccination," said Jay G. Wohlgemuth M.D., Senior Vice President and Chief Medical Officer for Quest Diagnostics. "These insights may aid clinical management of certain patients at high risk of severe COVID-19 disease or who may be at risk for vaccination, such as people with a history of severe vaccine allergy or women who are pregnant. While the science is evolving, many individuals may have an interest in understanding their immune response status over time and post-vaccination."
"Importantly, we also believe semi-quantitative testing will improve public health surveillance as researchers across the United States seek to better understand the contributions of vaccination and prior infections on herd immunity," Dr. Wohlgemuth added.
In its commitment to advancing COVID-19 science and public health response, Quest Diagnostics currently provides COVID-19 semi-qualitative antibody testing services and variant genomic sequencing services to aid public health monitoring by the Centers for Disease Control and Prevention.
The new semi-quantitative testing service is the latest addition to the company's existing menu of COVID-19 qualitative IgG and IgG/IgM test services. These services aid in identifying a relative level of adaptive immune response to recent or prior infection with SARS-CoV-2. The Quest Diagnostics menu of serology testing services are based on several FDA emergency use authorized tests from leading manufacturers.
While there is no recommended minimum interval between infection and vaccination, current evidence suggests that the risk of SARS-CoV-2 reinfection is low in the first few months after initial infection but may increase with time due to waning immunity. Based on available science, it is unclear how long an individual will sustain an effective immune response to SARS-CoV-2 following infection or vaccination. However, research of other coronaviruses, including SARS, and the low rate of known SARS-CoV-2 re-infections, suggests those with antibodies may be at lower risk of symptomatic infection. A study recently published in the New England Journal of Medicine found no symptomatic infections in individuals with antibodies to SARS-CoV-2 over six months. Another study suggests COVID-19 antibodies may remain stable for more than 8 months.
According to the CDC, vaccination should be offered to persons regardless of history of prior symptomatic or asymptomatic SARS-CoV-2 infection. The CDC also advises that while vaccine supply remains limited, persons with recent documented acute SARS-CoV-2 infection may choose to temporarily delay vaccination up to 90 days, if desired, recognizing that the risk of reinfection, and therefore the need for vaccination, might increase with time following initial infection. Pre-vaccination testing can help tell whether antibodies are present in an individual patient regardless of the cause of their presence.
Ordering a Test
Serology testing employs a blood specimen. Quest Diagnostics operates more than 2,200 patient service centers across the United States that perform blood draws for COVID-19 antibody testing consistent with health and safety guidelines from the Centers for Disease Control and Prevention (CDC). Healthcare providers can also collect blood specimens in their offices for patients for testing by Quest Diagnostics. For more information on visiting our patient service centers, refer more about our Peace of Mind program.
Only a healthcare provider can order a Quest Diagnostics serology antibody test. Assuming a provider places an order for testing, patients may schedule appointments ahead of time through the Quest Diagnostics MyQuest patient portal or at www.QuestDiagnostics.com.
About COVID-19 Testing at 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 50,000 employees understand that, in the right hands and with the right context, our diagnostic insights can inspire actions that transform lives. 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 50,000 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 Changes COVID-19 Rapid Testing Landscape with Highly Sensitive Point of Care Antigen Test for Mass Screening Financial Information
23 February 2021 - Company expands portfolio of SARS-CoV-2 testing solutions with rapid antigen test benchmarked against gold standard RT-PCR
WALTHAM, Mass., Feb. 23, 2021 -- PerkinElmer, Inc. today announced the launch of the PerkinElmer® COVID-19 Antigen Test for the qualitative detection of SARS-CoV-2 nucleocapsid protein antigen in nasal (NS) or nasopharyngeal (NP) swab specimens. The lateral flow immunoassay test can be used to screen or to aid in diagnoses of COVID-19 in asymptomatic or symptomatic individuals. A positive or negative result can be obtained in as little as 15 minutes to facilitate immediate isolation or treatment decisions.
This latest addition to the Company’s portfolio of SARS-CoV-2 testing solutions is available in more than 30 countries that accept the CE mark. The in vitro diagnostic device is ideally suited for professional use point-of-care (POC) clinical and non-clinical settings such as healthcare centers, travel hubs, businesses and educational institutions. Clinical studies in symptomatic and asymptomatic populations, including individuals with low viral load, have shown sensitivity of greater than 97% amongst all NS and NP samples. Specificity of the test across 202 negative samples was 100%, which means no false positives were identified.
“While RT-PCR tests remain the gold standard in COVID-19 diagnostics, there is an unmet need in the market for a highly reliable antigen test that can support the reopening strategies of organizations worldwide,” said Masoud Toloue, Ph.D., Senior Vice President, Diagnostics, PerkinElmer. “Sensitivity and reliability matters, especially in this challenging environment. Just like with our RT-PCR test, significant talent and effort was put behind developing a lateral flow antigen test that sets the benchmark for rapid testing, and may help facilitate the safe return of in-person education, commerce and everyday life.”
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.
Based on comparative data released by the U.S. Food and Drug Administration, the PerkinElmer® New Coronavirus Nucleic Acid Detection Kit has the lowest limit of detection among authorized COVID-19 molecular diagnostic tests reported, deeming it the most sensitive assay. This RT-PCR assay originally obtained FDA EUA in the spring of 2020 and recently received EUA to test individuals without symptoms or other reasons to suspect COVID-19 infection.
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 $3.8 billion in 2020, 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 Announces Collaboration for At-Home Rapid Test for COVID-19
22 February 2021 - Aims to Pair BD Antigen Test with Scanwell Health Mobile App
FRANKLIN LAKES, N.J., Feb. 22, 2021 -- BD (Becton, Dickinson and Company), a leading global medical technology company, and Scanwell Health, a leader in smartphone-enabled at-home medical tests, today announced a collaboration to create an at-home rapid test for SARS-CoV-2 using a BD antigen test and the Scanwell Health mobile app.
As part of the collaboration, BD plans to produce a lateral flow antigen test and pair it with the Scanwell Health mobile app. The app is expected to provide step-by-step instructions on how to collect and transfer a nasal swab sample and use the mobile device's camera to analyze and interpret results. The test result will be displayed onscreen, and the companies are also planning to develop functionality to assist in automated reporting to public health agencies. This approach is intended to provide an efficient and scalable rapid antigen home testing solution.
"Testing at home before going out into the public is a critical safeguard to help stop the spread of COVID-19," said Dave Hickey, president of Life Sciences for BD. "BD and Scanwell Health are bringing the best of our innovations together to develop a reliable test with a convenient and simple user experience. We see the development of an at-home lateral flow rapid antigen test as a complementary solution to our best-in-class BD Veritor™ system."
Stephen Chen, founder and CEO of Scanwell Health said, "Partnering with an industry leader like BD creates a unique opportunity to help millions of people test for the SARS-CoV-2 virus from the safety and comfort of their homes. Scanwell's innovative computer vision technology closely mirrors that of point-of-care and laboratory diagnostic systems. We're excited to leverage our experience in building FDA-cleared apps to bring this solution to market."
BD has been on the forefront of the COVID-19 response providing innovative solutions for immunology research, molecular- and antigen-based diagnostics, devices that aid in therapeutics and injection devices for vaccine administration.
About BD Veritor™ Plus System for Rapid Detection of SARS-CoV-2
The BD Veritor™ Plus System for Rapid Detection of SARS-CoV-2 Assay has not been cleared or approved by FDA. The test has been authorized by FDA under an 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. For more information on the BD Veritor™ system, please visit bdveritor.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 70,000 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 or connect with us on LinkedIn at www.linkedin.com/company/bd1/ and Twitter @BDandCo.
About Scanwell Health
Scanwell Health empowers health care consumers and companies through at-home medical testing with instant results. Scanwell pairs proven diagnostics with patented computer vision technology to put testing into the hands of people, enabling quick detection of acute illnesses and convenient monitoring of chronic diseases. The company is the first and only to receive FDA 510(k) clearance for an over-the-counter diagnostic smartphone application. Learn more at scanwellhealth.com.
Reference: https://news.bd.com/2021-02-22-BD-Announces-Collaboration-for-At-Home-Rapid-Test-for-COVID-19
Luminex Receives BARDA Funding to Support Development and Validation of Test Combining SARS-CoV-2 and Flu/RSV Respiratory Panel
19 February 2021 - ARIES® Assay will simultaneously detect influenza A/B, RSV, and SARS-CoV-2 in a single test, and could help accelerate testing and reduce supply pressures
AUSTIN, Texas, Feb. 19, 2021 -- Luminex Corporation today announced that it has received $11.3 million in funding 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. These funds will support the rapid development and validation of a respiratory panel combining Flu A/B & respiratory syncytial virus (RSV) targets with the SARS-CoV-2 target that can be run on all ARIES® Systems. These 6- and 12-cassette systems are automated molecular diagnostic platforms used in moderate- and high-complexity labs with a number of FDA cleared tests already available for use on them. The systems produce results in less than two hours with minimal hands-on time required.
Clinical labs already challenged by continued COVID-19 testing are now under additional pressure to simultaneously meet the testing demand associated with seasonal flu and RSV, whenever these pathogens are in circulation at the same time. These respiratory illnesses can cause symptoms similar to COVID-19, making it difficult for physicians to distinguish between them. A single test that can simultaneously detect these pathogens would allow clinical labs to get more complete answers quickly, while using fewer reagents and other consumables, easing pressure on an already stressed supply chain.
"We believe that this targeted multiplex assay will play a pivotal role in helping healthcare professionals efficiently and effectively manage individuals with respiratory illness symptoms for years to come," said Nachum "Homi" Shamir, Chairman, President and CEO of Luminex. "We are grateful to BARDA for its continued support as we seek to streamline respiratory testing with a single assay for the most common pathogens. This will allow laboratories, most of which are already operating in resource-constrained environments, to run one test instead of two or more without sacrificing clinical results."
Luminex developed the original ARIES® SARS-CoV-2 (EUA) Assay with financial support from BARDA in 2020.
Luminex will submit the targeted multiplex respiratory panel, the ARIES® Flu A/B & RSV+SARS-CoV-2 Assay, to the FDA for Emergency Use Authorization as soon as possible, and eventually plans to submit the panel for 510(k) clearance as well.
About Luminex Corporation
At Luminex, our mission is to empower labs to obtain reliable, timely, and actionable answers, ultimately advancing health. We offer a wide range of solutions applicable in diverse markets including clinical diagnostics, pharmaceutical drug discovery, biomedical research, genomic and proteomic research, biodefense research, and food safety. We accelerate reliable answers while simplifying complexity and deliver certainty with a seamless experience. To learn more about Luminex, please visit us at luminexcorp.com. To learn more about Luminex's COVID-19 Testing and Research Solutions, please visit: https://www.luminexcorp.com/solutions/.
First shipments to US of Genedrive® 96 SARS-CoV-2 Kit
17 February 2021
17 February 2021 -- genedrive plc, the near patient molecular diagnostics company, announces the first shipments to the United States of its Genedrive® 96 SARS-CoV-2 Kits. Following the Company’s announcement on 28th January 2021 confirming genedrive’s distribution agreement with Beckman Coulter Life Sciences (“Beckman Coulter”), genedrive can confirm that it has completed its commercial and technical training with the Beckman Coulter sales representatives and has now shipped its first 96 SARS-CoV-2 Kits to the USA. This shipment will allow Beckman Coulter to commence initial sales activities and prepare the market for wider commercial rollout. This shipment coincides with the formal launch of the Genedrive® 96 SARS-CoV-2 Kit by Beckman Coulter today.
To learn more about the partnership or to request a quote, Beckman Coulter customers can visit: https://www.beckman.com/reagents/genomic/viral-detection/genedrive-96-sars-cov-2
David Budd, CEO of genedrive plc, said: “This is an important milestone for genedrive as the first shipments of our Genedrive 96 SARS-CoV-2 Kit are exported to the US. We are very optimistic about the US market for Covid PCR testing and it has market drivers that are favorable to the adoption of the genedrive assay: efficiency, ease of use, automation friendly, and scalability.”
Reference: https://www.genedrive.com/news/index.php
Labcorp Adds High Sensitivity Antigen Test to Screen for Active COVID-19 Infection
17 February 2021 - Antigen Test Is the Latest Offering by Labcorp to Fight COVID-19 at Every Stage, from Diagnostic Testing to Clinical Trials and Vaccination Services
BURLINGTON, N.C., Feb. 17, 2021 -- Labcorp, a leading global life sciences company, today announced the availability of a new laboratory-based antigen test that will help doctors determine if an individual is actively infected with COVID-19.
Developed by DiaSorin, the antigen test is available to patients through a doctor’s order and allows for testing to determine if individuals are still infected with and could spread COVID-19. The test is performed by a doctor or other healthcare provider using a nasal or nasopharyngeal swab to collect a sample and is then picked up and processed by Labcorp. Results are available on average within 24-48 hours from time of pick up.
“This new high-sensitivity antigen test is another example of Labcorp’s commitment to providing people with the information they need to make important health decisions,” said Dr. Brian Caveney, chief medical officer and president, Labcorp Diagnostics. “PCR tests are still considered the gold standard in diagnosing COVID-19, as they are able to detect the smallest traces of the virus. However, an antigen test is an additional tool to help individuals know if they could still be carrying the virus or if they are safe to resume work and life activities.”
According to the Centers for Disease Control and Prevention (CDC), antigen tests can be used in a variety of testing strategies to respond to the COVID-19 pandemic and are helpful in determining whether a person diagnosed with COVID-19 remains infectious.
Labcorp continues to recommend that individuals follow health guidelines, including wearing a mask in public, socially distancing, frequently washing hands and avoiding large groups, and receiving a COVID-19 vaccine as availability increases and the CDC guidance expands to more eligible groups. For more information about Labcorp’s COVID-19 response and testing options, visit Labcorp’s COVID-19 microsite.
The DiaSorin LIAISON® SARS-CoV-2 Ag antigen test has been made available to the U.S. market following notification to the U.S. Food and Drug Administration (FDA) on October 26, 2020 pursuant to the FDA’s Policy for Diagnostic Tests for Coronavirus Disease-2019 during the Public Health Emergency (Revised) and published May 11, 2020.
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 improve lives. With over 75,000 employees, we serve clients in more than 100 countries. Labcorp reported revenue of $14 billion in FY2020. Learn about Labcorp at www.Labcorp.com.
FDA Grants Emergency Use Authorization for New COVID-19, Flu A, Flu B Combo Kit
16 February 2021 - One multiplex real-time PCR diagnostic kit can simultaneously detect and differentiate SARS-CoV-2, influenza A and influenza B
CARLSBAD, Calif., Feb. 16, 2021 -- The U.S. Food and Drug Administration (FDA) has granted emergency use authorization (EUA) for the Applied Biosystems TaqPath COVID-19, Flu A, Flu B Combo Kit from Thermo Fisher Scientific, the company announced today.
The TaqPath COVID-19, Flu A, Flu B Combo Kit is a real-time PCR test for the detection and differentiation of RNA from the SARS-CoV2, influenza A and influenza B viruses in nasopharyngeal and nasal swabs.
"Understanding that the flu season would overlap with surges in COVID-19 infections, Thermo Fisher worked rapidly to develop a new multiplex real-time PCR diagnostic kit for detecting and differentiating SARS-CoV-2, influenza A and influenza B. These are illnesses which can present with similar clinical symptoms, but for which patient management, including quarantining measures, greatly differs," said Mark Smedley, president of Genetic Sciences for Thermo Fisher Scientific. Thermo Fisher. "This new kit offers clinical and public health laboratories a single test to help diagnose and monitor the spread of COVID-19 and the flu."
The TaqPath COVID-19, Flu A, Flu B Combo Kit helps labs expand their existing COVID-19 testing menu for respiratory samples while maintaining low operational costs and workflow simplicity. The kit includes Applied Biosystems Pathogen Interpretive Software to automatically convert genetic analysis data into a readable report, helping reduce risk of user interpretation error. For more information on the kit, visit thermofisher.com/covid19flu.
Testing with the TaqPath COVID-19, Flu A, Flu B Combo Kit is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. 263a, to perform high-complexity tests, or by similarly qualified non-U.S. laboratories.
The TaqPath COVID-19, Flu A, Flu B Combo Kit has not been FDA cleared or approved and is only authorized for the duration of the EUA granted 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 Thermo Fisher Scientific
Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $30 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 80,000 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.
Two COVID-19 Nucleic Acid Detection Kits of BGI Get CE Mark
10 February 2021
10 February 2021 -- BGI Genomics announces its Rapid Identification Kit for B.1.1.7 lineage (N501Y and P681H) of SARS-CoV-2 (ARMS-PCR = amplification refractory mutation system-polymerase chain reaction) and Rapid Nucleic Acid Detection Kit for 2019-nCoV (PCR fluorescent probe method) have been CE marked. Both kits are manufactured by BGI PathoGenesis Pharmaceutical Technology Co. Ltd., a subsidiary of BGI Genomics.
The Rapid Identification Kit is a qualitative in vitro nucleic acid amplification assay to identify the B.1.1.7 lineage (N501Y and P681H) of SARS-CoV-2 in throat swab specimens or sputum that have been confirmed by RT-PCR to be SARS-CoV-2 positive. The kit will be able to identify mutant strains quickly and effectively, thus facilitating the global pandemic prevention and control.
The second kit obtaining the CE mark this time is the Rapid Nucleic Acid Detection Kit for 2019-nCoV (PCR fluorescent probe method). Compared with the kit which got CE mark last April, the new detection kit follows an optimized reaction procedure and can assist healthcare
and medical institutions in different countries to effect timely and effective prevention in a shorter period of time.
In December 2020, the United Kingdom reported a new strain of SARS-CoV-2 lineage B.1.1.7, with data indicating that the new variant was highly infectious. The World Health Organization has recommended all countries should increase surveillance of new variants of COVID-19 to better understand the spread of the virus.
To date, BGI’s COVID-19 detection reagent has covered the nucleic acid detection kit, the antibody detection kit, the antigen detection kit and the mutant identification kit, which can meet the clinical needs of different applications.
Reference: https://www.bgi.com/global/company/news/two-covid-19-nucleic-acid-detection-kits-of-bgi-get-ce-mark/
Forscher haben Virus-Mutationen im Blick (MDR)
10 February 2021 - Video-Beitrag der MDR mit Dr. Martin Roskos, CMO der SYNLAB Deutschland zu Coronavirus-Mutationen
10 February 2021 -- Das Coronavirus mutiert 23 Mal pro Jahr. Bisher bereiten Varianten aus Brasilien, Großbritannien und Südafrika große Sorgen. Um sie schneller zu lokalisieren, werden seit Januar mehr Abstriche auf Mutationen untersucht. Sehen Sie jetzt den aktuellen Video-Beitrag der MDR mit Dr. Martin Roskos, CMO der SYNLAB Deutschland.
Reference: https://www.synlab.de/human/news-artikel/forscher-haben-virus-mutationen-im-blick-mdr-1334
Thermo Fisher Scientific Partners with Mindray on Clinical Chemistry Analyzers for use with Drugs of Abuse Immunoassays
9 February 2021
FREMONT, Calif., Feb. 9, 2021 -- Thermo Fisher Scientific, the world leader in serving science, today announced a partnership with Mindray, a leading global developer, manufacturer and supplier of medical devices, to make available to customers two clinical chemistry analyzers in the United States (U.S.) and Canada for drug screening in clinical and drug court laboratories.
"Systematically and reliably testing for drugs of abuse is key to helping addicted individuals rehabilitate, ensuring prescribed drugs are not abused and ultimately, helping to combat this crisis," said Stefan Wolf, president of the clinical diagnostics business at Thermo Fisher Scientific. "Through this exclusive partnership with Mindray we are able to address the needs of our customers in commercial labs, hospitals and the criminal justice field. Now we can better cater to the needs of those laboratories seeking to expand or increase their testing volumes, and laboratories working to consolidate and centralize their testing sites with these two medium- to high-throughput instruments."
To provide access to drug testing, Thermo Fisher and Mindray have entered into an agreement to offer the FDA-cleared and Health Canada–approved BS-480 (400 tests/hour) and BA-800M (800 tests/hour) analyzers to toxicology labs. Thermo Fisher will also provide an extensive menu of wet lab–validated Thermo Scientific DRI and CEDIA drugs of abuse immunoassay reagents with the instruments to enable the screening of urine samples for the presence of a given drug or a class of drugs.
Taken together, the world-class DRI and CEDIA drugs of abuse immunoassay reagents, validated on Mindray's instruments, bring a combination of performance and reliability from a single source in a cost-effective, plug-and-play solution. The solution streamlines the drug screening workflow and automates it to reduce risk of human error. The instruments also come with onboard software that has many advanced features, including sample/reagent probe collision protection, sample aggregate detection and a five-minute daily push-button self-service maintenance program.
Thermo Fisher began distributing, installing, training and servicing Mindray BS-480 and BA-800M instruments in the U.S. and Canada last month.
About Thermo Fisher Scientific
Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $30 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 80,000 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 and Sysmex Extend Hemostasis Agreement
9 February 2021 - Together, the companies will continue to provide one of the largest portfolios of hemostasis testing systems and reagents that caters to laboratories' diverse needs. As part of the agreement Siemens Healthineers will distribute the new Sysmex CN Systems.
Erlangen, Germany, 9 February 2021 -- Siemens Healthineers and Sysmex Corporation announced the renewal of the companies' long-standing global supply, distributorship, sales and service agreement for a broad portfolio of hemostasis products including a multi-year extension. Additionally, the companies’ agreement includes the future distribution of Sysmex's CN-Series automated blood coagulation analyzers, the CN-3000 and CN-6000, by Siemens Healthineers bringing the next generation of fully-automated solutions for mid- and high-volume coagulation testing to laboratories. The companies plan for Siemens Healthineers to start commercialization of the Sysmex CN Systems in various countries later this year.
A broad menu of both routine and specialty coagulation assays from Siemens Healthineers can be performed on these newest additions to the Sysmex family portfolio of hemostasis analyzers, which offer laboratories a compact and comprehensive hemostasis testing solution. The Sysmex CN Systems are designed to integrate with Atellica® Data Manager and Aptio® Automation to further streamline hands-free workflow and to automate sample processing, including sample preparation as well as storage, refrigeration and retrieval, if needed.
"Siemens Healthineers and Sysmex have built a solid hemostasis partnership for more than 25 years since initially signing the global alliance agreement in 1995," said Deepak Nath, PhD, President of Laboratory Diagnostics for Siemens Healthineers. "Together we are able to deliver both quality and comprehensive hemostasis testing solutions to laboratories of all sizes across the world."
Siemens Healthineers and Sysmex provide hemostasis products used to test for blood clotting disorders, preoperative bleeding risk management, and the monitoring of patients on anticoagulant therapy medications.
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 diagnostics, 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 2020, which ended on September 30, 2020, Siemens Healthineers, which has approximately 54,000 employees worldwide, generated revenue of €14.5 billion and adjusted EBIT of €2.2 billion. Further information is available at www.siemens-healthineers.com.
Reference: https://www.siemens-healthineers.com/press-room/press-releases/partnerschaft-sysmex
Thermo Fisher Scientific Launches CE-IVD-Marked High Throughput COVID-19 Diagnostic Assay for Use On Its Automated Amplitude Platform
8 February 2021 - Applied Biosystems TaqPath COVID-19 High Throughput Combo Kit also receives Interim Order Authorization from Health Canada
CARLSBAD, Calif., Feb. 8, 2021 -- Thermo Fisher Scientific, the world leader in serving science, today launched its CE-IVD-Marked, Applied Biosystems TaqPath COVID-19 HT Kit that is compatible with the Amplitude platform. The high-throughput solution enables clinical and public health laboratories to efficiently test up to 8,000 COVID-19 samples a day with fewer staffing requirements and a reliable supply of kits, reagents and consumables.
The highly automated Amplitude platform is a molecular diagnostic system that allows labs to increase their COVID-19 testing capacity by combining Thermo Fisher's extraction and real-time PCR instruments with liquid handling products from Tecan Group. The system leverages a high-throughput version of Thermo Fisher's TaqPath COVID-19 CE-IVD RT-PCR Kit, which received CE-IVD Mark in March 2020.
The high throughput diagnostic assay, compatible with the Amplitude platform, also received Interim Order Authorization from Health Canada on January 21. Thermo Fisher has secured a contract with a large provincial authority in Canada for Amplitude systems to help fight the pandemic.
"Accurate and reliable testing that can scale is essential in addressing the spread of any disease, especially COVID-19," said Mark Smedley, president of the genetic sciences business of Thermo Fisher Scientific. "The Amplitude platform embodies our goal of empowering public health and clinical lab professionals to generate accurate results at higher volumes and use them to make informed health care decisions that lead to the management of a pandemic that is still raging around the world."
With the Amplitude platform, customers receive a reliable supply agreement and up-front monthly delivery of reagents to ensure that COVID-19 testing needs are met. Thermo Fisher now has capacity to produce more than 20 million tests per week and continues to work closely with laboratories, governments, academic institutions and other stakeholders to ensure each has a reliable supply of tests and materials.
About Thermo Fisher Scientific
Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $30 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 80,000 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 grants Breakthrough Device Designation for Roche's Elecsys Growth Differentiation Factor-15 (GDF-15) assay to help identify patients suitable for innovative treatment addressing unintentional weig
8 February 2021 - FDA BDD acknowledges the importance of GDF-15 testing in identifying eligible cachexic patients with solid tumours to be treated with Pfizer's investigational drug PF-06946860. Unintentional weight loss (cachexia) is a highly prevalent complication of cancer, affecting more than half of all cancer patients worldwide, potentially leading to significant functional impairment and increased risk of death. Successful cachexia treatment can potentially contribute to improved cancer treatment worldwide.
Basel, 8 February 2021 -- Roche announced today that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation to their Elecsys® GDF-15 assay as a companion diagnostic (CDx) in cancer treatment. This in vitro diagnostic immunoassay is intended for measurement of Growth Differentiation Factor-15 (GDF-15) in cachectic patients 18 years of age and older with solid tumours for treatment with Pfizer Inc.'s investigational drug PF-06946860.
Cachexia is a metabolic disorder and comorbidity that occurs with several chronic diseases including cancer, heart failure, chronic obstructive pulmonary disease (COPD), and chronic kidney disease (CKD). It impacts more than 30 million people globally. Cachexia manifests as marked involuntary body weight loss, muscle atrophy, and reduced appetite, progressing to significant functional impairment and increased risk of death. Elevated GDF-15 is associated with cachexia in cancer patients. Cachexia is a highly prevalent complication of cancer, affecting between 50 to 80% of all cancer patients. This range depends on the tumour type, the patient response to tumour progression and on individual body type.
“We are pleased to partner with Pfizer to address this unmet medical need in oncology through strong companion diagnostics”, said Thomas Schinecker, CEO Roche Diagnostics. “The FDA BDD grant for the Elecsys GDF-15 assay shows the importance of these strong partnerships. The ability to detect elevated GDF-15 in patients who are experiencing weight loss may provide a precision-medicine approach to identifying patients likely to respond to a GDF-15 therapeutic treatment.”
About Elecsys GDF-15
Elecsys GDF-15 is a quantitative serologic, two-incubation step electrochemiluminescence immunoassay (ECLIA) using the sandwich test format for the detection of GDF-15 in human serum. The Elecsys GDF-15 assay is indicated as an aid in identifying cachectic patients 18 years of age and older with solid tumours for treatment with PF-06946860. The electrochemiluminescence immunoassay “ECLIA” is intended for use on cobas e immunoassay analyzers. GDF-15 has CE approval in several intended uses in cardiology including risk prediction of major bleeding events of atrial fibrillation patients, risk stratification of patients with acute coronary syndrome or chronic heart failure.
About Cachexia
Cachexia impacts more than 30 million people globally but is poorly understood due to its complexity. It has traditionally been seen as a complication of chronic diseases or end stages of cancer. The burden cachexia poses on patients, their caregivers and loved ones, as well as the healthcare system, is significant. Cancer cachectic patients experience numerous complications including, but not limited to, reduced effectiveness of chemotherapy, reduced mobility and reduced functionality of muscle-dependent systems, such as the respiratory and cardiovascular systems, leading to decreased quality of life and survival.
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 2020 employed more than 100,000 people worldwide. In 2020, Roche invested CHF 12.2 billion in R&D and posted sales of CHF 58.3 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-2021-02-08.htm
Dev Kurdikar Named President of BD Diabetes Care
8 February 2021
FRANKLIN LAKES, N.J., Feb. 8, 2021 – BD (Becton, Dickinson and Company), a leading global medical technology company, today announced the appointment of Dev Kurdikar, 52, to the position of worldwide president, BD Diabetes Care, effective Feb. 10.
In his new role, Kurdikar will have responsibility for driving global strategic, operational and commercial performance across a portfolio of solutions that aims to minimize the burdens and complications for people with diabetes.
“Dev has spent his career in the health care industry, in roles that have spanned operations, finance, strategy and general management,” said Alberto Mas, executive vice president and president of the BD Medical Segment. “This cross functional experience, coupled with a hands-on and authentic leadership style, has enabled him to build high-performing teams and a winning culture. His bold and strategic approach and the demonstrated ability to iterate, try new things and embrace change make him well suited to lead the Diabetes Care business.
Most recently, Kurdikar served as CEO and president for Cardiac Science, a global manufacturer of automated external defibrillators (AEDs). Previously, he was the general manager for the men’s health business within American Medical Systems (AMS) and held positions of increasing responsibility and leadership with Baxter, including vice president of the Infusion Systems business in the U.S. and vice president of Marketing/Strategy for enterprise-wide commercial initiatives.
Kurdikar earned an MBA with an emphasis in Finance & Strategy from Washington University in Missouri and a Ph.D. in Chemical Engineering from Purdue University in Indiana. He is currently a member of the Board of Directors of LMG Holdings.
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 70,000 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.
Reference: https://news.bd.com/2021-02-08-Dev-Kurdikar-Named-President-of-BD-Diabetes-Care
Sysmex and Siemens Healthineers Extend Long-standing Global Alliance in Hemostasis Testing
3 February 2021
3 February 2021 -- Sysmex Corporation (HQ: Kobe, Japan; Chairman and CEO: Hisashi Ietsugu) and Siemens Healthcare Diagnostics Inc. (HQ: NY, U.S.A.; hereinafter, "Siemens Healthineers") today announced that, on February 2, 2021, the two companies agreed to extend their long-standing alliance on global supply, distribution, and sales and service for hemostasis products through at least 2023. The agreement enables global laboratory customers to continue to benefit from the world’s largest portfolio of hemostasis systems and reagents.
For more than 20 years since signing the global alliance agreement on hemostasis products in 1995, the two companies have built a solid partnership. The extension of the agreement will continue to allow Sysmex and Siemens Healthineers to mutually supply hemostasis systems and reagents, respectively, on a global basis, thus achieving the world’s most extensive product portfolio that caters to laboratory customers' diverse needs.
The renewed agreement contains a partial review of the list of products and territories for mutual supply. Sysmex hopes that it will reinforce the sales of Sysmex's CN-Series automated blood coagulation analyzer and allow the two companies to maintain the proven cooperative framework to offer ample solutions for hemostasis testing to customers the world over.
Sysmex and Siemens Healthineers will continue to harness each other's strengths to expand the hemostasis business, with a view toward contributing to the standardization and enhanced quality of hemostasis testing.
Quidel opens new manufacturing facility to mass produce QuickVue® rapid antigen tests for COVID-19
3 February 2021 - Carlsbad, CA facility aims to reach a run rate of 600 million QuickVue® tests per year by end of 2021. Future plans call for production of numerous popular QuickVue® diagnostic tests to serve the emerging at-home testing market,
SAN DIEGO, 3 February 2021 -- Quidel Corporation (“Quidel”), a leading provider of rapid diagnostic testing solutions, cellular-based virology assays and molecular diagnostic systems, today announced the opening of a new manufacturing facility in Carlsbad, CA that will be dedicated to the production of Quidel’s popular QuickVue® line of products. The 128,000 square-foot facility will be the company’s highest-volume production plant in the world and begins operations in the second half of 2021 with a mission to produce 600 million QuickVue® SARS rapid antigen tests per year for the detection and diagnosis of COVID-19 infections.
Quidel plans to install multiple manufacturing lines at the Carlsbad facility and hire approximately 400 new employees with a mission to scale Quidel’s operations from 50 million QuickVue® tests per year to 50 million tests per month at full capacity, including non-COVID-19 diagnostic assays currently in-market or under development. The company is actively hiring to fill open positions including engineers, chemists, technicians, manufacturing, purchasing, sourcing and support services.
“From the first days of the pandemic, Quidel has stepped up to meet the COVID-19 challenge head-on with innovative diagnostic technologies to detect coronavirus infections and expanded manufacturing to democratize access to affordable and high-quality testing,” said Douglas Bryant, president and CEO of Quidel Corporation. “The opening of our massive new QuickVue® manufacturing plant is our boldest move yet and is expected to provide Quidel with the scale necessary to serve the needs of communities and institutions for frequent testing now and for years to come.”
Quidel received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) for its QuickVue® SARS Antigen Test for COVID-19 in December. The company’s QuickVue® lateral-flow technology is visually read by the user and provides results in 10 minutes from nasal swab samples. Initial applications for QuickVue® COVID-19 tests range from hospitals and physician offices to schools and pharmacies. Quidel is seeking EUA for a new QuickVue® At-Home COVID-19 Test for over-the-counter sale directly to consumers.
Quidel’s new QuickVue® SARS Antigen test offers excellent performance for the detection of SARS-CoV-2, with positive results agreeing with PCR 96.6% of the time and negative results agreeing 99.3% of the time, thereby providing quick, reliable results to patients, their families and healthcare workers alike.
In the professional segment, Quidel has manufactured the QuickVue® line for over 30 years. Quidel was the first company to introduce a visually read 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.
Today, Quidel’s QuickVue® diagnostic products that test for Influenza, RSV, Strep A, fecal occult blood, pregnancy, chlamydia, infectious mononucleosis, adenoviral conjunctivitis and H. pylori. Over the years, more than 150 million QuickVue® diagnostic testing units have been sold.
To learn more about our available positions, please visit: https://careers.quidel.com/
Background Information:
Throughout this pandemic, Quidel has been at the forefront of diagnostic innovation. From the company’s Lyra® PCR tests, to its Sofia® rapid antigen tests for COVID-19, to its Sofia® “ABC” combination test for the Influenza A+B and coronavirus, to its QuickVue SARS-CoV-2 test authorized for emergency use by the FDA in December, Quidel has significantly advanced the science and the scale of its operations.
Quidel was the first company to receive EUA from the FDA for a rapid point-of-care antigen test for COVID-19 and remains at the forefront of the battle against the coronavirus pandemic.
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.
In 2020, Quidel quickly increased its production of Sofia® rapid antigen tests from approximately 500,000 units per week to a rate of over 2 million tests per week at the end of December. Quidel is building additional production lines with a goal to reach a run-rate of over 240 million Sofia® tests per year by the third quarter of 2021. In 2020, the company also increased the installed base of Sofia® diagnostic instruments to more than 65,000 point-of-care locations.
Quidel’s QuickVue® and Sofia® SARS Antigen test kits are made in the greater San Diego metropolitan area of California.
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.
bioMérieux announces the CE marking of NEPHROCHECK® test on VIDAS®
3 February 2021
Marcy l’Etoile, France, February 3rd , 2021 – bioMérieux, a world leader in the field of in vitro diagnostics, today announced the CE marking of the innovative NEPHROCHECK® assay to detect kidney stress in patients at risk of acute kidney injury (AKI).
AKI is a common complication, affecting between 7 and 18% of all hospitalized patients and up to 50% of critically ill patients. The condition is associated with a 10-fold increase in hospital mortality and a higher rate of chronic kidney disease among post-op patients.
While a number of acute risk factors and patient characteristics have been identified which predispose patients to AKI, there is no reliable way for a clinician to establish a clear risk profile for any given patient. Delays in recognizing AKI can potentially lead to irreversible consequences. In many cases, adverse patient outcomes are avoidable if the condition is identified and managed in a timely fashion.
About NEPHROCHECK®
NEPHROCHECK® is an innovative test that detects kidney stress prior to actual damage, when a timely intervention can still make a difference. It is intended to be used in conjunction with clinical evaluation as an aid to support the risk assessment of moderate or severe AKI in acutely ill patients. With this early information, clinicians may either rule out kidney stress with confidence, or implement a series of protective measures for the kidneys.
The NEPHROCHECK® test relies on the detection of 2 innovative urinary biomarkers: TIMP-2 (tissue inhibitor of metalloproteinases-2) and IGFBP-7 (insulin-like growth factor-binding protein 7). Both proteins are produced by stressed kidney cells as an early warning signal, before the onset of AKI. Specific to kidney stress, they are not affected by any of the usual co-morbidities (such as sepsis, trauma, chronic kidney disease or cancer).
“As a predictive tool for AKI, NEPHROCHECK ® provides clinicians with high medical-value information and can lead to benefits in patient care and improved outcomes. The development of this test is consistent with our focus on improving care for individuals with acute medical and critical conditions. It complements our existing pioneering assays for these patients, such as procalcitonin (PCT),” said Mark Miller, Executive Vice President and Chief Medical Officer, bioMérieux.
“Considering the proportion of patients affected each year, AKI represents a significant burden on the functioning of intensive care units and has a huge economic impact on healthcare systems. Innovative assays like NEPHROCHECK® not only contribute to improved patient outcomes but could potentially help optimize hospital costs,” said Pierre Boulud, Chief Operating Officer, Clinical Operations of bioMérieux.
Effective immediately, VIDAS® NEPHROCHECK® is available in key European markets and will gradually be deployed in countries that recognize CE marking. Hospitals and private laboratories will be able to run the tests on bioMérieux’s VIDAS® 3 system, which allows for higher throughput, automation and traceability. bioMérieux is planning a submission for FDA clearance in the near future.
ABOUT VIDAS®
Launched 30 years ago, VIDAS® has transformed the field of immunoassays offering laboratories universal access to a simple, automated and robust technology providing fast and safe results. Today, VIDAS® is still the most widely used immunoassay system in clinical laboratories worldwide.
The VIDAS® menu comprises over 100 parameters, covering a wide range of pathologies, including infectious diseases and chronic diseases, as well as a range of tests dedicated to emergency and critical care. A number of these parameters are part of the bioMérieux full solution to address the global challenges of antimicrobial resistance (AMR) and sepsis. As it enters into its fourth decade, VIDAS® remains a major focus of the bioMérieux immunoassay strategy with ongoing research into new parameters and frequent launches that create value for labs and clinicians, ultimately bringing benefits for patients.
Reference: https://www.biomerieux.com/en/biomerieux-announces-ce-marking-nephrocheckr-test-vidasr
Sysmex establishes new subsidiary in Portugal
3 February 2021 - Increasing portuguese market presence by enhancing sales and after-sales support networks
3 February 2021 -- Sysmex Corporation (HQ: Kobe, Japan; Chairman and CEO: Hisashi Ietsugu) announced today the establishment of a new subsidiary, Sysmex Portugal, S.A. Going forward, Sysmex aims to increase its market presence by enhancing its sales and after-sales support networks in the country.
Since the 1979 creation of its public healthcare system, Portugal has maintained universal health insurance coverage, and its IVD market currently ranks 12th among European countries.1 Its per capita annual healthcare expenses are high, and demand for new testing in the life science field and elsewhere is expected to grow.
Sysmex first expanded to foreign markets in the early 1970s and, since establishing a UK subsidiary in 1991, has built direct sales and after-sales support networks outside of Japan. Now, 58 overseas affiliates (as of October 2020) deliver Sysmex products to over 190 countries and regions worldwide.
By building stable and long term relationships with customers, Sysmex hopes to develop insights into the needs of local customers to offer better solutions and to further increase its penetration into the IVD market, including hematology and urinalysis, while also expediting the market introduction of its products and services in the life science field.
Sysmex will remain committed to enhancing its global networks and offering a broad product line and attentive services and support, thus bringing greater trust and confidence to medical professionals.
LGC’s ValuPanel Reagents help public laboratories detect SARS-CoV-2 and influenza
2 February 2021
2 February 2021 -- LGC, Biosearch Technologies today announces the release of a new set of ValuPanel™ Reagents to help the efforts of public health laboratories to detect SARS-CoV-2, influenza A, and influenza B.
The CDC Influenza SARS-CoV-2 (Flu SC2) Multiplex ValuPanel Reagents - which are for research use only and not for use in diagnostic procedures - consists of probes and primers for multiplex RT-PCR detection and allows discrimination of SARS-CoV-2, influenza A, and influenza B from a single patient sample.
Mark Dearden, Managing Director, Genomics, LGC, said, “LGC was one of the first companies to support the initial US public health response to COVID-19, partnering with the CDC to provide oligonucleotides used to support the CDC 2019-nCoV Real-Time PCR Diagnostic Panel. The CDC Flu SC2 Multiplex ValuPanel has been added to our growing line of ValuPanel Reagents, which includes our US CDC 2019-nCoV ValuPanel, the Charité 2019-nCoV BHQ™/BBQ-650™ ValuPanel, and our recently-released Yale 2019-nCoV SalivaDirect™ ValuPanel.”
“In today’s crisis, LGC’s core purpose of Science for a Safer World could not be more relevant and important. We are involved in many aspects of the global response, doing everything we can to accelerate delivery and scale our capacity and output in order to deliver these critical testing supplies and help our customers ramp up their testing capability.”
The ValuPanel Reagents were designed to match the sequences and performance of the probes and primers from the CDC’s Flu SC2 Multiplex Assay, which was granted EUA in July 2020.
Each line of ValuPanel Reagents consists of separately delivered probes and primers, which allow assay flexibility and sizes that can help facilitate scale-up. The full portfolio offers additional components across the PCR workflow, including master mix and enzymes manufactured in an ISO13485-certified facility and extraction reagents.
LGC is the inventor of specific chemistries, such as Black Hole Quencher™ (BHQ™), BlackBerry™ Quencher (BBQ-650™) and other critical dyes and components for diagnostic kit developers. It has previously provided detection solutions for viruses including seasonal influenza, H1N1 (swine flu), Chikungunya, Zika, and Ebola and also has CDC-qualified lots of SARS-CoV-2 probe and primer kits available for sale. Each kit contains enough material for 1,000 reactions, equivalent to 1,000 tests.
LGC’s probes and primers are manufactured and shipped from a facility entirely separate from positive control production to protect the integrity of customer COVID-19 workflows.
Reference: https://www.lgcgroup.com/newsroom-and-blog/news-and-blog/reagents-detect-sars-cov-2-and-influenza/
Roche announces the upcoming launch of the SARS-CoV-2 Rapid Antigen Test Nasal allowing for patient self-collection
1 February 2021 - The SARS-CoV-2 Rapid Antigen Test Nasal uses a nasal swab to quickly and conveniently collect specimens from people suspected of having an active infection Nasal sampling allows for collection of the sample from the front area of the nose instead of the nasopharynx resulting on a less invasive testing experience for patients The test also provides patients with the option to self-collect their nasal sample
Basel, 01 February 2021 -- Roche today announced it has obtained the CE mark for its new SARS-CoV-2 Rapid Antigen Test Nasal. The test will be available in countries accepting the CE mark by mid-February 2021.
In comparison to the existing Roche SARS-CoV-2 Rapid Antigen Test, the SARS-CoV-2 Rapid Antigen Test Nasal collects the sample from the front area of the nose instead of the nasopharynx, resulting in a simplified and faster testing procedure. This testing method can help reduce overall patient discomfort, particularly in sensitive individuals such as children, elderly people and/or people with disabilities.
Besides being less invasive, the test also provides patients with the option to self-collect their nasal sample under the supervision of a healthcare professional. Through reduced physical contact, this method of testing can help to decrease the risk of exposure to the virus for healthcare professionals. Whether the test could also be used without supervision of a healthcare professional will depend on local regulatory requirements.
“Rapid testing continues to play an important role in the fight against COVID-19, especially in places when laboratory testing is not available and quick results are needed, such as nursing homes, healthcare facilities, and schools.” said Thomas Schinecker, CEO Roche Diagnostics. “The SARS-CoV-2 Rapid Antigen Test Nasal provides patients with a more comfortable testing experience.”
The launch is a partnership with SD Biosensor Inc., with whom Roche has also launched a SARS-CoV-2 Rapid Antibody Test in July and a SARS-CoV-2 Rapid Antigen Test in September 2020. SD Biosensor, is currently preparing to submit an Emergency Use Authorisation (EUA) to the U.S. Food and Drug Administration (FDA).
The test is the latest addition to Roche's comprehensive COVID-19 portfolio to support healthcare systems in diagnosing SARS-CoV-2 infection.
About the SARS-CoV-2 Rapid Antigen Test Nasal
The SARS-CoV-2 Rapid Antigen Test Nasal is a rapid chromatographic immunoassay for the qualitative detection of the nucleocapsid protein of SARS-CoV-2 present in human nasal specimens. In clinical studies, the SARS-CoV-2 Rapid Antigen Test Nasal showed a relative sensitivity of 90.6% (Ct value ≤ 30; 95 % CI: 75.0 % - 98.0 %) and a specificity of 98.6% for professionally collected samples. For self-collected samples a sensitivity of 84.4 % (Ct value ≤ 30; 95 % CI: 67.2 % - 94.7 %) and a specificity of 99.2% was detected. Overall the studies contained 468 symptomatic and asymptomatic individuals. This test is intended to detect antigen from SARS‑CoV‑2 in individuals suspected of COVID‑19 or with known or suspected exposure to SARS‑CoV‑2.
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 and can be offered as a rapid strip test that is performed at the point of care. If the target antigen is present in sufficient concentrations in the sample, it will bind to specific antibodies and generate a visually detectable signal on the test strip, typically with results ready in 15 minutes. A rapid antigen test can reliably detect individuals with a high viral load allowing healthcare professionals to quickly identify those patients at greatest risk of spreading the infection.
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 2020 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 2020, 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 of last year 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 of 2020, we added a Rapid Antibody Test, with SD Biosensor as manufacturing partner, to the portfolio, that allows the detection of antibodies against COVID-19 at the point of care, a Rapid Antigen Test in September and a lab-based Antigen Test in December. Roche is working closely with governments and health authorities around the world, and has significantly increased production to help ensure availability of tests globally.
Roche is actively involved in understanding the potential of the existing portfolio and is 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 2020 Roche 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 2020, Roche 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 SD Biosensor
SD Biosensor is a global bio-diagnostic company that provides in vitro products engrafted with innovative technologies. Established in 2010, SD Biosensor has successfully launched diagnostics of blood glucose, glycated hemoglobin and cholesterols globally. Through these innovative products, they are striving to become a leading global in vitro diagnostic company.
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-2021-02-01.htm
Distribution agreement with Beckman Coulter Life Sciences for COVID-19 PCR Testing
28 January 2021
28 January 2021 -- genedrive plc, the near patient molecular diagnostics company, announces that it has entered into a distribution agreement with Beckman Coulter Life Sciences (“Beckman Coulter”) for its Genedrive® 96 SARS-CoV-2 Kit. The agreement enables Beckman Coulter to sell and distribute genedrive’s high-throughput COVID-19 PCR Kit in the United States and Europe for use on upper respiratory viral samples. The agreement is the result of the collaboration agreement announced in August 2020, under which the companies worked to develop and validate a fully automated PCR process for Beckman Coulter’s Biomek automated workstation in conjunction with its RNAdvance Viral XP extraction kit.
The Genedrive® 96 SARS-CoV-2 test is ideally suited for use on the high throughput robotic Biomek i7 instrument. The ready-to-go nature of the test removes many of the fluid dispensing steps required in competitor assays, increasing the overall throughput of the Biomek compared to using a liquid reagent based test formulation. Full automation of the overall PCR workflow can allow laboratories to run large numbers of tests over extended working hours or workstation platforms. Beckman Coulter estimates that this new turnkey solution could process circa 1,000 PCR samples per Biomek workstation installed during a standard 8-hour working day, using just a 0.5 full-time-equivalent in technician time for processing.
David Budd, CEO of genedrive plc, said: “We are very pleased to have the partnership of Beckman Coulter in accessing significant COVID testing opportunities throughout the United States and Europe, where the incidence of COVID continues to escalate and the need for high throughout testing solutions remains a priority. The combination of genedrive and Beckman Coulter products and expertise provides the Company with a new, innovative, and competitive solution, and a new sales channel for the American market, which we did not have previously.
“We are very pleased to now take our initial collaboration and development agreement to the commercial stage. Beckman Coulter is an important and significant company in these core geographies, well suited to promoting, selling, and supporting our products.”
The Companies are planning commercial introduction of the Genedrive kit from mid February, following commercial and technical training of the Beckman sale and support organisations.
Reference: https://www.genedrive.com/news/index.php
Ortho Clinical Diagnostics Announces Launch of Initial Public Offering
27 January 2021
Raritan, NJ, 27 January 2021 -- Ortho Clinical Diagnostics Holdings plc (“Ortho”), the world’s largest pure-play in vitro diagnostics company dedicated to improving and saving lives through innovative laboratory testing and blood-typing solutions, today announced the pricing of its initial public offering of 76 million ordinary shares at $17.00 per share. The gross proceeds raised from this offering are expected to be $1,292 million. Ortho’s ordinary shares are expected to begin trading on The Nasdaq Global Select Market on January 28, 2021, under the symbol “OCDX,” and the offering is expected to close on February 1, 2021, subject to customary closing conditions.
Ortho has granted the underwriters a 30-day option to purchase up to 11.4 million additional ordinary shares at the initial public offering price less underwriting discounts and commissions.
Ortho intends to use the net proceeds from the offering to redeem $160 million in aggregate principal amount of 7.375% senior notes due 2025 and $270 million in aggregate principal amount of 7.250% senior notes due 2028, in each case issued by certain of Ortho’s subsidiaries, repay borrowings under its dollar term loan facility, and for working capital and general corporate purposes, which may include further repayment of indebtedness.
The offering is being made through an underwriting group led by J.P. Morgan, BofA Securities, and Goldman Sachs & Co. LLC, who are acting as lead bookrunning managers, Barclays, Morgan Stanley, Citigroup, Credit Suisse, UBS Investment Bank, Evercore ISI and Piper Sandler, who are acting as joint bookrunning managers, and ING, Macquarie Capital, Nomura, TCG Capital Markets L.L.C., Drexel Hamilton, H.C. Wainwright & Co., Ramirez & Co., Inc. and Siebert Williams Shank, who are acting as co-managers.
A registration statement on Form S-1 relating to these securities has been declared effective by the Securities and Exchange Commission. This news release shall not constitute an offer to sell or a solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.
About Ortho Clinical Diagnostics
Ortho Clinical Diagnostics is a global leader of in vitro diagnostics dedicated to improving and saving lives through innovative laboratory testing and blood-typing solutions.
Because Every Test is a Life™, we never stop innovating to offer streamlined, sustainable laboratory solutions that deliver fast, accurate, reliable test results that support exceptional patient care.
As a trusted partner of hospitals, hospital networks, blood banks, and labs around the world, we proudly serve the clinical laboratory and transfusion medicine communities with customized solutions that enhance clinical outcomes, improve lab performance, overcome staffing challenges and better manage costs.
We are powered by Ortho Care™, our global, award-winning, holistic approach to service, which supports customers with best-in-class technical support, award-winning field support, and remote service and inventory support.
LGC launches SARS-CoV-2 molecular solution for Oral Fluid Testing
26 January 2021
26 January 2021 -- LGC has expanded its innovative portfolio of SARS-CoV-2 quality solutions with the release of AccuPlex™ SARS-CoV-2 in Synthetic Oral Fluid reference material. The product is designed to support development and testing efforts around novel saliva-based SARS-CoV-2 diagnostics. It serves as an ideal research tool for assay developers as well as a complete quality solution for clinical laboratories employing such tests.
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. AccuPlex SARS-CoV-2 in Synthetic Oral Fluid can be utilized for oral fluid-based diagnostic development, as well as for assay verification at installation and day-to-day performance monitoring.
Michael Sweatt, Executive Vice President, Clinical Diagnostics, LGC, stated, “As the need for solutions for SARS-CoV-2 diagnostics evolves to include alternative sample types, we are pleased to offer innovative tools for both test manufacturers and clinical testing labs. This addition to our suite of AccuPlex SARS-CoV-2 quality solutions is just the latest innovation in our efforts to support novel diagnostics development and implementation in response to the COVID-19 pandemic.”
To learn more about AccuPlex SARS-CoV-2 in Synthetic Oral Fluid reference material, as well as the complete line of SARS-CoV-2 Quality Solutions, please visit the SeraCare website.
PerkinElmer Launches Industry-First GPCR TR-FRET Binding Assay and Beta-Arrestin Kits to Help Advance Therapeutics Discovery
26 January 2021 - New offerings join PerkinElmer’s leading GPCR Portfolio across characterization and screening assays, screening libraries and workflow optimization
WALTHAM, Mass., January 26, 2021 – PerkinElmer, a global leader committed to innovating for a healthier world, today announced the addition of new assay kits to help further GPCR (G Protein-Coupled Receptor) therapeutic discovery. The new PerkinElmer offerings extend the company’s leading GPCR analysis portfolio, which includes innovative assays, plate readers, automation technologies and software solutions combined with siRNA, shRNA, CRISPR, and cDNA/ORF libraries to help scientists more easily and accurately characterize receptors, screen compounds and streamline workflows.
The new assays, which enable researchers to use the preferred cell models of their choice, include the HTRF GTP Gi binding kit, the industry’s first TR-FRET based assay for GTP binding; the B-arr2 recruitment kit; and HTRF total kits for B-Arrestin 1, B-Arrestin 2 and AP2. These assays will help scientists continue to better understand the important role GPCRs play in disease by studying the interaction, expression and potential modulation of intracellular proteins involved in GPCR signaling mechanisms.
Further, when the new kits are leveraged as part of PerkinElmer’s comprehensive range of GPCR solutions, users can fully characterize the GPCRs being studied -- from ligand binding with the Tag-Lite® platform, and 2nd messenger with the cAMP and IP-One™ kits, to downstream GPCR signaling with hundreds of available assays. With the recent acquisition of Horizon Discovery, the PerkinElmer portfolio also includes siRNA, shRNA, CRISPR guide RNA, and cDNA/ORF libraries, such as ON-TARGETplus™, SMARTvector™ and Edit-R™ and screening services, which help researchers better explore the impact of gene modulation and editing on GPCR disease drivers.
“With GPCR-targeting drugs accounting for more than 30% of all FDA approved therapeutics and 20% of all drugs being studied, this area of research and development has been incredibly fruitful and holds immense potential for the future,” said Alan Fletcher, VP and GM of Life Sciences, PerkinElmer. “By adding these new assays to our already robust GPCR capabilities, we are giving researchers an end-to-end solution for continuing to unlock the role GPCRs play in disease so new and better therapeutics can be uncovered.”
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 Panbio Rapid Antigen Test receives CE Mark for asymptomatic screening and self-administered sample collection with nasal swab
26 January 2021 - Panbio™ COVID-19 Ag Rapid Test Device supports mass testing in congregate populations of people (mass screening) who are asymptomatic. Frequent screening of asymptomatic and symptomatic people helps restore a sense of safety at workplaces, schools, travel and recreational settings, and other places where people gather in large numbers. Test is approved for use with a patient-friendly and minimally invasive nasal swab; patients can self-administer sample collection under a healthcare professional's supervision. Panbio COVID-19 Ag delivers results in as early as 15 minutes with no instrumentation, using proven Abbott lateral flow technology. Test performance in clinical study demonstrated 93.8% sensitivity and 100.0% specificity in asymptomatic people with high viral loads. Along with the test, Abbott will offer complementary digital solutions: the NAVICA™ mobile app to allow people to display negative results for proof of testing and Sympheos™ for surveillance management to understand epidemiological trends. Since August 2020 to date, Abbott has shipped 200 million Panbio rapid antigen tests to 120 countries worldwide.
ABBOTT PARK, Ill., Jan. 26, 2021 -- Abbott announced today it has received CE Mark for two new uses of its Panbio™ COVID-19 Ag Rapid Test Device for the detection of the SARS-CoV-2 virus: asymptomatic testing and self-swabbing.
Panbio COVID-19 Ag's label has been updated with clinical data on asymptomatic individuals, which enables mass testing (mass screening) of people who do not currently present symptoms of the disease. According to a recent study published in JAMA, at least 50% of COVID-19 infections are estimated to have originated from exposure to asymptomatic individuals.
The other update to the label allows self-collection of nasal specimens under the supervision of a healthcare worker. Self-swabbing with a patient-friendly nasal swab improves patient comfort and reduces the risk of accidental exposure to the virus for healthcare workers as they can maintain distance during the testing procedure.
"Rapid testing continues to be one of our most important tools for fighting this pandemic, and the ability to perform mass screening allows us to expand testing and reach more people in more places," said Robert B. Ford, president and chief executive officer, Abbott. "Now that Abbott's Panbio rapid antigen test has an asymptomatic indication, it becomes an even more valuable tool for enabling a safer return to work, school, travel and other activities of daily life."
Since last August to date, Abbott has shipped 200 million Panbio rapid antigen tests to 120 countries across Europe, the Americas, Asia and Africa. Healthcare professionals globally have seen the clinical utility of the test in detecting COVID-19 infections. In coordination with the Global Fund, the World Health Organization and the Bill & Melinda Gates Foundation, Abbott continues to make Panbio rapid antigen tests available to low- and middle-income countries.
Panbio COVID-19 Ag is not available in the U.S., where Abbott manufactures and sells the BinaxNOW™ COVID-19 Ag Card, which has received emergency use authorization (EUA) by the U.S. Food and Drug Administration (FDA). Abbott is in the process of pursuing FDA EUA of an asymptomatic indication for BinaxNOW.
Both Panbio and BinaxNOW rapid antigen tests use similar biologics and are highly portable, reliable and affordable.
Widespread, frequent and fast testing facilitates return to work
The large number of COVID-19 cases and fear of disease spread has resulted in a global economic recession, increased workplace absenteeism and the inability of employers to bring their employees back to the office. As a result, employers and governments around the world are looking for ways to ensure business continuity and restart their economies.
Frequent and fast screening of employees using rapid antigen tests such as Panbio COVID-19 Ag – along with preventative measures such as mask-wearing, social distancing, handwashing, disinfecting facilities and any other actions required by government – can support a safer return to work by quickly identifying and isolating infected and contagious individuals. Employees who test negative can be admitted to facilities and resume their work.
"Since October 2020, Abbott has used rapid antigen tests in a phased rollout of employee testing across multiple sites globally," said Mary Moreland, executive vice president, Human Resources, Abbott. "Our experience proves that testing helps our employees feel safer and more comfortable coming into the office during this time, so they can more effectively collaborate with each other and perform their duties."
Expanded rapid antigen testing plays critical role in restoring freedom of mobility
Beyond workplace screening, the ability to conduct mass screenings at ports of entry using the Panbio rapid antigen test will facilitate the resumption of global travel. A number of governments now mandate proof of a negative COVID-19 viral test before entering the country.
Additionally, various airlines and cruise ship companies require that passengers present negative test results before boarding. The International Air Transport Association (IATA) and the Airports Council International (ACI) have publicly called for a systematic approach to testing that is fast, accurate, affordable, easy-to-use, scalable and supported by public health authorities. Mass screening can help restore freedom of mobility across borders and will allow people to travel safely and with confidence.
"Being able to effectively screen asymptomatic people – along with other hygienic measures already in place – is the best way to ensure the safety of our passengers and all air transport workers," said Olivier Jankovec, director general, Airports Council International Europe. "Over 100 airports across Europe are already providing COVID-19 testing facilities in close cooperation with their health authorities. Rapid screening using high-quality and affordable antigen tests is a crucial part of resuscitating global travel until the vast majority of the world's travelers and crews are vaccinated."
Digital solutions facilitate return to daily life and understanding epidemiological trends
Digital health technologies play an important role in pandemic response. Integrated into testing strategies, digital technologies can support mass screening of people for safe entry into facilities and disease surveillance management to understand epidemiological trends. Abbott is offering two distinct digital solutions to support each of these functions.
Abbott's NAVICA mobile app for iPhone and Android devices allows people who test negative to display a temporary digital health certificate that is renewed each time a person is tested by a healthcare worker together with the date of the test result. Organizations using the NAVICA verifier app can scan and verify the information on a mobile device to manage safe entry into workplaces, airplanes and cruise ships, schools and universities, and other places where people come together in large numbers. NAVICA for use with Panbio Ag is soon to be available at no charge to customers outside the U.S.
In support of public health strategies, Abbott is offering Sympheos™, a web-based data collection and visualization tool, for use with Panbio Ag. Sympheos allows healthcare workers to log real-time test results on a smart phone, aggregate the collected data, and display it in a dashboard with heat maps, disease surveillance and testing trends. Sympheos data visualization may help health authorities better understand the epidemiological status of their epidemic and mobilize their COVID-19 response more effectively. Sympheos, which is available now to customers outside the U.S., can also be used to track in parallel other diseases such as malaria and HIV where there are high rates of co-infection.
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 the U.S. only) and the Panbio™ COVID-19 Ag Rapid Test Device (available in countries outside the U.S.).
About Panbio COVID-19 Ag Rapid Test Device
Panbio COVID-19 Ag Rapid Test Device is a lateral flow assay for rapid, qualitative detection of SARS-CoV-2 virus. A nasal or nasopharyngeal swab is used for collection of specimens from individuals. Test results are delivered in as early as 15 minutes with no instrumentation.
Negative results must be combined with clinical observations, patient history and epidemiological information. Negative results do not preclude COVID-19 infection and cannot be used as the sole basis for treatment or other management decisions.
Clinical performance of Panbio COVID-19 Ag Rapid Test Device was determined by testing 483 asymptomatic people for SARS-CoV-2 antigen and comparing results against a PCR reference method.
Positive results (n=50) were stratified by cycle threshold (Ct) counts in order to understand the correlation between product performance and the amount of virus present in the clinical sample. A lower Ct value corresponds to a higher concentration of the virus.
Specificity of the test across 433 negative samples was 100.0%, which means no false positives were identified. Results for sensitivity were:
- 93.8% in 32 samples with Ct values less than or equal to 30
- 80.0% in 40 samples with Ct values less than or equal to 33
- 66.0% across all 50 positive samples (at all Ct counts)
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.
Panbio COVID-19 Ag is CE-Marked for use with a nasal swab on asymptomatic and symptomatic people. Abbott has submitted documentation to the World Health Organization for Emergency Use Listing for the two new claims for asymptomatic testing and self-swabbing. Panbio COVID-19 Ag Rapid Test device is available in countries outside of the U.S. and subject to local regulatory and commercialization requirements.
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.
Beckman Coulter brings the productivity and efficiency benefits of large volume hematology analyzers to small- and medium-sized labs
25 January 2021 - The new DxH 560 AL enables clinics and physician’s offices to continually load up to 50 samples per run, freeing up valuable time and resources. With less than a drop of blood, one of the lowest sample volumes on the market, the analyzer delivers high-quality results in 60 seconds or less.
BREA, CALIF., JAN. 25, 2020 — Beckman Coulter, a global leader in clinical diagnostics, announced today the launch of the DxH 560 AL, a tabletop analyzer geared to reduce the time and resource constraints faced by small to mid-sized laboratories. With the analyzer’s Auto-Loading functionality, closed tube aspiration and walkaway capabilities, users can continually add up to 50 samples, provide safety against blood-borne pathogens and spend less time on manual instrument tasks. Compactly designed, the DxH 560 AL uses ~30% less counter space than other analyzers in its class.
The DxH 560 AL delivers results in 60 seconds or less, and is the ideal instrument to use with difficult-to-draw patients (infants, oncology and elderly) as it only needs a 17 μL sample – less than a drop of blood, one of the smallest aspiration volumes on the market. The analyzer also provides industry-leading privacy and security features including customizable user login, paperless data management and fully traceable automated timeouts that guards patient electronic personal health information.
“With proven performance and low-cost to operate, the DxH 560 AL includes the analytical strengths and data management capabilities of high-throughput analyzers in a small footprint,” said Peter Soltani, Ph.D., senior vice president and general manager of hematology at Beckman Coulter. “The industry-leading functionality and auto-load capabilities of the DxH 560 AL enables smaller labs to reap the same efficiency and productivity benefits as their larger counterparts without blowing the budget.”
The DxH 560 AL is part of Beckman Coulter’s DxH 500 series of small footprint tabletop hematology analyzers, including the recently launched DxH 500 and the award winning DxH 520. The full DxH 500 series of analyzers include dynamic gating for its 5-part differential, eliminating rejected results and lowering manual interventions.
Beckman Coulter’s DxH 560 AL builds on the organization’s strength in hematology innovation and complements its broad spectrum of hematology analyzers, including the award winning DxH 690T for mid-volume, DxH 900 for high-volume and DxH connected workcell solutions for ultra-high-volume facilities. For more information on the DxH 560 AL, or the full DxH 500 series, visit https://www.beckmancoulter.com/en/products/hematology.
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.
Roche renews partnership with Sysmex to deliver haematology testing solutions
25 January 2021 - This successful long-running partnership continues to evolve and bring haematology testing innovations to laboratories, globally. The new agreement aims to utilise the IT systems to lead to improved clinical decision making and customer experience. Blood disorders have a high impact, not only for patients but for society as a whole, accounting for a third of all central laboratory tests.
Basel, 25 January 2021 -- Roche today announced that, on 14 December, 2020, it signed a Global Business Partnership Agreement (GBP) with Sysmex. Under this new framework, the parties renewed their commitment to the long standing Distribution, Sales and Service (DSS) agreement, allowing Roche to continue to distribute Sysmex haematology products, including instruments and reagents. This GBP sees the introduction of an IT Solutions Collaboration Agreement. In the newly defined collaboration, the two companies have agreed to utilise their respective IT platforms to improve customer experience, in the short to mid-term, with a longer term ambition to use the IT systems to lead to improved clinical decision making. The GBP agreement will run until the end of 2030.
“Roche is committed to supporting improvements in haematology testing, which helps patients with the diagnosis and management of blood diseases, as diverse as anemia and leukaemia”, said Thomas Schinecker, CEO Roche Diagnostics. “Extending our longstanding partnership with Sysmex underscores our unique synergy and our objective to offer our customers high-quality haematology solutions to improve the testing efficiency in central laboratories in hospitals and commercial laboratories, ultimately benefiting the millions of patients living with blood disorders.”
The burden of blood disorders is very high, not only for patients but for society as a whole. Recent studies estimated that, in Europe, 80 million people suffer from haematological disorders and the economic impact of blood disorders in Europe amounts to EUR 23 billion per year, mostly in healthcare expenditure. Improved management is a key factor to counteract the rise of this economic burden for healthcare and society.
About the Roche and Sysmex partnership
In 1999, Sysmex and Roche entered into a Distributorship Sales and Service Agreement (DSS), under which Roche distributed Sysmex hematology products and provided services in overseas markets. This mutually beneficial arrangement has since advanced as demands for haematology testing have evolved, with greater focus on automation of manual processes and streamlining workflow, expanding the utility of haematological parameters so as to support diagnosis, monitoring and treatment across disease areas, beyond routine testing. In 2018, Roche and Sysmex entered into a non-exclusive collaboration agreement to offer Total Laboratory Solutions (TLS). This means that customers who want to purchase products for clinical chemistry, immunochemistry, and hematology testing from one vendor, could do so seamlessly with Roche and Sysmex.
The GBP agreement will allow Roche and Sysmex to deliver tailored haematology solutions to new and existing customers, while having the benefits of working with a single provider. Streamlining testing efficiency and effectiveness are an important part of a laboratory’s remit. Having the opportunity to integrate the technologies from two leading IVD companies, while simultaneously having a single service provider, can support laboratories to improve their testing solution and service delivery. Utilising a single service provider can simplify laboratory workflows, inventory management and service solutions, while maintaining access to high-quality, market-leading systems and solutions. The partnership will also strive to develop a joint framework to ensure and promote connectivity through standardisation of cybersecurity measures.
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-2021-01-25b.htm
QIAGEN confirms effectiveness of its SARS-CoV-2 PCR tests in the face of mutations of the coronavirus
20 January 2021 - QIAstat-Dx and NeuMoDx tests continue to detect all known viral variants extremely effectively. QIAGEN started cross-checking variants in May 2020 and continues to conduct biweekly assessments. QIAseq SARS-CoV-2 Primer Panel helps with sequencing RNA and identifying mutations.
Germantown, Maryland, and Hilden, Germany, January 20, 2021 – QIAGEN N.V. today announced its polymerase chain reaction (PCR) tests remain accurate and effective in detecting SARS-CoV-2 infections – and will continue to closely monitor their performance as global concerns mount regarding the detection of new viral variants by established testing methods.
QIAGEN has successfully assessed its SARS-CoV-2 PCR tests against genetic mutations of the virus uploaded to the GISAID and GenBank public databases since May 2020. A latest round of assessments conducted in January 2021 again confirmed that no recorded mutations affected the sensitivity of QIAGEN assays for detection of SARS-CoV-2. Surveillance of genetic variations will continue on a biweekly basis.
“We are pleased to report the known viral variants have had no impact on the effectiveness of our three SARS-CoV-2 PCR tests – PCR remains the gold standard for detecting RNA viruses like SARS-CoV-2,” said Davide Manissero, M.D., Chief Medical Officer - Infection and Immune Diagnostics at QIAGEN. “Further genomic sequencing of SARS-CoV-2 samples worldwide will vastly increase transparency and help us identify and respond to potentially dangerous mutations of the virus, while at the same time broadening the database we can use to verify if vaccines and tests continue to be effective.”
Variants with potentially increased transmissibility include VUI 202012/01 (first detected in the United Kingdom), 501Y.V2 (identified in South Africa), and B.1.1.28 P1 (most recently discovered in Brazil). As a virus encoded by RNA nucleotides, SARS-CoV-2 frequently mutates due to erroneous or ineffective replication of the virus genome. These mutations can sometimes produce viruses with altered properties or even entirely new strains.
To better identify potentially dangerous variants, countries like Germany and the U.S. are increasing the frequency of sequencing positive SARS-CoV-2 samples to monitor the occurrence of potential mutations. In August 2020, QIAGEN launched the QIAseq SARS-CoV-2 solution for comprehensive monitoring of sequence drift of the virus around the world. Consisting of a CoV-2 targeting panel, the QIAseq Fx UNGS library kit, and QDI bioinformatic analysis solution, this system allows for the identification of both known and novel variants in the CoV-2 genome.
A recent paper published by scientists from the Center of Genomics at the School of Medicine at the Loma Linda University in California measured performance variation across several SARS-CoV-2 whole genome sequencing technologies using clinical nasopharyngeal swab samples. Results demonstrated the QIAseq SARS-CoV-2 Primer Panel enabled preferential amplification of the SARS-CoV-2 genome by up to 100-fold compared to human or bacterial genomes in human samples. In comparison with RNA-seq metagenomics-based technologies, it achieved more than 100-fold higher coverage of the SARS-CoV-2 genome, depending on viral load and sequencing depth.
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/2021/20210120_sars_cov_mutations
Labcorp Appoints Dr. Deborah Ann Sesok-Pizzini as Chief Medical Officer, Labcorp Diagnostics
19 January 2021 - Industry Leader Will Assume the Role Previously Held by Dr. Dot Adcock Who is Retiring in April
BURLINGTON, N.C., Jan. 19, 2021 -- Labcorp, a leading global life sciences company, announced today that Dr. Deborah Ann Sesok-Pizzini has been appointed Chief Medical Officer of Labcorp Diagnostics, following the retirement of Dr. Dot Adcock in April 2021. Dr. Sesok-Pizzini assumed the role starting on January 11, 2021.
Dr. Sesok-Pizzini joins Labcorp with over two decades of experience in healthcare. Prior to joining Labcorp, she held multiple appointments with The Children’s Hospital of Philadelphia, including Patient Safety Officer, Chief of the Division of Transfusion Medicine and Vice-Chief of Pathology and Laboratory Medicine. She was also a professor of clinical pathology and laboratory medicine at the Perelman School of Medicine at the University of Pennsylvania in Philadelphia, PA.
“We are thrilled to welcome Dr. Sesok-Pizzini to Labcorp,” said Dr. Brian Caveney, chief medical officer and president of Labcorp Diagnostics. “Her significant contributions to scientific communities and research, along with her esteemed career in healthcare and pathology, will provide invaluable expertise and insight to our leadership team. We are also extremely grateful to Dr. Dot Adcock for her dedication and years of stellar service to Labcorp and wish her the best in retirement.”
Dr. Sesok-Pizzini holds her doctorate from Pennsylvania State University and a MBA from Villanova University. She belongs to an extensive list of professional and scientific organizations and has authored dozens of articles, abstracts and publications related to her research.
“I am excited to be joining Labcorp Diagnostics and look forward to helping further the mission to improve health and improve lives,” said Dr. Sesok-Pizzini. “My top priority has always been the patient. I hope to use my experiences and education to provide insights that can be used to enhance the patient experience, enable health provider decisions and develop innovative testing solutions.”
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 reported revenue of $11.5 billion in FY2019. Learn more about us at www.Labcorp.com.
PepTalk: The Protein Science and Production Week
19-21 January 2021
19-21 January 2021 -- PepTalk is celebrating its 20th year! This is a fully integrated virtual event that will continue to serve as a content hub for the latest research and biotherapeutics developments, provide a 1:1 networking platform, offer an interactive exhibit hall, live Q&A sessions, breakout groups, research posters, and so much more.
Dana Holzinger, Head of Product Management at PROGEN will be attending and presenting a poster focusing on 'Developing reliable AAV standards for ELISA'.
Download the full event guide from the PepTalk conference website for more information.
We look forward to meeting you virtually!
Reference: https://company.progen.com/news/article/view/peptalk-the-protein-science-and-production-week/
Thermo Fisher Scientific to Acquire Point-of-Care Molecular Diagnostics Provider Mesa Biotech
19 January 2021
WALTHAM, Mass., Jan. 19, 2021 -- Thermo Fisher Scientific Inc., the world leader in serving science, today announced it has entered into a definitive agreement to acquire Mesa Biotech, Inc., a privately held molecular diagnostic company, for approximately $450 million in cash. Under the terms of the agreement, Thermo Fisher will pay up to an additional $100 million in cash upon the completion of certain milestones following the close of the transaction.
Mesa Biotech has developed and commercialized a PCR-based rapid point-of-care testing platform available for detecting infectious diseases including SARS-CoV-2, Influenza A and B, respiratory syncytial virus (RSV) and Strep A. Mesa Biotech's patented technology expands the availability of gold standard nucleic acid PCR amplification to point-of-care diagnostics. The company is based in San Diego, California and has approximately 500 employees and revenues in 2020 of approximately $45 million.
Mesa Biotech's Accula™ Flu A/Flu B, RSV and Strep A tests have obtained 510(k) clearance and Clinical Laboratory Improvements Amendments (CLIA) waivers from the U.S. Food and Drug Administration (FDA). Additionally, the Accula System has received Emergency Use Authorization (EUA) from the FDA for SARS-CoV-2 in vitro diagnostic testing and is now available for use in patient care settings, providing results within 30 minutes, with higher accuracy than other rapid tests on the market.
"Mesa Biotech's innovative platform will enable us to accelerate the availability of reliable and accurate advanced molecular diagnostics at the point of care. Since the start of the pandemic, Thermo Fisher has acted quickly to provide support to the scientists and healthcare professionals at the frontlines of combating COVID-19," said Mark Stevenson, executive vice president and chief operating officer of Thermo Fisher Scientific. "The addition of Mesa Biotech's easy-to-use, rapid PCR-based test is highly complementary to our existing offering and will further help us meet the continuing demand for COVID-related testing while we work to rapidly scale and develop point-of care tests for other infectious diseases in the future."
Ingo Chakravarty, president and chief executive officer of Mesa Biotech said, "I am extremely proud of the remarkable accomplishments Mesa Biotech has achieved to date and excited about the prospects of becoming a part of Thermo Fisher. Mesa's innovative rapid PCR platform technology, combining PCR accuracy with mobility and test results in 30 minutes, has already played a meaningful role in the collective efforts combating the pandemic. Thermo Fisher's scale, innovation and global reach will allow us to more significantly amplify the impact our technology will have on human health, during the pandemic, and far beyond."
The transaction is expected to be completed in the first quarter of 2021, subject to customary closing conditions, including regulatory approval. Upon completion, the business will become part of Thermo Fisher's Life Sciences Solutions Segment.
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.
SYNLAB bietet Genom-Sequenzierung von SARS-CoV-2 Varianten an
18 January 2021 - Angesichts der aktuellen Verbreitung neuer SARS-CoV-2 Varianten bieten wir die vollständige Genom-Sequenzierung des Virus in unserem Labor mittels Next Generation Sequencing (NGS) an. Darunter fallen auch die in Großbritannien (SARS-CoV-2 VOC 202012/01) sowie in Südafrika (SARS-CoV-2 501Y.V2) zirkulierenden Varianten.
Im Rahmen einer Verordnung des Bundesgesundheitsministeriums zur molekulargenetischen Surveillance des Coronavirus soll auf diese Weise die Voraussetzung dafür geschaffen werden, kurzfristig mehr Genomsequenzdaten der in Deutschland zirkulierenden Varianten von SARS-CoV-2 für Analysen zur Verfügung zu stellen.
Bei Interesse und allen weiteren Fragen zum Thema SARS-CoV-2-Sequenzierung wenden Sie sich bitte an unseren Chief Medical Officer (CMO), Dr. Martin Roskos telefonisch unter +49 3641 50740 oder senden Sie uns Ihre Anfrage über unser Kontakformular:
https://www.synlab.de/kontaktformular/anfrage-sars-cov-2-testung
Quest Diagnostics Granted CDC Contract to Sequence COVID-19 Gene Variants to Aid Public Health Response to COVID-19
18 January 2021 - Quest's genomic sequencing and infectious disease expertise will identify novel SARS-CoV-2 mutations, providing insights on prevalence and transmission in the United States
SECAUCUS, N.J., Jan. 18, 2021 -- Quest Diagnostics, the world's leading provider of diagnostic information services, today announced that it has entered into an agreement with the Centers for Disease Control and Prevention (CDC) to provide genomic sequencing to identify new mutations in, and patterns of transmission of SARS-CoV-2, the virus that causes COVID-19. Financial terms of the agreement are not disclosed.
The goal of the collaboration is to aid the CDC in conducting a large-scale longitudinal genomic survey of the SARS-CoV-2 virus using a random set of samples collected from Quest's labs across the United States. The company will perform the sequencing from its advanced diagnostics laboratory in San Juan Capistrano, Calif.
Viruses can mutate over time. In recent weeks, highly transmissible variants of the SARS-CoV-2 virus first discovered in the United Kingdom and South Africa have been identified in the United States.
Quest Diagnostics will sequence the viral genomes of random de-identified samples that test positive in the course of providing molecular diagnostic testing for SARS-CoV-2 for providers and patients, and provide the CDC with completed whole viral sequences. These data will be combined with the results of other data provided to the CDC by national, state, academic, and commercial labs to help meet the CDC survey's aims.
"Public and private collaboration is essential to mobilizing an effective response to COVID-19," said Jay G. Wohlgemuth, M.D., Senior Vice President and Chief Medical Officer. "Quest has the expertise in genomics and infectious diseases, as well as extensive COVID-19 testing data and access to patient samples. Our program will complement and extend the efforts of the CDC to discover and track new virus mutations and thereby improve public health response to the pandemic."
The CDC's 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.
Quest Diagnostics and the CDC have a long history of collaboration to improve public health initiatives. Most recently, Quest joined the CDC's seroprevalence survey, which analyzes results of de-identified COVID-19 antibody tests to identify rates of COVID-19 prevalence in the United States. In addition, Quest is a member of the SARS-CoV-2 Sequencing for Public Health Emergency Response, Epidemiology and Surveillance (SPHERES) consortium, which launched in May 2020. Quest and the CDC are also long-time collaborators to identify trends in screening, diagnosis and treatment in viral hepatitis, HIV and sexually transmitted infections in the United States, based on insights revealed by analysis of Quest's national testing database.
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. Learn more about Quest Diagnostics at www.QuestDiagnostics.com.
Grifols begins clinical trial of a new treatment that would provide immediate immunity against COVID-19
18 January 2021 - The treatment could be administered in primary care centers to people who test positive for COVID-19, avoiding hospitalization due to the progression of the disease and complementing the vaccine in the early phase after vaccination. The medicine, an anti-SARS-CoV-2 immunoglobulin, given subcutaneously, would provide immediate protection after exposure to the virus and could be used to protect the elderly and healthcare workers. It could also be given to immunocompromised patients for whom the vaccination isn’t indicated. The treatment is based on the Grifols immunoglobulin Gamunex®-C, and contains anti-SARS-COV-2 polyclonal antibodies from plasma donors who have recovered from COVID-19. The clinical trial to evaluate the safety and efficacy of the plasma-derived medicine will have doctors Oriol Mitjà and Bonaventura Clotet as the principal researchers and is expected to begin in early 2021.
Barcelona, Spain, January 18, 2021 -- 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 will begin a clinical trial in Spain to evaluate the safety and efficacy of a new COVID-19 drug based on the Grifols immunoglobulin Gamunex®-C and containing anti-SARS-CoV-2 polyclonal antibodies from plasma donors who have recovered from the disease.
The new drug would provide immediate post-exposure protection against the virus and would be especially useful as a complement to the vaccine in the early phase after vaccination. In addition, it could protect the elderly and healthcare workers as well as immunocompromised patients for whom vaccination isn’t recommended. It could also help contain outbreaks in places where the vaccination hasn’t begun or is still underway.
Grifols expects this clinical trial, led by the researchers Oriol Mitjà and Bonaventura Clotet, from Germans Trias i Pujol Hospital in Barcelona, to begin in February 2021, with the possibility of results in the spring.
About 800 patients, all asymptomatic but having tested positive for the virus in a diagnostic test, will participate in the clinical study, receiving subcutaneously Grifols’ immunoglobulin rich with anti-SARS-CoV-2 antibodies.
The Grifols immunoglobulin Gamunex®-C, whether administered intravenously, intramuscularly or subcutaneously, has proven to be safe and efficacious in the prevention of diverse infectious diseases in immunocompromised patients and has been used for this for more than 15 years.
According to Dr. Mitjà, “This treatment based on immunoglobulins would provide a combination of polyclonal antibodies that, compared with monoclonal antibodies, offers a greater diversity that could improve the degree of protection against the virus.”
Dr. Antonio Páez, Medical Director at Grifols, underscores that the potential treatment “is easy to refrigerate while its subcutaneous administration facilitates its distribution and use in any doctor’s office, avoiding hospitalization. If the new therapy’s efficacy is confirmed, it could be administered to people who test positive for the virus through PCR and antigen tests in hospitals and primary care offices.”
Grifols, a global leader in the production and distribution of immunoglobulins and hyperimmune immunoglobulins, currently has underway more than 25 research initiatives to treat different stages of COVID-19, from early exposure to the virus to severe cases requiring hospitalization and intensive care.
In October 2020, Grifols, together with other companies and various U.S. health agencies, began the clinical trial ITAC (Inpatient Treatment with Anti-Coronavirus Immunoglobulin) to evaluate the efficacy and safety of the anti-SARS-CoV-2 hyperimmune globulin in hospitalized and serious cases. Results are expected during the first half of 2021.
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.
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