Roche launches new quantitative antibody test to measure SARS-CoV-2 antibodies, to support the evaluation of vaccines
18 September 2020 - The new Elecsys Anti-SARS-CoV-2 S test can quantitatively measure the level of antibodies against SARS-CoV-2 in patients who have been exposed to the virus. The test targets antibodies against the spike protein. This is the focus of vaccines in development and convalescent plasma therapy. Using the Elecsys Anti-SARS-COV-2 S antibody test, together with the Elecsys Anti-SARS-CoV-2 test launched in May, can help to more effectively determine the percentage of a population who already have antibodies against SARS-COV-2.
Basel, 18 September 2020 -- Roche today announced the launch of its Elecsys® Anti-SARS-CoV-2 S antibody test for markets accepting the CE Mark. Roche has filed for Emergency Use Authorisation (EUA) from the U.S. Food and Drug Administration (FDA).
The Elecsys Anti-SARS-CoV-2 serology test can be used to quantitatively measure antibodies in people who have been exposed to the Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) and can play an important part in characterising a vaccine-induced immune response. Specifically, the test targets antibodies which are directed against the particular region of the viral spike protein responsible for binding to the host cell receptor, which is required for the virus to enter the host cell. The majority of current candidate vaccines aim to induce an antibody response against the spike protein.
“As the possibility of an effective SARS-CoV-2 vaccine becomes a reality, quantitative measurement of antibodies will be crucial in the evaluation of any potential vaccine. The new quantitative Elecsys antibody test can play a pivotal role in vaccine clinical trials as well as helping clinicians assess patients immune response. This will be instrumental in protecting people most vulnerable to the virus, as well as in overcoming COVID-19 for society in general.” said Thomas Schinecker, CEO Roche Diagnostics. "This new test, the twelfth in the Roche SARS-CoV-2 testing portfolio, is another essential addition to support healthcare systems and patients as we jointly fight COVID-19.”
Before a vaccine is administered it is important to know the starting level of antibodies a person has, in order to evaluate any change in antibody levels that the vaccine induces, especially the development of antibodies directed against the SARS-CoV-2 spike protein. These antibodies have been shown to have potent antiviral activity and correlate to potential immunity. Measuring antibody levels could also be vital in establishing vaccine efficacy in the prevention of infection and/or the development of severe COVID-19.
Alongside its importance to vaccine design and efficacy evaluations, the Elecsys Anti-SARS-CoV-2 S serology test can be used to determine antibody levels in plasmapheresis donations. Performing a combination of the Elecsys Anti-SARS-CoV-2 S and Elecsys Anti-SARS-CoV-2 tests can also help to more effectively define what percentage of a given population has developed antibodies (seroprevalence) against SARS-COV-2, especially in low to moderate seroprevalence settings. Knowing a given population’s seroprevalence is important in understanding how to contain the spread of the virus, as well as how to safely ease lockdown restrictions.
The test is the latest addition to the comprehensive Roche diagnostic portfolio to help healthcare systems combat COVID-19 through testing in the laboratory and at the point of care. Currently, this portfolio includes molecular, serology and digital solutions which help diagnose and manage COVID-19 during the initial stages of infection, during the recovery phase, as well as following the resolution of infection.
About SARS-CoV-2
Coronaviruses (CoV) are a large family of viruses that cause illness ranging from the common cold to more severe diseases such as Middle East Respiratory Syndrome (MERS-CoV) and Severe Acute Respiratory Syndrome (SARS-CoV). The novel coronavirus (SARS-CoV-2) is a new strain which has not previously been identified in humans.
Signs of infection include respiratory symptoms such as cough, shortness of breath, difficulty breathing, and fever. In more severe cases, pneumonia, severe acute respiratory syndrome, kidney failure and death can occur.
About potential SARS-COV-2 vaccines
As of 3 September 2020, 47 candidate vaccines are in clinical evaluation and 3 vaccines have been approved for early or limited use, while at least 91 preclinical vaccines are under active investigation. All candidate vaccines in Phase III or approved for limited / early use aim to induce an antibody response against the SARS-CoV-2 spike protein. Any potential vaccine for SARS-CoV-2 would work (amongst other mechanisms) by triggering the immune response to develop neutralising antibodies, in the person receiving the vaccine. In doing so, the vaccine trains the body’s immune system to recognize and fight an exposure to SARS-CoV-2, in a controlled way, without being exposed to the actual virus.
About Elecsys Anti-SARS-CoV-2 S and Elecsys Anti-SARS-CoV-2 serology tests
The Elecsys® Anti-SARS-CoV-2 S is an immunoassay for the quantitative, in vitro determination of antibodies to SARS-CoV-2 in human serum and plasma. Through a blood sample, the test can measure the quantity of antibodies to the spike protein of the coronavirus, which could signal whether a person has been already infected and potentially developed immunity to the virus. This can also be used to determine antibody levels in plasmapheresis donations. Plasmapheresis is a procedure which separates and removes the plasma from a patient’s blood. This plasma is then replaced with plasma from a donor. It is assumed that plasma from a donor who has already had SARS-CoV-2 will have direct antiviral properties for the donor recipient.6 This is being explored as an adjunctive treatment for the management of COVID-19.6 The test has both a high clinical specificity of 99.98% (N=5991) and sensitivity of 98.8% (N=1423), 14 days or later after diagnosis with PCR. Additionally, across panels of potentially cross-reactive samples (N=1100) from endemic human coronaviruses, infectious respiratory diseases, other infectious diseases, auto-immune and liver related diseases, the test demonstrated zero cross-reactivity.
Hospitals and reference laboratories can run the test on Roche’s cobas e analyzers which are widely available around the world. These fully-automated systems can provide SARS-CoV-2 test results in approximately 18 minutes, with a test throughput of up to 300 tests/hour, depending on the analyzer.
About Roche response to COVID-19 section
The COVID-19 pandemic continues to evolve globally with varying developments from country to country and we are partnering with healthcare providers, laboratories, authorities and organisations to help make sure that patients receive the tests, treatment and care they need. This new test is an additional step in Roche’s fight against the COVID-19 pandemic, which has already included:
- Launching COVID-19 diagnostic tests for active infection and the detection of antibodies in patients who have been exposed to the virus,
- Investigating treatments from our existing portfolio to better understand their potential to treat patients with COVID-19,
- Increasing manufacturing and supply chain capacity to meet product demand across our portfolio within the wider context of COVID-19 treatment,
- Ensuring the supply of our existing medicines and diagnostics to patients around the world under exceptional conditions.
Reliable, high-quality testing is essential to help healthcare systems overcome this pandemic. On 13 March we received FDA Emergency Use Authorisation for a high-volume molecular test to detect SARS-CoV-2, the virus that causes COVID-19, which is also available in countries accepting the CE Mark. On 3 May, Roche announced that its COVID-19 antibody test, aimed at detecting the presence of antibodies in the blood, also received FDA Emergency Use Authorisation and is available in markets accepting the CE mark. Also in June we received an FDA EUA for the Elecsys® IL-6 test to assist in identifying severe inflammatory response in patients with confirmed COVID-19, as well as launching Roche v-TAC, which could help simplify the screening, diagnosis and monitoring of patients with respiratory compromise in the current COVID-19 pandemic. In July, we added a Rapid Antibody Test, with SD Biosensor as distribution partner, to our portfolio, that allows the detection of antibodies against Covid-19 at the point of care. Roche is working closely with governments and health authorities around the world, and has significantly increased production to help ensure availability of tests globally.
We are actively involved in understanding the potential of our existing portfolio and are researching options for the future. Roche has an ongoing clinical trial program evaluating the role of Actemra©/RoActemra© (tocilizumab) in COVID-19 pneumonia. On 29 July we announced that the COVACTA trial did not meet its primary endpoint of improved clinical status in patients with COVID-19 associated pneumonia, or the key secondary endpoint of reduced patient mortality. The study was the first global, randomised, double-blind, placebo-controlled phase III trial investigating Actemra/RoActemra in this setting. Roche remains committed to continuing the Actemra/RoActemra clinical trial programme in COVID-19 to further explore Actemra/RoActemra in other treatment settings, including in combination with an antiviral. In addition to COVACTA, Roche has initiated several studies to further investigate Actemra/RoActemra as a potential treatment for patients with COVID-19 associated pneumonia, including two phase III clinical trials, REMDACTA and EMPACTA, as well as the phase II MARIPOSA trial. Roche has further initiated an internal early research programme focused on the development of medicines for COVID-19 and is engaged in multiple research collaborations. On 19 August, we announced a partnership with Regeneron to develop, manufacture and distribute REGN-COV2, Regeneron’s investigational antiviral antibody combination, to people around the globe.
In these exceptional times, Roche stands together with governments, healthcare providers and all those working to overcome the pandemic.
About Roche
Roche is a global pioneer in pharmaceuticals and diagnostics focused on advancing science to improve people’s lives. The combined strengths of pharmaceuticals and diagnostics under one roof have made Roche the leader in personalised healthcare – a strategy that aims to fit the right treatment to each patient in the best way possible.
Roche is the world’s largest biotech company, with truly differentiated medicines in oncology, immunology, infectious diseases, ophthalmology and diseases of the central nervous system. Roche is also the world leader in in vitro diagnostics and tissue-based cancer diagnostics, and a frontrunner in diabetes management.
Founded in 1896, Roche continues to search for better ways to prevent, diagnose and treat diseases and make a sustainable contribution to society. The company also aims to improve patient access to medical innovations by working with all relevant stakeholders. More than thirty medicines developed by Roche are included in the World Health Organization Model Lists of Essential Medicines, among them life-saving antibiotics, antimalarials and cancer medicines. Moreover, for the eleventh consecutive year, Roche has been recognised as one of the most sustainable companies in the Pharmaceuticals Industry by the Dow Jones Sustainability Indices (DJSI).
The Roche Group, headquartered in Basel, Switzerland, is active in over 100 countries and in 2019 employed about 98,000 people worldwide. In 2019, Roche invested CHF 11.7 billion in R&D and posted sales of CHF 61.5 billion. Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan. For more information, please visit www.roche.com.
Reference: https://www.roche.com/media/releases/med-cor-2020-09-18b.htm
Quest Diagnostics Now Offers Two Consumer-Initiated and Physician-Ordered COVID-19 Diagnostic Test Options for Active COVID-19 Infection Through QuestDirect™
17 September 2020 - QuestDirect™ Active Infection allows individuals to collect a specimen at home or by drive-thru at more than 500 Walmart Neighborhood Market locations. Results are interpreted by a physician via telecare and provided digitally through the MyQuest™ patient portal so individuals may share results securely online with friends, family and physicians.
SECAUCUS, N.J., Sept. 17, 2020 -- Individuals can now purchase a test to diagnose COVID-19 online, without visiting a doctor's office, through QuestDirect, the consumer-initiated testing business of Quest Diagnostics, the world's leading provider of diagnostic information services. The QuestDirect COVID-19 Active Infection test can be purchased online with specimen collection available in two ways: at-home or at one of more than 500 Walmart Neighborhood Market drive-thru pharmacy locations across the United States.
"Accessible, high-quality COVID-19 diagnostic testing is essential to containing the spread of COVID-19," said Jay Wohlgemuth, M.D., Senior Vice President and Chief Medical Officer for Quest Diagnostics. "With our new QuestDirect COVID-19 Active Infection self-collection kit, anyone can access a high-quality COVID-19 test with access to interpretation and referral into care from a physician. Additionally, individuals can receive a self-collection kit either at home or at a nearby Walmart drive thru location, for the ultimate in speed, safety and convenience."
The new test uses the gold standard of COVID-19 diagnostic testing – highly sensitive molecular diagnostic technologies that have received emergency use authorization from the FDA to aid the detection of the RNA of SARS-COV-2, the virus that causes COVID-19. The test is appropriate for individuals who seek access to COVID-19 diagnostic testing, due to COVID-19-like symptoms or exposure to someone with COVID-19.
The kit includes a device for anterior nares (nasal) swab collection, a comparatively noninvasive specimen collection technique that involves inserting a swab into one nostril in the front of the nose.
Easy-to-Order Process with Two Access Options
After an individual purchases the test online, a licensed physician with an independent national network of physicians providing clinical oversight for QuestDirect services, will promptly review the order and, if deemed appropriate, order the test.
Unlike other consumer-initiated COVID-19 diagnostic tests, Quest provides two options for specimen collection:
- A specimen collection kit is mailed to the individual's home. The individual may then submit the specimen in the kit via FedEx overnight to a Quest Diagnostics laboratory for testing.
- An individual may also opt to purchase the kit online and take it to one of more than 500 Walmart drive-thru pharmacy window locations in the United States for observed collection. At these Walmart locations, a trained pharmacist will observe the collection process and the specimen will be picked-up from a secure drop box and delivered to a Quest laboratory for testing.
Test results are available in an easy-to-read report on MyQuest, the company's secure patient portal accessible on a smartphone, tablet, or desktop.
Physicians are available post-test via telehealth to help consumers with interpretation of the result and referral into appropriate care.
The new service complements the QuestDirect™ COVID-19 Antibody Test, which was launched in April 2020.
MyQuest™ Patient Portal Makes it Easy to Share Test Results
As areas of the country continue to reopen, and people are spending more time together in person, consumers are looking to learn that the people they spend time with pose a reduced risk for spreading COVID. Like all QuestDirect test results, the QuestDirect COVID-19 Active Infection test results are sent directly to Quest's patient portal, MyQuest, where they can be downloaded and/or shared with friends, or directly imported into a consumer's MyCircle – an online platform that securely links the results across authorized individuals, such as caregivers and dependents.
Additionally, through MyQuest, patients can share their QuestDirect COVID-19 Active Infection test results in combination with other test results performed by Quest with their physician, in order to provide a more comprehensive view of their state of health.
About Our Commitment to Consumer Empowered Health
Quest Diagnostics has long been at the forefront of the movement for consumer empowerment in healthcare. The company was among the first diagnostic information services providers to offer free access to test results online and other channels. Its mobile app and patient portal, called MyQuest, provides millions of people a way to securely access and track their test results and other health data. The company's QuestDirect service provides dozens of tests for conditions ranging from heart health and sexually transmitted diseases. For added convenience, the company now offers at-home self-collection devices for tests including COVID-19 active infection, diabetes, and hormones. Through its collaborations with Safeway and Walmart, Quest Diagnostics operates approximately 200 patient service centers in retail store locations, for the utmost in convenient access. Quest Diagnostics also provides next generation sequencing and genotyping services for Ancestry.
About COVID-19 Testing by Quest Diagnostics
Quest Diagnostics is at the forefront of the response to the COVID-19 pandemic, working to broaden access to laboratory insights to help us all lead healthier lives. We provide both molecular diagnostic and antibody serology tests to aid in the diagnosis of COVID-19 and immune response. Our COVID-19 test services are based on tests that have received FDA emergency use authorization and which also meet our high standards for quality. We are providing these test services under the Public Readiness and Emergency Preparedness Act. We provide data on COVID-19 testing to various federal and state public health authorities, including the Centers for Disease Control and Prevention, and participate in studies with government and private institutions, aiding COVID-19 public health response and research. Through our team of dedicated phlebotomists, air fleet team, couriers and laboratory professionals, Quest Diagnostics works hard every day to help patients and communities across the United States access quality COVID-19 testing.
About Quest Diagnostics
Quest Diagnostics empowers people to take action to improve health outcomes. Derived from the world's largest database of clinical lab results, our diagnostic insights reveal new avenues to identify and treat disease, inspire healthy behaviors and improve health care management. Quest annually serves one in three adult Americans and half the physicians and hospitals in the United States, and our 47,000 employees understand that, in the right hands and with the right context, our diagnostic insights can inspire actions that transform lives. www.QuestDiagnostics.com
QIAGEN fully acquires NeuMoDx Molecular, Inc., rounding out portfolio of PCR-based diagnostic automation systems
17 September 2020 - Transaction strengthens QIAGEN’s leadership position in automated molecular testing. QIAGEN acquires remaining 80.1% stake in NeuMoDx Molecular, Inc. for $248 million. Medium- and high-throughput NeuMoDx automation solutions based on PCR testing technology to now be integrated into QIAGEN’s portfolio on a global basis. Menu of test solutions for infectious diseases – which already includes COVID-19 – to be expanded, especially in the U.S.
Hilden, Germany and Ann Arbor, Michigan, September 17, 2020 – QIAGEN N.V. today announced the acquisition of the remaining 80.1% of diagnostics instruments company NeuMoDx Molecular, Inc. for $248 million in cash. The move rounds out QIAGEN’s portfolio of automated molecular testing solutions based on the proven PCR technology.
The transaction was completed after QIAGEN received U.S. regulatory clearance for the full acquisition. In 2018, QIAGEN had purchased a 19.9% stake in NeuMoDx along with the right to acquire the remaining NeuMoDx stake at a price of $234 million. The final payment price for this remaining stake includes customary purchase price adjustments for cash, indebtedness and transaction costs. Also as part of the 2018 agreement, QIAGEN has distributed the high-throughput NeuMoDx™ 288 and the medium-throughput NeuMoDx™ 96 platforms in Europe and other markets outside the U.S.
“NeuMoDx’s automated molecular testing platforms offer a unique combination of speed, flexibility, throughput and ease of use for molecular diagnostics assays, including laboratory-developed tests,” said Thierry Bernard, Chief Executive Officer of QIAGEN. “NeuMoDx has built an unparalleled platform that has demonstrated superior value during the coronavirus pandemic. This will expand QIAGEN’s portfolio of automated testing solutions and provide another driver for future growth.”
“NeuMoDx devices offer labs with medium to high throughput exactly what they need,” Bernard added. “Labs want compact systems with true random access, fast turnaround time, full automation and comprehensive menus. The full integration of the NeuMoDx systems will allow QIAGEN to address laboratory needs in almost any setting for molecular diagnostics. We are excited to be able to build on NeuMoDx’s success and will jointly work on expanding our product portfolio and global distribution.”
“Becoming a part of QIAGEN allows us to take our successes at NeuMoDx to the next level,” said Jeff Williams, Chairman and Chief Executive Officer of NeuMoDx Molecular. “We have built a broad testing portfolio and created strong customer enthusiasm around the world with our device’s unique combination of speed, flexibility, throughput and ease of use. This transaction is a testament to the achievements of the entire NeuMoDx team and we are excited to finally become a full part of the QIAGEN family.”
As rapid, integrated PCR-based devices, NeuMoDx™ 288 and NeuMoDx™ 96 already offer 13 CE-IVD-marked assays for different infectious diseases in Europe. These include a dedicated COVID-19 test, which has also received FDA Emergency Use Authorization for the U.S. market, complementing the FDA-approved GBS assay (group B Streptococcus). A new multiplex test for influenza, respiratory syncytial virus (RSV) and the SARS-CoV-2 virus is scheduled for launch in the fourth quarter of 2020.
The NeuMoDx devices have features that set them apart from other lab-based PCR diagnostics systems: they have the fastest fully automated turnaround time, delivering insights in an hour rather than their competitors’ three hours; they allow clinical molecular diagnostic laboratories to process ever-larger volumes and deliver ever-faster insights into many infectious diseases including COVID-19; their flexibility and efficiency is driving a growing menu of in vitro diagnostic (IVD) tests and enables the devices to process commercial and laboratory-developed tests (LDTs – IVD tests made by clinical labs for in-house use).
About NeuMoDx
NeuMoDx Molecular designs and develops revolutionary molecular diagnostic solutions for hospital and clinical reference laboratories. The company’s patented, ‘sample-to-result’ platform offers market-leading ease of use, true continuous random-access, and rapid turnaround time while achieving optimal operational and clinical performance for our customers and the patients they serve. For more information visit www.neumodx.com.
About QIAGEN
QIAGEN N.V., a Netherlands-based holding company, is the leading global provider of Sample to Insight solutions that enable customers to gain valuable molecular insights from samples containing the building blocks of life. Our sample technologies isolate and process DNA, RNA and proteins from blood, tissue and other materials. Assay technologies make these biomolecules visible and ready for analysis. Bioinformatics software and knowledge bases interpret data to report relevant, actionable insights. Automation solutions tie these together in seamless and cost-effective workflows. QIAGEN provides solutions to more than 500,000 customers around the world in Molecular Diagnostics (human healthcare) and Life Sciences (academia, pharma R&D and industrial applications, primarily forensics). As of June 30, 2020, QIAGEN employed more than 5,200 people in over 35 locations worldwide. Further information can be found at www.qiagen.com.
Reference: https://corporate.qiagen.com/newsroom/press-releases/2020/20200917_neumodx
Abbott introduces Libre Sense Glucose Sport Biosensor in Europe, world's first glucose biosensor designed for athletes
17 September 2020 - Abbott's Libre Sense Glucose Sport Biosensor, with CE Mark, is built upon the company's world-leading continuous glucose monitoring technology. Abbott is collaborating with sports performance technology company Supersapiens to advance this first-of-its-kind product. As part of an observational trial, two cycling teams leading into the world's largest annual sporting event, the Tour de France, trained with Abbott's Libre Sense biosensor to track the correlation between glucose levels and their athletic performance.
ABBOTT PARK, Ill., Sept. 17, 2020 -- Abbott is introducing the world's first glucose sport biosensor, Libre Sense Glucose Sport Biosensor, which is designed for athletes to continuously measure glucose to better understand the correlation between their glucose levels and their athletic performance. The Libre Sense biosensor is based on Abbott's world-leading FreeStyle Libre continuous glucose monitoring technology, which was originally developed for people living with diabetes. Based on that technology, this is the first personal-use product that allows for use beyond diabetes.
Abbott's Libre Sense Glucose Sport Biosensor, with CE Mark (Conformité Européenne), is a consumer over-the-counter product that provides glucose monitoring via a mobile app to athletes (ages 16 years and older) performing sports such as cycling, running, and swimming, to understand the efficacy of their nutrition choices on training and competition. Tracking and understanding glucose levels enable athletes to fuel appropriately through nutrition to help avoid fatigue from low glucose and to know when to replenish during training and competition to maintain peak performance.
"FreeStyle Libre changed the way millions of people manage their diabetes to get and stay healthier, and now with Libre Sense we're bringing that same proven technology to empower athletes to help them reach their athletic performance goals," said Jared Watkin, senior vice president, Diabetes Care, Abbott. "This is just the beginning – our breakthrough sensing technology has the potential to go beyond glucose and provide a lens into what's happening in the human body that could provide meaningful insights into other conditions, treatments, and ultimately improve health."
Proper nutrition at the right intervals allows athletes to maintain a stable glucose level during endurance activities, which is important for managing overall energy and avoiding muscle fatigue. A study published in the American College of Sports Medicine showed that an athlete who understands the effects of their nutritional intake will have a better chance at improving their performance during exercise. In addition, research has shown that understanding real-time glucose levels can guide nutritional intake to help improve muscle recovery and athletic performance.
To obtain glucose readings from Abbott's Libre Sense Glucose Sport Biosensor, athletes will wear the small round biosensor (approximately the size of a two Euro coin) on the back of their upper arm. The biosensor will provide real-time glucose values and can be worn for up to 14 days. The user will automatically receive streaming glucose data, via Bluetooth® wireless technology, every minute designed to work with compatible mobile apps and wrist readers.
Working together with sports technology companies for distribution, Abbott's Libre Sense Glucose Sport Biosensor is designed to be compatible with these companies' mobile apps and other accessory devices. Abbott's first non-exclusive collaboration is with Supersapiens, an Atlanta-based sports technology company that is focused on improving athletic performance. Their mission is to provide athletes with actionable and personalized insights on real-time biometric data, starting with glucose.
"With Abbott's Libre Sense, for the first time, an athlete will have access to glucose data to help give them insight into their body's fuel level at all times, fundamentally changing the way athletes think about energy management," said Phil Southerland, founder of Supersapiens and former professional cyclist. "By combining Abbott's proven track record in glucose sensing technology along with Supersapiens' app and personalized analytics, athletes will be primed to sustain peak performance."
Supersapiens has partnered with some of the top teams at the Tour de France, the largest annual sporting event in the world, who are utilizing the energy management system and have worn the Libre Sense biosensor in training as part of an observational trial. Through this experience, the athletes were able to track their glucose data to help inform them of fueling strategies to prepare them for the race.
Abbott's Libre Sense Glucose Sport Biosensor will be available in the coming weeks directly through the Supersapiens website. The product will initially be made available across eight European countries: Austria, France, Germany, Ireland, Italy, Luxembourg, Switzerland and the United Kingdom.
About Abbott Libre Sense Glucose Sport System
The Abbott Libre Sense Glucose Sport Biosensor is intended for athletes to measure glucose. Athletes are defined as individuals who perform exercise with the purpose of improving wellness and performance. When used with a compatible product, the biosensor allows athletes to correlate their glucose levels and their athletic performance. The biosensor is not intended for use in the diagnosis, treatment, or monitoring of a disease.
About Abbott
Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 107,000 colleagues serve people in more than 160 countries.
Thermo Fisher Scientific Further Expands Laboratory Plastics Production to Support COVID-19 Testing, Therapies and Vaccines
15 September 2020
WALTHAM, Mass. , Sept. 15, 2020 -- Thermo Fisher Scientific Inc., the world leader in serving science, today announced it is investing more than $140 million to further expand its laboratory plastics consumables production to support significant global demand for COVID-19 testing, as well as development and manufacturing of therapies and vaccines.
"Early in the pandemic, we quickly joined forces with governments, public health agencies and industry to increase capacity across our laboratory plastics production facilities and address the growing COVID-19 threat," said Fred Lowery, senior vice president and president of Life Sciences Solutions and Laboratory Products at Thermo Fisher Scientific. "However, demand quickly exceeded those early expansion projects, so we began a series of additional expansions to meet the growing needs of our customers. These investments, along with many others across the company, will ensure that our customers have the supplies they need to continue meeting the unprecedented demands of the COVID-19 response."
The rapid increase in production related to COVID-19 testing, and development and manufacturing of therapies and vaccines, has created historic demand for laboratory plastics, including pipette and automation tips, storage tubes and plates, transfer pipettes, and packaging vials and bottles. To support these needs, Thermo Fisher is creating more than 1,000 jobs across manufacturing sites globally, increasing automation capabilities and optimizing warehouse and sterilization capacity to improve supply chain agility.
Among the Thermo Fisher sites currently being expanded are Rochester, N.Y.; Petaluma, Calif.; Monterrey and Tijuana, Mexico; and Joensuu, Finland.
Thermo Fisher offers an extensive range of laboratory plastics, including Thermo Scientific Nalgene and Nunc plasticware and the Thermo Scientific Manual and Electronic Pipetting Systems. From bottles, beakers, funnels and tubes to pipettes, tips and diagnostic plates, Thermo Fisher consumables support critical COVID-19 work globally and include sample collection vials for diagnostic test kits, pipettes for test processing, lab essentials for research into therapies and vaccines, lab plastics to support clinical and epidemiological studies, and materials for vaccine production and biobanking.
For more information about the Thermo Scientific range of laboratory plastic consumables, please visit www.thermofisher.com/backtothelab.
About Thermo Fisher Scientific
Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $25 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, improving patient diagnostics and therapies or increasing productivity in their laboratories, we are here to support them. Our global team of more than 75,000 colleagues delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services and Patheon. For more information, please visit www.thermofisher.com.
Siemens Healthineers Collaboration with CDC Will Define Threshold for Neutralizing Antibody Sufficient to Confer Immunity
15 September 2020 - The collaboration will standardize SARS-CoV-2 assays by defining concentrations of antibodies to specific viral proteins to confer neutralization that could one day be extrapolated to thresholds considered sufficient to confer immunity. Standardization across manufacturers is also expected to improve patient care by enabling long-term antibody level comparison.
15 September 2020 -- Siemens Healthineers announced today a collaboration with the U.S. Centers for Disease Control and Prevention (CDC) and the JRC (Joint Research Centre) of the European Commission on a research project to develop a novel process for standardizing SARS-CoV-2 assays.
Antibody tests differ among test manufacturers and currently cannot be analytically compared because they target different SARS-CoV-2 proteins. These include the spike protein, S1/S2, S1 RBD, and N protein, which are found in different parts of the SARS-CoV-2 virus. As the pandemic has evolved, antibody test results have progressed from qualitative positive/negative results to more recent assays capable of numerical measurements that gauge the level of IgG antibodies in a patient’s blood sample.
The reportable numerical patient results of the current semi-quantitative assays are expressed in units that are not actual concentrations of antibodies, but rather the antibody activity to the virus. Because comparing test results across manufacturers has not been possible, establishing immunity associated with these tests has been challenging.
Siemens Healthineers' collaboration with the CDC and the JRC will develop a novel process for standardizing SARS-CoV-2 assays by anchoring each protein to a neutralization antibody titer—a level of antibody present to block virus from entering cells in laboratory experiments. The thresholds displayed in the standardized unit of measure for IgG—arising either from natural infection or vaccination—may likely contribute to a standardized interpretation of immunity through test results.
"One barrier to antibody test adoption is we don't currently have an established process to determine immunity," said Deepak Nath, PhD, President of Laboratory Diagnostics, Siemens Healthineers. "Different SARS-CoV-2 antibody targets produce different levels of neutralization. Our R&D team recognized that if you could define a level at which neutralization is conferred for different targets, you could create a common ground to standardize assays—not just on antibody production, but their ability to provide immunity. Our collaboration with the CDC and JRC will develop the framework that all antibody test manufacturers would be expected to adopt moving forward for greater benefit to patient care as the pandemic evolves."
Developing a standardized process will define which concentration confers neutralization for different manufacturers’ antigen targets. Each manufacturer currently standardizes their assays independently with internal standards that are not linked to a common reference. The results of this collaborative research project will support the JRC's production of a reference material. This reference material with assigned concentrations of antibody specific to each viral protein will allow manufacturers to refer to standardized values.
With an international standard established and adopted by manufacturers, clinicians would be positioned to track their patients' antibody concentrations, regardless of the test method or manufacturer used. This capability is expected to improve patient care by enabling long-term antibody level comparison—clinical information that is important for verifying natural immunity acquired by patient’s infection with the virus, as well as for determining the effectiveness of vaccines.
About Siemens Healthineers AG
Siemens Healthineers AG is shaping the future of Healthcare. As a leading medical technology company headquartered in Erlangen, Germany, Siemens Healthineers enables healthcare providers worldwide through its regional companies to increase value by empowering them on their journey towards expanding precision medicine, transforming care delivery, improving the patient experience, and digitalizing healthcare. Siemens Healthineers is continuously developing its product and service portfolio, with AI-supported applications and digital offerings that play an increasingly important role in the next generation of medical technology. These new applications will enhance the company’s foundation in in-vitro diagnostic, image-guided therapy, and in-vivo diagnostics. Siemens Healthineers also provides a range of services and solutions to enhance healthcare providers ability to provide high-quality, efficient care to patients. In fiscal 2019, which ended on September 30, 2019, Siemens Healthineers, which has approximately 52,000 employees worldwide, generated revenue of €14.5 billion and adjusted profit of €2.5 billion. Further information is available at www.siemens-healthineers.com.
Reference: https://www.siemens-healthineers.com/press-room/press-releases/covid-19-cdc.html
Aptima® HIV-1 Quant Dx Assay Awarded WHO Prequalification for Dried Blood Spot Samples
14 September 2020
MARLBOROUGH, Mass., September 14, 2020 -- Hologic, Inc. announced today that its CE-marked Aptima® HIV-1 Quant Dx assay has been awarded World Health Organization (WHO) prequalification for testing of dried blood spot (DBS) samples.
The Aptima® HIV-1 Quant Dx assay can be used with DBS samples to monitor viral load and disease progression among HIV-1 infected individuals, and to aid in the diagnosis of HIV-1 infected infants under 18 months. It is the first and only dual-claim assay for both viral load and early infant diagnosis (EID).
DBS sampling improves access to HIV diagnostic testing and care, particularly among HIV-infected populations living in remote areas. DBS samples are more stable and easily transportable compared to liquid whole blood or plasma samples. A finger stick or heel prick produces an adequate sample that is dried on a specially designed card. The DBS samples do not require refrigeration and when stored properly can withstand extreme conditions, including excess heat and humidity.
This additional approval is notable for the African market, where DBS is the primary sample type in several countries, and is expected to enable countries to expand their use of the Aptima® HIV-1 Quant Dx assay, the leading assay under Hologic’s Global Access Initiative (GAI). The GAI launched in 2018 and offers customers a single, all-inclusive pricing structure with no upfront cost or capital expenditure. Qualified products include molecular assays for HIV, Hepatitis B and C, and human papillomavirus (HPV), as well as the ThinPrep® Pap test for cervical cancer screening.
“With 25 million people infected with HIV in sub-Saharan Africa, there continues to be an urgent need for access to cost-effective and quality diagnostic testing,” said Joao Malagueira, vice president, Europe South, Middle East and Africa. “The ability to test DBS samples underlines Hologic’s commitment to promote simple, scalable and sustainable solutions for countries that need it most. The new product extension will ultimately enhance patient care and allow for partner governments to mitigate the burden of disease and respond to broader health needs.”
Despite substantial progress toward the UNAIDS 95-95-95 targets, there continue to be gaps across the HIV testing and treatment cascade, with 15.7 million people living with HIV who have an unsuppressed viral load globally. In addition, children and infants continue to be affected by the epidemic. In 2019, only 60% of infants born to pregnant women living with HIV received the recommended HIV test within two months of birth. About 86% of the estimated 160,000 children newly infected with HIV in 2018 were in sub-Saharan Africa.
The DBS sample type is the second approval Hologic has received from the WHO, following prequalification of the Aptima® HIV-1 Quant Dx assay for in vitro diagnostic use with plasma samples in December 2017.
About Hologic’s Global Access Initiative
The Hologic Global Access Initiative is a partnership with the Clinton Health Access Initiative, Inc. (CHAI) and MedAccess (backed by the UK government) to mitigate the burden of viral diseases in areas with high prevalence by providing greater access to testing using the Panther® system. Together with these organizations, Hologic delivers a pricing structure that allows eligible countries to procure testing with an all-inclusive ceiling price of $12 per patient test, with no requirement for capital expenditure. The test result price is inclusive of all necessary reagents and consumables, instrument placement, service and maintenance, freight and logistics, and replacement tests.
About Hologic
Hologic, Inc. is an innovative medical technology company primarily focused on improving women’s health and well-being through early detection and treatment. For more information on Hologic, visit www.hologic.com.
Genomic Leaders Collaborate to Create Australia’s First National COVID-19 Tracking System
14 September 2020
MELBOURNE, Australia, 14 September 2020 -- Illumina announced today that the Australian public health laboratories will aim to sequence the virus genomes of all positive COVID-19 tests in Australia and track COVID-19 using genomics across the country, rather than state by state, under a ground-breaking initiative spearheaded by Australia’s public health laboratory organisations and leading industry partners.
The Communicable Disease Genomics Network (CDGN) and Illumina are collaborating to track COVID-19 using next-generation genomic sequencing technology, which enables real-time data sharing and integration to better understand the transmission and spread of the virus. Coordinated by the CDGN, this will be the first national implementation of pathogen surveillance and a critical step forward in Australia’s pandemic response.
The Australian Government has provided a AUD $3.3M Medical Research Future Fund (MRFF) grant through The University of New South Wales (UNSW) Sydney’s School of Medical Sciences. As part of the research project, Illumina has further contributed more than AUD $2M worth of its genomic sequencing systems and related consumables.
UNSW Conjoint Professor Bill Rawlinson, Senior Medical Virologist, said the research project will address the urgent need for national implementation of COVID-19 genomics in Australia.
“This research will provide us with a better understanding of the behaviour, spread and evolution of COVID-19, thanks to the precision of next-generation sequencing technology. The project will enable us to measure the impact of using this technology not only for the COVID-19 pandemic, but also for future responses,” Prof. Rawlinson said.
Illumina’s systems are expected to be delivered next week to the Doherty Institute, Westmead Hospital, UNSW at the Prince Of Wales Hospital and Queensland Health Forensic and Scientific Services, expanding the capacity of the four major public health laboratories in New South Wales, Victoria and Queensland to sequence pathogens, including COVID-19 samples.
The Medical Research Future Fund grant will also help to build support in other jurisdictional public health laboratories and, with the added support of State and Territory Governments, will aim to sequence virus genomes of all positive COVID-19 tests in Australia.
“This is a leading global example that will demonstrate the unique value of genomics surveillance in understanding and helping to control the COVID-19 pandemic and Illumina is thrilled to be an instrumental partner of this effort,” Dr Phil Febbo, Illumina’s Chief Medical Officer, said. “The program will allow sharing of vital pathogen data with the use of bioinformatics across states and territories assuring that the sequencing of viral and other pathogens is not limited to this pandemic but will continue to expand in both academic research and the public health systems going forward.”
Pathogen genomics can reveal information that would otherwise be missed, including rapid insights into the behaviour, spread and evolution of COVID-19. This project will have an immediate application in the investigation of outbreaks, including identification of emerging outbreaks and transmission events as part of efforts to reduce community transmission.
Other benefits of genomics include the ability to identify mutations of COVID-19 in the Australian population to inform the design of treatments and vaccines, and the capacity to precisely identify persistent infection versus reinfection or inactive infection. This holds particular significance to healthcare workers and can help protect the capacity of the frontline workforce and vulnerable patients.
“The CDGN has been working to establish a nationally integrated pathogen genomics initiative that will facilitate the rapid implementation of this project, ensuring national access and consistency in genomics analyses. Information on the national transmission of the virus that causes COVID-19 will be important to informing future public health responses in Australia,” said University of Melbourne Professor Ben Howden, Co-chair of the CDGN and Director of the Microbiological Diagnostics Unit Public Health Laboratory at the Doherty Institute.
About Illumina
Illumina is improving human health by unlocking the power of the genome. Our focus on innovation has established us as the global leader in DNA sequencing and array-based technologies, serving customers in the research, clinical, and applied markets. Our products are used for applications in the life sciences, oncology, reproductive health, agriculture, and other emerging segments. To learn more, visit www.illumina.com and follow @illumina.
About the Peter Doherty Institute for Infection and Immunity
Finding solutions to prevent, treat and cure infectious diseases and understanding the complexities of the immune system requires innovative approaches and concentrated effort. This is why The University of Melbourne – a world leader in education, teaching and research excellence – and The Royal Melbourne Hospital – an internationally renowned institution providing outstanding care, treatment and medical research – have partnered to create the Peter Doherty Institute for Infection and Immunity (Doherty Institute); a centre of excellence where leading scientists and clinicians collaborate to improve human health globally.
About UNSW Sydney
UNSW aims to improve and transform lives through excellence in research, outstanding education and a commitment to advancing a just society. The University is one of the leading research and teaching-intensive universities in the world, known for innovative, pioneering research and high quality education with a global impact. The University offers an extensive range of undergraduate, postgraduate and research programs that attract students from across Australia and around the world. Visit www.unsw.edu.au and follow @unsw
RECOVERY COVID-19 Phase 3 trial to evaluate Regeneron's REGN-COV2 investigational antibody cocktail in the UK
14 September 2020 - One of the world's largest efforts to find effective COVID-19 treatments will evaluate the impact of REGN-COV2 on mortality, hospital stays, and the need for ventilation
TARRYTOWN, N.Y. and OXFORD, England, Sept. 14, 2020 -- Regeneron Pharmaceuticals, Inc. and the University of Oxford today announced that RECOVERY (Randomised Evaluation of COVid-19 thERapY), one of the world's largest randomized clinical trials of potential COVID-19 treatments, will evaluate Regeneron's investigational anti-viral antibody cocktail, REGN-COV2. The Phase 3 open-label trial in patients hospitalized with COVID-19 will compare the effects of adding REGN-COV2 to the usual standard-of-care versus standard-of-care on its own.
Peter Horby, Professor of Emerging Infectious Diseases and Global Health, Nuffield Department of Medicine, University of Oxford and chief investigator of the trial, said "We have already discovered that one treatment, dexamethasone, benefits COVID-19 patients, but the death rate remains too high so we must keep searching for others. The RECOVERY trial was specifically designed so that when promising investigational drugs such as REGN-COV2 became available they can be tested quickly. We are looking forward to seeing whether REGN-COV2 is safe and effective in the context of a large-scale randomized clinical trial; this is the only way to be certain about whether it works as a treatment for COVID-19."
"The world urgently needs new medicines to combat COVID-19, and well-designed trials to evaluate new treatment options will quickly help us learn which are most effective," said George D. Yancopoulos, M.D., Ph.D., President and Chief Scientific Officer of Regeneron. "REGN-COV2 was specifically designed by Regeneron scientists to target the virus that causes COVID-19. RECOVERY will be the fourth late-stage randomized clinical trial evaluating REGN-COV2 and will add to our knowledge about how this novel antibody cocktail may help hospitalized patients in need."
REGN-COV2 is the first specifically designed COVID-19 therapy being evaluated by RECOVERY. It was selected in part based on its emerging safety profile in humans, pre-clinical data showing it could protect against viral escape mutations, and prevention and treatment studies in non-human primates showing it reduced the amount of virus and associated damage in the lungs. REGN-COV2 is currently being studied in two Phase 2/3 clinical trials for the treatment of COVID-19 and in a Phase 3 trial for the prevention of COVID-19 in household contacts of infected individuals.
Martin Landray, Professor of Medicine & Epidemiology, Nuffield Department of Population Health, University of Oxford, added, "Throughout the COVID-19 pandemic we have seen the power of randomized trials to provide rigorous assessment of potential treatments. Up to now, we have largely been studying whether existing drugs can be re-purposed to tackle this new disease, but we now have the opportunity to rigorously assess the impact of a drug specifically designed to target this coronavirus. There are good reasons to be excited about this new development – RECOVERY will provide a robust assessment of the effect of this lab-manufactured monoclonal antibody combination treatment in hospitalized patients.
"We are very grateful to the patients who have already taken part in the trial and to those who will participate in this next phase of RECOVERY. We would not be able to find the best treatments without their support and that of the thousands of hospital and research staff who are working with us."
The open-label RECOVERY trial will assess the impact of adding REGN-COV2 to the usual standard-of-care on all-cause mortality 28 days after randomization. Other endpoints include the impact on hospital stay and the need for ventilation. It is anticipated that at least 2,000 patients will be randomly allocated to receive REGN-COV2 plus usual standard-of-care, and results will be compared with at least 2,000 patients who receive standard-of-care on its own. Usual standard-of-care varies by local hospital.
The trial is being coordinated by researchers at the University of Oxford, which acts as the sponsor for the research, working with clinical teams at 176 hospital sites across the UK.
About the Trial
The RECOVERY trial is conducted by the registered clinical trials units in the Nuffield Department of Population Health in partnership with the Nuffield Department of Medicine. The trial is supported by a grant to the University of Oxford from UK Research and Innovation/National Institute for Health Research (NIHR) and by core funding provided by NIHR Oxford Biomedical Research Centre, Wellcome, the Bill and Melinda Gates Foundation, the Department for International Development, Health Data Research UK, the Medical Research Council Population Health Research Unit and NIHR Clinical Trials Unit Support Funding.
The trial involves many thousands of doctors, nurses, pharmacists, and research administrators at 176 hospitals across the whole of the UK, supported by staff at the NIHR Clinical Research Network, NHS DigiTrials, Public Health England, Department of Health & Social Care, the Intensive Care National Audit & Research Centre, Public Health Scotland, the Secure Anonymised Information Linkage at University of Swansea, and the NHS in England, Scotland, Wales and Northern Ireland.
The inclusion of convalescent plasma in the RECOVERY trial was announced in June. The trial will compare adding convalescent plasma (plasma taken from patients who have recovered from COVID-19) to usual standard-of-care versus standard-of-care on its own.
About REGN-COV2
REGN-COV2 comprises two monoclonal antibodies (REGN10933 and REGN10987) and was designed specifically by Regeneron scientists to block infectivity of SARS-CoV-2, the virus that causes COVID-19. They evaluated thousands of fully-human antibodies produced by the company's VelocImmune® mice, which have been genetically modified to have a human immune system, as well as antibodies identified from humans who have recovered from COVID-19. The two potent, virus-neutralizing antibodies that form REGN-COV2 bind non-competitively to the critical receptor binding domain of the virus's spike protein, which diminishes the ability of mutant viruses to escape treatment and protects against spike variants that have arisen in the human population, as detailed in Science.
An Independent Data Monitoring Committee is monitoring all Regeneron-led REGN-COV2 Phase 2 and 3 trials, and all trials continue to enroll patients.
REGN-COV2's development and manufacturing has been funded in part by the Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response at the U.S. Department of Health and Human Services under OT number: HHSO100201700020C. Regeneron has recently partnered with Roche to increase the global supply of REGN-COV2. If REGN-COV2 proves safe and effective in clinical trials and regulatory approvals are granted, Regeneron will manufacture and distribute it in the U.S. and Roche will develop, manufacture and distribute it outside the U.S.
About Regeneron
Regeneron is a leading biotechnology company that invents life-transforming medicines for people with serious diseases. Founded and led for over 30 years by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to seven FDA-approved treatments and numerous product candidates in development, all of which were homegrown in our laboratories. Our medicines and pipeline are designed to help patients with eye diseases, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, pain, infectious diseases and rare diseases.
Regeneron is accelerating and improving the traditional drug development process through our proprietary VelociSuite technologies, such as VelocImmune®, which uses unique genetically-humanized mice to produce optimized fully-human antibodies and bispecific antibodies, and through ambitious research initiatives such as the Regeneron Genetics Center, which is conducting one of the largest genetics sequencing efforts in the world.
False Positive Test Cases in Sweden Explained
9 September 2020
9 September 2020 -- Last month, Sweden’s Public Health Agency announced that two laboratories discovered an RT- PCR kit for SARS-CoV-2 detection had returned around 3,700 false-positive results. The agency expressed concerns that the kits from BGI Genomics could not distinguish between very low levels of the virus and a negative result.
Lars Engstrand, director and professor at Karolinska Institutet/Science for Life Laboratory in Sweden, performed an analysis of the BGI RT- PCR kit for SARS-CoV-2. When asked about the possibility of false-positive results, he explained in an interview that the rate of positive detection can be linked to test sensitivity.
“This test is very sensitive, and this means that you want to catch all the positive cases in the population…” Professor Engstrand said. “When you have many cases, this kit is very good. It will not miss any positive cases. This means that you can rely on the results, but you also have a chance to get ‘false positive.’ But when the situation changes, and you have a very low number of infected individuals in society, as we have now, then you can lower the sensitivity and be sure that you pick up the right positive cases so you have not so many false positive cases. This is the situation now and we have now changed the threshold or the sensitivity of the test, so now it works perfectly fine in Sweden. We can rely on the test today.”
According to Reuters, “The Swedish labs that evaluate the tests have adjusted their methodology. The agency could not say how many tests had been done using the kit but only a minority of cases appeared to be involved, when the virus is at very low levels.”
Decisions made about the threshold may affect the interpretation of the results, which changes in accordance with the situation. Professor Engstrand explains: “With all tests, it’s a balance if you want to have high sensitivity or not. And in the beginning of the pandemic in Sweden, that was good. Now we don’t need that high sensitivity. We can actually be more precise and don’t risk to catch the false-positive cases. And today we have the situation with this kit.” Despite the special situation of COVID-19, “no test is 100 percent specific or sensitive,” he added. “That means every test has this kind of balance. You have to find out what this balance should be. And this is what we’ve done now in Sweden, for this test.”
Professor Engstrand also assured the public that “this test has been used in many, many countries. And in our hands today, it works perfectly fine. We can validate with other kits and other labs and we have 100 percent agreement between the answers.”
In a response to Sweden’s concern, BGI Genomics stated that the “high positive rate” was due to the amount of virus inside asymptomatic patients, and different countries and regions define asymptomatic patients differently. Different strategies have been implemented around the world. As a country with high population density, China prefers to implement stringent rules, conduct thorough tests, and set high sensitivity to avoid any blind spots and possible infections.
Reference: https://www.bgi.com/global/company/news/false-positive-test-cases-in-sweden-explained/
FBI Approves Thermo Fisher Scientific's Rapid DNA Solution for National DNA Index System
8 September 2020 - Applied Biosystems RapidHIT ID System plays key role in arrestee testing and investigative lead generation
SOUTH SAN FRANCISCO, Calif., Sept. 8, 2020 -- The U.S. Federal Bureau of Investigation (FBI) has approved Thermo Fisher Scientific's Applied Biosystems RapidHIT ID System for use by accredited forensic DNA laboratories to process DNA reference samples and search resulting profiles against the U.S. National DNA Index System (NDIS) CODIS database without manual interpretation and review.
The RapidHIT ID System is a fully automated, sample-to-answer genetic analyzer, allowing for analysis of DNA reference samples in as little as 90 minutes. This frees up DNA analyst time for more complex cases and quickly provides actionable information to help solve crimes faster. Faster turnaround time means law enforcement can more efficiently catch repeat offenders, exonerate the innocent, reduce costs to the criminal justice system and make communities safer.
NDIS approval of the RapidHIT ID System by the FBI paves the way for the technology to be used in booking stations for fast DNA processing. Previously, data generated from the RapidHIT ID System required review and interpretation from a qualified DNA analyst. Now, the system can perform automated review for the vast majority of resulting profiles. Pilot studies have been conducted by the FBI and participating agencies, enabling wider implementation in booking stations nationwide in the near future.
In a multi-site study of over 1,100 buccal samples, the RapidHIT ID System performance was proven suitable for single source reference samples and shown to be comparable to traditional laboratory results. Agencies participating in the study included the Louisiana State Police Crime Laboratory, Arizona Department of Public Safety, Alameda County Sheriff's Office Crime Laboratory, Florida Department of Law Enforcement, and Miami-Dade Police Department Forensic Services Bureau.
"NDIS approval of the RapidHIT ID system is a crucial step in supporting the FBI's vision of producing a DNA profile – and searching CODIS – while a qualifying arrestee is in police custody," said Martin Guillet, vice president and general manager for the Human Identification business at Thermo Fisher Scientific. "We remain committed to the standards of quality and integrity set forth by the forensics community, and to partnering with the law enforcement community to ensure booking station implementation is a success."
The NDIS-approved Rapid DNA system comprises the Applied Biosystems RapidHIT ID instrument, GlobalFiler Express typing kit, RapidHIT ID ACE GlobalFiler Express sample cartridge, RapidHIT ID System Software version 1.3, and RapidHIT ID Expert System software version 1.0.
Learn more at www.thermofisher.com/rapidDNA
About Thermo Fisher Scientific
Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $25 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, improving patient diagnostics and therapies or increasing productivity in their laboratories, we are here to support them. Our global team of more than 75,000 colleagues delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services and Patheon. For more information, please visit www.thermofisher.com.
Roche receives FDA clearance for BK virus quantitative test on cobas 6800/8800 Systems to support better care for transplant patients
8 September 2020 - Immunocompromised transplant patients are at risk of major complications when infected with BK virus. cobas BKV test addresses critical need for hospitals and laboratories to have standardised and comparable results across institutions. New Breakthrough Device test expands Roche molecular test menu for transplant patients, enabling simultaneous testing of BK virus with Cytomegalovirus and Epstein-Barr virus.
Basel, 8 September 2020 -- Roche today announced U.S. Food and Drug Administration (FDA) 510k clearance for the cobas® BKV Test on the cobas® 6800 and 8800 Systems. The test was previously granted FDA Breakthrough Device designation demonstrating the improved treatment or diagnosis of life-threatening diseases or conditions for transplant patients. The test provides standardised, high-quality results that can help healthcare professionals better assess the risk of complications caused by the BK virus in transplant patients and identify effective treatment options.
BK virus (BKV) is a member of the polyomavirus family that can cause severe transplant-associated complications. Infection can occur without symptoms and happen early in life. After primary infection, the virus can remain inactive, only to possibly reactivate in immunocompromised individuals such as transplant recipients.
“Our diagnostic tests can help clinicians greatly improve patient treatment plans and make quick adjustments for personalised healthcare,” said Thomas Schinecker, CEO Roche Diagnostics. “This FDA clearance allows Roche to offer healthcare professionals a transplant testing portfolio that includes Cytomegalovirus, Epstein-Barr virus and BK virus so they can simultaneously monitor and improve care for transplant patients who are at risk for these common infections or viral reactivations which can cause further illness or death.”
The cobas BKV Test is a polymerase chain reaction (PCR) viral load test that runs on the fully automated and widely available cobas® 6800 and cobas® 8800 Systems. Along with the previously approved cobas® EBV and CMV Tests, the cobas BKV Test has been calibrated to the World Health Organization (WHO) International Standard. This means that test results are reported in international units, making it possible for laboratories anywhere in the U.S. to obtain comparable results when measuring levels of BKV DNA.
About the cobas BKV Test
The cobas BKV Test was previously granted Breakthrough Device Designation by the FDA, together with the cobas EBV Test.
The cobas BKV Test is a real-time polymerase chain reaction (PCR) test with dual-target technology that provides quantitative accuracy and guards against the risk of sequence variations that may be present in the BK virus. The cobas BKV Test has robust coverage with a limit of detection of 21.5 IU/mL and an expanded linear range from 21.5 IU/mL to 1E+08 IU/mL in EDTA plasma.
The test offers an alternative to lab-developed tests (LDTs) or Analyte Specific Reagent (ASR) combinations, potentially minimising variability and complexity in testing, reducing workload and alleviating risk for laboratories. The test supports the goal of result standardisation across institutions by providing reproducible, high-quality results for clinical decision-making.
The fully automated cobas BKV Test and the cobas CMV and cobas EBV Tests can run on the cobas 6800/8800 Systems simultaneously, providing absolute automation with proven performance and flexibility, leading to time savings and increased efficiency.
About BK polyomavirus
BK polyomavirus (BKV) is a member of the polyomavirus family that can cause transplant-associated complications including nephropathy in kidney transplantation and hemorrhagic cystitis in hematopoietic stem cell transplantation. Infection can occur early in life, often with no symptoms. After primary infection, the virus can remain inactive throughout life, only to possibly reactivate in immunocompromised individuals, such as patients who receive solid-organ transplants. For kidney transplant patients, BKV infection is considered the most common viral complication, causing polyomavirus nephropathy (PVN) in up to 10 percent of kidney transplant recipients, and about 50 percent of PVN-affected patients will experience transplant graft failure. BKV is also associated with hemorrhagic cystitis after allogeneic hematopoietic stem cell transplantation.
About the cobas 6800/8800 Systems
When every moment matters, the fully automated cobas 6800/8800 Systems offer the fastest time to results with the highest throughput and the longest walk-away time available among automated molecular platforms. The systems provide up to 96 results in about three hours and 384 results for the cobas 6800 System and 1,056 results for the cobas 8800 System in an eight hour shift.
Both systems make it possible for labs to perform up to three tests in the same run with no pre-sorting required. The systems also enable up to eight hours (cobas 6800 System) and four hours (cobas 8800 System) of walk-away time with minimal user interaction.*
These real-time PCR systems serve the areas of infectious disease, donor screening, sexual health, transplant, respiratory and antimicrobial stewardship.
Through an ever-increasing worldwide install base of cobas 6800/8800 Systems, labs are quickly and easily processing millions of tests per month to meet the changing demands of their communities, their customers, and the patients relying on the results of each assay. Globally, labs know and trust that a Roche assay guarantees high precision, accuracy, and traceability to World Health Organization standards.
Today, rapid advancements in healthcare technology, a shortage of skilled workers, industry-wide consolidation, and the proven need to be ready for the next outbreak have health systems looking to lay a reliable foundation for the future. With proven performance, absolute automation, and unmatched flexibility delivering unparalleled throughput 24/7—cobas 6800/8800 Systems are designed to ensure a lab’s long-term sustainability and success … now, more than ever.
About Roche
Roche is a global pioneer in pharmaceuticals and diagnostics focused on advancing science to improve people’s lives. The combined strengths of pharmaceuticals and diagnostics under one roof have made Roche the leader in personalised healthcare – a strategy that aims to fit the right treatment to each patient in the best way possible.
Roche is the world’s largest biotech company, with truly differentiated medicines in oncology, immunology, infectious diseases, ophthalmology and diseases of the central nervous system. Roche is also the world leader in in vitro diagnostics and tissue-based cancer diagnostics, and a frontrunner in diabetes management.
Founded in 1896, Roche continues to search for better ways to prevent, diagnose and treat diseases and make a sustainable contribution to society. The company also aims to improve patient access to medical innovations by working with all relevant stakeholders. More than thirty medicines developed by Roche are included in the World Health Organization Model Lists of Essential Medicines, among them life-saving antibiotics, antimalarials and cancer medicines. Moreover, for the eleventh consecutive year, Roche has been recognised as one of the most sustainable companies in the Pharmaceuticals Industry by the Dow Jones Sustainability Indices (DJSI).
The Roche Group, headquartered in Basel, Switzerland, is active in over 100 countries and in 2019 employed about 98,000 people worldwide. In 2019, Roche invested CHF 11.7 billion in R&D and posted sales of CHF 61.5 billion. Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan. For more information, please visit www.roche.com.
Reference: https://www.roche.com/media/releases/med-cor-2020-09-08.htm
LabCorp Launches First Combined Test for Covid-19, Flu and RSV in Time for Flu Season
8 September 2020 - Single Test Detects Multiple Respiratory Infections Including COVID-19 and Flu to Inform Treatment Options. At-Home Use Through Pixel by LabCorp™ Pending FDA Authorization.
BURLINGTON, N.C., Sep. 8, 2020 -- LabCorp, a leading global life sciences company that is deeply integrated in guiding patient care, today announced the launch of the first testing method to simultaneously detect COVID-19, influenza A / B, and respiratory syncytial virus (RSV). The single-panel test, which detects multiple types of infections, can help doctors diagnose patients and make decisions about treatment options. The test is available to patients through doctors, hospitals, and other authorized healthcare providers nationwide. LabCorp has also submitted an application to the U.S. Food and Drug Administration (FDA) to offer the combined test through its Pixel by LabCorp™ at-home test collection kit, which would offer added convenience and accessibility.
“The U.S. is facing the most challenging health crisis in a century and is about to enter flu season, which has the potential to put additional strain on our healthcare system and cost lives,” said Dr. Brian Caveney, chief medical officer and president of LabCorp Diagnostics. “Individuals infected with COVID-19, influenza A / B, or RSV, often experience similar symptoms of cough, fever, chest tightness, and body aches, providing a potential surge of patients seeking testing. Leveraging our scientific and technological expertise to simultaneously test for four major respiratory viruses, including COVID-19, will provide doctors a simple, efficient way to diagnose their patients.”
LabCorp’s COVID-19, influenza A / B, and RSV testing method is part of the company’s continued commitment to meet the demand for diagnostic testing as the country addresses the overlap of the COVID-19 health crisis and flu season. Between October 1, 2019, and April 4, 2020, the Centers for Disease Control and Prevention estimated that there were 39 to 56 million flu illnesses, resulting in 18 to 26 million medical visits. A significant flu and RSV season this year could put an added strain on the healthcare system, as people experience similar symptoms – fever, cough, and aches, for example – with COVID-19 and respiratory viruses.
Pending authorization by the FDA, the Pixel by LabCorp at-home test will be another convenient option for individuals to determine if they have the flu, COVID-19, or RSV. Thousands of people have used the company’s COVID-19 Pixel by LabCorp at-home test kit, with 95 percent of users being very satisfied or satisfied with their experience. The Pixel by LabCorp at-home test uses a short swab that is easily inserted into the individual’s lower nostril, reducing the discomfort associated with much longer swabs.
In addition to its novel respiratory flu test, LabCorp offers a suite of readily accessible prevention-to-detection solutions for COVID-19 and flu that doctors, healthcare providers, individuals, employers, and students can access. The company has performed over 13 million molecular tests since March, using several sample collection methods, including simple nasal swabs and nasopharyngeal swabs. For more information, individuals can speak to their doctor, healthcare provider or visit LabCorp's COVID-19 website.
About LabCorp
LabCorp, an S&P 500 company, is a leading global life sciences company that is deeply integrated in guiding patient care, providing comprehensive clinical laboratory and end-to-end drug development services. With a mission to improve health and improve lives, LabCorp delivers world-class diagnostics solutions, brings innovative medicines to patients faster, and uses technology to improve the delivery of care. LabCorp reported revenue of more than $11.5 billion in 2019. To learn more about LabCorp, visit www.LabCorp.com, and to learn more about LabCorp’s drug development business, Covance, visit www.Covance.com.
QIAGEN to launch rapid portable test that can analyze over 30 samples per hour for SARS-CoV-2 antigen
8 September 2020 - Combination of speed and scale is an important step towards decentralized mass testing for coronavirus that has so far been elusive. Access Anti-SARS-CoV-2 Antigen Test, developed in collaboration with Ellume, is easy to use and provides accurate results in less than 15 minutes. Complements QIAGEN’s antibody and PCR tests to provide full range of COVID-19 testing solutions. Each Digital eHub device with capacity for up to 8 eSticks can simultaneously run QIAGEN Access Antigen and Antibody tests.
Hilden, Germany, and Germantown, Maryland, September 08, 2020 – QIAGEN today announced plans to launch a rapid portable test that can detect SARS-CoV-2 antigens in people with active infections in less than 15 minutes and process on average around 30 swab samples per hour using a small digital detection system.
The Access Anti-SARS-CoV-2 Antigen Test, which is expected to become available in the fourth quarter of 2020, is designed for environments that require a high volume of fast and accurate test results. The portable test offers a new combination of speed and scale that marks an important step towards decentralized mass testing that health authorities all over the world have been urgently seeking.
The Access Anti-SARS-CoV-2 Antigen Test extends the partnership with Ellume, an Australian digital diagnostics company. It is the second QIAGEN COVID-19 test to make use of Ellume’s digital eHub and eStick system. QIAGEN in August announced the Access Anti-SARS-CoV-2 Antibody Test that uses the same devices.
Two versions of the Antigen Test are scheduled for US launch in the fourth quarter – one for labs and one for point-of-care (POC) use. QIAGEN will apply for FDA Emergency Use Authorization and seek CE-IVD registration in Europe. A CLIA Waiver in the US would allow the POC version to be used in settings like airports or stadiums.
Feasibility tests have shown the Access Antigen Test to have a sensitivity of at least 90% and a specificity of 100%.
“The Access Antigen Test is fast, easy to use and cost-effective and will be a valuable tool to address the so far unmet high-volume testing needs for SARS-CoV-2 antigens in situations where time is of the essence,” said Thierry Bernard, Chief Executive Officer of QIAGEN. “It will deliver highly accurate results and will complement the gold-standard PCR tests used for detection of active COVID-19 infection. PCR tests offer a high level of diagnostic accuracy but are time-consuming and lab-bound.”
The Access Anti-SARS-CoV-2 Antigen Test uses the QIAGEN eHub that was launched in August, a rugged portable machine, to analyze nasal-swab samples from up to eight symptomatic people at once. The easy-to-use eStick uses nanoparticle fluorescent detection technology to flag the SARS-CoV-2 nucleocapsid protein, an antigen present on the surface of the virus. The device delivers negative results in 15 minutes – and in as little as three minutes in the case of a strong positive.
This means one eHub can process on average about 30 tests per hour with the possibility for one user to operate more than one eHub. As Access Anti-SARS-CoV-2 Antibody test, released late August, also uses the device, lab professionals will be able to run tests to detect both previous and active infections on one device at the same time – with each testing slot operating independently of the others. Knowledge of past and present infections is essential to understanding and inhibiting the spread of the disease.
The Antibody Test strengthens QIAGEN’s robust COVID-19 testing portfolio that addresses customer needs from fundamental research to diagnostics. The Access Anti-SARS-CoV-2 Antigen Test and the Access Anti-SARS-CoV-2 Antibody Test run on the eHub platform that QIAGEN is using for Access QuantiFERON-TB. This is a new solution still in development that will help low-resource and high-burden regions diagnose latent tuberculosis infection.
QIAGEN employees are addressing the urgent demand for testing solutions needed in the global response to the coronavirus pandemic. They are massively ramping up production capacity and building the most comprehensive portfolio of solutions for COVID-19 testing.
These include viral RNA extraction for use on QIAGEN’s QIAcube, QIAsymphony and EZ1 platforms as well as third-party instruments; a range of PCR tests on the QIAstat-Dx and NeuMoDx systems that enable COVID-19 detection while analyzing samples at the same time for other respiratory infections; and the Access Anti-SARS-CoV2-Antbody Test for detection of immune response in people who have been exposed to the virus in the past.
QIAGEN also provides universal next-generation sequencing (NGS) solutions for research use with any sequencer, in particular gene panels integrated with bioinformatics for analysis of the SARS-CoV-2 virus And QIAGEN is also providing reagents sold to other companies for use in their own COVID-19 tests.
QIAGEN products are being used for the development of vaccines against COVID-19. QIAGEN expects that the availability of vaccines will drive ongoing demand for testing as the immune response in the population will have to be assessed and monitored.
Further information on QIAGEN’s response to the coronavirus outbreak can be found here.
About QIAGEN
QIAGEN N.V., a Netherlands-based holding company, is the leading global provider of Sample to Insight solutions that enable customers to gain valuable molecular insights from samples containing the building blocks of life. Our sample technologies isolate and process DNA, RNA and proteins from blood, tissue and other materials. Assay technologies make these biomolecules visible and ready for analysis. Bioinformatics software and knowledge bases interpret data to report relevant, actionable insights. Automation solutions tie these together in seamless and cost-effective workflows. QIAGEN provides solutions to more than 500,000 customers around the world in Molecular Diagnostics (human healthcare) and Life Sciences (academia, pharma R&D and industrial applications, primarily forensics). As of June 30, 2020, QIAGEN employed more than 5,200 people in over 35 locations worldwide. Further information can be found at http://www.qiagen.com.
Reference: https://corporate.qiagen.com/newsroom/press-releases/2020/20200908_access_antigen
Roche receives FDA Emergency Use Authorization for the cobas SARS-CoV-2 & Influenza A/B Test for use on the cobas 6800/8800 Systems
4 September 2020 - First commercial test for fully automated high throughput systems to detect and differentiate SARS-CoV-2, influenza A virus and/or influenza B virus with a single sample. As COVID-19 and influenza infections can hardly be differentiated based on symptoms, healthcare professionals can confidently provide the right diagnosis and best course of treatment for patients. Test for use on high-throughput cobas 6800/8800 Systems will continue to support high volume testing. This test is also available in markets accepting the CE mark.
Basel, 04 September 2020 -- Roche today announced that the cobas® SARS-CoV-2 & Influenza A/B Test for use on the cobas® 6800/8800 Systems has received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA). This test is intended for the simultaneous qualitative detection and differentiation of SARS-CoV-2, Influenza A and Influenza B in patients suspected by their healthcare provider of having respiratory viral infection consistent with COVID-19. Additionally, it is available in markets accepting the CE mark.
“With the approaching flu season, this new test is particularly important as SARS-CoV-2 and influenza infections can hardly be differentiated by symptoms alone. Now, with a single test, healthcare professionals can confidently provide the right diagnosis and most effective treatment plan for their patients,” said Thomas Schinecker, CEO of Roche Diagnostics. “As a leader in diagnostics testing solutions, this launch demonstrates our ongoing commitment to stop the spread of serious infectious diseases by increasing access to accurate, reliable and efficient testing options.”
Roche’s widely-available, fully-automated cobas 6800/8800 Systems, which are used to perform the SARS-CoV-2 & Influenza A/B Test, offer the fastest time to results with the highest throughput and the longest walk-away time available among automated molecular platforms. The systems provide up to 96 results in about 3 hours and 384 results for the cobas 6800 System and 1,056 results for the cobas 8800 System in an 8-hour shift. Roche is committed to delivering as many tests as possible within the limits of supply.
The test is another key addition to the comprehensive Roche diagnostic portfolio to help healthcare providers combat COVID-19 and make informed decisions for optimised patient care. Currently, this portfolio includes molecular, serology and digital solutions, which help during the initial stages of infection, during the recovery phase, as well as following the resolution of infection.
About cobas SARS-CoV-2 & Influenza A/B Test
The cobas SARS-CoV-2 & Influenza A/B Test is a multiplex reverse transcription polymerase chain reaction (RT-PCR) assay intended for the simultaneous qualitative detection and differentiation of SARS-CoV-2, Influenza A virus, and Influenza B virus in nasal or nasopharyngeal swab samples collected from individuals suspected of a respiratory infection, and is not intended for the detection of Influenza C virus. Under FDA EUA, the test can be taken by individuals suspected of a respiratory viral infection like COVID-19 by their healthcare provider. The test runs on the cobas 6800/8800 Systems and has a full-process negative control, positive control and internal control. Multiplexing will increase lab efficiency and save resources in the labs.
Negative results do not preclude infection from SARS-CoV-2 or Influenza virus and should not be used as the sole basis of treatment or other patient management decisions. Negative results must be combined with clinical observations, patient history and epidemiological information.
The cobas SARS-CoV-2 & Influenza A/B Test is intended for use by trained clinical laboratory personnel specifically instructed and trained in the techniques of real-time PCR and in vitro diagnostic procedures. In the United States, the cobas SARS-CoV-2 & Influenza A/B Test for use on the cobas® 6800 and cobas® 8800 Systems is only for use under the FDA’s Emergency Use Authorization.
About SARS-CoV-2 (coronavirus)
Coronaviruses (CoV) are a large family of viruses that cause illness ranging from the common cold to more severe diseases such as Middle East Respiratory Syndrome (MERS-CoV) and Severe Acute Respiratory Syndrome (SARS-CoV). The novel coronavirus (SARS-CoV-2) is a new strain which has not previously been identified in humans.
Signs of infection include respiratory symptoms such as cough, shortness of breath, difficulty breathing, and fever. In more severe cases, pneumonia, severe acute respiratory syndrome, kidney failure and death can occur.
To control the spread of the infection, the World Health Organisation (WHO) recommends regular hand washing, covering mouth and nose when coughing and sneezing, and avoiding close contact with anyone showing symptoms of respiratory illness.
About Roche’s response to the COVID-19 pandemic
The COVID-19 pandemic continues to evolve globally with varying developments from country to country and we are partnering with healthcare providers, laboratories, authorities and organisations to help make sure that patients receive the tests, treatment and care they need. This new test is an additional step in Roche’s fight against the COVID-19 pandemic, which has already included:
- Launching COVID-19 diagnostic tests for active infection and the detection of antibodies in patients who have been exposed to the virus,
- Investigating treatments from our existing portfolio to better understand their potential to treat patients with COVID-19,
- Increasing manufacturing and supply chain capacity to meet product demand across our portfolio within the wider context of COVID-19 treatment, and
- Ensuring the supply of our existing medicines and diagnostics to patients around the world under exceptional conditions.
Reliable, high-quality testing is essential to help healthcare systems overcome this pandemic. On 13 March we received FDA Emergency Use Authorisation for a high-volume molecular test to detect SARS-CoV-2, the virus that causes COVID-19, which is also available in countries accepting the CE Mark. On 3 May, Roche announced that its COVID-19 antibody test, aimed at detecting the presence of antibodies in the blood, also received FDA Emergency Use Authorisation and is available in markets accepting the CE mark. Also in June we received an FDA EUA for the Elecsys® IL-6 test to assist in identifying severe inflammatory response in patients with confirmed COVID-19, as well as launching Roche v-TAC, which could help simplify the screening, diagnosis and monitoring of patients with respiratory compromise in the current COVID-19 pandemic. In July, we added a Rapid Antibody Test, with SD Biosensor as distribution partner, to our portfolio, that allows the detection of antibodies against Covid-19 at the point of care. On 1 September we announced that we will launch a SARS-CoV-2 Rapid Antigen Test, in late September, for markets accepting the CE Mark. We also intend to file for Emergency Use Authorisation (EUA) to the U.S. Food and Drug Administration (FDA). The SARS-CoV-2 Rapid Antigen Test is for use in point of care settings for both symptomatic and asymptomatic people.
Roche is working closely with governments and health authorities around the world, and has significantly increased production to help ensure availability of tests globally.
We are actively involved in understanding the potential of our existing portfolio and are researching options for the future. Roche has an ongoing clinical trial program evaluating the role of Actemra©/RoActemra© (tocilizumab) in COVID-19 pneumonia. On 29 July we announced that the COVACTA trial did not meet its primary endpoint of improved clinical status in patients with COVID-19 associated pneumonia, or the key secondary endpoint of reduced patient mortality. The study was the first global, randomised, double-blind, placebo-controlled phase III trial investigating Actemra/RoActemra in this setting. Roche remains committed to continuing the Actemra/RoActemra clinical trial programme in COVID-19 to further explore Actemra/RoActemra in other treatment settings, including in combination with an antiviral. In addition to COVACTA, Roche has initiated several studies to further investigate Actemra/RoActemra as a potential treatment for patients with COVID-19 associated pneumonia, including two phase III clinical trials, REMDACTA and EMPACTA, as well as the phase II MARIPOSA trial. Roche has further initiated an internal early research programme focused on the development of medicines for COVID-19 and is engaged in multiple research collaborations. On 19 August, we announced a partnership with Regeneron to develop, manufacture and distribute REGN-COV2, Regeneron’s investigational antiviral antibody combination, to people around the globe.
In these exceptional times, Roche stands together with governments, healthcare providers and all those working to overcome the pandemic.
About Influenza A and B (flu)
Influenza is an acute respiratory illness caused by infection with the influenza virus. Influenza viruses consist of three types: Influenza A, Influenza B, and Influenza C. In the U.S., Influenza A/H1N1, A/H3N2 and Influenza B are the predominant seasonal viruses. Influenza A and B viruses are among the leading causes of respiratory infections, estimated to affect 5-10% of adults and 20-30% of children every year worldwide. Influenza is primarily spread by breathing in infected droplets formed when a person with the flu sneezes, coughs, or talks. Symptoms include fever, cough, headache, fatigue, muscle pain, sore throat, and runny nose. Elderly people, young children and people with weakened immune systems or chronic medical conditions can be at high risk for serious disease. Each year, approximately 3 to 5 million people develop severe illness and 290,000 to 650,000 people die from the flu.
About the cobas 6800/8800 Systems
When every moment matters, the fully automated cobas 6800/8800 Systems offer the fastest time to results with the highest throughput and the longest walk-away time available among automated molecular platforms. With proven performance, absolute automation and unmatched flexibility delivering unparalleled throughput 24/7— cobas 6800/8800 Systems are designed to ensure a lab’s long-term sustainability and success … now, more than ever.
About Roche
Roche is a global pioneer in pharmaceuticals and diagnostics focused on advancing science to improve people’s lives. The combined strengths of pharmaceuticals and diagnostics under one roof have made Roche the leader in personalised healthcare – a strategy that aims to fit the right treatment to each patient in the best way possible.
Roche is the world’s largest biotech company, with truly differentiated medicines in oncology, immunology, infectious diseases, ophthalmology and diseases of the central nervous system. Roche is also the world leader in in vitro diagnostics and tissue-based cancer diagnostics, and a frontrunner in diabetes management.
Founded in 1896, Roche continues to search for better ways to prevent, diagnose and treat diseases and make a sustainable contribution to society. The company also aims to improve patient access to medical innovations by working with all relevant stakeholders. More than thirty medicines developed by Roche are included in the World Health Organization Model Lists of Essential Medicines, among them life-saving antibiotics, antimalarials and cancer medicines. Moreover, for the eleventh consecutive year, Roche has been recognised as one of the most sustainable companies in the Pharmaceuticals Industry by the Dow Jones Sustainability Indices (DJSI).
The Roche Group, headquartered in Basel, Switzerland, is active in over 100 countries and in 2019 employed about 98,000 people worldwide. In 2019, Roche invested CHF 11.7 billion in R&D and posted sales of CHF 61.5 billion. Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan. For more information, please visit www.roche.com.
Reference: https://www.roche.com/media/releases/med-cor-2020-09-04.htm
Merck Supports Eijkman Institute to Expedite Covid-19 Vaccine Development Research
3 September 2020 - Eijkman Institute for Molecular Biology developing Covid-19 vaccine based on local strain virus strain. Institute to receive research instruments and materials to advance production.
Jakarta, Indonesia, September 3, 2020 — Merck, a leading science and technology company, today announced the donation of research instruments and materials worth IDR 1.2 billion (€ 74,000) to support the efforts of Eijkman Institute for Molecular Biology, Indonesia, in its efforts to accelerate vaccine development research. The institute is developing a Covid-19 vaccine based on a local virus strain, in collaboration with several local research institutions.
“Merck supplies critical products and services and provides solutions for scientists to identify and characterize viruses and develop vaccines and therapies – work that is especially important as vaccine developers race to fight Covid-19,” said Christopher Thomas, president director at Merck in Indonesia. “Eijkman Institute’s work is promising and we are committed to supporting them.”
Merck is donating reagents and consumables to make viral transport medium, which are tubes that store patients’ swab test samples, allowing them to be safely transported from swab sampling locations (i.e., clinics, hospitals, health centers) to testing labs. The company is also donating RiOs™ Essential water purification systems, which produce high-quality type-3 pure water by integrating pre-treatment and high-performance reverse osmosis membranes.
"The utmost priority in combating Covid-19 is accelerating the discovery of Covid-19 vaccine to protect people and breaking the chain of infection in Indonesia,” said Professor Amin Soebandrio, chairman of Eijkman Institute for Molecular Biology. “Prevention is certainly better than cure. Global partners and qualified state-of-the-art research instruments will greatly help in expediting this vaccine research. We are grateful for Merck’s support in donating instruments and materials to help us in developing Indonesia’s Covid-19 vaccine."
Eijkman Institute’s research has progressed to the generation of sub-unit protein as the chosen platform. In general, vaccine manufacturing can take years to finish, but the institute is racing to generate the vaccine seed in only a year. It is estimated that the vaccine will be made available for further processes including clinical trials in Indonesia by early 2021.
About Merck
Merck, a leading science and technology company, operates across healthcare, life science and performance materials. Around 57,000 employees work to make a positive difference to millions of people’s lives every day by creating more joyful and sustainable ways to live. From advancing gene editing technologies and discovering unique ways to treat the most challenging diseases to enabling the intelligence of devices – the company is everywhere. In 2019, Merck generated sales of €16.2 billion in 66 countries.
Scientific exploration and responsible entrepreneurship have been key to Merck’s technological and scientific advances. This is how Merck has thrived since its founding in 1668. The founding family remains the majority owner of the publicly listed company. Merck holds the global rights to the Merck name and brand. The only exceptions are the United States and Canada, where the business sectors of Merck operate as EMD Serono in healthcare, MilliporeSigma in life science, and EMD Performance Materials.
Reference: https://www.merckmillipore.com/DE/de/20200902_133550
Chlamydia and Gonorrhea Positivity Surges in Women Ages 18-30 Years, Finds Quest Diagnostics Health Trends Study
3 September 2020 - Analysis of 18 million de-identified lab tests also reveals shift in positivity rate toward older women, with more females "aging out" of annual screening guidelines that end at age 25
SECAUCUS, N.J., Sept. 3, 2020 -- The rate at which women 18-30 years of age tested positive for the two most common reportable sexually transmitted infections grew by double digits between 2010 and 2017, finds an analysis of nearly 18 million de-identified test results from Quest Diagnostics.
The new Health Trends® study from Quest Diagnostics is believed to be one of the largest to examine rates of clinical laboratory test results for Chlamydia trachomatis (chlamydia) and Neisseria gonorrhoeae (gonorrhea) on a national scale. The study examined 17,794,680 co-testing laboratory results for both infections from females aged 12–30 years tested at Quest Diagnostics during 2010–2017.
The study is available in the American Journal of Preventive Medicine (AJPM) online ahead of print here.
In addition to showing sharp increases in the positivity rates of chlamydia and gonorrhea, the study also found that the positivity rates of both infections shifted toward older ages over the eight-year study period. This observed shifts in age-based risk is significant because it raises the prospect that current medical guidelines for screening are not aligned with the sexual behaviors of, and associated risk of infection in, women in the United States.
Guidelines from the Centers for Disease Control and Prevention (CDC) and the U.S. Preventive Services Task Force (USPSTF) recommend annual screening for both infections in all sexually active women younger than 25 years of age. Screening in women 25 years of age and older is recommended only for those with certain risk factors, such as a new or multiple sexual partners or inconsistent condom use.
Yet, according to the study, the positivity rate for chlamydia for 27-year-old women in 2017 (3.5%) was the same as the positivity rate for 24-year-old women in 2010. A similar dynamic was observed for gonorrhea infections, with the positivity rate in 30-year-olds in 2017 (0.5%) identical to that found in 23-year-olds in 2010.
Overall, the peak age of positivity for both infections increased by one to two years and, in test results at the farthest distribution, by 3 to 7 years for chlamydia and gonorrhea respectively, over the eight-year study period.
Infections with chlamydia and gonorrhea often lack symptoms and, left untreated, may result in pelvic inflammatory disease and infertility.
"Our Health Trends data shows that sexually transmitted infections do not discriminate by age," said lead researcher Harvey W. Kaufman, M.D., Senior Medical Director and Director, Health Trends Research Program at Quest Diagnostics. "When a sexually transmitted infection goes undetected and untreated, the result can be long-term health problems such as infertility and unknowing transmission of the infection to others. Sexual behaviors have changed in the United States, and guidelines need to reflect that women may be spending longer periods of time being sexually active and with more partners prior to childbearing than in the past."
Among the key findings:
- The annual chlamydia positivity rate increased by 18 percent overall (4.9% in 2010 to 5.8% in 2017), while annual gonorrhea positivity increased by 33 percent overall (0.7% in 2010 to 0.9% in 2017).
- Although women ages 18-24 were more likely to test positive for either infection, women 25-30 years of age experienced a higher increase over the 8-year period. Among women 25-30 years of age, the positivity rate increased by 50 percent (from 2.2% in 2010 to 3.3% in 2017), compared to women in the 18-24 age group, at 21 percent (6.1% to 7.4%).
- Among the youngest (12-17) age group, the positivity rate declined 17 percent for chlamydia (8.9% in 2010 to 7.4% in 2017) and 14 percent for gonorrhea (1.33% in 2010 to 1.17% in 2017).
"Our analysis raises the possibility that some women in the United States are prematurely aging out of access to annual screening, given current guidelines," said co-author Damian P. Alagia, III, M.D., Senior Medical Director of Woman's Health for Quest Diagnostics. "As such, women over the age of 24 years can only access testing if they are symptomatic or labeled 'high risk' by their healthcare provider following a potentially uncomfortable dialogue about their sexual behavior. Given changing sexual mores, a more thoughtful and inclusive population screening approach supporting screening access for women above the age of 24 years is overdue."
The study, "Chlamydia and Gonorrhea: Shifting Age-Based Positivity among Young Females, 2010-2017," is available at: https://www.sciencedirect.com/science/article/pii/S0749379720302713#!
Approximately 1,760,000 cases of chlamydia and 583,000 cases of gonorrhea infections were reported to the Centers for Disease Control and Prevention in 2018.
About Quest Diagnostics
Quest Diagnostics empowers people to take action to improve health outcomes. Derived from the world's largest database of clinical lab results, our diagnostic insights reveal new avenues to identify and treat disease, inspire healthy behaviors and improve health care management. Quest annually serves one in three adult Americans and half the physicians and hospitals in the United States, and our 47,000 employees understand that, in the right hands and with the right context, our diagnostic insights can inspire actions that transform lives. www.QuestDiagnostics.com.
Roche receives FDA approval for first HIV-1/HIV-2 Qualitative Test on the cobas 6800/8800 Systems in the fight against HIV/AIDS
1 September 2020 - Detects, confirms and differentiates HIV-1 and HIV-2 infections providing clinicians with critical diagnostic data for personalised management of patients with HIV - from appropriate counseling on disease differences to targeted therapy. Supports rapid molecular detection of acute HIV infection, which is critical in curbing further disease transmission. Combines confirmatory HIV testing and HIV-1/HIV-2 differentiation into one single test.
Basel, 1 September 2020 -- Roche today announced U.S. Food and Drug Administration (FDA) approval for the cobas® HIV-1/HIV-2 Qualitative Test for use on the fully automated cobas® 6800/8800 Systems in the U.S. The test provides healthcare professionals with a single result to confirm HIV diagnosis and differentiate HIV-1 and HIV-2, an important distinction needed to identify appropriate treatment options.
“Roche is committed to improving diagnostic technologies in the fight against HIV/AIDS,” said Thomas Schinecker, CEO Roche Diagnostics. “Being able to reliably determine a person’s HIV status and accurately diagnose which HIV type they may have is crucial for patients and healthcare providers in preventing further community transmission and selecting an individual’s best treatment options.”
Studies show that 50% of new HIV infections may be transmitted during the acute period, between three days and three weeks from the time of infection. Current serology-based testing methods rely on the ability to detect an antibody or antigen response. As a result, they can fail to identify an infection if the person is tested prior to having a detectable antibody or antigen response, which can take several weeks to generate. The higher sensitivity of PCR technology, which is used with the cobas HIV-1/HIV-2 Qualitative Test, can reduce this time-to-detection period by one week or more. This significant reduction in time to detection is critical to improve personalised healthcare while curbing further disease transmission.
About the cobas HIV-1/HIV-2 Qualitative Test
cobas HIV-1/HIV-2 Qualitative for use on the cobas 6800/8800 Systems is an in vitro nucleic acid amplification test for the qualitative detection and differentiation of human immunodeficiency virus type 1 (HIV-1) and type 2 (HIV-2) RNA in human serum and plasma.
The test is intended to be used as an aid in diagnosis of HIV-1/HIV-2 infection. Detection of HIV-1 or HIV-2 nucleic acid is indicative of HIV-1 or HIV-2 infection, respectively. The presence of HIV-1 or HIV-2 nucleic acid in the plasma or serum of individuals without antibodies to HIV-1 or HIV-2 is indicative of acute or primary infection. cobas HIV-1/HIV-2 Qualitative may also be used as an additional test to confirm the presence of HIV-1 or HIV-2 infection in an individual with specimens reactive for HIV-1 or HIV-2 antibodies or antigens. The assay may also be used as an aid in the diagnosis of infection with HIV-1 and/or HIV-2 in pediatric subjects and pregnant women.
About HIV-1 and HIV-2 in the U.S.
The U.S. Centers for Disease Control and Prevention (CDC) estimated in 2018 that 1.2 million people were living with HIV in the United States. Among them, more than 160,000 people did not know their HIV status, and only 53 percent were virally suppressed having low amounts of virus circulating in their blood. During this same year, 37,968 people became newly infected with HIV.
Human immunodeficiency virus (HIV) is categorized into two types, HIV-1 and HIV-2. Worldwide, most HIV infections are HIV-1, whereas HIV-2 largely has been confined to persons in or from West Africa. However, HIV-2 has been steadily increasing in the U.S. due to immigration. HIV-1 and HIV-2 have the same routes of transmission, and both can cause acquired immunodeficiency syndrome (AIDS); however, it is important to differentiate HIV-2 infections from HIV-1 infections because they require different clinical management.
About the cobas 6800/8800 Systems
When every moment matters, the fully automated cobas 6800/8800 Systems offer the fastest time to results with the highest throughput and the longest walk-away time available among automated molecular platforms. With proven performance, absolute automation and unmatched flexibility delivering unparalleled throughput 24/7 — cobas 6800/8800 Systems are designed to ensure a lab’s long-term sustainability and success … now, more than ever.
About Roche
Roche is a global pioneer in pharmaceuticals and diagnostics focused on advancing science to improve people’s lives. The combined strengths of pharmaceuticals and diagnostics under one roof have made Roche the leader in personalised healthcare – a strategy that aims to fit the right treatment to each patient in the best way possible.
Roche is the world’s largest biotech company, with truly differentiated medicines in oncology, immunology, infectious diseases, ophthalmology and diseases of the central nervous system. Roche is also the world leader in in vitro diagnostics and tissue-based cancer diagnostics, and a frontrunner in diabetes management.
Founded in 1896, Roche continues to search for better ways to prevent, diagnose and treat diseases and make a sustainable contribution to society. The company also aims to improve patient access to medical innovations by working with all relevant stakeholders. More than thirty medicines developed by Roche are included in the World Health Organization Model Lists of Essential Medicines, among them life-saving antibiotics, antimalarials and cancer medicines. Moreover, for the eleventh consecutive year, Roche has been recognised as one of the most sustainable companies in the Pharmaceuticals Industry by the Dow Jones Sustainability Indices (DJSI).
The Roche Group, headquartered in Basel, Switzerland, is active in over 100 countries and in 2019 employed about 98,000 people worldwide. In 2019, Roche invested CHF 11.7 billion in R&D and posted sales of CHF 61.5 billion. Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan. For more information, please visit www.roche.com.
Reference: https://www.roche.com/media/releases/med-cor-2020-09-01.htm
Abbott's FreeStyle® Libre 2 iCGM system now available to medicare beneficiaries
1 September 2020 - U.S. Centers for Medicare & Medicaid Services (CMS) reimbursement expands access of the FreeStyle Libre 2 system to Medicare patients to better manage their diabetes. The FreeStyle Libre 2 technology is the only integrated continuous glucose monitoring (iCGM) system available that continuously measures glucose data every minute without the need for painful fingersticks. Widely available in the U.S., the FreeStyle Libre 2 system is priced 70% lower than other available continuous glucose monitoring devices.
ABBOTT PARK, Ill., Sept. 1, 2020 -- Abbott, the worldwide leader in continuous glucose monitoring (CGM), announced today its next-generation FreeStyle® Libre 2 integrated continuous glucose monitoring (iCGM) system is now available to Medicare patients. Having met the codes for therapeutic CGM systems used for coverage by the U.S. Centers for Medicare & Medicaid Services (CMS), the FreeStyle Libre 2 system is now accessible to all Medicare patients with diabetes who meet the eligibility criteria.
"Abbott designed the FreeStyle Libre portfolio for performance, access and affordability to make it broadly available to people with diabetes who need it," said Jared Watkin, senior vice president, Diabetes Care, Abbott. "By securing reimbursement, Abbott is making sure our latest life-changing technology can get to everyone who needs it, whether they're children, adults or seniors eligible for Medicare."
The FreeStyle Libre 2 system includes a sensor that is the easiest to apply and is worn on the back of the upper arm for up to 14 days, measuring glucose every minute. With a one-second scan using a handheld reader over the sensor, the system provides users with a real-time glucose reading, trend arrow and eight-hour history to help them and their healthcare providers make more informed treatment decisions.
The FreeStyle Libre 2 system includes optional real-time alarms and measures glucose levels every minute, meeting the highest level of accuracy standards over 14 days, including superior day one6 accuracy compared to the other iCGM and excellent accuracy and alarm performance at low end glucose levels. With a 14-day wear time, the FreeStyle Libre 2 system is the longest-lasting, self-applied iCGM sensor currently available, eliminating the need for fingersticks – and priced at a third of the cost of other CGM systems.
The pandemic is changing the way healthcare is delivered with greater acceptance of telehealth and medical technologies with remote monitoring capabilities such as CGMs. For instance, during the public health emergency, CMS is giving healthcare professionals more flexibility to prescribe CGMs to those who qualify. Additionally, the U.S. Food and Drug Administration (FDA) is allowing the FreeStyle Libre system to be used in hospital settings during the pandemic, making Abbott's diabetes technology more easily accessible.
As the #1 sensor-based glucose monitoring system used in the U.S. and worldwide, Abbott's FreeStyle Libre portfolio has changed the lives of more than 2 million people across more than 50 countries by providing breakthrough technology that is accessible and affordable. Abbott has secured partial or full reimbursement for the FreeStyle Libre portfolio in 37 countries, including Canada, France, Germany, Japan, the United Kingdom and the U.S. For more information, visit www.freestylelibre.us.
Indications and Important Safety Information
The FreeStyle Libre 2 Flash Glucose Monitoring System is a continuous glucose monitoring (CGM) device with real time alarms capability indicated for the management of diabetes in persons age 4 and older.
WARNINGS/LIMITATIONS:
The System must not be used with automated insulin dosing (AID) systems, including closed loop and insulin suspend systems. Remove the sensor before MRI, CT scan, X-ray, or diathermy treatment. Do not take high doses of vitamin C (more than 500 mg per day), as this may falsely raise your Sensor readings. Failure to use the System according to the instructions for use may result in missing a severe low blood glucose or high blood glucose event and/or making a treatment decision that may result in injury. If glucose alarms and readings from the System do not match symptoms or expectations, use a fingerstick blood glucose value to make diabetes treatment decisions. Seek medical attention when appropriate and contact Abbott Toll Free (855-632-8658) or visit www.freestylelibre.us for detailed indications for use and safety information.
About Abbott
Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 107,000 colleagues serve people in more than 160 countries.
Noninvasive detection of Helicobacter pylori – reliable and safe for the patient
31 August 2020 - Helicobacter pylori can cause serious diseases. The symptoms of a Helicobacter infection vary widely in their form and expression. Detection is therefore critical for diagnosis and treatment. Identifying an infection is easy and safe using the noninvasive Helicobacter assays from R-Biopharm.
31 August 2020 -- Helicobacter pylori is a widespread bacterium that causes gastritis, dyspepsia, and gastric ulcers, among other things. In many cases, the latter can develop into stomach cancer. Prevalence rises with increasing age and varies depending on region and genetic predisposition. It is believed that nearly half of the world’s adult population is infected with the bacterium.
Immunoassays like the RIDA®QUICK Helicobacter immunochromatographic rapid test and the RIDASCREEN® Helicobacter enzyme immunoassay can detect a Helicobacter pylori infection extremely quickly via analysis of human stool samples. Both tests can be used for patients of any age and without any additional preparation. The tests can also be used after eradication therapy to verify the success of treatment.
A small stool sample from the patient is all that is needed to detect Helicobacter pylori. This noninvasive sample collection is patient-friendly, inexpensive, and less prone to failure than invasive and semi-invasive methods and has comparable sensitivity and specificity. It is suitable especially for patients in whom a biopsy is not indicated or whose compliance is not guaranteed (children).
In a study, the French National Reference Center for Campylobacters and Helicobacters (CNRCH) tested the clinical performance of RIDA®QUICK Helicobacter and RIDASCREEN® Helicobacter using 132 prepared samples from patients who had been previously tested for Helicobacter pylori using invasive methods (PCR and biopsy culture).
All 94 negative patients in both reference procedures correctly tested negative in the two stool antigen tests (RIDA®QUICK und RIDASCREEN®). Of the 38 PCR-positive samples, both antigen tests correctly identified 3 samples as positive that tested negative in the culture versus positive in the PCR.
The sensitivity of both test methods is highly comparable to the detection of Helicobacter pylori using a PCR or biopsy culture.
The results from RIDA®QUICK Helicobacter were quick and easy to analyze and the chromatography of the stool samples proceeded smoothly in all the tests conducted. Thus, RIDA®QUICK Helicobacter and RIDASCREEN® Helicobacter demonstrate very good test performance and high diagnostic certainty compared to the invasive applications.
Reference: https://clinical.r-biopharm.com/news/noninvasive-detection-of-helicobacter-pylori/
Roche announces FDA approval of FoundationOne Liquid CDx, a comprehensive pan-tumour liquid biopsy test
28 August 2020 - FoundationOne Liquid CDx analyses more than 300 cancer-related genes and multiple genomic signatures to help inform treatment decisions for all solid tumour cancers. Using a simple blood draw, the test allows more patients with advanced cancer to benefit from the insights of comprehensive genomic profiling, for example when a tissue biopsy is not possible or recommended. FoundationOne Liquid CDx adds to Foundation Medicine’s genomic testing portfolio supporting Roche’s mission to deliver truly personalised healthcare. Roche is committed to improve patient outcomes by providing multiple testing options that support decision-making during all lines of therapy. FoundationOne Liquid CDx is available to order, as of 28 August 2020, replacing Foundation Medicine’s currently available liquid biopsy test FoundationOne Liquid.
Basel, 28 August 2020 -- Roche today announced that the U.S. Food and Drug Administration (FDA) has approved FoundationOne®Liquid CDx, Foundation Medicine’s comprehensive pan-tumour liquid biopsy test for patients with solid tumours. FoundationOne Liquid CDx is a comprehensive genomic profiling (CGP) test that analyses more than 300 cancer-related genes and multiple genomic signatures to optimise patient care. Cancer is a disease of the genome, driven by genetic mutations within a tumour’s DNA. CGP is used to identify these unique mutations to determine how a tumour behaves and grows, and these insights can help physicians to determine a personalised treatment plan for each individual patient based on the specific mutations identified.
As well as approving FoundationOne Liquid CDx as a CGP test for patients with any solid tumour, the FDA approved the test for use as a companion diagnostic to identify patients who may benefit from treatment with certain prostate and lung cancer therapies, including Rubraca® (rucaparib), a poly (ADP-ribose) polymerase (PARP) inhibitor for treatment in patients with BRCA 1/2-mutant metastatic castration-resistant prostate cancer, and three first-line tyrosine kinase (TKI) inhibitors for the treatment of patients with non-small cell lung cancer. By incorporating multiple genes, including several companion diagnostic biomarkers, the test can help save time versus sequential biomarker testing.
“Many cancer patients are unable to have a tissue biopsy. FoundationOne Liquid CDx may provide a minimally-invasive option for patients who otherwise might not have benefitted from comprehensive genomic profiling,” said Levi Garraway, M.D., Ph.D., Roche’s Executive Vice President, Chief Medical Officer, Head of Global Product Development and Co-Founder of Foundation Medicine Inc. “The convenience of testing a blood sample may also enable more rapid treatment decisions, so that patients can feel reassured they are not losing time to fight their disease.”
FoundationOne Liquid CDx analyses circulating cell-free DNA from a patient’s blood sample and uses massively parallel sequencing to detect the four main classes of genomic alterations. The test is FDA-approved to report short variants in 311 genes including rearrangements and copy number losses in BRCA1 and BRCA2 genes. The results are delivered in an integrated report that identifies alterations matched to FDA-approved therapies. The report also delivers information about genomic signatures, including microsatellite instability and blood tumour mutational burden, as well as single gene alterations, including all NTRK fusions, to help inform the use of other therapies including immunotherapies, and provides relevant clinical trial information.
“With the acceleration towards precision therapy approaches, it is important that physicians have the highest quality tools that can provide an accurate picture of their patients’ cancers in a timely manner,” said Fortunato Ciardiello, M.D., Ph.D, Professor of Medical Oncology, Director of the Division of Medical Oncology at the Università della Campania Luigi Vanvitelli, Italy. “With the approval of FoundationOne Liquid CDx physicians have the choice of two high-quality, FDA-approved comprehensive genomic profiling tests, enabling them to select the most optimal option for their patients.”
The FDA approval of FoundationOne Liquid CDx was based on analytical and clinical validation studies including more than 7,500 samples and 30,000 unique variants across more than 30 cancer types. Evaluation of the platform using multiple validation methods across a broad range of tumour types demonstrated high sensitivity and specificity, even at the low allele frequencies often observed in clinical blood samples.
FoundationOne Liquid CDx is the latest addition to Foundation Medicine’s portfolio of high-quality CGP tests and the second of the company’s CGP tests to receive FDA approval. FoundationOne®CDx, Foundation Medicine’s tissue-based genomic test for patients with solid tumours received FDA approval in 2017. Together, these high-quality genomic profiling tests offer physicians important options for detecting specific genomic alterations that help guide efficient, personalised treatment decisions, while reducing the time and sample needed when testing for multiple biomarkers one at a time. FoundationOne Liquid CDx can also provide complementary insights to tissue-based testing regarding tumour heterogeneity (the differences between cancer cells), and clonal evolution (how tumours evolve over time).
About FoundationOne®Liquid CDx
FoundationOne Liquid CDx is a qualitative next-generation sequencing based in vitro diagnostic test for prescription use only that uses targeted high throughput hybridisation-based capture technology to analyse 324 genes utilising circulating cell-free DNA (cfDNA) isolated from plasma derived from anti-coagulated peripheral whole blood of advanced cancer patients. The test is FDA-approved to report short variants in 311 genes, including rearrangements and copy number losses in BRCA1 and BRCA2, and is a companion diagnostic to identify patients who may benefit from treatment with specific targeted therapies (listed in Table 1 of the Intended Use) in accordance with the approved therapeutic product labeling. Additional genomic findings may be reported and are not prescriptive or conclusive for labeled use of any specific therapeutic product. Use of the test does not guarantee a patient will be matched to a treatment. A negative result does not rule out the presence of an alteration. Patients who are negative for companion diagnostic mutations should be reflexed to tumour tissue testing and mutation status confirmed using an FDA-approved tumour tissue test, if available. For the complete label, including companion diagnostic indications and complete risk information, please visit www.F1LCDxLabel.com.
About Roche
Roche is a global pioneer in pharmaceuticals and diagnostics focused on advancing science to improve people’s lives. The combined strengths of pharmaceuticals and diagnostics under one roof have made Roche the leader in personalised healthcare – a strategy that aims to fit the right treatment to each patient in the best way possible.
Roche is the world’s largest biotech company, with truly differentiated medicines in oncology, immunology, infectious diseases, ophthalmology and diseases of the central nervous system. Roche is also the world leader in in vitro diagnostics and tissue-based cancer diagnostics, and a frontrunner in diabetes management.
Founded in 1896, Roche continues to search for better ways to prevent, diagnose and treat diseases and make a sustainable contribution to society. The company also aims to improve patient access to medical innovations by working with all relevant stakeholders. More than thirty medicines developed by Roche are included in the World Health Organization Model Lists of Essential Medicines, among them life-saving antibiotics, antimalarials and cancer medicines. Moreover, for the eleventh consecutive year, Roche has been recognised as one of the most sustainable companies in the Pharmaceuticals Industry by the Dow Jones Sustainability Indices (DJSI).
The Roche Group, headquartered in Basel, Switzerland, is active in over 100 countries and in 2019 employed about 98,000 people worldwide. In 2019, Roche invested CHF 11.7 billion in R&D and posted sales of CHF 61.5 billion. Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan. For more information, please visit www.roche.com.
Reference: https://www.roche.com/media/releases/med-cor-2020-08-28.htm
Thermo Fisher Scientific Officially Opens New Site for Manufacturing COVID-19 Sample Collection Products
28 August 2020 - New facility in Lenexa, Kansas built in six weeks to rapidly expand production of viral transport media
LENEXA, Kan., Aug. 28, 2020 -- Thermo Fisher Scientific Inc., the world leader in serving science, officially cut the ribbon on its new $40 million facility in Lenexa, Kansas dedicated to viral transport media (VTM) production. The company is also announcing that the site will continue to expand to meet expected sustained demand for COVID-19 testing. The facility has created more than 300 new full-time jobs and added 120,000 square feet of manufacturing capacity.
In early May, Thermo Fisher received a contract from the U.S. government to provide a significant quantity of highly specialized VTM for COVID-19 sample collection. VTM is dispensed into plastic tubes that are used to safely collect and transport clinical specimens containing viruses. This ensures that the sample collected from a COVID-19 nose swab maintains viability while it is shipped to a lab for testing. Thermo Fisher has responded quickly to meet increased demand for VTM by ramping up production in Lenexa from 50,000 units per week to now more than 8 million per week since the new facility began production in early July.
"Thermo Fisher is proud to support virtually every aspect of the global COVID-19 response and our colleagues in Lenexa have played a key role in those efforts," said Gianluca Pettiti, senior vice president and president of the company's Specialty Diagnostics business. "Thanks to their hard work, Lenexa significantly increased production of VTM units. The team has worked with unrelenting intensity to build out and open a new site in just about six weeks. They understood the urgent national need, accepted the challenge and have delivered for the American people."
Company executives and government leaders, including Governor Laura Kelly, U.S. Senator Jerry Moran and Lenexa City Mayor Michael Boehm, will attend the ribbon cutting and ground-breaking ceremony on August 28. The site will allow for social distancing for the 200 guests expected in attendance.
"Widespread testing is a necessary component to keep the American economy running safely," said U.S. Senator Jerry Moran. "Thermo Fisher has stepped up to produce additional test tubes to help meet the national demand for COVID-19 testing and has created 300 new jobs by expanding its manufacturing base in Lenexa. Kansans never fail to do their part in our country's time of need, and this is no different. Thermo Fisher's ability to manufacture test tubes and significantly increase production is important for making certain Americans can feel secure in their health and safely return to work."
"I'm grateful to the team at Thermo Fisher for the many ways they've stepped up for the health and safety of people in Kansas and across the country," Governor Laura Kelly said. "This facility will do important work innovating and supporting the tools we have to fight this pandemic. I applaud Thermo Fisher's commitment to this critical endeavor."
To ensure accuracy of COVID-19 test results, VTM must be manufactured and dispensed into tubes in an aseptic environment. The new facility is dedicated to accelerating production and ensuring quality control by utilizing the proven blueprint for high-quality VTM production that has been developed in Lenexa. In addition to supporting America's pandemic response, the products will be used for collection and sampling for flu and other viruses.
About Thermo Fisher Scientific
Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $25 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, improving patient diagnostics and therapies or increasing productivity in their laboratories, we are here to support them. Our global team of more than 75,000 colleagues delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services and Patheon. For more information, please visit www.thermofisher.com.
Abbott's fast, $5, 15-minute, easy-to-use COVID-19 Antigen test receives FDA Emergency Use Authorization; mobile app displays test results to help our return to daily life; ramping producton to 50 mil
26 August 2020 - Abbott's BinaxNOW™ COVID-19 Ag Card is a rapid, reliable, highly portable, and affordable tool for detecting active coronavirus infections at massive scale. Test delivers results in just 15 minutes with no instrumentation, using proven lateral flow technology with demonstrated sensitivity of 97.1% and specificity of 98.5% in clinical study. Abbott to offer a no-charge complementary phone app, which allows people to display their BinaxNOW test results when asked by organizations where people gather, such as workplaces and schools. Company will ship tens of millions of tests in September, ramping to 50 million tests a month at the beginning of October.
ABBOTT PARK, Ill., Aug. 26, 2020 -- Abbott announced today that the U.S. Food and Drug Administration (FDA) has issued Emergency Use Authorization (EUA) for its BinaxNOW™ COVID-19 Ag Card rapid test for detection of COVID-19 infection. Abbott will sell this test for $5. It is highly portable (about the size of a credit card), affordable and provides results in 15 minutes. BinaxNOW uses proven Abbott lateral flow technology, making it a reliable and familiar format for frequent mass testing through their healthcare provider. With no equipment required, the device will be an important tool to manage risk by quickly identifying infectious people so they don't spread the disease to others.
Abbott will also launch a complementary mobile app for iPhone and Android devices named NAVICA™. This first-of-its-kind app, available at no charge, will allow people who test negative to display a temporary digital health pass that is renewed each time a person is tested through their healthcare provider together with the date of the test result. Organizations will be able to view and verify the information on a mobile device to facilitate entry into facilities along with hand-washing, social distancing, enhanced cleaning and mask-wearing.
"We intentionally designed the BinaxNOW test and NAVICA app so we could offer a comprehensive testing solution to help Americans feel more confident about their health and lives," said Robert B. Ford, president and chief executive officer, Abbott. "BinaxNOW and the NAVICA app give us an affordable, easy-to-use, scalable test, and a complementary digital health tool to help us have a bit more normalcy in our daily lives."
In data submitted to the FDA from a clinical study conducted by Abbott with several leading U.S. research universities, the BinaxNOW COVID-19 Ag Card demonstrated sensitivity of 97.1% (positive percent agreement) and specificity of 98.5% (negative percent agreement) in patients suspected of COVID-19 by their healthcare provider within the first seven days of symptom onset.
"The massive scale of this test and app will allow tens of millions of people to have access to rapid and reliable testing," said Joseph Petrosino, Ph.D., professor and chairman, Molecular Virology and Microbiology, Baylor College of Medicine, whose labs have been leading efforts to provide COVID-19 testing for the college and Harris County. "With lab-based tests, you get excellent sensitivity but might have to wait days or longer to get the results. With a rapid antigen test, you get a result right away, getting infectious people off the streets and into quarantine so they don't spread the virus."
Under FDA EUA, the BinaxNOW COVID-19 Ag Card is for use by healthcare professionals and can be used in point-of-care settings that are qualified to have the test performed and are operating under a CLIA (Clinical Laboratory Improvement Amendments) Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation. Within these settings, the test can be performed by doctors, nurses, school nurses, medical assistants and technicians, pharmacists, employer occupational health specialists, and more with minimal training and a patient prescription.
"Our nation's frontline healthcare workers and clinical laboratory personnel have been under siege since the onset of this pandemic," said Charles Chiu, M.D., Ph.D., professor of Laboratory Medicine at University of California, San Francisco. "The availability of rapid testing for COVID-19 will help support overburdened laboratories, accelerate turnaround times and greatly expand access to people who need it."
Currently, AdvaMed (The Advanced Medical Technology Association) estimates that test manufacturers are shipping about 1 million tests per day. Abbott will ship tens of millions of tests in September, ramping to 50 million tests a month at the beginning of October. The company has invested hundreds of millions of dollars since April in two new U.S. facilities to manufacture BinaxNOW at massive scale.
The BinaxNOW COVID-19 Ag Card can be used as a first line of defense to identify people who are currently infected and who should isolate themselves to help prevent the spread of the disease. It is intended for the qualitative detection of nucleocapsid protein antigen from SARS-CoV-2 in nasal swabs from individuals suspected of COVID-19 by their healthcare provider within the first seven days of symptom onset.
As a near-person rapid antigen test, BinaxNOW was engineered for point-of-care settings, near-patient, and not for reference labs. Patient samples should be tested immediately and should not be diluted in viral transport media.
NAVICA mobile app will help facilitate return to daily activities
Abbott is also offering a mobile app at no charge that will allow people to display their results obtained through a healthcare provider when entering facilities requiring proof of testing. The NAVICA app is optional and an easy-to-use tool that allows people to store, access and display their results with organizations that accept the results so people can move about with greater confidence. The app is supported by Apple and Android digital wallets and will be available from public app stores in the U.S.
"While BinaxNOW is the hardware that makes knowing your COVID-19 status possible, the NAVICA app is the digital network that allows people to share that information with those who need to know," said Ford. "We're taking our know-how from our digitally-connected medical devices and applying it to our diagnostics at a time when people expect their health information to be digital and readily accessible."
If test results are negative, the app will display a digital health pass via a QR code, similar to an airline boarding pass. If test results are positive, people receive a message to quarantine and talk to their doctor. As they're required to do for all COVID-19 tests, healthcare providers in all settings will be required to report positive results to the CDC and other public health authorities, regardless of whether they use the app. The digital health pass is stored in the app temporarily and expires after the time period specified by organizations that accept the app.
The app's user interface is supported by a back-end digital infrastructure that is cloud-based, scalable and secure. It's been designed to support a very large number of users and enable access from anywhere. The app is not for contact tracing and only collects a person's first and last name, email address, phone number, zip code, date of birth and test results.
About the BinaxNOW COVID-19 Ag Card Test
The BinaxNOW COVID-19 Ag Card is an assay for the qualitative detection of specific antigens to COVID-19 in the human nasal cavity. A simple nasal swab is used to collect specimens from people suspected of having an active infection. No equipment is required to process samples or read test results. In addition, minimal chemical reagents are required, which lessens exposure to biohazardous materials and improves safety for those administering the test.
The BinaxNOW COVID-19 Ag Card is the sixth test that Abbott is launching in the U.S. to help fight the coronavirus pandemic. Abbott's tests are performed on its high-volume m2000™ and Alinity® m molecular laboratory systems; its ID NOW™ rapid molecular point-of-care platform; antibody tests for its high-throughput ARCHITECT® i1000SR and i2000SR and Alinity™ i laboratory instruments.
Abbott has provided more than 27 million COVID-19 tests in the U.S. to date, including 14 million detection tests and 13 million antibody tests.
About Abbott
Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 107,000 colleagues serve people in more than 160 countries.
Q BioMed Announces Initiation of GMP Production of Novel COVID-19 Therapeutic for Clinical Trial Program
26 August 2020 - COVID-19 clinical trial planned for Q1 2021 supported by Canadian Government. Proof of concept would validate platform for multiple indications and therapeutic alternatives in infectious diseases and others.
NEW YORK, August 26, 2020 -- Q BioMed Inc., a commercial stage biotech company, announced today that with its technology partner, Mannin Research, a GMP production contract has been initiated for MAN-19, a clinical grade therapeutic intended to treat complications caused by COVID-19. The Phase 1 clinical trial is slated to begin patient enrollment in February 2021.
The accelerated development of this novel virus-agnostic and host-directed therapeutic is being supported in part by funding from the Canadian and German governments under various R&D incentive and COVID-19 response initiatives.
More than 800,000 deaths have occurred worldwide as a result of COVID-19 as of August 25th 2020, and the number continues to climb rapidly. Clinicians have reported a range of physiological abnormalities in severely ill COVID-19 patients, including respiratory distress and vascular complications. Research also suggests that death rates are alarmingly high for patients requiring ventilator support, demonstrating the need for therapeutic interventions that can prevent the escalation of disease severity.
Human observational and genetic studies, as well as animal models of endothelial dysfunction collectively suggest that by targeting Tie2 receptor, MAN-19 may be effective in the treatment of a number of complications associated with viral infections such as COVID-19 and the seasonal flu.Therapeutics based on the Mannin platform have the potential to offer clinicians an intervention to rapidly stabilize the patient's vascular endothelium in hospital settings, such as the Intensive Care Unit (ICU), to prevent vascular leakage, pulmonary pathology, and acute respiratory distress syndrome (ARDS). Such an intervention could improve outcomes in the current COVID-19 pandemic around the world.
Q BioMed CEO Denis Corin stated, “This program is advancing very rapidly. We are very pleased with the input and support from government institutions and other industry stakeholders. There has been much talk of vaccines, but treatments are always going to be needed for people affected by these types of diseases, whether it's SARS-Cov-2 or another pathogen resulting in similar symptoms and complications. The Mannin Tie2 platform is designed to address life threatening complications from a number of infectious diseases, including future potential viral threats. With the support of regulators we expect this treatment to be in the clinic very early next year.”
About Mannin
Mannin is developing therapeutics with mechanism of action involving the Angiopoietin-Tie2 signaling pathway, which is a major regulator of vascular development, vessel remodelling, post-natal angiogenesis, and vessel permeability. Therefore, targeting this pathway has very broad therapeutic applications.
Mannin’s core R&D program is based on the Angiopoeitin-Tie2 Mechanism of Action. Mannin's small molecules and its biologic therapeutic target the endothelium of the patient, stabilizing endothelial barrier integrity by activating Tie2, which in turn reduces lung endothelial vascular leakage, inflammation and cell death that occurs during severe viral infection. This is a novel and promising therapeutic strategy as its mechanism of action is independent of viral replication, but instead focuses on endothelium of the host as the critical target for treatment intervention.
About Q BioMed Inc.
Q BioMed Inc. is a biotech acceleration and commercial stage company focused on licensing and acquiring undervalued biomedical assets in the healthcare sector. Q BioMed is dedicated to providing these target assets the strategic resources, developmental support, and expansion capital needed to ensure they meet their developmental potential, enabling them to provide products to patients in need.
Please visit http://www.QBioMed.com and sign up for regular updates.
Vela Diagnostics’ Automated COVID-19 Detection Test Approved for Use in Australia
26 August 2020
Singapore, August 26 2020– Vela Diagnostics announced today that the ViroKey™ SARS-CoV-2 RT-PCR Test v2.0 has been approved by the Australian Therapeutic Goods Administration (TGA) for in vitro diagnostic use.
The ViroKey™ SARS-CoV-2 RT-PCR Test v2.0 is a reverse transcription-polymerase chain reaction (RT-PCR) test that detects SARS-CoV-2 by targeting conserved regions on the SARS-CoV-2 genome, specifically the ORF1a and N genes. The automated test is optimized for a workflow consisting of the Sentosa™ SX101 instrument and works in conjunction with the Sentosa™ SA201 instrument or the ABI 7500 Fast Dx. The workflow tests up to 46 samples in a single run, with minimal hands-on time required.
“This timely approval from the TGA for our automated test will allow Vela Diagnostics to facilitate efficient testing for suspected COVID-19 patients in Australia,” said Sam Dajani, acting CEO and Chairman of the Board.
To date, the ViroKey™ SARS-CoV-2 RT-PCR Test v2.0 has received the CE mark for Europe and the provisional authorization from the Singapore Health Sciences Authority.
About Vela Diagnostics
Vela Diagnostics is a leading provider for integrated IVD system solutions, from sample to result. VELA’s test solutions utilize the automated Sentosa™ platform, providing the unique ability to leverage one system for NGS and PCR testing in infectious disease and oncology.
Workforce Drug Testing Positivity Climbed to Highest Rate in 16 Years, New Quest Diagnostics Drug Testing Index™ Analysis Finds
25 August 2020 - Marijuana positivity climbed by double digits across nearly all employee testing categories, while opiate and heroin positivity decline. Analysis of more than nine million workplace drug test results showed cocaine and methamphetamine positivity surges in Midwest.
SECAUCUS, N.J., Aug. 25, 2020 -- The rate of workforce drug positivity hit a sixteen-year high in 2019, according to a new analysis released today by Quest Diagnostics, the world's leading provider of diagnostic information services. Positivity rates in the combined U.S. workforce increased in urine drug tests, climbing to the highest level since 2003 (4.5%) and more than 28% percent higher than the thirty-year low of 3.5 percent recorded between 2010 and 2012.
In addition to overall increases in workforce drug positives, specific regions of the United States, particularly the Midwest, experienced dramatic increases in positivity for cocaine and methamphetamine as well as marijuana.
The new findings of the Quest Diagnostics Drug Testing Index™, which include an analysis of industry-specific data, were unveiled in advance of the Substance Abuse Program Administrators Association (SAPAA) virtual conference taking place on August 25, 2020.
For an interactive map with positivity rates and trend lines by three-digit zip code in the United States, visit DTIDrugMap.com.
The Quest Diagnostics findings generally align with other research. Drug deaths in the United States rose 5 percent in 2019, driven largely by methamphetamine, cocaine and fentanyl, following a decline in 2018. During the first few months of 2020, drug deaths increased about 13 percent compared with last year, attributable partly to social isolation and other disruptions caused by COVID-19.
"There is no question that before COVID-19, rates of workplace drug positivity were trending in the wrong direction, based on our Quest Diagnostics data, The enormous strain caused by COVID-19 may prove to be an accelerant on this disturbing trend," said Dr. Barry Sample, senior director of science and technology, Quest Diagnostics. "Organizations will need to consider the impact of COVID-19 not only on workplace safety but also as a health concern for their employees for some time to come."
Positivity rates for methamphetamine surged in the Midwest
Over the last five years, methamphetamine positivity in the general U.S. workforce testing increased nearly 12 percent (0.17% in 2015 versus 0.19% in 2019). The Midwest region experienced year-over-year increases, driven primarily by double-digit increases in the East North Central region during this period. Over the past five years, methamphetamine positivity in the Midwest increased nearly 78 percent (0.09% in 2015 versus 0.16% in 2019). Illinois (0.03% in 2015 versus 0.10% in 2019), Indiana (0.14% in 2015 versus 0.29% in 2019), Michigan (0.014% in 2015 versus 0.05 in 2019), and Ohio (0.04% in 2015 versus 0.11% in 2019) increased at least two-fold; while Wisconsin (0.05% in 2015 versus 0.09% in 2019) nearly doubled.
"While the national debate on drug misuse in the workforce has focused primarily on marijuana, increasing positivity rates for cocaine and methamphetamine are also cause for concern," said Dr. Sample. "Positivity by drug and region can be random and unpredictable. Our data is a reminder that it is important to remain vigilant about all drug misuse in the workforce.
Between 2019 and 2018. methamphetamine positivity inched up nearly 6 percent (0.18% in 2018 versus 0.19% in 2019) in general U.S. workforce tests and fell 6.3 percent (0.15% in 2018 versus 0.16% in 2019) in federally mandated, safety-sensitive testing. Methamphetamine positivity changed little in the general U.S. workforce (up 12 percent) and was flat in federally mandated, safety sensitive testing over five years.
The increased positivity rates for methamphetamine in urine test results were bolstered by similar patterns in other specimen types. Oral fluid methamphetamine positivity, which also assesses recent use, was up 4.3 percent since 2018 and up 69 percent since 2015; while methamphetamine positivity from hair tests, which gauges a pattern of drug use over time, was up 20 percent since 2018 and 60 percent since 2015.
"Testing with multiple specimen types can reveal a fuller understanding of patterns of misuse than one alone," said Dr. Sample. "Our data suggests that testing for methamphetamine with hair and oral fluid may be appropriate for employers with concerns about misuse of this particular drug to complement the standard urine drug screen."
Cocaine positivity increased in the Midwest and West
Cocaine positivity in the general U.S. workforce testing increased in the Midwest and West regions over the past five years. Cocaine positivity in the Midwest increased by 40 percent (0.20% in 2015 versus 0.28% in 2019) and in the West by 53 percent (0.15% in 2015 versus 0.23% in 2019). The Midwest was 20 percent less than the national rate in 2015 but 3.7 percent above the national rate in 2019, suggesting a surge in positivity in the region last year.
In the West, where cocaine positivity has been historically far lower, the cocaine positivity rate rose from 40 percent below the national rate in 2015 to 14.8 percent below in 2019. These increases in the West were primarily driven by increasing positivity in Colorado (0.19% in 2015 versus 0.30% in 2019), Nevada (0.13% in 2015 versus 0.22% in 2019), and Oregon (0.09% in 2015 versus 0.13% in 2019).
Opiate positivity declines throughout United States
In the general U.S. workforce, positivity for opiates in urine drug testing continues to decline across all opiate categories. Urine drug test positivity for opiates (primarily codeine and/or morphine) in the general U.S. workforce declined more than 19 percent (0.31% in 2018 versus 0.25% in 2019) and 49 percent over five years (0.49% in 2015 versus 0.25% in 2019). Among the more specific tests for other prescription opiates, the positivity for the semi-synthetic opiates (hydrocodone and/or hydromorphone) dropped 26 percent over the past year (0.50% in 2018 versus 0.37% in 2019) and more than 45 percent over five years (0.68% in 2015 versus 0.37% in 2019). Similarly, positivity for oxycodones (oxycodone and/or oxymorphone) declined 21 percent (0.43% in 2018 versus 0.34% in 2019) over the past year and nearly 55 percent over five years (0.75% in 2015 versus 0.34% in 2019).
Marijuana most commonly detected drug in U.S. workforce
Marijuana continues to top the list of the most commonly detected illicit substances across all workforce categories (general U.S. workforce; federally mandated, safety-sensitive workforce; and combined U.S. workforce, which includes the prior two populations) and specimen types (urine, oral fluid, and hair).
In the general U.S. workforce, marijuana positivity increased nearly 11 percent in urine testing (2.8% in 2018 versus 3.1% in 2019) and 29 percent since 2015 (2.4%). In the Midwest, marijuana positivity outpaced national increases in positivity in 2018 and 2019. Marijuana positivity increased in the Midwest by nearly 14 percent (2.9% in 2018 versus 3.3% in 2019). The West region also outpaced national positivity and saw double digit increases, as compared to the previous year, in 2017 through 2019. Marijuana positivity increased in the West by 24 percent (3.3% in 2018 versus 4.1% in 2019) and 78 percent since 2015 (2.3%).
"Marijuana continues to be an enduring presence in the U.S. workforce. Changing attitudes toward its use could pose heightened risks especially in safety-sensitive positions and those states exploring legalization," said Dr. Sample.
Positivity rates for heroin continue to decline in general U.S. and federally mandated, safety-sensitive workforce testing
Urine drug test results for the general U.S. workforce for heroin use, indicated by the presence of the 6-acetylmorphine (6-AM) metabolite, declined 33 percent (0.03% in 2018 versus 0.02% in 2019) and 50 percent decline since its peak in 2015 and 2016 (0.04%).
Positivity for 6-AM in the federally mandated, safety-sensitive workforce declined 15 percent between 2018 and 2019 (0.013% versus 0.011%), with a decrease of more than 45 percent since 2015 (0.02%).
Workforce positivity increases significantly in multiple industries
The Quest Diagnostics Drug Testing Index Industry Insights of general U.S. workforce positivity rates, based on more than 18 million urine drug test results (between 2015 and 2019), shows year-over-year increases in overall workplace drug positivity in 15 of the 17 sectors reported. The Retail Trade industry had the highest overall positivity rate (4.7% in 2015, 5.1% in 2016, 5.3% in 2017, 5.4% in 2018 and 5.5% in 2019) across all five years of the analysis. The Other Services (not including Public Administration) category, which includes services not listed in the other categories such as grantmaking, advocacy, and providing personal services, also had a 5.5% positivity rate in 2019. The Accommodations and Food Service category had the highest workforce positivity for marijuana, at 4.8%, a relative increase of 65 percent over five years (2.9% in 2015 versus 4.8% in 2019).
Workforce Drug Testing Webinar
Barry Sample, PhD, senior director of science and technology, for Quest Diagnostics will discuss the latest data and analysis from the Drug Testing Index via a webinar on Thursday, September 10, 2020 at 2:00 PM EDT. Click here to register and attend.
About the Quest Diagnostics Drug Testing Index™
The Quest Diagnostics Drug Testing Index™ (DTI) is a series of reports that provide insights into trends in workforce drug use, based on positivity results for de-identified laboratory testing performed by Quest Diagnostics for a range of illicit, legal and prescription drugs. It examines test results according to three categories of workers: federally mandated, safety-sensitive workers; the general workforce; and the combined U.S. workforce. Federally mandated, safety-sensitive workers include pilots, bus and truck drivers, and workers in nuclear power plants, for whom routine drug testing is mandated by the U.S. Department of Health and Human Services.
The strengths of the DTI analysis include its large, nationally representative sample size, longitudinal monitoring, a testing population that is generally reflective of the U.S. workforce and the quality of the company's drug testing services to confirm positive results. Limitations include analysis only of employers that perform drug testing with the company, and a lack of exact cross-specimen comparisons due to variations in substances for which employers test. Quest Diagnostics has analyzed annual workplace drug testing data since 1988 and publishes the findings as a public service.
In addition to workplace drug testing, Quest is a leader in clinician-ordered drug testing services through its Clinical Drug Monitoring program to aid the detection of potentially dangerous forms of prescription and illicit drug use. For more information on Quest's drug monitoring services for healthcare providers, visit QuestDrugMonitoring.com
About Quest Diagnostics
Quest Diagnostics empowers people to take action to improve health outcomes. Derived from the world's largest database of clinical lab results, our diagnostic insights reveal new avenues to identify and treat disease, inspire healthy behaviors and improve health care management. Quest annually serves one in three adult Americans and half the physicians and hospitals in the United States. Our 47,000 employees understand that, in the right hands and with the right context, our diagnostic insights can inspire actions that transform lives. www.QuestDiagnostics.com.
QIAGEN to launch easy-to-use digital test in the U.S. for rapid detection of SARS-CoV-2 antibodies following FDA emergency use authorization
24 August 2020 - Access Anti-SARS-CoV-2 is an easy-to-use 10-minute test on a portable device that provides highly accurate results on Total Ig antibodies (IgA, IgM, IgG). New test based on QIAGEN partner Ellume’s proprietary technology, addresses current test shortfalls in terms of automation and convenient read-out of results. Digital eHub and eStick system provides rapid qualitative serological in-vitro detection of total antibodies to SARS-CoV-2 in plasma and serum. U.S. launch set to start in late August 2020 after submission for FDA Emergency Use Authorization, European CE-IVD marking and commercialization start planned in coming weeks.
Germantown, Maryland, and Hilden, Germany, August 24, 2020 – QIAGEN N.V. today announced the U.S. launch of the new Access Anti-SARS-CoV-2 Total test, an easy-to-use digital test done on a portable device that provides results in about 10 minutes to detect antibodies in people exposed to the SARS-CoV-2 virus, which is the case of COVID-19.
The launch of this antibody test, which was developed in partnership with the Australian digital diagnostics company Ellume, comes after the submission by QIAGEN of this unique antibody test to the U.S. Food and Drug Administration (FDA) for Emergency Use Authorization (EUA). First shipments are planned for late August 2020. A CE-IVD marking for Europe and other markets is planned in the coming weeks.
The new serological test has been shown to have sensitivity of 100% (CI 88.43–100.00%) and specificity of 100% (CI 95.20–100.00%).
“Increased testing is the only way to gain visibility on the magnitude of the pandemic, which will ultimately lead to helping control it,” said Dr. Davide Manissero, M.D., Chief Medical Officer of QIAGEN. “As a trusted partner in the fight against COVID-19, QIAGEN has now added the Access Anti-SARS-CoV-2 to our portfolio as a smart solution for antibody testing that provides results with confidence. This is a rugged and portable platform that requires no hardware, can process a wide range of tests and provides fast results. We look forward to working with Ellume to discover and develop additional tests for this platform.”
The test is performed on the eHub, a small portable digital device that provides reliable results in 10 minutes. Each eHub can handle up to eight patient samples simultaneously and can perform up to 32 total tests per hour. The nanoparticle fluorescent detection technology uses serum or plasma from patient samples. The same platform is being used for QuantiFERON-TB Access, a new solution in development for diagnosis of latent tuberculosis (TB) infection in low-resource regions with a high TB disease burden.
Currently available rapid lateral flow antibody tests fall short when it comes to the automated and convenient read-out of results. Manual and visual result reporting, and potential pitfalls in read-out timing can lead of uncertain testing results. The Access Anti-SARS-CoV-2 eHub and digital eStick approach mitigates those risks, providing reliable results no matter when the results are read and also providing true walk-away capability to free up laboratory personnel.
Serological testing for antibodies is central to identifying people who have been recently infected by the virus or have been infected in the recent past, especially those who did not show any symptoms and therefore might not know of an infection. Understanding more about COVID-19 immunity in a population could help societies return faster to normal daily routines by helping to inform and guide public health measures, such as contact tracing and individual measures under clinical guidance. Antibody testing could also become fundamental in supporting vaccine development as well as guiding, planning, and assessing future SARS-CoV-2 immunization programs.
Access Anti-SARS-CoV-2 will complement QIAGEN’s array of COVID-19 testing solutions with a cost-effective way to detect immune responses in people who have been exposed to the virus.
QIAGEN employees around the world are fully mobilized to address the urgent demand for testing solutions needed in the global response to the coronavirus pandemic. QIAGEN’s initiatives focus on building the most comprehensive portfolio of solutions for COVID-19 testing. These include production of viral RNA extraction for use on QIAGEN’s QIAcube, QIAsymphony and EZ1 platforms as well as third-party instruments; building up a range of PCR tests on the QIAstat-Dx and NeuMoDx systems that enable COVID-19 detection while analyzing samples at the same time for other respiratory infections; QIAGEN is also providing universal next-generation sequencing (NGS) solutions for research use with any sequencer, in particular gene panels integrated with bioinformatics for analysis of the SARS-CoV-2 virus. QIAGEN is also scaling up production capacity for reagents sold to other companies for use in their own COVID-19 tests.
About QIAGEN
QIAGEN N.V., a Netherlands-based holding company, is the leading global provider of Sample to Insight solutions that enable customers to gain valuable molecular insights from samples containing the building blocks of life. Our sample technologies isolate and process DNA, RNA and proteins from blood, tissue and other materials. Assay technologies make these biomolecules visible and ready for analysis. Bioinformatics software and knowledge bases interpret data to report relevant, actionable insights. Automation solutions tie these together in seamless and cost-effective workflows. QIAGEN provides solutions to more than 500,000 customers around the world in Molecular Diagnostics (human healthcare) and Life Sciences (academia, pharma R&D and industrial applications, primarily forensics). As of June 30, 2020, QIAGEN employed more than 5,200 people in over 35 locations worldwide. Further information can be found at http://www.qiagen.com.
Reference: https://corporate.qiagen.com/newsroom/press-releases/2020/20200824_access_sars_cov_2
Trinity Biotech announces EUA submission for Covid-19 ELISA Antibody test
20 August 2020
DUBLIN, Ireland, August 20, 2020 -- Trinity Biotech plc, a leading developer and manufacturer of diagnostic products for the point-of-care and clinical laboratory markets announced that it has filed its submission for an Emergency Use Authorization (EUA) for its Covid-19 IgG ELISA antibody test with the FDA. This test will determine which individuals within the population have been exposed to the SARS-CoV-2 virus. The transfer of production to our facility in Jamestown, New York is complete, our manufacturing capability is very significant and the instrumentation platforms that perform ELISA testing are available in virtually every testing laboratory in the world.
The product demonstrates specificity in excess of 98% and sensitivity in excess of 95%, in samples of 14 days or more from symptom onset. EUA submission allows us to begin marketing the product immediately.
In addition, the Company is developing a rapid point-of-care Covid-19 test to detect antibodies to the virus that can be run in 12 minutes using one drop of blood procured by finger prick. This test will have utility similar to that outlined above for the ELISA antibody test. Once development and transfer to manufacturing of this rapid test is complete we intend to avail of the FDA’s EUA pathway to expedite its approval for sale in the USA.
This pipeline of Covid-19 products complements our existing Viral Transport Media (VTM) product, which is used in the Covid-19 sample collection process for PCR molecular testing. We have scaled up the manufacture of VTM to meet increased levels of demand over the past months and we expect demand to continue as Covid19 testing remains critical to the management of the pandemic.
Ronan O’Caoimh, Chief Executive Offer commented “We are very pleased to announce the submission of our Covid-19 ELISA antibody test for FDA Emergency Use Authorization (EUA). The test demonstrates both impressive specificity and sensitivity. Meanwhile, the ELISA testing platform with its excellent reputation for quality and widespread adoption makes it an ideal format for large scale antibody testing.”
About Trinity Biotech
Trinity Biotech develops, acquires, manufactures and markets diagnostic systems, including both reagents and instrumentation, for the point-of-care and clinical laboratory segments of the diagnostic market. The products are used to detect infectious diseases and to quantify the level of Haemoglobin A1c and other chemistry parameters in serum, plasma and whole blood. Trinity Biotech sells direct in the United States, Germany, France and the U.K. and through a network of international distributors and strategic partners in over 75 countries worldwide. For further information please see the Company's website: www.trinitybiotech.com.
QIAGEN announces new Chairman of Supervisory Board
21 August 2020 - Lawrence A. Rosen appointed by Supervisory Board as new Chairman with immediate effect. Appointment comes after Dr. Håkan Björklund decided to step down as Chairman of the Supervisory Board and as a Supervisory Board member.
Venlo, The Netherlands, August 21, 2020 – QIAGEN N.V. today announced a transition in the leadership of its Supervisory Board after an extraordinary meeting of the Supervisory Board and Managing Board.
Lawrence A. Rosen, a member of the QIAGEN Supervisory Board since 2013, was appointed by the Supervisory Board as the new Chairman with immediate effect. Mr. Rosen, a U.S. citizen who spent more than 20 years in senior leadership positions in Europe, also serves on the Supervisory Board of Lanxess AG. He was a member of the Board of Management and Chief Financial Officer of Deutsche Post DHL Group in Germany until September 2016. Prior to that, he served as Chief Financial Officer of Fresenius Medical Care AG & Co. KGaA in Germany from 2003 to 2009. Prior to that, he was Senior Vice President and Treasurer for Aventis SA in Strasbourg, France. Between 1984 and 2000, he held various positions at the Aventis predecessor companies Hoechst AG and American Hoechst / Hoechst Celanese Inc.
The appointment comes after Dr. Håkan Björklund decided to step down as Chairman and as a member of the Supervisory Board, and will not stand for re-election at the next Annual General Meeting planned for June 2021. Dr. Björklund was appointed as a new Supervisory Board member in March 2017 and as Chairman in June 2018. The number of Supervisory Directors has been reduced to six.
“As the leadership and composition of the Supervisory Board changes, and also in light of the recent outcome of the proposed acquisition by Thermo Fisher, the Supervisory Board wants to express its full commitment to QIAGEN pursuing a growth strategy focused on execution and greater value creation. We also look forward to working on a long-term basis with the Managing Board members. The contributions of QIAGEN to society have never been more critical due to the unprecedented magnitude of the coronavirus pandemic,” said Mr. Rosen. “On behalf of my colleagues in the Supervisory Board, I would like to thank Dr. Björklund for his contributions to QIAGEN during his time on the Board and wish him all the best in his future endeavors.”
“It has been a pleasure to be part of QIAGEN, a company having a critical role in modern molecular testing,” said Dr. Håkan Björklund. “I wish my colleagues on the Supervisory Board and Managing Board, and above all the more than 5,200 QIAGEN employees who are truly making a difference during this public health crisis, continued success in helping to improve the lives of people around the world.”
About QIAGEN
QIAGEN N.V., a Netherlands-based holding company, is the leading global provider of Sample to Insight solutions that enable customers to gain valuable molecular insights from samples containing the building blocks of life. Our sample technologies isolate and process DNA, RNA and proteins from blood, tissue and other materials. Assay technologies make these biomolecules visible and ready for analysis. Bioinformatics software and knowledge bases interpret data to report relevant, actionable insights. Automation solutions tie these together in seamless and cost-effective workflows. QIAGEN provides solutions to more than 500,000 customers around the world in Molecular Diagnostics (human healthcare) and Life Sciences (academia, pharma R&D and industrial applications, primarily forensics). As of June 30, 2020, QIAGEN employed more than 5,200 people in over 35 locations worldwide.
Reference: https://corporate.qiagen.com/newsroom/press-releases/2020/20200821_sb_chairman
Quidel to update packaging of point-of-care Sofia® SARS Antigen test for COVID-19 to include either nasal or nasopharyngeal swabs
19 August 2020
SAN DIEGO, 19 August 2020 -- Quidel Corporation (“Quidel”), a provider of rapid diagnostic testing solutions, cellular-based virology assays and molecular diagnostic systems, announced today that labeling for Quidel’s Emergency Use Authorization (EUA) for the Sofia® SARS Antigen FIA has been amended to include either nasal or nasopharyngeal swabs.
The new kit labeling, with the addition of a nasopharyngeal swab, allows Quidel to offer a second kit configuration to support the nasopharyngeal sample commonly performed in hospitals and helps alleviate some of the supply chain constraints around nasal swab-based kits. Quidel’s Sofia® SARS Antigen FIA has always been authorized for use with either nasal or nasopharyngeal swabs specimens. Due to customer preference, the Sofia SARS Antigen kit has been sold only with a nasal swab. A new kit configuration including nasopharyngeal swabs allows Quidel to increase its weekly delivery of the Sofia Antigen test.
“In our quest to do the most good during the novel coronavirus pandemic, offering our hospital customers another kit configuration with an NP collection device option allows us to work through some of the near-term nasal swab shortages we face to be able to ship more Sofia® SARS Antigen FIA kits and thereby enable more patients to be tested,” said Douglas Bryant, president and CEO of Quidel Corporation. “We strongly believe that frequent testing using an accurate point-of-care antigen test allows for more successful implementation of contact tracing and self-isolation programs, which are key to help reduce the spread of COVID-19.”
Quidel currently sells the Sofia® SARS Antigen FIA in the United States under Emergency Use Authorization (EUA) by the FDA.
About Quidel Corporation
Quidel Corporation serves to enhance the health and well-being of people around the globe through the development of diagnostic solutions that can lead to improved patient outcomes and provide economic benefits to the healthcare system. Marketed under the Sofia®, QuickVue®, D3® Direct Detection, Thyretain®, Triage® and InflammaDry® leading brand names, as well as under the new Solana®, AmpliVue®and Lyra® molecular diagnostic brands, Quidel’s products aid in the detection and diagnosis of many critical diseases and conditions, including, among others, COVID-19, influenza, respiratory syncytial virus, Strep A, lyme, herpes, pregnancy, thyroid disease and fecal occult blood. Quidel's Triage® system of tests comprises a comprehensive test menu that provides rapid, cost-effective treatment decisions at the point-of-care (POC), offering a diverse immunoassay menu in a variety of tests to provide diagnostic answers for quantitative BNP, CK-MB, d-dimer, myoglobin, troponin I and qualitative TOX Drug Screen. Quidel’s research and development engine is also developing a continuum of diagnostic solutions from advanced immunoassay to molecular diagnostic tests to further improve the quality of healthcare in physicians’ offices and hospital and reference laboratories. For more information about Quidel’s comprehensive product portfolio and to explore exciting employment opportunities, visit quidel.com.
Roche and Regeneron collaborate to significantly increase global supply of REGN-COV2 investigational antibody combination for COVID-19
19 August 2020 - REGN-COV2 is Regeneron’s two-antibody combination currently in late-stage clinical trials for the treatment and prevention of COVID-19 infection. The companies will collaborate on developing and manufacturing REGN-COV2. Regeneron will distribute REGN-COV2 in the U.S. and Roche will be responsible for distribution outside the U.S. Under this collaboration, the overall capacity of REGN-COV2 is expected to increase by at least three and a half times, substantially increasing the number of doses available to patients in the U.S. and around the world.
Basel, 19 August 2020 -- Roche and Regeneron announced today that they are joining forces in the fight against COVID-19 to develop, manufacture and distribute REGN-COV2, Regeneron’s investigational antiviral antibody combination, to people around the globe. REGN-COV2 could provide a much-needed treatment option for people already experiencing symptoms of COVID-19, and also has the potential to prevent infection in people exposed to the virus, thus slowing the spread of the global pandemic. This collaboration is expected to increase supply of REGN-COV2 to at least three and a half times the current capacity, with the potential for even further expansion.
REGN-COV2 is currently being studied in two Phase 2/3 clinical trials for the treatment of COVID-19 and in a Phase 3 trial for the prevention of COVID-19 in household contacts of infected individuals. If it proves safe and effective in clinical trials and regulatory approvals are granted, Regeneron will distribute and record sales for REGN-COV2 in the U.S. and Roche will be responsible for distribution outside the U.S.
“We are excited about the potential for one medicine to serve both as a treatment for those infected as well as protection for people exposed to the virus. REGN-COV2 could be a critical line of defense against the COVID-19 pandemic,” said Bill Anderson, Chief Executive Officer of Roche Pharmaceuticals. “We’re committing our manufacturing expertise and capacity, and our global distribution network to bring Regeneron’s potential antibody combination to as many people around the world as we possibly can.”
“Regeneron has progressed the REGN-COV2 research and development program at record speed and worked tirelessly to maximize our in-house manufacturing capacity,” said Leonard S. Schleifer, M.D., Ph.D., President and Chief Executive Officer of Regeneron. “This major collaboration with Roche provides important scale and global expertise to bring REGN-COV2 to many more patients in the United States and around the globe.”
Under the terms of the agreement, each company has committed to dedicate a certain manufacturing capacity to REGN-COV2 each year, and the collaborators have already begun the technology transfer process. Each company will bear its own distribution expenses in their designated territories. The collaborators will jointly fund and execute the ongoing Phase 3 prevention and Phase 1 healthy volunteers safety studies as well as additional global studies to evaluate further the potential for REGN-COV2 in treating or preventing COVID-19. Roche will be primarily responsible for securing regulatory approvals outside the U.S., following the initial European Medicines Agency (EMA) approval, and conducting any additional studies specifically required for approval by regulators outside the U.S.
About REGN-COV2
REGN-COV2 was designed specifically by Regeneron scientists to block infectivity of SARS-CoV-2, the virus that causes COVID-19. They evaluated thousands of fully-human antibodies produced by the company's proprietary VelocImmune® mice, which have been genetically-modified to have a human immune system, as well as antibodies identified from humans who have recovered from COVID-19. The two potent, virus-neutralizing antibodies that form REGN-COV2 bind non-competitively to the critical receptor binding domain of the virus's spike protein, which diminishes the ability of mutant viruses to escape treatment and protects against spike variants that have arisen in the human population, as detailed in recent Science publications.
REGN-COV2's development, manufacturing and clinical trials have been funded in part by the Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response at the U.S. Department of Health and Human Services under OT number: HHSO100201700020C.
About Roche’s response to the COVID-19 pandemic
The COVID-19 pandemic continues to evolve globally with varying developments from country to country and we are partnering with healthcare providers, laboratories, authorities and organisations to help make sure that patients receive the tests, treatment and care they need. This partnership is an additional step in Roche’s fight against the COVID-19 pandemic, which has already included:
- Launching COVID-19 diagnostic tests for active infection and the detection of antibodies in patients who have been exposed to the virus,
- Investigating treatments from our existing portfolio to better understand their potential to treat patients with COVID-19,
- Increasing manufacturing and supply chain capacity to meet product demand across our portfolio within the wider context of COVID-19 treatment, and
- Ensuring the supply of our existing medicines and diagnostics to patients around the world under exceptional conditions.
Reliable, high-quality testing is essential to help healthcare systems overcome this pandemic. On 13 March we received FDA Emergency Use Authorisation for a high-volume molecular test to detect SARS-CoV-2, the virus that causes COVID-19, which is also available in countries accepting the CE Mark. On 3 May, Roche announced that its COVID-19 antibody test, aimed at detecting the presence of antibodies in the blood, also received FDA Emergency Use Authorisation and is available in markets accepting the CE mark. Also in June we received an FDA EUA for the Elecsys® IL-6 test to assist in identifying severe inflammatory response in patients with confirmed COVID-19, as well as launching Roche v-TAC, which could help simplify the screening, diagnosis and monitoring of patients with respiratory compromise in the current COVID-19 pandemic. Roche is working closely with governments and health authorities around the world, and has significantly increased production to help ensure availability of tests globally.
We are actively involved in understanding the potential of our existing portfolio and are researching options for the future. Roche has an ongoing clinical trial program evaluating the role of Actemra©/RoActemra© (tocilizumab) in COVID-19 pneumonia. On 29 July we announced that the COVACTA trial did not meet its primary endpoint of improved clinical status in patients with COVID-19 associated pneumonia, or the key secondary endpoint of reduced patient mortality. The study was the first global, randomised, double-blind, placebo-controlled phase III trial investigating Actemra/RoActemra in this setting. Roche remains committed to continuing the Actemra/RoActemra clinical trial programme in COVID-19 to further explore Actemra/RoActemra in other treatment settings, including in combination with an antiviral. In addition to COVACTA, Roche has initiated several studies to further investigate Actemra/RoActemra as a potential treatment for patients with COVID-19 associated pneumonia, including two phase III clinical trials, REMDACTA and EMPACTA, as well as the phase II MARIPOSA trial. Roche has further initiated an internal early research programme focused on the development of medicines for COVID-19 and is engaged in multiple research collaborations.
In these exceptional times, Roche stands together with governments, healthcare providers and all those working to overcome the pandemic.
About Roche
Roche is a global pioneer in pharmaceuticals and diagnostics focused on advancing science to improve people’s lives. The combined strengths of pharmaceuticals and diagnostics under one roof have made Roche the leader in personalised healthcare – a strategy that aims to fit the right treatment to each patient in the best way possible.
Roche is the world’s largest biotech company, with truly differentiated medicines in oncology, immunology, infectious diseases, ophthalmology and diseases of the central nervous system. Roche is also the world leader in in vitro diagnostics and tissue-based cancer diagnostics, and a frontrunner in diabetes management.
Founded in 1896, Roche continues to search for better ways to prevent, diagnose and treat diseases and make a sustainable contribution to society. The company also aims to improve patient access to medical innovations by working with all relevant stakeholders. More than thirty medicines developed by Roche are included in the World Health Organization Model Lists of Essential Medicines, among them life-saving antibiotics, antimalarials and cancer medicines. Moreover, for the eleventh consecutive year, Roche has been recognised as one of the most sustainable companies in the Pharmaceuticals Industry by the Dow Jones Sustainability Indices (DJSI).
The Roche Group, headquartered in Basel, Switzerland, is active in over 100 countries and in 2019 employed about 98,000 people worldwide. In 2019, Roche invested CHF 11.7 billion in R&D and posted sales of CHF 61.5 billion. Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan. For more information, please visit www.roche.com.
Reference: https://www.roche.com/media/releases/med-cor-2020-08-19.htm
QIAGEN expands integrated coronavirus NGS and software solutions to accelerate COVID-19 research
18 August 2020 - QIAseq SARS-CoV-2 Primer Panel converts viral RNA samples into libraries ready for sequencing. QIAGEN Digital Insights solutions support COVID-19 drug, vaccine and epidemiology research.
Hilden, Germany, and Germantown, Maryland, August 18, 2020 – QIAGEN launched the innovative QIAseq SARS-CoV-2 Primer Panel for next-generation sequencing (NGS) of the novel coronavirus genome, along with integrated analysis and interpretation workflows for insights into the evolution and spread of the virus that causes COVID-19 disease. The new products are an expansion of QIAGEN’s broad offering of sample technologies, diagnostic tests and instruments, and research tools for use in the global effort to combat the COVID-19 pandemic.
“These solutions aim to accelerate research into COVID-19 prevention and treatment by enabling deeper, more holistic insights into the biology of SARS-CoV-2. The more we understand the novel coronavirus and its development, the better equipped the world will be to stop the pandemic,” said Thierry Bernard, Chief Executive Officer of QIAGEN. “We are partnering with leading institutes and companies to accelerate this vital research. Our new QIAseq SARS-CoV-2 Primer Panel and software pipeline will guide researchers into insights on the epidemiology, metatranscriptomics, immune response and pathways of the coronavirus – contributing to drug and vaccine development and public health strategies.”
QIAGEN’s new QIAseq SARS-CoV-2 Primer Panel provides optimized, single-day workflows to prepare libraries for sequencing as researchers use NGS to track viral genome changes in studying the epidemiology of virus outbreaks. The two-step process uses advanced QIAseq technologies to conduct reverse transcription and cDNA synthesis from a viral RNA sample, then generate libraries compatible with Illumina sequencing platforms. The workflow is faster and has lower-input requirements compared to hybrid capture solutions.
The panel is supported with software pipelines tailored to SARS-CoV-2 genome analysis using QIAGEN’s CLC Genomics Workbench. The optimized and configurable pipelines allow researchers to identify viral genome sequence variation across samples, and to visualize strain divergence across populations and geographies using phylogenetic approaches. QIAGEN also provides a complete Sample to Insight SARS-CoV-2 Whole Genome Sequencing Service covering all aspects of the workflow, from RNA isolation to NGS library preparation and data analysis.
The first independent study using the new QIAGEN workflows, an analysis of COVID-19 epidemiology in India, has been published in the Journal of Biosciences. The study used QIAGEN’s QIAamp Viral RNA Mini Kit for extraction of RNA. Researchers used the QIAseq SARS-CoV-2 Primer Panel for viral genome amplification in samples that did not generate sufficient NGS reads, converting the RNA to double-stranded cDNA and amplifying it, then generating libraries for sequencing on an Illumina instrument. The sequences were assembled and analyzed using QIAGEN CLC Genomics Workbench. The full study can be found at https://www.ias.ac.in/article/fulltext/jbsc/045/0076.
“We urgently need more research into the evolution of this virus. As we found in eastern India, mutations are emerging in the SARS-CoV-2 genome that might modulate viral transmission, replication efficiency and virulence in different regions of the world. Genomic research is required to improve understanding of transmission patterns, tracking of the outbreak and formulation of effective containment measures,” said Dr. Arindam Maitra, Associate Professor at the National Institute of Biomedical Genomics in India, one of the authors. “We found that a viral genome amplification method like the QIAseq SARS-CoV-2 Primer Panel was ideal for looking at low copy number, or high CT samples when compared to other methods.”
As a global leader in NGS solutions for evaluation of microbiomes and metagenomics, QIAGEN also offers a complete QIAseq workflow to expedite metatranscriptomics research and efficiently decipher the complex interplay between the SARS-CoV-2 virus, the host and its microbiota. A recently published study by Shah, S.J., et al. (2020) has illustrated the application of QIAseq FastSelect rRNA removal technology in facilitating SARS-CoV-2 metatranscriptomics, leading to a more comprehensive evaluation of co-infection rates in COVID-19 patients.
Since the start of the COVID-19 pandemic, QIAGEN’s initiatives focus on building the most comprehensive portfolio of solutions for COVID-19 testing. These include ramping up production of viral RNA extraction for use on QIAGEN’s QIAcube, QIAsymphony and EZ1 platforms as well as third-party instruments; building up a range of PCR tests on the QIAstat-Dx and NeuMoDx systems that enable COVID-19 detection while analyzing samples at the same time for other respiratory infections; and delivering universal next-generation sequencing (NGS) solutions for use with any sequencer, in particular gene panels like the QIAseq SARS-CoV-2, which are integrated with bioinformatics for analysis of the SARS-CoV-2 virus. QIAGEN is also scaling up production capacity for reagents sold to other companies for use in their own COVID-19 tests.
For an overview of QIAGEN’s coronavirus testing solutions, please visit http://www.qiagen.com/coronavirus.
To explore QIAGEN’s NGS-specific solutions for COVID-19 research, please visit https://go.qiagen.com/CoronavirusNGS
For details of QIAGEN’s SARS-CoV-2 Whole Genome Sequencing Service, please visit https://www.qiagen.com/applications/genomic-services/sars-cov-2-whole-genome-sequencing-services
About QIAGEN
QIAGEN N.V., a Netherlands-based holding company, is the leading global provider of Sample to Insight solutions that enable customers to gain valuable molecular insights from samples containing the building blocks of life. Our sample technologies isolate and process DNA, RNA and proteins from blood, tissue and other materials. Assay technologies make these biomolecules visible and ready for analysis. Bioinformatics software and knowledge bases interpret data to report relevant, actionable insights. Automation solutions tie these together in seamless and cost-effective workflows. QIAGEN provides solutions to more than 500,000 customers around the world in Molecular Diagnostics (human healthcare) and Life Sciences (academia, pharma R&D and industrial applications, primarily forensics). As of June 30, 2020, QIAGEN employed more than 5,200 people in over 35 locations worldwide. Further information can be found at http://www.qiagen.com.
Reference: https://corporate.qiagen.com/newsroom/press-releases/2020/20200818_qiaseq_sars_cov_2
PerkinElmer Launches Modular and Scalable explorer™ Workstations for High-throughput COVID-19 Detection
17 August 2020 - Enables Labs to Quickly Ramp up Testing Capacity and Generate Results Faster
WALTHAM, Mass., Aug. 17, 2020 -- PerkinElmer, Inc., a global leader committed to innovating for a healthier world, today announced the launch of a series of explorer™ workstations for SARS-CoV-2 testing capable of preparing and running up to 10,000 COVID-19 tests per day. These modular and scalable workstations enable laboratories to ramp up SARS-CoV-2 testing capacity quickly to generate results.
Currently many laboratories are unable to deliver COVID-19 testing results in a timely manner. Slow results and delayed responses can increase the risk of further spread of the disease.
PerkinElmer’s scalable and modular explorer automated workstations streamline testing workflows, speeding up SARS-CoV-2 RT-PCR and ELISA testing. The workstations help laboratories improve their efficiency, while eliminating errors. In addition, they reduce labor requirements by automating and standardizing disparate workflow steps. They also provide varying degrees of automation based on workload and staffing resources.
To better respond to the COVID-19 pandemic, laboratories need the ability to obtain all workflow components – from reagents to equipment, to consumables at the scale they need, when they need them. Today, PerkinElmer is able to deliver these workflow components globally.
“The global economy is reeling from this pandemic, and laboratories need to be able to rapidly scale their testing capacity up and down,” said Masoud Toloue, Ph.D., Vice President and General Manager, Diagnostics, PerkinElmer. “PerkinElmer is developing innovative solutions giving laboratories the flexibility they need to meet the ever-changing COVID-19 testing demand. The best-in-class explorer workstations enable laboratories to efficiently work through the COVID-19 pandemic.”
PerkinElmer has more than 20 years of experience in optimizing complete workflows (including reagents, equipment, and consumables) based on testing, throughput, and staffing requirements. The Company’s comprehensive SARS-CoV-2 offerings span high throughput RNA extraction, RT-PCR assays, automation, ELISA, and other laboratory solutions. Its ELISA offerings are available through EUROIMMUN, a PerkinElmer company.
About PerkinElmer
PerkinElmer enables scientists, researchers and clinicians to address their most critical challenges across science and healthcare. With a mission focused on innovating for a healthier world, we deliver unique solutions to serve the diagnostics, life sciences, food and applied markets. We strategically partner with customers to enable earlier and more accurate insights supported by deep market knowledge and technical expertise. Our dedicated team of about 13,000 employees worldwide is passionate about helping customers work to create healthier families, improve the quality of life, and sustain the wellbeing and longevity of people globally. The Company reported revenue of approximately $2.9 billion in 2019, serves customers in 190 countries, and is a component of the S&P 500 index. Additional information is available through 1-877-PKI-NYSE, or at www.perkinelmer.com.
Thermo Fisher Scientific Announces Results of Offer to Acquire QIAGEN, Lapse of Offer and Termination of Acquisition Agreement
13 August 2020
WALTHAM, Mass., Aug. 13, 2020 -- Thermo Fisher Scientific Inc., the world leader in serving science, today announced that its offer to acquire all of the ordinary shares of QIAGEN N.V. has lapsed.
Based on information provided by the settlement agents for the offer, Deutsche Bank Aktiengesellschaft and American Stock Transfer & Trust Company, 107,546,187 QIAGEN shares, representing 47.02% of the issued and outstanding ordinary shares of QIAGEN, were validly tendered into the offer by the end of the acceptance period at 24:00 hours (Frankfurt am Main local time) / 18:00 hours (New York local time) on August 10, 2020. Accordingly, the minimum acceptance threshold condition to the offer has not been satisfied, and the offer has lapsed in accordance with its terms.
Thermo Fisher has terminated the acquisition agreement with QIAGEN, and QIAGEN will pay to Thermo Fisher an expense reimbursement payment of USD 95 million in cash in accordance with the terms of the acquisition agreement.
Marc N. Casper, chairman, president and chief executive officer of Thermo Fisher Scientific, said, "Thermo Fisher is a disciplined acquirer with a strong track record of executing value-creating transactions. We remain extremely well-positioned to deliver on our proven growth strategy and continue to generate significant returns for our shareholders."
About Thermo Fisher
Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $25 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, improving patient diagnostics and therapies or increasing productivity in their laboratories, we are here to support them. Our global team of more than 75,000 colleagues delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services and Patheon. For more information, please visit www.thermofisher.com.
Philips launches Rapid Equipment Deployment Kit to COVID-19 response
13 August 2020 - New initiative can provide critical care patient monitoring anywhere, anytime to help meet the urgent challenges of ICU capacity. Helps mitigate the impact of natural disasters and pandemics like the ongoing COVID-19 outbreak.
Amsterdam, the Netherlands, 13 August 2020 – Royal Philips, a global leader in health technology, today introduced its Rapid Equipment Deployment Kit for ICU ramp-ups, allowing doctors, nurses, technicians and hospital staff to quickly support critical care patient monitoring capabilities during the COVID-19 pandemic. Currently successfully in use in the first health systems across the US, the Rapid Equipment Deployment Kit combines Philips advanced patient monitoring technology with predictive patient centric algorithms enabling care teams to quickly scale up critical care patient monitoring capabilities within a few hours. As health systems in the U.S. continue to experience surges in critical care and emergency care demand related to the COVID-19 crisis, the kit provides hospitals a way to quickly and easily expand their critical care capacity.
Innovative approach to help manage capacity surge in the ICU
The Philips Rapid Equipment Deployment Kit is a fully configured and ready-to-deploy ICU patient monitoring solution, which includes 20 ICU monitors, 20 measurement servers and one central management monitoring station. The kits are pre-built, pre-configured and pre-packed into sturdy cases that can elevate a hospital’s general care area to a critical care level in a matter of hours. Kits are complete with step-by-step instructions allowing the pre-configured system to be deployed by hospital staff, with remote technical and clinical support from Philips. Kits can be transferred from hospital to hospital as needed. Once a crisis/surge passes, the kits are disinfected, packed up and stored to have available in preparation for future emergencies.
“The current health crisis has demonstrated a clear need for us to deliver innovative solutions to our customers that provide a complete critical care monitoring solution with all of the equipment they require on demand. This eliminates the need to source and configure individual pieces of high-demand equipment during a crisis,” said Peter Ziese, General Manager of Monitoring Analytics at Philips. “To help ensure economical and more efficient use of hospital resources, the Rapid Equipment Deployment Kits provide the speed, flexibility and ease of implementation for advanced critical care patient monitoring that many of our customers must have during this most pressing time.”
Philips critical care patient monitoring solutions
In June, Philips announced it had received Emergency Use Authorization from the FDA for Philips’ IntelliVue Patient Monitors MX750/MX850 and its IntelliVue Active Displays AD75/AD85, for use in the US during the COVID-19 health emergency. These patient monitoring solutions support infection-control protocols and remotely provide critical patient information when caring for hospitalized COVID-19 patients. The MX750 and MX850 monitors are the latest additions to Philips’ portfolio of integrated patient monitoring solutions to help support improved clinical and operational workflows. Updated features, include enhancements to monitor and assess clinical and network device performance, and additional functionalities to strengthen cybersecurity. Visit Philips critical care patient monitoring for more information on the Rapid Equipment Deployment Kits in the US market and Philips full suite of critical care patient monitoring solutions.
Philips COVID-19 solutions portfolio
Philips has a comprehensive portfolio of services and solutions to help support the delivery of high-quality care to COVID-19 patients. Solutions include secure, connected and intelligent approaches to diagnosis, treatment and predictive monitoring in the hospital, plus screening, remote patient monitoring and care at home. With healthcare under more pressure than ever before, Philips’ telehealth and AI-enabled data analytics can help support workflows, facilitate remote collaboration and optimize resources. Philips’ COVID-19-related solutions are designed for rapid deployment and scalability. For more information on how Philips is addressing COVID-19 globally, please visit the Philips centralized COVID-19 hub.
About Royal Philips
Royal Philips is a leading health technology company focused on improving people's health and enabling better outcomes across the health continuum from healthy living and prevention, to diagnosis, treatment and home care. Philips leverages advanced technology and deep clinical and consumer insights to deliver integrated solutions. Headquartered in the Netherlands, the company is a leader in diagnostic imaging, image-guided therapy, patient monitoring and health informatics, as well as in consumer health and home care. Philips generated 2019 sales of EUR 19.5 billion and employs approximately 81,000 employees with sales and services in more than 100 countries. News about Philips can be found at www.philips.com/newscenter.
LabCorp Will Perform Antibody Test at No Charge to Accelerate COVID-19 Blood Plasma Donation
11 August 2020 - No Charge Program Uses High-Affinity Test to Detect SARS-CoV-2 Antibodies
BURLINGTON, N.C., Aug. 11, 2020 -- LabCorp, a leading global life sciences company that is deeply integrated in guiding patient care, today announced details of a no charge antibody testing program in response to federal health authorities’ request to increase donations of COVID-19 blood plasma. Plasma with COVID-19 antibodies may be helpful when treating patients with an active COVID-19 infection and is being evaluated as a possible treatment.
Beginning today for the next three months, LabCorp will perform the high-affinity antibody test at no charge to patients, insurance companies, or the government. When patients are receiving other medically necessary blood tests as part of a medically necessary exam or treatment, this program allows providers to add the SARS-CoV-2 Antibodies Test to the same order at no charge. The no-charge high-affinity antibody testing program will use only the Roche Elecsys® Anti-SARS-CoV-2 and does not apply to other COVID-19 antibody tests, such as the IgG test.
Patients will be able to access their results through the LabCorp Patient™ portal and through their doctor. Result data from the antibody testing program will also be reported to the CDC and state public health agencies to further support COVID-19 surveillance and response efforts.
Individuals who have tested positive for COVID-19 and have not experienced symptoms for at least two weeks, or who have been confirmed to have antibodies to the virus are likely candidates for plasma donation. Many people who have had COVID-19 do not experience symptoms and may be unaware they have antibodies that can help other patients. The antibody test performed by LabCorp can help determine if an individual has been exposed to the virus by detecting antibodies in the blood. Antibodies comprise part of the immune response to the virus.
Patients who test positive for COVID-19 antibodies are encouraged to donate their blood plasma. Donating plasma does not affect the donor’s immunity, as their body will continue to produce antibodies. More information can be found about plasma donation at TheFightIsInUs.org.
Adam Schechter, chairman and CEO of LabCorp, said: “Many people have antibodies and are unaware that they could potentially use them to help save lives. LabCorp is offering antibody tests at no charge through a patient’s doctor to make it easier for more people to know if they should consider giving plasma. If you have antibodies and donate your plasma, you are helping the fight against the pandemic.”
For more information on antibody tests and LabCorp’s diagnostic COVID-19 testing options, as well as information on how to get involved, go to our website. Patients interested in donating plasma should visit TheFightIsInUs.org. The website can help check eligibility criteria and connect patients directly to plasma and blood donation centers nearby.
For Healthcare Providers
Under this program, providers can order the high-affinity antibody test that is based on an in-solution double-antigen sandwich format and can detect antibodies to SARS-CoV-2, the virus that causes COVID-19. The test will be performed at no charge for the next three months. Antibodies could signal whether a person has already been infected and potentially developed immunity to the virus. LabCorp’s antibody test uses the Roche Elecsys® Anti-SARS-CoV-2 platform, has 99.8 percent specificity and shows no cross-reactivity to the common cold, HIV and other coronaviruses. This means it can lower the chance of false positives due to the detection of similar antibodies that may be present in an individual. The Anti-SARS-CoV-2 test detected antibodies with 100% sensitivity in samples taken 14 days after a PCR-confirmed infection. Please note, the no-charge antibody testing program includes the Roche Elecsys® Anti-SARS-CoV-2 and does not apply to specific antibody tests, such as the IgG test.
Emergency Use Authorization (EUA) Status
The Elecsys Anti-SARS-CoV-2 test has not been FDA cleared or approved. It has been authorized by FDA under an EUA for use by authorized laboratories. This test has been authorized only for detecting the presence of antibodies against SARS-CoV-2, not for any other viruses or pathogens. It is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.
About LabCorp
LabCorp (NYSE: LH), an S&P 500 company, is a leading global life sciences company that is deeply integrated in guiding patient care, providing comprehensive clinical laboratory and end-to-end drug development services. With a mission to improve health and improve lives, LabCorp delivers world-class diagnostics solutions, brings innovative medicines to patients faster, and uses technology to improve the delivery of care. LabCorp reported revenue of more than $11.5 billion in 2019. To learn more about LabCorp, visit www.LabCorp.com, and to learn more about LabCorp’s drug development business, Covance, visit www.Covance.com.
Hologic Launches Validated Pooling Protocol for COVID-19 Testing
11 August 2020 - In Time of Extraordinary Need, New Protocol Expected to Help Laboratories Deliver Greater Quantities of Highly Accurate Molecular Test Results and Reduce Turnaround Times
MARLBOROUGH, Mass., 11 August 2020 -- Hologic, Inc. announced today that it has validated use of its Aptima® and Panther Fusion® molecular diagnostic COVID-19 assays with pooled patient samples and completed an emergency use notification to the U.S. Food and Drug Administration (FDA) to make this workflow available to laboratory customers in the United States. By allowing samples from multiple individuals to be tested simultaneously, pooling is expected to help laboratories deliver increasing numbers of highly accurate molecular test results more quickly.
Hologic believes it is the first test manufacturer in the country to validate and launch a pooling workflow that ensures highly accurate detection of the SARS-CoV-2 virus. As described in the protocol, pooling is used most effectively in areas or populations of lower disease prevalence.
“By providing a pooling protocol, we are helping our lab customers meet the extraordinary demand for highly accurate molecular test results during this unprecedented time,” said Kevin Thornal, president, Diagnostic Solutions Division at Hologic. “Pooling will enable more samples to be tested each day, but at the same time, help test results get back to patients and their caregivers faster. I am very proud of the ingenuity and innovations that our Hologic teams continue to bring to fighting this pandemic.”
Hologic’s pooling protocol enables clinical laboratories to combine up to five patient samples into a single tube for processing. A negative result means that all five individuals have tested negative for SARS-CoV-2. In cases of a positive result, all five samples are re-tested individually to determine which patient or patients are infected.
The pooling workflow for the Aptima and Panther Fusion SARS-CoV-2 assays has not yet been reviewed by FDA. This workflow is being made available in accordance with Section IV.C. of FDA’s policy for diagnostic tests for Coronavirus disease – 2019 during the public health emergency at https://www.fda.gov/media/135659/download [fda.gov].
Hologic’s Aptima and Panther Fusion SARS-CoV-2 assays detect the genetic material of the virus and run on fully automated testing platforms that return initial results in approximately three hours. The Aptima SARS-CoV-2 test runs on Hologic’s Panther® system, and the Panther Fusion SARS-CoV-2 test runs on the Panther Fusion® system. More than 1,100 of these automated systems are installed in U.S. clinical laboratories. Each Panther and Panther Fusion system can process more than 1,000 SARS-CoV-2 tests in 24 hours. Hologic is currently producing an average of more than one and a half million COVID-19 tests per week.
This project has been funded in whole or in part with Federal funds from the Department of Health and Human Services; Office of the Assistant Secretary for Preparedness and Response; Biomedical Advanced Research and Development Authority, as part of an $8.9 million award under Contract No. 75A50120P00100.
About COVID-19
For more information about the novel coronavirus, visit: https://www.cdc.gov/coronavirus/2019-ncov/summary.html.
About Hologic
Hologic, Inc. is an innovative medical technology company primarily focused on improving women’s health and well-being through early detection and treatment. For more information on Hologic, visit www.hologic.com.
State of Maryland allows point-of-care testing for COVID-19; Quidel expands training program
10 August 2020
SAN DIEGO, 10 August 2020 -- Quidel Corporation (“Quidel”), a provider of rapid diagnostic testing solutions, cellular-based virology assays and molecular diagnostic systems, announced that the State of Maryland has allowed point-of-care testing for COVID-19.
The Maryland Department of Health has allowed point-of-care testing for COVID-19, stating:
“Any healthcare provider or healthcare facility, subject to certain terms and conditions, may perform COVID-19 point-of-care (POC) test analysis pursuant to Executive Order 20-03-23-02.” The order is effective August 10, 2020.
Under the new directive, Maryland residents who believe they should be tested can now contact their healthcare provider, who can order a “COVID-19 test for any individual who believes it necessary, regardless of symptoms.”
Quidel Expands Training Program
Separately, as part of its Nursing Home Program, and in collaboration with the U.S. Department of Health and Human Services (HHS), Quidel has expanded its Point-of-Care training protocol to help ensure that nursing home health care workers are appropriately trained in the use of the Sofia® 2 instrument and the Sofia® SARS Antigen FIA. Quidel now offers nursing home customers a multifaceted approach to training including: online self-guided step by step videos, live virtual training events, certificate programs, Virena® data management system connection and other support functions via Quidel’s dedicated nursing home site: togetheragain.quidel.com.
Quidel currently sells several different Sofia assays in the United States, including the Sofia® SARS Antigen FIA under FDA EUA and other FDA-cleared and CLIA-waived assays, including tests for Influenza A and B, Respiratory Syncytial Virus (RSV), Group A Strep, and a 15-minute finger-stick whole blood test for Lyme Disease. In addition, Quidel also markets Sofia® tests for Lyme Disease, Legionella, and S. pneumoniae in Europe.
About Quidel Corporation
Quidel Corporation serves to enhance the health and well-being of people around the globe through the development of diagnostic solutions that can lead to improved patient outcomes and provide economic benefits to the healthcare system. Marketed under the Sofia®, QuickVue®, D3® Direct Detection, Thyretain®, Triage® and InflammaDry® leading brand names, as well as under the new Solana®, AmpliVue®and Lyra® molecular diagnostic brands, Quidel’s products aid in the detection and diagnosis of many critical diseases and conditions, including, among others, COVID-19, influenza, respiratory syncytial virus, Strep A, lyme, herpes, pregnancy, thyroid disease and fecal occult blood. Quidel's Triage® system of tests comprises a comprehensive test menu that provides rapid, cost-effective treatment decisions at the point-of-care (POC), offering a diverse immunoassay menu in a variety of tests to provide diagnostic answers for quantitative BNP, CK-MB, d-dimer, myoglobin, troponin I and qualitative TOX Drug Screen. Quidel’s research and development engine is also developing a continuum of diagnostic solutions from advanced immunoassay to molecular diagnostic tests to further improve the quality of healthcare in physicians’ offices and hospital and reference laboratories. For more information about Quidel’s comprehensive product portfolio and to explore exciting employment opportunities, visit quidel.com.
Thermo Fisher Scientific Develops COVID-19 Antibody Assay Targeting Transplant Community
10 August 2020 - Powerful new solution provides more accurate COVID-19 antibody detection
WEST HILLS, Calif., Aug. 10, 2020 -- Thermo Fisher Scientific continues to expand its response to the COVID-19 pandemic, developing a new serological assay targeted towards transplant candidates and recipients that can detect antibodies directed against COVID-19 (SARS-CoV-2). The assay will be provided under the company's One Lambda brand representing leading in vitro diagnostic products for the transplant community. This novel antibody detection panel is part of Thermo Fisher's continued efforts to support transplant patients during the pandemic.
In collaboration with histocompatibility, infectious disease and nephrology laboratories at Emory University, Stanford University, University of Cincinnati and the University Health Network in Toronto, Thermo Fisher's transplant diagnostic business has developed the LABScreen COVID Plus Assay. The assay leverages the Luminex xMAP technology to detect multiple distinct antibodies and fragments, making it more specific than current assays and able to reduce false positives caused by infections with common coronavirus. In combination with HLA antibody detection, the LABScreen COVID Plus reagents can help provide a more complete picture of a patient's antibody profile.
The LABScreen COVID Plus Assay will be available for research use only by August 2020. Additionally, the assay will be submitted for Emergency Use Authorization (EUA).
"We approached Thermo Fisher's transplant diagnostic business because we believe their expertise with antibody assay development and commitment to the transplant community is critical to develop an assay for transplant patients that could both detect neutralizing antibodies and rule out false positives," said Dr. Howard Gebel, co-director of the Emory University Hospital HLA laboratory.
"A semi-quantitative multiplex assay that can simultaneously detect the response to spike, receptor-binding domain, nucleocapsid and other SARS-CoV-2 proteins will be a huge step forward towards fully characterizing the immune response to COVID-19," said Dr. Robert Bray, co-director of the Emory University Hospital HLA laboratory.
"We're proud of the role we play in responding to the pandemic, and this is one of many examples that demonstrate our ability and our commitment to fight COVID-19," said Nicole Brockway, president of the transplant diagnostic business for Thermo Fisher. "Transplant patients have unique needs compared to other COVID-19 patients, and with the support of Luminex and our research partners, we're delivering an innovative solution that's tailored to meet those needs."
As the global leader in transplant diagnostics for more than thirty-five years, Thermo Fisher's transplant diagnostics business is committed to improving the lives of patients worldwide by driving innovation and delivering quality products. The company's comprehensive product portfolio includes a broad range of antibody detection assays, post-transplant monitoring solutions including the novel Molecular Microscope Diagnostic System, HLA typing products, laboratory instrumentation and software, and industry-leading customer support.
Laboratories interested in the LABScreen COVID Plus Assay may visit www.onelambda.com for more information.
About Thermo Fisher Scientific
Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $25 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, improving patient diagnostics and therapies or increasing productivity in their laboratories, we are here to support them. Our global team of more than 75,000 colleagues delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services and Patheon. For more information, please visit www.thermofisher.com.
FDA issues Emergency Use Authorization to Vela Diagnostics' Coronavirus PCR test
6 August 2020 - The ViroKey™ SARS-CoV-2 RT-PCR Test receives Emergency Use Authorization from the FDA
Fairfield, New Jersey, August 6, 2020 – Vela Diagnostics announced that the manual version of its coronavirus PCR test has obtained Emergency Use Authorization from the U.S. Food and Drug Administration (FDA). By targeting conserved regions of the viral genome, the probe-based reverse transcription PCR test detects SARS-CoV-2, the coronavirus that causes COVID-19. The EUA allows the emergency use of FDA medical products in qualified labs, thus facilitating widespread access to the diagnostic test.
"RT-PCR is currently the gold standard for diagnosing SARS-CoV-2 infections. Given the escalating number of COVID-19 cases in the U.S., Vela Diagnostics is helping Americans get tested so as to detect and slow the spread of the virus,” said Sam Dajani, interim CEO and Chairman of the Board. “Our coronavirus test will assist healthcare professionals in managing the COVID-19 pandemic."
The ViroKey™ SARS-CoV-2 RT-PCR Test detects SARS-CoV-2 in nasopharyngeal and oropharyngeal swabs.The manual version of the ViroKey™ SARS-CoV-2 RT-PCR Test enables flexible sample processing and quick adoption of the test by laboratories with existing ABI 7500 Fast Dx instruments. For high throughput testing, Vela Diagnostics has also developed an automated version of the assay optimized for a workflow consisting of the Sentosa™ SX101 instrument, in conjunction with the Applied Biosystems 7500 Fast Dx Real-Time (ABI 7500 Fast Dx) PCR instrument or the Sentosa™ SA201 instrument.
In addition to being authorized by the FDA for emergency use, the ViroKey™ SARS-CoV-2 RT-PCR Test has also received the CE mark and provisional approval from the Singapore Health Sciences Authority.
About Vela Diagnostics
Vela Diagnostics is a leading provider for integrated IVD system solutions, from sample to result. VELA’s test solutions utilize the automated Sentosa™ platform, providing the unique ability to leverage one system for NGS and PCR testing in infectious disease and oncology.
Thermo Fisher Scientific's COVID-19 Response Continues to Expand with New High-Throughput Automated Testing Solution
5 August 2020
WALTHAM, Mass., Aug. 5, 2020 -- Thermo Fisher Scientific Inc., the world leader in serving science, today introduced a new highly automated, real-time PCR solution designed to analyze up to 6,000 samples in a single day to meet increasing global demand for COVID-19 testing. The high-throughput system enables laboratories to double or even triple their testing capacity to support global efforts to return communities back to work and school.
The Thermo Fisher Scientific Amplitude Solution is a molecular diagnostic testing system that leverages the company's Applied Biosystems QuantStudio 7 Flex Real-time PCR instruments along with liquid handling products from Tecan Group, a global leader in laboratory automation and liquid handling. The modular solution delivers test results in a four-step process requiring minimal hands-on time, laboratory space and staffing resources.
"Increased testing capability is an essential part of any community's plan to reopen schools and businesses," said Marc N. Casper, chairman, president and chief executive officer of Thermo Fisher Scientific. "Current approaches to scale up testing require substantial resources and personnel. This more automated, high-throughput solution will enable laboratories around the world to increase testing volumes and help the public get their test results faster."
The Amplitude Solution utilizes Thermo Fisher's Applied Biosystems TaqPath COVID-19 Combo Kit, a fast, highly sensitive multiplex diagnostic test that contains the assays and controls needed for the qualitative detection of nucleic acid from SARS-CoV-2, the virus that causes COVID-19. The company will submit this new end-to-end solution to the U.S. Food and Drug Administration for Emergency Use Authorization (EUA) and plans to secure additional authorizations globally.
The system also includes instruments from Tecan's Fluent Laboratory Workstation family, the highest-performance platform within its extensive portfolio of liquid-handling solutions for laboratory automation. The Fluent instruments will be supplied through Tecan's Partnering Business.
As part of this offering, Amplitude Solution customers will enter into a supply agreement with Thermo Fisher to secure an up-front, confirmed and reliable supply of reagents and consumables. Backed by dedicated, 24/7 customer support from Thermo Fisher, the end-to-end solution, including the reagents, consumables and test kits, is available from a single source.
The launch of the Amplitude Solution adds to the company's significant COVID-19 response. Since developing one of the first diagnostic tests to be granted EUA in the U.S., Thermo Fisher has expanded diagnostic testing to more than 50 countries globally and now has the capacity to produce more than 10 million COVID-19 test reactions per week to meet demand. The company has marshalled its leading scale and depth of capabilities in the fight against COVID-19, from collaborating with laboratory customers and governments to expand testing capacity, to quickly scaling production to meet demand for sample collection products, to supporting more than 200 vaccine and therapy development and manufacturing projects around the world.
For more information on the Amplitude Solution, please visit www.thermofisher.com/amplitude.
About Thermo Fisher Scientific
Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $25 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, improving patient diagnostics and therapies or increasing productivity in their laboratories, we are here to support them. Our global team of more than 75,000 colleagues delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services and Patheon. For more information, please visit www.thermofisher.com.
Roche announces FDA authorisation for the first Epstein-Barr virus quantitative test on the cobas 6800/8800 Systems to improve care for transplant patients
5 August 2020 - FDA granted de novo class II for cobas EBV test following the agency’s Breakthrough Device designation. Accurate monitoring of Epstein-Barr virus DNA levels is critical, as they are associated with a range of life threatening-diseases including cancer in transplant patients. Test meets World Health Organization standards for consistent result reporting among laboratories across the U.S., allowing for results to be easily comparable across hospitals and labs.
Basel, 5 August 2020 -- Roche today announced that the U.S. Food and Drug Administration (FDA) has authorised the cobas® EBV test. This is the first quantitative in vitro diagnostic test for Epstein-Barr virus (EBV) DNA in the United States. This authorisation gives healthcare professionals a key tool in monitoring transplant patients at risk for complications from infections or reactivations of EBV, by providing the ability to run a large number of patient tests for this virus in a short period of time.
“Monitoring of Epstein-Barr virus DNA can help prevent progression of life-threatening diseases, such as cancer in transplant patients,” said Thomas Schinecker, CEO Roche Diagnostics. “The EBV test helps set a new standard of care for patients, as healthcare professionals now can act early in the management of this virus with best-in-class monitoring tools and can make more informed decisions when treating patients.”
The cobas EBV test is a polymerase chain reaction (PCR) viral load test that runs on the fully automated and widely available cobas® 6800 and cobas® 8800 Systems. The test has been calibrated to the World Health Organization (WHO) International Standard. This means that test results are reported in international measures, making it possible for laboratories anywhere in the U.S. to obtain comparable results when measuring levels of EBV DNA.
The test was previously granted FDA Breakthrough Device designation, which enables an expedited review process for medical devices that provide improved treatment or diagnosis of life-threatening diseases or conditions.
About the cobas EBV test
The cobas EBV test is a real-time PCR (polymerase chain reaction) viral load test with dual target technology, which provides quantitative accuracy and guards against the risk of sequence variations that may be present in the Epstein-Barr virus. The cobas EBV test has robust coverage with a limit of detection of 18.8 IU/mL and an expanded linear range from 35 IU/mL to 1E+08 IU/mL in EDTA plasma.
The test offers an alternative to lab-developed tests (LDTs) or Assay Specific Reagents (ASR) combinations, potentially minimising variability and complexity in testing, reducing workload and alleviating risk for laboratories. The test supports the goal of result standardisation across institutions by providing reproducible, high-quality results for clinical decision-making.
The fully automated cobas EBV test can be run on the cobas 6800/8800 Systems providing absolute automation with proven performance and flexibility. Simultaneous testing with CMV or other virology tests leads to time savings and increased efficiency.
About Epstein-Barr virus (EBV)
Epstein-Barr virus is a member of the herpes virus family and has been associated with a range of cancers in transplant patients, such as post-transplant lymphoproliferative disorder (PTLD). Once infection with EBV occurs, the virus establishes as a latent form and can remain in the body. Most people harbor EBV with no long-term clinical ramifications.
EBV spreads most commonly through bodily fluids, primarily saliva. This does not always cause symptoms, but people with weakened immune systems, including transplant patients, are more likely to develop symptoms if EBV reactivates.
About the cobas 6800/8800 Systems
When every moment matters, the fully automated cobas 6800/8800 Systems offer the fastest time to results with the highest throughput and the longest walk-away time available among automated molecular platforms. The systems provide up to 96 results in about 3 hours and 384 results for the cobas 6800 System and 1,056 results for the cobas 8800 System in an 8-hour shift.*
Both systems make it possible for labs to perform up to three tests in the same run with no pre-sorting required. The systems also enable up to eight hours (cobas 6800 System) and four hours (cobas 8800 System) of walk-away time with minimal user interaction.
These real-time PCR systems serve the areas of infectious disease, donor screening, sexual health, transplant, respiratory and antimicrobial stewardship.
Through an ever-increasing worldwide install base of cobas 6800/8800 Systems, labs are quickly and easily processing millions of tests per month to meet the changing demands of their communities, their customers and the patients relying on the results of each assay. Globally, labs know and trust that a Roche assay guarantees high precision, accuracy and traceability to World Health Organization standards.
Today, rapid advancements in healthcare technology, a shortage of skilled workers, industry-wide consolidation, and the proven need to be ready for the next outbreak have health systems looking to lay a reliable foundation for the future. With proven performance, absolute automation and unmatched flexibility delivering unparalleled throughput 24/7—cobas 6800/8800 Systems are designed to ensure a lab’s long-term sustainability and success … now, more than ever.
About Roche
Roche is a global pioneer in pharmaceuticals and diagnostics focused on advancing science to improve people’s lives. The combined strengths of pharmaceuticals and diagnostics under one roof have made Roche the leader in personalised healthcare – a strategy that aims to fit the right treatment to each patient in the best way possible.
Roche is the world’s largest biotech company, with truly differentiated medicines in oncology, immunology, infectious diseases, ophthalmology and diseases of the central nervous system. Roche is also the world leader in in vitro diagnostics and tissue-based cancer diagnostics, and a frontrunner in diabetes management.
Founded in 1896, Roche continues to search for better ways to prevent, diagnose and treat diseases and make a sustainable contribution to society. The company also aims to improve patient access to medical innovations by working with all relevant stakeholders. More than thirty medicines developed by Roche are included in the World Health Organization Model Lists of Essential Medicines, among them life-saving antibiotics, antimalarials and cancer medicines. Moreover, for the eleventh consecutive year, Roche has been recognised as one of the most sustainable companies in the Pharmaceuticals Industry by the Dow Jones Sustainability Indices (DJSI).
The Roche Group, headquartered in Basel, Switzerland, is active in over 100 countries and in 2019 employed about 98,000 people worldwide. In 2019, Roche invested CHF 11.7 billion in R&D and posted sales of CHF 61.5 billion. Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan. For more information, please visit www.roche.com.
Reference: https://www.roche.com/media/releases/med-cor-2020-08-05b.htm
Beckman Coulter collaboration to automate high throughput SARS-CoV-2 PCR testing
4 August 2020
4 August 2020 -- genedrive plc, announces that it has entered into a collaboration with Beckman Coulter Life Sciences to fully automate the entire laboratory PCR testing process for COVID-19. The two companies are working to combine and validate the Genedrive® 96 SARS-CoV-2 Kit on the Biomek i7 automated workstation with saliva samples extracted using Beckman Coulter’s RNAdvance viral extraction chemistry.
The freeze-dried bead chemistry of the Genedrive® 96 SARS-CoV-2 test is ideally suited for use on high throughput robotic platforms like the Biomek i7. Stable at room temperature for 4 hours after unsealing, many Genedrive® 96 SARS-CoV-2 Kit 96-well plates can be left arrayed and open in the laboratory environment during the set-up process. The ready-to-go nature of the test bead also removes the fluid dispensing steps required in other assays, increasing the overall throughput of the Biomex i7 compared to using a liquid based test set-up. Accordingly, once validated, Beckman Coulter estimates that this new turnkey solution could process circa 1,000 PCR samples per Biomek installed during a standard 8-hour working day, using just a 0.5 full-time-equivalent in technician time for processing.
Genedrive has already completed initial evaluation of Beckman Coulter’s RNA extraction chemistry to confirm compatibility with the Genedrive® 96 SARS-CoV-2 test. Further work is ongoing to validate clinical saliva samples which are a very relevant sample type for applications such as high volume occupational screening. Beckman’s RNAdvance Viral XP has already been listed as an extraction method for swab samples for use with the Centers for Disease Control’s EUA-authorized COVID-19 test in FDA’s FAQ on testing for SARS-CoV-2.
Greg Milosevich, President at Beckman Coulter Life Sciences, said “The integration of Beckman Coulter Life Sciences’ and genedrive’s technologies produces a formidable workhorse solution for specialized laboratories looking to establish new or next level laboratory automation with labor cost reduction. Our ability to fully integrate the RNA extraction process on the Biomek while simultaneously preparing the plates for analysis is a critical step forward in advancing COVID testing workflows. Speed up the testing workflow, reduce labor time and costs. This is the goal of our collaboration with Genedrive and we are excited to be bringing this solution forward to the market.”
David Budd, Chief Executive Officer of genedrive plc, said ”We are very pleased to have the opportunity to work with Beckman Coulter in delivering an innovative high throughput COVID-19 PCR solution. It’s been our focus to work with a top tier, high throughput lab automation partner like Beckman to drive uptake of our test and further differentiate our unique capabilities in the market. The combination of our ready to use chemistry with robotics and on-board RNA extraction would give laboratories a unique and rapid workflow that can achieve impressive throughput and result turnaround times. We are both working to have the ongoing validation completed in approximately 6 weeks, with initial introduction in the USA at an already identified clinical laboratory.”
The integrated Genedrive/Beckman Coulter solution will be introduced in selected, relevant geographies subject to validation and any required regulatory approvals.
Reference: https://www.genedrive.com/news/index.php
Siemens Healthineers obtains first FDA EUA authorization for Semi-Quantitative SARS-CoV-2 IgG Antibody Test
4 August 2020 - The SARS-CoV-2 IgG Antibody Test offers the first EUA-authorized semi-quantitative assay to help clinicians assess the level of an individual‘s immune response. With this numerical result expressed as index value, clinicians will be better equipped to evaluate the duration and level of an individual’s immune response. The SARS-CoV-2 IgG antibody test offers 100% sensitivity and 99.9% specificity, which is critical for detecting adaptive immune response accurately. The test also attained the CE-mark and is now broadly available globally.
Erlangen, Germany, 4 August 2020 -- Siemens Healthineers announced today that it received FDA Emergency Use Authorization (EUA) for the SARS-CoV-2 IgG (COV2G) antibody test. This is the first antibody test authorized with a semi-quantitative detection claim and the fifth antibody test from the company to receive EUA that offers sensitivity and specificity of greater than 99 percent. The COV2G antibody test offers both a positive or negative result for IgG antibodies and reports a numerical result expressed as index value. The test also attained the CE-mark and is now broadly available globally.
A positive or negative result for IgG antibodies provides insight into an individual’s prior exposure to SARS-CoV-2 virus. Importantly, a semi-quantitative result enables clinicians to gauge the level of IgG antibodies in a patient’s blood sample. With this numerical value, clinicians can establish a baseline and be better equipped to assess changes of an individual’s immune response to the SARS-CoV-2 virus. Comparison of numerical results will help determine how SARS-CoV-2 antibodies develop in an individual and persist over time. A semi-quantitative result is necessary to accurately establish the level of IgG that may be protective, and Siemens Healthineer’s COV2G assay is well positioned to support this global pursuit.
When an individual is infected with the SARS-CoV-2 virus, unique antibodies will develop at different stages of the infection. Whereas the Siemens Healthineers SARS-CoV-2 Total antibody test detects antibodies to IgM and IgG that are present both early and later during the immune response, the COV2G antibody test specifically detects IgG antibodies that persist, and are the basis for an individual’s longer term immune response. The combination of these tests provides a complete picture of a patient’s serological status for the most accurate results throughout his or her contiuum of care.
“Our high-quality antibody test helps clinicians assess the level of a person‘s immune response, which is an important tool to have at this stage of the pandemic,” said Deepak Nath, PhD, President of Laboratory Diagnostics for Siemens Healthineers. “Siemens Healthineers offers a robust portfolio of reliable tests to help support patient care and fight COVID-19.”
Highly accurate antibody test results support key decision-making for individuals and communities. Antibody tests have multiple uses:
- As an adjunct to PCR tests to aid in clinical assessment
- To help determine prior exposure to the virus, by detecting antibodies that may neutralize the virus
- To potentially identify donors of convalescent plasma
- For epidemiological purposes including establishing prevalence of disease in populations
- To potentially help verify effectiveness of vaccines as they become available
Antibody tests from Siemens Healthineers are well-positioned to aid vaccine development efforts. The COV2G antibody test, and all SARS-CoV-2 antibody tests from Siemens Healthineers, detect antibodies to S1RBD. Multiple potential vaccines in development for SARS-CoV-2 include the spike protein, specifically S1RBD—a key protein on the surface of the SARS-CoV-2 virus—within their focus.
Among the considerations for accelerated vaccine approval, according to most recent FDA Guidance issued on June 30, 2020, validated serology testing in clinical trials may play a pivotal role in assessing surrogate endpoints such as immune response to a vaccine. This requires additional understanding of SARS-CoV-2 immunology and, specifically, vaccine immune responses that might be reasonably likely to predict protection against COVID-19 and post-marketing studies to affirm predicted efficacy. The COV2G test meets or exceeds FDA requirements.
The COV2G antibody test is available on an expansive installed base of analyzers installed in the U.S. and in countries that accept the CE mark worldwide. This includes the Atellica® Solution and ADVIA Centaur® XP and XPT families of analyzers. Comparable tests for Siemens Healthineers Dimension Vista® and Dimension® EXL™ systems also are being pursued.
Siemens Healthineers has distinguished itself during the pandemic as a provider of quality antibody tests. For example, in a recent head-to-head evaluation of four commercial antibody tests conducted by Public Health England, in partnership with the University of Oxford, Siemens Healthineers’ COV2T assay was the only test that met both sensitivity and specificity targets.
About Siemens Healthineers AG
Siemens Healthineers AG (listed in Frankfurt, Germany: SHL) is shaping the future of Healthcare. As a leading medical technology company headquartered in Erlangen, Germany, Siemens Healthineers enables healthcare providers worldwide through its regional companies to increase value by empowering them on their journey towards expanding precision medicine, transforming care delivery, improving the patient experience, and digitalizing healthcare. Siemens Healthineers is continuously developing its product and service portfolio, with AI-supported applications and digital offerings that play an increasingly important role in the next generation of medical technology. These new applications will enhance the company’s foundation in in-vitro diagnostic, image-guided therapy, and in-vivo diagnostics. Siemens Healthineers also provides a range of services and solutions to enhance healthcare providers ability to provide high-quality, efficient care to patients. In fiscal 2019, which ended on September 30, 2019, Siemens Healthineers, which has approximately 52,000 employees worldwide, generated revenue of €14.5 billion and adjusted profit of €2.5 billion. Further information is available at www.siemens-healthineers.com.
Reference: https://www.siemens-healthineers.com/press-room/press-releases/covid-19-antibody-igg.html
OIE Approves Registration of VetMAX African Swine Fever Virus Detection Kit in Diagnostics Manual
3 August 2020 - First African swine fever PCR test to be registered in OIE manual of testing
LISSIEU, France, August 3, 2020 — The World Organization for Animal Health (OIE) recently approved the registration of the Applied Biosystems VetMAX African Swine Fever Virus Detection Kit from Thermo Fisher Scientific in the OIE manual of diagnostic testing. It is the first African swine fever (ASF) kit to be registered by the OIE.
“The addition of our ASF detection kit to the OIE manual marks a key milestone in our effort to help our customers address the epidemic,” said Peter Vuong, General Manager AgriBusiness. “Veterinary authorities and labs now have access to a validated diagnostic tool that can quickly track infections and help countries take appropriate action against further spread of the ASF virus.”
ASF virus is rapidly spreading around the world, especially in Asia and Europe, wreaking havoc in domestic pig populations. Non-infected countries have stepped up their biosecurity efforts to ensure the virus does not cross their border. Diagnostics can play a critical role in both outbreaks and monitoring non-infected pig populations in non-infected countries.
Established ASF diagnostics
The VetMAX African Swine Fever Virus Detection Kit is listed in the OIE Register of diagnostic kits and has been validated as fit for purpose for the detection of the African swine fever virus from blood, serum and tissues of pigs and wild pigs (including wild boars). This is the result of a rigorous evaluation by a panel of third-party experts. The kit is sensitive and specific, detecting all ASF virus genotypes known to currently circulate. It allows for reliable and rapid screening during outbreaks as well as ongoing monitoring. The VetMAX African Swine Fever Virus PCR test has been validated as part of an entire workflow for ASF detection, from sample to answer including Applied Biosystems MagMAX CORE nucleic acid extraction kits and QuantStudio PCR instruments, and has proven useful in more than 1.5 million clinical ASF samples tested around the world. The kit is also the preferred detection technology in the current outbreak of ASF in China.
PCR-based testing identifies the virus by detecting its DNA, rather than antibodies that are generated against the virus. Thus, it provides detection of the virus earlier in the infection cycle compared to other diagnostic methods. The kit can detect virus DNA using serum, whole blood or tissue and allows users to test in pools of up to 10 samples while delivering fast results. Validations have been performed that show the test also works well on meat samples and nasal swabs.
For more information about the VetMAX African Swine Fever Virus Detection Kit, please visit www.thermofisher.com/animalhealth
About ASF
African Swine Fever Virus (ASFV) is a notifiable, highly contagious disease that can cause significant economic losses. The DNA virus can infect all Suidae (domestic and wild animals) but is not a human health threat. The virus is found in all body fluids and tissues of infected pigs. They usually become infected by direct contact with sick animals or by ingestion of infected products. ASFV is highly resistant in the environment. ASF disease is characterized by high fever, loss of appetite, hemorrhages in the skin and internal organs, and death can occur within two to 10 days. ASF cannot be differentiated from classical swine fever by either clinical or post-mortem examination.
About Thermo Fisher Scientific
Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $25 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, improving patient diagnostics and therapies or increasing productivity in their laboratories, we are here to support them. Our global team of more than 75,000 colleagues delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services and Patheon. For more information, please visit www.thermofisher.com.
Reference: https://thermofisher.mediaroom.com/press-releases?item=123477
Quest Diagnostics Completes Acquisition of Mid America Clinical Laboratories, Now Provides Professional Lab Management for Nearly 30 Hospitals of Community Health Network and Ascension St. Vincent in
3 August 2020
SECAUCUS, N.J. and INDIANAPOLIS, Aug. 3, 2020 -- Quest Diagnostics, the world's leading provider of diagnostic information services, today announced that it has completed its previously announced acquisition of its joint venture partners' interests in Mid America Clinical Laboratories ("MACL").
Quest now wholly owns MACL's laboratory in Indianapolis and approximately 50 patient service centers across Indiana. Quest also now provides professional lab management services for about 30 hospitals owned and operated by Community Health Network and Ascension St. Vincent in Indiana. Community Health Network and Ascension St. Vincent are formerly joint venture partners in MACL. In addition, AmeriPath, the specialty pathology business of Quest Diagnostics, will continue to provide services to these hospitals and broadly across Indiana.
With the completed transaction, patients and providers in Indiana now have direct access to a broader menu of innovative clinical laboratory and pathology services to patients and providers in Indiana.
About Quest Diagnostics
Quest Diagnostics empowers people to take action to improve health outcomes. Derived from the world's largest database of clinical lab results, our diagnostic insights reveal new avenues to identify and treat disease, inspire healthy behaviors and improve health care management. Quest Diagnostics annually serves one in three adult Americans and half the physicians and hospitals in the United States, and our 47,000 employees understand that, in the right hands and with the right context, our diagnostic insights can inspire actions that transform lives.
Members of the COVID R&D Alliance and Quantum Leap Healthcare Collaborative Enroll First Patients in I-SPY COVID Trial
3 August 2020 - I-SPY COVID will evaluate the impact of cenicriviroc, Otezla®, and Firazyr® on inflammatory response in COVID-19 patients. Additional candidates from COVID R&D member companies entering platform trials in coming weeks.
SAN FRANCISCO, CA Aug 3, 2020 – Today, members of the COVID R&D Alliance AbbVie, Inc., Amgen Inc., and Takeda Pharmaceutical Co. Ltd. announced the first patients enrolled in the I-SPY COVID Trial (Investigation of Serial Studies to Predict Your COVID Therapeutic Response with Biomarker Integration and Adaptive Learning) clinical trial. The I-SPY COVID Trial will evaluate the efficacy of cenicriviroc, a chemokine (CCR2 and CCR5) dual-receptor antagonist, Otezla® (apremilast), a PDE4 inhibitor, and Firazyr® (icatibant injection), a bradykinin B2 receptor antagonist in severely ill, hospitalized COVID-19 patients who require high-flow oxygen.
The I-SPY COVID Trial utilizes Quantum Leap Healthcare Collaborative's adaptive platform trial design, which is intended to increase trial efficiency by minimizing the number of participants and time required to evaluate potential treatments.
"Collaborative research efforts leveraging adaptive platform trials enable faster and more complete learning about what works for patients, and they are especially critical for addressing urgent public health threats like COVID-19,” said Dr. Mark McClellan, director of the Robert J. Margolis, Center for Health Policy at Duke University and former commissioner of the U.S. FDA and administrator of the Centers for Medicare and Medicaid Services. "Platform trials bring down the cost and increase the ease of executing well-powered, high quality studies, especially when multiple, potential therapies need to be evaluated quickly. The I-SPY COVID Trial is expanding a timely and effective platform trial strategy to evaluate promising treatments while maintaining an appropriate level of safety and statistical rigor necessary for regulatory evaluation.”
The study is a collaboration between members of the COVID R&D Alliance, Quantum Leap, and the U.S. Food and Drug Administration (FDA). AbbVie, Amgen, and Takeda are members of the COVID R&D Alliance (COVID R&D), a group of more than 20 of the world’s leading biopharmaceutical and life science companies working to speed the development of potential therapies, novel antibodies, and anti-viral therapies for COVID-19 and its related symptoms.
“Sick patients in hospitals cannot wait; options are urgently needed. I’m proud to partner with AbbVie and Amgen and the dozens of other companies who have joined the COVID R&D Alliance, to initiate critical platform trials like I-SPY COVID,” remarked Andy Plump, President of R&D at Takeda Pharmaceuticals and co-founder of the COVID R&D Alliance. “The world learned of COVID-19 only six months ago, and the speed at which the scientific community has joined forces to address the critically high unmet need is inspiring. Together, experts across our companies and industry can accelerate trials with promising, well-understood therapies that upon investigation, may show efficacy in this devastating disease.”
The therapies under investigation were selected based on their potential to impact the immune system response of COVID-19 patients who need respiratory support. Approximately 10-15 percent of patients afflicted by COVID-19 develop acute respiratory distress syndrome (ARDS), and up to 60 percent of those patients admitted to an ICU require ventilation for an average of two weeks. It is estimated that half of those patients will not survive. Based on the respective mechanisms of action, Otezla® may suppress inflammation resulting from an immune response, Firazyr® may ameliorate bradykinin-driven pulmonary edema, and cenicriviroc acts by blocking monocytes trafficking to tissues, features that may help to reduce or mitigate the severity of ARDS response in severely ill COVID-19 patients.
Dr. Laura Esserman, co-founder of Quantum Leap Healthcare Collaborative and lead investigator of the I-SPY Trials stated, “The level of cooperation among pharma companies in response to the pandemic is unprecedented. The COVID R&D Alliance stepped forward to streamline the process of identifying safe, scalable and potentially effective agents and joined with the I-SPY consortium to propel our efforts forward at record speed. We are excited to open the trial and work to reduce the devastating effects of the virus in severely ill COVID patients, and to do it now, when we need it most.”
I-SPY COVID is one of several platform studies being pursued by members of COVID R&D to test promising therapeutic candidates faster than any single company could do operating alone. Members are investigating marketed and late-stage therapies indicated for other disease states, which, based on their mechanisms of action may have a potential treatment effect in COVID-19 patients. The group is employing adaptive platform trial methodologies that enable the ability to test multiple therapies simultaneously and modify protocols in real-time based on outcomes observed.
In addition to designing and sponsoring several platform trials, the COVID R&D Alliance is:
- Evaluating more than 1,900 preclinical candidates against active controls to uncover which hold the greatest promise for COVID-19.
- Reviewing promising early-stage candidates that may show potential efficacy against COVID-19, and connecting them with potential funders from venture capital or pharmaceutical developers to enable rapid advancement.
- Working with TransCelerate’s DataCelerate® platform to enable real-time data sharing and real-world evidence to inform ongoing and future studies in COVID-19, so research communities benefit from learnings and avoid duplication.
- Operating as an interlocutor with governments, regulators, and non-governmental organizations to share insights and engage in other platform trials.
About the I-SPY COVID Trial
The I-SPY COVID Trial (Investigation of Serial Studies to Predict Your COVID Therapeutic Response with Biomarker Integration and Adaptive Learning) is an adaptive platform trial designed to increase trial efficiency by minimizing the number of participants and time required to evaluate experimental and/or repurposed drugs. The focus of the trial is to improve outcomes for severely-ill COVID-19 patients—those who require at least 6L of high-flow oxygen either by mask or nasal cannula, known as level 5 on the World Health Organization (WHO) COVID scale, an 8 point ordinal scale of clinical severity status. The primary endpoint of I-SPY COVID is time to achieve level 4 (or less) for at least 48 hours on the WHO COVID scale. Key secondary endpoints include duration of time on ventilator and mortality.
About the COVID R&D Alliance
Organized in March 2020, the COVID R&D Alliance is operating unconstrained by past models of development and is accelerating study candidates without regard to company affiliation. Members are sharing clinical trial data and real-world evidence, as well as crowd-sourcing early stage candidates to identify mechanisms and treatments that may be effective against COVID-19. Initial efforts by the group focus on advancing well understood therapies and late-stage investigational medicines for severely ill patients who need options. Future activities will expand to testing re-purposed molecules, early stage candidates, and therapeutic drug combinations.
Additional information on the COVID R&D Alliance is available at www.CovidRDAlliance.com.
About Cenicriviroc (CVC)
CVC is an oral, once-daily, potent immunomodulator that blocks two chemokine receptors, CCR2 and CCR5, which are intricately involved in the inflammatory and fibrogenic pathways in nonalcoholic steatohepatitis (NASH) known to cause liver damage including cirrhosis, liver cancer, or liver failure. These pathways have also been shown to be closely involved with the respiratory sequelae of COVID-19 and of related viral infections. Because of CVC’s unique mechanisms of action, the drug has been viewed as having a potential role in the treatment of COVID-19 patients, in addition to its potential in the management liver fibrosis due to NASH, including as a part of combination-treatment strategies. CVC has been studied in both NASH patients and in HIV+ patients, and is in Phase 3 development for NASH. CVC has been granted Fast Track status in adults with liver fibrosis due to NASH, the population at highest risk of progression to cirrhosis.
About Otezla® (apremilast)
OTEZLA® (apremilast) is an oral small-molecule inhibitor of phosphodiesterase 4 (PDE4) specific for cyclic adenosine monophosphate (cAMP). PDE4 inhibition results in increased intracellular cAMP levels, which is thought to indirectly modulate the production of inflammatory mediators. The specific mechanism(s) by which Otezla exerts its therapeutic action in patients is not well defined.
Otezla is currently approved for use in more than 45 countries as an oral treatment for inflammatory diseases including psoriasis, psoriatic arthritis and Behcet’s disease. By inhibiting PDE4, Otezla is thought to modulate the production of inflammatory cytokines and other mediators, which may prove helpful in inhibiting the inflammatory response associated with the signs, symptoms and pulmonary involvements observed in some COVID-19 patients. Amgen plans to collaborate with platform trials to investigate Otezla’s ability to prevent clinical deterioration in patients with COVID-19.
About Firazyr® (icatibant injection)
FIRAZYR® (icatibant injection) is a bradykinin B2 receptor antagonist indicated for the treatment of acute attacks of hereditary angioedema (HAE) in adults 18 years of age and older. Indication may vary by country. It is administered by subcutaneous injection. It is thought that icatibant may ameliorate bradykinin-driven pulmonary edema by blocking the bradykinin-2 receptors.
About AbbVie
AbbVie's mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, women's health, and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, YouTube, and LinkedIn.
Quidel receives preliminary contract leading to definitive agreement for $71 million unter NIH’s RADx-ATP program to accelerate the expansion of its manufacturing capacity for Sofia® SARS-COV-2 antige
31 July 2020
SAN DIEGO, 31 July 2020 -- Quidel Corporation (“Quidel”), a provider of rapid diagnostic testing solutions, cellular-based virology assays and molecular diagnostic systems, announced today that Quidel has entered into a preliminary letter contract with the National Institutes of Health (NIH) through its newly launched Rapid Acceleration of Diagnostics - Advanced Technology Platforms (RADx-ATP) initiative to support the expansion of its manufacturing capacity in San Diego for its diagnostic assays that test for SARS-CoV-2 Antigen using its Sofia® Fluorescence Immunoassay (FIA) platform. Quidel and the NIH endeavor to enter into a definitive agreement to support the initiative by mid-September.
The NIH RADx-ATP investment, subject to entering into the definitive agreement with key deliverables and identified milestones, would directly support the upgrade and addition of new manufacturing lines, thereby expanding capacity for test cassettes from approximately 84 million cassettes per year to in excess of 220 million cassettes per year. This investment would also support the outfitting of a larger distribution center that would be needed for the greatly expanded yield of rapid diagnostic assays, including not only those for COVID-19 diagnosis, but also for influenza, RSV, and other infectious diseases. The contract period would be for one year beginning on July 30, 2020.
Quidel is known for its production of fast, accurate, affordable rapid diagnostic products—and, importantly for their ease-of-use and CLIA waiver—making them especially well-suited for Point-of-Care applications. Sofia® is the name of Quidel’s best-selling instrumented system. Sofia and Sofia 2, its second-generation Analyzer, both employ a fluorescence-based, lateral flow immunochemistry design and state-of-the-art optics to provide an accurate, objective and automated result in 15 minutes or less. When needed, its Read Now or Batch Test Mode enables getting results for up to 50 patient specimens within one hour. The Sofia Analyzers also come connected to Virena®, Quidel’s data management system, which wirelessly provides aggregated, de-identified testing data in near real time to users of the system for laboratory management and to public health agencies, state and federal, for bio-surveillance.
Quidel currently sells several different Sofia assays in the United States, including the Sofia® SARS Antigen FIA under FDA EUA and other FDA-cleared and CLIA-waived assays, including tests for Influenza A and B, Respiratory Syncytial Virus (RSV), Group A Strep, and a 15-minute finger-stick whole blood test for Lyme Disease. In addition, Quidel also markets Sofia® tests for Lyme Disease, Legionella, and S. pneumoniae in Europe.
About Quidel Corporation
Quidel Corporation serves to enhance the health and well-being of people around the globe through the development of diagnostic solutions that can lead to improved patient outcomes and provide economic benefits to the healthcare system. Marketed under the Sofia®, QuickVue®, D3® Direct Detection, Thyretain®, Triage® and InflammaDry® leading brand names, as well as under the new Solana®, AmpliVue®and Lyra® molecular diagnostic brands, Quidel’s products aid in the detection and diagnosis of many critical diseases and conditions, including, among others, COVID-19, influenza, respiratory syncytial virus, Strep A, lyme, herpes, pregnancy, thyroid disease and fecal occult blood. Quidel's Triage® system of tests comprises a comprehensive test menu that provides rapid, cost-effective treatment decisions at the point-of-care (POC), offering a diverse immunoassay menu in a variety of tests to provide diagnostic answers for quantitative BNP, CK-MB, d-dimer, myoglobin, troponin I and qualitative TOX Drug Screen. Quidel’s research and development engine is also developing a continuum of diagnostic solutions from advanced immunoassay to molecular diagnostic tests to further improve the quality of healthcare in physicians’ offices and hospital and reference laboratories. For more information about Quidel’s comprehensive product portfolio and to explore exciting employment opportunities, visit quidel.com.
About the project:
This project is supported by the NIH Rapid Acceleration of Diagnostics - Advanced Technology Platforms (RADx-ATP) program and has been funded in whole or in part with Federal funds from the Office of the Director, National Institutes of Health, Department of Health and Human Services, under Contract No. 75N92020C00013.
LabCorp Working With Public Health Authorities on No-Charge Antibody Test Program to Accelerate COVID-19 Blood Plasma Donation
30 July 2020 - More details of the three-month program will be provided in the near future
BURLINGTON, N.C., Jul. 30, 2020 -- LabCorp, a leading global life sciences company that is deeply integrated in guiding patient care, today announced plans to create a program to offer total antibody testing at no charge through the patient’s doctor in support of increased blood plasma donations for use as a possible COVID-19 treatment.
LabCorp is proud to be part of The Fight Is In Us coalition to increase donations of blood plasma with COVID-19 antibodies. Blood plasma is being evaluated as a possible treatment for patients with an active COVID-19 infection. Public health authorities have asked for help with expanding the population of potential plasma donors, and LabCorp is seeking to meet that challenge by creating a program to offer total antibody testing at no charge through the patient’s doctor. Patients who are interested in donating blood plasma can speak with their doctor about the total antibody testing program during their next routine visit or treatment. LabCorp is currently working with public health authorities and the provider community on the details of the three-month program and will provide additional information in the near future.
About LabCorp
LabCorp (NYSE: LH), an S&P 500 company, is a leading global life sciences company that is deeply integrated in guiding patient care, providing comprehensive clinical laboratory and end-to-end drug development services. With a mission to improve health and improve lives, LabCorp delivers world-class diagnostics solutions, brings innovative medicines to patients faster, and uses technology to improve the delivery of care. LabCorp reported revenue of more than $11.5 billion in 2019. To learn more about LabCorp, visit www.LabCorp.com, and to learn more about LabCorp’s drug development business, Covance, visit www.Covance.com.
BD Announces $24 Million U.S. Government Investment to Support Scale Up of U.S. Manufacturing of COVID-19 Diagnostic Tests
30 July 2020 - Capital investments will enable U.S. manufacturing of 8 million BD Veritor™ brand SARS-CoV-2 tests per month
FRANKLIN LAKES, N.J., July 30, 2020 – BD (Becton, Dickinson and Company), a leading global medical technology company, today announced a $24 million investment from the U.S. Department of Defense in collaboration with the U.S. Department of Health and Human Services to support the scale up of U.S. manufacturing capabilities for BD Veritor™ Solution for Rapid Detection of SARS-CoV-2.
The additional capital equipment will bolster domestic production and increase total production capacity by 50 percent. These investments will enable global production of more than 12 million test kits per month by the end of February 2021.
“Making COVID-19 diagnostic tests widely available is critical to expanding rapid detection of COVID-19 infections, and mitigating the impact of the disease by identifying affected patients, quickly quarantining infectious individuals and tracing their contacts,” said Dave Hickey, president of Integrated Diagnostic Solutions for BD. “This investment will bolster our U.S. manufacturing capabilities helping us quickly scale our production of point-of-care COVID-19 tests to ensure we have a robust supply for our U.S. customers.”
BD announced that it had received FDA emergency use authorization for the BD Veritor™ Plus SARS-CoV-2 antigen assay on July 6, 2020 and plans to leverage its growing U.S. installed base of more than 25,000 BD Veritor™ Plus instruments to enable the deployment of the SARS-CoV-2 assay across the U.S. The easy-to-use design of the instrument, slightly larger than a cell phone, makes it ideal for use in a variety of clinical settings including hospitals, clinician offices, urgent care centers, and retail pharmacies, where it has already been used in influenza, group A strep and RSV testing for several years.
U.S. customers interested in BD diagnostic solutions for COVID-19 should visit BD.com/covid19 or contact IDS.Covidtests@bd.com.
About BD
BD is one of the largest global medical technology companies in the world and is advancing the world of health by improving medical discovery, diagnostics and the delivery of care. The company supports the heroes on the frontlines of health care by developing innovative technology, services and solutions that help advance both clinical therapy for patients and clinical process for health care providers. BD and its 65,000 employees have a passion and commitment to help enhance the safety and efficiency of clinicians' care delivery process, enable laboratory scientists to accurately detect disease and advance researchers' capabilities to develop the next generation of diagnostics and therapeutics. BD has a presence in virtually every country and partners with organizations around the world to address some of the most challenging global health issues. By working in close collaboration with customers, BD can help enhance outcomes, lower costs, increase efficiencies, improve safety and expand access to health care.
For more information on BD, please visit bd.com.
Roche provides an update on the phase III COVACTA trial of Actemra/RoActemra in hospitalised patients with severe COVID-19 associated pneumonia
29 July 2020 - COVACTA trial did not meet its primary endpoint of improved clinical status in patients with COVID-19 associated pneumonia, or the key secondary endpoint of reduced patient mortality. The study is the first global, randomised, double-blind, placebo-controlled phase III trial investigating Actemra/RoActemra in this setting. Roche remains committed to continuing the Actemra/RoActemra clinical trial programme in COVID-19 to further explore Actemra/RoActemra in other treatment settings, including in combination with an antiviral.
Basel, 29 July -- Roche today announced that the phase III COVACTA study of Actemra®/RoActemra® (tocilizumab) did not meet its primary endpoint of improved clinical status in hospitalised adult patients with severe COVID-19 associated pneumonia. In addition, the key secondary endpoints, which included the difference in patient mortality at week four, were not met; however, there was a positive trend in time to hospital discharge in patients treated with Actemra/RoActemra. The COVACTA study did not identify any new safety signals for Actemra/RoActemra. Further analysis of the trial results is needed to fully understand the data. The results will be submitted for publication in a peer-reviewed journal.
“People around the world are waiting for further effective treatment options for COVID-19 and we are disappointed that COVACTA did not demonstrate a benefit for patients in either clinical status or mortality at week four. We will continue to generate evidence to provide a more complete understanding of Actemra/RoActemra in COVID-19 associated pneumonia,” said Levi Garraway, M.D., Ph.D., Roche’s Chief Medical Officer and Head of Global Product Development. “We are grateful for the patients and physicians around the world who helped us to complete this study quickly during a public health crisis, while upholding the highest standards of scientific rigour. We will keep working to help combat the COVID-19 pandemic.”
The COVACTA trial was conducted in collaboration with the Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response at the United States Department of Health and Human Services.
COVACTA evaluated the safety and efficacy of intravenous Actemra/RoActemra added to standard-of-care treatment compared to treatment with placebo plus standard of care. The primary endpoint of clinical status in hospitalised adult patients with severe COVID-19 associated pneumonia was measured by a 7-category ordinal scale, which tracked patients’ clinical status based on the need for intensive care and/or ventilator use, as well as supplemental oxygen requirements. The COVACTA trial is the first global, randomised, double-blind, placebo-controlled phase III study to investigate Actemra/RoActemra in adult patients hospitalised with severe COVID-19 associated pneumonia, with study locations in the US, Canada and Europe.
Summary of Key COVACTA Clinical and Safety Findings
- Primary endpoint not met: The difference in clinical status between Actemra/RoActemra and placebo in patients assessed using a 7-category ordinal scale at week four was not statistically significant (p=0.36; odds ratio [95% CI] = 1.19 [0.81, 1.76], a statistically significant odds ratio greater than 1 would have favoured Actemra/RoActemra).
- There was no difference between Actemra/RoActemra and placebo in the percentage of patients that died by week four (Actemra/RoActemra = 19.7% and placebo = 19.4% with a difference [95% CI] of 0.3% [-7.6%, 8.2%], p=0.9410)
- Time to hospital discharge or ‘ready to discharge’ was shorter in patients treated with Actemra/RoActemra than in those treated with placebo. The median time to discharge or ‘ready to discharge’ for Actemra/RoActemra was 20 days and for placebo was 28 days (median time [95% CI]: Actemra/RoActemra = 20.0 [17.0, 27.0]; placebo = 28.0 [20.0, NE], p=0.0370). However, the difference cannot be considered statistically significant as the primary endpoint was not met.
- The difference in ventilator-free days between Actemra/RoActemra and placebo was not statistically significant (median of 22 days for Actemra/RoActemra and 16.5 days with placebo, difference in medians [95% CI] = 5.5 [-2.8, 13.0], p=0.3202).
- At week four, rates of infections were 38.3% and 40.6% in the Actemra/RoActemra and placebo arms, respectively, and the rates of serious infections were 21.0% and 25.9% in the Actemra/RoActemra and placebo arms, respectively. The COVACTA study did not identify any new safety signals for Actemra/RoActemra.
In addition to COVACTA, Roche has initiated several studies to further investigate Actemra/RoActemra as a potential treatment for patients with COVID-19 associated pneumonia, including two phase III clinical trials, REMDACTA and EMPACTA, as well as the phase II MARIPOSA trial. There are also a number of independent trials of Actemra/RoActemra in this setting. Actemra/RoActemra has not previously been studied in, nor approved for, COVID-19 associated pneumonia.
For more information on how Roche is responding to the global COVID-19 pandemic, please visit our COVID-19 response page.
About the COVACTA Trial
COVACTA is a global, randomised, double-blind, placebo-controlled phase III study (COVACTA, NCT04320615) evaluating the safety and efficacy of intravenous Actemra/RoActemra added to standard of care in adult patients hospitalised with severe COVID-19 associated pneumonia compared to placebo plus standard of care. The primary and secondary endpoints include clinical status, mortality, mechanical ventilation and intensive care unit (ICU) variables at week four. Patients will be followed for 60 days post randomisation.
About Actemra/RoActemra
Actemra/RoActemra was the first approved anti-IL-6 receptor biologic available in both intravenous (IV) and subcutaneous (SC) formulations for the treatment of adult patients with moderate-to-severe active rheumatoid arthritis (RA). Actemra/RoActemra can be used alone or with methotrexate (MTX) in adult RA patients who are intolerant to, or have failed to respond to, other disease-modifying anti-rheumatic drugs (DMARDs). In Europe, RoActemra IV and SC are also approved for use in adult patients with severe, active and progressive RA who previously have not been treated with MTX. Actemra/RoActemra IV and SC are approved globally for polyarticular juvenile idiopathic arthritis (pJIA) and in the US and Europe for systemic juvenile idiopathic arthritis (sJIA) in children two years of age and older. Actemra/RoActemra SC injection is also the first approved therapy for the treatment of giant cell arteritis (GCA) in more than 40 countries, including the US and Europe. In the US and Europe, Actemra/RoActemra IV injection is approved for the treatment of chimeric antigen receptor (CAR) T-cell-induced severe or life-threatening cytokine release syndrome (CRS) in people two years of age and older. Actemra/RoActemra was the first approved treatment for CRS in this setting. A prefilled auto-injector ACTPen has been approved in the US and Europe. In Japan, Actemra is also approved for the treatment of Castleman’s disease, adult Still's disease and Takayasu arteritis, in addition to the above mentioned indications. Actemra/RoActemra is part of a co-development agreement with Chugai Pharmaceutical Co., Ltd and has been approved in Japan since April 2005. Actemra/RoActemra is approved in more than 110 countries worldwide.
About Roche’s Response to the COVID-19 Pandemic
The COVID-19 pandemic continues to evolve globally, with varying developments from country to country. We are partnering with healthcare providers, laboratories, authorities and organisations to help ensure patients receive the tests, treatment and care that they need.
Reliable, high-quality testing is essential to help healthcare systems overcome this pandemic. On 12 March, we received FDA Emergency Use Authorisation (EUA) for a high-volume molecular test to detect SARS-CoV-2, the virus that causes COVID-19. It is also available in countries accepting the CE Mark. On 3 May, Roche announced that its COVID-19 antibody test, aimed at detecting the presence of antibodies in the blood, also received FDA EUA and is available in markets accepting the CE mark. Also in June, we received an FDA EUA for the Elecsys® IL-6 test to assist in identifying severe inflammatory response in patients with confirmed COVID-19, as well as launching Roche v-TAC, which could help simplify the screening, diagnosis and monitoring of patients with respiratory compromise in the current COVID-19 pandemic. Roche is working closely with governments and health authorities around the world, and has significantly increased production to help ensure availability of tests globally.
We are actively involved in understanding the potential of our existing portfolio for COVID-19 and are researching options for the future.
About Roche
Roche is a global pioneer in pharmaceuticals and diagnostics focused on advancing science to improve people’s lives. The combined strengths of pharmaceuticals and diagnostics under one roof have made Roche the leader in personalised healthcare – a strategy that aims to fit the right treatment to each patient in the best way possible.
Roche is the world’s largest biotech company, with truly differentiated medicines in oncology, immunology, infectious diseases, ophthalmology and diseases of the central nervous system. Roche is also the world leader in in vitro diagnostics and tissue-based cancer diagnostics, and a frontrunner in diabetes management.
Founded in 1896, Roche continues to search for better ways to prevent, diagnose and treat diseases and make a sustainable contribution to society. The company also aims to improve patient access to medical innovations by working with all relevant stakeholders. More than thirty medicines developed by Roche are included in the World Health Organization Model Lists of Essential Medicines, among them life-saving antibiotics, antimalarials and cancer medicines. Moreover, for the eleventh consecutive year, Roche has been recognised as one of the most sustainable companies in the Pharmaceuticals Industry by the Dow Jones Sustainability Indices (DJSI).
The Roche Group, headquartered in Basel, Switzerland, is active in over 100 countries and in 2019 employed about 98,000 people worldwide. In 2019, Roche invested CHF 11.7 billion in R&D and posted sales of CHF 61.5 billion. Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan. For more information, please visit www.roche.com.
Reference: https://www.roche.com/media/releases/med-cor-2020-07-29.htm
FDA Authorizes New Quest Diagnostics Lab Method Designed to Increase COVID-19 Molecular Diagnostics Capacity
29 July 2020 - Technique to increase COVID-19 molecular diagnostic testing capacity and provide faster test results reporting
SECAUCUS, N.J., July 29, 2020 -- Quest Diagnostics today announced that the U.S. Food and Drug Administration (FDA) has granted emergency use authorization (EUA) for a new laboratory technique that speeds the process of extracting viral RNA from specimens and will enable the company to expand its daily capacity of COVID-19 molecular diagnostic tests on behalf of patients in the United States.
"Laboratory innovation is key to optimizing testing capacity for COVID-19," said Steve Rusckowski, Chairman, Chief Executive and President, Quest Diagnostics. "We appreciate the collaboration of the FDA to bring this technique to several of our labs spanning the U.S. With more testing capacity, we expect to improve turnaround times for our customers and patients."
With the new FDA EUA, six of the company's laboratories in the U.S. may now run this new RNA extraction method, including on pooled specimens. Those laboratories are well situated geographically to address high testing demand in states where the virus has been surging. The labs are in San Juan Capistrano and Valencia, California; Lewisville, Texas; Lenexa, Kansas; Chantilly, Virginia; and Marlborough, Massachusetts.
Optimizing Capacity for Faster Testing
In its submission to the FDA, the company explained that "the method is needed to address availability of extraction supplies and increase testing capacity."
The company currently has the capacity to perform 135,000 COVID-19 molecular diagnostic tests a day. The new method is expected to add an additional 35,000 tests a day in overall capacity over the next several weeks. In addition, the company will be able to use specimen pooling with the new method to increase capacity even further.
Consequently, Quest now expects to have the capacity to perform 150,000 tests per day by next week and to continue to build additional capacity beyond that to 185,000 tests per day by Labor Day. Quest expects this innovation will help it to achieve average turnaround times of 1 day for "Priority 1" patients and 2-3 days for all other patients in coming weeks.
The new extraction technique may be used with the Quest Diagnostics SARS-CoV-2 RNA, Qualitative Real Time RT-PCR (Quest SARS-CoV-2 rRT-PCR), a proprietary test developed and validated by Quest Diagnostics for use on respiratory specimens from individuals suspected of COVID-19 by their healthcare provider. On July 17, the FDA granted an EUA for the test to be used with pooled specimens.
Quest Diagnostics is a leader in infectious disease testing services, with a broad menu of molecular, antibody, and other test services to aid diagnosis, treatment and monitoring. The new FDA EUA follows several others received by the company for its COVID-19 test innovations.
About Our COVID-19 Testing
Quest Diagnostics is at the forefront of the response to the COVID-19 pandemic, working to broaden access to laboratory insights to help us all lead healthier lives. We provide both molecular diagnostic and antibody serology tests to aid in the diagnosis of COVID-19 and immune response. Our COVID-19 test services are based on tests that have received FDA emergency use authorization and which also meet our high standards for quality. We are providing these test services under the Public Readiness and Emergency Preparedness Act. We provide data on COVID-19 testing to various federal and state public health authorities, including the Centers for Disease Control and Prevention, and participate in studies with government and private institutions, aiding COVID-19 public health response and research. Through our team of dedicated phlebotomists, air fleet team, couriers and laboratory professionals, Quest Diagnostics works hard every day to help patients and communities across the United States access quality COVID-19 testing.
About Quest Diagnostics
Quest Diagnostics empowers people to take action to improve health outcomes. Derived from the world's largest database of clinical lab results, our diagnostic insights reveal new avenues to identify and treat disease, inspire healthy behaviors and improve health care management. Quest annually serves one in three adult Americans and half the physicians and hospitals in the United States, and our 47,000 employees understand that, in the right hands and with the right context, our diagnostic insights can inspire actions that transform lives. www.QuestDiagnostics.com
LGC SeraCare SARS-CoV-2 Molecular Controls Kit now CE-Marked
28 July 2020
28 July 2020 -- LGC SeraCare is pleased to announce that the AccuPlex™ SARS-CoV-2 Reference Material Kit v2 is now CE-marked for in vitro diagnostic use (CE-IVD). With this change in regulatory status, the new product name is AccuPlex SARS-CoV-2 Molecular Controls Kit. Bearing the CE mark and IVD symbol signifies that the AccuPlex SARS-CoV-2 Molecular Controls Kit meets extensive design control requirements.
LGC SeraCare’s proprietary AccuPlex technology mimics wild-type pathogenic viruses, but is safe, non-infectious, and replication deficient. These materials serve as true, full-process controls that challenge the entire PCR test procedure, making them the preferred alternative to infectious materials. The AccuPlex SARS-CoV-2 Molecular Controls Kit is designed to measure day-to-day assay performance and contains positive materials directed against the published CDC and WHO consensus sequences and the S gene, and negative materials targeting the human RNase P gene.
Michael Sweatt, Executive Vice President, LGC SeraCare, stated, “Achieving this regulatory milestone for this SARS-CoV-2 control kit provides added value to our customers, especially throughout the European Union where this registration is sometimes required. We are committed to continuing to support the worldwide diagnostic community with dependable quality controls for infectious diseases, including COVID-19.”
To learn more about the AccuPlex SARS-CoV-2 Molecular Controls Kit as well as the complete line of SARS-CoV-2 Molecular & Serology Quality Solutions, please visit the LGC SeraCare website.
Grifols delivers first manufactured batches of its anti-SARS-CoV-2 hyperimmune globulin for clinical trials
28 July 2020 - The therapy, which provides passive immunity and could be used for both prevention and treatment, will undergo clinical trials this summer to evaluate its safety and efficacy. This is part of a collaboration agreement with U.S. government entities, including the Food and Drug Administration (FDA), the National Institutes of Health (NIH) and the Biomedical Advanced Research Development Authority (BARDA), among other healthcare agencies. In the past months Grifols has been collecting convalescent plasma in more than 245 Grifols U.S. donation centers from healthy recovered COVID-19 donors who have met the highest eligibility criteria.
Barcelona, Spain, July 28, 2020 -- Grifols, a global leader in the development of therapies with plasma-derived proteins with a track record of more than 100 years dedicated to enhancing people’s health and well-being, today announced it has delivered the first manufactured batches of its anti-SARS-CoV-2 hyperimmune globulin for clinical trials.
This medicine specifically targets SARS-CoV-2 by providing passive immunity to infected patients and boosting their immune system’s ability to fight the disease. The therapy, which could be used for both prevention and immediate treatment of COVID-19, will undergo clinical trials this summer to test its safety and efficacy.
The anti-SARS-CoV-2 hyperimmune globulin, which is derived from the blood plasma of healthy donors recovered from COVID-19, has the potential to be a highly specific, pure and safe medicine that delivers a high and consistent concentration of protective antibodies against the novel coronavirus.
As a medicine class, hyperimmune globulins have been increasingly used since the 1970s to prevent and treat common diseases including measles, rabies and tetanus. They are also a potential therapy option in response to future outbreaks of emerging viruses and other pathogens.
Since April, Grifols has moved quickly to collect COVID-19 convalescent plasma for its anti-SARS-CoV-2 hyperimmune globulin in more than 245 Grifols U.S. donation centers from donors who have met the highest eligibility criteria. Their plasma, rigorously tested and quality controlled, had high levels of anti-SARS-CoV-2 neutralizing antibodies.
The efforts form part of a collaboration agreement with U.S. government entities, including the Food and Drug Administration (FDA), the National Institutes of Health (NIH) and the Biomedical Advanced Research Development Authority (BARDA), among other healthcare agencies.
Previous experiences, particularly that with Ebola, have enabled the company to react rapidly to the challenge. During the Ebola outbreak in Liberia in 2014, Grifols collected convalescent plasma and designed and activated a plant in Clayton, North Carolina, especially equipped and staffed with personnel specialized in the production of plasma-derived medicines for infectious diseases.
“Grifols is grateful to all the plasma donors who through their generosity are now helping to develop a medicine, a hyperimmune globulin, whose concentrated antibodies will potentially provide others with passive immunity to overcome the disease,” said Victor Grifols Deu, co-CEO of Grifols.
Added Grifols co-CEO Raimon Grifols Roura: “All of us at Grifols are proud to devote our time, talent and energies to fight this health crisis.”
In addition to clinical trials in the U.S., Grifols is working on a European clinical trial of a hyperimmune globulin using convalescent plasma collected in Europe.
Grifols is the worldwide leader in the production and distribution of immunoglobulins and hyperimmune globulins, and is firmly committed to its mission of addressing the current and future needs of patients in the world.
Sysmex Launches Lab Assay Service for Research on Cytokines Related to the Novel Coronavirus (SARS-CoV-2)
27 July 2020 - Aiming to monitor the risk of increasing severity and treatment effects in clinical applications
27 July 2020 -- On July 1, 2020, Sysmex Corporation (HQ: Kobe, Japan; Chairman and CEO: Hisashi Ietsugu) began providing a lab assay service for research on cytokines,1which have been suggested as a useful indicator in monitoring the risk of increasing severity and treatment effects for the novel coronavirus (SARS-CoV-2), which causes the novel coronavirus disease COVID-19. Sysmex plans to continue conducting R&D with a view to expanding target parameters for lab assay and providing reagents for research.
The majority of patients suffer only light symptoms from COVID-19, the infection that occurs when SARS-CoV-2 enters the body. However, many asymptomatic carriers exist, and among otherpatientsthe disease can rapidly grow more severe. In preparation for a predicted resurgence of COVID-19, an urgent need exists for efforts to establish diagnostic tests that cover the time period spanningfromimmediately after infection through to treatment and recovery. This calls for a testing method that accommodates clinical applications, such as the confirmation of initial diagnosis, confirmed diagnosis, risk of increasing severity, and confirmation of treatment effect, and that satisfiesmeasurement parameters and measurement times (number of samples processed).
When a virus enters the body and attacks cells, those cells secrete immunoregulatory proteins called cytokines. By communicating the existence of the virus to immune cells, cytokines help immune cells to destroy cells infected by the virus. In some individuals, excessively active immune cells can begin attacking normal cells and tissues, which is known to injure the lungs and various other organs. In this process, large numbers of cytokines are released into the bloodstream in a phenomenon known as a cytokine storm. Cytokine storms are thought to be related to the increasing severity of COVID-19, and expectations are growing for the elucidation of this mechanism and the practical realization of clinical tests.
Against this backdrop, on July 1, 2020 Sysmex began providing “cytokine measurement for research,” a cytokine lab assay service for research using the chemiluminescence enzyme immunoassay method. Targeting research institutions, universities, medical institutions and pharmaceutical companies, we will provide data that can be used toconfirm testing methods suitable to such clinical applications as determiningthe risk of increasing severity and treatment effect, as well as data that can be usedfor vaccines, antiviral drugs and other drug discovery research. We will start by providing a lab assay service for research onthe six cytokines most relevant to COVID-19. We will gradually expand the parameters and continue development with a view to providing reagents for research.
Through the provision of a lab assay service for research that leverages its proprietary measurement platforms and the technologies it possesses, Sysmex will continue promoting R&D toward the practical realization of biomarkers with high clinical value, working with customers to help achieve advances in healthcare.
LabCorp Receives Authorization for COVID-19 Sample Pooling
25 July 2020 - New Method Aims to Improve Efficiency of COVID-19 Testing, Optimize Testing Supplies and Increase Overall Capacity
BURLINGTON, N.C.--(BUSINESS WIRE)--Jul. 25, 2020-- LabCorp (NYSE: LH), a leading global life sciences company that is deeply integrated in guiding patient care, today announced it received an Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) permitting diagnostic testing of groups of individuals for active COVID-19 infections utilizing matrixed pooled testing, a method that tests several patient samples at once.
LabCorp’s unique matrixed pooled strategy for COVID-19 provides an efficient testing approach for populations by allowing for larger groups of samples to be tested at one time. This methodology can quickly provide quality test results for individuals within the group, without requiring retesting in the majority of cases. Pooled testing may be used for populations at low risk of COVID-19, when testing demand exceeds laboratory capacity, or when testing reagents are in short supply.
“We believe science and technology are the best ways to beat the virus, and our matrixed pooled testing method is another way LabCorp is helping to respond to this health crisis,” said Brian Caveney, chief medical officer and president of LabCorp Diagnostics. “Pooling methods test groups of individuals efficiently and with high quality, while increasing our overall testing capacity. The demand for testing continues to increase and we are committed to finding innovative solutions to ensure testing is available.”
LabCorp’s matrixed pooled testing method involves testing up to five samples at once. If there is a positive sample in the pool, LabCorp can identify the individual positive sample in the pool using patterns detected by its robotic testing platform. Pooled testing can reduce the number of tests required in specific populations, optimize laboratory testing supplies, and increase testing capacity.
LabCorp received the EUA from the FDA on July 24 for the qualitative detection of nucleic acid from SARS-CoV-2 in upper and lower respiratory specimens from individuals suspected of COVID-19, using a matrix pooling strategy (i.e., group pooling strategy), containing up to five individual upper respiratory swab specimens (nasopharyngeal, mid-turbinate, anterior nares or oropharyngeal swabs) per pool and 25 specimens per matrix, where each specimen is collected under observation or by a healthcare provider using individual vials containing transport media. Negative results from pooled testing should not be treated as definitive. If a patient’s clinical signs and symptoms are inconsistent with a negative result or results are necessary for patient management, then the patient should be considered for individual testing. Specimens included in pools where the positive sample cannot be identified using the matrix must be tested individually prior to reporting a result. Specimens with low viral loads may not be detected in sample pools due to decreased sensitivity of pooled testing.
LabCorp’s COVID-19 molecular test has been authorized by the FDA under an EUA only for the detection of nucleic acid from SARS-CoV-2, and not for any other viruses or pathogens, and has not been FDA cleared or approved. The test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostic tests for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.
This EUA is effective until the declaration that circumstances exist justifying the authorization of the emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 is terminated under Section 564(b)(2) of the Act or the EUA is revoked under Section 564(g) of the Act.
About LabCorp
LabCorp (NYSE: LH), an S&P 500 company, is a leading global life sciences company that is deeply integrated in guiding patient care, providing comprehensive clinical laboratory and end-to-end drug development services. With a mission to improve health and improve lives, LabCorp delivers world-class diagnostics solutions, brings innovative medicines to patients faster, and uses technology to improve the delivery of care. LabCorp reported revenue of more than $11.5 billion in 2019. To learn more about LabCorp, visit www.LabCorp.com, and to learn more about LabCorp’s drug development business, Covance, visit www.Covance.com.
Grifols acquires 10% stake in Bloodbuy, cloud-based marketplace for blood products
23 July 2020 - Investment forms part of the company’s ongoing commitment to leading technologies and solutions that reinforce and complement its core businesses. Transaction will offer synergies to Grifols’ Bio Supplies Division and its Diagnostic Division’s leading transfusion medicine business.
Barcelona, Spain, July 23, 2020 -- Grifols, a leading global producer of plasma-derived medicines and a leader in the development of innovative diagnostic solutions, today announced it has acquired 10% of Bloodbuy (BloodSolutions, LLC), a cloud-based marketplace that facilitates buying and selling of blood components in the U.S.
Bloodbuy’s (www.bloodbuy.com) proprietary technology platform and computer-based algorithms enable regional blood-collection centers to expand their customer base across the U.S., while providing hospitals and other healthcare providers greater access to vital blood components in an efficient and efficacious manner connecting supply and demand.
Along with this equity investment, Grifols will obtain a seat on the Bloodbuy Board of Directors where it will be able to not only contribute to Bloodbuy’s growth but also closely analyze the blood-component-product marketplace, potentially allowing the company to make further investments in the digital healthcare space.
Bloodbuy’s platform allows participating healthcare providers to supplement their blood component needs on both a recurring and on-demand basis, ensuring hospitals can continue to provide the best care possible for their patients while providing blood-collection centers the ability to distribute their lifesaving products more broadly. The platform also reduces wastage costs of precious biological products while improving profitability.
“Grifols has always been interested in how digital technologies can disrupt the healthcare model to deliver better patient care more effectively,” said David Bell, Chief Innovation Officer of Grifols. “We believe Bloodbuy provides a unique opportunity to use technology to ensure critical blood components reach the patients who need them quickly and efficiently.”
“COVID-19 has created unprecedented challenges for our blood supply, both with respect to supply and demand shocks related to social distancing, suspension of elective procedures, and other necessary public health interventions,” said Chris Godfrey, Founder & CEO of Bloodbuy. “These externalities have had profoundly negative effects on blood product availability and utilization from region-to-region. Our online platform has played an integral role in connecting these geographies to create a digitally integrated network of blood centers and hospitals; so, we can easily redistribute available blood products and connect stakeholders around much-needed COVID-19 convalescent plasma.”
Bloodbuy’s cloud-based marketplace is available across the United States for all qualified hospitals, medical centers, integrated delivery networks, and blood collection centers. Bloodbuy’s current participants include some of the most prestigious medical institutions in the country, as well as nearly 30 independent blood collection centers. The recent COVID-19 crisis has spurred further adoption as hospitals and blood collection centers employ methods to reduce operational uncertainty in this unpredictable environment.
According to a recent U.S. Department of Health and Human Services report, nearly 23% of all hospitals surveyed were forced to cancel elective surgery for one or more days as a result of blood inventory shortages. Additionally, various studies have indicated some U.S. regions experience platelet wastage rates between 5% and 25% due to unpredictable supply and demand characteristics in local markets.
FDA Clears First Blood Test for Identifying a Novel Allergic Sensitization to Red Meat
23 July 2020 - Thermo Fisher Scientific's ImmunoCAP Specific IgE alpha-Gal Allergen Component test helps clinicians pinpoint a potentially fatal allergy often resulting from tick bites
PORTAGE, Mich., July 23, 2020 -- ImmunoCAP Specific IgE alpha-Gal Allergen Component test has been cleared by the U.S. Food & Drug Administration (FDA) for in vitro diagnostic use. Test results can aid specialists and other healthcare providers as they diagnose a patient's sensitization to the alpha-Gal carbohydrate found in mammalian (red) meat and assess his or her risk for an anaphylactic reaction.
According to the American Academy of Asthma, Allergy and Immunology, an allergy to alpha-Gal can cause patients to have a severe and potentially life-threatening reaction to galactose-alpha-1, 3-galactose that is found in most mammalian (red) meat. Unlike other food allergies, reactions from eating red meat may be delayed, occurring three to eight hours after eating. Symptoms range from hives and itching, to abdominal pain, nausea or vomiting. In severe cases the allergy can cause anaphylaxis which can be potentially fatal. The condition can appear in patients who have tolerated meat for many years, with researchers believing that sensitization to alpha-Gal may be the result of a bite from the lone star tick (Amblyomma americanum).
"Alpha-gal is dramatically different from other forms of food allergy," said Thomas Platts-Mills, MD, professor of medicine and microbiology at the University of Virginia School of Medicine and a leading researcher on the topic. "Previously healthy adults can suddenly develop potentially life-threatening reactions to red meats such as beef, pork and lamb. The delayed nature of the reactions adds to the difficulty that clinicians and patients have in identifying the cause of the symptoms. This unique set of circumstances makes an accurate diagnosis critical for managing this disease."
ImmunoCAP Specific IgE blood testing is the most widely used specific IgE blood test, and its use is documented in more than 6,000 peer-reviewed publications. The tests can help identify allergic sensitization to common environmental allergens – seasonal and perennial, outdoor and indoor– as well as common food allergens such as peanut, egg and milk. The ImmunoCAP Specific IgE Stinging Insect Allergen Component tests were recently cleared by the FDA to help improve the diagnosis of bee and wasp allergies. ImmunoCAP Specific IgE blood tests, which are available in most major U.S. laboratories, can be ordered for patients of any age regardless of skin condition, current medication, disease activity or pregnancy status.
"Sensitization to the alpha-Gal carbohydrate has been notoriously difficult to measure in patients," said Dr. Lakiea Wright, MD MAT MPH, Medical Director, US ImmunoDiagnostics at Thermo Fisher Scientific. "Skin prick testing to red meats such as beef, pork, or lamb often gives weak or negative results, which is why, based on clinical studies, quantification of IgE antibodies to alpha-Gal in the blood is the preferred diagnostic method. Information from these tests can help providers be more precise in their diagnosis and management recommendations."
For more information on testing for alpha-Gal allergy, symptoms and diagnosis, please visit allergyinsider.com.
About Thermo Fisher Scientific
Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $25 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, improving patient diagnostics and therapies or increasing productivity in their laboratories, we are here to support them. Our global team of more than 75,000 colleagues delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services and Patheon. For more information, please visit www.thermofisher.com.
QIAGEN announces publication of Supplemental Reasoned Position Statement for proposed acquisition by Thermo Fisher
22 July 2020
Venlo, the Netherlands, July 22, 2020 -- QIAGEN N.V. announced today the publication of its Supplemental Reasoned Position Statement in response to the amended Offer Document published by Thermo Fisher Scientific Inc on July 17, 2020. The Offer Document relates to the recommended offer by Thermo Fisher to fully acquire all issued ordinary shares in QIAGEN for an increased offer price of €43.00 per QIAGEN share in cash, as announced on July 16, 2020.
QIAGEN has published the Supplemental Reasoned Position Statement of the Managing Board and the Supervisory Board in accordance with Section 27 para. 3 in connection with Section 14 para. 3 of the German Securities Acquisition and Takeover Act (Wertpapiererwerbs- und Übernahmegesetz) and Section 18 para. 2 in connection with Annex G of the Dutch Public Offer Decree (Besluit openbare biedingen Wft).
The Supplemental Reasoned Position Statement, together with the Reasoned Position Statement already published on May 18, 2020, provides in detail the underlying financial and non-financial aspects and the overall circumstances which the Managing Board and Supervisory Board considered when reaffirming their unanimous recommendation of the offer and their unanimous recommendation that all QIAGEN shareholders accept and tender all of their QIAGEN shares in the offer prior to the end of the acceptance period on August 10, 2020. Each of the members of the Supervisory Board and Managing Board has tendered or will tender all of their QIAGEN shares in the offer.
The English and German version of the statement is published on QIAGEN’s website at http://www.qiagen.com/investors. Copies of the German version of the statement can also be obtained free of charge by contacting QIAGEN via e-mail at IR@qiagen.com or by telephone at +49 (0)2103 29 11709.
About QIAGEN
QIAGEN N.V., a Netherlands-based holding company, is the leading global provider of Sample to Insight solutions that enable customers to gain valuable molecular insights from samples containing the building blocks of life. Our sample technologies isolate and process DNA, RNA and proteins from blood, tissue and other materials. Assay technologies make these biomolecules visible and ready for analysis. Bioinformatics software and knowledge bases interpret data to report relevant, actionable insights. Automation solutions tie these together in seamless and cost-effective workflows. QIAGEN provides solutions to more than 500,000 customers around the world in Molecular Diagnostics (human healthcare) and Life Sciences (academia, pharma R&D and industrial applications, primarily forensics). As of June 30, 2020, QIAGEN employed approximately 5,200 people in over 35 locations worldwide. Further information can be found at http://www.qiagen.com.
Reference: https://corporate.qiagen.com/newsroom/press-releases/2020/20200722_supplemental_rps
BD receives FDA Approval for HPV Test with Extended Genotyping Capabilities
22 July 2020 - BD Onclarity™ HPV Assay is the only FDA-approved HPV assay to individually identify and report genotypes beyond 16, 18 and 45
FRANKLIN LAKES, N.J., July 22, 2020 -- BD (Becton, Dickinson and Company), a leading global medical technology company, today announced that it received approval for a pre-market approval (PMA) supplement from the U.S. Food and Drug Administration (FDA) for an expanded version of its BD Onclarity™ HPV Assay. The PMA supplement includes the expansion for genotype reporting beyond HPV genotypes 16, 18, and 45 to include types 31, 51, 52, 33/58, 35/39/68, and 56/59/66 genotypes making the BD Onclarity™ HPV Assay the only FDA-approved assay to individually identify and report these genotype results.
The value of extended genotyping for cervical cancer screening and triage has been reported from large clinical studies since 2015. Additionally, the need for expanded HPV genotyping for cervical screening has been recognized since 2016. In many cases, the reporting of HPV genotypes with the screening test result could improve risk stratification and support risk-based patient management. The April 2020 publication of the ASCCP risk-based management consensus guidelines anticipated that extended genotyping would be introduced soon.
"BD Onclarity™ extended genotyping is data-driven precision medicine at its best, helping us effectively and efficiently manage our patients,” said Mark H. Stoler, MD Professor Emeritus of Pathology, University of Virginia Health System. “Contemporary management of women with abnormal cervical cancer screening results demands an assessment of their risk of pre-cancer. An abundance of recent science clearly shows that knowing the HPV genotype of the patient provides excellent differential stratification of those risks.”
“It is well known that different HPV genotypes carry different risk of cervical cancer, and without the specific knowledge of the HPV genotype in a screening sample many women will be over-treated needlessly,” said Jesper Bonde, PhD, Senior Researcher and Molecular Pathology Laboratory Manager, Hvidovre Hospital, Denmark. “Screening strategies that employ HPV tests with simultaneous genotyping offer a simple way to improve cervical cancer screening to the benefit of the woman and health care providers by allowing risk stratification already on the screening sample.”
The reporting of HPV genotypes with the screening tests and surveillance tests will facilitate same-genotype persistence tracking and risk-based management. A recent systematic review by Bottari et al concluded that, “evaluation of the HPV genotype persistence may represent a valid option to monitor patients treated for CIN 2+ lesions, because relapses were detected only in patients with persistence of the same genotype detected at baseline.”
“With this FDA approval, BD can now offer laboratories, clinicians and patients access to critical information in screening for cervical cancer in the United States and other countries recognizing the PMA supplement or CE mark,” said Dave Hickey, president, Integrated Diagnostic Solutions at BD. “Our goal is to continue the global fight towards eliminating diseases and associated deaths due to cervical cancer with our comprehensive diagnostic solutions.”
About BD Onclarity™ HPV Assay
The BD Onclarity™ HPV Assay detects and identifies 14 high-risk human papillomavirus (HPV) types in a single analysis and provides genotyping information from specimens collected for cervical cancer screening purposes in the BD SurePath™ Collection Vial and in the Hologic PreservCyt® Solution (not approved in the United States). The assay is for use in accordance with clinical guidelines and within the scope of local regulatory authorizations as part of a comprehensive approach to cervical cancer screening. The BD Onclarity™ HPV Assay has FDA approval for clinical use in cytology-based screening with ASC-US triage, in co-testing paradigm, and in primary HPV screening. BD Onclarity™ HPV Assay has FDA approval for use in vaccinated women. As the previously vaccinated subpopulation ages, the screening population will progressively include women with reduced prevalence of HPV 16 and 18, increasing the value of extended genotype reporting in a mixed population of vaccinated and unvaccinated women. Visit bd.com to learn more.
About BD
BD is one of the largest global medical technology companies in the world and is advancing the world of health by improving medical discovery, diagnostics and the delivery of care. The company supports the heroes on the frontlines of healthcare by developing innovative technology, services and solutions that help advance both clinical therapy for patients and clinical process for healthcare providers. BD and its 65,000 employees have a passion and commitment to help enhance the safety and efficiency of clinicians' care delivery process, enable laboratory scientists to accurately detect disease and advance researchers' capabilities to develop the next generation of diagnostics and therapeutics. BD has a presence in virtually every country and partners with organizations around the world to address some of the most challenging global health issues. By working in close collaboration with customers, BD can help enhance outcomes, lower costs, increase efficiencies, improve safety and expand access to healthcare.
For more information on BD, please visit bd.com.
PerkinElmer Releases New Dried Blood Spot Based COVID-19 Serology Test
21 July 2020 - Fully automated kit detects human antibodies of immunoglobulin class IgG to help identify individuals with adaptive immune response
WALTHAM, Mass., 21 July 2020 -- PerkinElmer, Inc., a global leader committed to innovating for a healthier world, today announced the launch of a dry blood spot (DBS) based test for SARS-CoV-2 IgG using its GSP®/DELFIA® platform, enabling processing of up to 5,000 samples per day. The finger-prick sample collection device allows for both decentralized sample collection and high-throughput testing. The product is being marketed as a CE-IVD test, and the Company plans to apply for Emergency Use Authorization (EUA) with the U.S. Food and Drug Administration (FDA).
Serological tests detect antibodies that are formed after an immune reaction to the pathogen has taken place. These tests can determine if an individual has developed immunity to a virus. Researchers are still studying how long antibodies last and whether they are protective against the COVID-19 virus.
The DBS assay is run on PerkinElmer’s GSP® analyzer, a fully automated and high throughput system for large population testing. The GSP combined with the universal TRF (time resolved fluorescence) of the DELFIA platform screens more than 30 percent of all newborn babies worldwide, spanning 32 countries. The traceable DBS workflow consists of five main elements: sample collection, punching, measurement on the GSP analyzer, reagents, and software, to detect anti-SARS-CoV-2 IgG antibodies. The SARS-CoV-2 IgG assay can also be run with serum or plasma samples via the Company’s Victor2™D platform. With an install base of over 2,500 GSP and Victor2D instruments, the capability for laboratories to meet heightened demand for COVID-19 testing is robust.
“Dried blood spot samples have been used in large scale population screening programs for decades and can help alleviate the costs and logistical constraints associated with collecting, transporting and processing venous blood for SARS-CoV-2 antibody testing,” said Masoud Toloue, Ph.D., Vice President and General Manager, Diagnostics, PerkinElmer. “This CE-IVD marked assay enables decentralized collection, a much-needed tool in COVID-19 testing.”
PerkinElmer’s comprehensive SARS-COV-2 offerings span RT-PCR, high throughput RNA extraction, automation, ELISA and other laboratory solutions. This DBS based test follows the recently CE-Marked ELISAs for detection of IgG antibodies from EUROIMMUN, a PerkinElmer company.
About PerkinElmer
PerkinElmer enables scientists, researchers, and clinicians to address their most critical challenges across science and healthcare. With a mission focused on innovating for a healthier world, we deliver unique solutions to serve the diagnostics, life sciences, food, and applied markets. We strategically partner with customers to enable earlier and more accurate insights supported by deep market knowledge and technical expertise. Our dedicated team of about 13,000 employees worldwide is passionate about helping customers work to create healthier families, improve the quality of life, and sustain the wellbeing and longevity of people globally. The Company reported revenue of approximately $2.9 billion in 2019, serves customers in 190 countries, and is a component of the S&P 500 index. Additional information is available through 1-877-PKI-NYSE, or at www.perkinelmer.com.
Grifols to acquire Green Cross plasma fractionation facility in Montreal and a plasma collection organization in the U.S. for US$460 million
20 July 2020 - Grifols makes a significant investment to become the only large-scale commercial manufacturer of plasma products in Canada, with a fractionation capacity of 1.5 million liters/year. The operation aligns with Grifols’ commitment to helping countries reach self-sufficiency of life-sustaining plasma-derived medicines. The acquisition includes 11 collection centers in the United States.
Barcelona, Spain, July 20, 2020 -- Grifols, a global healthcare company and one of world’s top producers of plasma-derived medicines, today announced it has executed purchase arrangements with the South Korean-based GC Pharma (Group) whereby Grifols will acquire the Montreal-based plasma fractionation facility and two purification facilities, along with 11 U.S.-based plasma collection centers for a total amount of US$460 million.
The transaction is part of Grifols’ sustainable global growth strategy to expand plasma collection and fractionation capacity to ensure patients worldwide have safe and secure access to life-saving plasma-derived medicines. Most importantly, this strategic acquisition will strengthen Grifols’ presence in Canada, building on a legacy of partnership in Canada’s blood system.
For more than three decades, Grifols has been a fractionator of Canadian plasma under contract manufacturing services, providing trusted plasma-derived medicines for Canadian patients and their healthcare providers. Throughout these many years Grifols has gained firsthand knowledge of the Canadian healthcare system. This transaction further demonstrates Grifols’ commitment to supporting domestic self-sufficiency and security of plasma-protein-product supply.
According to Víctor Grífols Deu, co-CEO of Grifols, “This deal builds on our long-term vision and strategy of sustainable growth, and wholly aligns with our commitment to helping countries reach self-sufficiency of life-sustaining plasma-derived medicines, which are critical for patients who need them.”
Added Joel Abelson, President of Grifols’ Bioscience Commercial Division: “This transaction represents a unique opportunity for Grifols to intensify our global expansion and presence in North America. Canada is a market with one of the highest rates of plasma consumption per capita in the world and one with significant growth potential.”
As Grifols co-CEO Raimon Grífols Roura noted, “It has been a very meditated decision to invest in the midst of these unprecedented circumstances. This pandemic underscores the need to support robust and sustainable health infrastructures that, in case of other emergent pathogens in the future, will help ensure the availability of plasma medicines.”
No additional financing will be required for the acquisition. Upon completion of the transaction certain net worth, working capital and cash targets have been guaranteed. Once the facilities are fully licensed and approved, Grifols will become the only large-scale commercial manufacturer of plasma products in Canada, with a fractionation capacity of 1.5 million liters annually. Grifols plans to be ready to manufacture IVIG and Albumin in the facilities to supply the Canadian market starting in 2023.
As part of the transaction, by means of a plasma-supply agreement, Grifols has also committed to supplying certain output of plasma arising out of the Green Cross Collection Centers to GC Pharma (Group) for a 24-month period. The collection centers achieved a collection volume of 350,000 litres of plasma in 2019.
The completion of the transaction is subject to regulatory approvals and is expected to close prior to the end of 2020.
Grifols retained Osborne Clarke, S.L.P and Stikeman Elliott, L.L.P as legal advisors and Nomura Securities International, Inc. as a financial advisor.
BGI Genomics: Helping citizens in the fight against the pandemic
20 July 2020 - BGI Genomics: Helping Hong Kong citizens in the fight against the pandemic with daily inspection of more than 5,000 samples with strict confidentiality.
20 July 2020 -- The third wave of the new crown pneumonia epidemic broke out in Hong Kong recently. The daily number of confirmed cases continues to rise. Many of the cases are of unknown origin. Epidemic prevention and anti-epidemic situation are extremely severe. The Hong Kong government has introduced two private mainland organizations to conduct free new coronavirus tests for high-risk groups of more than 400,000 people in Hong Kong. One of these organizations is the Huasheng Diagnostic Center opened by BGI.
Wang Shihua, manager of BGI’s genetic laboratory in Hong Kong, said in an exclusive interview with our reporter that the current testing center cooperates with medical institutions and adopts automated testing methods. It can test about 5,000 samples per day and issue a test report in only half a day. At the same time, people’s privacy will be kept strictly confidential, hoping to help the Hong Kong government effectively control the epidemic as soon as possible.
Based on the anti-epidemic experience in Beijing, South Korea, and other places, as well as the recommendations of the World Health Organization, virus testing is currently the fastest and most effective way to locate and track cases including “invisible communicators” and cut off the local transmission chain. Recently, the epidemic situation in Hong Kong has changed drastically. Many Hong Kong citizens flocked to the border, hoping to return to the mainland to avoid the epidemic. Guangdong Province announced that from 10 am on July 17th, except for approved personnel, those entering Hong Kong from Hong Kong must hold a valid nucleic acid test negative certificate within 72 hours (3 days), and they will still be compulsory for 14 days after entry In quarantine, Hong Kong citizens’ demand for nucleic acid testing has increased rapidly.
Wang Shihua said that due to the rapid increase in the amount of testing, the original manual testing method was cumbersome and took 4 hours to produce the results, which could not meet the current huge testing needs. At the same time, to help high-risk community groups perform testing and screening, automated nucleic acid was introduced. The extraction instrument, coupled with the upgrade and transformation of the laboratory, only needs 5 to 6 chemists and can do about 5000 tests every day, which replaces nearly 10 times the manpower requirement. I believe that with the increase of automated nucleic acid extraction instruments in the future, The detection volume will increase exponentially.
Self-produced reagents are certified by WHO
In Hong Kong’s current medical system, Hong Kong usually uses foreign reagents. The cost is high and the supply is unstable. Taking German-made reagents as an example, each kit costs about 600 yuan. As for the remaining costs, including nucleic acid testing machines, laboratory quality control, and certification costs, most institutions still cost as high as 1,500 to 2,500 yuan per time.
Wang Shihua said that BGI has taken the lead in completing the research and development of the new coronavirus nucleic acid detection kit in early 2020 and quickly produced it. It has been supplied to more than 180 countries and regions around the world. It has been certified by different medical authorities such as the United States, Europe, and Japan. It has also been certified by the World Health Organization. The organization is included in the emergency use list (WHO EUL). BGI has been preparing to produce reagents locally in Hong Kong and hopes that 100% of the reagents will be produced in Hong Kong in the future to meet the growing demand for testing. I believe that the cost of each test can be reduced to less than 1,000 yuan.
Wang Shihua also pointed out that the inspection center collects throat samples for testing, instead of the deep throat saliva samples commonly used in Hong Kong, because Hong Kong’s methods are time-limited. “It can only be taken in the morning before brushing your teeth. We believe that in such a severe situation of the epidemic. It’s very inconvenient. The deep throat saliva collection bottle is 70ml. If 1,000 samples are to be collected, the inspection center will have to deal with 1,000 plastic bottles, which will cause huge work pressure and is not environmentally friendly.”
Privacy information is strictly confidential, so citizens do not need to worry
Regarding certain opposition groups intimidating citizens and stating: “If mainland institutions conduct nucleic acid tests, sensitive privacy information will be sent to the mainland.” In an attempt to create social panic and undermine Hong Kong’s anti-epidemic work, Wang Shihua said that under Hong Kong’s laws and regulations according to the requirements of the American Society of Pathology, the information received by the testing center generally only has a serial code, and at most only the name of the patient is known. No other personal information will be received. Except for the virus-positive samples, they will be sent to the Department of Health. Other samples will be destroyed and will not be sent back to the Mainland. The public need not worry.
Reference: https://www.bgi.com/global/company/news/bgi-help-hong-kong/
FDA Authorizes Quest Diagnostics COVID-19 Diagnostic Testing for Specimen Pooling for Emergency Use
18 July 2020 - First FDA authorization of laboratory technique for use in COVID-19 diagnostic testing. Company also receives new FDA emergency use authorizations for use of self-collection molecular diagnostic kit on the Hologic and Roche platforms, expanding use with healthcare provider supervision via telemedicine.
SECAUCUS, N.J., July 18, 2020 -- Quest Diagnostics, the world's leading provider of diagnostic information services, today announced that it has received emergency use authorization (EUA) from the U.S. Food and Drug Administration (FDA) to use specimen pooling with its proprietary molecular diagnostic test for COVID-19. Quest is the first lab provider to receive FDA authorization for the technique for COVID-19 testing in the United States.
In pooling, specimens must still be collected into individual vials, but then are combined into small batches or pools by the laboratory. A negative result for a batch means that all patients in that pool are considered negative (If a positive result occurs for the batch, each specimen is retested individually). The technique is an efficient way to evaluate patients in regions or populations with low rates of disease. Pooling is used routinely in blood banking to screen donated blood for a variety of viruses, among other applications.
With the new pooling EUA, the Quest Diagnostics SARS-CoV-2 RNA ("Quest SARS-CoV-2 rRT-PCR") test may be used with pooled upper respiratory specimens (nasopharyngeal, mid-turbinate, anterior nares or oropharyngeal swabs). In clinical data presented by Quest to the FDA, none of 3,091 total specimens from a population with a prevalence rate of 1-10 percent, if pooled, would have been incorrectly determined to be negative (95%CI 0.0-0.1%).
The company expects to deploy the technique at its laboratories in Chantilly, VA and Marlborough, Mass., by the end of next week with additional laboratories to follow.
"As COVID-19 continues to spread around the country, access to timely, quality laboratory testing is critical to patients and an effective public health response," said Steve Rusckowski, Chairman, CEO and President, Quest Diagnostics. "Pooled specimen testing is a proven technique that will help us to optimize testing capacity at this critical time for our country."
"We applaud FDA for taking this important step to empower Quest to increase capacity across our national laboratory network," said Jay G. Wohlgemuth, M.D., Senior Vice President and Chief Medical Officer, Quest Diagnostics. "Pooling will help expand testing capacity but it is not a magic bullet, and testing times will continue to be strained as long as soaring COVID-19 test demand outpaces capacity. Each of us can practice behaviors that will reduce COVID-19 infections in our communities, so our national healthcare system can better respond to this crisis."
On July 13, 2020, Quest issued a statement that soaring demand for COVID-19 molecular diagnostics is slowing turnaround times to report results.
FDA EUAs for Telemedicine Self-Collection
Yesterday, the FDA also granted three emergency use authorizations to Quest Diagnostics for the use of its Quest Diagnostics Self-Collection Kit with the Hologic Panther Fusion, Hologic Aptima and Roche cobas molecular platforms. The new EUAs expand the use of the self-collection kit beyond the EUA, granted on May 27th, for the use of the kit on the Quest SARS-CoV-2 rRT-PCR test. The company expects the new EUAs will allow it to use self-collection more broadly on behalf of clients and patients in the United States. Self-collected specimens that were not observed by a healthcare professional are not eligible for pooling.
New FDA EUAs Follows EUAs for Other Quest Innovations
Quest Diagnostics is a leader in infectious disease testing services, with a broad menu of molecular, antibody, and other test services to aid diagnosis, treatment and monitoring. The new FDA EUAs follow several others received by the company for its COVID-19 test innovations.
In March 2020, Quest received FDA EUA for The Quest Diagnostics SARS-CoV-2 RNA, Qualitative Real-Time RT-PCR ("Quest SARS-CoV-2 rRT-PCR"), a real-time RT-PCR test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in upper and lower respiratory specimens collected from individuals suspected of COVID-19 by their healthcare provider. In May 2020, the company received an FDA EUA to use the test nasal swab specimens that are self-collected at home or in a healthcare setting by individuals using an authorized home-collection kit when determined to be appropriate by a healthcare provider.
About Our COVID-19 Testing
Quest Diagnostics is at the forefront of the response to the COVID-19 pandemic, working to broaden access to laboratory insights to help us all lead healthier lives. We provide both molecular diagnostic and antibody serology tests to aid in the diagnosis of COVID-19 and immune response. Our COVID-19 test services are based on tests that have received FDA emergency use authorization and which also meet our high standards for quality. We are providing these test services under the Public Readiness and Emergency Preparedness Act. We provide data on COVID-19 testing to various federal and state public health authorities, including the Centers for Disease Control and Prevention, and participate in studies with government and private institutions, aiding COVID-19 public health response and research. Through our team of dedicated phlebotomists, air fleet team, couriers and laboratory professionals, Quest Diagnostics works hard every day to help patients and communities across the United States access quality COVID-19 testing.
For more information about the latest developments with our COVID-19 testing, visit: newsroom.questdiagnostics.com/COVIDTestingUpdates
About Quest Diagnostics
Quest Diagnostics empowers people to take action to improve health outcomes. Derived from the world's largest database of clinical lab results, our diagnostic insights reveal new avenues to identify and treat disease, inspire healthy behaviors and improve health care management. Quest annually serves one in three adult Americans and half the physicians and hospitals in the United States, and our 47,000 employees understand that, in the right hands and with the right context, our diagnostic insights can inspire actions that transform lives. www.QuestDiagnostics.com
Quidel’s Sofia® SARS Antigen FIA updates EUA performance data to 96.7% PPA versus PCR; product supports U.S. initiatives to expand access to COVID-19 testing in nursing homes; receives CE Mark for use
17 July 2020
SAN DIEGO, 17 July 2020 -- Quidel Corporation (“Quidel”), a provider of rapid diagnostic testing solutions, cellular-based virology assays and molecular diagnostic systems, announced today that Quidel has updated the performance data for its Sofia® SARS Antigen FIA test on its package insert to 96.7% using direct nasal swab specimens versus PCR as a result of further studies included in its amended Emergency Use Authorization (EUA) that were submitted to the U.S. Food and Drug Administration (FDA).
“The majority of PCR tests, including our Lyra® assay, have been shown to be effective in diagnosing COVID-19 within a specific window of SARS-CoV-2 exposure, generally within 5 days after the onset of patient symptoms. Further studies have validated that our Sofia® SARS Antigen FIA offers sensitivity that is comparable to PCR within this 5-day window, providing healthcare workers with confidence in their ability to accurately diagnose their patients,” said Douglas Bryant, president and chief executive officer of Quidel Corporation. “We expect that this test will continue to play a critical role as an effective first line of defense against COVID-19.”
Healthcare professionals can purchase the Sofia® SARS Antigen FIA in the United States through distribution representatives for Cardinal Health, Fisher Healthcare, Henry Schein, McKesson, or Medline.
Sofia® SARS Antigen FIA in Nursing Homes
The U.S. Department of Health and Human Services (HHS) has indicated its intent to purchase both Sofia® 2 instruments and the Sofia® SARS Antigen FIA for distribution and use in nursing homes. Under the proposed terms, HHS will purchase 2,000 Sofia® instruments and 750,000 Sofia® SARS Antigen FIA tests over the next few months to expand access to COVID-19 testing in nursing homes throughout the U.S.
Sofia® SARS Antigen FIA Receives CE Mark
Separately, the Sofia® SARS Antigen FIA received CE Mark for use with the Sofia® and Sofia® 2 instruments. The CE Mark allows Quidel to market and sell the Sofia® SARS Antigen FIA in Europe, as well as other countries that accept the CE Mark.
About Quidel Corporation
Quidel Corporation serves to enhance the health and well-being of people around the globe through the development of diagnostic solutions that can lead to improved patient outcomes and provide economic benefits to the healthcare system. Marketed under the Sofia®, QuickVue®, D3® Direct Detection, Thyretain®, Triage® and InflammaDry® leading brand names, as well as under the new Solana®, AmpliVue® and Lyra® molecular diagnostic brands, Quidel’s products aid in the detection and diagnosis of many critical diseases and conditions, including, among others, COVID-19, influenza, respiratory syncytial virus, Strep A, lyme, herpes, pregnancy, thyroid disease and fecal occult blood. Quidel's Triage® system of tests comprises a comprehensive test menu that provides rapid, cost-effective treatment decisions at the point-of-care (POC), offering a diverse immunoassay menu in a variety of tests to provide diagnostic answers for quantitative BNP, CK-MB, d-dimer, myoglobin, troponin I and qualitative TOX Drug Screen. Quidel’s research and development engine is also developing a continuum of diagnostic solutions from advanced immunoassay to molecular diagnostic tests to further improve the quality of healthcare in physicians’ offices and hospital and reference laboratories. For more information about Quidel’s comprehensive product portfolio and to explore exciting employment opportunities, visit quidel.com.
New Rapid Molecular Test For Tuberculosis Can Simultaneously Detect Resistance To First- And Second-Line Drugs
16 July 2020 - Xpert® MTB/XDR cartridge enables expanded drug-resistance profiling in less than 90 minutes. Used to empower clinicians to quickly prescribe treatment regimens for multidrug-resistant TB (MDR-TB) and extensively drug-resistant TB (XDR-TB), the test could help fill a critical gap that is currently jeopardizing global TB targets.
GENEVA and SUNNYVALE, Calif., July 16, 2020 -- The Foundation for Innovative New Diagnostics (FIND) and Cepheid, Inc, announced today the launch of the new Xpert® MTB/XDR test, which enables expanded drug-resistance tuberculosis (TB) profiling in less than 90 minutes. Xpert MTB/XDR can be used to empower clinicians to quickly prescribe treatment regimens for extensively drug-resistant TB (XDR-TB).
Able to detect TB that is resistant to multiple first- and second-line TB drugs, the test could help fill a critical gap that is currently jeopardizing global TB elimination targets. By contrast, current methods for identifying drug-resistance profiles for XDR-TB are very complex to perform, can take up to 16 weeks to deliver results, and as a result are often completely unavailable to patients.
XDR-TB is the most complicated form of TB, with the worst outcomes. Mortality has been reported as high as 41% in some cohorts. The scientific community has been focused on coordinating innovation to improve both diagnosis and treatment of XDR-TB for years. The World Health Organization (WHO) recommends rapid molecular testing and detection of drug-resistant TB as an essential condition for the implementation of new treatment regimens.
"An ordinary TB diagnosis is awful, but XDR-TB is the worst nightmare of every TB doctor and every patient," said Catharina Boehme, CEO of FIND. "Recent treatment advances are already making a huge impact, but for the best chances of survival, patients need to be able to start on treatment as soon as possible – and the only way for that to happen is through rapid diagnosis. By providing test results in just a few hours, the Xpert MTB/XDR test will save lives."
Xpert MTB/XDR leverages Cepheid's new 10-colour technology, which enables the detection of multiple mutations across several genes, from a single sample. Xpert MTB/XDR can detect resistance to isoniazid, ethionamide, fluoroquinolones, amikacin, kanamycin and capreomycin. Access to testing that can reliably identify resistance towards isoniazid as well as to fluoroquinolones and amikacin will help enable clinicians to quickly select the most appropriate MDR-TB treatment for each individual patient.
"Rapid testing of resistance to isoniazid and fluoroquinolones is a critical step towards ensuring those who are ill with drug-resistant TB, and in particular XDR-TB, can access treatment and care early – in line with the latest WHO guidelines on the treatment of drug-resistant TB," said Tereza Kasaeva, Director of the WHO Global TB Programme. "WHO is looking forward to receiving all relevant data on the GeneXpert MTB/XDR cartridge from Cepheid and partners to rapidly proceed with an evaluation of the new test."
The test runs on Cepheid GeneXpert® systems equipped with 10-colour multiplexing modules. GeneXpert 10-colour modules are capable of processing the already widely used Xpert MTB/RIF and Xpert MTB/RIF Ultra tests for diagnosis of TB and rifampicin resistance.
"This test is the first to leverage 10-colour homogeneous detection within the GeneXpert system," said Dr David H Persing, Executive Vice President and Chief Medical and Technology Officer at Cepheid. "In partnership with Dr David Alland and his team at Rutgers University as well as FIND, we have demonstrated the ability to detect a wide array of TB drug resistance mutations directly from clinical specimens with a high level of accuracy comparable with standard testing."
A study conducted by Cepheid showed promising results for the detection of mutations associated with first- and second-line drug resistance, while preliminary data from independent analytical and clinical evaluation studies conducted by FIND indicate that the test's sensitivity (ability to correctly identify drug-resistance) and specificity (ability to correctly identify drug-susceptibility) is comparable with current standard tests (culture-based phenotypic drug-susceptibility testing) and sequencing, and that the test meets the performance characteristics defined by the high-priority target product profiles for new TB diagnostics.
Data from the FIND evaluations will form part of the dossier now being prepared for WHO review at the end of this year. If the test is recommended for use by WHO, countries could include it in their national policies and accelerate its scale up – particularly in high-burden TB countries such as India and China.
"Reflex testing of MDR-TB patients, to rapidly and accurately diagnose XDR-TB within 2 hours and minimum expertise needed, has the potential to be the cornerstone in the rapid initiation of tailored treatment," said Camilla Rodrigues, Consultant Microbiologist, Chairperson Infection Control Committee, P.D. Hinduja Hospital, Mumbai.
"It is great to have the Xpert MTB/XDR test that can be deployed in the peripheral laboratories and greatly improve access to diagnosis of drug-resistant TB and selection of the most appropriate treatment regimens," said Lucica Ditiu, Executive Director of the Stop TB Partnership. "We should all work together to ensure that this and any other new TB diagnostics are fast-tracked from development, to WHO recommendation, to scale up and use by countries."
FIND is now working with Cepheid and WHO to support the rollout of the test.
About FIND
FIND is a global non-profit organization that drives innovation in the development and delivery of diagnostics to combat major diseases affecting the world's poorest populations. Our work bridges R&D to access, overcoming scientific barriers to technology development; generating evidence for regulators and policy-makers; addressing market failures; and enabling accelerated uptake and access to diagnostics in low- and middle-income countries (LMICs). Since 2003, we have been instrumental in the development of 24 new diagnostic tools used in 150 LMICs. Over 50 million FIND-supported products have been provided to our target markets since the start of 2015. A WHO Collaborating Centre, we work with more than 200 academic, industry, governmental, and civil society partners worldwide, on over 70 active projects that cross six priority disease areas. FIND is committed to a future in which diagnostics underpin treatment decisions and provide the foundation for disease surveillance, control and prevention. For more information, please visit www.finddx.org
About Cepheid
Based in Sunnyvale, Calif., Cepheid is a leading molecular diagnostics company that is an operating company within Danaher Corporation's (NYSE: DHR) Diagnostics platform. Cepheid is dedicated to improving healthcare by developing, manufacturing, and marketing accurate yet easy-to-use molecular systems and tests. By automating highly complex and time-consuming manual procedures, the company's solutions deliver a better way for institutions of any size to perform sophisticated molecular diagnostic testing for organisms and genetic-based diseases. Through its strong molecular biology capabilities, the company is focusing on those applications where accurate, rapid, and actionable test results are needed most, such as managing infectious diseases and cancer. For more information, visit http://www.cepheid.com.
BIOFIRE® Respiratory Panel 2.1 plus with SARS-CoV-2 is CE marked
15 July 2020
15 July 2020 -- bioMérieux, a world leader in the field of in vitro diagnostics, today announced that the BIOFIRE® Respiratory Panel 2.1 plus (RP2.1plus) is CE marked. The BIOFIRE® Respiratory Panel 2.1 plus (RP2.1plus) tests for 23 pathogens (19 viruses, including SARS-CoV-2, and 4 bacteria) responsible for the most frequent respiratory tract infections. It will be commercially available in all countries that recognize CE marking from now on or shortly thereafter.
The BIOFIRE® RP2.1plus advances the existing BIOFIRE® Respiratory Panel 2 plus (RP2plus) by adding SARS-CoV-2 to the panel menu while maintaining an assay runtime of about 45 minutes. The BIOFIRE® RP2.1plus panel also includes an assay for the Middle East Respiratory Syndrome Coronavirus (MERS-CoV). This new panel allows healthcare providers to quickly identify patients with common respiratory pathogens and differentiate those with COVID-19, using one single test. The BIOFIRE® RP2.1plus runs on the fully automated BIOFIRE® FILMARRAY® 2.0 and BIOFIRE® FILMARRAY® TORCH systems and is extremely easy to use.
“The availability of BIOFIRE® RP2.1plus in all countries recognizing CE marking represents a global syndromic response to this unprecedented COVID-19 pandemic,” said Pierre Boulud, Chief Operating Officer, Executive Vice President, Clinical Operations at bioMérieux. “With increasing reagent production capacity and an installed base of more than 14 000 BIOFIRE® units throughout the world, BIOFIRE® RP2.1plus will play a key role now and in the upcoming respiratory season as healthcare providers face the regular group of respiratory pathogens as well as SARS-CoV-2”, he added.
The BIOFIRE® RP2.1plus Panel is part of a suite of products in response to the COVID - 19 pandemic. The ARGENE® SARS-CoV-2 R-GENE® was launched in March 2020, followed by the U.S. FDA EUA cleared BIOFIRE® RP2.1 panel and the VIDAS® anti-SARS- CoV-2 IgM and anti-SARS-CoV-2 IgG tests. These complementary tests help meet the varying needs of bioMérieux’s diverse customers and patients throughout the world.
Reference: https://www.biomerieux.com/en/biofirer-respiratory-panel-21-plus-sars-cov-2-ce-marked
LGC expands SARS-CoV-2 molecular solutions to full genome coverage
15 July 2020
15 July 2020 -- LGC continues to innovate its portfolio of products supporting SARS-CoV-2 diagnostics. Initially designed to target the published CDC and WHO consensus sequences, the new AccuPlex™ SARS-CoV-2 Verification Panel and Reference Material Kit are now available with full SARS-CoV-2 viral genome coverage. This expansion allows for compatibility with any SARS-CoV-2 assay target, while maintaining the safety features and performance monitoring advantages of AccuPlex technology.
LGC’s proprietary AccuPlex technology mimics wild-type pathogenic viruses, but is safe, non-infectious, and replication deficient. These materials serve as true, full-process, quality solutions that challenge the entire PCR test procedure, making them the preferred alternative to infectious materials. Together, the AccuPlex SARS-CoV-2 Verification Panel and AccuPlex SARS-CoV-2 Reference Material Kit offer an ideal solution for clinical laboratories looking for a safe, effective tool to verify and monitor SARS-CoV-2 molecular assay performance.
Michael Sweatt, Executive Vice President, LGC SeraCare, stated, “We are proud to continue to expand our SARS-CoV-2 product offering to adapt to the evolving needs of the diagnostic community. Our full genome AccuPlex products are just the latest innovations in our line of SARS-CoV-2 molecular and serology quality solutions designed to support early detection of infection and antibody surveillance efforts throughout the ongoing COVID-19 pandemic.”
To learn more about the full genome AccuPlex SARS-CoV-2 Verification Panel and Reference Material Kit as well as the complete line of SARS-CoV-2 Quality Solutions, please visit the LGC SeraCare website.
Vela Diagnostics receives CE-IVD approval and Provisional Authorisation from the Health Sciences Authority in Singapore for automated COVID-19 detection test
13 July 2020
Singapore, July 13, 2020 – Vela Diagnostics announced today that an automated version of its COVID-19 detection test, the ViroKey™ SARS-CoV-2 RT-PCR Test v2.0, has received the CE mark for in vitro diagnostic use as well as Provisional Authorisation from the Health Sciences Authority in Singapore.
The ViroKey™ SARS-CoV-2 RT-PCR Test v2.0 is a probe-based reverse transcription PCR Test that detects SARS-CoV-2 by targeting conserved regions of the SARS-CoV-2 genome, specifically the ORF1a and N genes. The automated test is optimized for a workflow consisting of the Sentosa™ SX101 instrument, in conjunction with the Sentosa™ SA201 instrument or the ABI 7500 Fast Dx. The automated workflow enables high throughput testing with significantly reduced hands-on time. Up to 48 tests, including controls, can be performed in a single run. “Receiving CE certification and Provisional Authorisation from the Health Sciences Authority in Singapore for our automated test facilitates efficient testing of SARS-CoV-2 in patients suspected of COVID-19 in Europe, Africa, Middle East and Asia, where there is an urgent need to identify individuals infected with SARS-CoV-2 for effective management of the global pandemic,” said Managing Director, Andreas Goertz.
In April this year, an earlier version of the test, the ViroKey™ SARS-CoV-2 RT-PCR Test, also received the CE mark and Provisional Authorisation from the Health Sciences Authority in Singapore.
About Vela Diagnostics
Vela Diagnostics is a leading provider for integrated IVD system solutions, from sample to result. VELA’s test solutions utilize the automated Sentosa™ platform, providing the unique ability to leverage one system for NGS and PCR testing in infectious disease and oncology.
SARS-CoV-2 antibody test from Siemens Healthineers evaluated against other leading antibody assays in Public Health England study
10 July 2020 - New SARS-CoV-2 total antibody tests are appraised by Public Health England (PHE), in partnership with the University of Oxford, in a new head-to-head evaluation of four commercial tests. The laboratory-based COV2T antibody test from Siemens Healthineers was the only assay found to meet both sensitivity and specificity requirements as set out in the MHRA’s TPP for enzyme immunoassays. The test identifies antibodies to a spike protein on the surface of the SARS-CoV-2 virus, also a focus of many vaccine studies.
Erlangen, 10 July 2020 -- Public Health England, in partnership with the University of Oxford, recently conducted a head-to-head evaluation of four commercial immunoassay tests available in the UK and used for the detection of SARS-CoV-2 antibodies.Siemens Healthineers’ laboratory-based total antibody test distinguished itself as the only assay tested found to meet both the sensitivity and specificity requirements set out within the Target Product Profile (TPP) for immunoassays by the UK Medicines and Healthcare products Regulatory Agency (MHRA). The test is broadly available globally.
The evaluation was commissioned by the Department of Health and Social Care (DHSC) and conducted by Public Health England, the clinical research team at the University of Oxford and Oxford University Hospitals NHS Foundation Trust. Several commercial antibody tests were appraised over a three-week period in May - June 2020, with a view to assessing respective performance metrics on precision, using a large, well-characterised sample set. Primary data included evaluation of the assays’ sensitivity and specificity, each of which is key to assessing the overall clinical performance of a test.
The SARS-CoV-2 total antibody test from Siemens Healthineers is CE marked and has FDA Emergency Use Authorization. The test detects the presence of both IgM and IgG antibodies in blood. This allows for the identification of patients who have developed an adaptive immune response, indicating prior exposure to COVID-19. Critically, the test identifies antibodies to a key protein on the surface of the SARS-CoV-2 virus – a spike protein, which binds the virus to human cells. Multiple potential vaccines in development for SARS-CoV-2 include the spike protein within their focus, raising the possibility that the Siemens Healthineers total antibody test could support the determination of the effectiveness of these vaccines in the future.
“High-quality antibody tests will be critical to successfully reopening economies across the globe. From the start, our mission has been to develop highly accurate tests for SARS-CoV-2 and now we have an external appraisal that confirms our test offers exceptional quality,” said Deepak Nath, PhD, President of Laboratory Diagnostics at Siemens Healthineers. “Laboratories worldwide can be confident that our assay delivers the sensitivity and specificity we promised.”
The role of Public Health England
Public Health England is an executive agency of the Department of Health and Social Care and is not a regulator. PHE evaluations confirm that the Siemens Healthineers SARS-CoV-2 total antibody test meets the Target Product Profile. The Siemens Healthineers SARS-CoV-2 total antibody test has received the CE mark before PHE testing. The CE mark confirms that the test meets EU regulatory standards and could already be lawfully placed on the market in the UK and other Member States. Siemens Healthineers announced on June 1 that it has received FDA Emergency Use Authorization in the United States.
Siemens Healthineers AG is shaping the future of Healthcare. As a leading medical technology company headquartered in Erlangen, Germany, Siemens Healthineers enables healthcare providers worldwide through its regional companies to increase value by empowering them on their journey towards expanding precision medicine, transforming care delivery, improving the patient experience, and digitalizing healthcare. Siemens Healthineers is continuously developing its product and service portfolio, with AI-supported applications and digital offerings that play an increasingly important role in the next generation of medical technology. These new applications will enhance the company’s foundation in in-vitro diagnostic, image-guided therapy, and in-vivo diagnostics. Siemens Healthineers also provides a range of services and solutions to enhance healthcare providers ability to provide high-quality, efficient care to patients. In fiscal 2019, which ended on September 30, 2019, Siemens Healthineers, which has approximately 52,000 employees worldwide, generated revenue of €14.5 billion and adjusted profit of €2.5 billion. Further information is available at www.siemens-healthineers.com.
Reference: https://www.siemens-healthineers.com/press-room/press-releases/covid-19-antibody-phe.html
Sonora Quest Collaborates with State and Healthcare Leaders to Significantly Expand COVID-19 Testing Capacity in Arizona
10 July 2020
PHOENIX, July 10, 2020 – Governor Doug Ducey announced today a strategic collaboration with Sonora Quest Laboratories, the market share leader in diagnostic laboratory testing in Arizona, the Arizona Department of Health Services (ADHS) and PerkinElmer, Inc., a global leader committed to innovating for a healthier world, with one goal: expand COVID-19 testing in Arizona. The collaboration will support the strategic plan to catapult Sonora Quest’s COVID-19 diagnostic testing capacity in a material way to meet and exceed the rising demand in Arizona.
“This partnership will enable Arizona to continue rapidly expanding testing across the state, helping ensure all Arizonans have access to affordable, available testing with speedy turnaround of results,” said Governor Ducey. “I’m grateful to Sonora Quest Laboratories, PerkinElmer and the Arizona Department of Health Services for their innovative solutions to help protect the health and safety of Arizonans."
Through this collaboration, the State of Arizona and Arizona Department of Health Services are providing Sonora Quest Laboratories $2 million toward the purchase of new processing equipment. Sonora Quest continues to be committed to investing time and resources for community testing, and is contributing an additional $6 million toward the expansion to increase access to health care for Arizonans.
Sonora Quest expects to reach the capacity to perform up to 35,000 diagnostic tests per day by the end of July, and up to 60,000 tests per day by the end of August. The dedicated project team at Sonora Quest will be working 24 hours a day to install, validate and deploy the new production lines, which will include chemagic™ 360 instruments, JANUS® G3 Primary Sample Reformatters and PCR+ Workstations, to automate PerkinElmer’s RNA extraction and RT-PCR testing. The breadth of PerkinElmer’s total workflow solutions will enable Sonora Quest to rapidly process samples at higher volumes, ultimately helping decrease turnaround time in testing.
“The goal is to have test results available within 24 hours for anyone tested,” said David A. Dexter, President & CEO, Sonora Quest Laboratories. “I wish to express my sincere thanks and appreciation to Dr. Cara Christ, Director of ADHS, and PerkinElmer for supporting Sonora Quest. Together, we are making a significant difference in the Arizona healthcare community to provide ample testing throughout this pandemic.”
“Despite the recent resurgence of COVID-19 cases in the United States and some testing locations experiencing capacity shortfalls, PerkinElmer has complete SARS-CoV-2 testing solutions available and ready for delivery. We are teaming with Sonora Quest to meet their increased testing volume requirements and will continue to build capacity to support broad-based testing globally,” said Masoud Toloue., Ph.D., Vice President & General Manager, Diagnostics, PerkinElmer.
Sonora Quest’s priority remains the health and safety of all the patients and communities they serve. These efforts continue to build upon outreach and actions to expand testing for all Arizonans, including the most vulnerable and underserved populations.
“We are excited to partner with Sonora Quest to expand COVID-19 testing in Arizona,” said Dr. Cara Christ, ADHS director. “Since the start of the pandemic, ADHS has worked with Sonora Quest and several other private laboratories across Arizona to increase access to testing and laboratory capacity. We will continue to work with all of our lab partners to find ways to make testing more available to everyone in our state.”
Patients who believe they may have active COVID-19 are strongly encouraged to contact their healthcare provider or locate an Arizona Testing Blitz site for sample collection at https://www.azdhs.gov/testingblitz. Patients suspected of having or confirmed to have active COVID-19 infection or disease should not visit a Sonora Quest Patient Service Center. Sonora Quest Patient Service Centers do not offer collection for diagnostic COVID-19 testing.
The collaboration between Sonora Quest and PerkinElmer is an expansion of its existing relationship, in which EUROIMMUN, a PerkinElmer company, provides tests to support Sonora Quest’s antibody testing.
For more information about the COVID-19 testing service, visit www.SonoraQuest.com/coronavirus.
About COVID-19 testing at Sonora Quest
Sonora Quest is the leader in infectious disease testing services in Arizona with a broad menu of molecular, antibody, and other test services to aid in diagnosis, treatment and monitoring. On March 20, 2020, the company introduced an RT-PCR test allowing for the detection of nucleic acid in respiratory specimens of patients meeting CDC's clinical criteria for COVID-19 testing. RT-PCR tests for COVID-19 are generally used to aid diagnosis during active disease. Sonora Quest has performed and reported results of more than 400,000 diagnostic COVID-19 tests. Ramping up its fight against COVID-19, Sonora Quest began offering antibody testing for COVID-19 using blood specimens on April 24, with a physician order. That was quickly followed by a direct-to-consumer offering through their My Lab ReQuest ™ solution starting May 8, giving patients the ability to order the antibody test without a doctor’s order or insurance.
About Sonora Quest Laboratories
Sonora Quest Laboratories, a joint venture between Banner Health and Quest Diagnostics (NYSE: DGX), is part of the nation’s largest integrated laboratory system with approximately 3,500 employees serving more than 26,000 patients every day throughout Arizona. Sonora Quest Laboratories is the market share leader in clinical laboratory testing in Arizona, performing nearly 90 million diagnostic tests per year. Sonora Quest Laboratories offers a local comprehensive test menu which encompasses routine, molecular, prescription drug monitoring, genetic/genomic, women’s health and pathology testing services. My Lab ReQuest provides consumers direct access to a diverse range of affordable screening tests that can be ordered online at SonoraQuest.com or in any of Sonora Quest’s 75 patient service centers across Arizona. Ninety-eight percent of all testing is performed at the primary testing facilities located in Phoenix, Tucson, Flagstaff, Prescott and Yuma. Sonora Quest Laboratories is accredited by the College of American Pathologists (CAP), which is the gold standard in laboratory accreditation, helping laboratories to maintain accuracy of test results and ensure accurate patient diagnosis. This accreditation ensures the highest standard of care for all laboratory patients as CAP inspectors examine laboratory staff.
About PerkinElmer
PerkinElmer enables scientists, researchers and clinicians to address their most critical challenges across science and healthcare. With a mission focused on innovating for a healthier world, we deliver unique solutions to serve the diagnostics, life sciences, food and applied markets. We strategically partner with customers to enable earlier and more accurate insights supported by deep market knowledge and technical expertise. Our dedicated team of about 13,000 employees worldwide is passionate about helping customers work to create healthier families, improve the quality of life, and sustain the wellbeing and longevity of people globally. The Company reported revenue of approximately $2.9 billion in 2019, serves customers in 190 countries, and is a component of the S&P 500 index. Additional information is available through 1-877-PKI-NYSE, or at www.perkinelmer.com.
LGC acquires The Native Antigen Company, strengthening its offer to the IVD sector
9 July 2020
9 July 2020 -- Today, LGC announced the acquisition of The Native Antigen Company (NAC), one of the world’s leading suppliers of high quality infectious disease antigens and antibodies.
NAC is a developer, manufacturer and supplier of critical reagents to the in vitro diagnostic (IVD), pharmaceutical and academic sectors. It offers a comprehensive portfolio of native and recombinant infectious disease antigens and related products including pathogen receptors, virus-like particles and antibodies for use in immunoassay applications, vaccine development and quality control solutions. NAC was one of the first companies globally to offer antigens for SARS-COV-2 and continues to play an important role in supporting the global response to the COVID-19 pandemic.
The acquisition strengthens LGC’s existing product offering to the IVD sector, which includes a range of quality assurance tools, immunoassay reagents and disease state plasma as well as probes and primers for molecular diagnostics.
Michael Sweatt, Executive Vice President and General Manager, Clinical Diagnostics, LGC, said, “NAC is a natural fit with our clinical diagnostics business and will enable us to provide an expanded portfolio of critical reagents to our customers. NAC’s focus on infectious disease is highly complementary with our existing offer to this segment comprising controls, reference materials, MDx tools and other components. We are excited to welcome our new colleagues into our organisation.”
“We are delighted to be joining LGC as an integral part of their fast growing clinical diagnostics business”, said Nick Roesen, COO of NAC, “even more so, we are excited to join such a well-respected organisation that shares our purpose and mission, and that will support our diagnostic customers by providing even more world-leading products and services.”
Formed in 2010, NAC is based in Oxford, UK and currently employs over 30 people. It maintains an ISO 9001 accreditation.
NAC’s portfolio includes more than 60 viral and infectious disease products, with strengths in Dengue, Cytomegalovirus, Zika, Chikungunya and Clostridium difficile (C. diff).
Reference: https://www.lgcgroup.com/newsroom-and-blog/news-and-blog/lgc-acquires-nac/
Dia.Pro launches four COVID-19 serology EIA kits
9 July 2020
9 July 2020 -- Dia.Pro Launch Diagnostics Limited is pleased to announce that Dia.Pro Diagnostic Bioprobes srl, has developed and launched four new EIA microplate kits for the detection of novel Coronavirus COVID-19 antibodies in human serum and plasma.
Dia.Pro is a specialist Italian diagnostic company which develops, manufactures & markets a wide range of high-quality & trusted IVD’s for infectious disease diagnostics,
There are two kits for the detection of IgG or IgM to COVID-19 nucleocapsid and spike antigens, a kit for IgG to COVID-19 spike 1 and 2 and a fourth module-based immunoassay for the confirmation and typing of IgG antibodies to COVID-19 major-antigens.
These kits have been developed and evaluated in Northern Italy and are CE marked. The assays are intended to be used to show antibody response and immune status following COVID-19 infection.
Key Points
- Four assays are currently available based on EIA, 96 well, microplate technology
- The Dia.Pro COVID-19 assays can be run manually or automated on an ELISA processor
- Method files are available for the Stratec Gemini, Dynex DS2 and Dynex DSX
- The confirmation assay is a modular system to individually detect antibodies against COVID-19 Spike protein 1, Spike protein 2 and Nucleocapsid
Reference: https://www.launchdiagnostics.com/dia-pro-launches-three-covid-19-serology-eia-kits/
HPV Test Misses Twice as Many Women Who Develop Cervical Cancer as Cotesting, Quest Diagnostics Health Trends™ Study Finds
8 July 2020 - Largest study of a nationally representative American population demonstrates cotesting outperforms HPV or Pap testing alone in detecting cancer and precancer in women 30 years and older
SECAUCUS, N.J., July 8, 2020 -- A Health Trends™ study from researchers at Quest Diagnostics and the University of Pittsburgh Medical Center (UPMC) provides new evidence that the HPV screening test is significantly less likely to detect cervical cancer and precancer than cotesting, a method which combines HPV and Pap (Papanicolaou test by liquid based cytology) testing using the same specimen.
The study is significant because it is the largest to date to assess the performance of guideline-recommended cervical cancer screening methods in a diverse population of American women in real-world care settings. It reveals stark differences in the performance of the various recommended methods in detecting cancer and precancers in women 30 years of age and older.
Published online today in the American Journal of Clinical Pathology, the peer-reviewed study assesses sensitivity rates of HPV alone, Pap alone and cotesting (HPV and Pap testing together) in detecting cancer and precancer of the cervix in nearly 19 million de-identified cotest results performed by Quest Diagnostics on behalf of 13.6 million women in the United States from 2010 to 2018. Of these cases, 1,259 were diagnosed with cervical cancer – twice the number of diagnosed cancer cases as the next largest study.v
"This Health Trends analysis of a notably large and diverse population firmly validates the critical role of cotesting as a cancer and precancer screening method for women 30 and older," said R. Marshall Austin, MD, PhD, Emeritus Professor of Pathology, University of Pittsburgh Medical Center (UPMC). "It should put to rest any notion that HPV alone achieves the same bar for quality cancer screening."
HPV testing identifies the genetic material of the human papillomavirus virus, which can cause cervical cancer, while Pap identifies cellular changes on the cervix that may be or become cancer. The United States Preventive Services Task Force (USPSTF) recommends screening in women 30-65 years of age every three years with Pap, every five years with cotesting or every five years with primary HPV testing.
Among the key findings:
- HPV and Pap testing alone fails to detect twice as many women who develop cervical cancer as cotesting. Of 1,615 cotests taken at any time prior to a cancer diagnosis, 86.9 percent were positive by cotesting, a non-detection rate (also known as false negative) of about 13.1 percent. By comparison, Pap and HPV testing alone had non-detection rates nearly twice as high: Pap at 26.4 percent and HPV at 28.4 percent.
- Cotesting detected significantly more women who developed biopsy-confirmed adenocarcinomas, a typically aggressive form of cervical cancer, identifying 82.3 percent of this cancer compared to only 61.2 percent by HPV and 59.7 percent by Pap.
- HPV testing fails to identify one in five women who develop cancer when performed within a year of cancer diagnosis. Among women screened within one year of a cancer diagnosis, the non-detection rate for HPV testing alone was 22.5 percent, nearly 1.5 times higher than Pap (14.9%) and four times higher than cotesting (5.9%).
- Cotesting detected more women who developed biopsy-confirmed precancers than HPV or Pap alone, identifying 95.6 percent of these precancers, compared to 92.6 percent by HPV and 77.9 percent by Pap.
According to a report published in January 2020 by the American Cancer Society, cervical cancer is the second leading cause of cancer death nationally in women 20-39 years of age, causing 10 premature deaths per week in this age group.
"While widespread screening has helped cut cervical cancer mortality by three fourths in the past 80 years, this disease is still far too common," said co-author Harvey W. Kaufman, M.D., Senior Medical Director and Director, Health Trends Research Program, Quest Diagnostics. "Because most cervical cancers develop in the absence of regular screening, ensuring women have access to the most reliable screening method, cotesting, when they are screened is an essential step in lowering mortality from this disease."
Health Trends study builds on prior research
The new findings confirm previous Quest Diagnostics research published in Cancer Cytopathology in 2015, a journal of the American Cancer Society, which found HPV-only cervical screening would not have detected approximately 19 percent of 526 women who developed confirmed cervical cancer. An analysis of data from Magee-Women's Hospital (MWH) of the University of Pittsburgh Medical Center (UPMC) reported a higher percent of positive Pap than HPV tests among 109 cotesting results within 12 months from cancer diagnosis, similar to the present Quest Diagnostics Health Trends study.
By comparison, analysis of a regional dataset from Kaiser Permanente Northern California (KPNC) also found that cotesting outperformed other methods, but the authors of that study concluded that "the contribution of cytology to screening is shown to be very small." The KPNC data were also limited in its ability to identify cytological abnormalities associated with confirmed adenocarcinomas, an aggressive cancer, as compared to the Quest and MWH data.
"It is important to reconcile the similar conclusions of Quest Diagnostics and Magee-Women's Hospital with the different findings of Kaiser Permanente in Northern California," said Lee H. Hilborne, MD, Professor of Pathology and Laboratory Medicine at UCLA, Senior Medical Director, Quest Diagnostics. "KPNC has an exemplary care model, but this very strength may limit the usefulness of KPNC data for drawing conclusions about the real-world care experience of most American women who receive care in less integrated practice settings."
"For women who may otherwise not be screened at all, there is no question that cytology or HPV primary are useful screening technologies," said Damian P. Alagia, III, MD, Senior Medical Director of Woman's Health for Quest Diagnostics. "Yet, that should not obscure the fact that cotesting is fundamentally the better screening option for women and is widely available in the U.S."
Study Strengths and Limitations
The strengths of the study include the large, longitudinal, nationally representative sample size and a study population believed to be reflective of adult women in the United States. The study period covers nine years (2010-2018). The study was limited only to women who sought medical care and were referred to laboratory services at Quest Diagnostics. The Quest Diagnostics Health Trends study was deemed exempt by the Western Institutional Review Board.
About Health Trends™
Quest Diagnostics Health Trends™ is a series of scientific reports that provide insights into health topics, based on analysis of objective clinical laboratory data, to empower better patient care, population health management and public health policy. The reports are based on the Quest Diagnostics database of more than 50 billion de-identified laboratory test results, believed to be the largest of its kind in healthcare. Health Trends has yielded novel insights to aid the management of allergies and asthma, prescription drug monitoring, diabetes, Lyme disease, heart disease, influenza and workplace wellness. Quest Diagnostics also produces the Drug Testing Index (DTI)™, a series of reports on national workplace drug positivity trends based on the company's employer workplace drug testing data. www.QuestDiagnostics.com/HealthTrends
About Quest Diagnostics
Quest Diagnostics empowers people to take action to improve health outcomes. Derived from the world's largest database of clinical lab results, our diagnostic insights reveal new avenues to identify and treat disease, inspire healthy behaviors and improve health care management. Quest annually serves one in three adult Americans and half the physicians and hospitals in the United States, and our 47,000 employees understand that, in the right hands and with the right context, our diagnostic insights can inspire actions that transform lives. www.QuestDiagnostics.com
Regeneron announces start of REGN-COV2 Phase 3 COVID-19 prevention trial in collaboration with National Institute of Allergy and Infectious Diseases (NIAID)
6 July 2020 - Anti-viral antibody cocktail REGN-COV2 is also in Phase 2/3 treatment trials following positive Phase 1 safety review
TARRYTOWN, N.Y., July 6, 2020 -- Regeneron Pharmaceuticals, Inc. today announced the initiation of late-stage clinical trials evaluating REGN-COV2, Regeneron's investigational double antibody cocktail for the treatment and prevention of COVID-19. A Phase 3 trial will evaluate REGN-COV2's ability to prevent infection among uninfected people who have had close exposure to a COVID-19 patient (such as the patient's housemate), and is being run jointly with the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH). REGN-COV2 has also moved into the Phase 2/3 portion of two adaptive Phase 1/2/3 trials testing the cocktail's ability to treat hospitalized and non-hospitalized (or "ambulatory") patients with COVID-19.
This clinical progress follows a positive review from the Independent Data Monitoring Committee of REGN-COV2 Phase 1 safety results in an initial cohort of 30 hospitalized and non-hospitalized patients with COVID-19.
The Phase 3 prevention trial is being conducted at approximately 100 sites and is expected to enroll 2,000 patients in the U.S.; the trial will assess SARS-CoV-2 infection status. The two Phase 2/3 treatment trials in hospitalized (estimated enrollment =1,850) and non-hospitalized (estimated enrollment =1,050) patients are planned to be conducted at approximately 150 sites in the U.S., Brazil, Mexico and Chile, and will evaluate virologic and clinical endpoints, with preliminary data expected later this summer. All trials are adaptively-designed, and the ultimate numbers of patients enrolled will depend on trial progress and insights from Phase 2 studies.
"We are running simultaneous adaptive trials in order to move as quickly as possible to provide a potential solution to prevent and treat COVID-19 infections, even in the midst of an ongoing global pandemic," said George D. Yancopoulos, M.D., Ph.D., Co-Founder, President and Chief Scientific Officer of Regeneron. "We are pleased to collaborate with NIAID to study REGN-COV2 in our quest to further prevent the spread of the virus with an anti-viral antibody cocktail that could be available much sooner than a vaccine."
About REGN-COV2
Regeneron scientists evaluated thousands of fully-human antibodies produced by the company's proprietary VelocImmune® mice, which have been genetically-modified to have a human immune system, as well as antibodies isolated from humans who have recovered from COVID-19. They selected the two most potent, non-competing and virus-neutralizing antibodies to create REGN-COV2 and have scaled up this dual-antibody cocktail for clinical use with the company's in-house VelociMab® and manufacturing capabilities. REGN-COV2's two antibodies bind non-competitively to the critical receptor binding domain of the virus's spike protein, which diminishes the ability of mutant viruses to escape treatment and protects against spike variants that have arisen in the human population, as detailed in recent Science publications. More recent research also demonstrates coverage against the now prevalent D614G variant.
Regeneron used the same 'rapid response' capabilities and cocktail approach to develop REGN-EB3, a novel triple antibody treatment for Ebola that is now under regulatory review by the FDA. REGN-COV2's development and manufacturing has been funded in part with federal funds from the BARDA under OT number: HHSO100201700020C.
About Regeneron
Regeneron (NASDAQ: REGN) is a leading biotechnology company that invents life-transforming medicines for people with serious diseases. Founded and led for over 30 years by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to seven FDA-approved treatments and numerous product candidates in development, all of which were homegrown in our laboratories. Our medicines and pipeline are designed to help patients with eye diseases, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, pain, infectious diseases and rare diseases.
Regeneron is accelerating and improving the traditional drug development process through our proprietary VelociSuite® technologies, such as VelocImmune® which uses unique genetically-humanized mice to produce optimized fully-human antibodies and bispecific antibodies, and through ambitious research initiatives such as the Regeneron Genetics Center, which is conducting one of the largest genetics sequencing efforts in the world.
BD Launches Portable, Rapid Point-of-Care Antigen Test to Detect SARS-CoV-2 in 15 minutes, Dramatically Expanding Access to COVID-19 Testing
6 July 2020 - Simple new assay leverages more than 25,000 BD Veritor™ instruments already used across the U.S. to immediately increase access to COVID-19 testing in frontline health care settings. BD will begin shipping the new test this week and expects to ramp-up manufacturing capacity to 2 million tests per week by the end of September. This is the company's third diagnostic test to receive Emergency Use Authorization by U.S. FDA for detecting COVID-19.
FRANKLIN LAKES, N.J., July 6, 2020 -- BD (Becton, Dickinson and Company), a leading global medical technology company, today announced that the U.S. Food and Drug Administration (FDA) granted Emergency Use Authorization (EUA) for a rapid, point-of-care, SARS-CoV-2 diagnostic test for use with its broadly available BD Veritor™ Plus System. The launch of this new assay that delivers results in 15 minutes on an easy-to-use, highly portable instrument is critical for improving access to COVID-19 diagnostics because it enables real-time results and decision making while the patient is still onsite.
The BD Veritor™ System, which is slightly larger than a cell phone, is currently in use at more than 25,000 hospitals, clinician offices, urgent care centers and retail pharmacies in all 50 U.S. states. Its one-button functionality, workflow flexibility, and ease-of-use make it an ideal solution for settings without laboratory personnel. It also offers customers real-time reporting capabilities through the BD Synapsys™ informatics solution providing them with the ability to easily report data for disease monitoring and surveillance purposes.
BD is leveraging its global manufacturing network and scale and expects to increase capacity to be able to produce 2 million tests per week by the end of September. The company already expects to produce up to 10 million tests from July through September.
"This will be a game-changer for frontline health care workers and their patients to be able to access a quick diagnostic test for COVID-19, offering results in real-time at convenient locations like retail pharmacies, urgent care centers and doctors' offices," said Dave Hickey, president of Integrated Diagnostic Solutions for BD. "Such tests will also help communities be more informed and better prepared to help prevent new spikes and additional waves of COVID-19 by enabling public health workers to quickly identify infectious individuals and trace their contacts. The highly portable, easy-to-use, point-of-care format of this test, large quantity of test kits available and existing, expansive footprint of BD Veritor™ Plus instruments will help bring widespread access to COVID-19 testing in the United States and around the world as additional country-specific regulatory requirements are met."
The launch of the BD Veritor™ Plus System for Rapid Detection of SARS-CoV-2 Assay is the latest effort in the company's comprehensive response to address critical health needs related to the global pandemic. The new immunoassay test joins a portfolio of three molecular solutions for COVID-19 testing that have been registered for use with the BD MAX™ Molecular System, including two with EUAs and two with CE mark. So far this year, the company has provided health care providers globally with approximately 48 million swabs for flu and COVID-19 testing, more than 2.85 million COVID-19 rapid molecular diagnostic tests on the BD MAX™ System, and millions of products used in the treatment of COVID-19 patients, including infusion pumps, infusion sets and catheters.
All BD COVID-19 diagnostic products have regulatory authorizations in the markets where they are sold. BD intends to pursue 510(k) clearance for the BD Veritor™ Plus SARS-CoV-2 assay from the FDA at a later time. U.S. customers interested in BD diagnostic solutions for COVID-19 should contact IDS.COVIDtests@bd.com.
About the BD Veritor™ SARS-CoV-2 Assay
The BD Veritor™ Plus System for Rapid Detection of SARS-CoV-2 Assay is deemed to be a CLIA-waived immunoassay designed to be used in health care settings to provide an aid to rapid diagnosis of COVID-19 in symptomatic individuals. BD clinical studies performed at more than 20 sites across the U.S. demonstrated that the test is capable of achieving 84% sensitivity and 100% specificity, which is in line with the performance from similar immunoassay tests for Flu A/B, RSV and Strep A on the BD Veritor™ Plus System — all of which are widely-used, highly relevant and clinically valid. Similar to all immunoassay tests, FDA recommends that negative test results be confirmed by a molecular method to confirm the result, if necessary, for patient management.
The BD point-of-care test has not been cleared or approved by FDA. The test has been authorized by FDA under an EUA only for the detection of SARS-CoV-2 nucleocapsid antigens to aid in the diagnosis of SARS-CoV-2 virus infection. It has not been authorized for use to detect any other viruses or pathogens. The test is authorized in the United States 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 BD
BD is one of the largest global medical technology companies in the world and is advancing the world of health by improving medical discovery, diagnostics and the delivery of care. The company supports the heroes on the frontlines of healthcare by developing innovative technology, services and solutions that help advance both clinical therapy for patients and clinical process for healthcare providers. BD and its 65,000 employees have a passion and commitment to help enhance the safety and efficiency of clinicians' care delivery process, enable laboratory scientists to accurately detect disease and advance researchers' capabilities to develop the next generation of diagnostics and therapeutics. BD has a presence in virtually every country and partners with organizations around the world to address some of the most challenging global health issues. By working in close collaboration with customers, BD can help enhance outcomes, lower costs, increase efficiencies, improve safety and expand access to healthcare. For more information on BD, please visit bd.com.
Thermo Fisher Scientific Launches New MAS Omni Infectious Disease Quality Controls
1 July 2020
FREMONT, Calif., July 1, 2020 -- Thermo Fisher Scientific, the world leader in serving science, today announced the availability of the Thermo Scientific MAS Omni Infectious Disease quality control sets for monitoring serological assays for analytes such as HIV 1&2, Hepatitis B & C virus, Syphilis and HTLV I/II.
Serology testing for infectious diseases continues to be on the rise and newer instrument platforms are offering serology markers with improved sensitivity than previously available. In addition, there is continued progression with infectious disease screening protocols requiring serology testing for diagnosis, monitoring and treatment of infectious agents.
The Thermo Scientific MAS Omni Infectious positive and negative quality controls are third-party, independent external controls used to assess the performance of serological assays for infectious diseases. Our new control set supports assays for HIV, Hepatitis C, Hepatitis B, HTLV and Syphilis. As with all Thermo Scientific MAS Quality Controls users can efficiently monitor assay performance, streamline operations and potentially reduce your spending without sacrificing quality or throughput.
"We are expanding our quality control offering into a space which continues to increase each year as new pharma drugs are developed and enabling better identification and treatment for infectious diseases. Our team is committed to providing innovative solutions to support our customers productivity," said Fernando Beils, vice president and general manager, Thermo Fisher's niche diagnostics business. "The Thermo Scientific MAS Omni Infectious Controls are the first in a line of products we are continuing to develop to support the monitoring of in vitro diagnostic tests."
The Thermo Scientific MAS Omni Infectious Controls are available in the U.S. and Japan as IVD products and are intended for clinical use. For more information, visit https://thermofisher.com/mas-infectious
About Thermo Fisher Scientific
Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $25 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, improving patient diagnostics and therapies or increasing productivity in their laboratories, we are here to support them. Our global team of more than 75,000 colleagues delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services and Patheon. For more information, please visit www.thermofisher.com.
Abbott and Tandem Diabetes Care advance development of integrated technologies for future automated insulin delivery systems
29 June 2020 - Companies partner to integrate Abbott's FreeStyle Libre continuous glucose monitoring technology with Tandem's insulin delivery products to provide options to simplify and tailor diabetes management
ABBOTT PARK, Ill. and SAN DIEGO, June 29, 2020 -- Abbott and Tandem Diabetes Care announced today that they have finalized an agreement to develop and commercialize integrated diabetes solutions that combine Abbott's world-leading continuous glucose monitoring (CGM) technology with Tandem's innovative insulin delivery systems to provide more options for people to manage their diabetes. The companies first announced their intention to work together in October 2019, and this resulting agreement covers the technical development of device integration and associated commercial support activities.
"We're excited to integrate our insulin delivery systems with Abbott's glucose-sensing technology, and we look forward to expanding options for our customers so that they can combine devices that best suit their personal needs," said John Sheridan, president and CEO of Tandem Diabetes Care. "We are proud to have an insulin pump capable of remote software updates that can make access to future integrations possible for in-warranty t:slim X2 users at the time of release without requiring a new pump."
The need for interoperability between diabetes devices is widely recognized. Tandem's t:slim X2™ insulin pump was the first to receive U.S. Food and Drug Administration (FDA) clearance in a new device category called alternate controller enabled (ACE) infusion pumps in 2019. The special controls for ACE pumps allow for reliable and secure communication with compatible external devices. Abbott's FreeStyle Libre 2 integrated continuous glucose monitoring (iCGM) system was recently cleared by the FDA for adults and children (4 years and older). Through this collaboration, Abbott and Tandem will work to digitally connect their technologies for future automated insulin delivery systems, which will provide people with options to tailor and simplify how they manage their diabetes.
"Abbott is working with our partners to bring integrated technologies at an affordable price for people with diabetes who rely on using insulin pumps," said Jared Watkin, senior vice president, Diabetes Care, Abbott. "By combining our glucose sensing technology with Tandem's proven insulin delivery systems, we will be able to create a cohesive ecosystem for people with diabetes that can fit easily into their daily lives."
The companies will focus initial commercial activities in the U.S. and Canada with additional geographies considered in the future.
About the FreeStyle Libre 2 System
Abbott's FreeStyle Libre 2 system was recently cleared by the U.S. Food and Drug Administration (FDA) as an integrated continuous glucose monitoring (iCGM) system for adults and children ages 4 and older with diabetes. It is the only iCGM system with optional real-time alarms that measures glucose levels every minute, meeting the highest level of accuracy standards. The FreeStyle Libre 2 next-generation sensor is worn on the back of the upper arm for up to 14 days and with a one-second scan using a handheld reader, users can see their glucose reading, trend arrow and eight-hour history.
As the #1 sensor-based glucose monitoring system used in the U.S. and worldwide, Abbott's FreeStyle Libre portfolio has changed the lives of more than 2 million people across 50 countries by providing breakthrough technology that is accessible and affordable. Abbott has secured partial or full reimbursement for the FreeStyle Libre system in 36 countries, including Canada, France, Germany, Japan, the United Kingdom and the U.S.
Indications and Important Safety Information – FreeStyle Libre 2 System
The FreeStyle Libre 2 Flash Glucose Monitoring System is a continuous glucose monitoring (CGM) device with real-time alarms capability indicated for the management of diabetes in persons age 4 and older. It is intended to replace blood glucose testing for diabetes treatment decisions, unless otherwise indicated.
The System also detects trends and tracks patterns and aids in the detection of episodes of hyperglycemia and hypoglycemia, facilitating both acute and long-term therapy adjustments. Interpretation of the System readings should be based on the glucose trends and several sequential readings over time.
The System is also intended to autonomously communicate with digitally connected devices. The System can be used alone or in conjunction with these digitally connected devices where the user manually controls actions for therapy decisions.
About the t:slim X2 Insulin Pump
The t:slim X2 pump was the first insulin pump classified by the FDA in a new device category called alternate controller enabled (ACE) infusion pumps and the first system approved as compatible with interoperable continuous glucose monitoring (iCGM) devices. The system includes advanced features like a large color touchscreen, rechargeable battery, Bluetooth® wireless technology, USB connectivity and watertight construction (IPX7). It is capable of remote software updates using a personal computer, offering the potential for in-warranty users to access new features as they become available.
Indications and Important Safety Information – t:slim X2 Insulin Pump
RX ONLY. The t:slim X2 insulin pump with interoperable technology is an alternate controller enabled (ACE) pump that is intended for the subcutaneous delivery of insulin, at set and variable rates, for the management of diabetes mellitus in people requiring insulin. The pump is able to reliably and securely communicate with compatible, digitally connected devices, including automated insulin dosing software, to receive, execute, and confirm commands from these devices. The pump is indicated for use in individuals six years of age and greater. The pump is intended for single patient, home use and requires a prescription. The pump is indicated for use with NovoLog or Humalog U-100 insulin. The t:slim X2 pump must be removed before MRI, CT, or diathermy treatment. Visit tandemdiabetes.com/safetyinfo for additional important safety information.
About Abbott
Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 107,000 colleagues serve people in more than 160 countries.
Connect with us at www.abbott.com, on LinkedIn at www.linkedin.com/company/abbott-/, on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews and @AbbottGlobal.
About Tandem Diabetes Care, Inc.
Tandem Diabetes Care, Inc. (www.tandemdiabetes.com) is a medical device company dedicated to improving the lives of people with diabetes through relentless innovation and revolutionary customer experience. The company takes an innovative, user-centric approach to the design, development, and commercialization of products for people with diabetes who use insulin. Tandem's flagship product, the t:slim X2 insulin pump, is capable of remote software updates using a personal computer and features integrated continuous glucose monitoring. Tandem is based in San Diego, Calif.
LabCorp Launches New Neutralizing Antibody Test
25 June 2020 - Neutralizing Antibody Assay Could Be Used to Assist in Development of COVID-19 Vaccines and Plasma-Based Treatments
BURLINGTON, N.C., Jun. 25, 2020 -- LabCorp, a leading global life sciences company that is deeply integrated in guiding patient care, today announced the launch of a new test that can be used to assess the capacity of antibodies in patient plasma to inhibit the SARS-CoV-2 virus. This information could be used in the development of COVID-19 vaccines and the screening of convalescent plasma for prophylactic and therapeutic use. This neutralizing antibody test will be available to biopharmaceutical companies, hospitals, blood banks and other plasma-screening facilities.
“By leveraging our drug development and diagnostic capabilities, we are working tirelessly to find solutions to prevent and treat COVID-19,” said Paul Kirchgraber, M.D., chief executive officer, LabCorp’s Drug Development business. “The launch of this neutralizing antibody assay is the latest effort in our company’s commitment to accelerate the evaluation of vaccine candidates so that a successful candidate may reach patients sooner.”
As the research for a safe and effective vaccine continues, some clinicians are relying on the serum collected from convalescent patients who had COVID-19 to support treatment of the severely ill. As research advances, the PhenoSense® assay may be an essential element in defining the neutralizing antibody activity correlated with the therapeutic efficacy of convalescent plasma administration, as well as the relative protective immunity of vaccine candidates.
“This assay, available only through LabCorp, is based on a proven and trusted platform developed by our scientists that has been used for decades in the evaluation of vaccine candidates designed to prevent other viral infections, including HIV, Ebola virus, influenza virus, and respiratory syncytial virus (RSV),” continued Kirchgraber.
For more information, visit: https://www.covance.com/coronavirus-disease-covid-19/vaccines.html.
About LabCorp
LabCorp, an S&P 500 company, is a leading global life sciences company that is deeply integrated in guiding patient care, providing comprehensive clinical laboratory and end-to-end drug development services. With a mission to improve health and improve lives, LabCorp delivers world-class diagnostics solutions, brings innovative medicines to patients faster, and uses technology to improve the delivery of care. LabCorp reported revenue of more than $11.5 billion in 2019.
To learn more about LabCorp, visit www.LabCorp.com, and to learn more about LabCorp’s Covance drug development business, visit www.Covance.com.
Coronavirus test kit receives CE label
23 June 2020
23 June 2020 -- In February 2020, R-Biopharm was one of the first diagnostics companies worldwide to launch a test kit for the novel coronavirus SARS-CoV-2. Now, the test has received the CE label and is thus approved for diagnostic use in the EU.
With the multiplex real-time PCR test kit RIDA®GENE SARS-CoV-2, R-Biopharm has made a valuable contribution to coronavirus diagnostics during the COVID-19 pandemic in recent months. The German Institute for Medical Documentation and Information (Deutsches Institut für Medizinische Dokumentation und Information, DIMDI) has now approved the product as a CE-certified IVD product in the EU. This enables hospital laboratories, reference laboratories, private laboratories and state laboratories to reliably and rapidly detect SARS-CoV-2 specific RNA from human respiratory samples (nasal/pharyngeal swabs).
A recent study confirms the excellent performance of the test kit: According to the Dutch Institute for Health and Environment (Rijksinstituut voor Volksgezondheid en Milieu, RIVM), the test has the best performance in identifying coronavirus infections. Due to the high specificity and sensitivity, even people with only mild or no symptoms can be reliably diagnosed.
The RIDA®GENE SARS-CoV-2 provides a number of benefits to clinical laboratories:
- Best performance in the WHO assay comparison
- Maximum sensitivity and specificity
- Economically reasonable one-target detection – no confirmation testing needed
- Rapid results in only 70 minutes
- Simultaneous analysis of up to 96 samples
- Can be combined with all other RIDA®GENE assays in one run
Reference: https://clinical.r-biopharm.com/news/coronavirus-test-kit-receives-ce-label/
LGC expands SARS-CoV-2 serology offering with 11-member positive-patient Performance Panel
19 June 2020
19 June 2020 -- LGC has released the AccuSet™ SARS-CoV-2 Performance Panel (material #0820-0410), intended for use by clinical laboratories and diagnostic manufacturers alike, to evaluate SARS-CoV-2 antibody assays. This eleven-member validation panel contains highly characterised, true patient specimens, offering an out-of-the-box solution to provide confidence, mitigate sourcing challenges and accelerate antibody assay development, validation, verification and onboarding.
Comprised of undiluted, naturally occurring human plasma samples, this panel demonstrates a range of SARS-CoV-2 antibody reactivity. Ten panel members represent collections from multiple individuals positive for antibodies to SARS-CoV-2; a single negative member is also included. A comprehensive data sheet, generated using commercially available SARS-CoV-2 antibody assays, is provided for comparative analysis.
Michael Sweatt, Executive Vice President, LGC SeraCare, stated, “Whether generating validation data for a regulatory submission, or performing assay verification in a clinical laboratory setting, LGC SeraCare’s panel products offer a comprehensive solution to rigorously evaluate your assay. Our suite of products will allow you to confidently develop, challenge, troubleshoot, verify, and validate your assay from initial proof of concept through production and onboarding into the clinical laboratory.”
Reference: https://www.lgcgroup.com/newsroom-and-blog/news-and-blog/sars-cov-2-serology-offering-expanded/
Brian Caveney, Chief Medical Officer and President of LabCorp Diagnostics, Named to Modern Healthcare's 50 Most Influential Clinical Executives List
16 June 2020
BURLINGTON, N.C., June 16, 2020 — LabCorp, a leading global life sciences company that is deeply integrated in guiding patient care, today announced that Dr. Brian Caveney, chief medical officer and president of LabCorp Diagnostics, was recognized by Modern Healthcare as one of this year’s 50 Most Influential Clinical Executives.
The recognition program acknowledges clinicians working in the healthcare industry who are deemed by their peers and an expert panel to be the most influential in terms of demonstrating leadership and impact.
“It’s an honor and a privilege to be recognized by my peers for this distinction from Modern Healthcare,” said Dr. Caveney. “I am extremely proud of LabCorp’s diagnostics and drug development businesses, which have stood ready to address the COVID-19 situation with increased testing capacity, multiple testing options and clinical research on vaccines and therapies. I am also humbled to work alongside my colleagues, who through science, technology, and delivery, are working to address significant, unmet healthcare needs to improve health and improve lives.”
“Healthcare organizations are utilizing their greatest assets as they transform: their former front-line clinicians," said Aurora Aguilar, editor of Modern Healthcare. “Former and practicing physicians and nurses have taken the helms of healthcare providers across the country and improved quality of care, patient satisfaction and margins. Modern Healthcare congratulates the honorees and thanks them for their contributions to patient care.”
Dr. Caveney joined LabCorp after serving as chief medical officer of Blue Cross and Blue Shield of North Carolina (Blue Cross NC). He also served as chief clinical officer of Mosaic Health Solutions, a wholly owned subsidiary of Blue Cross NC for strategic investments in diversified health solutions. Prior to Blue Cross NC, Dr. Caveney was a practicing physician and assistant professor at Duke University Medical Center.
The complete ranking is featured in the June 15 issue of Modern Healthcare, and profiles of the honorees are available at ModernHealthcare.com/50MostInfluential.
About LabCorp
LabCorp (NYSE: LH), an S&P 500 company, is a leading global life sciences company that is deeply integrated in guiding patient care, providing comprehensive clinical laboratory and end-to-end drug development services. With a mission to improve health and improve lives, LabCorp delivers world-class diagnostics solutions, brings innovative medicines to patients faster, and uses technology to improve the delivery of care. LabCorp reported revenue of more than $11.5 billion in 2019.
To learn more about LabCorp, visit www.LabCorp.com, and to learn more about LabCorp’s Covance drug development business, visit www.Covance.com.
New data show use of Abbott's FreeStyle® Libre System reduces all-cause, diabetic ketoacidosis-related hospitalization rates and acute diabetes events
16 June 2020 - Findings from the RELIEF study in France showed for the first time, in the largest retrospective analysis of its kind of nearly 75,000 people living with diabetes, use of the FreeStyle Libre system dramatically decreases diabetic ketoacidosis-related hospitalizations. Additional real-world data demonstrate meaningful outcomes for people living with diabetes who use Abbott's glucose sensing technology, including lower rates of acute diabetes events and all-cause hospitalizations as well as significant reductions in HbA1c levels.
ABBOTT PARK, Ill., June 16, 2020 -- Today, Abbott announced results from multiple new real-world studies that demonstrate how use of the FreeStyle Libre system, the world-leading continuous glucose monitoring (CGM) technology, can lead to significant clinical benefits among people living with type 1 and type 2 diabetes. Notable findings, presented at this year's American Diabetes Association (ADA) 80th Scientific Sessions, show that using the FreeStyle Libre technology is associated with substantial reductions in hospitalizations from diabetic ketoacidosis (DKA), a serious condition that can lead to diabetic coma or even death. Results also showed a decrease in rates of acute diabetes events (ADE) and all-cause hospitalizations as well as lowered and sustained hemoglobin A1c (HbA1C) levels.
Data were presented as part of the RELIEF study (Abstract 68-OR), the largest retrospective study of its kind analyzing the impact of FreeStyle Libre portfolio use on the incidence of hospitalizations for DKA. In the study, researchers assessed nationwide reimbursement claims data in France of 74,158 people living with diabetes, including 33,203 people with type 1 diabetes and 40,955 people with type 2 diabetes.
Notable findings demonstrated:
- Overall, annual DKA rates dramatically dropped by 52% in those with type 1 diabetes and 47% in those with type 2 diabetes when using the FreeStyle Libre system.
- Greatest reductions in DKA-related hospitalizations occurred in people who did not conduct traditional fingerstick testing, as well as those who performed fingersticks more than five times per day, regardless of previous test strip usage.
- In those who did not fingerstick, results showed decreases of 60% and 51% in people with type 1 and type 2 diabetes, respectively.
- For people who performed fingersticks more than five times per day, findings showed drops of 59% for people with type 1 diabetes and 52% for people with type 2 diabetes.
"The results of this study strongly support our hypothesis that the use of the FreeStyle Libre technology enables people to identify and reduce hyperglycemia, and in turn, limit diabetic ketoacidosis," said Ronan Roussel, M.D., Ph.D., chief of the endocrinology, diabetes and nutrition department at Hôpital Bichat, Fédération de Diabétologie, AP-HP in Paris, France, and lead author for the RELIEF study. "These data are suggestive of significant, long-term health benefits and cost savings from use of Abbott's sensor-based glucose monitoring system."
ADDITIONAL STUDIES DEMONSTRATE MEANINGFUL OUTCOMES FOR PEOPLE WITH DIABETES
Additional abstracts presented at ADA showed:
- Sustainable HbA1c Decrease at 12 Months for Adults with Type 1 and Type 2 Diabetes Using the FreeStyle Libre System (Abstract 74-LB): Through a real-world analysis of the National Diabetes Register in Sweden, researchers identified 39,554 people with type 1 or type 2 diabetes using the FreeStyle Libre system. A subgroup of people who had used the FreeStyle Libre system for nine to 15 months were able to significantly lower their HbA1C levels with a sustained effect at 12 months (0.44% drop in people with type 1 diabetes and a 0.66% reduction in those with type 2 diabetes). These A1c changes are usually associated with intensification of diabetes treatment regimens and highlight the important clinical benefits the FreeStyle Libre system may have in people with diabetes.
- FreeStyle Libre System Use is Associated with Reduction in Inpatient and Outpatient Emergency Acute Diabetes Events (ADE) and All-Cause Hospitalizations in Patients with Type 2 Diabetes (69-OR): In a retrospective, observational analysis of 1,244 people with type 2 diabetes on short-acting insulin in the U.S., researchers found use of the FreeStyle Libre system was associated with substantial reductions of 51% in acute diabetes events (ADE) and 28% in all-cause hospitalizations. These findings suggest positive health economics outcomes and use of the FreeStyle Libre technology, priced at a third of the cost of other CGMs, provides significant cost-savings.
- Utilization of Continuous Glucose Monitors is Associated with Reduction in Inpatient and Outpatient Emergency Acute Diabetes Events (ADE) Regardless of Prior Blood Test Strip Usage (875-P): Through a retrospective, observational study of 12,521 people living with type 1 or type 2 diabetes in the U.S., researchers found that use of CGMs, including Abbott's FreeStyle Libre system, was associated with a 46% reduction in ADE, regardless of test strip usage prior to the start of using CGMs.
"These new data further reinforce the life-changing benefits of Abbott's glucose sensing technology in delivering meaningful outcomes for people living with both type 1 and type 2 diabetes," said Mahmood Kazemi, M.D., divisional vice president, global medical and scientific affairs and chief medical officer, Diabetes Care, Abbott. "Through improved glucose control and reductions in diabetes-related complications or hospitalizations, the findings underpin why millions of people globally choose our FreeStyle Libre system to manage their condition and improve their quality of life."
About the FreeStyle Libre System:
Abbott's FreeStyle Libre technology, the #1 sensor-based glucose monitoring system used worldwide, reads glucose levels through a sensor that can be worn on the back of the upper arm, eliminating the need for fingersticks. The FreeStyle Libre portfolio has changed the lives of more than two million people across 50 countries and has secured partial or full reimbursement in 36 countries, including France, Ireland, Japan, the United Kingdom, and the U.S.
INDICATIONS AND IMPORTANT SAFETY INFORMATION
FreeStyle Libre and FreeStyle Libre 14 day Flash Glucose Monitoring systems are continuous glucose monitoring (CGM) devices indicated for replacing blood glucose testing and detecting trends and tracking patterns aiding in the detection of episodes of hyperglycemia and hypoglycemia, facilitating both acute and long-term therapy adjustments in persons (age 18 and older) with diabetes. The systems are intended for single patient use and require a prescription.
CONTRAINDICATIONS: Remove the sensor before MRI, CT scan, X-ray, or diathermy treatment.
WARNINGS/LIMITATIONS: Do not ignore symptoms that may be due to low or high blood glucose, hypoglycemic unawareness, or dehydration. Check sensor glucose readings with a blood glucose meter when Check Blood Glucose symbol appears, when symptoms do not match system readings, or when readings are suspected to be inaccurate. The system does not have alarms unless the sensor is scanned, and the system contains small parts that may be dangerous if swallowed. The system is not approved for pregnant women, persons on dialysis, or critically-ill population. Sensor placement is not approved for sites other than the back of the arm and standard precautions for transmission of blood borne pathogens should be taken. The built-in blood glucose meter is not for use on dehydrated, hypotensive, in shock, hyperglycemic-hyperosmolar state, with or without ketosis, neonates, critically-ill patients, or for diagnosis or screening of diabetes. When using FreeStyle LibreLink app, access to a blood glucose monitoring system is required as the app does not provide one. Review all product information before use or contact Abbott Toll Free (855-632-8658) or visit www.freestylelibre.us for detailed indications for use and safety information.
About Abbott:
Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 107,000 colleagues serve people in more than 160 countries.
Global Collaboration Establishes Wales’ National Covid-19 Testing Laboratory
16 June 2020
16 June 2020 -- An advanced laboratory dedicated to leading Wales’ national Covid-19 testing has been established in Cardiff, thanks to collaboration between Public Health Wales and one of the world’s leading diagnostics companies.
Creating a national Covid-19 testing lab at the University Hospital of Wales is an important part of the Welsh Government’s Test, Trace, Protect strategy and has been made possible thanks to the support of multinational diagnostics company, PerkinElmer Inc., a global leader committed to innovating for a healthier world.
The onset of the global pandemic saw countries across the globe searching for vital testing resources to identify and combat the spread of Covid-19. Public Health Wales’ laboratory staff had been working to address issues with a restricted supply chain to find an alternative, reliable system to undertake a large volume of testing for Covid-19 infection in Wales.
PerkinElmer responded to an industry call to action issued by Life Sciences Hub Wales, with an offer to source testing kits and state-of-the-art lab equipment required to process them.
Working together, Life Sciences Hub Wales, Public Health Wales and the team at PerkinElmer identified Wales’ key resource needs and set about securing access to vital sources of advanced equipment and test materials needed for the lab in Cardiff.
Staff in the Wales Specialist Virology Centre, operated by Public Health Wales, rapidly evaluated an offer from PerkinElmer and verified the company’s ability to meet Public Health Wales’ requirements. Public Health Wales was also able to quickly navigate procurement and contractual arrangements so that the equipment could be used without delay.
With established bases in Wales and the UK, PerkinElmer was able to work quickly with its UK customers to requisition technology devices that could be rapidly repurposed for Covid-19 testing.
In addition to sourcing advanced extraction equipment, PerkinElmer has also provided Wales with a crucial supply of its proprietary Covid-19 specific testing kits that are in demand the world over.
As the organisation appointed by Welsh Government to be the primary point of contact for initial industry engagement with the NHS in Wales, Life Science Hub Wales was quick to identify PerkinElmer’s ability to support Wales’ Covid-19 testing strategy.
Cari-Anne Quinn, CEO, Life Sciences Hub Wales, said: “We have a thriving life sciences sector in Wales, which has been playing a key part in producing urgently needed products not only for Wales, but as part of the global response to the pandemic.
“Life Sciences Hub Wales works with health and social care services in Wales to understand the challenges they are facing. With our experience in the life sciences sector, we then work with companies and innovators across the country, the UK and globally to identify solutions.
“PerkinElmer understood the real need to think, operate and deliver innovatively to meet immediate needs. Their ability to locate and donate resources to address Wales’ urgent requirements must be applauded, as should their continued work with Public Health Wales to establish a lab in the country that is fully equipped to meet the country’s ongoing testing requirements.”
After arranging for equipment held by its existing UK customers to be transported to Wales, PerkinElmer then worked with Public Health Wales to create a supply chain that would allow Wales to further enhance its testing capabilities at the University Hospital of Wales.
“In this pandemic, governments are seeking guidance on best Covid-19 testing practices to resume normal business and economic activities, while ensuring the safety of their citizens,” said Masoud Toloue, Ph.D., Vice President & General Manager, Diagnostics, PerkinElmer. “Our collaboration with Public Health Wales ensures a stable supply chain of nucleic acid extraction and RT-PCR kits and the required equipment to provide the Welsh government with the best testing solution.”
PerkinElmer is a worldwide organisation that has been in Wales for over 50 years. The company’s local manufacturing site is based at Llantrisant Business Park and presently employs over 130 highly skilled employees at a 50,000 sq. ft facility.
David Heyburn, head of operations for microbiology and health protection at Public Health Wales, said: “It was clear from the offset the PerkinElmer team was driven by the need to help and was committed to working with us to support the development of Wales’ testing capabilities.
“PerkinElmer moved quickly to provide equipment it was able to source from within the UK that would enable work to begin while additional resources were being sourced from outside of the UK. This was offered unconditionally and exemplifies the underlying mood of many partners across Wales’ life science sector.
“This has led to an active collaboration in which NHS Wales has ordered testing platforms and reagents to test for Covid-19 infection.”
Scaling up testing capacity forms an important part of the Welsh Government’s Test, Trace, Protect strategy, and this includes increasing capacity to process more tests through Welsh laboratories.
Welsh Government Minister for Economy, Transport and North Wales, Ken Skates said: “The response of businesses across Wales to support our efforts in beating coronavirus has been truly remarkable.
“PerkinElmer is world renowned and its crucial role and expertise in setting up this advanced laboratory ensures it joins our first-class testing facilities here in Wales.
“I’d like to thank PerkinElmer and all partners involved for their commitment and effort in establishing this lab.
“I’d also like to thank Life Sciences Hub Wales for the crucial role they are playing in supporting such vital work.”
About Life Sciences Hub Wales
Life Sciences Hub Wales is leading industry efforts to combat Covid-19 by launching a nation-wide drive to encourage companies to respond to the needs of the current health crisis.
The organisation, which works to improve Wales’ health and wellbeing by facilitating collaborations and innovations between NHS Wales, industry and academia, has identified key challenge areas that must be urgently addressed to support healthcare services during the outbreak: medical devices, infection control and digital solutions.
Life Sciences Hub Wales aims to drive transformational systematic change within the health and care sectors to create a better future for the people of Wales.
We know that health and economic wellbeing go hand-in-hand. Our role is to inspire innovation and collaboration between industry, health and social care, and research organisations to make a positive difference to people and families across the nation.
We are a catalyst for change. We work with NHS Wales to understand issues and identify how innovation can help deliver better care. We support businesses to create health and care solutions.
We create connections. We enable people and organisations to work with us in partnership and create networking and matchmaking opportunities for innovators.
To find out more, visit: https://lshubwales.com/covid-19
About PerkinElmer
PerkinElmer enables scientists, researchers and clinicians to address their most critical challenges across science and healthcare. With a mission focused on innovating for a healthier world, we deliver unique solutions to serve the diagnostics, life sciences, food and applied markets. We strategically partner with customers to enable earlier and more accurate insights supported by deep market knowledge and technical expertise. Our dedicated team of about 13,000 employees worldwide is passionate about helping customers work to create healthier families, improve the quality of life, and sustain the wellbeing and longevity of people globally. The Company reported revenue of approximately $2.9 billion in 2019, serves customers in 190 countries, and is a component of the S&P 500 index. Additional information is available through 1-877-PKI-NYSE, or at www.perkinelmer.com.
New late-breaking data show use of Abbott's FreeStyle® Libre system significantly reduces HbA1c levels in people with type 2 diabetes using insulin or not
13 June 2020 - Real-world data presented at the American Diabetes Association 80th Scientific Sessions suggest people with type 2 diabetes can achieve similar outcomes to adding insulin therapy for both long-acting insulin or non-insulin users. A separate late-breaking trial demonstrates FreeStyle Libre portfolio use is associated with significant reductions of acute diabetes events and hospitalizations for a similar population.
ABBOTT PARK, Ill., June 13, 2020 -- Today, Abbott announced new late-breaking data demonstrating use of its FreeStyle Libre system, the world's leading continuous glucose monitoring (CGM) technology, is associated with significant reduction in hemoglobin A1c (HbA1c) levels for people living with type 2 diabetes on either long-acting insulin or non-insulin therapy. These results are similar to outcomes typically seen when adding insulin therapy to treatment regimens, indicating people may be able to manage their glucose levels with CGM technology instead of adding insulin. The real-world data were presented as a late-breaking abstract at the American Diabetes Association (ADA) 80th Scientific Sessions.
In an observational, retrospective study, researchers assessed changes in HbA1c levels in people with type 2 diabetes who were either on long-acting insulin or non-insulin therapy. They analyzed HbA1c levels from baseline to six months and baseline to 12 months after initiating use of the FreeStyle Libre system.
The results demonstrated overall lower HbA1c levels associated with the use of Abbott's technology, specifically a 0.8% drop after six months (from 8.5% to 7.7%) and 0.6% drop after one year of FreeStyle Libre system use (from 8.5% to 7.9%) – clinically significant reductions of average glucose levels over time toward the ADA's recommended A1c goal of 7% for adults with diabetes. Additional notable findings showed:
- The greatest HbA1c decreases occurred among the non-insulin users with type 2 diabetes, including a 0.9% reduction at six months and 0.7% drop after 12 months.
- Among those people with type 2 diabetes on long-acting insulin, HbA1c reductions were 0.6% and 0.5% at six and 12 months, respectively.
"The real-world results are among the first studies that show use of the FreeStyle Libre system can deliver substantial reduction in HbA1c levels for those with type 2 diabetes, whether using insulin or not," said Dr. Eden Miller, D.O., family practice physician at High Lakes Health Care and one of the lead investigators of the study. "These data highlight how use of Abbott's continuous glucose monitor could be game-changing for people beyond intensive insulin users, translating to broader use of the technology to benefit all those living with diabetes, no matter where they are in the spectrum of care."
ADDITIONAL LATE-BREAKERS SHOW REDUCTION IN HBA1C AND HOSPITALIZATIONS
Two additional late-breaking abstracts assessed the impacts of using the FreeStyle Libre system in people living with type 2 diabetes not on intensive insulin therapy (such as bolus insulin). Results demonstrated the following:
- HbA1c Reduction Associated with a FreeStyle Libre System in People with Type 2 Diabetes Not on Bolus Insulin Therapy: A retrospective study found that a prescription for the FreeStyle Libre system in people with type 2 diabetes not on intensive insulin who had poor glucose control was associated with a substantial decrease in HbA1c, with the greatest reduction in those with higher baseline HbA1c levels. Specifically, A1c levels decreased 0.99% after six months in those on long-acting insulin and 1.56% after six months in those not on insulin. For those not using insulin, these results imply that using FreeStyle Libre technology can have a similar impact to using insulin therapy, meaning people could use the FreeStyle Libre system to manage their glucose levels instead of adding insulin.
- FreeStyle Libre System Use Associated with Reduction in Acute Diabetes Events and All-Cause Hospitalizations in Patients with Type 2 Diabetes Without Bolus Insulin: In a retrospective, observational analysis, researchers found that using the FreeStyle Libre system was associated with a sizeable reduction of 30% in acute diabetes events, or complications that can arise from diabetes, and 13% in all-cause hospitalizations among people with type 2 diabetes not on intensive insulin therapy. These late-breaking data suggest significant cost-savings associated with use of the FreeStyle Libre technology, which is priced at a third of the cost of other CGMs, by lowering costly diabetes-related complications and hospitalizations.
"Over time, researchers around the world have generated unparalleled clinical and real-world evidence that reinforce the proven benefits of Abbott's glucose sensing technology," said Mahmood Kazemi, M.D., divisional vice president, global medical and scientific affairs and chief medical officer, Diabetes Care, Abbott. "These new data underscore how our wearable technology provides actionable information to deliver positive outcomes in anyone with diabetes, emphasizing the power of the FreeStyle Libre system to change countless lives among the millions of people with diabetes."
About the FreeStyle Libre System:
Abbott's FreeStyle Libre technology, the #1 sensor-based glucose monitoring system used worldwide, reads glucose levels through a sensor that can be worn on the back of the upper arm, eliminating the need for fingersticks. The FreeStyle Libre portfolio has changed the lives of more than two million people across 50 countries and has secured partial or full reimbursement in 36 countries, including France, Ireland, Japan, the United Kingdom, and the U.S.
About Abbott:
Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 107,000 colleagues serve people in more than 160 countries.
Grifols starts production of its hyperimmune immunoglobulin as a potential passive immune therapy against COVID-19
11 June 2020 - Grifols continues to lead initiatives to combat COVID-19 with the development of the first specific drug
Barcelona, June 11, 2020 -- Grifols, a global leader in the development of therapies with plasma-derived proteins with a track record of more than 100 years dedicated to enhancing people’s health and well-being, today announced the start of production of its anti-SARS-CoV-2 hyperimmune immunoglobulin with specific antibodies using the plasma of people who have overcome the disease. It is the first specific drug developed to combat COVID-19.
Grifols is leading the production of this potential anti-COVID-19 passive immune therapy as part of a collaboration agreement with U.S. government entities, including the Food and Drug Administration (FDA), the National Institutes of Health (NIH) and the Biomedical Advanced Research Development Authority (BARDA), among other healthcare agencies. The agreement also encompasses the development of preclinical and clinical trials required to determine treatment efficacy. The company is also moving forward to establish collaborations in Europe.
Grifols’ anti-SARS-CoV-2 hyperimmune immunoglobulins are being produced in its Clayton (North Carolina, U.S.) facility, which has been specifically designed to process specialty immunoglobulins.
The first doses are expected to be available in July 2020 as part of a clinical trial.
Grifols leverages its broad expertise and experience in previous healthcare emergencies like the Ebola outbreak to become the first company to start production of an anti-SARS-CoV-2 hyperimmune immunoglobulin.
At the same time, Grifols is moving forward with its clinical trial in Spain to assess the effectiveness of high-dose intravenous immunoglobulin to stabilize or improve the condition of COVID-19 patients.
In this regard, the trial aims to assess the action of neutralizing antibodies (proteins that bind viruses and prevent them from infecting human cells), as well as determine the immunomodulatory potential (immune modulation response) of immunoglobulins as therapy to block the cytokine storm in patients with severe cases of COVID-19.
Immunoglobulins: plasma proteins with a broad therapeutic potential and complex action mechanisms that are difficult to replicate
Immunoglobulins are plasma proteins that act like antibodies as part of the body’s defense system, with complex and hard-to-replicate mechanisms of action. Thanks to their broad scope of action - including their immunomodulatory effects - immunoglobulins have a vast and varied range of clinical applications, such as the prevention of infection in immunodeficient patients and autoimmune diseases, both neurological and in other organs.
Treatment with immunoglobulins is essential in the prevention of infections in the event of accidental exposure to infectious agents such as Hepatitis B or the Rabies virus. They are also essential in the prevention of infections in patients with primary immunodeficiencies (PID), which include more than 300 diseases, 150 of which stem from a congenital defect. These diseases are the result of a quantitative and/or functional alteration of the various mechanisms involved in the immune response.
Immunoglobulin has also been proven as a safe and effective treatment for a number of neurological diseases, including Guillain Barré syndrome, chronic inflammatory demyelinating polyneuropathy (CIDP), multifocal motor neuropathy, myasthenia gravis, and Lambert-Eaton syndrome, among others.
These highly complex diseases are difficult to treat without intravenous immunoglobulin due to limitations in reproducing all of their mechanisms of action, which are the result of the natural evolution of the human immune system.
With broad therapeutic potential, immunoglobulins are also used to treat secondary immunodeficiencies, which occur when a disease or therapeutic treatment decreases the immune cells’ ability to react against pathogens and form antibodies, requiring that part of the immune system to be replaced.
This type of immunodeficiency can also appear in autoimmune diseases like rheumatoid arthritis, lupus and multiple sclerosis as a consequence of the use of immunosuppressive drugs. Treatments for diseases such as cancer may also lead to weakened immune systems. Thus, research is currently underway to discover new immunotherapy and immunoglobulin strategies for cancer patients.
At present, there are more than 5,000 clinical trials around the world to further explore the treatment potential of this plasma protein.
Grifols is the worldwide leader in the production and sale of immunoglobulins and remains firmly committed to addressing the current and future needs of patients in need of this plasma protein thanks to the generosity of its donors.
Regeneron begins first clinical trials of anti-viral antibody cocktail REGN-COV2 for the treatment and prevention of COVID-19
11 June 2020 - Clinical program consists of four separate study populations: two for treatment and two for prevention. First studies evaluate safety and efficacy in hospitalized and non-hospitalized patients with COVID-19. Two-antibody 'cocktail' is designed to help protect against viral escape.
TARRYTOWN, N.Y., June 11, 2020 -- Regeneron Pharmaceuticals, Inc. today announced initiation of the first clinical trial of REGN-COV2, its investigational dual antibody cocktail for the prevention and treatment of COVID-19. The REGN-COV2 clinical program will consist of four separate study populations: hospitalized COVID-19 patients, non-hospitalized symptomatic COVID-19 patients, uninfected people in groups that are at high-risk of exposure (such as healthcare workers or first responders) and uninfected people with close exposure to a COVID-19 patient (such as the patient's housemate). The placebo-controlled trials will be conducted at multiple sites.
"We have created a unique anti-viral antibody cocktail with the potential both to prevent and treat infection, and also to preempt viral 'escape,' a critical precaution in the midst of an ongoing global pandemic," said George D. Yancopoulos, M.D., Ph.D., Co-Founder, President and Chief Scientific Officer of Regeneron. "REGN-COV2 could have a major impact on public health by slowing spread of the virus and providing a needed treatment for those already sick – and could be available much sooner than a vaccine. The antibody cocktail approach may also have long-term utility for elderly and immuno-compromised patients, who often do not respond well to vaccines. Ultimately, the world needs multiple solutions for COVID-19, and the innovative biopharma industry is collectively working hard to help as many people as possible with a variety of complementary approaches."
Regeneron scientists evaluated thousands of fully-human antibodies produced by the company's proprietary VelocImmune® mice, which have been genetically-modified to have a human immune system, as well as antibodies isolated from humans who have recovered from COVID-19. They selected the two most potent, non-competing and virus-neutralizing antibodies and have scaled them up for clinical use with the company's in-house VelociMab® and manufacturing capabilities. The two antibodies bind non-competitively to the critical receptor binding domain (RBD) of the virus's spike protein, which diminishes the ability of mutant viruses to escape treatment, as demonstrated in upcoming Science publications of preclinical research.
Regeneron used the same 'rapid response' capabilities and cocktail approach to develop REGN-EB3, a novel triple antibody treatment for Ebola that is now under regulatory review by the U.S. Food and Drug Administration (FDA). REGN-COV2's preclinical development and preclinical/clinical manufacturing has been funded in part with federal funds from the Biomedical Advanced Research and Development Authority (BARDA), part of the office of the Assistant Secretary for Preparedness and Response at the U.S. Department of Health and Human Services, under OT number: HHSO100201700020C.
The first two adaptive Phase 1/2/3 studies are evaluating REGN-COV2 (REGN10933+REGN10987) as a treatment for hospitalized and non-hospitalized patients with COVID-19. The Phase 1 portion will focus on virologic and safety endpoints, and the Phase 2 portion will focus on virologic and clinical endpoints. Data from the Phase 1 and Phase 2 studies will be used to refine the endpoints and determine size for the Phase 3 studies.
"We are particularly excited to begin studies of REGN-COV2, which is a novel antibody cocktail targeted specifically against SARS-CoV-2," said trial investigator Dr. Suraj Saggar, Chief of Infectious Disease at Holy Name Medical Center in Teaneck, New Jersey. "Over the last long months, we have learned that repurposing existing medicines unfortunately does not offer a broadly effective solution for COVID-19. For this reason, we need to investigate custom-designed approaches like REGN-COV2. The first studies will evaluate if REGN-COV2 can improve disease outcomes in both hospitalized and non-hospitalized patients with COVID-19."
About Regeneron's Anti-Viral Antibodies
When faced with a harmful pathogen, such as a virus or bacteria, the human immune system typically produces antibodies to fight the invader. Specifically, the immune system produces 'anti-viral' antibodies that recognize, bind, and kill or neutralize the virus. Vaccination involves injecting a dead or weakened virus, or a critical small piece of a virus, to induce this protective immune response, resulting in the same antibodies the immune system would typically make in a person who actually had the infectious disease.
Regeneron's core technologies allow for rapid and efficient generation of these protective anti-viral antibodies outside of the body, derived from either genetically-humanized mice or convalescent humans. The resulting antibodies correspond to the most potent of anti-viral antibodies that could be elicited by a vaccine or through exposure to a pathogen. These antibodies can be delivered to people via injection, providing "passive immunity" and protection from the disease immediately, though they must be re-administered to remain effective over time. These antibodies can also treat an existing infection, unlike vaccines which can only be used preventatively.
The concept that drug cocktails can prevent viral escape has previously been demonstrated for traditional antiviral drugs used to treat HIV and other viruses. In the upcoming Science publications, Regeneron scientists report the fundamental realization that this can also be true for antibody-based therapies. Regeneron's preclinical studies demonstrate that, in the setting of a single therapeutic antibody that blocks the ability of a virus to infect healthy cells, spontaneously arising mutant forms of the virus are able to 'escape' or evade the antibody's blocking action. These mutants are then 'selected' (i.e., are able to survive and proliferate despite the single antibody treatment) and may ultimately become the dominant strain of the virus. Regeneron therefore pursues a multi-antibody cocktail approach designed to decrease the potential for the virus to escape.
Regeneron has developed additional technologies that allow for the large-scale manufacturing and purification of these anti-viral antibodies, potentially allowing many people to be granted immunity before vaccines become widely available.
About Regeneron
Regeneron (NASDAQ: REGN) is a leading biotechnology company that invents life-transforming medicines for people with serious diseases. Founded and led for over 30 years by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to seven FDA-approved treatments and numerous product candidates in development, all of which were homegrown in our laboratories. Our medicines and pipeline are designed to help patients with eye diseases, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, pain, infectious diseases and rare diseases.
Regeneron is accelerating and improving the traditional drug development process through our proprietary VelociSuite® technologies, such as VelocImmune® which uses unique genetically-humanized mice to produce optimized fully-human antibodies and bispecific antibodies, and through ambitious research initiatives such as the Regeneron Genetics Center, which is conducting one of the largest genetics sequencing efforts in the world. For additional information about the company, please visit www.regeneron.com or follow @Regeneron on Twitter.
PerkinElmer Launches Pre-eclampsia Kit for Enhanced Management
10 June 2020 - Addition of sFlt-1 for second and third trimester pre-eclampsia management rounds out portfolio
WALTHAM, Mass., June 10, 2020 – PerkinElmer, Inc., a global leader committed to innovating for a healthier world, announced today the addition of the DELFIA® Xpress sFlt-1 kit to its CE-IVD pre-eclampsia product offerings. This kit will enable short term prediction of pre-eclampsia and aid in diagnosis in the second and third trimesters of pregnancy together with the previously launched DELFIA® Xpress PlGF 1-2-3™ assay. It is easily adaptable for current screening customers using the DELFIA® Xpress instrument.
In the second and third trimesters of pregnancy among symptomatic women, the concentrations of DELFIA Xpress sFlt-1 and DELFIA Xpress PlGF 1-2-3 assays can be used to calculate a ratio to predict the onset of pre-eclampsia and for aid in diagnosis. The addition of sFlt-1 completes PerkinElmer’s pre-eclampsia product portfolio as the Company now offers different solutions for managing pre-eclampsia during all trimesters.
“For risk assessment and diagnosis of pre-eclampsia, accurate results enable health care to primarily predict and prevent pre-eclampsia and also to provide improved management for all women,” said Petra Furu, GM, Reproductive Health, PerkinElmer. “With the sFlt-1 assay, we offer the ability to better manage and assess this condition throughout all stages of pregnancy, furthering PerkinElmer’s mission of encouraging healthier families and improved prenatal care.”
The newly launched DELFIA Xpress sFlt-1 is the latest product to the family dedicated to the prediction of pre-eclampsia that includes PlGF kits on various platforms as well as the recently launched Pre-eclampsia Detection Kit, the first urinary true point-of-care kit utilizing Congo Red technology.
PerkinElmer’s prenatal screening assays and testing solutions are clinically validated and are ideal for all modern prenatal management strategies. The Company's screening solutions are also used in many international prenatal and maternal health studies, including ASPRE, a ground-breaking study into the role of aspirin in the prevention of pre-eclampsia. To learn more about PerkinElmer’s prenatal screening platforms and management solutions, please visit prenataltesting.perkinelmer.com.
About PerkinElmer
PerkinElmer enables scientists, researchers and clinicians to address their most critical challenges across science and healthcare. With a mission focused on innovating for a healthier world, we deliver unique solutions to serve the diagnostics, life sciences, food and applied markets. We strategically partner with customers to enable earlier and more accurate insights supported by deep market knowledge and technical expertise. Our dedicated team of about 13,000 employees worldwide is passionate about helping customers work to create healthier families, improve the quality of life, and sustain the wellbeing and longevity of people globally. The Company reported revenue of approximately $2.9 billion in 2019, serves customers in 190 countries, and is a component of the S&P 500 index. Additional information is available through 1-877-PKI-NYSE, or at www.perkinelmer.com.
Cepheid Announces Development of Four-in-One Combination Test for SARS-CoV-2, Flu A, Flu B and RSV
9 June 2020 - Four Viral Infections Have Similar Patient Presentations, Making Accurate Detection and Differentiation Critical During Next Flu Season
SUNNYVALE, Calif., June 9, 2020 -- Cepheid today announced the development of a next-generation test to assist global efforts in the fight against the spread of COVID-19 during the upcoming respiratory virus season. The Xpert® Xpress SARS-CoV-2/Flu/RSV four-in-one test is expected to deliver qualitative detection of SARS-CoV-2, Flu A, Flu B and RSV from a single patient sample. The test is designed for use on any of Cepheid's more than 25,000 GeneXpert® Systems placed worldwide, with results expected in as little as 35 minutes.
"Patients infected by SARS-CoV-2, Flu A, Flu B, and RSV have overlapping clinical presentations, but fundamentally different treatment and management pathways," said Dr. David Persing, MD, Ph.D., Chief Medical and Technology Officer at Cepheid. "Unlike the common cold viruses, infection with these four viruses is often associated with fever and other systemic manifestations that may be coupled with severe outcomes, especially in the elderly."
In the coming weeks, Cepheid intends to pursue the FDA's Emergency Use Authorization (EUA) pathway for regulatory authorization and make the test available globally on its cartridge-based GeneXpert Systems, which features instruments that can be configured for both near patient point-of-care and high volume laboratory testing needs.
"On March 20th, Cepheid was granted the first-ever EUA by the FDA for use in point-of-care settings for our Xpert Xpress SARS-CoV-2 test," said Cepheid President Warren Kocmond. "Since then, we have experienced unprecedented demand for this technology. Leveraging the quality design of Xpert Xpress SARS-CoV-2 and our widely utilized Xpert Xpress Flu/RSV tests, we're combining two world-class products in a single, rapid solution ahead of the upcoming flu season. This will enable our customers to have increased testing throughput on their current GeneXpert System and increase our ability to provide supply continuity for the market."
GeneXpert's Modular Design Enables High-Volume Laboratory and Near-Patient Point-of-Care Testing
The GeneXpert System was built for simple, reference lab quality PCR testing – on location at medical centers and hospitals or closer to patient in health clinics and nursing homes. At the core of every GeneXpert System is the module (or testing bay) where a test cartridge is loaded onto the machine. Our line of GeneXpert Systems can be configured with a varying number of modules, or test bays, to meet the volume requirements of any setting. Smaller GeneXpert Systems are configured with 2 or 4 modules – meaning up to four different tests can be run at one time. Our largest GeneXpert System is configured with up to 80 modules – meaning as many as 80 tests can operate independently at any given time with a capacity of about 2,000 tests per day.
About Cepheid
Based in Sunnyvale, Calif., Cepheid is a leading molecular diagnostics company that is an operating company within Danaher Corporation's (NYSE: DHR) Diagnostics platform. Cepheid is dedicated to improving healthcare by developing, manufacturing, and marketing accurate yet easy-to-use molecular systems and tests. By automating highly complex and time-consuming manual procedures, the company's solutions deliver a better way for institutions of any size to perform sophisticated molecular diagnostic testing for organisms and genetic-based diseases. Through its strong molecular biology capabilities, the company is focusing on those applications where accurate, rapid, and actionable test results are needed most, such as managing infectious diseases and cancer. For more information, visit http://www.cepheid.com.
Quidel receives amended Emergency Authorization for Rapid Antigen COVID-19 Diagnostic Assay using "Sofia 1" instrument
9 June 2020 - Sofia® SARS Antigen FIA Point-of-Care test offers positive results in 15 minutes
SAN DIEGO, 9 June 2020 -- 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 Quidel to run its Sofia® SARS Antigen FIA, a rapid point-of-care test for COVID-19, on the Sofia® Fluorescent Immunoassay Analyzer (“Sofia 1”), Quidel’s first-generation automated immunoassay instrument. Quidel previously received EUA to run the Sofia SARS Antigen FIA on the second-generation Sofia 2 instrumented system.
Sofia 1 is Quidel’s first-generation instrumented system, which provides an accurate, objective and automated result in 15 minutes. Like the Sofia 2, the original Sofia 1 instrument offers 2 distinct workflows: depending upon the user’s choice, the Sofia SARS Antigen FIA cartridge is placed inside the instrument for automatically timed development (WALK AWAY Mode); or test cartridges can be placed on the counter or bench top for a manually timed development and then placed into the instrument to be scanned (READ NOW Mode), allowing the user to markedly increase testing throughput per hour. There are approximately 20,000 Sofia 1 instruments installed in hospitals and physician offices worldwide.
“This EUA amendment permits our novel Sofia® SARS Antigen test to be used on both models of our Sofia instruments, leveraging our worldwide installed base of over 43,000 combined placements, allowing many of our larger healthcare facilities to be able to quickly diagnose first responders, healthcare workers, and other high priority personnel,” said Douglas Bryant, president and chief executive officer of Quidel Corporation. “The demand for the Sofia SARS Antigen test kits and Sofia instruments has been phenomenal. In under 10 days, we had over 1,000 sites on contract and continue to expect that we will ship every cartridge that we can manufacture for the foreseeable future.”
The Sofia SARS Antigen FIA is to be used as an aid in the rapid detection of SARS-CoV-2 in nasal or nasopharyngeal specimens from patients meeting the Centers for Disease Control and Prevention’s (CDC) criteria for suspected COVID-19 infection. The assay is currently available for sale in the United States under EUA, and Quidel is now shipping the product to its customers. Quidel offers several other Sofia assays for sale, which are FDA cleared and CLIA waived, including tests for Influenza A and B, Respiratory Syncytial Virus (RSV), Group A Strep, and a 15-minute finger-stick whole blood test for Lyme Disease. In addition, Quidel also markets Sofia® tests for Lyme Disease, Legionella and S. pneumoniae in Europe.
Healthcare professionals can purchase the Sofia SARS Antigen FIA through distribution representatives for Cardinal Health, Fisher Healthcare, Henry Schein, McKesson, or Medline.
About Quidel Corporation
Quidel Corporation serves to enhance the health and well-being of people around the globe through the development of diagnostic solutions that can lead to improved patient outcomes and provide economic benefits to the healthcare system. Marketed under the Sofia®, QuickVue®, D3® Direct Detection, Thyretain®, Triage® and InflammaDry® leading brand names, as well as under the new Solana®, AmpliVue®and Lyra® molecular diagnostic brands, Quidel’s products aid in the detection and diagnosis of many critical diseases and conditions, including, among others, influenza, respiratory syncytial virus, Strep A, lyme, herpes, pregnancy, thyroid disease and fecal occult blood. Quidel's Triage® system of tests comprises a comprehensive test menu that provides rapid, cost-effective treatment decisions at the point-of-care (POC), offering a diverse immunoassay menu in a variety of tests to provide diagnostic answers for quantitative BNP, CK-MB, d-dimer, myoglobin, troponin I and qualitative TOX Drug Screen. Quidel’s research and development engine is also developing a continuum of diagnostic solutions from advanced immunoassay to molecular diagnostic tests to further improve the quality of healthcare in physicians’ offices and hospital and reference laboratories. For more information about Quidel’s comprehensive product portfolio and to explore exciting employment opportunities, visit quidel.com.
Illumina Receives First FDA Emergency Use Authorization for a Sequencing-Based COVID-19 Diagnostic Test
9 June 2020
SAN DIEGO, 9 June 2020 -- Illumina, Inc. is paving the way for large-scale, next-generation sequencing-based (NGS) COVID-19 testing. Today, the U.S. Food and Drug Administration (FDA) issued an Emergency Use Authorization (EUA) for the Illumina COVIDSeq™ Test, a high-throughput, sequencing-based, in vitro diagnostic (IVD) workflow enabling the detection of SARS-CoV-2. The end-to-end workflow extends the options available for labs to scale diagnostic testing.
COVIDSeq uses upper respiratory specimens, including a nasopharyngeal or oropharyngeal swab, and delivers sample receipt to result in 24 hours using the NovaSeq™ 6000 Sequencing System. The differentiated diagnostic design includes 98 amplicons that target the full SARS-CoV-2 genome, creating accurate detection and high sensitivity. COVIDSeq is currently available to a limited number of early access sites, and is expected to be more broadly available this summer.
The workflow accommodates up to 3,072 samples per NovaSeq run leveraging the S4 flow cell, and includes steps for viral RNA extraction, RNA-to-CDNA conversion, PCR, library preparation, sequencing and report generation. The key components leveraged include the NovaSeq 6000, coupled with Illumina Tagmentation library preparation technology, and the DRAGEN™ COVIDSeq Test Pipeline for rapid reporting.
“COVIDSeq leverages the performance of NGS to help address the global need for diagnostic testing to fight the COVID-19 pandemic,” said Francis deSouza, Chief Executive Officer of Illumina. “Beyond diagnostic testing, Illumina and a number of our customers are exploring NGS-based workflows to enable high-volume screening to support a return to work and school.”
COVIDSeq has not been FDA cleared or approved. This test is authorized by FDA under an EUA 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. COVIDSeq is only authorized for use in laboratories in the U.S., certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, to perform moderate and high complexity tests. Outside the U.S., COVIDSeq will be labeled either as Research Use Only (RUO), or with labeling aligned with local regulations.
For additional information, please visit www.illumina.com/covidseq
About Illumina
Illumina is improving human health by unlocking the power of the genome. Our focus on innovation has established us as the global leader in DNA sequencing and array-based technologies, serving customers in the research, clinical, and applied markets. Our products are used for applications in the life sciences, oncology, reproductive health, agriculture, and other emerging segments. To learn more, visit www.illumina.com and follow @illumina.
AbbVie, Harbour BioMed, Utrecht University and Erasmus Medical Center Announce Collaboration to Develop Monoclonal Antibody Therapy to Prevent and Treat COVID-19
5 June 2020
NORTH CHICAGO, Ill. and CAMBRIDGE, Mass. and UTRECHT, Netherlands and ROTTERDAM, Netherlands and SUZHOU, China, June 5, 2020 -- AbbVie, Harbour BioMed (HBM), Utrecht University (UU) and Erasmus Medical Center (EMC) today announced they have entered into a collaboration to develop a novel antibody therapeutic to prevent and treat COVID-19, the pandemic respiratory disease caused by the SARS-CoV-2 virus. The focus of the collaboration is on advancing the fully human, neutralizing antibody 47D11 discovered by UU, EMC and HBM and recently reported in Nature Communications. This antibody targets the conserved domain of the spike protein of SARS-CoV-2.
Under the terms of the collaboration, AbbVie will support UU, EMC and HBM through the preclinical activities, while simultaneously undertaking preparations for later stage preclinical and clinical development work. AbbVie will receive an option to exclusively license the antibody from the three parties for therapeutic clinical development and commercialization worldwide.
"Treatment and prevention of COVID-19 remains a critical global need. The antibody discovered by UU, EMC and Harbour BioMed is extremely promising based on the mechanism by which it targets the virus and on its developability as a fully human protein," said Tom Hudson, M.D., Senior Vice President, Research and Development and Chief Scientific Officer, AbbVie. "We look forward to working with this outstanding team to advance this antibody towards clinical trials."
"AbbVie is a global leader in developing innovative antiviral therapies," said Dr. Jingsong Wang, Founder, Chairman & Chief Executive Officer of HBM. "This collaboration will greatly accelerate our efforts to bring this antibody forward into clinical trials as quickly as possible and contribute a solution to this pandemic."
"The SARS-CoV-2 pandemic has highlighted the importance of understanding coronavirus biology," said Berend-Jan Bosch, PhD, Associate Professor, Research leader at UU. "The collaboration with AbbVie provides an excellent opportunity to translate our research into a clinical candidate with great potential for advancing the fight against this disease."
Frank Grosveld, PhD, Academy Professor of Cell Biology, EMC, Rotterdam and Founding Chief Scientific Officer at Harbour BioMed, commented, "The collaboration is an endorsement of our approach to fully human antibody discovery and development. Through this collaboration, we are well positioned to move rapidly towards clinical trials."
The antibody discovery, published online on May 4 in Nature Communications, targets a conserved region of the virus' spike protein. In cell culture studies the antibody blocked infection by the SARS-CoV-2 and a second coronavirus SARS-CoV. The antibody is fully human, which is designed to facilitate its development and minimize immune-related side effects.
About AbbVie
AbbVie's mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, women's health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn.
About Utrecht University
Founded in 1636, Utrecht University is one of the largest research universities of Europe, with over thirty thousand students and a staff of more than six thousand. We invest in creating the leaders of the future through innovative education of the highest quality, as reflected by the University's consistently high position in international rankings. Dedicated to performing groundbreaking research aimed at resolving large global issues, our culture of cooperation is a breeding ground for innovation, new insights and social impact. www.uu.nl.
About Erasmus Medical Center
Erasmus MC is the largest University Medical Center in the Netherlands. Our primary goal is a healthy population. Nearly 14,000 employees devote themselves every day to providing outstanding care, facilitating world-class education and conducting pioneering research. These professionals are instrumental in developing expertise on health and illness. They link the latest scientific insights to practical treatments and prevention measures to provide maximum benefit to patients and to enable healthy people to stay healthy longer. Being visibly better and leading the way in the areas of complex, innovative and acute care by collaborating with others: these are key ambitions at Erasmus MC.
About Harbour BioMed
Harbour BioMed is a global, clinical stage biopharmaceutical company developing innovative therapeutics in the fields of immuno-oncology and inflammatory diseases. The company is building its proprietary pipeline through internal R&D programs, collaborations with co-discovery and co-development partners and select acquisitions.
The company's internal discovery programs are centered around its two patented transgenic mouse platforms (Harbour Mice®) for generating both fully human monoclonal antibodies and heavy chain only antibodies (HCAb) and HBICE™ immune cell engager technology for developing bispecific antibodies. Harbour BioMed also licenses the platforms to companies and academic institutions. The company has operations in Cambridge, Massachusetts; Rotterdam, The Netherlands; and Suzhou & Shanghai, China. For more information, please visit www.harbourbiomed.com
Roche’s Elecsys IL-6 test receives FDA Emergency Use Authorisation to help in identifying patients at high risk of severe inflammatory response
4 June 2020 - FDA EUA now makes IL-6 testing accessible to patients in the United States to assist in identifying severe inflammatory response in patients with confirmed COVID-19 and is also available in markets accepting the CE-mark. Interleukin 6 (IL-6) is an early indicator for acute inflammation to aid in the management of critically ill patients. This test is available on Roche’s cobas e analysers which are widely available around the world.
Basel, 04 June 2020 -- Roche announced today that the U.S. Food and Drug Administration (FDA) has issued an Emergency Use Authorisation (EUA) for the Elecsys® IL-6 test. This test measures levels of the biomarker interleukin 6 (IL-6) and can be used to help identify patients with confirmed COVID-19 disease who could be at high risk of intubation with mechanical ventilation.
The test can support physicians, in combination with other examinations and vital signs, to decide early on if a patient with confirmed COVID-19 illness requires mechanical ventilation.“The FDA EUA approval of Elecsys IL-6 is another step in our commitment to deliver fast and reliable diagnostic tests to help fight the coronavirus pandemic,” said Thomas Schinecker, CEO Roche Diagnostics. “In the current situation, time is specifically critical. The test could help physicians in the quick identification of severe inflammatory response in patients infected with the SARS CoV-2 virus.”
“In the current pandemic, Roche’s Elecsys IL-6 test was helpful as an early indicator for acute inflammation and in the management of critically ill patients,” said Tobias Herold, MD from the Emergency Department, University Hospital, LMU University Munich, Germany. "Elevated IL-6 values help us to identify patients with a high risk of upcoming respiratory failure.
Hospitals and reference laboratories can run the Elecsys IL-6 test on Roche’s cobas e® analysers which are widely available around the world. These fully-automated systems can provide test results in approximately 18 minutes, with a test throughput of up to 300 tests/hour, depending on the analyser.
About Elecsys IL-6
The IL-6 immunoassay is an in vitro diagnostic test for the quantitative determination of IL-6 (interleukin-6) in human serum or plasma. This assay is used in countries accepting CE-mark to aid in the management of critically ill patients, as an early indicator for acute inflammation. Under the Emergency Use Authorisation in the US, this assay can be used to assist in identifying severe inflammatory response in patients with confirmed COVID‑19 illness to aid in determining the risk of intubation with mechanical ventilation, in conjunction with clinical findings and the results of other laboratory testing. IL-6 is released by immune cells, once they are activated by virus, bacteria or other immune cells. IL-6 acts like a messenger to activate other immune cells to fight the infection. Because IL-6 is released so early during a severe infection, it helps physicians to identify severely ill COVID-19 patients as early as possible. Hospitals and reference laboratories can run the test on Roche’s cobas e analysers which are widely available around the world. These fully-automated systems can provide test results in approximately 18 minutes, with a test throughput of up to 300 tests/hour, depending on the analyser.
About Roche’s response to the COVID-19 pandemic
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.
Reliable, high-quality testing is essential to help healthcare systems overcome this pandemic. On 13 March we received FDA Emergency Use Authorisation for a high-volume molecular test to detect SARS-CoV-2, the virus that causes COVID-19, which is also available in countries accepting the CE Mark. On 3 May, Roche announced that its COVID-19 antibody test, aimed at detecting the presence of antibodies in the blood, also received FDA Emergency Use Authorisation and is available in markets accepting the CE mark. Our existing diagnostics portfolio for critical care has also been playing a significant role in supporting patient management during the COVID-19 crisis, with our blood gas and sepsis products being used to monitor patients in the acute setting. Roche is working closely with governments and health authorities around the world, and has significantly increased production to help ensure availability of tests globally.
While there are currently no approved medicines for the treatment of patients with COVID-19, we are actively involved in understanding the potential of our existing portfolio and are researching options for the future. 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. Roche has also initiated an internal early research programme focused on the development of medicines for COVID-19 and is evaluating a large number of potential collaborations.
In these exceptional times, Roche stands together with governments, healthcare providers and all those working to overcome the pandemic.
About Roche
Roche is a global pioneer in pharmaceuticals and diagnostics focused on advancing science to improve people’s lives. The combined strengths of pharmaceuticals and diagnostics under one roof have made Roche the leader in personalised healthcare – a strategy that aims to fit the right treatment to each patient in the best way possible.
Roche is the world’s largest biotech company, with truly differentiated medicines in oncology, immunology, infectious diseases, ophthalmology and diseases of the central nervous system. Roche is also the world leader in in vitro diagnostics and tissue-based cancer diagnostics, and a frontrunner in diabetes management.
Founded in 1896, Roche continues to search for better ways to prevent, diagnose and treat diseases and make a sustainable contribution to society. The company also aims to improve patient access to medical innovations by working with all relevant stakeholders. More than thirty medicines developed by Roche are included in the World Health Organization Model Lists of Essential Medicines, among them life-saving antibiotics, antimalarials and cancer medicines. Moreover, for the eleventh consecutive year, Roche has been recognised as one of the most sustainable companies in the Pharmaceuticals Industry by the Dow Jones Sustainability Indices (DJSI).
The Roche Group, headquartered in Basel, Switzerland, is active in over 100 countries and in 2019 employed about 98,000 people worldwide. In 2019, Roche invested CHF 11.7 billion in R&D and posted sales of CHF 61.5 billion. Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan. For more information, please visit www.roche.com.
Reference: https://www.roche.com/media/releases/med-cor-2020-06-04.htm
LabCorp Launches New COVID-19 Clinical Trial Site to Connect Patients With U.S. Research Trials
1 June 2020 - Streamlining recruitment into studies to speed research
BURLINGTON, N.C., Jun. 1, 2020 -- LabCorp, a leading global life sciences company that is deeply integrated in guiding patient care, today announced that Covance, its drug development business, has created COVID-19 Clinical Trial Connect in the U.S., a site designed to help people access information about how to participate in COVID-19 research.
“Through COVID-19 Clinical Trial Connect, our goal is to link people interested in these clinical trials with sponsors so that together we may find solutions for this global pandemic,” said Michael Brooks, president, Clinical Development and Commercialization Solutions, Covance. “There are currently hundreds of COVID-19-related clinical trials underway or planned to begin in the near future, and we recognize that many patients may not know how to go about finding information about a clinical trial. With our COVID-19 Clinical Trial Connect, we’re helping bridge the gap. We are thrilled to have the capability to directly engage with patients who would not otherwise be aware of ongoing trials and give them the opportunity to consider participation, especially at this time.”
The COVID-19 clinical trial opportunities are diverse, with sponsors recruiting patients who currently have COVID-19, those who may be now recovered, and those who may have been exposed to coronavirus. Through the Covance COVID-19 Clinical Trial Connect site, prospective patients would be notified of studies run by Covance on behalf of a biopharmaceutical company, as well as those listed in clinicaltrials.gov.
“People who choose to participate in a clinical trial are true medical heroes,” Brooks said. “It is only through well-designed clinical research that we will find effective treatments and vaccines against COVID-19.”
People visiting the Covance COVID-19 Clinical Trial Connect will be invited to opt-in to register their details. This information will be used to connect people with suitable clinical studies in their area. If a study is unavailable in their area at this time, prospective participants will have the option to be contacted when one becomes available.
To register, visit: https://covid-19clinicaltrialconnect.com/
About LabCorp
LabCorp, an S&P 500 company, is a leading global life sciences company that is deeply integrated in guiding patient care, providing comprehensive clinical laboratory and end-to-end drug development services. With a mission to improve health and improve lives, LabCorp delivers world-class diagnostics solutions, brings innovative medicines to patients faster, and uses technology to improve the delivery of care. LabCorp reported revenue of more than $11.5 billion in 2019. To learn more about LabCorp, visit www.LabCorp.com, and to learn more about LabCorp’s drug development business, Covance, visit www.Covance.com.
LGC expands SARS-CoV-2 offering to include serology quality solutions
28 May 2020
LGC’s SeraCare has released ACCURUN® Anti-SARS-CoV-2 Reference Materials to address the critical need for clinical laboratories to be able to report antibody testing results with confidence, in response to the ongoing COVID-19 pandemic. The ACCURUN kit is designed to support assay installation as well as to monitor day-to-day assay performance, as required by CLIA, CAP, ISO-15189 and many other regulatory or accrediting bodies, providing a complete quality solution for SARS-CoV-2 antibody testing.
28 May 2020 -- To support the multiple SARS-CoV-2 serology assay formats available, the product is currently offered in two configurations, one designed for IgG-specific assays and the other for total antibody tests. Both versions include positive materials for antibodies against the SARS-CoV-2 virus as well as complementary negative materials. ACCURUN reference materials are specifically formulated to exhibit low-positive reactivity in true patient-like matrices, to test assay performance near critical signal cutoff boundaries.
Michael Sweatt, Executive Vice President, LGC SeraCare, stated, “SeraCare has provided gold standard third-party run controls and reference materials to clinical laboratories for more than 30 years. We are privileged to be able to apply our expertise and expand our premier ACCURUN line of infectious disease quality solutions to support expanded SARS-CoV-2 antibody testing during this pandemic. The ACCURUN Anti-SARS-CoV-2 Reference Material Kit is a valuable tool to accelerate development, validation, and implementation of antibody testing, necessary to ensure accurate evaluation of COVID-19 infection status to support treatment and containment efforts.”
To learn more about ACCURUN Anti-SARS-CoV-2 Reference Materials and the complete line of SARS-CoV-2 Quality Solutions, please visit the LGC SeraCare website.
Reference: https://www.lgcgroup.com/newsroom-and-blog/news-and-blog/seracare-expands-sars-cov-2-offering/
Roche initiates phase III clinical trial of Actemra/RoActemra plus remdesivir in hospitalised patients with severe COVID-19 pneumonia
28 May 2020 - Roche is also close to completing enrolment of a global randomised, double-blind, placebo-controlled phase III clinical trial of Actemra®/RoActemra® (tocilizumab) in hospitalised patients with severe COVID-19 pneumonia (COVACTA), with results expected this summer.
Basel, 28 May 2020 -- Roche today announced the initiation of a global phase III, randomised, double-blind, multicentre study (REMDACTA) to evaluate the safety and efficacy of Actemra/RoActemra plus the investigational antiviral remdesivir, versus placebo plus remdesivir in hospitalised patients with severe COVID-19 pneumonia, in collaboration with Gilead Sciences, Inc.
“As more information about COVID-19 pneumonia becomes available in these unprecedented times, it is more important than ever to work together to fight this disease,” said Levi Garraway, M.D., Ph.D., Roche’s Chief Medical Officer and Head of Global Product Development. "Based on our current understanding, we believe that combining an antiviral with an immune modulator could potentially be an effective approach to treating patients with severe disease. We're pleased to partner with Gilead to determine whether combining these medicines could potentially help more patients during this pandemic.”
The study is expected to begin enrolling in June with a target of approximately 450 patients globally.
In addition to REMDACTA, Roche is close to completing enrolment of the global randomised, double-blind, placebo-controlled phase III clinical trial (COVACTA, NCT04320615) to evaluate the safety and efficacy of intravenous Actemra/RoActemra plus standard of care (SOC), versus placebo plus SOC in hospitalised adult patients with severe COVID-19 pneumonia. The first patient was randomised on April 3. In total, approximately 450 patients will be enrolled in COVACTA. This increase from the original target of 330 patients will allow for even more robust data, while minimally extending the recruitment period. Roche is committed to sharing data from the COVACTA study as soon as possible this summer. In addition, the protocol for COVACTA allows the inclusion of patients who are being treated with antivirals, including investigational antivirals. Data from the REMDACTA trial are designed to supplement the COVACTA study.
The COVACTA study is conducted in collaboration with the US Food & Drug Administration (FDA) and the Biomedical Advanced Research and Development Authority (BARDA), a part of the US Health and Human Services Office of the Assistant Secretary for Preparedness and Response (ASPR). Roche is also a participant in the Accelerated COVID-19 Therapeutic Interventions and Vaccines (ACTIV) partnership, led by the National Institutes of Health (NIH) and the Foundation of the NIH.
Remdesivir has been issued an Emergency Use Authorisation by the US Food & Drug Administration (FDA) for the treatment of hospitalised patients with severe COVID-19. Remdesivir is an investigational antiviral drug that is being studied in multiple ongoing international clinical trials, and the safety and efficacy of remdesivir for the treatment of COVID-19 are not yet established. Remdesivir has not been approved by the US FDA for any use. For information about the authorized use of remdesivir and mandatory requirements of the Emergency Use Authorisation in the US, please review the Fact Sheet for Healthcare Providers and FDA Letter of Authorisation available at www.gilead.com/remdesivir.
About the REMDACTA Clinical trial
REMDACTA is a two-armed global phase III, randomised, double-blind, multicentre study to evaluate the efficacy and safety of Actemra/RoActemra plus remdesivir, versus placebo plus remdesivir in hospitalised patients with severe COVID-19 pneumonia receiving standard of care (SOC). The primary and secondary endpoints include clinical status, mortality, mechanical ventilation, and intensive care variables. Patients will be followed for 60 days post-randomisation.
About the COVACTA Clinical Trial
COVACTA is a double-blind, placebo-controlled phase III study (COVACTA, NCT04320615) evaluating the safety and efficacy of intravenous Actemra/RoActemra added to standard of care in approximately 450 adult patients hospitalised with severe COVID-19 pneumonia compared to placebo plus standard of care. The primary endpoint is clinical status assessed using a 7-Category Ordinal Scale at day 28. The ordinal scale ranges from one (discharged from hospital) to seven (death), and covers different hospital locations such as non-intensive care unit (non-ICU) or ICU, and ventilation/treatment requirements, including not requiring supplemental oxygen, or requiring extracorporeal membrane oxygenation (ECMO) or mechanical ventilation and additional organ support. Key secondary endpoints include mortality, mechanical ventilation, clinical status at day 14, time to clinical improvement, and time to discharge.
About Actemra/RoActemra
Actemra/RoActemra was the first approved anti-IL-6 receptor biologic available in both intravenous (IV) and subcutaneous (SC) formulations for the treatment of adult patients with moderate-to-severe active rheumatoid arthritis (RA). Actemra/RoActemra can be used alone or with methotrexate (MTX) in adult RA patients who are intolerant to, or have failed to respond to, other disease-modifying anti-rheumatic drugs (DMARDs). In Europe, RoActemra IV and SC are also approved for use in adult patients with severe, active and progressive RA who previously have not been treated with MTX. Actemra/RoActemra IV and SC are approved globally for polyarticular juvenile idiopathic arthritis (pJIA) and in the US and Europe for systemic juvenile idiopathic arthritis (sJIA) in children two years of age and older. Actemra/RoActemra SC injection is also the first approved therapy for the treatment of giant cell arteritis (GCA) in more than 40 countries, including the US and Europe. In the US and Europe, Actemra/RoActemra IV injection is approved for the treatment of chimeric antigen receptor (CAR) T-cell-induced severe or life-threatening cytokine release syndrome (CRS) in people two years of age and older. Actemra/RoActemra was the first approved treatment for CRS in this setting. A prefilled autoinjector ACTPen has been approved in the US and Europe. In Japan, Actemra is also approved for the treatment of Castleman’s Disease, adult Still's disease and Takayasu Arteritis. Actemra/RoActemra is part of a co-development agreement with Chugai Pharmaceutical Co., Ltd and has been approved in Japan since April 2005. Actemra/RoActemra is approved in more than 110 countries worldwide.
About Roche’s response to the COVID-19 pandemic
The COVID-19 pandemic continues to evolve globally with varying developments from country to country 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.
Reliable, high-quality testing is essential to help healthcare systems overcome this pandemic. On 13 March we received FDA Emergency Use Authorisation for a high-volume molecular test to detect SARS-CoV-2, the virus that causes COVID-19, which is also available in countries accepting the CE Mark. On 3 May, Roche announced that its COVID-19 antibody test, aimed at detecting the presence of antibodies in the blood, also received FDA Emergency Use Authorisation and is available in markets accepting the CE mark. Our existing diagnostics portfolio for critical care has also been playing a significant role in supporting patient management during the COVID-19 crisis, with our blood gas and sepsis products being used to monitor patients in the acute setting. Roche is working closely with governments and health authorities around the world, and has significantly increased production to help ensure availability of tests globally.
While there are currently no approved medicines for the treatment of patients with COVID-19, we are actively involved in understanding the potential of our existing portfolio and are researching options for the future. 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. Roche has also initiated an internal early research programme focused on the development of medicines for COVID-19 and is evaluating a large number of potential collaborations.
In these exceptional times, Roche stands together with governments, healthcare providers and all those working to overcome the pandemic.
About Roche
Roche is a global pioneer in pharmaceuticals and diagnostics focused on advancing science to improve people’s lives. The combined strengths of pharmaceuticals and diagnostics under one roof have made Roche the leader in personalised healthcare – a strategy that aims to fit the right treatment to each patient in the best way possible.
Roche is the world’s largest biotech company, with truly differentiated medicines in oncology, immunology, infectious diseases, ophthalmology and diseases of the central nervous system. Roche is also the world leader in in vitro diagnostics and tissue-based cancer diagnostics, and a frontrunner in diabetes management.
Founded in 1896, Roche continues to search for better ways to prevent, diagnose and treat diseases and make a sustainable contribution to society. The company also aims to improve patient access to medical innovations by working with all relevant stakeholders. More than thirty medicines developed by Roche are included in the World Health Organization Model Lists of Essential Medicines, among them life-saving antibiotics, antimalarials and cancer medicines. Moreover, for the eleventh consecutive year, Roche has been recognised as one of the most sustainable companies in the Pharmaceuticals Industry by the Dow Jones Sustainability Indices (DJSI).
The Roche Group, headquartered in Basel, Switzerland, is active in over 100 countries and in 2019 employed about 98,000 people worldwide. In 2019, Roche invested CHF 11.7 billion in R&D and posted sales of CHF 61.5 billion. Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan. For more information, please visit www.roche.com.
Reference: https://www.roche.com/media/releases/med-cor-2020-05-28.htm
Merck and Baylor College of Medicine Collaborate to Advance a Vaccine Manufacturing Platform to Fight Covid-19
27 May 2020 - Company will focus on process development and improvements for manufacturing Baylor’s Covid-19 vaccine candidates
Darmstadt, Germany, May 27, 2020 — Merck, a leading science and technology company, and Baylor College of Medicine, Houston, Texas, USA, today announced an extension of their ongoing collaboration to advance a manufacturing platform to fight Covid-19, designed to accelerate transition to Phase 1 clinical trials.
“Vaccine manufacturing is extremely complicated, so we are collaborating on a process development approach to accelerate manufacturing of Baylor’s Covid-19 vaccine candidates,” said Udit Batra, member of the Merck Executive Board and CEO, Life Science. “To fight this pandemic, we will need to produce an unprecedented amount of vaccine in a very short period of time, and we need as many approaches as possible to be successful.”
There are no standard manufacturing templates or processes due to the complexity and diversity of vaccine modalities, which makes production a challenge for every organization racing to develop a safe and effective Covid-19 vaccine. Using key learnings from their ongoing collaboration on a schistosomiasis vaccine, Merck, along with researchers at Baylor College of Medicine and the Texas Children’s Hospital Center for Vaccine Development, is optimizing the production processes to advance two Covid-19 vaccine candidates, including the CoV RBD219-N1 vaccine candidate expected to enter clinical trials later this year. Merck will help to accelerate their suitability for large-scale manufacturing. This collaboration will focus on improvements to production efficiency, yield, robustness, scalability and costs.
“Our initial collaboration with Merck built an important and critical framework for us to quickly validate and ready the production of our portfolio of neglected tropical disease vaccines for global access,” said Dr. Peter Hotez, dean of the National School of Tropical Medicine at Baylor College of Medicine and co-director of the Texas Children’s Hospital Center for Vaccine Development, alongside Dr. Maria Elena Bottazzi.
“The expansion of our collaboration to include diseases of pandemic importance will now allow us to accelerate the development of a scalable and affordable manufacturing process of our Covid-19 vaccine candidates and enable them to advance as quickly as possible to support vaccine production in low- and middle- income countries,” said Bottazzi, who leads the product development activities and serves as associate dean of the National School of Tropical Medicine at Baylor.
The Merck-Baylor teams will improve the manufacturing platform for the CoV RBD219-N1 vaccine candidate, which was originally developed to target SARS in 2011-2016. Additionally, they will develop a new manufacturing platform for a second Covid-19 vaccine candidate to shorten the time to enter into Phase 1 clinical trials. The goal for the partnership is to develop a manufacturing process and steps that would lead to a scale-up approach suitable for pilot and later industrial production.
Researchers from the Texas Children’s Center for Vaccine Development first formed a partnership with Merck’s process development scientists and biomanufacturing engineers in 2018 to advance vaccine development and production and enhance the response to outbreaks, such as Covid-19. Because the initial groundwork is laid through their existing process development platform work, the team can quickly shorten the time to the clinic, realizing a key goal.
Baylor College of Medicine and the Texas Children’s Hospital Center for Vaccine Development received funding from NAID for their earlier work in developing the CoV RBD219-N1 vaccine candidate and recently to initiate development of the second Covid-19 vaccine candidate. In addition, Baylor and Texas Children’s, through their alliance with PATH, expect to advance the Covid-19 candidates to support access to low- and middle-income countries.
About Merck
Merck, a leading science and technology company, operates across healthcare, life science and performance materials. Around 57,000 employees work to make a positive difference to millions of people’s lives every day by creating more joyful and sustainable ways to live. From advancing gene editing technologies and discovering unique ways to treat the most challenging diseases to enabling the intelligence of devices – the company is everywhere. In 2019, Merck generated sales of €16.2 billion in 66 countries.
Scientific exploration and responsible entrepreneurship have been key to Merck’s technological and scientific advances. This is how Merck has thrived since its founding in 1668. The founding family remains the majority owner of the publicly listed company. Merck holds the global rights to the Merck name and brand. The only exceptions are the United States and Canada, where the business sectors of Merck operate as EMD Serono in healthcare, MilliporeSigma in life science and EMD Performance Materials.
Three questions to Sebastian Kronmueller, Head of Molecular Diagnostics
26 May 2020
Erlangen, Germany, May 26, 2020 -- Three questions to Sebastian Kronmueller, Head of Molecular Diagnostics:
Mr. Kronmueller, what exactly is behind the product name „Fast Track Diagnostics SARS-CoV-2 Assay Testkit“?
This is a molecular test developed by our subsidiary Fast Track Diagnostics. It detects infection with the novel corona virus. Molecular tests evaluate the organism at its most basic level: DNA and RNA. For our test, genetic material is isolated from a smear from a patient's nose/throat space. Viral RNA in this material is then converted into DNA by so-called reverse transcriptase. This is selectively propagated using a technique called polymerase chain reaction (PCR) if it contains specific genes of the SARS-CoV-2 virus. Once the DNA has been sufficiently propagated, it can be measured using fluorescence methods. PCR is used in biological and medical laboratories, for example for the detection of viral infections or hereditary diseases. Today, PCR is one of the most important methods of modern molecular biology.
Specifically, we use this test to look for the genetic material of the SARS-CoV-2 virus that causes the Covid-19 disease. The great advantage of molecular testing is its effectiveness at an early stage of infection and thus effective in urgent test situations.
The test has a 100% (91.8-100, 95% CI) diagnostic sensitivity and a 100% (88.7-100, 95% CI) diagnostic specificity2. What does this mean?
The specificity of a diagnostic test procedure indicates the likelihood that healthy people who do not suffer from the disease in question will also be recognized as healthy. Sensitivity indicates how many sufferers were actually identified as such during a test. The higher the sensitivity of a test, the safer it detects the disease.
The "100 percent" of both the sensitivity and the specificity of our test means that we have achieved the right result in all clinical tests in validation. This means that with a limited number of tests, we have not found a wrong result. The second number is the "Confidence Interval" (CI) in parentheses. The CI is a statistical measure that states that with 95 percent statistical probability we can say that the actual performance of the test is in the range of 91.8 to 100 percent.
Why are these parameters so important?
Both parameters give medical staff certainty as to whether a sick person is actually recognized as such and can be treated accordingly. On the other hand, with a very high percentage, it is possible to reduce the number of false positive results in healthy people, i.e. fewer people are wrongly identified as infected. So the higher both parameters are, the more reliable the correct results are achieved and thus the best possible treatment is initiated.
About the Fast Track Diagnostics SARS-CoV-2 Assay1 Testkit
CE-marked for sale in the EU. This test has not been FDA cleared or approved. This test has been authorized by FDA under an EUA for use by authorized laboratories. This test has been authorized only for the detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens. This 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. Product availability may vary by country and is subject to regulatory requirements.
About diagnostic specificity
In method comparison studies, FTD SARS-CoV-2 has shown Positive Percent Agreement: 100% (91.8-100, 95% CI) and Negative Percent Agreement: 100% (88.7-100, 95% CI) when tested in Copan eSwab nasopharyngeal and oropharyngeal swabs.
About Siemens Healthineers AG
Siemens Healthineers AG is shaping the future of Healthcare. As a leading medical technology company headquartered in Erlangen, Germany, Siemens Healthineers enables healthcare providers worldwide through its regional companies to increase value by empowering them on their journey towards expanding precision medicine, transforming care delivery, improving the patient experience, and digitalizing healthcare. Siemens Healthineers is continuously developing its product and service portfolio, with AI-supported applications and digital offerings that play an increasingly important role in the next generation of medical technology. These new applications will enhance the company’s foundation in in-vitro diagnostic, image-guided therapy, and in-vivo diagnostics. Siemens Healthineers also provides a range of services and solutions to enhance healthcare providers’ ability to provide high-quality, efficient care to patients. In fiscal 2019, which ended on September 30, 2019, Siemens Healthineers, which has approximately 52,000 employees worldwide, generated revenue of €14.5 billion and adjusted profit of €2.5 billion. Further information is available at www.siemens-healthineers.com.
Philips launches next generation wearable biosensor for early patient deterioration detection, including clinical surveillance for COVID-19
26 May 2020 - Wireless wearable biosensor (Philips Biosensor BX100) receives 510(k) clearance from the FDA and CE mark to help monitor COVID-19 patients in hospital, with first install at OLVG Hospital in the Netherlands. Further enhances Philips portfolio of devices, software and services for identifying patients at risk for deterioration while limiting exposure to help improve staff and patient safety and preserve valuable personal protective equipment .
Amsterdam, the Netherlands, 26 May 2020 – Royal Philips, a global leader in health technology, today announced it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its wearable biosensor (Philips Biosensor BX100) to help manage confirmed and suspected COVID-19 patients in the hospital. The next generation wireless wearable biosensor enhances clinical surveillance in the Philips patient deterioration detection solution to help clinicians detect risk so they can intervene earlier and help improve care for patients in lower acuity care areas. The solution has already received CE mark, and is currently in use with the first install at the OLVG Hospital in the Netherlands to help manage the triage and clinical surveillance of COVID-19 patients.
The Philips Biosensor BX100 is designed to address a new approach to vital signs measurements, supporting surveillance of higher acuity patients moving from intensive care units into lower acuity general care areas of a hospital. The lightweight, disposable biosensor is a 5-day, single-use wearable patch which can be integrated with a scalable hub to monitor multiple patients across multiple rooms. Built to incorporate into existing clinical workflows for mobile viewing and notifications, the device requires no cleaning or charging. The medical-grade wireless wearable biosensor, intended for use by healthcare professionals on patients 18 years of age and older, adheres discreetly to the chest to collect, store, measure and transmit respiratory rate and heart rate every minute – the top two predictors of deterioration – as well as contextual parameters such as posture, activity level and ambulation.
OLVG, a top clinical, referral and training hospital in the Netherlands is responding to the COVID-19 emergency situation by remotely monitoring patients in isolation rooms who are diagnosed or suspected of COVID, but don’t need ventilation. To meet the hospital’s need to support COVID-19 patients in isolation, OLVG has implemented Philips patient deterioration detection solution comprised of data-driven intelligent analytics software (IntelliVue GuardianSoftware) for early warning scoring, advanced patient monitors (EarlyVue VS30), and the Philips Biosensor BX100 wearable sensors.
“During this unprecedented time of COVID-19, the Philips Biosensor BX100 helps provide rapid deployment for clinical surveillance to help decrease risk of exposure of healthcare workers while acquiring frequent patient vitals, and easing the demand for personal protective equipment (PPE),” said Peter Ziese, General Manager Monitoring and Analytics at Philips. “The biosensor is an integral component in our Patient Deterioration Detection solution which helps aid in the identification of the subtle signs of deterioration in a patient’s condition at the point of care, hours before a potential adverse event would occur.”
“With the help of this new biosensor, we can continuously and remotely monitor patients, which is especially important on the COVID-19 wards,” said Florian van der Hunnik, Chief Nursing Information Officer and team leader of the COVID-19 ward at OLVG Hospital in Amsterdam. “Because we cannot walk in and out of the patient rooms without protective gear, we welcome this innovation as it helps improve how we can do our jobs better.”
The Philips next generation wearable biosensor is part of the Philips comprehensive portfolio of solutions to address patient deterioration, supporting general care around the world with smart clinical intelligence. For more information on how Philips is addressing the Coronavirus globally, please visit the Philips centralized COVID-19 hub.
About Royal Philips
Royal Philips is a leading health technology company focused on improving people's health and enabling better outcomes across the health continuum from healthy living and prevention, to diagnosis, treatment and home care. Philips leverages advanced technology and deep clinical and consumer insights to deliver integrated solutions. Headquartered in the Netherlands, the company is a leader in diagnostic imaging, image-guided therapy, patient monitoring and health informatics, as well as in consumer health and home care. Philips generated 2019 sales of EUR 19.5 billion and employs approximately 81,000 employees with sales and services in more than 100 countries. News about Philips can be found at www.philips.com/newscenter.
Abbott releases interim clinical study data von ID NOW COVID-19 rapid test showing strong agreement to lab-based molecular PCR tests
21 May 2020 - Urgent care clinic study shows ID NOW test performance of ≥94.7% positive agreement (sensitivity) and ≥98.6% negative agreement (specificity) compared to lab-based PCR reference tests. The Everett Clinic study shows 91.3% positive agreement and 100% negative agreement. Ongoing study of hospitalized and nursing home patients tested with late symptom onset shows ≥83.3% positive agreement and ≥96.5% negative agreement. Abbott's studies suggest ID NOW performs best in patients tested earlier post symptom onset. ID NOW delivers results in minutes rather than days and is helping reduce the spread of infection by detecting more positive patients faster than would otherwise be the case
ABBOTT PARK, Ill., May 21, 2020 -- Abbott announced today an interim analysis of an ongoing multi-site clinical study in urgent care clinics that indicates its ID NOW COVID-19 rapid test is showing strong agreement to lab-based molecular polymerase chain reaction (PCR) instruments. The interim results are demonstrating ID NOW COVID-19 test performance is ≥94.7% in positive agreement (sensitivity) and ≥98.6% negative agreement (specificity) when compared to two different lab-based PCR reference methods.
Data from this, as well as two other Abbott-sponsored studies – The Everett Clinic in Washington and an ongoing study of hospitalized and nursing home patients – suggest ID NOW performs best in patients tested earlier post symptom onset, when they are most likely to go for care. In these studies, ID NOW was used as intended with variations in patient populations based on the number of days a patient was tested after first experiencing symptoms.
"We're pleased that ID NOW is delivering on what it was designed to do – quickly detect the virus in people who need to know now if they're infected," said Philip Ginsburg, M.D., senior medical director, infectious disease, Rapid Diagnostics, Abbott. "This is great news for people who are experiencing symptoms and want to take action before they infect others, reducing the spread of infection in society."
"These new interim results reflect what we're hearing from hundreds of our customers, which is that they're seeing results with positive rates from ID NOW that are at, or above, their local COVID-19 infection rates," continued Dr. Ginsburg. "This tells us that ID NOW is performing comparable to molecular laboratory tests in detecting the virus."
Urgent Care Clinic Study
In 256 subjects enrolled to date, ID NOW has identified 29 of 29 positive samples (100% positive agreement) and 226 of 227 negative samples (99.6% negative agreement) when compared to a commonly-used lab-based molecular PCR assay (the Roche cobas® SARS-CoV-2 assay).
In parallel, ID NOW has demonstrated 94.7% positive agreement and 98.6% negative agreement compared to the Centers for Disease Control (CDC) 2019-Novel Coronavirus (COVID-19) Real-Time RT-PCR Diagnostic Panel. In comparison, Roche has demonstrated 95.0% positive agreement and 98.7% negative agreement when compared to the CDC assay.
In these subjects, the mean number of days from symptom onset is 4.1 days with 90% of subjects tested within 7 days post symptom onset, when patients typically show up for care.
"This corresponds to what my colleagues and I are seeing every day when using ID NOW, which is that it combines strong sensitivity and specificity with rapid results so that we can provide immediate information and care," said Warren Wollin, D.O., senior medical director, Physicians Immediate Care, who is not affiliated with this study. "It is a powerful tool for near-patient testing and is essential to us in helping reduce the spread of this virus."
The ongoing study is examining ID NOW COVID-19 test performance at five urgent care clinics (New Jersey, Tennessee, Louisiana, Texas and South Carolina). This is one of the first studies conducted on the ID NOW COVID-19 test in a real-world setting as it is intended to be used, compared with other studies that have used banked or retained samples.
The Everett Clinic Study
These interim results are consistent with results from a 955 subject study (763 symptomatic and 192 asymptomatic) presented last week in an Association for Molecular Pathology webinar by Yuan-Po Tu, M.D., of The Everett Clinic in Washington in a similar setting, which showed 91.3% positive agreement (sensitivity) and 100% negative agreement (specificity greater than 99.5% at the lower confidence limit) for ID NOW compared to lab-based PCR assays.
Study with Hospitalized and Nursing Home Patients
Abbott is conducting another ongoing study looking at ID NOW's performance compared to two lab-based reference methods in nursing home and hospitalized settings later in post symptom onset than the populations in the urgent care and The Everett Clinic settings.
In an interim analysis, the mean number of days from symptom onset is 12.2 days with more than 68% presenting with ≥8 days post symptom onset. In comparison, the Everett study mean was 9.7 days post symptom onset and the urgent care clinic at 4.1 days post symptom onset.
In the hospitalized and nursing home analysis to date, ID NOW has shown 85.7% positive agreement and 97.6% negative agreement compared to the CDC assay, and 83.3% positive agreement and 96.5% negative agreement when compared to Hologic's Panther Fusion® SARS-CoV-2 test. In comparison, the Hologic assay has demonstrated 91.8% positive agreement and 98.2% negative agreement when compared to the CDC assay.
Data from these studies suggest ID NOW performs best in people tested earlier after they first begin experiencing symptoms. This is consistent with a recent study published in the Annals of Internal Medicine, where researchers from Johns Hopkins found that even the most sensitive lab-based molecular tests can have false negatives when viral load levels are ramping down, near the end of the infection cycle when viral load winds down and patients may no longer be infectious.
Abbott will report full results from these studies when the studies and analyses are completed.
About the ID NOW™ Point-of-Care Molecular Platform
First introduced in 2014, ID NOW is the leading molecular point-of-care platform for Influenza A & B, Strep A and RSV testing in the U.S.
ID NOW is a rapid, instrument-based, isothermal system for the qualitative detection of infectious diseases. Its unique isothermal nucleic acid amplification technology provides molecular results in just minutes, allowing clinicians to make evidence-based clinical decisions during a patient visit.
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.
Connect with us at www.abbott.com, on LinkedIn at www.linkedin.com/company/abbott-/, on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews and @AbbottGlobal.
The ID NOW COVID-19 EUA has not been FDA cleared or approved. It has been authorized by the FDA under an emergency use authorization for use by authorized laboratories and patient care settings. The test has been authorized only for the detection of nucleic acid 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 Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.
CE marking of bioMérieux serology tests for SARS-CoV-2 on VIDAS®
21 May 2020
21 May 2020 -- bioMérieux, a world leader in the field of in vitro diagnostics, today announced the CE marking of VIDAS® anti-SARS-CoV-2 serology tests to detect antibodies in people who have been exposed to SARS-CoV-2 which causes the COVID-19 disease.
VIDAS® anti-SARS-CoV-2 IgM and anti-SARS-CoV-2 IgG are used to measure the presence of antibodies in people who have been infected with SARS-CoV-2. In this context, clinical specificity is particularly important to ensure that testing of uninfected individuals consistently delivers a negative result. Both VIDAS® anti-SARS-CoV-2 IgM and anti-SARS-CoV-2 IgG provide results in less than 30 minutes and demonstrate excellent performance on a large number of clinical specimens, with 99.6% and 100% specificity, respectively.
“We are pleased to provide laboratories with high quality serology tests for the confirmation of SARS-COV-2 infections. Specialized in the development of diagnostic solutions to fight infectious diseases for over 55 years, bioMérieux now offers a wide range of tests that meet the needs of health professionals in a variety of clinical situations related to patients’ conditions in the context of the COVID-19 pandemic,” said François Lacoste, Executive VP R&D at bioMerieux.
From now on, the tests are available in Europe and in countries that recognize CE marking. Hospital and private laboratories will be able to run the tests on bioMérieux’s VIDAS® systems (MINI VIDAS®, VIDAS® and VIDAS® 3) which are widely used with more than 30 000 systems installed around the world.
bioMérieux is planning to submit a request for Emergency Use Authorization (EUA) to the US Food and Drug Administration shortly.
Reference: https://www.biomerieux.com/en/ce-marking-biomerieux-serology-tests-sars-cov-2-vidasr
LGC working closely with customers and partners to expedite detection solutions
20 May 2020
20 May 2020 -- LGC, Biosearch Technologies, manufacturer and inventor of mission-critical dyes and components for diagnostic kits, and QuantuMDx, a life sciences company developing transformational point-of-care molecular diagnostics, are working together on the supply of a SARS-CoV-2 assay for laboratory use, and which delivers a result in approximately 70 minutes.
The sensitive test targets three SARS-Cov-2 genomic loci; the S, N and Orf1 genes and can run on multiple high- and low-throughput PCR platforms that can be calibrated for the fluorophores FAM and HEX. As all the assay reagents are lyophilised in a single tube, the assay is more convenient for shipping than liquid based assay kits.
Brian Kim, President and Managing Director at LGC, Biosearch Technologies, said, “We are the inventor of mission critical components that are being recommended for use in kits for diagnosis and surveillance. In times like this, we need to enable laboratories to move fast and safely. Collaborating with QuantuMDx allows labs to roll out a diagnostic solution in a robust and standardized setting that requires virtually no eyes-on time.”
Colin Toombs, VP R&D at QuantuMDx, said: “To support national and international efforts to tackle COVID-19, we needed to act fast, secure our supply chain and scale up at speed. Working with LGC, Biosearch Technologies we have been able to expedite our product development and have established an ongoing partnership for the future.”
LGC, Biosearch Technologies has been working closely with suppliers and customers – such as Co-Diagnostics, LifeRiver and UgenTec - in order to expedite detection solutions and ensure they are available where and when necessary.
Arkansas Health & Wellness, Arkansas Total Care and Quest Diagnostics Team Up to Increase Access to COVID-19 Testing in Underserved Communities
20 May 2020 - 1,000 COVID-19 test kits will be distributed each week to Federally Qualified Health Centers in Arkansas
LITTLE ROCK, Ark., May 20, 2020 -- Arkansas Health & Wellness and Arkansas Total Care announced today a collaboration with Quest Diagnostics (NYSE: DGX), the world's leading provider of diagnostic information services, to increase access to real-time reverse transcription polymerase chain reaction (rRT-PCR) COVID-19 testing in critical areas of need in Arkansas. Through this collaboration, Arkansas Health & Wellness and Arkansas Total Care will facilitate the distribution of approximately 1,000 Quest COVID-19 test kits each week to Community Health Centers of Arkansas. The FQHCs will conduct testing as part of a broader initiative to test persons who are symptomatic and asymptomatic in our underserved communities.
"I am delighted to hear of the partnership between Arkansas Health and Wellness (AHW), Arkansas Total Care and the Community Health Centers of Arkansas (CHCA) to increase our real-time testing capacity in Arkansas," said Governor Asa Hutchinson. "This private sector partnership plays an important role in our effort to reach 60,000 tests per month. This initiative ensures Arkansans will have access to critical testing and assist us in moving forward to our goal of Phase 2 and beyond. Together, we will keep our families safe and emerge stronger than ever."
This collaboration leverages the plan's extensive network of critical safety net providers to ensure that testing capacity is routed to where it is needed most. As part of the collaboration, Arkansas Health and Wellness and Arkansas Total Care will provide oversight and training to ensure test kits are received and processed efficiently. Distribution of kits will begin in May, and Quest Diagnostics will conduct the COVID-19 testing through its network of laboratories across the United States.
"Collaborations like these allow us to leverage our capabilities to do our part in making sure our communities, including those who need it most, have access to the health care services they need," said John Ryan, President and CEO, of Arkansas Health & Wellness, Arkansas Total Care.
LaShannon Spencer, CEO of Community Health Centers of Arkansas (CHCA), has been a strong advocate for partnering with entities to improve access for some of the most vulnerable populations around the state of Arkansas. "COVID-19 has impacted nearly every corner of the state and impacted many lives for years to come. Every day is filled with more changes of how we are to live and work. Even though the way in which medicine is practiced will change, partnerships with key business entities like Arkansas Health & Wellness and Arkansas Total Care will be critical for our future. That's why I value such partnerships with each of these Arkansas-based health plans. "I am pleased to see Arkansas Health & Wellness and Arkansas Total Care supporting targeted statewide testing for our health centers. It is a key first step and an important investment in future sustainability in our rural health system," said LaShannon Spencer.
Arkansas Health & Wellness/Arkansas Total Care members are encouraged to contact the Community Health Centers of Arkansas at 1-833-508-0774 for additional information about testing. Members can also find more information about COVID-19 and how Arkansas Health & Wellness can support them at ARHealthWellness.com.
About Arkansas Health & Wellness and Arkansas Total Care
Founded in 2014, Arkansas Health & Wellness and Arkansas Total Care are managed care companies that deliver quality health care throughout Arkansas. Committed Helping Arkansas Live Better, Arkansas Health & Wellness and Arkansas Total Care support active local community involvement in all 75 Arkansas counties, with more than 600 employees statewide. Arkansas Health & Wellness and Arkansas Total Care are wholly and partially owned subsidiaries (respectively) of Centene Corporation, a leading multi-national healthcare enterprise offering both core Medicaid, Medicare and specialty services. More information on Arkansas Health & Wellness and Arkansas Total Care can be found at https://www.arhealthwellness.com/ and https://www.arkansastotalcare.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, and our 47,000 employees understand that, in the right hands and with the right context, our diagnostic insights can inspire actions that transform lives. www.QuestDiagnostics.com.
About COVID-19 Testing by Quest Diagnostics
Quest Diagnostics is at the forefront of 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 aiding the diagnosis of COVID-19 and immune response. Our COVID-19 test services are based on tests that have received or are expected to receive FDA emergency use authorization and which also meet our high standards for quality. We provide data on COVID-19 testing to various federal and state public health authorities, including the Centers for Disease Control and Prevention, and participate in studies with government and private institutions, aiding COVID-19 public health response and research.
Through our team of dedicated phlebotomists, couriers, air fleet team, and laboratory professionals, Quest Diagnostics won't stop until quality testing is broadly available to patients and communities across the United States.
Roche highly accurate antibody test for COVID-19 goes live at more than 20 initial lab sites in the US
LabCorp and other commercial labs will have the ability to perform more than 2 million tests per week by June
INDIANAPOLIS, May 19, 2020 -- Roche today announced its Elecsys® Anti-SARS-CoV-2 antibody test is live at more than 20 commercial and hospital lab sites throughout the United States, with plans in the next several weeks to increase to more than 200 commercial and hospital lab sites with the ability to perform millions of tests per week. The Elecsys® Anti-SARS-CoV-2 antibody test received Emergency Use Authorization from the FDA earlier this month.
"Roche is proud to make this highly accurate serology test available in the U.S. to determine if a person has developed antibodies to COVID-19," said Matt Sause, President and CEO of Roche Diagnostics North America. "Reliable, high-quality antibody testing is essential to help us overcome this pandemic and will play an important role in getting people back to work. We are proud to partner with LabCorp in making this test available in the U.S."
The Roche antibody test is uniquely designed to identify mature (high affinity) antibodies developed late in the immune response, significantly reducing the chance of a false positive result. It provides 99.8 percent specificity, which is greater than previously available antibody tests. This specificity is crucial to determine reliably if a person has been exposed to the virus and has developed antibodies. Tests with lower specificity and sensitivity can lead to a high number of misidentified cases in a population. A false positive result may put a patient at risk by indicating they have antibodies when they do not.
"Our long-standing relationship and collaboration with Roche enables us to introduce many innovative, high-quality tests for clinicians and patients, which is more important now than ever before," said Dr. Brian Caveney, chief medical officer and president of LabCorp Diagnostics. "Roche's new antibody test allows LabCorp to provide more options and increase COVID-19 testing capacity as we support the country's response to the health crisis."
Roche has more than 3,000 analyzers that perform the antibody test installed across the United States. Roche is distributing millions of tests per week to U.S. labs that can implement quickly, enable the broadest geographic reach and provide testing to areas hardest hit by COVID-19.
Roche is working to meet demand by scaling global production rapidly in an effort to expand broader access as quickly as possible.
Healthcare providers can order the test for patients through their normal clinical laboratory process.
About the Elecsys® Anti-SARS-CoV-2 test
The Elecsys® Anti-SARS-CoV-2 test, which is based on an in-solution double-antigen sandwich format, can detect antibodies to the new coronavirus causing COVID-19, which could signal whether a person has already been infected and potentially developed immunity to the virus. Based on the measurement of a total of 5272 samples, the Elecsys® Anti-SARS-CoV-2 assay has 99.8% specificity and shows no cross-reactivity to the common cold, HIV and other coronaviruses. This means it can lower the chance of false positives due to the detection of similar antibodies that may be present in an individual. Elecsys® Anti-SARS-CoV-2 detected antibodies with 100% sensitivity in samples taken 14 days after a PCR-confirmed infection. As of 24 April 2020, no study has evaluated whether the presence of antibodies to SARS-CoV-2 confers immunity to subsequent infection by this virus in humans.
More information for healthcare providers, patients and the general public is available at diagnostics.roche.com. Technical information about the test is available at Elecsys® Anti-SARS-CoV-2 test.
About Emergency Use Authorization Status
The Elecsys Anti-SARS-CoV-2 test has not been FDA cleared or approved. It has been authorized by FDA under an EUA for use by authorized laboratories. This test has been authorized only for detecting the presence of antibodies against SARS-CoV-2, not for any other viruses or pathogens. It is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.
About Roche
Roche is a global pioneer in pharmaceuticals and diagnostics focused on advancing science to improve people's lives. The combined strengths of pharmaceuticals and diagnostics under one roof have made Roche the leader in personalised healthcare – a strategy that aims to fit the right treatment to each patient in the best way possible.
Roche is the world's largest biotech company, with truly differentiated medicines in oncology, immunology, infectious diseases, ophthalmology and diseases of the central nervous system. Roche is also the world leader in in vitro diagnostics and tissue-based cancer diagnostics, and a frontrunner in diabetes management.
Founded in 1896, Roche continues to search for better ways to prevent, diagnose and treat diseases and make a sustainable contribution to society. The company also aims to improve patient access to medical innovations by working with all relevant stakeholders. More than thirty medicines developed by Roche are included in the World Health Organization Model Lists of Essential Medicines, among them life-saving antibiotics, antimalarials and cancer medicines. Moreover, for the eleventh consecutive year, Roche has been recognised as one of the most sustainable companies in the Pharmaceuticals Industry by the Dow Jones Sustainability Indices (DJSI).
The Roche Group, headquartered in Basel, Switzerland, is active in over 100 countries and in 2019 employed about 98,000 people worldwide. In 2019, Roche invested CHF 11.7 billion in R&D and posted sales of CHF 61.5 billion. Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan. For more information, please visit www.roche.com or diagnostics.roche.com.
Thermo Fisher Scientific's Support of COVID-19 Response Continues to Expand with U.S. Government Contract for Products Used in Sample Collection
18 May 2020
WALTHAM, Mass., May 18, 2020 -- Thermo Fisher Scientific Inc., the world leader in serving science, today announced it has received a contract from the U.S. government to provide highly specialized viral transport media (VTM) for COVID-19 sample collection. The VTM is used during collection of patient samples for proper transport to laboratories that can test for the presence of the virus.
To ensure accuracy of COVID-19 test results, VTM must be manufactured and dispensed into tubes in an aseptic environment. Thermo Fisher currently produces VTM at its site in Lenexa, Kansas, which meets this requirement, and has ramped production from 50,000 to more than one million VTM-filled tubes per week.
Given the significant demand for COVID-19 testing and associated sample collection, Thermo Fisher will expand capacity in Lenexa with a new $40 million facility dedicated to VTM production and quality control. The added capacity and increased efficiencies will allow the company to scale production to more than eight million VTM-filled tubes per week.
The company plans to complete the new Lenexa facility in Q3 and expects that it will create approximately 300 new full-time jobs.
"Our production ramp-up in Lenexa has been impressive and our employees deserve recognition for their ingenuity and dedication to making this happen," said Marc N. Casper, chairman, president and chief executive officer of Thermo Fisher Scientific. "We have a proven blueprint for high-quality VTM production in Lenexa and look forward to bringing significant new capacity on line as quickly as possible to continue the necessary testing ramp-up in the U.S."
Casper added, "We're proud of our role in helping customers to battle the pandemic. With our leading scale and depth of capabilities, Thermo Fisher can support virtually every aspect of the COVID-19 response, which demonstrates what it means to be the world leader in serving science."
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.
Ortho's COVID-19 IgG Antibody Test Receives CE Mark
18 May 2020 - Ortho’s IgG test demonstrates 100% specificity and can be used to support decisions for getting people back to work and can support convalescent plasma screening. Ortho’s Total antibody test received CE Mark on May 8, 2020. Ortho’s two COVID-19 antibody tests run on Ortho’s VITROS® platform, which does not require an external water source to run. Ortho has already begun shipping its antibody test to customers in highly impacted geographies and plans to manufacture several million COVID-19 antibody tests each month.
Raritan, NJ, 18 May 2020 -- Ortho Clinical Diagnostics, a global leader of in vitro diagnostics with a rich history of bringing critical tests for infectious diseases to market, today announced its second COVID-19 antibody test—the VITROS® Immunodiagnostic Products Anti-SARS-CoV-2 IgG Test (COVID-19 IgG antibody test) received CE Mark. The test offers 100% specificity.
“The observed 100% specificity with Ortho’s VITROS SARS-CoV-2 tests allows an extremely high level of confidence so that people will not be identified as having an immune response to the virus when in fact they do not,” said Christopher D. Hillyer, MD, President and CEO, New York Blood Center. “Statistically, the chance of error rises dramatically even with a very small decline from 100% in specificity, given our understanding of the prevalence of the COVID-19 virus today.”
“Ortho is proud that both of our COVID-19 total and IgG tests are achieving 100% specificity,” said Chris Smith, Ortho Clinical Diagnostics’ Chief Executive Officer. “During this health crisis, good is simply not good enough. This high level of specificity is a testament to Ortho’s strong belief that every test is a life.”
Ortho’s COVID-19 IgG antibody test detects the IgG antibody. It closely follows the introduction of Ortho’s COVID-19 Total test and the two tests offer greater choice in tracking and surveillance, patient management, and screening convalescent plasma. Both of Ortho’s tests help health care professionals understand if a patient has been exposed to and has developed antibodies to the SARS-CoV-2 virus.
Ortho’s COVID-19 IgG antibody test received Emergency Use Authorization from the U.S. Food and Drug FDA administration on April 24, 2020. Ortho’s total antibody test received CE Mark on May 8, 2020 and FDA Emergency Use Authorization on April 14, 2020.
The tests run on Ortho’s high-throughput, fully automated analyzers including its flagship VITROS® XT 7600 Integrated System, the VITROS® 3600 Immunodiagnostic System, the VITROS® 5600 Integrated System and will soon be available on VITROS® ECi/ECiQ Immunodiagnostic Systems. Ortho has over 5,600 Immunodiagnostic systems installed around the world. VITROS Systems are self-contained and do not require an external water source to run, offering labs placement flexibility.
Ortho is manufacturing the COVID-19 IgG antibody tests at its Pencoed, U.K., facility. It plans to manufacture several million tests in the coming weeks.
Ortho’s COVID-19 IgG antibody tests are designed and solely intended to be performed by laboratory professionals and cannot be directly used by patients as they are not for home use. Patients should consult with their health care provider to discuss antibody testing and back-to-work options.
The VITROS Anti-SARS-CoV-2 Total and IgG tests have not been FDA cleared or approved. They have been authorized by the FDA under an emergency use authorization and testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, to perform moderate or high complexity tests. The VITROS Antibody tests have been authorized only for the detection of either Total or IgG antibodies from SARS-CoV-2, not for any other viruses or pathogens, and results should not be used as the sole basis for diagnosis. These tests are 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.
Beckman Coulter launches DxH 690T mid-volume hematology analyzer, featuring the Early Sepsis Indicator in U.S. market
18 May 2020
Brea, Calif, May 18, 2020 — Beckman Coulter announced today the availability of its DxH 690T hematology analyzer in the U.S. Designed to streamline workflow and minimize downtime in mid-volume laboratories, the DxH 690T delivers all of the benefits of the company’s flagship DxH 900 large-volume hematology analyzer in a table-top configuration.
Hematology analysis is a critical part of triaging patients in urgent care settings. The DxH 690T brings mid-volume laboratories advanced features such as the Early Sepsis Indicator (ESId) available on Beckman Coulter’s larger high-volume analyzer, the DxH900. ESId is a novel FDA-cleared, hematology-based cellular biomarker included as part of a standard CBC with differential, which is designed to help emergency department physicians identify adult patients with sepsis or at increased risk of developing sepsis.
“Managing increased demand for testing, while maximizing resource efficiency is top of mind for laboratorians even in the best of circumstances,” said Peter Soltani, Ph.D., senior vice president and general manager of the hematology business unit at Beckman Coulter. “For mid-volume labs, this is no exception. The DxH 690T reports high confidence results and improves turnaround time by reducing procedural steps and manual touchpoints, making it an ideal solution to help relieve some of this burden. The DxH 690T also supports standardization across hospital networks to a single platform—DxH 900 for larger-volume labs and DxH 690T for mid-volume.”
The DxH 690T applies Beckman Coulter’s core hematology technologies—the enhanced Coulter Principle, VCS 360 and DataFusion—to streamline throughput, minimize reflex testing and reduce manual interventions. Utilizing these technologies for high-resolution analysis of cells in their near native-states, the DxH 690T ensures mid-volume laboratories can achieve the right results the first time without unnecessary reflex or repeats.
Commercially available worldwide today, the DxH 690T builds on Beckman Coulter’s strength and history in hematology innovation and complements its broad hematology portfolio, including the DxH 520 for low-volume, the DxH 900 for high-volume and the DxH connected workcell solutions for ultra-high-volume facilities.
For more information on the DxH 690T or Beckman Coulter’s full portfolio of hematology solutions, visit www.beckmancoulter.com/DxH690T.
About Beckman Coulter
Beckman Coulter is committed to advancing healthcare for every person by applying the power of science, technology and the passion and creativity of our teams to enhance the diagnostic laboratory’s role in improving healthcare outcomes. Our diagnostic systems are used in complex biomedical testing, and are found in hospitals, reference laboratories and physician office settings around the globe. Beckman Coulter offers a unique combination of people, processes and solutions designed to elevate the performance of clinical laboratories and healthcare networks. We do this by accelerating care with a menu that matters, bringing the benefit of automation to all, delivering greater insights through clinical informatics and unlocking hidden value through performance partnership. An operating company of Danaher Corporation (NYSE: DHR) since 2011, Beckman Coulter is headquartered in Brea, Calif., and has more than 11,000 global associates working diligently to make the world a healthier place.
Quidel’s Lyra® Direct SARS-COV-2 Assay receives Emergency Use Authorization and CE Mark for molecular detection of COVID-19, without extraction step
18 May 2020
SAN DIEGO, 18 May 2020 -- Quidel Corporation (“Quidel”),a provider of rapid diagnostic testing solutions, cellular-based virology assays and molecular diagnostic systems, announced today that Quidel has received Emergency Use Authorization (EUA) for the Lyra® Direct SARS-CoV-2 Assay from the Food and Drug Administration (FDA) to allow direct sample processing.
Lyra® Direct Removes RNA Extraction Processing Step, Removes Supply Bottleneck
Under the new EUA, the Lyra® Direct SARS-CoV-2 Assay no longer requires an up-front sample extraction. The Lyra® Direct SARS-CoV-2 Assay uses a reformulated buffer that replaces the extraction step with a simple 10-minute heat step, saving approximately 50 minutes in processing time. The assay retains its versatility in that it is capable of running on any of seven possible thermocyclers (Applied Biosystems 7500 Standard®, Applied Biosystems 7500 Fast®, Bio-Rad CFX96 Touch®, Qiagen Rotor-Gene Q®, Roche LightCycler® 480, Roche Cobas® z480, and Thermo Fisher QuantStudio 7 Pro®).
Lyra® Direct Receives CE Mark
Separately, the Lyra® Direct SARS-CoV-2 Assay received CE Mark on May 8, 2020. The CE Mark allows Quidel to market and sell the Lyra® Direct SARS-CoV-2 Assay in Europe, as well as other countries that accept the CE Mark.
The assay is currently available for sale in the United States under EUA. The Lyra® Direct SARS-CoV-2 Assay can be purchased by laboratory professionals through Quidel directly, or through their Cardinal Health representative.
bout Quidel Corporation
Quidel Corporation serves to enhance the health and well-being of people around the globe through the development of diagnostic solutions that can lead to improved patient outcomes and provide economic benefits to the healthcare system. Marketed under the Sofia®, QuickVue®, D3® Direct Detection, Thyretain®, Triage® and InflammaDry® leading brand names, as well as under the new Solana®, AmpliVue®and Lyra® molecular diagnostic brands, Quidel’s products aid in the detection and diagnosis of many critical diseases and conditions, including, among others, influenza, respiratory syncytial virus, Strep A, lyme, herpes, pregnancy, thyroid disease and fecal occult blood. Quidel's Triage® system of tests comprises a comprehensive test menu that provides rapid, cost-effective treatment decisions at the point-of-care (POC), offering a diverse immunoassay menu in a variety of tests to provide diagnostic answers for quantitative BNP, CK-MB, d-dimer, myoglobin, troponin I and qualitative TOX Drug Screen. Quidel’s research and development engine is also developing a continuum of diagnostic solutions from advanced immunoassay to molecular diagnostic tests to further improve the quality of healthcare in physicians’ offices and hospital and reference laboratories. For more information about Quidel’s comprehensive product portfolio, visit quidel.com.
Beckman Coulter awarded expanded partnership with BARDA to assess sepsis diagnostic and prediction algorithm with COVID-19 patients
15 May 2020
BREA, CALIF., May 15, 2020 — Beckman Coulter today announced it was awarded an expanded partnership with BARDA as part of their rapidly expanding COVID-19 medical countermeasure portfolio. The partnership was awarded to Beckman Coulter, in collaboration with Dascena, Inc., for additional advanced research and development toward optimization of a machine-learning based sepsis diagnostic and prediction algorithm to include assessing its use with coronavirus (COVID-19) patients.
The sepsis diagnostic and prediction algorithm builds on Beckman Coulter’s existing Early Sepsis Indicator, which received FDA 510(k) clearance in April 2019, combining the monocyte distribution width (MDW) novel laboratory test parameter values with Dascena’s electronic health record data based machine-learning algorithm to help accurately predict and detect those with sepsis.
“Until recently, the majority of sepsis cases have been thought to be caused by bacterial pathogens,” said Shamiram R. Feinglass, M.D., MPH, chief medical officer, Beckman Coulter. “COVID-19 is changing that, and causing a paradigm shift in how we think about sepsis. The aim of the study is to determine whether MDW, as part of the sepsis prediction algorithm, will be able to aid in the detection of sepsis regardless of whether it is bacterial or viral-induced.”
“The global impact that COVID-19 has had on the health system is undeniable. It has changed the way the industry thinks about so many things, and sepsis is no exception,” said Peter Soltani, Ph.D., senior vice president and general manager of the hematology business unit at Beckman Coulter. “Beckman Coulter is deeply committed to the fight against COVID-19 and has been working diligently to quickly bring quality SARS-CoV-2 serology assays to the market. We are thrilled to expand our partnership with BARDA, so we can extend that commitment to our sepsis research and begin clinical trials that include COVID-19 patients.”
“We are excited to deepen our partnership with Beckman Coulter to help respond to the global pandemic that has exacerbated the challenge of sepsis, a condition that already kills an American every two minutes,” said Jana Hoffman, Ph.D., vice president of science at Dascena.
This COVID-19 specific study is part of BARDA’s Rapidly Deployable Capabilities program to identify and pilot near-term innovative solutions for COVID-19, leveraging the development of Beckman Coulter’s digital sepsis prediction algorithm under BARDA’s Division of Research Innovation and Venture’s (DRIVe’s) Solving Sepsis Program.
For more information on Beckman Coulter’s Early Sepsis Indicator, visit www.beckmancoulter.com/sepsis. For more information on BARDA’s rapidly-expanding COVID-19 medical countermeasure portfolio, visit BARDA’s COVID-19 Portfolio.
About Beckman Coulter
Beckman Coulter is committed to advancing healthcare for every person by applying the power of science, technology and the passion and creativity of our teams to enhance the diagnostic laboratory’s role in improving healthcare outcomes. Our diagnostic systems are used in complex biomedical testing, and are found in hospitals, reference laboratories and physician office settings around the globe. Beckman Coulter offers a unique combination of people, processes and solutions designed to elevate the performance of clinical laboratories and healthcare networks. We do this by accelerating care with a menu that matters, bringing the benefit of automation to all, delivering greater insights through clinical informatics and unlocking hidden value through performance partnership. An operating company of Danaher Corporation (NYSE: DHR) since 2011, Beckman Coulter is headquartered in Brea, Calif., and has more than 11,000 global associates working diligently to make the world a healthier place.
About Dascena
Dascena, Inc. is developing machine learning diagnostic algorithms to enable early disease intervention and improve care outcomes for patients. For more information, visit Dascena.com.
Hologic Granted FDA Emergency Use Authorization for Its Second Molecular Test for COVID-19
15 May 2020 - Significant Test Manufacturing Capacity, Large Installed Base of Automated Instruments Yield Testing Breakthrough
MARLBOROUGH, Mass., 15 May 2020 -- Hologic, Inc. announced today that it has received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) for its Aptima SARS-CoV-2 assay to detect the novel coronavirus.
The newly authorized test runs on Hologic’s fully automated Panther® system, more than 1,000 of which are already installed in clinical laboratories throughout the United States. Each Panther system can provide initial results in approximately three hours and process more than 1,000 coronavirus tests in 24 hours. Hologic has begun distributing its new coronavirus test, and expects to produce an average of one million tests per week. Combining significant manufacturing capacity for the new test with the world’s largest installed base of high-throughput molecular instruments is expected to dramatically increase testing capabilities.
“Delivering test results when and where they are needed – so people can either get back to work or quarantine themselves – is key to re-opening global economies safely,” said Steve MacMillan, the Company’s Chairman, President and CEO. “I’m so proud of the incredible teamwork across the company that brought this test to market so quickly.”
The Panther system is a fully automated, high-throughput molecular diagnostic platform that is widely used around the world, with more than 1,800 systems installed in 60 countries. In the United States, instruments are installed across all 50 states. Approximately 750 U.S. hospital, public health and reference labs use the Panther system and its suite of Aptima assays to perform tens of millions of molecular tests annually for sexually transmitted infections, cervical cancer screening and viral load monitoring in people with HIV and hepatitis.
Certain aspects of the Aptima SARS-CoV-2 assay project were conducted under a $13 million contract, initially announced on April 29, 2020, with the Biomedical Advanced Research and Development Authority, part of the Office of the Assistant Secretary for Preparedness and Response at the U.S. Department of Health and Human Services.
Hologic plans to register its Aptima SARS-CoV-2 assay for a CE Mark for diagnostic use in Europe later in May.
About the Panther System
The Panther molecular diagnostics system is a best-in-class, fully automated, sample-to-result platform that can be used in low-, medium- or high-throughput laboratories. With a small footprint, adaptable workflow options and consolidated testing menu, it combines women’s health, sexually transmitted infections and viral testing, which can all be done simultaneously. In addition, patient samples can be loaded onto the Panther system as they arrive in the laboratory, a capability known as “random access” that improves efficiency and workflow. Overall, the instrument’s high throughput and quick turnaround time enable more patients to get results sooner.
The Panther system, launched in Europe in 2010 and the U.S. in 2012, employs a suite of proprietary Aptima technologies that are familiar to clinical laboratory customers. Notably, extraction and purification of microbial nucleic acids is done via a process called target capture, in which specific viral nucleic acids are bound to magnetic particles. Then, amplification is performed in a single tube by Transcription Mediated Amplification, or TMA, which produces billions of copies of the target genetic material. This genetic material is then detected via chemiluminescent probes.
About COVID-19
For more information about the novel coronavirus, visit: https://www.cdc.gov/coronavirus/2019-ncov/summary.html.
About Hologic
Hologic, Inc. is an innovative medical technology company primarily focused on improving women’s health and well-being through early detection and treatment. For more information on Hologic, visit www.hologic.com.
Roche launches new blood gas digital solution designed to improve patient care
15 May 2020 - Roche v-TAC is a new digital diagnostics solution that allows clinicians to obtain arterial blood gas values from patients in need of blood gas testing via a simpler, less painful and less invasive venous method. Roche’s new digital tool could help simplify the screening, diagnosis and monitoring of patients with respiratory compromise in the current COVID-19 pandemic. Roche v-TAC is available in markets accepting the CE mark.
Basel, 15 May 2020 -- Roche today announced the CE mark availability of Roche v-TAC, a new digital diagnostic solution that allows clinicians to obtain results for arterial blood gas values from patients with respiratory or metabolic abnormalities via a simpler, less invasive venous puncture through the use of a digital algorithm.
Blood gas analysis is typically used in hospital point of care (POC) settings, where quick and accurate results are needed. This includes emergency rooms, intensive care units and operating rooms. The analysis provides clinicians with information about a patient’s pulmonary function and acid‐base status, both of which are essential to make a diagnosis, provide treatment and monitor progress.
A traditional blood gas test requires the collection of an arterial blood sample, which can be a painful experience for the patient since most arteries lie deeper in the tissue than veins and have a thicker wall to be punctured. This procedure is usually carried out by medical doctors or specially-trained staff. Through the Roche v-TAC digital solution, staff without specific training to draw arterial blood samples are now able to withdraw a venous blood sample instead and digitally convert these values into arterial blood gas values, which can help free up specialist healthcare staff to other tasks. Roche’s v-TAC is fully integrated for use with Roche’s cobas b 123 POC and cobas b 221 systems using the Roche cobas infinity POC solution.
“In an emergency situation such as the COVID-19 pandemic, Roche v-TAC could also help healthcare professionals to assess disease severity faster in patients and closely monitor potential deterioration in patients with respiratory compromise,” said Thomas Schinecker, CEO Roche Diagnostics. “Digital tools based on clinical algorithms like Roche v-TAC can help improve and simplify delivery of care in emergency situations faster and where it is most needed.”
Roche acquired the v-TAC technology at the end of March with the acquisition of Obi Medical Aps, a privately-held company based in Hadsund, Denmark that focuses on developing disruptive blood gas testing technology.
About Blood Gas testing
Blood gas and electrolyte testing is used in a number of critical care situations, during surgery and in a number of other clinical areas, including neonatal and dialysis units. For example, it can help determine whether a patient is receiving sufficient respiratory support, or suffering from heavy trauma or acute heart and lung diseases.
Blood gas and electrolyte systems provide fast, accurate, quantitative measurements of whole blood for pH, pCO2, pO2, Sodium , Potassium , Chloride , Calcium, Glucose, Lactate, Haematocrit, Total bilirubin and CO-Oximetry (tHb, O2Hb, COHb, MetHb, HHb).
About cobas b 123 POC and b 221 systems
The cobas b 123 POC system is a mobile, cartridge-based, blood gas analyser designed for POC testing to measure blood gases, electrolytes, metabolites and oxygen saturation and neonatal bilirubin. With various configurations and a throughput of up to 30 samples per hour, the cobas b 123 POC system can easily be customized to the clinical needs of the ICU, ER, NICU, OR, dialysis units or the laboratory.
The cobas b 221 system is a fully automated blood gas analyser for the quantitative measurement of blood gases, electrolytes, metabolites and oxygen saturation and neonatal bilirubin. The system is designed to be used in POC settings such as emergency departments, intensive care units and laboratories.
Connectivity to the hospital network for both cobas b 123 and cobas b 221 is enabled wirelessly or via a network port using the cobas infinity POC software which is available worldwide. For more information, visit diagnostics.roche.com
About OBI Medical Aps
In March 2020, Roche acquired OBI Medical Aps, a privately held company based in Denmark that focuses on developing disruptive blood gas testing technology. OBI Medical Aps was founded in 2002 by a group of leading scientists, researchers and clinicians from Aalborg University Hospital and from the Centre for Model-based Medical Decision Support at Aalborg University.
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.
Reliable, high-quality testing is essential to help healthcare systems overcome this pandemic. On 13 March we received FDA Emergency Use Authorisation for a high-volume molecular test to detect SARS-CoV-2, the virus that causes COVID-19, which is also available in countries accepting the CE Mark. On 3 May, Roche announced that its COVID-19 antibody test, aimed at detecting the presence of antibodies in the blood, also received FDA Emergency Use Authorisation and is available in markets accepting the CE mark. Our existing diagnostics portfolio for critical care has also been playing a significant role in supporting patient management during the COVID-19 crisis, with our blood gas and sepsis products being used to monitor patients in the acute setting. Roche is working closely with governments and health authorities around the world, and has significantly increased production to help ensure availability of tests globally.
While there are currently no approved medicines for the treatment of patients with COVID-19, we are actively involved in understanding the potential of our existing portfolio and are researching options for the future. 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. Roche has also initiated an internal early research programme focused on the development of medicines for COVID-19 and is evaluating a large number of potential collaborations.
In these exceptional times, Roche stands together with governments, healthcare providers and all those working to overcome the pandemic.
About Roche
Roche is a global pioneer in pharmaceuticals and diagnostics focused on advancing science to improve people’s lives. The combined strengths of pharmaceuticals and diagnostics under one roof have made Roche the leader in personalised healthcare – a strategy that aims to fit the right treatment to each patient in the best way possible.
Roche is the world’s largest biotech company, with truly differentiated medicines in oncology, immunology, infectious diseases, ophthalmology and diseases of the central nervous system. Roche is also the world leader in in vitro diagnostics and tissue-based cancer diagnostics, and a frontrunner in diabetes management.
Founded in 1896, Roche continues to search for better ways to prevent, diagnose and treat diseases and make a sustainable contribution to society. The company also aims to improve patient access to medical innovations by working with all relevant stakeholders. More than thirty medicines developed by Roche are included in the World Health Organization Model Lists of Essential Medicines, among them life-saving antibiotics, antimalarials and cancer medicines. Moreover, for the eleventh consecutive year, Roche has been recognised as one of the most sustainable companies in the Pharmaceuticals Industry by the Dow Jones Sustainability Indices (DJSI).
The Roche Group, headquartered in Basel, Switzerland, is active in over 100 countries and in 2019 employed about 98,000 people worldwide. In 2019, Roche invested CHF 11.7 billion in R&D and posted sales of CHF 61.5 billion. Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan. For more information, please visit www.roche.com.
Reference: https://www.roche.com/media/releases/med-cor-2020-05-15.htm
Thermo Fisher Scientific Response to COVID-19 Expands to Include New Serology Test
13 May 2020 - Collaboration with WuXi Diagnostics and Mayo Clinic on serology test will complement Thermo Fisher's widely adopted TaqPath COVID-19 molecular diagnostic test
WALTHAM, Mass., May 13, 2020 -- Thermo Fisher Scientific Inc., the world leader in serving science, announced it will expand its response to the COVID-19 pandemic by developing a total antibodies test in collaboration with WuXi Diagnostics and Mayo Clinic. The new test is the result of ongoing collaboration between all three organizations, including clinical evaluation and support from Mayo Clinic. Thermo Fisher will seek U.S. FDA Emergency Use Authorization (EUA) and international regulatory authorizations for the test over the next few weeks.
Once approved for use, the Thermo Scientific OmniPath COVID-19 Total Antibody ELISA test will detect Immunoglobulin M (IgM) and Immunoglobulin G (IgG) to help clinicians determine if a patient has been exposed to SARS-CoV-2. The test is designed to run on an open instrument platform, and the determination of antibody status will aid in the diagnosis of the disease during the acute and recovery stages of infection.
"Since the outbreak was first detected, we have mobilized our scientific, regulatory and commercial teams to support virus analysis, identification, deployment of personal protective equipment as well as development of therapies and vaccines," said Marc N. Casper, chairman, president and chief executive officer of Thermo Fisher Scientific. "Stopping the spread of COVID-19 requires comprehensive testing solutions, and we are very pleased to join forces with WuXi Diagnostics and Mayo Clinic to respond to the widespread need for antibody-based tests. Working together, we will now be able to provide governments, healthcare systems and communities with yet another important tool to aid in the fight against the pandemic."
The global call to ramp up testing requires a combination of both PCR-based molecular tests and serological tests. Molecular tests, such as Thermo Fisher's Applied Biosystems TaqPath Combo Kit, are considered the gold standard for determining if a patient has an active infection. Serological tests determine if a patient has antibodies to SARS-CoV-2 that indicate whether they have had – or still have – the virus and have built up an immune response. When used in combination, these tests provide greater clinical efficacy, support contact tracing and enhance epidemiological efforts to stop the spread of the virus.
Thermo Fisher will begin manufacturing the Thermo Scientific OmniPath COVID-19 Total Antibody ELISA test at its sites in the U.S. and Europe in the next few weeks as it prepares to submit for EUA.
Jason Liu, Ph.D., chief executive officer of WuXi Diagnostics, said, "We are pleased to join forces with Thermo Fisher and Mayo Clinic in the battle against the pandemic. This global collaboration of R&D, clinical expertise, manufacturing and commercialization capability will significantly advance serological testing for COVID-19. WuXi Diagnostics offers an open-access platform for innovative diagnostic solutions. By collaborating with our partners, we're dedicated to supporting healthcare professionals and their patients around the world."
Gianrico Farrugia, M.D., chief executive officer and president of Mayo Clinic, said, "Rapidly expanding access to high-quality testing requires bold collaborations across the laboratory industry. This marks a significant milestone in our national testing response to COVID-19 and was made possible by bringing together the commercialization capabilities of Thermo Fisher Scientific, testing development abilities of WuXi Diagnostics, and clinical and laboratory expertise of Mayo Clinic physicians and scientists."
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.
Philips receives FDA clearance for the use of its ultrasound portfolio to manage COVID-19-related lung and cardiac complications
13 May 2020 - Philips’ ultrasound portfolio, including Lumify with Reacts handheld tele-ultrasound solution, provides valuable diagnostic insight for front-line care providers
Amsterdam, the Netherlands, 13 May 2020 -- Royal Philips, a global leader in health technology, today announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market a wide range of its ultrasound solutions for the management of COVID-19-related lung and cardiac complications. Handheld and portable ultrasound solutions in particular have become valuable tools for clinicians treating COVID-19 patients due to their imaging capabilities, portability and ease of disinfection. As a result of this regulatory clearance, which is an industry first, Philips can provide detailed, practical guidance to support clinicians using its systems and software for patients affected by COVID-19. The clearance applies to Philips ultrasound systems including the EPIQ series, Affiniti series, Lumify, CX50 and Sparq diagnostic ultrasound systems, and to off-cart solutions like QLAB Advanced Quantification Software.
Ultrasound has shown value in imaging peripheral lung tissue affected by pneumonia, which is closely tied to COVID-19 lung complications. As respiratory strain can also lead to cardiac dysfunction, COVID-19 patients are at increased risk for cardiac complications. A cardiac ultrasound exam can help in evaluating the effects that disease progression may have on heart function. By imaging COVID-19 patients at the point of care, such as in the Emergency Department (ED) or Intensive Care Unit (ICU), clinicians can diagnose and monitor patients without the need to move them around the hospital, helping to reduce the risk of virus transmission to other patients or to healthcare professionals.
“Many healthcare providers have told us that our handheld and portable ultrasound solutions are playing a valuable role in their efforts to combat COVID-19,” said Bich Le, Senior Vice President and General Manager Ultrasound at Philips. “With this regulatory clearance we can offer clear guidance to ensure safe and effective use of ultrasound to manage COVID-19-related lung and cardiac complications. At the same time, we are investing significantly to ramp up production globally, including at our ultrasound manufacturing plants in the US.”
With its broad portfolio, leadership in areas including cardiac ultrasound and the unique capabilities of the Lumify with Reacts handheld tele-ultrasound solution, Philips is well positioned to support healthcare providers with ultrasound solutions as they combat the pandemic. The Lumify with Reacts point-of-care ultrasound solution, which works in conjunction with a compatible smartphone or tablet, is the world’s first ultra-portable ultrasound device with advanced telehealth capabilities. The Reacts communications platform enables two-way audio-visual calls with live ultrasound streaming, so both parties can simultaneously view the live ultrasound image and probe positioning, while discussing and interacting at the same time. In the context of COVID-19, this solution can help minimize the risk of virus transmission for the medical team.
The new guidance highlights the specific presets, transducers, quantification tools and other capabilities available on Philips’ ultrasound systems that are relevant in assessing and managing COVID-19-related lung and cardiac complications. For example, the EPIQ CVx premium cardiology ultrasound system includes automated applications for 2D assessment of the heart, as well as robust 3D right ventricle volume and ejection fraction measurements.
The regulatory clearance includes the following Philips ultrasound systems: EPIQ series, Affiniti series, Lumify, CX50, and Sparq diagnostic ultrasound systems and off-cart solutions like QLAB Advanced Quantification Software. More information on how Philips is responding to COVID-19 can be found on the company’s global newscenter.
LabCorp Significantly Expands Availability of Its COVID-19 At-Home Collection Test Kit
12 May 2020 - Consumers Now Have Access to the At-Home Test Collection Kit Online with No Upfront Costs, In Addition to Healthcare Workers and First Responders
BURLINGTON, N.C., May 12, 2020 -- LabCorp, a leading global life sciences company that is deeply integrated in guiding patient care, today announced that its COVID-19 at-home collection test kit is now being offered to individuals nationwide who have symptoms consistent with COVID-19 infection and individuals without symptoms who may have been exposed to the virus. The test is available through the company’s Pixel by LabCorp™ online platform. Initially, the at-home collection test kits were made available in April to frontline healthcare workers and first responders and this latest move expands access in line with U.S.CDC guidelines.
LabCorp’s COVID-19 at-home test kit is physician-authorized and enables individuals to self-collect nasal swab specimens at home. This collection method helps minimize transmission of the virus and the use of personal protective equipment (PPE) as it does not require an in-person visit to a medical professional. Individuals can obtain the test with no upfront out-of-pocket costs if they qualify after completing a COVID-19 health screening questionnaire on the Pixel by LabCorp online platform. LabCorp now has over 200,000 at-home collection test kits available and is prepared to significantly expand capacity as required.
“LabCorp has been leading the industry in developing and bringing high-quality diagnostic tests to market, and we continue to make those tests more accessible to people in need,” said Adam Schechter, president and CEO of LabCorp. “Expanding access to our at-home collection test kit is another example of our response to this health crisis and makes it possible for individuals needing testing to perform the collection without having to leave their home.”
LabCorp also offers a COVID-19 antibody blood test which can be helpful to understand if an individual has developed antibodies to the virus that causes COVID-19. The antibody test is also available with no upfront cost for the test on LabCorp.com, or through a doctor, including through telemedicine programs. To learn more about the antibody test or access the antibody test online, go to LabCorp.com.
The test kit received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) on April 20. LabCorp’s COVID-19 test at-home collection kit has been authorized by the FDA under an EUA only for the detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens, and has not been FDA cleared or approved. The test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostic tests for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.
About LabCorp
LabCorp, an S&P 500 company, is a leading global life sciences company that is deeply integrated in guiding patient care, providing comprehensive clinical laboratory and end-to-end drug development services. With a mission to improve health and improve lives, LabCorp delivers world-class diagnostics solutions, brings innovative medicines to patients faster, and uses technology to improve the delivery of care. LabCorp reported revenue of more than $11.5 billion in 2019.
To learn more about LabCorp, visit www.LabCorp.com, and to learn more about LabCorp’s Covance drug development business, visit www.Covance.com.
Abbott receives FDA Emergency Use Authorization for COVID-19 molecular test on new Alinity™ m system
12 May 2020 - Alinity m is Abbott's new molecular lab system, which was approved by the U.S. FDA in March. The Alinity m system is highly advanced and greatly improves speed and efficiency, running up to 1,080 tests in 24 hours. Abbott is launching Alinity m to U.S. customers and will be making the SARS-CoV-2 test available for use under an Emergency Use Authorization. This is Abbott's fifth COVID-19 test to receive FDA EUA, helping to provide hospitals and labs across the U.S. with broad, reliable molecular and antibody testing during this pandemic.
ABBOTT PARK, Ill., May 12, 2020 -- Abbott announced today that the U.S. Food and Drug Administration (FDA) has issued Emergency Use Authorization (EUA) for the company's molecular test for the novel coronavirus (COVID-19) for use on its new Alinity™ m molecular laboratory instrument. Abbott is in the process of launching the Alinity m system to U.S. customers.
The Alinity m system was cleared by the FDA for use with Abbott's HCV (hepatitis C) assay in late March. Abbott is working with hospitals and health systems in the U.S. to install this new instrument, which will help keep up with the growing demand for testing.
"Molecular lab tests play a critical role in detecting the virus for COVID-19. As a leader in diagnostics, we are pushing forward to develop high-performing tests across our platforms to help combat this pandemic," said Robert B. Ford, president and chief executive officer, Abbott. "As we continue to develop and improve our testing technologies, we want to ensure they are meeting the needs of our customers – and right now that means having reliable tests for COVID-19 on all of our diagnostic instruments."
The Alinity m system is Abbott's most advanced laboratory molecular instrument. It is an automated platform, which can run more tests in less time to give laboratories improved efficiency and flexibility when using the system. The Alinity m system is able to run up to 1,080 tests in 24 hours, and our m2000 RealTime system can run up to 480 tests in 24 hours.
With current systems, running different types of tests at the same time will slow down the time to results and/or volume throughput. Alinity m delivers true random access, allowing labs to run any test, any time for different types of infectious diseases while still providing results in less than two hours. This is especially critical during the COVID-19 pandemic when volume, speed and flexibility are needed.
Our contributions to bring broad scale access to reliable testing
As a leader in infectious disease testing, Abbott is working to bring as many tests as possible across our platforms to customers and patients around the world. This is Abbott's fifth COVID-19 test to receive FDA EUA, helping to provide hospitals and labs across the U.S. with broad, reliable molecular and antibody testing during this pandemic.
About Alinity™
Abbott's Alinity family of harmonized solutions is unprecedented in the diagnostics industry, working together to address the challenges of using multiple diagnostic platforms and simplifying diagnostic testing. Alinity systems are designed to be more efficient – running more tests in less space and minimizing human errors – while continuing to provide quality results. The availability of the Alinity systems and tests varies by geography. More information is available at abbott.com/alinity.
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.
LGC's innovative SARS-CoV-2 Quality Solutions now includes S gene
7 May 2020
7 May 2020 -- In response to the critical need for accurate testing to combat the COVID-19 pandemic, LGC SeraCare continues to innovate and expand their novel AccuPlex™ SARS-CoV-2 Quality Solutions in support of improved diagnostic assay development and testing. The newly launched Version 2 Verification Panel, and Reference Material Kit, offer expanded genome coverage over the products first launched in March to now include the S gene region. As testing priorities shift from molecular to serological, LGC also plans to expand their product offering to antibody controls in continued support of public health efforts against COVID-19.
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 control solutions that challenge the entire PCR test procedure, making them the preferred alternative to infectious materials. Together, the AccuPlex SARS-CoV-2 Verification Panel and AccuPlex SARS-CoV-2 Reference Material Kit offer an ideal solution for clinical laboratories looking for a safe, effective tool to verify and monitor SARS-CoV-2 molecular assay performance.
Michael Sweatt, Executive Vice President, LGC SeraCare, stated, “AccuPlex technology offers an urgently needed tool supporting assay installation and verification, and daily performance monitoring, in support of a growing footprint of available testing laboratories, and to meet an ever-increasing testing demand. LGC is committed to providing quality measurement tools to support in vitro diagnostic assay developers and clinical laboratories to help ensure accurate and reliable patient test results.”
Abbott receives FDA Emergency UseAuthorization for COVID-19 antibody blood test on Alinity™ i system
11 May 2020
ABBOTT PARK, Ill., May 11, 2020 -- Abbott announced today that the U.S. Food and Drug Administration (FDA) issued Emergency Use Authorization (EUA) for the company's SARS-CoV-2 IgG lab-based serology blood test on the Alinity™ i system. Abbott plans to ship nearly 30 million antibody tests globally in May across its ARCHITECT® and Alinity i™ platforms and will have capacity for 60 million tests in June.
Antibody testing will help provide a greater understanding of the virus, including how long antibodies stay in the body and how much of the population has been infected. Last month, Abbott received FDA EUA and CE Mark for its SARS-CoV-2 IgG antibody blood test on the ARCHITECT system.* Abbott has already begun shipping antibody tests for use on the ARCHITECT systems globally including in the U.S., UK, Italy, Spain and India.
"Having more options of highly reliable tests across our platforms will help healthcare workers and health officials as they conduct broad scale testing for COVID-19," said Robert B. Ford, president and chief executive officer, Abbott. "Abbott is a leader in providing antibody testing at large scale on multiple systems, which is helping meet the needs of laboratories as they look to build testing capacity."
The Alinity i system is Abbott's next-generation immunoassay instrument, which was designed to offer greater efficiencies to lab clinicians running tests. Alinity i systems are in use around the world in hospital and academic centers as well as reference laboratories. Abbott also expects to submit this week for CE Mark to the IVD Directive (98/79/EC) in the European Union for the Alinity i SARS-CoV-2 IgG test.
Our contributions to bring broad scale access to reliable testing
As a leader in infectious disease testing, Abbott's goal is to bring highly reliable tests for customers and patients around the world. A study to determine the clinical performance of Abbott's SARS-CoV-2 IgG assay found it had greater than 99.6% specificity (ability to exclude false positives) and 100% sensitivity (ability to exclude false negatives) in patients tested 14 days after symptoms began.
Abbott is collaborating with leading virology labs to validate test results and is working to quickly install additional instruments to help contribute to large scale testing.
This is Abbott's fourth COVID-19 test to receive FDA EUA, helping to provide hospitals and labs across the U.S. with broad, reliable molecular and antibody testing during this pandemic.
About Alinity™
Abbott's Alinity family of harmonized solutions is unprecedented in the diagnostics industry, working together to address the challenges of using multiple diagnostic platforms and simplifying diagnostic testing. Alinity systems are designed to be more efficient – running more tests in less space and minimizing human errors – while continuing to provide quality results. The availability of the Alinity systems and tests varies by geography. More information is available at abbott.com/alinity.
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.
A formative figure in the company's history: Roche Honorary Chairman Fritz Gerber dies at the age of 91
11 May 2020
Basel, 11 Mai 2020 -- On May 10th 2020 Dr. h.c. Fritz Gerber died in his 92nd year. For more than two decades, he had shaped Roche's development into a leading global healthcare company in an exceptionally successful dual role as Group CEO (1978-1998) and Chairman of the Board (1978-2001). He remained closely associated with Roche throughout his life as Honorary Chairman.
Starting at the end of the 1970s, Fritz Gerber led the company from a difficult situation to new success. Under his leadership, Roche's Group structures were fundamentally renewed and decentralized– ranging from focusing on the core businesses to modernizing the capital structure. This created a fundamental change at Roche that still encourages entrepreneurial thinking today, and empowers employees to make their mark.
Fritz Gerber made numerous major acquisitions with intuition and a keen sense of when something is ripe. Roche still benefits today from his foresight in investing in biotechnology in the early 1990s when he acquired a majority stake in Genentech. Fritz Gerber led Roche to the global forefront of molecular and laboratory diagnostics with the acquisition of PCR technology and the takeover of Boehringer Mannheim. He laid the foundation for the accelerated development of personalised medicine, an area in which Roche is now a leader.
The Faculty of Science at the University of Basel awarded him an honorary doctorate for his services to the development of biomedicine.
In addition to his entrepreneurial activities, Fritz Gerber was particularly committed to education and culture. In 1996 he played a major role in the founding of the Museum Tinguely by Roche. In 1999 he created the Fritz Gerber Foundation for Gifted Young People, which provides financial support for the education and training of young athletes, craftsmen and artists. Fritz Gerber was also active in the Paul Sacher Foundation for Contemporary Music, on the Board of Trustees of the Lucerne Music Festival and the Orchestra Academy of the Berlin Philharmonic Orchestra.
"It is largely thanks to Fritz Gerber that Roche found its way back onto the road to success at the end of the last millennium. He was deeply convinced of the value of long-term thinking, which still characterizes Roche today. He impressed me very much with his friendliness and Bernese charm, but also with his clarity and consistency,' explained Dr Christoph Franz, Chairman of the Roche Board of Directors. "For 17 years, he even led Roche in a dual mandate with the Chairman's Office of the Zurich Insurance Company, which made him one of the most influential Swiss managers of global stature at the time. During this time he was a member of numerous other boards of directors, including that of IBM. His outstanding services to our company and the Swiss economy as a whole will be remembered. On behalf of the Board of Directors, the Corporate Executive Committee and all Roche employees, I would like to express our sincere condolences to his wife, children and relatives," Christoph Franz continued.
About Roche
Roche is a global pioneer in pharmaceuticals and diagnostics focused on advancing science to improve people’s lives. The combined strengths of pharmaceuticals and diagnostics under one roof have made Roche the leader in personalised healthcare – a strategy that aims to fit the right treatment to each patient in the best way possible.
Roche is the world’s largest biotech company, with truly differentiated medicines in oncology, immunology, infectious diseases, ophthalmology and diseases of the central nervous system. Roche is also the world leader in in vitro diagnostics and tissue-based cancer diagnostics, and a frontrunner in diabetes management.
Founded in 1896, Roche continues to search for better ways to prevent, diagnose and treat diseases and make a sustainable contribution to society. The company also aims to improve patient access to medical innovations by working with all relevant stakeholders. More than thirty medicines developed by Roche are included in the World Health Organization Model Lists of Essential Medicines, among them life-saving antibiotics, antimalarials and cancer medicines. Moreover, for the eleventh consecutive year, Roche has been recognised as one of the most sustainable companies in the Pharmaceuticals Industry by the Dow Jones Sustainability Indices (DJSI).
The Roche Group, headquartered in Basel, Switzerland, is active in over 100 countries and in 2019 employed about 98,000 people worldwide. In 2019, Roche invested CHF 11.7 billion in R&D and posted sales of CHF 61.5 billion. Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan. For more information, please visit www.roche.com.
Reference: https://www.roche.com/media/releases/med-cor-2020-05-11b.htm
BGI’s Real-time Fluorescent RT-PCR Kit for Detecting 2019-nCoV was Listed in the Emergency Use Listing of WHO
10 May 2020
May 10, 2020 -- BGI Europe A/S, a subsidiary of BGI Genomics today announced that its Real-time fluorescent RT-PCR kit for detecting 2019-nCoV was listed in the World Health Organization Emergency Use Listing (EUL).
On January 30, 2020, WHO declared the outbreak of COVID-19 to be a public health emergency of international concern, and initiated EUL for In vitro diagnostics (IVDs) Detecting SARS-CoV-2 Nucleic Acid. There are five SARS-CoV-2 detection kit providers listed in WHO’s EUL till now. Among them, BGI is the first Chinese company to be listed in EUL as qualified provider of WHO’s in vitro diagnostic procedures.
BGI’s highly-sensitive RT-PCR testing kit, which can return results within three hours, detects the RNA of SARS-CoV-2 extracted from a wide range of respiratory samples. It features
- High sensitivity: Limit of detection as low as 100 viral copies/mL
- High specificity: No cross-reactivity with 54 human respiratory pathogens
- Ease to use: All-inclusive with pre-mixed reaction reagents
- Easy interpretation: Analysis of one target with well-defined controls
“BGI’s RT-PCR kit is one of the most widely recognized molecular products for SARS-CoV-2 detection by global regulatory agencies,” said Yin Ye, CEO of BGI Genomics. “It is another testament to our strong commitment to enabling safe and effective COVID-19 testing on a global scale.”
BGI’s RT-PCR Test for Detecting SARS-CoV-2 is one of the most reliable and widely used testing methods available, with over 20 million tests already performed, covering more than 80 countries and regions around the world. In 2020, BGI’s testing kit for SARS-CoV-2 received emergency approval from China’s National Medical Products Administration (NMPA), followed by the European CE mark, the U.S. FDA Emergency Use Authorization (EUA), Japan’s PMDA approval, Australia’s TGA approval, and Health Canada Authorization.
For more information please contact: info@bgi.com
Quidel receives Emergency Authorization for rapid antigen COVID-19 diagnostic assay
8 May 2020 - Sofia® 2 SARS Antigen FIA Point-of-Care test offers positive results in 15 minutes
SAN DIEGO, 8 May 2020 -- Quidel Corporation (“Quidel”), a provider of rapid diagnostic testing solutions, cellular-based virology assays and molecular diagnostic systems, announced today that Quidel has received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) to market its Sofia® 2 SARS Antigen FIA, a rapid point-of-care test to be used with the Sofia 2 Fluorescent Immunoassay Analyzer for the rapid detection of SARS-CoV-2 in nasal or nasopharyngeal specimens from patients meeting the Centers for Disease Control and Prevention’s (CDC) criteria for suspected COVID-19 infection.
Sofia 2 is Quidel’s next-generation version of its best-selling Sofia instrumented system. Sofia 2 utilizes the original Sofia fluorescent chemistry design while improving upon the graphical user interface and optics system to provide an accurate, objective and automated result in 15 minutes. The next-generation Sofia 2 system also comes connected to Virena®, Quidel’s data management system, which provides aggregated, de-identified testing data in near real-time.
The Sofia 2 instrument also offers 2 distinct workflows: depending upon the user’s choice, the Sofia 2 SARS Antigen FIA cartridge is placed inside Sofia 2 for automatically timed development (WALK AWAY Mode); or test cartridges can be placed on the counter or bench top for a manually timed development and then placed into Sofia 2 to be scanned (READ NOW Mode), allowing the user to markedly increase testing throughput per hour.
“In the fight against COVID-19, our employees are truly making a difference, and I am tremendously proud of our organization’s ability to quickly develop and mobilize an accurate rapid antigen test,” said Douglas Bryant, president and chief executive officer of Quidel Corporation. “The EUA for our Sofia 2 SARS Antigen FIA allows us to arm our healthcare workers and first responders with a frontline solution for COVID-19 diagnosis, accelerating the time to diagnosis and potential treatment of COVID-19 for the patient.”
The assay is currently available for sale in the United States under EUA, and Quidel is now shipping the product to its customers. Quidel offers several other Sofia assays for sale, which are FDA cleared and CLIA waived, including tests for Influenza A and B, Respiratory Syncytial Virus (RSV), Group A Strep, and a 12-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.
Healthcare professionals can purchase the Sofia 2 SARS Antigen FIA through distribution representatives for Cardinal Health, Fisher Healthcare, Henry Schein, or McKesson.
About Quidel Corporation
Quidel Corporation serves to enhance the health and well-being of people around the globe through the development of diagnostic solutions that can lead to improved patient outcomes and provide economic benefits to the healthcare system. Marketed under the Sofia®, QuickVue®, D3® Direct Detection, Thyretain®, Triage® and InflammaDry® leading brand names, as well as under the new Solana®, AmpliVue®and Lyra® molecular diagnostic brands, Quidel’s products aid in the detection and diagnosis of many critical diseases and conditions, including, among others, influenza, respiratory syncytial virus, Strep A, lyme, herpes, pregnancy, thyroid disease and fecal occult blood. Quidel's Triage® system of tests comprises a comprehensive test menu that provides rapid, cost-effective treatment decisions at the point-of-care (POC), offering a diverse immunoassay menu in a variety of tests to provide diagnostic answers for quantitative BNP, CK-MB, d-dimer, myoglobin, troponin I and qualitative TOX Drug Screen. Quidel’s research and development engine is also developing a continuum of diagnostic solutions from advanced immunoassay to molecular diagnostic tests to further improve the quality of healthcare in physicians’ offices and hospital and reference laboratories. For more information about Quidel’s comprehensive product portfolio, visit quidel.com.
Peach State Health Plan and Quest Diagnostics Team Up to Increase Access to COVID-19 Testing in Underserved Communities
8 May 2020 - 1,000 COVID-19 test kits will be distributed each week to Federally Qualified Health Centers in Georgia
ATLANTA, GA, 8 May 2020 – Peach State Health announced today a collaboration with Quest Diagnostics (NYSE: DGX), the world’s leading provider of diagnostic information services, to increase access to real-time reverse transcription polymerase chain reaction (rRT-PCR) COVID-19 testing in critical areas of need Georgia. Through this collaboration, Peach State Health Plan will facilitate the distribution of approximately 1,000 Quest COVID-19 test kits each week to Federally Qualified Health Centers (FQHCs), including The Family Health Centers of Georgia, headquartered in Atlanta and Curtis V. Cooper Primary Health Care, headquartered in Savannah. The FQHCs will conduct testing as part of a broader initiative to test persons who are symptomatic and asymptomatic in our underserved communities.
"We are proud to join forces with Peach State Health Plan and Quest Diagnostics to enhance COVID-19 testing capacity,” said Governor Brian Kemp. “COVID-19 testing allows healthcare providers and state officials to quickly identify cases, target hotspots with more resources, protect our communities, and provide timely information to the public. We encourage Georgians who are symptomatic and critical infrastructure workers to schedule a virtual screening and get tested at one of 50 sites across the state. Together, we will keep our families safe and emerge stronger than ever.”
This collaboration leverages Peach State Health Plan’s extensive network of critical safety net providers to ensure that testing capacity is routed to where it is needed most. As part of the collaboration, Peach State Health Plan will provide oversight and training to ensure test kits are received and processed efficiently. Distribution of kits began May 6 and Quest Diagnostics will conduct the COVID-19 testing through its network of laboratories across the United States.
“Collaborations like these allow us to leverage our capabilities to do our part in making sure our communities, including those who need it most, have access to the health care services they need,” said Pam Shipley, Interim CEO, Peach State Health Plan.”
“Our relationship with Peach State Health Plan and Quest will bring life-saving COVID-19 testing into our communities. Testing is critical for treating our patients and preventing future outbreaks,” said Dr. Michael W Brooks, CEO, The Family Health Centers of Georgia and Mr. Albert B Grandy, Jr, CPA, CEO Curtis V Cooper Primary Health Care. “ We are pleased with Peach State Health Plan and Quest’s ongoing commitment to Federally Qualified Health Centers and underserved populations.”
Peach State Health Plan members are encouraged to contact the Family Health Centers of Georgia at 1-800-935-6721 and Curtis V. Cooper Primary Care at 912-527-1000 for additional information about testing. Members can also find more information about COVID-19 and how Peach State Health Plan can support them at www.pshp.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, and our 47,000 employees understand that, in the right hands and with the right context, our diagnostic insights can inspire actions that transform lives. www.QuestDiagnostics.com.
About COVID-19 Testing by Quest Diagnostics
Quest Diagnostics is at the forefront of 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 aiding the diagnosis of COVID-19 and immune response. Our COVID-19 test services are based on tests that have received or are expected to receive FDA emergency use authorization and which also meet our high standards for quality. We provide data on COVID-19 testing to various federal and state public health authorities, including the Centers for Disease Control and Prevention, and participate in studies with government and private institutions, aiding COVID-19 public health response and research.
Through our team of dedicated phlebotomists, couriers, air fleet team, and laboratory professionals, Quest Diagnostics won’t stop until quality testing is broadly available to patients and communities across the United States.
LGC’s ValuPanel reagents help public laboratories detect SARS-CoV-2 virus
6 May 2020
6 May 2020 -- LGC, Biosearch Technologies today announces the release of three new product groupings to help the efforts of public health laboratories to detect the SARS-CoV-2 virus that causes COVID-19.
The Charité 2019-nCoV BHQ™/BBQ-650™ and US CDC 2019-nCoV ValuPanel™ Reagents are part of the ValuPanel line of detection reagents and are composed of probes and primers that resolve genetic signatures of different pathogen strains. Each oligonucleotide is delivered in separate, individual tubes for added flexibility where customers can pick and choose their signature of choice when running their assay.
Mark Dearden, VP of Strategy and Marketing at LGC, Biosearch Technologies, 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. To build on this activity, we’re now also offering the Charité assay enabling anywhere from 1000 to 100,000 reactions per order and larger sizes of the US CDC 2019-nCoV assay for Research Use Only.”
“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 meet our customers’ ramp their testing capability.”
LGC, Biosearch Technologies is dedicated in delivering quality, uncompromised probes and primers that are manufactured and shipped from a facility entirely separate from positive control production to protect the integrity of customers’ COVID-19 workflows.
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.
In addition, LGC 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. Manufacturing capacity can build 1,000 kits per week, equivalent to 1,000,000 tests.
FDA Provides Emergency Use Authorization to PerkinElmer for Serological Test to Identify COVID-19 Antibodies
5 May 2020
WALTHAM, Mass., May 5, 2020 -- PerkinElmer, Inc., a global leader committed to innovating for a healthier world, announced today that the U.S. Food and Drug Administration (FDA) has provided Emergency Use Authorization (EUA) for EUROIMMUN’s (a PerkinElmer company) Anti-SARS-CoV-2 ELISA (IgG) serology test. Clinical laboratories certified to perform high complexity tests under Clinical Laboratory Improvement Amendments (CLIA) can immediately begin using this ELISA for the detection of antibodies of the immunoglobulin class G.
Serological tests detect antibodies in the blood and are detected when an immune reaction to the pathogen has already taken place. These tests can determine who had previously been infected with COVID-19 (2-4 weeks or more prior to testing) and may have developed immunity. How long antibodies last and whether they are protective is being actively studied. The EUROIMMUN Anti-SARS-CoV-2 ELISA (IgG) is intended for use as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection. The EUROIMMUN Anti-SARS-CoV-2 ELISA (IgG) has 99% specificity and 100% sensitivity after 21 days following the onset of symptoms.
“Leading with science is a fundamental part of our DNA at PerkinElmer, and the EUROIMMUN team recognized early on that understanding the pathogenesis of COVID-19 from a cellular biology level is paramount to developing a highly accurate and reliable antibody test,” said Prahlad Singh, president and chief executive officer, PerkinElmer. “As a result, the antigen used in the EUROIMMUN Anti-SARS-CoV-2 ELISA (IgG), the spike protein S1 domain, is more likely to reflect virus neutralizing antibodies than antibodies to N capsid nucleoprotein. This is also supported by the fact that most of the COVID-19 vaccine development programs in the U.S. and worldwide have chosen the spike protein as their target.”
“It is possible that 50 percent or more of people who have been infected with COVID-19 might not display symptoms, making it difficult to identify those who have previously contracted COVID-19,” said Prahlad Singh. “That’s why serological testing that utilizes an antigen highly specific to SARS-CoV-2 is such an important tool in understanding how pervasive this virus is.”
EUROIMMUN has the capacity to manufacture millions of assays per month. Since March, it has already started shipping its Anti-SARS-CoV-2 ELISA (IgG) to leading laboratories across the globe. EUROIMMUN intends to further build production capacity to meet heightened demand.
For more information about COVID-19 solutions from EUROIMMUN, a PerkinElmer company, please visit www.coronavirus-diagnostics.com.
The Anti-SARS-CoV-2 ELISA (IgG) EUA has not been FDA cleared or approved. It has been authorized by the FDA under an EUA for use by authorized laboratories. The test has been authorized only for the detection of SARS-CoV-2 antibodies (the antibodies detected should be specified, e.g., total, IgA, IgG and IgM) 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 Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.
About PerkinElmer
PerkinElmer enables scientists, researchers and clinicians to address their most critical challenges across science and healthcare. With a mission focused on innovating for a healthier world, we deliver unique solutions to serve the diagnostics, life sciences, food and applied markets. We strategically partner with customers to enable earlier and more accurate insights supported by deep market knowledge and technical expertise. Our dedicated team of about 13,000 employees worldwide is passionate about helping customers work to create healthier families, improve the quality of life, and sustain the wellbeing and longevity of people globally. The Company reported revenue of approximately $2.9 billion in 2019, serves customers in 190 countries, and is a component of the S&P 500 index. Additional information is available through 1-877-PKI-NYSE, or at www.perkinelmer.com.
COVID-19 Antibody Test Now Directly Available Through LabCorp.com
5 May 2020 - Expanding Access to Tests Through LabCorp’s Wide Network of Doctors, Healthcare Providers, and Now Online
BURLINGTON, N.C., May 5, 2020 -- LabCorp, a leading global life sciences company that is deeply integrated in guiding patient care, today announced that its COVID-19 Immunoglobulin G (IgG) antibody test is now available for individuals through LabCorp.com. With the addition of this latest offering, individuals have the ability to receive the COVID-19 IgG antibody test from their doctor, in person or through a telemedicine program, and now directly using LabCorp.com.
LabCorp does not require upfront out-of-pocket costs for the IgG antibody test. If the individual uses LabCorp.com to get the test, there is a non-reimbursable fee of $10 paid to PWNHealth to cover the independent physician service costs. If the test is ordered through the individual’s doctor or healthcare provider, the $10 PWNHealth fee does not apply.
“We are working as quickly as possible to develop and implement new solutions to combat COVID-19,” said Adam Schechter, president and CEO of LabCorp. “We continue to bring our deep research and scientific expertise to the market, and are now making it more convenient for people to access our tests through our wide network of physicians, hospitals and healthcare providers, and now through LabCorp.com.”
LabCorp.com is a convenient option that uses an independent physician service, PWNHealth, to determine if an individual is eligible for the test following the completion of a short health questionnaire. Individuals who meet PWNHealth’s criteria can go to one of LabCorp’s thousands of patient service centers. Test results will be available through their LabCorp PatientTM account and individuals can consult with an independent licensed healthcare provider from PWNHealth.
The COVID-19 IgG antibody blood test detects the presence of antibodies to the virus and can help determine if an individual may have been exposed to the virus. While antibody tests are helpful to understand if an individual has developed antibodies and a potential immune response, antibody testing should not be used as the sole basis to diagnose or exclude infection.
About LabCorp
LabCorp, an S&P 500 company, is a leading global life sciences company that is deeply integrated in guiding patient care, providing comprehensive clinical laboratory and end-to-end drug development services. With a mission to improve health and improve lives, LabCorp delivers world-class diagnostics solutions, brings innovative medicines to patients faster, and uses technology to improve the delivery of care. LabCorp reported revenue of more than $11.5 billion in 2019. To learn more about LabCorp, visit www.LabCorp.com, and to learn more about LabCorp’s Covance Drug Development business, visit www.Covance.com.
This test has not been FDA cleared or approved. This test has been authorized by the FDA under an emergency use authorization for use by authorized laboratories. This test has been authorized only for the detection of IgG antibodies against SARS-CoV-2, and not for any other viruses or pathogens. This 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.
Grifols completes development of very high sensitivity molecular test to detect SARS-CoV-2 virus
5 May 2020 - The company has developed the test in record time in a global coordinated effort of its facilities in San Diego, Barcelona and Bilbao, and has recently received the authorization of the Spanish Medicines and Medical Devices Agency (AEMPS) for its use in blood, plasma and respiratory samples. Grifols has a productive capacity of one million tests weekly in its plant in San Diego, U.S. The test technology, proprietary to Grifols, has a high sensitivity and specificity and uses the company’s own Procleix® platform, through the Panther® analyzer, a completely automated system with a high throughput capacity per day.
Barcelona, May 5, 2020 -- Grifols has announced today it has completed the development of a specific TMA (Transcription-Mediated Amplification) molecular test that permits the detection of the SARS-CoV-2 virus in plasma, blood and respiratory samples, with a sensitivity equal or even superior to that of other molecular tests currently available, such as those based on PCR.
Thanks to this high sensitivity, the molecular test will also permit testing of pools of samples (pool strategy), multiplying the capacity of testing the population.
The TMA test is a complete and automated testing solution that includes all the reagents, from the preparation of the sample to getting a result. It is processed on Procleix® Panther® systems, each unit with an analysis capacity of more than 1,000 samples daily.
“Having sufficient molecular test capacity is critical to helping control this pandemic, and having a high-sensitivity test to handle a possible ‘pooling’ strategy is, without a doubt, a differentiating factor, which could make it feasible,” said Victor Grifols Deu, Grifols co-CEO.
Grifols began developing its test to detect SARS-CoV-2 the first week of February, thanks to the combined efforts of its teams in San Diego (U.S.), Bilbao and Barcelona (Spain). The collective effort of teams in San Diego, Bilbao and Barcelona has enabled the accelerated test development and production in less than three months.
The design and manufacturing of the test took place in its San Diego facilities, where Grifols has its worldwide production of this type of test based on Transcription-Mediated Amplification technology, proprietary to Grifols.
Subsequently, the tests were validated in respiratory samples in the Grifols-Progenika laboratories in Bilbao, which have extensive experience in the development and validation of molecular diagnostic tools in any type of clinical sample.
“All of Grifols’ talent gave their complete dedication to develop, produce and validate this test in record time, an exceptional example of teamwork. We are very proud of the effort and commitment of our collaborators during these unprecedented times of crisis,” said Raimon Grifols Roura, Grifols co-CEO.
Grifols, with more than 100 years of history, is a global leader in diagnostic solutions and a standard in blood and plasma donation safety in countries such as the U.S. and Japan.
Bio-Rad Receives FDA Emergency Use Authorization for Droplet Digital PCR SARS-CoV-2 Test Kit
4 May 2020
HERCULES, Calif., 4 May 2020 -- Bio-Rad Laboratories Inc., a global leader of life science research and clinical diagnostic products, today announced that its SARS-CoV-2 Droplet Digital PCR (ddPCR) test kit has been granted Emergency Use Authorization (EUA) by the U.S. Food and Drug Administration (FDA). The SARS-CoV-2 Droplet Digital PCR (ddPCR) test runs on Bio-Rad's QX200 and QXDx ddPCR systems.
The high sensitivity of the test makes it well suited to screening upper respiratory samples in patients with a low viral load, including individuals in the early stages of infection as compared to classical quantitative PCR tests. The test can also play an important role in surveillance by detecting minimal residual disease in people recovering from COVID-19 informing them if they are negative for the virus. Bio-Rad’s single-well SARS CoV-2 ddPCR test provides clinicians with a high degree of sensitivity that can significantly improve the accuracy of reported results.
According to the World Health Organization, regular, accurate testing of COVID-19 is a key component in the fight against the global pandemic.
"We are pleased to receive Emergency Use Authorization for our SARS-CoV-2 ddPCR test that offers high sensitivity in detecting infection of COVID-19 at an early stage," said Simon May, Senior Vice President of Bio-Rad’s Digital Biology Group. "We believe the test will be a powerful complement to current diagnostics, helping clinicians and public health officials accurately identify infected individuals in a timely manner. With the EUA, our test is now available to clinical labs in the U.S.," he said.
Thousands of hospitals and molecular testing labs in the U.S. and around the world have Bio-Rad’s QX200 and QXDx ddPCR systems installed and have the capacity to perform SARS-CoV-2 ddPCR testing. The SARS-CoV-2 ddPCR test represents the latest addition to Bio-Rad’s product offerings related to COVID-19. This is the second EUA Bio-Rad has been granted for COVID-19. Last week, the company received an EUA for a serology test to detect antibodies to the virus.
About Bio-Rad
Bio-Rad Laboratories, Inc. (NYSE: BIO and BIOb) is a global leader in developing, manufacturing, and marketing a broad range of innovative products for the life science research and clinical diagnostic markets. With a focus on quality and customer service for over 65 years, our products advance the discovery process and improve healthcare. Our customers are university and research institutions, hospitals, public health and commercial laboratories, biotechnology, pharmaceutical, as well as applied laboratories that include food safety and environmental quality. Founded in 1952, Bio-Rad is based in Hercules, California, and has a global network of operations with more than 8,100 employees worldwide. Bio-Rad had revenues exceeding $2.3 billion in 2019. For more information, please visit bio-rad.com.
BIOFIRE® Respiratory Panel 2.1 (RP2.1) with SARS-CoV-2 obtains FDA Emergency Use Authorization
4 May 2020
4 May 2020 -- bioMérieux, a world leader in the field of in vitro diagnostics, today announced that BioFire Diagnostics, its subsidiary specialized in syndromic infectious disease testing, has received Emergency Use Authorization by the U.S. Food and Drug Administration for the BIOFIRE® RP2.1 panel, which includes 22 pathogens that cause respiratory infections, including SARS-CoV-2 (the cause of COVID-19 disease).
The inclusion of SARS-CoV-2 in the BIOFIRE® RP2.1 panel allows healthcare providers to quickly identify patients with common respiratory pathogens, as well as those with COVID-19, using one simple test. The BIOFIRE® RP2.1 panel takes approximately 45 minutes and tests nasopharyngeal swab samples in transport media. It runs on the fully automated FILMARRAY® 2.0 and FILMARRAY® TORCH systems and is extremely easy to use.
bioMérieux is currently making every effort to scale up supply of the BIOFIRE® RP2.1 panel at its production facilities in Salt Lake City (Utah, USA). Test kits will be available for commercial distribution in the USA under EUA as well as internationally where regulatory approval allows. In a context of high demand for COVID-19 testing, bioMérieux expects to steadily build inventory levels to address the needs of the thousands of labs and healthcare professionals using one of the nearly 12,000 FILMARRAY® systems worldwide.
Andrea Kendell, ad interim CEO at BioFire Diagnostics said: “The BIOFIRE® RP2.1 panel represents our syndromic solution to this unprecedented COVID-19 pandemic. BioFire is dedicated to responding to a rapidly-evolving global epidemiological landscape with urgency and accuracy and this illustrates our contribution to bioMérieux’s public health mission. We believe the syndromic BIOFIRE® RP2.1 panel will play a key role now and in the upcoming respiratory season as healthcare providers and patients will likely face the regular group of respiratory pathogens as well as SARS-CoV-2”. Kendell further highlighted the need for BioFire’s syndromic approach by pointing out that emerging data suggest patients with COVID-19 may frequently be co-infected with other viruses and/or bacteria.
bioMérieux plans to submit the BIOFIRE® RP2.1 panel for FDA de novo clearance. Outside of the USA, bioMérieux is simultaneously pursuing CE Mark certification for the BIOFIRE® Respiratory 2.1plus (RP2.1plus) panel, which also includes detection of MERS-CoV, on an accelerated timeline.
The BIOFIRE® RP2.1 test is the third molecular test from bioMérieux in response to the COVID-19 pandemic. The ARGENE® SARS-CoV-2 R-GENE® test and the BIOFIRE® COVID-19 test were launched in March. These three complementary tests help meet the varying needs of bioMérieux diverse customers and patients throughout the world.
About Emergency Use Authorization
The BIOFIRE® RP2.1 test has not been FDA cleared or approved. This test has been authorized by FDA under an EUA for use by authorized laboratories only for the detection and differentiation of nucleic acid of SARS-CoV-2 from multiple respiratory viral and bacterial organisms.
This test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics 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.
Roche’s COVID-19 antibody test receives FDA Emergency Use Authorization and is available in markets accepting the CE mark
3 May 2020 - The serology test has a specificity greater than 99.8% and sensitivity of 100% (14 Days post-PCR confirmation). The high specificity of the test is crucial to determine reliably if a person has been exposed to the virus and if the patient has developed antibodies. Roche will provide high double-digit millions of tests already in May for countries accepting the CE mark and in the U.S. under Emergency Use Authorization, further ramping up capacities thereafter. The test is available on Roche’s cobas e analysers which are widely available around the world.
Basel, 03 May 2020 -- Roche today announced that the U.S. Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) for its new Elecsys® Anti-SARS-CoV-2 antibody test. The test is designed to help determine if a patient has been exposed to the SARS-CoV-2 virus and if the patient has developed antibodies against SARS-CoV-2. Roche has already started shipping the new antibody test to leading laboratories globally and will ramp up production capacity to high double-digit millions per month to serve healthcare systems in countries accepting the CE mark as well as the U.S.
“Thanks to the enormous efforts of our dedicated colleagues we are now able to deliver a high-quality antibody test in high quantities, so we can support healthcare systems around the world with an important tool to better manage the COVID-19 health crisis,” said Severin Schwan, CEO Roche Group. ”I am in particular pleased about the high specificity and sensitivity of our test, which is crucial to support health care systems around the world with a reliable tool to better manage the COVID-19 health crisis.”
“Our best scientists have worked 24/7 over the last few weeks and months to develop a highly reliable antibody test to help fight this pandemic,” said Thomas Schinecker, CEO Roche Diagnostics. “Roche is committed to helping laboratories deliver fast, accurate, and reliable results to healthcare professionals and their patients.”
Roche’s SARS-CoV2 antibody test, which has a specificity greater than 99.8% and 100% sensitivity (14 Days post-PCR confirmation), can help assess patients’ immune response to the virus. As more is understood about immunity to SARS-CoV-2, the test may help to assess who has built up immunity to the virus.
With extensive global manufacturing capabilities, Roche will be able to deliver high double-digit millions of tests per month. Hospitals and reference laboratories can run the test on Roche’s cobas e analysers, which are widely available around the world.
For countries with specific regulatory requirements, local approval timelines apply. In addition there may be other country-specific regulations, such as import requirements, which will determine when the test becomes available locally. Roche will work closely with the respective regional representatives to ensure we appropriately support local registration efforts.
About antibody testing
An antibody test, also called a serology test, is used to determine whether a person might have gained immunity against a pathogen or not. The human body makes antibodies in response to many illnesses. In the current situation of the COVID-19 pandemic, antibody tests need to be able to specifically detect antibodies against SARS-CoV-2 with no cross-reactivity to other similar coronaviruses, which could generate a false positive result and thus wrongly indicate potential immunity. A false positive result happens when a person receives a positive test result, when they should have received a negative result. False positives are particularly critical when we do not know how many people in a given population have had COVID-19. As of 24 April 2020, no study has evaluated whether the presence of antibodies to SARS-CoV-2 confers immunity to subsequent infection by this virus in humans.
About Elecsys Anti-SARS-CoV-2 serology test
Elecsys® Anti-SARS-CoV-2 is an immunoassay for the in-vitro qualitative detection of antibodies (including IgG) to Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) in human serum and plasma. Through a blood sample, the test, which is based on an in-solution double-antigen sandwich format, can detect antibodies to the new coronavirus causing COVID-19, which could signal whether a person has already been infected and potentially developed immunity to the virus. Based on the measurement of a total of 5272 samples, the Elecsys® Anti-SARS-CoV-2 assay has 99.81% specificity and shows no cross-reactivity to the four human coronaviruses causing common cold. This means it can lower the chance of false positives due to the detection of similar antibodies that may be present in an individual, but are specific for coronaviruses other than SARS-CoV-2. Elecsys® Anti-SARS-CoV-2 detected antibodies with 100% sensitivity in samples taken 14 days after a PCR-confirmed infection. The importance of specificity and sensitivity of a particular test will be dependent on its purpose and disease prevalence within a given population.
Hospitals and reference laboratories can run the test on Roche’s cobas e analysers, which are widely available around the world. These fully automated systems can provide SARS-CoV-2 test results in approximately 18 minutes for one single test, with a test throughput of up to 300 tests/hour, depending on the analyser.
About Roche
Roche is a global pioneer in pharmaceuticals and diagnostics focused on advancing science to improve people’s lives. The combined strengths of pharmaceuticals and diagnostics under one roof have made Roche the leader in personalised healthcare – a strategy that aims to fit the right treatment to each patient in the best way possible.
Roche is the world’s largest biotech company, with truly differentiated medicines in oncology, immunology, infectious diseases, ophthalmology and diseases of the central nervous system. Roche is also the world leader in in vitro diagnostics and tissue-based cancer diagnostics, and a frontrunner in diabetes management.
Founded in 1896, Roche continues to search for better ways to prevent, diagnose and treat diseases and make a sustainable contribution to society. The company also aims to improve patient access to medical innovations by working with all relevant stakeholders. More than thirty medicines developed by Roche are included in the World Health Organization Model Lists of Essential Medicines, among them life-saving antibiotics, antimalarials and cancer medicines. Moreover, for the eleventh consecutive year, Roche has been recognised as one of the most sustainable companies in the Pharmaceuticals Industry by the Dow Jones Sustainability Indices (DJSI).
The Roche Group, headquartered in Basel, Switzerland, is active in over 100 countries and in 2019 employed about 98,000 people worldwide. In 2019, Roche invested CHF 11.7 billion in R&D and posted sales of CHF 61.5 billion. Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan. For more information, please visit www.roche.com.
Reference: https://www.roche.com/media/releases/med-cor-2020-05-03.htm
Bio-Rad’s SARS-CoV-2 (COVID-19) Serology Test Granted FDA Emergency Use Authorization, the First Total Antibody Test to Receive EUA from the FDA
30 April 2020
HERCULES, Calif, 30 April 2020 — Bio-Rad Laboratories, Inc., a global leader of life science research and clinical diagnostic products, today announced that it was granted U.S. Food and Drug Administration (FDA) Emergency Use Authorization (EUA) for the company's SARS-CoV-2 Total Ab test, the first total antibody test receiving EUA from the FDA. Bio-Rad's blood-based immunoassay test can help clinicians identify if an individual has developed antibodies against SARS-CoV-2, the virus associated with COVID-19 disease. The test has also met the CE mark requirements for Europe.
Clinical evaluation of the SARS-CoV-2 Total Ab test has demonstrated diagnostic specificity of more than 99 percent and diagnostic sensitivity of 98 percent. Cross-reactivity testing demonstrated specificity of 100 percent with no reactivity against other interfering specimens including non-CoV-2 coronaviruses.
“We are pleased to have received FDA Emergency Use Authorization for our SARS-CoV-2 Total Antibody test to support COVID-19 diagnosis,” said Dara Wright, Bio-Rad Clinical Diagnostics Group EVP & President. “The total antibody approach enables detection of antibodies in the majority of patients eight days after the onset of symptoms, versus an IgG-only approach," she said.
The SARS-CoV-2 Total Ab test can be used manually or on an automated immunoassay platform, such as Bio-Rad's EVOLIS System, which offers high throughput processing and sample traceability.
To learn more about how Bio-Rad products are being used in the fight against COVID-19, please visit our Newsroom at bio-rad.com.
BIO-RAD and EVOLIS are trademarks of Bio-Rad Laboratories, Inc., in certain jurisdictions.
About Bio-Rad
Bio-Rad Laboratories, Inc. (NYSE: BIO and BIOb) is a global leader in developing, manufacturing, and marketing a broad range of innovative products for the life science research and clinical diagnostic markets. With a focus on quality and customer service for over 65 years, our products advance the discovery process and improve healthcare. Our customers are university and research institutions, hospitals, public health and commercial laboratories, biotechnology, pharmaceutical, as well as applied laboratories that include food safety and environmental quality. Founded in 1952, Bio-Rad is based in Hercules, California, and has a global network of operations with more than 8,100 employees worldwide. Bio-Rad had revenues exceeding $2.3 billion in 2019. For more information, please visit bio-rad.com.
Virclia COVID-19 serology asays now available
30 April 2020
30 April 2020 -- Vircell has developed and launched two new VirClia monotest kits for the detection of novel Coronavirus COVID-19 antibodies in human serum and plasma.
There are two kits available for the VirClia automated CLIA system which are able to detect IgG or IgM + IgA antibodies from serum or plasma to COVID-19 infections. The tests have been developed and evaluated in Spain and are CE marked. The assays are intended to be used to show antibody response and immune status following COVID-19 infection.
Key Points
• Two assays are available based on VirClia monotest technology
• The COVID-19 IgG and IgM + IgA detection assays are run as an automated method on VirClia systems.
• The assays use a mix of COVID-19 recombinant nucleocapsid and spike glycoprotein antigens
• Results available in 40 minutes to 2 hours
Product Codes
• COVID-19 VirClia IgG Monotest (24 tests) Ref: VCM097
• COVID-19 VirClia IgM+IgA Monotest (24 tests) Ref: VCM098
For more information visit: VirClia – CLIA monotest system for infectious disease serology testing
Reference: https://www.launchdiagnostics.com/virclia-covid-19-serology-assays-now-available/
Centene And Quest Diagnostics Team Up To Increase Access To COVID-19 Testing
29 April 2020 - Company to join forces with Quest Diagnostics to expand access to COVID-19 testing at critical safety net providers across the country
ST. LOUIS, April 29, 2020 -- Centene announced today a collaboration with Quest Diagnostics (NYSE: DGX), the world's leading provider of diagnostic information services, to increase access to real-time reverse transcription polymerase chain reaction (rRT-PCR) COVID-19 testing in critical areas of need across the country. Through this collaboration, Centene will facilitate the distribution of 25,000 Quest COVID-19 test kits each week to Federally Qualified Health Centers (FQHCs) in ten states or districts across the country.
"Testing is a critical part of containing the spread of COVID-19, and preventing future outbreaks," said Michael F. Neidorff, Chairman, President and CEO of Centene. "We need to ensure every community has access to the testing they need, especially the most vulnerable and underserved populations."
This collaboration leverages Centene's extensive network of critical safety net providers to ensure that testing capacity is routed to where it is needed most. As part of the collaboration, Centene will provide oversight and training to ensure test kits are received and processed efficiently. Distribution of kits will begin May 4th, and Quest Diagnostics will conduct the COVID-19 testing through its network of laboratories across the United States.
"COVID-19 testing is critically needed in underserved communities and our collaboration with Centene will help ensure that necessary and life-saving diagnostic testing is available to address that need," said Steve Rusckowski, Chairman, CEO and President of Quest Diagnostics. "We are committed to serving the testing needs of Federally Qualified Health Centers during the COVID-19 pandemic."
This initiative is part of a broader set of actions that Centene is taking with key providers and stakeholders across the country to support safety net providers in addressing the pandemic.
"Gaining access to COVID-19 tests has been a challenge," says Dr. Michael W. Brooks, The Family Health Centers of Georgia's President & CEO. "This collaboration with Centene and Quest ensures we can keep fighting to make sure people are not left behind." The Family Health Centers of Georgia serves more than 29,000 patients annually; 87% of whom are African American and 32% are uninsured. Brooks continues, "We are pleased to be able to offer these additional testing opportunities to our communities."
About Centene Corporation
Centene Corporation, a Fortune 100 company, is a leading multi-national healthcare enterprise that is committed to helping people live healthier lives. The Company takes a local approach – with local brands and local teams - to provide fully integrated, high-quality, and cost-effective services to government-sponsored and commercial healthcare programs, focusing on under-insured and uninsured individuals. Centene offers affordable and high-quality products to nearly 1 in 15 individuals across the nation, including Medicaid and Medicare members (including Medicare Prescription Drug Plans) as well as individuals and families served by the Health Insurance Marketplace, the TRICARE program, and individuals in correctional facilities. The Company also serves several international markets, and contracts with other healthcare and commercial organizations to provide a variety of specialty services focused on treating the whole person. Centene focuses on long-term growth and the development of its people, systems and capabilities so that it can better serve its members, providers, local communities, and government partners.
Centene uses its investor relations website to publish important information about the company, including information that may be deemed material to investors. Financial and other information about Centene is routinely posted and is accessible on Centene's investor relations website, http://www.centene.com/investors.
About Quest Diagnostics
Quest Diagnostics empowers people to take action to improve health outcomes. Derived from the world's largest database of clinical lab results, our diagnostic insights reveal new avenues to identify and treat disease, inspire healthy behaviors and improve health care management. Quest annually serves one in three adult Americans and half the physicians and hospitals in the United States, and our 47,000 employees understand that, in the right hands and with the right context, our diagnostic insights can inspire actions that transform lives. www.QuestDiagnostics.com.
About COVID-19 Testing by Quest Diagnostics
Quest Diagnostics is at the forefront of 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 aiding the diagnosis of COVID-19 and immune response. Our COVID-19 test services are based on tests that have received or are expected to receive FDA emergency use authorization and which also meet our high standards for quality. We provide data on COVID-19 testing to various federal and state public health authorities, including the Centers for Disease Control and Prevention, and participate in studies with government and private institutions, aiding COVID-19 public health response and research. Through our team of dedicated phlebotomists, couriers, air fleet team, and laboratory professionals, Quest Diagnostics won't stop until quality testing is broadly available to patients and communities across the United States.
For more information about the latest developments with our COVID-19 testing, visit: newsroom.questdiagnostics.com/COVIDTestingUpdates
Abbott receives Health Canada authorization under interim order to use FreeStyle® Libre system for hospitalized patients during COVID-19 pandemic
27 April 2020 - New authorization from Health Canada allows FreeStyle Libre system to be used by frontline healthcare workers in hospitals to remotely monitor patients' glucose status to minimize exposure during COVID-19 and preserve use of personal protective equipment (PPE). Abbott will donate 3,000 FreeStyle Libre sensors to Canadian hospitals in need to help accelerate access to technology.
MISSISSAUGA, Ontario, April 27, 2020 -- Abbott announced today that Health Canada authorized use of FreeStyle Libre system, the world's leading sensor-based glucose monitoring technology, in hospital setting during the COVID-19 pandemic. This will permit frontline healthcare workers to remotely monitor patients' glucose status and glucose history. In addition, Abbott will donate 3,000 FreeStyle Libre sensors to ensure hospitals in need have immediate access to the technology.
"The in-hospital challenges presented by the COVID-19 pandemic have forced frontline workers to think creatively about how to safeguard against unnecessary exposure between themselves and patients, especially people with diabetes," said Bruce Perkins, M.D., Director, Leadership Sinai Centre for Diabetes and Clinician-Scientist, University of Toronto. "Having access to sensor-based glucose monitoring technology in hospitals is one such creative solution to significantly help healthcare workers closely monitor glucose status while limiting direct contact and preserving valuable personal protective equipment."
With a one-second scan using a reader or smartphone over the FreeStyle Libre sensor worn on the back of the upper arm, glucose readings are measured every minute and the user can get current glucose measurements, historical trends and patterns, and arrows showing where glucose levels are going without having to fingerstick. At the same time, physicians will receive glucose data and actionable information remotely to help make important treatment decisions through LibreView, a secure, cloud-based diabetes management system available at no cost to healthcare providers and users. Recent studies showed that users of the FreeStyle Libre system have improved glucose control, decreased time in hyperglycemia and hypoglycemia as well as reduced hospitalizations and HbA1C levels.
"Providing frontline healthcare workers with technology and equipment is critical in the fight against COVID-19," said Marie-Flore Nabor, general manager of Abbott's diabetes care business in Canada. "Health Canada's quick action to make FreeStyle Libre sensors available in hospitals will help frontline healthcare workers better monitor and manage the glucose levels of patients and, at the same time, help limit COVID-19 exposure."
More than 15% of Canadians diagnosed with COVID-19 are hospitalized, according to Health Canada. The use of the FreeStyle Libre system in Canadian hospitals received support from the country's leading diabetes organizations, including Diabetes Canada and Diabète Quebec.
For more information about using the FreeStyle Libre system in the hospital, please contact 1-855-421-6177.
About FreeStyle Libre Portfolio
As the #1 sensor-based glucose monitoring system used worldwide1, Abbott's FreeStyle Libre portfolio has changed the lives of more than 2 million people across 46 countries by providing breakthrough technology that is accessible. Abbott has also secured partial or full reimbursement for the FreeStyle Libre system in 36 countries, including Canada, Japan, the United Kingdom, and the U.S. For more information, please visit www.freestylelibre.ca.
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.
Connect with us at www.abbott.com, on LinkedIn at www.linkedin.com/company/abbott-/, on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews and @AbbottGlobal.
Indications and Important Safety Information
The FreeStyle Libre Flash Glucose Monitoring System Reader ("Reader")/ FreeStyle LibreLink app ("App") when used with a FreeStyle Libre Flash Glucose Monitoring System Sensor ("Sensor") is indicated for measuring interstitial fluid glucose levels in adults aged 18 years and older (with or without diabetes) in all hospital and all professional healthcare settings including patients receiving medical intervention/therapy for COVID-19. In home setting, FreeStyle Libre system is indicated for measuring interstitial fluid glucose levels in adults aged 18 years and older with diabetes. The Reader/App and Sensor are designed to replace blood glucose testing in the self-management of diabetes, including dosing of insulin. Treatment decisions should not be based on real-time Sensor glucose readings alone and instead should consider all the information on the results screen.
Ortho Launches Second COVID-19 Antibody Test With 100% Specificity
25 April 2020 - Ortho announces FDA Emergency Use Authorization received for its second COVID-19 antibody test. Similar to Ortho's total COVID-19 antibody test, Ortho's IgG test demonstrated 100% specificity and can be used to support decisions for getting people back to work. Ortho has already begun shipping its antibody test to customers in highly impacted geographies and plans to manufacture several million COVID-19 antibody test each month. Both tests can run on Ortho's VITROS® platform already installed in more than 1,000 hospitals and labs across the U.S.
Raritan, NJ, 25 April 2020 -- Ortho Clinical Diagnostics, a global leader of in vitro diagnostics with a rich history of bringing critical tests for infectious diseases to market, today introduced and announced the U.S. Food and Drug Administration (FDA) granted Emergency Use Authorization to its second COVID-19 antibody test—the VITROS® Immunodiagnostic Products Anti-SARS-CoV-2 IgG Test (COVID-19 IgG antibody test). This test is one of only a handful of antibody tests to be granted Emergency Use Authorization.
Ortho previously received FDA Emergency Use Authorization for its COVID-19 total antibody test on April 14, 2020. Of note, both tests have 100% specificity.
“The observed 100% specificity with Ortho’s VITROS SARS-CoV-2 tests allows an extremely high level of confidence so that people will not be identified as having an immune response to the virus when in fact they do not,” said Christopher D. Hillyer, MD, President and CEO, New York Blood Center. “Statistically, the chance of error rises dramatically even with a very small decline from 100% in specificity, given our understanding of the prevalence of the COVID-19 virus today.”
“Ortho is proud that both of our COVID-19 total and IgG tests are achieving 100% specificity,” said Chris Smith, Ortho Clinical Diagnostics’ Chief Executive Officer. “During this health crisis, good is simply not good enough. This high level of specificity is a testament to Ortho’s strong belief that every test is a life.”
Ortho’s total antibody test’s launch to market in the U.S. was announced on April 3, 2020. It detects all COVID-19 related antibodies, including IgM, which appears in the early, acute stage of infection, and helps determine the onset of a patient’s immune response by monitoring all antibodies generated through disease progression. Ortho’s newest test detects only the IgG antibody which appears in a patient’s blood in the later phase of the infection and remains elevated even after recovery.
Both of Ortho’s tests help health care professionals understand if a patient has been exposed to and has developed antibodies to the COVID-19 virus.
“COVID-19 is a novel virus and is being both researched and treated in real-time,” said Michael P. Busch, M.D., Ph.D., director, Vitalant Research Institute. “One of the main areas of research is identifying the time and level certain antibodies appear in the blood, which can help confirm whether a patient has been infected and whether or not they have developed antibodies. Ortho’s tests, which can detect both IgG and total antibodies, will help further our understanding of both infection and immunity to facilitate proper clinical guidance.”
The tests run on Ortho’s high-throughput, fully automated analyzers including its flagship VITROS® XT 7600 Integrated System, the VITROS® 3600 Immunodiagnostic System, the VITROS® 5600 Integrated System and will soon be available on VITROS® ECi/ECiQ Immunodiagnostic Systems. VITROS Systems, already installed in more than 1,000 hospitals and reference labs in the U.S., are self-contained and do not require an external water source to run, offering labs placement flexibility.
“Both tests run on the widely used Ortho VITROS platform and the results will paint a vivid picture of a patient’s immune response status,” said Chockalingam Palaniappan, Ph.D., chief innovation officer, Ortho Clinical Diagnostics. “Clinicians will now have invaluable information that will allow them to make decisions about the propriety of a patient returning to work. This is critical information for first responders, health care professionals and other essential personnel working with affected populations.”
Ortho plans to manufacture several million COVID-19 IgG antibody tests each month.
Questions from laboratories, healthcare providers, or government officials regarding the COVID-19 antibody test can be directed to: OrthoCOVID19Test@orthoclinicaldiagnostics.com.
Ortho’s COVID-19 IgG antibody tests are designed and solely intended to be performed by laboratory professionals and cannot be directly used by patients as they are not for home use. Patients should consult with their health care provider to discuss antibody testing and back-to-work options.
Vela Diagnostics Receives CE mark for COVID-19 Detection Test
24 April 2020
Hamburg, Germany, 24 April 2020 – Vela Diagnostics announced today that the manual version of the ViroKey™ SARS-CoV-2 RT-PCR Test has received the CE mark for in vitro diagnostic use. The test detects SARS-CoV-2 in patients suspected of COVID-19 by their healthcare providers.
The ViroKey™ SARS-CoV-2 RT-PCR Test is a probe-based reverse transcription PCR Test that detects SARS-CoV-2 by targeting conserved regions of the SARS-CoV-2 genome. The manual version of the assay enables quick adoption of the test by laboratories with existing Applied Biosystems 7500 Fast Dx (ABI 7500 Fast Dx) instruments.
“The CE mark enables Vela Diagnostics to expand COVID-19 testing capacity in Europe, where there is an urgent need to identify individuals infected with SARS-CoV-2,” said Sam Dajani, acting CEO and Chairman of the Board.
Vela Diagnostics has also developed an automated version of the test which is slated for CE-IVD registration in April 2020. The automated ViroKey™ SARS-CoV-2 RT-PCR Test is optimized for a workflow consisting of the Sentosa™SX101 instrument, in conjunction with the Sentosa™ SA201 instrument or the ABI 7500 Fast Dx.
About Vela Diagnostics
Vela Diagnostics is a leading provider of an automated IVD Next–Generation Sequencing (NGS) workflow in the global diagnostics market. VELA’s real-time PCR and NGS applications are available on an integrated Sentosa™ platform; this provides a unique ability to leverage one system for two workflows, while carrying out tests for various targets in order to answer current clinical and research questions, as well as to drive laboratory operational efficiency.
All Sentosa™ products listed above are by Vela Diagnostics. For more information, visit www.veladx.com.
Quidel’s LYRA® Direct SARS-COV-2 Assay submitted for Emergency Use Authorization for molecular detection of COVID-19, without extraction step
22 April 2020
SAN DIEGO, 22 April 2020 -- Quidel Corporation (“Quidel”), a provider of rapid diagnostic testing solutions, cellular-based virology assays and molecular diagnostic systems, announced today that Quidel has applied for an Emergency Use Authorization (EUA) for the Lyra® Direct SARS-CoV-2 Assay from the Food and Drug Administration (FDA) to allow direct sample processing. The assay will be run on the same six different instruments as the Lyra® SARS-CoV-2 Assay.
Lyra® Direct Removes RNA Extraction Processing Step, Removes Supply Bottleneck
Under the new EUA, the Lyra® Direct SARS-CoV-2 Assay no longer requires an upfront sample extraction. The Lyra® Direct SARS-CoV-2 Assay uses a reformulated buffer that replaces the extraction step with a simple 10-minute heat step, saving approximately 50 minutes in processing time. The assay retains its versatility in that it is still capable of running on any of six thermocyclers (Applied Biosystems 7500 Standard®, Applied Biosystems 7500 Fast®, Bio-Rad CFX96 Touch®, Qiagen Rotor-Gene Q®, Roche LightCycler® 480, and Thermo Fisher QuantStudio 7 Pro®).1
Quidel is manufacturing approximately 500,000 tests per week and has begun shipping the improved product to its customers. The assay is currently available for sale in the United States while under EUA review. The Lyra® Direct SARS-CoV-2 Assay can be purchased by laboratory professionals through Quidel directly, or through their Cardinal Health representative.
About Quidel Corporation
Quidel Corporation serves to enhance the health and well-being of people around the globe through the development of diagnostic solutions that can lead to improved patient outcomes and provide economic benefits to the healthcare system. Marketed under the Sofia®, QuickVue®, D3® Direct Detection, Thyretain®, Triage® and InflammaDry® leading brand names, as well as under the new Solana®, AmpliVue®and Lyra® molecular diagnostic brands, Quidel’s products aid in the detection and diagnosis of many critical diseases and conditions, including, among others, influenza, respiratory syncytial virus, Strep A, herpes, pregnancy, thyroid disease and fecal occult blood. Quidel's recently acquired Triage® system of tests comprises a comprehensive test menu that provides rapid, cost-effective treatment decisions at the point-of-care (POC), offering a diverse immunoassay menu in a variety of tests to provide diagnostic answers for quantitative BNP, CK-MB, d-dimer, myoglobin, troponin I and qualitative TOX Drug Screen. Quidel’s research and development engine is also developing a continuum of diagnostic solutions from advanced immunoassay to molecular diagnostic tests to further improve the quality of healthcare in physicians’ offices and hospital and reference laboratories. For more information about Quidel’s comprehensive product portfolio, visit quidel.com.
LabCorp COVID-19 At-Home Test Kit Receives FDA Emergency Use Authorization
21 April 2020 - Initial Distribution Prioritized for Frontline Healthcare Workers and First Responders
BURLINGTON, N.C., Apr. 21, 2020 -- LabCorp, a leading global life sciences company that is deeply integrated in guiding patient care, today announced that it has received an Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA). The EUA permits nasal swab specimens to be collected at home using the Pixel by LabCorp™ COVID-19 test home collection kit if recommended by a healthcare provider after completing a COVID-19 questionnaire.
LabCorp’s COVID-19 at-home test kit is part of the company’s continued commitment to increase the supply and availability of tests for healthcare workers and first responders who have symptoms consistent with COVID-19. Enabling individuals to self-administer sample collection will help prevent the risk of transmitting the virus to others and reduces the demand for personal protective equipment (PPE) as the tests do not require a clinician to perform the test collection.
“LabCorp continues to develop new ways to help patients and healthcare providers fight the COVID-19 crisis through our leading testing capabilities and deep scientific and research expertise,” said Adam Schechter, president and CEO of LabCorp. “Our at-home collection kits are designed to make it easier and safer to test healthcare workers and first responders during this important time.”
The kits will be offered through the company’s Pixel by LabCorp platform and initially be made available to healthcare workers and first responders who may have been exposed to COVID-19 or may be symptomatic. LabCorp intends to make COVID-19 self-collection kits available to consumers in the coming weeks. Future updates about the self-collection kits can be found on LabCorp’s COVID-19 microsite.
LabCorp’s COVID-19 test home collection kit has not been FDA cleared or approved, has been authorized 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. The test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostic tests for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.
About LabCorp
LabCorp, an S&P 500 company, is a leading global life sciences company that is deeply integrated in guiding patient care, providing comprehensive clinical laboratory and end-to-end drug development services. With a mission to improve health and improve lives, LabCorp delivers world-class diagnostics solutions, brings innovative medicines to patients faster, and uses technology to improve the delivery of care. LabCorp reported revenue of more than $11.5 billion in 2019.
To learn more about LabCorp, visit www.LabCorp.com, and to learn more about LabCorp’s Covance Drug Development business, visit www.Covance.com.
Vela Diagnostics’ COVID-19 Test Receives Provisional Authorisation From the Health Sciences Authority in Singapore
16 April 2020 - Vela Diagnostics’ COVID-19 test receives provisional authorisation from the Health Sciences Authority in Singapore
Singapore, April 16, 2020 - Vela Diagnostics announced today that the ViroKey™ SARS-CoV-2 RT-PCR Test has received provisional authorisation from the Health Sciences Authority in Singapore. This allows the test to be supplied to healthcare institutions, private hospitals, medical clinics and clinical laboratories licensed under the Private Hospitals and Medical Clinics (PHMC) Act in Singapore.
SARS-CoV-2 causes COVID-19. The ViroKey™ SARS-CoV-2 RT-PCR Test is a probe-based reverse transcription PCR Test that detects SARS-CoV-2 by targeting conserved regions of the SARS-CoV-2 genome. The manual version of the assay enables quick adoption of the test by laboratories with existing Applied Biosystems 7500 Fast Dx (ABI 7500 Fast Dx) instruments. For high throughput testing, Vela Diagnostics has also developed a research use only (RUO) automated version of the test which is optimized for a workflow consisting of the Sentosa™SX101 instrument, in conjunction with the Sentosa™ SA201 instrument or the ABI 7500 Fast Dx.
“Timely detection of individuals infected with SARS-CoV-2 will save lives and curb the spread of the virus in this global pandemic,” said Sam Dajani, Acting CEO and Chairman of the Board.
The test is also pending CE marking.
About Vela Diagnostics
Vela Diagnostics, headquarted in Singapore, is a leading provider of an automated IVD Next–Generation Sequencing (NGS) workflow in the global diagnostics market. VELA’s real-time PCR and NGS applications are available on an integrated Sentosa™ platform; this provides a unique ability to leverage one system for two workflows, while carrying out tests for various targets in order to answer current clinical and research questions, as well as to drive laboratory operational efficiency. All Sentosa™ products listed above are by Vela Diagnostics. For more information, visit www.veladx.com.
Abbott launches third COVID-19 test, a laboratory-based antibody blood test that will ship in the U.S. starting tomorrow
15 April 2020 - This adds to Abbott's previously announced COVID-19 molecular tests: the m2000™ lab-based test and ID NOW™ rapid point-of-care test. New antibody test will run on Abbott's ARCHITECT® i1000SR and i2000SR laboratory instruments and will expand to its new Alinity™ i system. Abbott begins shipping tomorrow and intends to distribute 4 million tests in April, ramping to 20 million in the U.S. per month in June and beyond.
ABBOTT PARK, Ill., April 15, 2020 -- Abbott announced today the launch of its third COVID-19 test, a lab-based serology blood test for the detection of the antibody, IgG, that identifies if a person has had the novel coronavirus (COVID-19). Antibody testing is an important next step to tell if someone has been previously infected. It will provide more understanding of the virus, including how long antibodies stay in the body and if they provide immunity. This type of knowledge could help support the development of treatments and vaccines.
This antibody test adds to Abbott's existing COVID-19 tests that are already being used, including its m2000™ molecular laboratory system and its ID NOW™ molecular point-of-care device.
"We continue to contribute in a significant and meaningful way by providing new solutions across our diagnostics testing platforms," said Robert B. Ford, president and chief executive officer, Abbott. "I'm extremely proud of the many Abbott people who are working around the clock to get as many tests as we can to healthcare workers and patients."
Antibody tests to expand testing and help healthcare workers
While molecular testing detects whether someone has the virus, antibody tests determine if someone was previously infected.
Abbott's SARS-CoV-2 IgG test identifies the IgG antibody, which is a protein that the body produces in the late stages of infection and may remain for up to months and possibly years after a person has recovered. Abbott's IgG antibody test will initially be available on its ARCHITECT® i1000SR and i2000SR laboratory instruments*. More than 2,000 of these instruments are in use in U.S. laboratories. These instruments can run up to 100-200 tests per hour.
Abbott is making the test available as part of the U.S. Food and Drug Administration (FDA) notification without an Emergency Use Authorization (EUA) pathway outlined in Policy for Diagnostic Tests for Coronavirus Disease-2019 during the Public Health Emergency. Additionally, Abbott plans to file an EUA submission with the FDA and plans to CE Mark to the IVD Directive (98/79/EC) in the European Union.
Abbott is significantly scaling up its manufacturing for antibody testing and is expecting to immediately ship close to 1 million tests this week to U.S. customers, and will ship a total of 4 million tests in total for April. The company is ramping up to 20 million tests in the U.S. in June and beyond as it expands the tests to run on its new Alinity™ i system. Abbott also will be expanding its laboratory antibody testing to the detection of the antibody, IgM, in the near future.
About Abbott
Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 107,000 colleagues serve people in more than 160 countries.
BGI’s Real-Time SARS-CoV-2 RT-PCR Test to Hit Australian Market with TGA Approval
14 April 2020
Brisbane, Australia, 14 April 2020 – BGI Group (BGI) is pleased to announce today that its subsidiary BGI Health (AU) Company Pty Ltd (BGI Health) received expedited TGA approval on April 10 to supply its Real-Time SARS-CoV-2 RT-PCR test to the local Australian market. As at 6:00am on 14 April 2020, there have been 6,366 confirmed cases of COVID-19 in Australia, resulting in 61 fatalities. The addition of BGI’s test kits will provide significant support for Australia’s fast and accurate screening capability amid the pandemic.
“In light of the escalating outbreak globally and logistics challenges, BGI is working hard to manage and expand our resources to help meet the increasing demands. The first batch of kits has arrived in Australia, with a plan for continuous local supply underway.” said Dr. Bicheng Yang, Director of BGI Australia and BGI Health. She added: “Virus knows no boundary. BGI is committed to providing our solution through the clinically validated testing to the broader Australian community to support the ongoing effort of the Australian government, medical and research institutions, and healthcare organizations to fight COVID-19. We are also keen to establish collaborative ties and work with the Australian life science community to facilitate the research”. BGI has also joined Minderoo Foundation’s COVID-19 initiative since last week.
The global genomic giant BGI Group’s highly-sensitive test can return results within three hours. The kit detects the RNA of SARS-CoV-2 extracted from upper respiratory tract swabs or lower respiratory tract sputum or bronchoalveolar lavage fluids. Intended as a Laboratory Test rather than a Point-of-Care Test, it has below features for healthcare professionals:
- High sensitivity: Limit of detection as low as 100 viral copies/mL
- High specificity: No cross-reactivity with 54 human respiratory pathogens
- Fast TAT: Sample to result in 3 hours
- Ease of use: All-inclusive with pre-mixed reaction reagents
- Easy interpretation: Analysis of one target with well-defined controls
BGI’s SARS-CoV-2 RT-PCR test has received emergency approval from China’s National Medical Products Administration (NMPA) on January 26, followed by the European CE-IVD marking on February 24, the U.S. FDA-issued Emergency Use Authorization (EUA) on March 26 as well as Japan’s marketing approval on March 27. As of April 9, BGI has reached a daily manufacturing capacity of 2 million reactions, and is actively scaling up to meet the rapidly-growing global demand. BGI has manufactured over 10 million tests, and performed over 600,000 SARS-CoV-2 tests in its own central laboratories in China and is distributing its SARS-CoV-2 detection kits to more than 80 countries and regions around the clock.
BGI Group has also presented its Huo-Yan Laboratory solutions to its international customers and partners. Huo-Yan (Fire-Eye) is an emergency test lab empowered by BGI’s RT-PCR kits and automated nucleic acid extraction systems such as MGISP-960, to enable mass diagnoses and identification of infections, release of recovered patients, and screening of close contacts and high-risk groups. The first Huo-Yan Laboratory constructed outside China was launched in the United Arab Emirates on March 29, immediately followed by the second facility in Brunei on March 30. Construction and discussions for additional Huo-Yan Laboratories are currently underway in more than 10 countries and regions.
About BGI Group
Headquartered in Shenzhen, China, BGI Group was founded in 1999 with the vision of using genomics to benefit humanity and has since become one of the largest genomics organizations in the world.
About BGI Australia
BGI Australia was established in 2016 in Brisbane, Queensland as BGI Group’s strategic research hub for the Asia Pacific region and is dedicated to facilitating cutting-edge research in healthcare, agriculture, environment and other related areas in the ANZ region.
Merck Supports Jenner Institute to Reach First Milestone in Covid-19 Vaccine Manufacturing
14 April 2020 - Recently developed manufacturing platform allows large-scale manufacturing. Joint team reduced process development time to two months from a year – a critical step to manufacturing Covid-19 vaccine at scale. “We have brought the future of vaccine manufacturing to the present,” says Udit Batra, member of the Merck Executive Board and CEO, Life Science.
Darmstadt, Germany, April 14, 2020 — Merck, a leading science and technology company, and The Jenner Institute today announced that the Jenner Institute has laid the foundation for large-scale production of its Covid-19 vaccine candidate, ChAdOx1 nCoV-19.
With patients enrolled for clinical trials for this vaccine, rapid development of the large-scale manufacturing process is a critical step in quickly and safely delivering it from the lab to patients.
“We have brought the future of vaccine manufacturing to the present,” said Udit Batra, member of the Merck Executive Board and CEO, Life Science. “This is an important step in treating Covid-19 and other diseases that impact global public health. This work marks a milestone in the vaccine manufacturing development journey, as clinical testing continues to advance.”
Tapping into Merck’s previous work provided a solid head start for plans to scale-up the manufacture of Jenner’s Covid-19 vaccine candidate. Developing the manufacturing process itself would normally take at least six months to a year, but in just two months’ time, Merck supported the Jenner team and their collaborators to evaluate the existing manufacturing platform for use with the new vaccine candidate, and improved critical process steps.
Over the last two years, Merck’s collaboration with The Jenner Institute has led to the development of a rapid, scalable platform following good manufacturing practices and using disposable technologies for the Institute’s adenovirus platform. While the initial work was developed with a rabies vaccine candidate, the platform was then validated with different adenovirus constructs aiming at accelerating future vaccine development and manufacturing. Speed is a major challenge when facing a new outbreak such as this unprecedented Covid-19 pandemic. The organizations first announced their partnership to develop more robust and scalable vaccine manufacturing processes in April 2018.
“In an unprecedented time period, The Jenner Institute’s team was able to develop the 10-liter manufacturing scale process based on the previously generated platform with Merck, preparing us for the next round of scale-up efforts,” said Dr. Sandy Douglas, vaccine manufacturing scale-up project lead at The Jenner Institute. “Industry collaborations, such as ours with Merck, showcase the value that these efforts have in accelerating our response to outbreaks and pandemics and quickly delivering lifesaving vaccines to benefit the global population.”
About the Jenner Institute
The Jenner Institute was founded in November 2005 to develop innovative vaccines against major global diseases. Uniquely it focuses both on diseases of humans and livestock and tests new vaccine approaches in parallel in different species. A major theme is translational research involving the rapid early-stage development and assessment of new vaccines in clinical trials.
The Institute comprises the research activities of more than 30 Jenner Investigators who head leading research groups spanning human and veterinary vaccine research and development. Together the Institute Investigators comprise one of the largest non-profit sector research and development activities in vaccinology.
Jenner Institute Investigators, through the support of many funders, are developing new vaccine candidates against major global infectious diseases. New vaccines against malaria, tuberculosis and HIV are currently in field trials in the developing world. Research is also underway on livestock vaccines against foot and mouth disease, avian influenza, bovine tuberculosis and other major causes of economic loss.
The Institute is a partnership between the University of Oxford and The Pirbright Institute and is the successor to the former Edward Jenner Institute for Vaccine Research. The Institute is supported by the Jenner Vaccine Foundation, a UK registered charity and advised by the Jenner Institute Scientific Advisory Board.
About Merck
Merck, a leading science and technology company, operates across healthcare, life science and performance materials. Around 56,000 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 – Merck is everywhere. In 2018, Merck KGaA, Darmstadt, Germany generated sales of €14.8 billion in 66 countries.
Scientific exploration and responsible entrepreneurship have been key to Merck’s technological and scientific advances. This is how Merck has thrived since its founding in 1668. The founding family remains the majority owner of the publicly listed company. Merck holds the global rights to the Merck name and brand. The only exceptions are the United States and Canada, where the business sectors of Merck operate as EMD Serono in healthcare, MilliporeSigma in life science, and EMD Performance Materials.
Ortho’s Total Antibody Test for COVID-19 Receives Emergency Use Authorization from FDA
14 April 2020
Raritan, NJ, 14 April 2020 -- The U.S. Food and Drug Administration (FDA) today announced it granted Emergency Use Authorization to Ortho Clinical Diagnostics’ total antibody assay for COVID-19—the VITROS® Immunodiagnostic Products Anti-SARS-CoV-2 Total Reagent Pack and Calibrators. This test is one of the first high-throughput, automated COVID-19 antibody tests to be granted Emergency Use Authorization.
Across the globe, health care professionals, researchers, and government officials are racing to find solutions to better manage COVID-19 and prevent it from impacting additional lives. Ortho’s COVID-19 total antibody test can help determine who can responsibly be permitted to go back to work by aiding in the identification of currently infected or previously exposed individuals who may have developed immunity.
“The COVID-19 pandemic continues to impact individuals, families, and communities around the world,” said Chris Smith, chief executive officer, Ortho Clinical Diagnostics. “Ortho is proud to be working toward large-scale solutions that will help people return to work, reducing the strain on both employees and the economy as a whole. Our focus on improving patients’ lives through diagnostics led us to rapidly develop this test, providing the one of the key resources needed for diagnosing and treating COVID-19. We remain committed to helping laboratories deliver fast, accurate, reliable results to healthcare professionals, patients and the researchers developing the long-term, sustainable management of this disease.”
The tests can be run on Ortho’s flagship laboratory analyzer, the VITROS® XT 7600 Integrated System, the VITROS® 3600 Immunodiagnostic System, the VITROS® 5600 Integrated System and will soon be available on VITROS® ECi/ECiQ Immunodiagnostic Systems (System based on country availability). VITROS Systems, already installed in more than 1,000 hospitals and reference labs in the U.S., are self-contained and do not require an external water source to run, offering labs placement flexibility.
A limited quantity of tests kits have already been shipped to areas of highest priority. Ortho will be in full production in the coming weeks and plans to manufacture several million SARS-CoV-2 antibody tests over the next month, with rapid production expansion following thereafter.
Following Ortho’s April 3 launch of the test under the FDA’s notification pathway for serology tests, Ortho further worked with the FDA to secure additional review of the data under its Emergency Use Authorization pathway, which allows the FDA to expedite review and authorization of SARS-CoV-2 diagnostic tests to rapidly expand testing capacity during the COVID-19 public health emergency.
The VITROS® Anti-SARS-CoV-2 antibody tests are designed and solely intended to be performed by laboratory professionals and cannot be directly used by patients as they are not for home use.
Questions from laboratories, healthcare providers, government, or media regarding the COVID-19 antibody test can be directed to: OrthoCOVID19Test@orthoclinicaldiagnostics.com.
BD Announces Second FDA Emergency Use Authorization, CE Mark for New COVID-19 Molecular Diagnostic for Global Use
13 April 2020 - New Test Uses BD MAX™ System to Augment Supply from Existing Collaborations; Test Results in Under Three Hours
FRANKLIN LAKES, N.J., April 13, 2020 -- BD (Becton, Dickinson and Company), a leading global medical technology company, today announced that the U.S. Food and Drug Administration (FDA) has granted Emergency Use Authorization (EUA) for an additional molecular diagnostic test for COVID-19 that can return results in two to three hours. The new test also has been CE marked to the IVD Directive (98/79/EC).
The test, which is run on the BD MAX™ System, provides additional testing capacity for COVID-19 in the United States and in countries that recognize the CE Mark to test patients and health care workers. The test is in addition to the other tests already available on the BD MAX™ System from collaborations with BioGX and CerTest and is based on the CDC assay design. The BD MAX™ System, a molecular diagnostic platform, is already in use at thousands of laboratories worldwide, and each unit is capable of analyzing hundreds of samples over a 24-hour period.
"The new BD COVID-19 test for the BD MAX™ System will help increase availability of these much-needed tests around the world," said Dave Hickey, president of Integrated Diagnostics for BD. "We continue to work towards a full portfolio of testing options to give health care workers choice and access to the right test for the right situation."
The majority of BD MAX™ Systems are installed in hospital laboratories, reducing the added time and complexity of needing to send samples to a reference lab. The system is fully automated, reducing the opportunity for human error and increasing the speed to result, and can process 24 samples simultaneously. The assay is based on the same viral RNA targeting sequences and real-time PCR detection method as the test developed by the U.S. Centers for Disease Control and Prevention (CDC).
Hospitals and laboratories that use a BD MAX™ System can order tests through their BD sales representative.
The BD SARS-CoV-2 Reagent Kit for BD MAX™ System has been CE marked to the IVD Directive (98/79/EC), but it has not been cleared or approved by FDA. The test has been authorized by FDA under an EUA only for the detection of RNA from SARS-CoV-2 virus to aid in the diagnosis of SARS-CoV-2 virus infection. It has not been authorized for use to detect any other viruses or pathogens. The test is authorized in the United States 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 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.
LGC Coronavirus Proficiency Test offers laboratories quality assurance
8 April 2020
8 April 2020 -- LGC today launched a Proficiency Testing (PT) service for the detection of SARS-CoV-2 (COVID 19) by nucleic acid amplification testing, one of the first global schemes for COVID-19.
As increasing numbers of diagnostic methods are made available in the global fight against COVID 19, it is essential that laboratories ensure that their application of methods and subsequent results are reliable and accurate - using external quality assurance tools including Proficiency Testing.
Brian Brookman, Director, Proficiency Testing, LGC, said, “In today’s crisis, our core purpose of Science for a Safer World could not be more relevant and important. LGC is directly involved in many areas of COVID-19 related work - from supporting diagnostic kit manufacturers, diagnostic testing and clinical research, to providing quality assurance tools to ensure reliability of measurements being made. By utilising this new proficiency testing program for SARS-CoV-2, clinical laboratories worldwide will have an additional vital tool to add to their external quality assurance measures and ensure confidence in their results.”
Derek Craston, Chief Scientific Officer, LGC, adds, “Recent political statements that ‘a bad test is worse than no test’ in our fight against the COVID-19 virus emphasise the need for an approach to testing that addresses quality at all levels.
“LGC is committed to this objective through the provision of carefully manufactured and quality controlled critical reagent components that form an integral part of testing protocols, by providing characterised materials for test validation and control, in supporting international comparative studies, and now by establishing a global proficiency testing scheme.
“Proficiency testing is a central component of a robust quality system and enables laboratories to benchmark performance and identify, where appropriate, areas for further improvement.”
Test Materials within the SARS-CoV-2 PT scheme are non-infectious and compatible with molecular assays targeting the Centers for Disease Control and Prevention (CDC) and World Health Organisation consensus gene sequence regions, ORF1a, RdRp, E (Envelope), N (Nucleocapsid) and/or S (Spike).
LGC provides PT schemes to over 13,000 laboratories in more than 160 countries, conducting over 1,700 proficiency tests each year. PT is a requirement for accreditation to ISO/IEC 17025 and ISO 15189.
Learn more about proficiency testing on the LGC Standards website.
Bio-Rad Announces the Launch of a Serology Assay to Detect Coronavirus (COVID-19) Antibodies
7 April 2020
HERCULES, Calif., 7 April 2020 – Bio-Rad Laboratories, Inc., a global leader of life science research and clinical diagnostic products, today announced that the company is launching a blood-based immunoassay kit to identify antibodies to the coronavirus SARS-CoV-2, the virus associated with COVID-19. Preliminary performance of the assay has been established and the kit is now undergoing clinical evaluation in several hospitals to further confirm clinical performance. Initial data collected on more than 700 samples has demonstrated specificity above 99 percent.
After infection with SARS-CoV-2, viral antigens stimulate the body's immune system to produce antibodies to fight the virus. Bio-Rad believes its blood-based immunoassay kit will help clinicians determine if an individual has been infected by the virus and therefore has developed an immune response against SARS-CoV-2.
"Using a serology test to support the diagnosis of COVID-19 and to screen populations can provide a more complete understanding of infection rates as well as immunity," said Dara Wright, Bio-Rad Clinical Diagnostics Group EVP & President. "The detection of antibodies to SARS-CoV-2 on a large scale may be used to guide public authorities in their decisions to lift partial or total containment orders according to the serological status of the population. Molecular and serology testing are highly complementary in this regard," she said.
Bio-Rad's immunoassay kit detects total immunoglobulin (IgG, IgM, and IgA), an approach which appears to be more sensitive than assays against a single immunoglobulin1. The test was designed for use manually or on an automated immunoassay platform, such as Bio-Rad’s EVOLIS System, which offers high throughput processing and sample traceability.
Bio-Rad plans to offer the immunoassay kit globally. In the United States, the company intends to use the FDA's Emergency Use Authorization process to expedite U.S. availability.
About Bio-Rad
Bio-Rad Laboratories, Inc. (NYSE: BIO and BIOb) is a global leader in developing, manufacturing, and marketing a broad range of innovative products for the life science research and clinical diagnostic markets. With a focus on quality and customer service for over 65 years, our products advance the discovery process and improve healthcare. Our customers are university and research institutions, hospitals, public health and commercial laboratories, biotechnology, pharmaceutical, as well as applied laboratories that include food safety and environmental quality. Founded in 1952, Bio-Rad is based in Hercules, California, and has a global network of operations with more than 8,100 employees worldwide. Bio-Rad had revenues exceeding $2.3 billion in 2019. For more information, please visit bio-rad.com.
Bio-Rad Announces the Launch of a Serology Assay to Detect Coronavirus (COVID-19) Antibodies
7 April 2020
HERCULES, Calif., 7 April 2020 – Bio-Rad Laboratories, Inc., a global leader of life science research and clinical diagnostic products, today announced that the company is launching a blood-based immunoassay kit to identify antibodies to the coronavirus SARS-CoV-2, the virus associated with COVID-19. Preliminary performance of the assay has been established and the kit is now undergoing clinical evaluation in several hospitals to further confirm clinical performance. Initial data collected on more than 700 samples has demonstrated specificity above 99 percent.
After infection with SARS-CoV-2, viral antigens stimulate the body's immune system to produce antibodies to fight the virus. Bio-Rad believes its blood-based immunoassay kit will help clinicians determine if an individual has been infected by the virus and therefore has developed an immune response against SARS-CoV-2.
"Using a serology test to support the diagnosis of COVID-19 and to screen populations can provide a more complete understanding of infection rates as well as immunity," said Dara Wright, Bio-Rad Clinical Diagnostics Group EVP & President. "The detection of antibodies to SARS-CoV-2 on a large scale may be used to guide public authorities in their decisions to lift partial or total containment orders according to the serological status of the population. Molecular and serology testing are highly complementary in this regard," she said.
Bio-Rad's immunoassay kit detects total immunoglobulin (IgG, IgM, and IgA), an approach which appears to be more sensitive than assays against a single immunoglobulin1. The test was designed for use manually or on an automated immunoassay platform, such as Bio-Rad’s EVOLIS System, which offers high throughput processing and sample traceability.
Bio-Rad plans to offer the immunoassay kit globally. In the United States, the company intends to use the FDA's Emergency Use Authorization process to expedite U.S. availability.
About Bio-Rad
Bio-Rad Laboratories, Inc. (NYSE: BIO and BIOb) is a global leader in developing, manufacturing, and marketing a broad range of innovative products for the life science research and clinical diagnostic markets. With a focus on quality and customer service for over 65 years, our products advance the discovery process and improve healthcare. Our customers are university and research institutions, hospitals, public health and commercial laboratories, biotechnology, pharmaceutical, as well as applied laboratories that include food safety and environmental quality. Founded in 1952, Bio-Rad is based in Hercules, California, and has a global network of operations with more than 8,100 employees worldwide. Bio-Rad had revenues exceeding $2.3 billion in 2019. For more information, please visit bio-rad.com.
Mesa Biotech To Ship 10,000 Accula SARS-CoV-2 Tests This Week For 30 Minute Rapid Molecular Point of Care Diagnosis
7 April 2020 - The only FDA authorized palm-sized system for COVID-19 testing enables broader use across healthcare facilities and closer to the patients with rapid results
SAN DIEGO, CA, April 7, 2020 – Today, Mesa Biotech announced it is shipping 10,000 of its Accula™ SARS-CoV-2 molecular rapid point of care (POC) tests this week. The company’s COVID-19 test uses patented technology to enable ‘near patient’ testing outside of the central laboratory with diagnostic results in 30 minutes. Mesa Biotech Inc., a San Diego based, molecular diagnostic company, has developed an affordable, easy to use, palm-sized molecular testing platform designed for rapid near patient infectious disease diagnosis.
“We will ship 10,000 tests this week and continue executing on our capacity expansion initiatives,” said Hong Cai, Co-founder and Chief Executive Officer, Mesa Biotech, Inc. “I am so proud of everyone in our company for their unwavering dedication during unprecedented circumstances to help meet the critical need for rapid near patient COVID-19 testing.”
The Accula System provides a true decentralized testing solution for COVID-19 at the point of care. The Accula SARS-CoV-2 is easy to use, fits in the palm of your hand and provides a highly accessible means for healthcare professionals to access laboratory quality results near the patient. With diagnostic results in 30 minutes, physicians can decide to isolate, treat or dismiss potential carriers of the virus.
The Accula SARS-CoV-2 Test is a visually read test using reverse transcription polymerase chain reaction (RT-PCR) technology to detect SARS-CoV-2 (the virus responsible for COVID-19) via throat and nasal swab samples. Similar to Mesa Biotech’s commercially available tests for influenza and RSV, the Accula SARS-CoV-2 Test is designed for point-of-care use, including temporary screening facilities, physician office labs, urgent care, and long term nursing facilities. The system complements central laboratories where current testing is performed.
Mesa Biotech’s technology was developed at Los Alamos National Lab supported by NIH grants from the National Institute of Allergy and Infectious Diseases (NIAID) and the Western Regional Centers for Excellence in Biodefense and Emerging Infectious Disease program. In mid-March, the company received funding from the U.S. Health and Human Services for development of its SARS-CoV-2 test and less than one week later received emergency use authorization. Since its inception, the company has focused on technology well-suited for emergency defense and rapid deployment for SARS, Ebola and other emerging infectious diseases. Mesa Biotech’s platform was specifically designed for use outside the lab to enable rapid responses to global pandemics, such as COVID-19.About Mesa Biotech Inc.Mesa Biotech designs, develops, manufactures and commercializes next generation molecular diagnostic tests, bringing the superior diagnostic performance of nucleic acid PCR amplification to the point-of-care. Mesa Biotech's Accula™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). Both products are distributed in the United States by Sekisui Diagnostics under the Silaris™ brand. Mesa Biotech has also secured a number of strategic agreements for distribution in Europe and Asia.
Reference: https://www.mesabiotech.com/news/euacoronavirusupdate
COVID-19 Antibody Test Released by Ortho Clinical Diagnostics
3 April 2020
Raritan, NJ, 3 April 2020 -- Aligned with its mission to improve and save lives with diagnostics, Ortho Clinical Diagnostics today announced it is launching to market its SARS-CoV-2 (COVID-19/coronavirus) antibody test—the VITROS® Immunodiagnostic Products Anti-SARS-CoV-2 Total Reagent Pack. Testing kits are expected to be available in a few weeks.
Ortho followed the guidelines established by the U.S. Food and Drug Administration’s (FDA) Policy for Diagnostic Tests for Coronavirus Disease-2019 during the Public Health Emergency.
“The unprecedented nature of this rapidly spreading virus required an immediate response from the diagnostics industry, and Ortho followed through on its commitment to help develop better ways to treat patients and provide robust data to help manage COVID-19,” said Chris Smith, chief executive officer. “At Ortho Clinical Diagnostics, the patient is at the heart of everything we do—because we believe behind every test is a life.”
The VITROS® Immunodiagnostic Products Anti-SARS-CoV-2 Total Reagent Pack detects antibodies (including IgG and IgM) to SARS-CoV-2 that can be used to detect immune response to the virus. The test may be used in epidemiological research to help better understand the spread of the disease and may also be used to aid in the diagnosis of suspected COVID-19 patients in conjunction with molecular tests.
“Ortho leveraged its history of innovation and history of advancing through science to quickly develop these solutions,” said Chockalingam Palaniappan, PhD, chief innovation officer. “It’s inspiring to think of the good the healthcare community can do by advancing the learning about this virus.”
The test will run on Ortho’s flagship analyzer, the VITROS® XT 7600 Integrated System, the VITROS® 3600 Immunodiagnostic System, the VITROS® 5600 Integrated System and VITROS® ECi/ECiQ Immunodiagnostic Systems and can process approximately 150 tests in an hour. The systems are designed to remove barriers and adaptable for non-traditional laboratory environments because they don’t require an external water supply to run and are already installed in more than 1,000 hospital and reference labs throughout the United States.
“Given the incredible demand for information to change the tide of this pandemic, Ortho felt it was necessary to market as quickly as possible with a notification to the FDA,” said Smith. “We are working to make our antibody test kit available to the areas with the greatest need first and will be working in parallel to both increase our test kit production and follow additional regulatory pathways to secure further approvals.”
As a trusted partner of hospitals, hospital networks, blood banks, and labs around the world for over 80 years, Ortho has a rich history of developing solutions that provide fast, accurate, reliable testing results. The test was developed at Ortho’s Global Center of Excellence for R&D in Rochester, New York.
Questions regarding the development of these COVID-19 antibody test can be directed to: OrthoCOVID19Test@orthoclinicaldiagnostics.com.
BD, BioGX Announce FDA Emergency Use Authorization for New COVID-19 Diagnostic for Use in U.S.
3 April 2020 - New Test Immediately Available to Increase Capacity of Rapid, On-Site Testing of COVID-19 at Hospitals Across the U.S.
FRANKLIN LAKES, N.J. and BIRMINGHAM, Ala. April 3, 2020 -- BD (Becton, Dickinson and Company), a leading global medical technology company, and BioGX Inc., a molecular diagnostics company, today announced that the U.S. Food and Drug Administration (FDA) has granted Emergency Use Authorization (EUA) for a new diagnostic test that will enable hospitals to screen for COVID-19 (coronavirus) on site and get results in under three hours.
The test helps fill an urgent need across the U.S. for hospitals to access an easy-to-use, rapid diagnostic test to screen patients and health care workers for COVID-19. The test will be run on the BD MAX™ System, a molecular diagnostic platform already in use at hundreds of laboratories in nearly every state across the country. Each unit is capable of analyzing hundreds of samples per day.
“The BioGx molecular test for the BD MAX™ System and our recently announced serology test that can help detect current and past exposure to COVID-19 are part of BD’s approach to give health care workers choice and access to the right test for the right situation,” said Dave Hickey, president of Integrated Diagnostic Solutions for BD. “We continue to work diligently on an antigen test for our point-of-care BD Veritor™ System that would complete a full portfolio of COVID-19 tests.”
The majority of BD MAX™ Systems are installed in hospital laboratories, reducing the added time and complexity of needing to send samples to a reference lab. The system is fully automated, reducing the opportunity for human error and increasing the speed to result. The BD MAX™ System can process 24 samples simultaneously. The tests are expected to add capacity for 50,000 tests per week nationwide.
“The collaboration with BD, combined with the new emergency use authorization process from FDA, enabled our companies to bring a new test to the BD MAX™ System quickly and efficiently,” said Shazi Iqbal, Ph.D., chief executive officer of BioGX. “The development and launch speed was critical to ensure hospitals and laboratories can have additional options and capacity for an automated, highly reliable SARS-CoV-2 test for their patients.”
BioGX developed the assay for the BD MAX™ System in their Sample-Ready™ ready-to-use format to detect the presence of the SARS-CoV-2 virus, the cause of COVID-19. The assay is based on the same viral RNA targeting sequences and real-time PCR detection method as the test developed by the U.S. Centers for Disease Control and Prevention (CDC).
Hospitals and laboratories that use a BD MAX™ System can order tests through their BD sales representative.
The BioGX SARS-CoV-2 Reagents for the BD MAX™ System has not been cleared or approved by FDA. However, it has been authorized by the FDA under an EUA. The test has been authorized only for the detection of RNA from SARS-CoV-2 virus to aid in the diagnosis of SARS-CoV-2 virus infection, 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 BD
BD is one of the largest global medical technology companies in the world and is advancing the world of health by improving medical discovery, diagnostics and the delivery of care. The company supports the heroes on the frontlines of healthcare by developing innovative technology, services and solutions that help advance both clinical therapy for patients and clinical process for healthcare providers. BD and its 65,000 employees have a passion and commitment to help enhance the safety and efficiency of clinicians' care delivery process, enable laboratory scientists to accurately detect disease and advance researchers' capabilities to develop the next generation of diagnostics and therapeutics. BD has a presence in virtually every country and partners with organizations around the world to address some of the most challenging global health issues. By working in close collaboration with customers, BD can help enhance outcomes, lower costs, increase efficiencies, improve safety and expand access to healthcare.
For more information on BD, please visit bd.com.
About BioGX
BioGX, Inc., headquartered in Birmingham, Alabama, and its wholly owned subsidiary BioGX B.V., based in Amsterdam, The Netherlands, (collectively “BioGX”), develop and commercialize molecular diagnostics reagents across diverse applications. BioGX operates in a cGMP compliant environment certified to International Standard ISO 13485. The company applies its proprietary platform-agnostic reagent technology to offer products and contract services across a variety of real-time PCR and Next Generation Sequencing platforms. The Sample-ReadyTM technology is at the core of all product offerings for Clinical, Food Safety, Pharma and Water Quality molecular testing. BioGX B.V.’s 50+ molecular diagnostic products are marketed and sold in 100+ countries through its Global Distribution Network. For more information on BioGX, please visit BioGX.com.
Siemens Healthineers Releases Test Kit for Coronavirus COVID-19
2 April 2020 - Siemens Healthineers test kit will help detect SARS-CoV-2, the cause of COVID-19. Company is pursuing Emergency Use approvals from WHO and FDA for clinical use.
Erlangen, Germany / Tarrytown, NY, Apr 02, 2020 -- Siemens Healthineers announced today the availability of its molecular Fast Track Diagnostics (FTD) SARS-CoV-2 Assay test kit used to aid in the diagnosis of infection by the SARS-CoV-2 virus that causes the COVID-19 disease. Test kits are already being shipped within the European Union for research use only (RUO) to expedite availability while the company continues to pursue Emergency Use Assessment and Listing (EUAL) from the World Health Organization (WHO) for clinical use. In addition, Siemens Healthineers has begun discussions with the U.S. Food and Drug Administration (FDA) for release of the test under Emergency Use Authorization (EUA). Both applications are in progress. While the controlled roll-out of the assay for research use is continuing, Siemens Healthineers is simultaneously expanding its production capacity.
“With this molecular diagnostic assay, we want to make a contribution to fight the current COVID-19 global pandemic by delivering fast and accurate SARS-CoV-2 testing,” said Sebastian Kronmueller, Head of Molecular Diagnostics at Siemens Healthineers. “The Siemens Healthineers assay is designed to help researchers positively identify the virus in less than three hours so that healthcare professionals can proceed as quickly as possible with the necessary next steps on their patients’ triage paths.”
Many molecular assays detect the presence of viral ribonucleic acid (RNA), determining the presence of the targeted virus directly in the patient sample. In this way, molecular testing is effective early in the lifecycle of the virus and is thus efficient in urgent testing situations, such as global pandemics. After regulatory approval, the commercial roll-out of the assay is intended in the U.S. and Europe.
The FTD SARS-CoV-2 Assay has been optimized on the Biomerieux EasyMag Extraction System and the Applied Biosystems 7500 Real-time PCR Thermocycler* and utilizes the same workflow, including PCR profile, as other FTD Respiratory Disease kits from Siemens Healthineers. It can be run in laboratories simultaneously with FTD Respiratory Pathogens 21**, a molecular syndromic testing panel from Siemens Healthineers that identifies 21 different upper respiratory pathogens that can cause acute respiratory infections.
The FTD SARS-CoV-2 Assay was developed by Fast Track Diagnostics, a Siemens Healthineers Company, in Esch-sur-Alzette, Luxembourg. Fast Track Diagnostics was acquired by Siemens Healthineers at the end of 2017.
About Siemens Healthineers
Siemens Healthineers AG (listed in Frankfurt, Germany: SHL) is shaping the future of Healthcare. As a leading medical technology company headquartered in Erlangen, Germany, Siemens Healthineers enables healthcare providers worldwide through its regional companies to increase value by empowering them on their journey towards expanding precision medicine, transforming care delivery, improving the patient experience, and digitalizing healthcare. Siemens Healthineers is continuously developing its product and service portfolio, with AI-supported applications and digital offerings that play an increasingly important role in the next generation of medical technology. These new applications will enhance the company’s foundation in in-vitro diagnostic, image-guided therapy, and in-vivo diagnostics. Siemens Healthineers also provides a range of services and solutions to enhance healthcare providers ability to provide high-quality, efficient care to patients. In fiscal 2019, which ended on September 30, 2019, Siemens Healthineers, which has approximately 52,000 employees worldwide, generated revenue of €14.5 billion and adjusted profit of €2.5 billion. Further information is available at www.siemens-healthineers.com.
BGI’s SARS-CoV-2 Real-Time Fluorescence Detection RT-PCR Kit Receives PMDA Approval
1 April 2020
April 1, 2020 -- BGI Today announced that its SARS-CoV-2 Real-Time Fluorescence Detection RT-PCR Kit has received regulatory approval from the Pharmaceuticals and Medical Devices Agency (PMDA) in Japan. The kit is a qualitative in vitro nucleic acid amplification assay used to detect SARS-CoV-2 using reverse transcription PCR from throat swab and Bronchoalveolar Lavage Fluid (BALF) samples.
BGI and Sysmex Corporation signed a partnership distribution agreement for the early delivery of test kits to clinical sites for the new coronavirus detection. Sysmex is a market leader in the field of clinical laboratory testing and health information technology – supplying laboratories, hospitals and healthcare organizations worldwide. The cooperation will bring this rapid and accurate tests to Japan and help more people receive better diagnosis.
BGI has been on the forefront of testing for SARS-CoV-2. Following the outbreak of the novel coronavirus in China, BGI was among the first few companies that developed the diagnostic test. The kit received emergency approval from China’s National Medical Products Administration (NMPA) on January 26, CE-IVD mark on February 26, and US FDA Emergency Use Authorization on March 27, had been used to diagnose more than 1 million individuals and is currently being distributed to more than 70 countries and regions. BGI’s technology has been deployed on the front lines of fighting the novel coronavirus in China, and the company aims to bring its experience and testing capability at scale to speed detection efforts across the world.
Philips enables hospitals and GPs to remotely screen and monitor patients with COVID-19
1 April 2020 - Philips provides healthcare institutions with telehealth solution to process high volume coronavirus-related healthcare requests via online screening, and supports healthcare providers in the use of external call centers to offer the correct care to patients. If medically justified, patients infected with COVID-19 can be remotely monitored via automated questionnaires about their home situation and state of health.
Amsterdam, the Netherlands, 1 April 2020 -- Royal Philips, a global leader in health technology, today announced that it can help general practitioners and healthcare institutions manage the increased patient flows resulting from the COVID-19 outbreak through a dedicated and scalable telehealth solution that facilitates the use of online screening, follow-up questionnaires and monitoring, and external call center collaborations. It aims to prevent unnecessary visits to general practitioners and hospitals and the remote monitoring of the vast majority of COVID-19 patients that are in quarantine at home.
As a first step, patients complete an online questionnaire at home. Based on the results, the caregiver can let the online solution assign patients to a risk class and take appropriate actions. If needed patients can be monitored via automated follow-up surveys. Patients with a high-risk score are called by a call center for additional information. If the call center determines that care is required, the patient is referred to the GP, who can then provide the necessary care or send them to the hospital. While the questionnaire is intended to support care providers, it is explicitly not a substitute for regular or emergency care. The solution is based on Philips’ existing and proven Patient Reported Outcomes Management solution, which is being used by more than 100 healthcare institutions globally.
The Groene Hart Hospital in Gouda, the Netherlands, is one of the healthcare institutions that has not only already started using the COVID-19 screening and monitoring solution but has also contributed to its development. “We are using this application to relieve the enormous pressure currently placed on our healthcare system,” said Ronald Liem, Head of Surgery at the Groene Hart Hospital. “Together with general practitioners and the Dutch public health service, we can now focus on the most urgent cases and determine, based on the answers from the surveys, which patients do and which do not need additional care.”
“The outbreak of the new coronavirus is a major challenge for everyone in healthcare,” said Roy Jakobs, Chief Business Leader Connected Care, member of the Executive Committee, Royal Philips. “That is why we have equipped one of our existing and proven telehealth solutions with the capabilities to screen and monitor patients remotely. This remote screening solution supports healthcare institutes to diagnose and treat patients at alternative points of care and is helping to safeguard the scarce critical care capacity.”
Roy Jakobs added: “We have a broad portfolio of telehealth and remote care solutions at Philips. We are now working with hospitals and GPs to see how we can use these solutions to help frontline healthcare workers and their patients during the COVID-19 crisis.”
Hospitals, general practitioners and other care providers who want to know more about Philips’ screening and monitoring solution for COVID-19 patients can visit our website.
AbbVie Donates $35 Million for COVID-19 Relief to Support Healthcare Systems, Patients and Communities
31 March 2020 - AbbVie partners with International Medical Corps, Direct Relief and Feeding America to increase healthcare capacity, supply critical equipment and deliver food and essential supplies. AbbVie offers 2-for-1 matching for employee donations and resources for assistance.
NORTH CHICAGO, Ill., March 31, 2020 -- AbbVie, a research-based global biopharmaceutical company, today announced a donation of $35 million to support COVID-19 relief efforts. In the U.S., AbbVie's funds will be used to support healthcare capacity for hospitals as well as protect vulnerable populations by enabling access to food and essential supplies. In Europe, the donation will provide critical equipment and supplies to patients and front-line healthcare workers in the hardest-hit countries.
"AbbVie is making this donation to nonprofit partners that will have an immediate and significant positive impact in communities that have been hit hardest by this unprecedented crisis," said Richard A. Gonzalez, chairman and chief executive officer, AbbVie. "Our 30,000 AbbVie team members around the world are proud to be able to help make a difference in the fight against this virus."
International Medical Corps – Immediate Hospital Support for U.S. Hotspots
AbbVie's donation to International Medical Corps will support increased healthcare capacity at overwhelmed hospital emergency departments in the U.S., where International Medical Corps is deploying a total of 20 mobile field hospitals to help increase surge capacity at overburdened hospitals. These mobile field units enable hospitals to expand the available triage and treatment space at existing facilities, improve patient flow and keep COVID-19 patients separated from other patients.
AbbVie is the sole donor funding the procurement of the tents, equipment, supplies as well as all of the operating expenses for these field hospitals through the end of 2020. AbbVie launched International Medical Corps' response in cities across the US, including in:
- Boston, MA
- Chicago, IL
- Cleveland, OH
- Detroit, MI
- Los Angeles, CA
- New Orleans, LA
- New York City, NY
- Puerto Rico
Each field hospital includes the equipment, personnel and resources to effectively provide urgent or outpatient care to hundreds of patients per day, including patient beds, medical examination supplies, portable sinks, power, lighting and HVAC units. The field hospital can be stood up in approximately six hours and withstand 80-mph sustained winds. International Medical Corps will pull from its roster of nearly 300 medical professionals to fill critical gaps in nursing and infection prevention and control. Each hospital will determine specifically how it intends to use the additional space and resources.
"AbbVie's extraordinary and swift support means that health workers on the frontlines of the COVID-19 pandemic in the U.S. will have more resources to save lives in the fight against this dangerous disease," said Nancy Aossey, president and CEO of International Medical Corps. "I'd like to thank AbbVie for always standing with us — and for helping to make sure that we are first there, no matter where, in fighting outbreaks of infectious disease in the U.S. and globally."
Direct Relief – Providing Equipment and Supplies in Europe
AbbVie is donating to Direct Relief to provide equipment and supplies in the hardest-hit European countries. Direct Relief is procuring and delivering personal protective equipment (PPE) for front line healthcare workers as well as oxygen concentrators and ventilators for patients. This equipment is critical as hospitals work to manage high patient demands and limited beds, particularly in intensive care units.
"Direct Relief is so deeply grateful for the leadership and commitment reflected by AbbVie's action today, which is keenly needed, will be put to immediate use, and is a perfect example of what's needed as we all face this historic threat to the health of people everywhere," said Thomas Tighe, Direct Relief president and CEO.
Feeding America – Protecting Vulnerable Populations and Communities
Feeding America is the nation's largest domestic hunger-relief organization and serves America's most vulnerable populations, including seniors. AbbVie's support means more people in need will benefit from Feeding America's services, which include food and essential supplies. As people continue to be under stay-at-home orders or are otherwise confined to home, Feeding America food banks are launching creative new delivery methods, including direct-to-home food drops and minimal-contact food pick-ups.
"We are incredibly grateful for AbbVie's generous commitment to Feeding America's COVID-19 Response Fund. During this unprecedented time, the Feeding America nationwide network of 200 food banks is working tirelessly to provide food and emergency assistance to children, seniors and families struggling with food insecurity and people experiencing job disruptions," said Claire Babineaux-Fontenot, CEO of Feeding America.
AbbVie Community Resilience Fund – Setting Aside Funds for Future Needs
As part of its $35 million commitment, AbbVie is designating up to $5 million in reserve funding for additional near-term commitments to help address the COVID-19 pandemic. With the situation rapidly evolving, AbbVie seeks to ensure flexibility in its donation program as funds emerge and new areas of need are identified. To that end, AbbVie is creating the Community Resilience Fund, which will provide funding to organizations improving community resilience in under-resourced areas impacted by the COVID-19 pandemic. Learn more and apply here.
Various Charities – Empower Employee Giving
AbbVie also announced that it is doubling the AbbVie Foundation match for COVID-19-related contributions by its employees. Through this program, AbbVie seeks to increase the impact the company can make on this crisis. Instead of the typical 1:1 match, the AbbVie Foundation will match $2 to every $1 employees donate to a nonprofit for this purpose. In 2019, the company's employee giving and matching program raised more than $13 million for charities.
AbbVie Employee Assistance Fund – Supporting Employees in Need
For employees impacted by the COVID-19 pandemic, AbbVie is offering support through the AbbVie Employee Assistance Fund's Employee Relief Program. Employees in need of assistance can apply for this program, which covers expenses such as mortgage/rent payments, utilities, food, childcare and medical expenses by going to AbbVie.com/EAF.
Learn more about the company's response to COVID-19 at AbbVie.com/coronavirus.
About AbbVie
AbbVie is a global, research and development-based biopharmaceutical company committed to developing innovative advanced therapies for some of the world's most complex and critical conditions. The company's mission is to use its expertise, dedicated people and unique approach to innovation to markedly improve treatments across four primary therapeutic areas: immunology, oncology, virology and neuroscience. In more than 75 countries, AbbVie employees are working every day to advance health solutions for people around the world. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, LinkedIn or Instagram.
Thermo Fisher Scientific Launches New AcroMetrix Coronavirus 2019 (COVID-19) RNA Control (RUO)
31 March 2020 - To monitor and validate COVID-19 molecular diagnostic tests
FREMONT, Calif., March 31, 2020 -- Thermo Fisher Scientific, the world leader in serving science, today announced the availability of the Thermo Scientific AcroMetrix Coronavirus 2019 (COVID-19) RNA Control, its latest quality control product to monitor and validate COVID-19 molecular diagnostic tests.
In an effort to combat the recent Coronavirus outbreak, Thermo Fisher designed and developed this control as a synthetic RNA, non-infectious control to help labs validate and monitor COVID-19 molecular diagnostic tests. Taking FDA guidelines into account, the controls were carefully designed at two different concentrations: a low positive control and an ultra-low positive control.
AcroMetrix Coronavirus 2019 (COVID-19) RNA Control is prepared by formulating synthetic RNA transcripts that contain highly unique N, S, E and Orf1ab regions of SARS-CoV-2 (COVID-19) genome into a proprietary buffer. The RNA is ready for reverse transcription, PCR amplification and detection, as appropriate to the test. The kit contains two vials of SARS-CoV-2 specific RNA at the concentration that will result low positive and ultra-low positive in most commonly used Polymerase Chain Reaction (PCR) based Coronavirus 2019 (COVID-19) nucleic acid testing methods.
"Our team is committed to providing innovative solutions to support our customers with better diagnostic tools," said Gianluca Pettiti, senior vice president and president, Thermo Fisher's specialty diagnostics business. "The AcroMetrix Coronavirus 2019 (COVID-19) RNA Control is a positive control to aid in validating and monitoring COVID-19 diagnostic tests."
Thermo Fisher has created an online resource to make it easier to find up-to-date information about its response to the COVID-19 pandemic, including availability of its diagnostic test kits. Please refer to https://corporate.thermofisher.com/en/COVID-19.html for current news, information and frequently asked questions about COVID-19-related products and services that are vital to researchers, labs, healthcare workers and first responders worldwide.
The AcroMetrix Coronavirus 2019 (COVID-19) RNA Control is available globally as a Research Use Only (RUO) product and is not intended for clinical use. For more information, visit www.thermofisher.com/covid-19-control
About Thermo Fisher Scientific
Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $25 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, improving patient diagnostics and therapies or increasing productivity in their laboratories, we are here to support them. Our global team of more than 75,000 colleagues delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services and Patheon. For more information, please visit www.thermofisher.com.
QIAGEN receives U.S. FDA EUA for QIAstat-Dx test kit, first and only syndromic solution integrating detection of SARS-CoV-2 coronavirus
31 March 2020 - First syndromic testing solution to be deployed in epidemic can differentiate novel coronavirus from 20 other serious respiratory infections. QIAstat-Dx Respiratory SARS-CoV-2 Panel delivers results in about one hour. Adds an important tool for clinicians as part of QIAGEN’s global mobilization to scale up testing supplies for the COVID-19 response.
Germantown, Maryland, and Hilden, Germany, March 31, 2020 – QIAGEN today announced that it has received emergency use authorization (EUA) from the U.S. Food and Drug Administration (FDA) for its newly developed QIAstat-Dx Respiratory SARS-CoV-2 Panel test for use in diagnosing patients infected with the novel COVID-19 coronavirus.
The QIAstat-Dx test kit can differentiate the SARS-CoV-2 coronavirus from 2o other serious respiratory infections in patients who may have similar symptoms in a single testing run of about one hour. It is a multiplexed nucleic acid test that evaluates samples such as nasopharyngeal swabs obtained from individuals suspected of respiratory tract infections. The newly approved panel includes assays targeting two genes used to detect the pathogen behind the disease, Severe acute respiratory syndrome-related coronavirus 2 (SARS-CoV-2), and is intended for use in laboratories certified under CLIA to perform moderate and high complexity tests.
“We are pleased to begin making QIAstat-Dx SARS-CoV-2 test kits available in the United States under the FDA’s emergency use authorization for clinical laboratories. The QIAstat-Dx syndromic panel adds an important tool for clinicians,” said Thierry Bernard, Chief Executive Officer at QIAGEN. “I am proud of our QIAGEN teams working tirelessly to implement 24/7 production of test cartridges and testing components. In addition to QIAstat-Dx, we are supplying RNA extraction kits under the QIAamp and EZ1 brands as well as numerous components and instruments for use in fighting this public health crisis around the world.”
The EUA approval status comes after QIAGEN announced on March 24 that it had begun shipping QIAstat-Dx SARS-CoV-2 test kits to the United States under a new FDA Policy allowing the kits to be made commercially available. QIAGEN has placed more than 1,100 QIAstat-Dx instruments worldwide in hospitals, clinics and laboratories, including over 200 in the U.S. since FDA clearance of the QIAstat-Dx Analyzer was granted in May 2019. QIAGEN received funding for this project in part from the U.S. 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 75A50120C00014.
The automation system enables fast, cost-effective and easy-to-use syndromic testing with Sample to Insight workflows. A technician simply loads a clinical sample (such as a swab) into a single-use QIAstat-Dx cartridge and places it in the analyzer. QIAGEN chemistries for DNA and RNA sample processing and analysis are built into the instrument, and the QIAstat-Dx instrument delivers results in about one hour.
A vídeo on QIAstat-Dx can be found here
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 December 31, 2019, QIAGEN employed approximately 5,100 people in over 35 locations worldwide. Further information can be found at http://www.qiagen.com.
Reference: https://corporate.qiagen.com/newsroom/press-releases/2020/20200331_fda_eua
G42 and BGI Announce COVID-19 Detection Lab
31 March 2020
Abu Dhabi, United Arab Emirates, 31 March 2020 -- Group 42 (G42), the leading technology company based in Abu Dhabi, and global genomics leader BGI announced today the launch of a new massive-throughput laboratory built to address the need for population-scale detection and diagnosis of COVID-19 in the United Arab Emirates. The lab is capable of conducting tens of thousands RT-PCR tests per day and is the first in the world of this scale to be operational outside of China. The lab showcases the joint commitment of G42 and BGI to the leadership and people of the UAE, working with the nation to combat the COVID-19 pandemic.
The laboratory, located in Masdar City, Abu Dhabi, was rapidly built and operationalized by G42 and BGI in only 14 days, providing an immediate solution to COVID testing scale-up needs in the UAE. Proactively learning from the China experience in handling the COVID-19 crisis, the lab ensures that the UAE continues to lead the world as the most tested country per capita (according to the WHO).
Mr. Peng Xiao, CEO of G42, said: “This high throughput lab provides the scale and firepower to enable all people in Abu Dhabi and the UAE to access the most reliable PCR tests, which are also provided by G42 in partnership with BGI. We thank the UAE leadership’s support in protecting the health and wellbeing of the country’s residents against this pandemic.”
“In such challenging times, we feel compelled to leverage our expertise, technological resources and international partnerships to bring rapid, accurate testing capabilities on a massive scale and bolster the detection efforts led by authorities,” he continued.
This new processing capacity will enable a rapid response to the current outbreak by accelerating the diagnosis, identification of suspected cases, the release of recovered patients, and the screening of close contacts and high-risk groups.
The lab will utilize BGI’s RT-PCR diagnostic kits for the detection of SARS-CoV-2, the virus that causes COVID-19 disease. It is the only RT-PCR diagnostic kit that has received approvals from China (NMPA), Europe (CE-IVD), the United States (FDA) and the World Health Organization (WHO). G42 and BGI, whose partnership began in December 2019 with the announcement of the Population Genome Program by the Department of Health – Abu Dhabi, have stepped up to the forefront in the battle against the COVID-19 pandemic. From the production of COVID-19 diagnostic kits to the supply of thermal sensors and medical goods, the two companies are deploying their expertise and technologies in support of international health authorities as they create effective prevention and detection protocols.
Wang Jian, Co-founder and Chairman of BGI Group, said: “Together with our partners at G42, we can bring the world’s best technology and experience in fighting global health threats to help the people of the UAE and beyond.”
The lab will prioritize testing within the UAE but could scale up to receive samples from neighboring regions. The partners also plan to enable cutting-edge monitoring of virus mutations and the ability to detect new pathogens in the future with high-throughput sequencing.
Reference: https://www.bgi.com/global/company/news/g42-and-bgi-announce-covid-19-detection-lab/
BD, BioMedomics Announce Launch of Rapid Serology Test to Detect Exposure to COVID-19
31 March 2020 - Point-of-care blood test detects evidence of present or past exposure in 15 minutes
FRANKLIN LAKES, N.J. MORRISVILLE, N.C., March 31, 2020 -- BD (Becton, Dickinson and Company), a leading global medical technology company, and BioMedomics, a privately held, North Carolina-based clinical diagnostics company, today announced the release of a new point-of-care test that can detect antibodies in blood to confirm current or past exposure to COVID-19 in as little as 15 minutes.
The new test, developed and manufactured by BioMedomics, will be available through BD and distributed exclusively by Henry Schein, Inc. to health care providers throughout the United States.
The test does not require special equipment and may be used in a laboratory or at the point of care. The test detects antibodies in the blood that are produced by the body in response to coronavirus infection. These antibodies are typically present in the middle to later stages of COVID-19 infection, but may remain present after exposure, which helps clinicians determine who has been exposed to the coronavirus, even if a person didn't exhibit any symptoms of the COVID-19 disease. Data on past exposure is important for researchers to more accurately understand the likely true occurrence of SARS-CoV-2 infection across a population. This information will be helpful in informing future strategies for combatting COVID-19.
"Serology tests are important because they provide an additional piece of information to aid in characterizing possible prior exposure to SARS-CoV-2, especially since many infections are mild or asymptomatic in severity," said Dave Hickey, president of Integrated Diagnostic Solutions for BD. "Initial evidence suggests that nearly all patients infected with SARS-CoV-2 will have developed a detectable antibody response within days of symptom onset, at which time a negative serologic test, along with molecular diagnostics, could be helpful in ruling out COVID-19. Our agreement with BioMedomics adds a rapid serology test that can augment current tests already on the market, and we are pleased to collaborate in this effort with Henry Schein, which has extensive knowledge of the point-of-care test field."
The test is completed in four, simple steps. First, blood is collected through normal blood collection devices such as the BD Microtainer® Contact-Activated Lancet. A few drops of blood are then transferred to the test cartridge, followed by two to three drops of a buffer. The results can be read in 15 minutes, similar to how over-the-counter pregnancy tests show multiple lines for positive results and a single line for negative results.
"BioMedomics designed the test to be easy to use and provide results in minutes, with no special equipment necessary or the need to transport the sample to a laboratory for analysis," said Frank Wang, CEO of BioMedomics. "Our test has been clinically validated at several hospitals and clinical laboratories in both the U.S. and China, and our published clinical data in the Journal of Medical Virology was one of the world's first for a COVID-19 serology test. It has been used widely in China during the COVID-19 outbreak and is now ready to help combat coronavirus in the U.S. through our collaboration with BD. We are committed to doing our part to battle this disease and are excited to have BD as a partner to help deliver our high-quality rapid test to those who need it most."
The test analyzes blood, serum or plasma samples for the presence of immunoglobulin M (IgM) and Immunoglobulin G (IgG) antibodies associated with the coronavirus (SARS-CoV-2). IgM provides the first line of defense during viral infections, followed by the generation of adaptive, high-affinity IgG responses for long-term immunity and immunological memory. The detection of COVID-19 IgM antibodies tends to indicate a recent exposure to COVID-19, and detection of COVID-19 IgG antibodies indicates a later stage of infection, so this combined antibody test could also provide information on the stage of the disease in patients. Current guidance from the U.S. Food and Drug Administration (FDA) recommends that results from antibody testing should not be used as the sole basis to diagnose or exclude coronavirus infection. Depending on the clinical scenario, additional testing, such as those used on the BD MAX™ System may be considered to further evaluate the possibility of SARS-CoV-2 infection.
"We look forward to working with such an outstanding company as BD to help make the antibody test part of the standard of care," said Stanley M. Bergman, Henry Schein's chairman of the board and chief executive officer. "The test will help to identify people who have developed antibodies to the virus, which may inform future strategies regarding COVID-19."
The test has not been reviewed by the FDA but is permitted for distribution and use under the public health emergency guidance issued by FDA on March 16, 2020, and BD expects to begin shipping tests in April. BD will have capacity to supply more than one million tests over the coming months, with the ability to scale up based on market demand and is working with medical products distribution company Henry Schein to make these tests available to medical care facilities throughout the United States. Health care providers can order the test and all collection devices needed to perform the test by contacting their BD or Henry Schein representatives.
About BD
BD is one of the largest global medical technology companies in the world and is advancing the world of health by improving medical discovery, diagnostics and the delivery of care. The company supports the heroes on the frontlines of healthcare by developing innovative technology, services and solutions that help advance both clinical therapy for patients and clinical process for healthcare providers. BD and its 65,000 employees have a passion and commitment to help enhance the safety and efficiency of clinicians' care delivery process, enable laboratory scientists to accurately detect disease and advance researchers' capabilities to develop the next generation of diagnostics and therapeutics. BD has a presence in virtually every country and partners with organizations around the world to address some of the most challenging global health issues. By working in close collaboration with customers, BD can help enhance outcomes, lower costs, increase efficiencies, improve safety and expand access to healthcare. For more information on BD, please visit bd.com.
About BioMedomics
BioMedomics is a point-of-care diagnostics company that aims to provide novel, rapid point-of-care tests to aid in the diagnosis of critical diseases. The company uses cutting-edge technology to create life-saving diagnostic solutions and address global health care needs. Its diagnostic tests produce rapid and accurate clinical results at the point-of-care without requiring complex and expensive lab equipment — placing immediate health care knowledge in the hands of providers. With that knowledge comes the power to make treatment decisions and save lives. Please visit biomedomics.com for more information.
Beckman Coulter announces development of tests to detect coronavirus antibodies
31 March 2020
BREA, CALIF., March 31, 2020 — In response to the global COVID-19 pandemic, Beckman Coulter today announced that it is developing assays to identify IgM and IgG antibodies to the coronavirus or SARS-CoV-2. The assays will be designed for use on any of its high- throughput Access family of immunoassay systems, including the Access 2 and DxI series installed globally.
Research has shown that after infection with SARS-CoV-2, viral antigens stimulate the body’s immune system to produce antibodies that can be detected with IgM and IgG tests. “Antibody assays play a critical role in understanding the measure of immunity an individual has developed against SARS-CoV-2,” said Kathleen Orland, senior vice president and general manager for Beckman Coulter’s chemistry and immunoassay business. “This type of understanding could help determine the identification of those who would require a vaccine once available or when an infected individual could safely return to work.”
“With the ability to assess a patient’s immunity to SARS-CoV-2, this testing modality may enable clinicians to clear hospital staff, emergency responders, and others to get back to work with an indication that have had prior exposure and therefore may have immunity to the disease,” said Shamiram R. Feinglass, M.D., MPH, chief medical officer, Beckman Coulter. “This test also could allow those without immunity to be identified and kept safe until the pandemic subsides.”
Once the assays are finalized, Beckman Coulter intends to follow FDA’s Emergency Use Notification process as provided in the FDA’s Policy for Diagnostic Tests for Coronavirus Disease-2019 during the Public Health Emergency (March 16, 2020).
For the latest information on the new assays, 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.
ALM e.V. stellt aktuelle Zahlen zur SARS-CoV-2-Testung der Labore in Deutschland vor
31 March 2020 - „Deutschlands Labore sind extrem leistungsfähig und im internationalen Vergleich weit vorne!“ In einer ab heute wöchentlich stattfindenden Pressekonferenz stellen die Akkreditierten Labore in der Medizin – ALM e.V. die aktuellen Zahlen zur Labordiagnostik im Zusammenhang zu Corona-Pandemie vor.
Berlin, 31 March 2020 -- In einer ab heute wöchentlich stattfindenden Pressekonferenz stellen die Akkreditierten Labore in der Medizin – ALM e.V. die aktuellen Zahlen zur Labordiagnostik im Zusammenhang zu Corona-Pandemie vor: Insgesamt wurden laut Datenanalyse des fachärztlichen Berufsverbandes, an der sich bundesweit 97 Labore beteiligen, seit Anfang März rund 800.000 Tests durchgeführt. „Im Vergleich zur letzten Erhebung (KW 12) stieg dabei die Zahl der durchgeführten Tests in unserer Erhebung um etwa 18 Prozent an“, sagt Dr. Michael Müller, 1. Vorsitzender des ALM e.V.. In der KW 13 (23.-29. März) wurden von den 97 teilnehmenden Laboren insgesamt rund 314.000 Tests durchgeführt (KW 12: 267.100). Die Testkapazität für die laufende Woche liegt laut ALM mit rund 93.000 Tests pro Tag nochmals höher als in der Vorwoche. „Das zeigt, dass die Labore ihre Kapazitäten weiter erhöht haben“, betont Müller. Die Analyse des ALM stellt einen großen Teil der SARS-CoV-2- Labordiagnostik in Deutschland dar und wird mit weiteren Daten im RKI zum Gesamtbild zusammengeführt. „Wir wollen mit dem wöchentlichen Update zur SARS-CoV-2-Labordiagnostik einen entscheidenden Beitrag zur Sicherung der Versorgung leisten und unterstützen hier ausdrücklich RKI, BMG und Krisenstäbe vor Ort“, so der Facharzt für Laboratoriumsmedizin.
Die Corona-Pandemie stellt das deutsche Gesundheitswesen und die Gesellschaft derzeit vor große Herausforderungen. Die fachärztlichen Labore arbeiten mit Hochdruck jeden Tag – zum Teil im Dreischichtbetrieb – daran, die steigenden Anforderungszahlen von PCR-Tests auf das Coronavirus SARS-CoV-2 zu bewältigen. Dafür gibt es seitens der Ärzteschaft, der Krisenstäbe beim Bund und in den Ländern, aber auch von Bundesgesundheitsminister Jens Spahn immer wieder Anerkennung: „Im Vergleich zu anderen Ländern haben wir einen echten Mehrwert, dass wir so große Laborkapazitäten haben“, betonte der Bundesgesundheitsminister vergangene Woche in einer Pressekonferenz des BMG. So testet Deutschland beispielsweise weitaus mehr als die meisten europäischen Länder. „Deutschlands Labore sind extrem leistungsfähig und im internationalen Vergleich auch weit vorne“, sagt auch Evangelos Kotsopoulos. „Aus unserer Sicht ist auch in Zukunft eine ausreichende Testung möglich, sofern die RKI-Richtlinien für die Testindikation eingehalten werden und die Lieferkette seitens der Hersteller für Test-Reagenz und Laborverbrauchsmaterial funktioniert“, so der ALMVorstand. Kotsopoulos weist darauf hin, dass es aber nicht nur auf die materiellen Ressourcen der Labore ankommt: Es geht auch um die Ressource Mensch: „Unsere Fachkräfte im Labor arbeiten momentan schon im Dreischichtbetrieb – und sie haben mit den gleichen Herausforderungen zu kämpfen, wie wir alle – geschlossenen Schulen und Kitas.“
Die derzeit immer häufiger gestellte Frage nach neuen Antikörper-Tests beantwortet Prof. Jan Kramer, Vorstand im ALM und Facharzt für Laboratoriumsmedizin und Innere Medizin: „Es sind erste Tests zugelassen und diese werden in einigen Mitgliedslaboren des ALM bereits eingesetzt. Die AntikörperTestung im Blut ist jedoch keinesfalls für die Akutdiagnostik erkrankter Patienten mit der Lungenerkrankung Covid-19 gedacht und ersetzt nicht die Diagnostik mittels PCR aus respiratorischen Materialien, da Antikörper erst ca. 2 Wochen nach Symptombeginn und ca. 4 Wochen nach Infektion nachweisbar sind. “
Die Antiköpertestung , so Prof. Kramer, könnte eine wichtige Säule für die zweite Phase der CoronaKrise werden. „Antikörper-Testungen können bei Patienten, die aufgrund schon länger bestehender Symptome in der PCR aus Nasen-Rachen-Abstrich bereits negativ getestet wurden, Infektionen im Nachhinein nachweisen. Auch zur Aufklärung von Infektionsketten können Antikörper-Tests im medizinischen Labor beitragen. Zum Nachweis einer Immunität nach durchgemachter Infektion sollte der Antikörper-Test zum aktuellen Zeitpunkt aber nicht eingesetzt werden: „Wie bei jedem Labortest können falsch-positive Resultate vorkommen,“ betont Prof. Kramer. „Daher ist dringend davon abzuraten, alleine aufgrund eines Antikörper-Nachweises auf die empfohlenen Schutzmaßnahmen im Umgang mit möglichen oder gesicherten Covid-19-Patienten zu verzichten. Zudem gibt es bisher keine belastbaren Daten, ob ein Antikörper-Nachweis mit sicherer Immunität gleichzusetzen ist und wie lange dann Immunität bestehen würde.” Diese offenen Punkte sollen nun im klinischen Einsatz in Zusammenarbeit mit verschiedenen Herstellern und wissenschaftlichen Einrichtungen geklärt werden und dann in offiziellen Empfehlungen resultieren. Vom Einsatz der sogenannten AntikörperSchnellteste in der Arztpraxis ist bis dahin auf jeden Fall noch abzuraten.
Unisono betonen die Vorstände des ALM in der Pressekonferenz: „Unsere Mitarbeiterinnen und Mitarbeiter sind hoch motiviert und arbeiten unter erschwerten Bedingungen sehr engagiert. Wir geben täglich unser Bestes und stellen uns immer wieder neu auf die Situation ein. Wir hoffen, dass wir so aufgestellt, diese Pandemie gemeinsam durchstehen können und dabei unsere wichtige Arbeit für die Versorgung der Bevölkerung mit medizinischer Labordiagnostik leisten können.“
Vela Diagnostics to offer manual ViroKey™ SARS-CoV-2 RT-PCR Test after completion of Emergency Use Authorization validation, targeted to be by early April 2020
30 March 2020 - Vela Diagnostics will offer RT PCR tests to detect SARS-CoV-2 after validation
Singapore, March 30, 2020 – Ahead of Emergency Use Authorization (EUA) and in accordance with the U.S. Food and Drug Administration (FDA) Policy for Diagnostic Tests for Coronavirus Disease-2019 during the Public Health Emergency guidance document issued on March 16, 2020, Vela Diagnostics will offer the manual ViroKey™ SARS-CoV-2 RT-PCR Test when validation is completed. Validation is targeted to be completed by early April 2020. After validating the test, Vela Diagnostics will offer the assay immediately in accordance with Section IV.C. of FDA’s policy for Diagnostic Tests for Coronavirus Disease-2019 during the Public Health Emergency, dated March 16, 2020.
Vela Diagnostics is currently working with the FDA for authorization of the manual test under the February 4, 2020 existing public health emergency authorizing EUA of in vitro diagnostics for detection and / or diagnosis of the virus that causes COVID-19. The manual ViroKey™ SARS-CoV-2 RT-PCR Test is also on track to receive CE-IVD approval by the end of March.
In February 2020, Vela Diagnostics announced the development of the ViroKey™ SARS-CoV-2 RT-PCR Test for the detection of SARS-CoV-2, the virus that causes COVID-19. The ViroKey™ SARS-CoV-2 RT-PCR Test detects and differentiates the SARS-CoV-2 from other respiratory pathogens such as influenza. The manual assay was developed to facilitate quick adoption of the test by laboratories with existing Applied Biosystems 7500 Fast Dx Real-Time (ABI 7500 Fast Dx) PCR instruments. The Research Use Only (RUO) test is configured for an automated workflow consisting of the Sentosa™ SX101 instrument, in conjunction with the ABI 7500 Fast Dx or the Sentosa™ SA201 instruments.
To date, COVID-19 has affected 199 countries and territories around the world, with more than 240 000 cases in US, Europe and China combined and at least 27 000 fatalities worldwide. On 11 March 2020, the World Health Organization declared COVID-19 a pandemic.
About Vela Diagnostics
Vela Diagnostics is a leading provider of an automated IVD Next–Generation Sequencing (NGS) workflow in the global diagnostics market. VELA’s real-time PCR and NGS applications are available on an integrated Sentosa™ platform; this provides a unique ability to leverage one system for two workflows, while carrying out tests for various targets in order to answer current clinical and research questions, as well as to drive laboratory operational efficiency. All Sentosa™ products listed above are by Vela Diagnostics. For more information, visit www.veladx.com.
First patient outsiede U.S. treated in global Kevzara® (sarilumab) clinical trial program for patients with severe COVID-19
30 March 2020 - Phase 2/3 trial initiated in Italy, Spain, Germany, France, Canada and Russia and is enrolling patients immediately. Kevzara inhibits IL-6, which may play a role in driving the inflammatory immune response that causes acute respiratory distress syndrome observed in patients with severe COVID-19 infection. Regeneron is leading U.S. trials, Sanofi is leading ex-U.S. trials
TARRYTOWN, N.Y. and PARIS, March 30, 2020 -- Regeneron Pharmaceuticals, Inc. and Sanofi today announced the first patient outside of the U.S. has been treated as part of a global clinical program evaluating Kevzara® (sarilumab) in patients hospitalized with severe COVID-19. The global clinical program has now been initiated in Italy, Spain, Germany, France, Canada, Russia and the United States – all countries that have been impacted by COVID-19.
This is the second multi-center, double-blind, Phase 2/3 trial as part of the Kevzara COVID-19 program, and the companies are continuing to work with health authorities around the world to secure initiation at additional sites. This follows Regeneron and Sanofi's announcement earlier this month of the initiation of the first trial, which is U.S.-based.
"Data from a single-arm study in China suggest that the interleukin-6 pathway may play an important role in the overactive inflammatory response in the lungs of patients with COVID-19. Despite this encouraging finding, it's imperative to conduct a properly designed, randomized trial to understand the true impact of Kevzara, which we are now doing through this global clinical trial program," said George D. Yancopoulos, M.D., Ph.D., Co-founder, President and Chief Scientific Officer of Regeneron. "In addition to the Kevzara program, Regeneron continues to rapidly advance a novel antibody cocktail for the prevention and treatment of COVID-19."
Kevzara is a fully-human monoclonal antibody that inhibits the interleukin-6 (IL-6) pathway by binding and blocking the IL-6 receptor. IL-6 may play a role in driving the overactive inflammatory response in the lungs of patients who are severely or critically ill with COVID-19 infection. The role of IL-6 is supported by preliminary data from a single-arm study in China using another IL-6 receptor antibody.
"Sanofi and Regeneron are relentlessly working to rapidly initiate trials around the world that will help determine whether Kevzara has the potential to play a role in addressing the COVID-19 disease global health crisis. These trials will provide important data to determine whether Kevzara ameliorates the life-threatening complications of COVID-19 infections by counteracting the overactive inflammatory immune responses in the lungs when damaged by the virus. In these unprecedented times, we are deeply grateful for the daily collaboration with health authorities that is enabling us to conduct this clinical work so quickly," said John Reed, M.D., Ph.D., Sanofi's Global Head of Research and Development. "In addition to this clinical trial aiming to help critically ill COVID-19 patients, our work continues to bring forth a vaccine for disease prevention, along with efforts to provide other important Sanofi medicines that may help patients impacted by COVID-19."
The trial outside of the U.S. will assess the safety and efficacy of adding a single intravenous dose of Kevzara to usual supportive care, compared to supportive care plus placebo. The trial has an adaptive design with two parts and is anticipated to enroll approximately 300 patients. The trial will recruit hospitalized patients from several countries who are severely or critically ill with COVID-19 infection.
Scientists have preliminary evidence that IL-6 may play a key role in driving the inflammatory immune response that causes acute respiratory distress syndrome (ARDS) in patients critically ill from COVID-19. In an initial, non-peer-reviewed case series from China, a 21-patient cohort of COVID-19 patients experienced rapidly reduced fevers, and 75% of patients (15 out of 20) reduced their need for supplemental oxygen within days of receiving another IL-6 receptor antibody (tocilizumab). Based on these results, China updated its COVID-19 treatment guidelines and approved the use of that IL-6 inhibitor to treat patients with severe or critical disease.
The use of Kevzara to treat the symptoms of COVID-19 is investigational and has not been fully evaluated by any regulatory authority.
About the Trial
This Phase 2/3, randomized, double-blind, placebo-controlled trial uses an adaptive design to evaluate the safety and efficacy of Kevzara in adults hospitalized with serious complications from COVID-19. To enter the trial, patients must have pneumonia and be hospitalized with laboratory-confirmed COVID-19 that is classified as severe or critical, or who are suffering from multi-organ dysfunction. After receiving the study dose, patients will be assessed for 60 days, or until hospital discharge or death.
In the Phase 2 part of the trial, patients will be randomized 2:2:1 into three groups: Kevzara higher dose, Kevzara lower dose and placebo. The Phase 2 findings will be utilized in an adaptive manner to determine transition into Phase 3, helping to determine the endpoints, patient numbers and doses.
If the trial continues with all three treatment arms to the end, it is expected to enroll approximately 300 patients, depending on the status of the COVID-19 outbreak and the proportion of patients with severe COVID-19.
About Kevzara® (sarilumab) Injection
Kevzara is currently approved in multiple countries to treat adults with moderately to severely active rheumatoid arthritis who have not responded to or tolerated previous therapy.
Kevzara was jointly developed by Regeneron and Sanofi under a global collaboration agreement. Kevzara is a fully-human monoclonal antibody that was invented using Regeneron's proprietary VelocImmune® technology, which uses a unique genetically-humanized mouse to produce optimized fully human antibodies. Kevzara binds specifically to the IL-6 receptor, and has been shown to inhibit IL-6-mediated signaling. IL-6 is an immune system protein produced in increased quantities in patients with rheumatoid arthritis and has been associated with disease activity, joint destruction and other systemic problems. Kevzara is being investigated for its ability to reduce the overactive inflammatory immune response associated with COVID-19 based on evidence of markedly elevated levels of IL-6 in severely ill patients infected with coronaviruses.
What is Kevzara?
Kevzara is an injectable prescription medicine called an interleukin-6 (IL-6) receptor blocker. Kevzara is used to treat adult patients with moderately to severely active rheumatoid arthritis (RA) after at least one other medicine called a disease-modifying antirheumatic drug (DMARD) has been used and did not work well or could not be tolerated.
Click here for full Prescribing Information including risk of SERIOUS SIDE EFFECTS and Medication Guide for KEVZARA.
About Regeneron
Regeneron (NASDAQ: REGN) is a leading biotechnology company that invents life-transforming medicines for people with serious diseases. Founded and led for over 30 years by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to seven FDA-approved treatments and numerous product candidates in development, all of which were homegrown in our laboratories. Our medicines and pipeline are designed to help patients with eye diseases, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, pain, infectious diseases and rare diseases.
Regeneron is accelerating and improving the traditional drug development process through our proprietary VelociSuite® technologies, such as VelocImmune® which uses unique genetically-humanized mice to produce optimized fully-human antibodies and bispecific antibodies, and through ambitious research initiatives such as the Regeneron Genetics Center, which is conducting one of the largest genetics sequencing efforts in the world.
For additional information about the company, please visit www.regeneron.com or follow @Regeneron on Twitter.
About Sanofi
Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions.
With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe.
Abbott launches molecular point-of-care test to detect novel coronavirus in as five minutes
27 March 2020 - The Abbott ID NOW™ COVID-19 test brings rapid testing to the front lines. Test to run on Abbott's point-of-care ID NOW platform - a portable instrument that can be deployed where testing is needed most. ID NOW has the largest molecular point-of-care installed base in the U.S. and is available in a wide range of healthcare settings. Abbott will be making ID NOW COVID-19 tests available next week and expects to ramp up manufacturing to deliver 50,000 tests per day. This is the company's second test to receive Emergency Use Authorization by the FDA for COVID-19 detection; combined, Abbott expects to produce about 5 million tests per month.
ABBOTT PARK, Ill., March 27, 2020 -- Abbott announced today that the U.S. Food and Drug Administration (FDA) has issued Emergency Use Authorization (EUA) for the fastest available molecular point-of-care test for the detection of novel coronavirus (COVID-19), delivering positive results in as little as five minutes and negative results in 13 minutes. The test will run on the company's ID NOW™ platform, providing rapid results in a wide range of healthcare settings such as physicians' offices, urgent care clinics and hospital emergency departments.
The ID NOW platform is small, lightweight (6.6 pounds) and portable (the size of a small toaster), and uses molecular technology, which is valued by clinicians and the scientific community for its high degree of accuracy. ID NOW is already the most widely available molecular point-of-care testing platform in the U.S. today.
"The COVID-19 pandemic will be fought on multiple fronts, and a portable molecular test that offers results in minutes adds to the broad range of diagnostic solutions needed to combat this virus," said Robert B. Ford, president and chief operating officer, Abbott. "With rapid testing on ID NOW, healthcare providers can perform molecular point-of-care testing outside the traditional four walls of a hospital in outbreak hotspots."
Abbott will be making ID NOW COVID-19 tests available next week to healthcare providers in urgent care settings in the U.S., where the majority of ID NOW instruments are in use today. The company is working with the Administration to deploy tests to areas where they can have the greatest impact.
The arrival of the Abbott ID NOW COVID-19 test comes a week after the company launched its Abbott m2000™ RealTime SARS-CoV-2 EUA test, which runs on the m2000™ RealTime System located in hospital and reference labs around the world. Between the two platforms, Abbott expects to produce about 5 million tests per month.
About the ID NOW™ Molecular Platform
As the world leader in point-of-care diagnostics, Abbott is adding its expertise and scale to help fight the COVID-19 global pandemic. First introduced in 2014, ID NOW is the leading molecular point-of-care platform for Influenza A & B, Strep A and RSV testing in the U.S.
ID NOW is a rapid, instrument-based, isothermal system for the qualitative detection of infectious diseases. Its unique isothermal nucleic acid amplification technology provides molecular results in just minutes, allowing clinicians to make evidence-based clinical decisions during a patient visit.
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.
Connect with us at www.abbott.com, on LinkedIn at www.linkedin.com/company/abbott-/, on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews and @AbbottGlobal.
The ID NOW COVID-19 EUA has not been FDA cleared or approved. It has been authorized by the FDA under an emergency use authorization for use by authorized laboratories and patient care settings. The test has been authorized only for the detection of nucleic acid 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 Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.
Corona: Schnelltest gesucht
27 March 2020
27 March 2020 -- Das ZDF-Morgenmagazin war bei R-Biopharm zu Gast, um mit CEO Christian Dreher über den neuen Coronavirus-Test RIDA®GENE SARS-CoV-2 RUO zu sprechen. Der Beitrag mit dem Titel “Corona: Schnelltest gesucht” wurde am 27. März 2020 im ZDF-Morgenmagazin ausgestrahlt und ist auch online auf der Webseite des ZDF verfügbar.
Reference: https://clinical.r-biopharm.com/de/news/corona-schnelltest-gesucht/
EUROIMMUN is one of first European manufacturers of diagnostic tests to provide CE-marked antibody detection systems to support COVID-19 diagnostics
25 March 2020
March 25, 2020 -- The Anti-SARS-CoV-2 ELISAs for immunoglobulin classes A and G from EUROIMMUN, a PerkinElmer, Inc. company, have received the CE mark and can now be applied to COVID-19 diagnostics. The PCR test EURORealTime SARS-CoV-2 has been submitted for CE mark.
COVID-19 is currently significantly affecting the lives of people worldwide. At the end of January 2020, the World Health Organization declared the new infectious disease COVID-19 a global emergency. The Johns Hopkins University has reported more than 441,000 infections and 19,700 deaths as of 25 March 2020.
Coronaviruses form a large family of viruses which can cause mild colds, but also severe, sometimes fatal diseases of the respiratory tract. In the case of COVID-19, the infection has a mild course in the majority of patients. However, it may also cause severe, life-threatening pneumonia with acute respiratory distress syndrome.
As is the case with other infectious diseases, RT-PCR and serological tests are suited to investigate patients with suspected infections with SARS-CoV-2. RT-PCR technology plays a role especially in the early stage of a viral infection, in which the virus reproduces quickly. It enables direct detection of the pathogen. Serological tests, on the other hand, detect neutralizing antibodies in the blood. This means they are applied when an immune reaction to the pathogen has already taken place. Using this test, researchers may be able to determine how quickly antibodies to the virus are made, which could have implications in identifying individuals who have developed immunity.
At EUROIMMUN, the development of tests was initiated promptly after the virus became known, resulting in the introduction of two ELISAs for the detection of anti-SARS-Cov-2 antibodies of classes IgA and IgG. These are two of the first antibody detection tests to be CE marked in Europe and available for COVID-19 testing. While IgG antibodies indicate a persisting or even past infection, IgA antibodies are described as early markers of acute respiratory tract infections. In a recent study (Okba et al., doi: 10.1101/2020.03.18.20038059; March 2020) the additional value of specific IgA detection for early diagnostics of acute SARS-CoV-2 infections was confirmed. The good sensitivity and specificity of the ELISAs have also been proven. The developers underline that the antigen used in the EUROIMMUN Anti-SARS-CoV-2 ELISAs (IgA and IgG), the spike protein S1 domain, is more specific for the serological detection of SARS-CoV-2 antibodies than the more highly conserved N- or full-length S-proteins.
“The ELISAs are suited for screening on a large scale in order to identify persons who may have had contact with the virus even without noticing, have had an immune response, and have probably developed immunity,” explains Katja Steinhagen, Head of EUROIMMUN’s Business Division Immunobiochemistry Infectious Serology. They can also be applied to collect epidemiological data. Like almost all other ELISAs from EUROIMMUN, the Anti-SARS-CoV-2 ELISAs can be processed automatically using laboratory instruments.
The SARS-CoV-2 product range is completed by the EURORealTime SARS-CoV-2 for direct virus detection. This PCR-based test is currently only available for research use and has been submitted for CE mark.
Dr. Ulf Steller, Head of EUROIMUN’s Business Division Molecular Genetic Diagnostics explains: “The EURORealTime SARS-CoV-2 was developed for specific detection of COVID-19. Because the test detects two different genetic sequences of the virus simultaneously, it is very sensitive.”
As the demand for reliable COVID-19 diagnostic tests is steadily increasing, EUROIMMUN is working to expand the test production. “The worldwide demand for these tests is very high. We will do our best to respond to this need with effective testing solutions,” says EUROIMMUN’s CEO, Dr. Wolfgang Schlumberger.
Reference: http://ir.perkinelmer.com/news-releases/news-release-details/notification
Thermo Fisher Scientific Receives CE Mark for its Diagnostic Test to Detect COVID-19
26 March 2020 - Test will now be available for qualified laboratories across the European Union. Company provides update on other designated approvals received to date.
WALTHAM, Mass., March 26, 2020 -- Thermo Fisher Scientific Inc., the world leader in serving science, today announced that it has received the CE mark in the European Union for its diagnostic test to detect nucleic acid from SARS-CoV-2, the virus that causes COVID-19.
"The CE mark certification is an important step in combatting the outbreak of COVID-19 across Europe," said Marc N. Casper, chairman, president and chief executive officer of Thermo Fisher Scientific. "We are committed to fighting this disease and we will continue to work with regulatory authorities and customers around the world to expand the availability of diagnostic testing and stem the spread of the coronavirus."
The Thermo Fisher test, which uses Applied Biosystems TaqPath Assay and real-time PCR technology, is designed to provide patient results within four hours of a sample being received by a lab. The estimated time-to-result also includes time for sample preparation and instrument analysis.
This CE mark represents Thermo Fisher's assurance that its test complies with the European Union's In vitro Diagnostic Directive, which applies to products that are manufactured in or designed to be sold in the European Economic Area.
For more information about the CE-marked test, visit www.thermofisher.com/covid19ceivd
Update on Other Designated Approvals
Thermo Fisher Scientific received Emergency Use Authorization by the U.S. Food and Drug Administration for its COVID-19 test on March 13, 2020. This authorization was amended on March 24, 2020, to include additional instruments, such as the company's Applied Biosystems 7500 Fast Real-Time PCR System. This expands testing capabilities in the U.S. from approximately 1,000 instruments to more than 3,000 instruments on which Thermo Fisher's diagnostic test can be run. The expansion also includes manual sample extraction using the MagMax Viral/Pathogen Nucleic Acid Isolation Kit as well as Applied Biosystems COVID-19 Interpretive Software.
In addition to receiving the designated approvals in the U.S. and E.U., Thermo Fisher's diagnostic test has received the designated approvals in Canada, Singapore, India, Australia and New Zealand.
Thermo Fisher has created an online resource to make it easier to find up-to-date information about its response to the COVID-19 pandemic, including availability of its diagnostic test kits. Please refer to https://corporate.thermofisher.com/en/COVID-19.html for current news, information and frequently asked questions about COVID-19-related products and services that are vital to researchers, labs, healthcare workers and first responders worldwide.
About Thermo Fisher Scientific
Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $25 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, improving patient diagnostics and therapies or increasing productivity in their laboratories, we are here to support them. Our global team of more than 75,000 colleagues delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services and Patheon. For more information, please visit www.thermofisher.com.
Grifols Announces Formal Collaboration with US Government to Produce the First Treatment Specifically Targeting COVID-19
25 March 2020
Barcelona, March 25, 2020 – Grifols today announces that it has entered into a formal collaboration with the United States Biomedical Advanced Research Development Authority (BARDA), the Food and Drug Administration (FDA) and other Federal public health agencies to collect plasma from convalescent COVID-19 patients, process this specific plasma into a hyperimmune globulin and support the necessary preclinical and clinical studies to determine if anti-SARS-CoV-2 hyperimmune globulin therapy can successfully be used to treat COVID-19 disease. Grifols will volunteer its expertise and resources in the areas of plasma collection using its network of FDA-approved plasma donor centers; test and qualify donors in conjunction with other health agencies; process plasma into hyperimmune globulin in its purpose-built facility in Clayton, North Carolina, for the isolated processing of immune globulins to treat emerging infectious diseases; and support preclinical and clinical studies to determine whether hyperimmune globulin made from the plasma of convalescent donors can live up to its promise as a viable treatment for COVID-19 disease and as a platform for the treatment of future emerging infectious diseases.
This innovative public-private partnership presents opportunities to expedite development and, if successful, availability of a front-line therapeutic in the face of the spreading COVID-19 pandemic. The FDA is specifically working to reduce unnecessary regulatory hurdles and ensure a rapid turnaround without compromise to product safety or integrity.
As indicated by FDA Commissioner Stephen Hahn, M.D., during the President’s March 19 Coronavirus Task Force briefing, “There is a cross agency effort about … convalescent plasma. This is an exciting area … If you’ve been exposed to coronavirus and you are better … we could collect the [plasma], concentrate that … to be able to give that to other patients. The immune response could provide a benefit to patients.”
In addition to the development of a hyperimmune globulin as a therapy for COVID-19, Grifols is also providing support to utilize convalescent plasma for transfusion as a potential therapy by providing viral inactivation technology (methylene blue) to ensure inactivated plasma units for treatment use. (Grifols will be building a new facility in the Clayton site for this purpose.)
At Grifols we believe this current and extraordinary situation requires companies to strive more than ever to serve patients and society around the world and is proud to be working with the United States Public Health Agencies and personnel to combat COVID-19 disease.
This unique collaboration will provide the opportunity to validate a therapy that, if proven effective, can be used today in the face of the COVID-19 pandemic and for future outbreaks of novel emerging viruses.
At the same time, in Spain Grifols is working on a clinical trial with inactivated plasma from recovered patients (methylene blue) through a collaboration with select donation centers and public hospitals since, unlike in the U.S., in Spain there are no Grifols-owned plasma donation centers. In addition, the company is collaborating with certain hospitals in the design of diverse clinical studies on the use of certain plasma-derived products, such as intravenous immunoglobulin and alpha-1 antitrypsin, with the goal of proving their efficacy in the treatment of COVID-19.
In addition, Grifols has accelerated the development and validation of a proprietary technology TMA (transcription-mediated amplification) based diagnostic procedure, able to detect the virus with a sensitivity equivalent or even superior to that of PCR (polymerase chain reaction). The test will be performed on automatic instrumentation, with each unit able to run more than 1,000 samples per day, and that will be ready in the following weeks.
We are very thankful to our Grifols employees for their efforts in these unsettling times, and especially grateful to our donors for continuing to donate plasma, helping us all to make a difference.
Quidel’s Lyra® SARS-CoV-2 Assay receives authorization for expanded use for molecular detection of COVID-19; also receives CE Mark, Health Canada authorization
25 March 2020
SAN DIEGO, 25 March 2020 -- Quidel Corporation, a provider of rapid diagnostic testing solutions, cellular-based virology assays and molecular diagnostic systems, announced today that Quidel’s Lyra® SARS-CoV-2 Assay has received expanded Emergency Use Authorization (EUA) claims from the Food and Drug Administration (FDA) to allow testing with three additional thermocyclers: Applied Biosystems 7500 Standard, Roche LightCycler 480, and Qiagen Rotor-Gene Q.
Acceptable Specimens Expanded to Include Nasal and Nasal Turbinate Swabs
Under the initial EUA, the Lyra® SARS-CoV-2 Assay real-time RT-PCR test was intended for the qualitative detection of nucleic acid from SARS-CoV-2 in nasopharyngeal or oropharyngeal swab specimens from patients suspected of COVID-19 by their healthcare provider. The list of acceptable specimens has been expanded by the CDC to include nasal and nasal turbinate swabs. Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, to perform high complexity tests. EUAs allow for the early availability of important diagnostic tools “when there are no adequate, approved and available alternatives.”
The Lyra® reagents include unique features that provide for simple transport and storage, improved workflow, shorter time to result, and other benefits that favorably affect diagnostic test outcome. The Lyra SARS-CoV-2 Assay provides these and certain additional advantages over many other tests currently on the market for this novel coronavirus, including easier set-up and faster time to result.
Quidel Receives CE Mark, Health Canada Authorization
Separately, the Lyra® SARS-CoV-2 Assay received CE-Mark on March 25, 2020. The CE Mark allows Quidel to market and sell the Lyra® SARS-CoV-2 Assay in Europe, as well as other countries that accept the CE Mark. Also, on March 25, 2020, Quidel received authorization from Health Canada to market and sell the assay in Canada. The assay is currently available for sale in the United States under EUA and can be purchased by laboratory professionals through Quidel directly, or through their Cardinal Health representative.
About Quidel Corporation
Quidel Corporation serves to enhance the health and well-being of people around the globe through the development of diagnostic solutions that can lead to improved patient outcomes and provide economic benefits to the healthcare system. Marketed under the Sofia®, QuickVue®, D3® Direct Detection, Thyretain®, Triage® and InflammaDry® leading brand names, as well as under the new Solana®, AmpliVue® and Lyra® molecular diagnostic brands, Quidel’s products aid in the detection and diagnosis of many critical diseases and conditions, including, among others, influenza, respiratory syncytial virus, Strep A, herpes, pregnancy, thyroid disease and fecal occult blood. Quidel's recently acquired Triage® system of tests comprises a comprehensive test menu that provides rapid, cost-effective treatment decisions at the point-of-care (POC), offering a diverse immunoassay menu in a variety of tests to provide diagnostic answers for quantitative BNP, CK-MB, d-dimer, myoglobin, troponin I and qualitative TOX Drug Screen. Quidel’s research and development engine is also developing a continuum of diagnostic solutions from advanced immunoassay to molecular diagnostic tests to further improve the quality of healthcare in physicians’ offices and hospital and reference laboratories. For more information about Quidel’s comprehensive product portfolio, visit quidel.com.
Italian Researchers Identify New SARS-CoV-2 Gene Variants That Provide Clues to Coronavirus's Epidemiology
25 March 2020 - Scientists say early data, generated with new NGS research panel from Thermo Fisher Scientific, suggest coronavirus is genetically stable, and could increase the effectiveness of vaccines in development
CARLSBAD, Calif., March 25, 2020 -- Two teams of infectious disease researchers in Italy say they have further analyzed the SARS-CoV-2 genome from samples acquired locally to generate early data that reveal a level of genetic variability suggesting the rapidly spreading virus's genome is stable. The findings, developed using a new next-generation sequencing (NGS) research assay from Thermo Fisher Scientific, increase the likelihood that future coronavirus vaccines can have a higher rate of effectiveness and could help the global scientific community's effort to better understand the epidemiology and spread of COVID-19.
The two independent research teams from "Lazzaro Spallanzani" National Institute for Infectious Diseases (IRCCS) in Rome and the Forensic Division of the Department of Biomedical Sciences and Public Health (DSBSP) at Ancona University Hospital sequenced multiple samples and identified the presence of gene variants when compared against the original Wuhan coronavirus reference genome. Viruses that mutate rapidly over short periods of time make it challenging to develop effective vaccines that protect people against infection. The low number of variants discovered in the Italian samples two months after the virus was first sequenced in China suggests that SARS-CoV-2, which has infected more than an estimated 64,000 people in Italy and 380,000 globally, is a relatively slow-mutating pathogen. Both teams in Italy carried out the sequencing work with Thermo Fisher's new Ion AmpliSeq SARS-COV-2 Research Panel, which features a 24-hour, end-to-end workflow.
"The ability to very quickly run multiple samples and accurately decipher key changes in the virus's genetic code will be crucial for the global scientific community to stay ahead of SARS-CoV-2 and to develop strategies against it that, ultimately, can be leveraged to help resolve the pandemic," said Dr. Maria Rosaria Capobianchi, head of the Virology Department, Lazzaro Spallanzani National Institute for Infectious Diseases, which was the first research center in Europe to generated whole genome sequencing data of the coronavirus on Thermo Fisher's Ion Torrent NGS platform. "Viral genomes are dynamic and these preliminary data need further analysis to determine the biological significance of the gene variants and to investigate the evolutionary path of the coronavirus."
Professor Stefano Menzo, head of Virology at Ancona University Hospital, said: "Had we investigated other viruses we might have expected up to dozens of new mutations after so many infectious cycles in patients. Our initial data show that this is a very stable RNA virus, with only five novel variants. A virus with a stable genome is good news for vaccine development because it indicates that the effectiveness of vaccines could be more consistent, possibly over many years."
The scientists now plan to further analyze the data with Thermo Fisher's new Ion SARS-CoV-2 analysis solution* for variant annotation and consensus sequencing assembly to better understand the impact on disease severity, mode of transmission, and phylogenetic studies. The Ion AmpliSeq SARS-COV-2 Research Panel is a targeted NGS solution that analyzes the entire SARS-CoV-2 genome. It provides an efficient, high-throughput end-to-end workflow for monitoring genomic evolution, which is critical during a rapidly developing pandemic. The panel is optimized to run on the Ion GeneStudio S5 Systems.
Panel Optimization for Genexus System Underway
To further expedite NGS analysis of SARS-CoV-2 and to help meet growing customer demand, Thermo Fisher has begun to optimize the Ion AmpliSeq SARS-COV-2 Research Panel 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 as little as 14 hours. Optimization and validation of the research panel on the Genexus System is now underway in collaboration with Thermo Fisher customers.
"Thermo Fisher's immediate response to first develop a PCR SARS-CoV-2 diagnostic assay and now a next-generation sequencing research solution to help customers investigate coronavirus is at the core of our mission," said Peter Silvester, senior vice president and president of Life Sciences Solutions at Thermo Fisher Scientific. "We share the global community's heightened concern during this unprecedented public health crisis and, for this reason, we are continuing to maximize our efforts to provide our laboratory partners, infectious disease researchers and vaccine developers with the most advanced tools in support of their very important work."
About Thermo Fisher Scientific
Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $25 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, improving patient diagnostics and therapies or increasing productivity in their laboratories, we are here to support them. Our global team of more than 75,000 colleagues delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services and Patheon. For more information, please visit www.thermofisher.com.
QIAGEN releases QIAstat-Dx test kit to the U.S. as first syndromic test for detection of SARS-CoV-2 coronavirus under new FDA Policy
24 March 2020 - QIAstat-Dx syndromic testing system can differentiate novel coronavirus from 20 other respiratory targets. Requires less than one minute for sample preparation and delivers results in about one hour. Adds an important tool for clinicians as part of QIAGEN’s global mobilization to dramatically scale up production of testing supplies for global response to COVID-19 pandemic.
Germantown, Maryland, and Hilden, Germany, March 24, 2020 – QIAGEN today announced that it has begun shipments to the United States of its new QIAstat-Dx Respiratory SARS-CoV-2 Panel test to aid in diagnosing patients infected with the novel COVID-19 coronavirus under a new Policy of the U.S. Food and Drug Administration (FDA) announced on March 16. QIAGEN will submit this week the related Emergency Use Authorization (EUA) to the FDA.
The QIAstat-Dx test kit can differentiate the SARS-CoV-2 coronavirus from 20 other respiratory infections in patients who may have similar symptoms in a single testing run of about one hour. It is a multiplexed nucleic acid test that evaluates samples such as nasopharyngeal swabs obtained from individuals suspected of respiratory tract infections. This new panel includes assays targeting two genes used to detect SARS-CoV-2, the pathogen behind the disease.
“We are pleased to begin making QIAstat-Dx SARS-CoV-2 test kits available in the United States as the first syndromic test not only to detect SARS-CoV-2, but also a range of more than 20 other respiratory targets. This is an important step in our commitment to offer a range of solutions to support the public health fight against COVID-19 and dramatically ramp up production,” said Thierry Bernard, Chief Executive Officer of QIAGEN. “Our teams have responded rapidly to the challenge, implementing 24/7 production of test components, adding staff and investing in expanding production capacity. In addition to QIAstat-Dx, we are supplying RNA extraction kits to the U.S. and other countries around the world, and are committed to accelerating these efforts.”
The release of this new QIAstat-Dx test also comes after it was announced on March 13, 2020, that QIAGEN receive funding for this project in part from the U.S. 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 75A50120C00014.
QIAGEN began shipping QIAstat-Dx SARS-CoV-2 test kits to other countries in February 2020 for clinical validation and has dramatically ramped up production of the respiratory panels. The kits run on QIAstat-Dx instruments, QIAGEN’s Sample to Insight syndromic system that automates molecular analysis to deliver differential diagnosis in about one hour. QIAGEN has placed more than 1,100 QIAstat-Dx instruments worldwide in hospitals, clinics and laboratories, including over 200 in the U.S. since FDA clearance of the QIAstat-Dx Analyzer was granted in May 2019.
The automation system enables fast, cost-effective and easy-to-use syndromic testing with Sample to Insight workflows. A technician simply loads a clinical sample (such as a swab) into a single-use QIAstat-Dx cartridge and places it in the analyzer. QIAGEN chemistries for DNA and RNA sample processing and analysis are built into the instrument, and the QIAstat-Dx instrument delivers results in about one hour.
In the evolving global response to the coronavirus outbreak, the regulatory status of the QIAstat-Dx Respiratory SARS-CoV-2 Panel will vary by location.
In addition, the panel detects the following pathogens and subtypes of respiratory infections: Adenovirus, Coronavirus 229E, Coronavirus HKU1, Coronavirus NL63, Coronavirus OC43, Human Metapneumovirus A+B, Influenza A, Influenza A H1, Influenza A H3, Influenza A H1N1/pdm09, Influenza B, Parainfluenza Virus 1, Parainfluenza Virus 2, Parainfluenza Virus 3, Parainfluenza Virus 4, Rhinovirus/Enterovirus, Respiratory Syncytial Virus A+B, Bordetella pertussis, Chlamydophila pneumoniae and Mycoplasma pneumoniae.
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, 2019, QIAGEN employed approximately 5,100 people in over 35 locations worldwide. Further information can be found athttp://www.qiagen.com.
Reference: https://corporate.qiagen.com/newsroom/press-releases/2020/20200323_qiastat_covid19_fda
Roche response to COVID-19 pandemic
24 March 2020 - Roche accelerates delivery and production of Actemra. Roche is working around the clock to increase availability of COVID 19-tests. Roche calls on governments across the world to work closely with industry to keep manufacturing and supply running.
Basel, 24 March 2020 -- Roche Group today provided an update on the various actions the company is taking to address the COVID-19 pandemic.
Roche initiates global phase III study and collects data on Actemra’s potential utility in severe COVID-19 pneumonia patients
On March 19, 2020, Roche confirmed initiation of a randomised, double-blind, placebo-controlled Phase III clinical trial in collaboration with the Biomedical Advanced Research and Development Authority (BARDA), a part of the US Health and Human Services Office of the Assistant Secretary for Preparedness and Response (ASPR). The study, COVACTA, will evaluate the safety and efficacy of intravenous Actemra®/RoActemra® (tocilizumab) on top of standard of care in hospitalised adult patients with severe COVID-19 pneumonia compared to placebo on top of standard of care.
This is the first global study of Actemra/RoActemra in this setting. In addition to the Roche trial, Roche is also carefully following independently-led clinical trials, on multiple medicines including Actemra, that are taking place around the world.
At the moment, there are no robust, well-controlled studies showing safety and efficacy of Actemra in clinical treatment of COVID-19 pneumonia, and Actemra is not currently approved for this use.
Actemra Manufacturing and Supply
Despite some of the supply and logistics challenges due to COVID-19, Roche has been able to continue to deliver life-saving medicines to patients around the world, thanks to the resilience of its global network. Currently, we continue to see limited disruption, and are continually monitoring the situation.
With the announcement of new clinical trials, and a potential increase in demand for Actemra, Roche is working urgently to accelerate manufacturing capacity to maximize production of Actemra wherever possible with the goal of increasing available supply globally.
While Roche is ensuring a coordinated, global overview of additional supply requests, provision of medicines is managed on a country level according to local rules and regulations and in close collaboration with the authorities.
Cobas® SARS-CoV-2 Test to detect the novel virus that causes COVID-19 disease
As a leader in diagnostics, Roche is committed to providing testing solutions for the world’s most challenging healthcare emergencies. On March 12, 2020, Roche received FDA Emergency Use Authorization for the cobas® SARS-CoV-2 Test to detect the novel virus that causes COVID-19 disease. The test is also available in markets accepting the CE mark.
Roche is committed to delivering as many tests as possible within the limits of supply and delivering its coronavirus tests to areas where they can be immediately effective. Tests will be shipped from Roche’s production sites to locations where appropriate infrastructure is in place and testing can begin without delay.
At the current maximum production rate, Roche can supply millions of tests per month on the cobas 6800/8800 instruments and on the MagnaPure / Lightcycler solution. Roche is working around the clock to increase that quantity as the company recognises the importance of patients having access to these critical tests.
To safeguard supply, Roche strongly advises to focus COVID-19 testing on patients with signs and symptoms of the disease, not broad testing of the healthy population.
Industry, governments and society must work together to tackle this pandemic
Roche is committed to doing all we can to ensure adequate supply of our medicines and tests during this pandemic, but we cannot do it alone. Roche is calling on governments across the world to work closely with industry to keep manufacturing and supply running, and to help us meet demand across the globe.
- Ensure the free flow of vital goods across national borders to keep manufacturing and supply running;
- Consider pragmatic temporary adjustments to regulations on packaging, reviews,
customs etc, to expedite delivery of urgently needed medical supplies; - Work together across governments internationally, in order to balance global needs.
About Roche
Roche is a global pioneer in pharmaceuticals and diagnostics focused on advancing science to improve people’s lives. The combined strengths of pharmaceuticals and diagnostics under one roof have made Roche the leader in personalised healthcare – a strategy that aims to fit the right treatment to each patient in the best way possible.
Roche is the world’s largest biotech company, with truly differentiated medicines in oncology, immunology, infectious diseases, ophthalmology and diseases of the central nervous system. Roche is also the world leader in in vitro diagnostics and tissue-based cancer diagnostics, and a frontrunner in diabetes management.
Founded in 1896, Roche continues to search for better ways to prevent, diagnose and treat diseases and make a sustainable contribution to society. The company also aims to improve patient access to medical innovations by working with all relevant stakeholders. More than thirty medicines developed by Roche are included in the World Health Organization Model Lists of Essential Medicines, among them life-saving antibiotics, antimalarials and cancer medicines. Moreover, for the eleventh consecutive year, Roche has been recognised as one of the most sustainable companies in the Pharmaceuticals Industry by the Dow Jones Sustainability Indices (DJSI).
The Roche Group, headquartered in Basel, Switzerland, is active in over 100 countries and in 2019 employed about 98,000 people worldwide. In 2019, Roche invested CHF 11.7 billion in R&D and posted sales of CHF 61.5 billion. Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan. For more information, please visit www.roche.com.
Reference: https://www.roche.com/media/releases/med-cor-2020-03-24.htm
Mesa Biotech Receives Emergency Use Authorization from FDA for a 30 Minute Point of Care Molecular COVID-19 Test
24 March 2020 - Easy to use, palm-sized system will enable broader use across healthcare facilities closer to the patients and will begin shipping immediately
SAN DIEGO, CA, March 24, 2020 – Today, Mesa Biotech announced it has received Emergency Use Authorization (EUA) from the U.S. Food & Drug Administration (FDA) for its Accula™ SARS-CoV-2 Test, which gives COVID-19 diagnostic results in 30 minutes. Mesa Biotech Inc., a privately-held, molecular diagnostic company has developed an affordable, easy to use, testing platform designed for point-of-care (POC) infectious disease diagnosis. The COVID-19 test uses this patented technology to enable ‘near patient’ testing allowing testing outside of the central laboratory.
“Mesa is excited to immediately begin shipping our rapid, molecular SARS-CoV-2 test so people can get answers in 30 minutes. Our Accula system is easy to use and fits in the palm of your hand. This allows many units to be run side by side in the doctor’s office further increasing the speed of COVID-19 diagnosis. Accula provides a true decentralized testing solution for COVID-19 at the point of care,” said Hong Cai, Co-founder and Chief Executive Officer, Mesa Biotech, Inc. “Our test will provide a highly accessible means for healthcare professionals to access laboratory quality results close in their office to aid in the decision to isolate, treat or dismiss potential carriers of the virus. The potential to reduce the growing strain on our nation’s hospitals is tremendous.”
The Accula SARS-CoV-2 Test is a visually read test using polymerase chain reaction (PCR) technology to detect SARS-CoV-2 (the virus responsible for COVID-19) via throat and nasal swab samples. Similar to Mesa Biotech’s commercially available tests for influenza and RSV, the Accula SARS-CoV-2 Test is designed for the point-of-care use, including temporary screening facilities, physician office labs, urgent care, and long term nursing facilities. The system complements central laboratories where current testing is performed. Mesa Biotech’s compact coronavirus test yields laboratory-quality results in approximately 30 minutes.
Mesa Biotech’s technology was developed at Los Alamos National Lab supported by NIH grants from the National Institute of Allergy and Infectious Diseases (NIAID) and the Western Regional Centers for Excellence in Biodefense and Emerging Infectious Disease program. Last week, the company received funding from the U.S. Health and Human Services for development of its SARS-CoV-2 test. Since its inception, the company has focused on technology well-suited for emergency defense and rapid deployment for SARS, Ebola and other emerging infectious diseases. Mesa Biotech’s platform was specifically designed for use outside the lab to enable rapid responses to global pandemics, such as COVID-19.
About Mesa Biotech Inc.
Mesa Biotech designs, develops, manufactures and commercializes next generation molecular diagnostic tests, bringing the superior diagnostic performance of nucleic acid PCR amplification to the point-of-care. Mesa Biotech's Accula™ 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). Both products are distributed in the United States by Sekisui Diagnostics under the Silaris™ brand. Mesa Biotech has also secured a number of strategic agreements for distribution in Europe and Asia. For more information visit http://www.mesabiotech.com/coronavirus
FDA Provides Emergency Use Authorization to PerkinElmer for COVID-19 Testing
24 March 2020
WALTHAM, Mass., March 24, 2020 -- PerkinElmer, Inc., a global leader committed to innovating for a healthier world, announced today that the U.S. Food and Drug Administration (FDA) has provided Emergency Use Authorization (EUA) for the Company’s New Coronavirus RT-PCR test. Clinical laboratories certified under Clinical Laboratory Improvement Amendments (CLIA) can immediately begin using this kit to detect SARS-CoV-2, the virus that causes COVID-19. PerkinElmer’s RT-PCR test is marketed as an in vitro diagnostic (IVD) device by meeting the requirements of the European In Vitro Diagnostic Directive (IVDD) and is available in over 30 countries worldwide.
“Despite the challenging environment, our employees have demonstrated unwavering commitment over the past two months to combat this global pandemic,” said Prahlad Singh, president and chief executive officer, PerkinElmer. “The breadth of PerkinElmer’s total workflow solution puts us in a unique position to rapidly address the needs of our clinical diagnostics customers.”
About PerkinElmer
PerkinElmer enables scientists, researchers and clinicians to address their most critical challenges across science and healthcare. With a mission focused on innovating for a healthier world, we deliver unique solutions to serve the diagnostics, life sciences, food and applied markets. We strategically partner with customers to enable earlier and more accurate insights supported by deep market knowledge and technical expertise. Our dedicated team of about 13,000 employees worldwide is passionate about helping customers work to create healthier families, improve the quality of life, and sustain the wellbeing and longevity of people globally. The Company reported revenue of approximately $2.9 billion in 2019, serves customers in 190 countries, and is a component of the S&P 500 index. Additional information is available through 1-877-PKI-NYSE, or at www.perkinelmer.com.
bioMérieux receives Emergency Use Authorization for BIOFIRE® COVID-19 test
24 March 2020
24 March 2020 -- bioMérieux, a world leader in the field of in vitro diagnostics, today announced that its subsidiary, BioFire Defense, has received Emergency Use Authorization by the U.S. Food and Drug Administration of its BIOFIRE® COVID-19 test for use in CLIA moderate and high complexity clinical laboratories to detect SARS-CoV-2.
The BIOFIRE® COVID-19 test detects SARS-CoV-2 in approximately 45 minutes from a nasopharyngeal swab in transport media. This test runs on the fully automated FILMARRAY® 2.0 and FILMARRAY® TORCH platforms and is extremely easy to use, therefore requiring minimal training and skills in molecular biology.
BIOFIRE® COVID-19 was developed with funding from the U.S. Department of Defense (DoD) by leveraging an existing contract agreement with BioFire Defense. This is the second of three tests being developed for diagnostic use as part of bioMérieux’s strategic response to the COVID-19 pandemic.
“The rapid development of this test is a combined result of the extensive effort and dedication of our employees, the assistance of our partner Midwest Research Institute Global, and the confidence entrusted to us by the U.S. Department of Defense”, said Bob Lollini, CEO of BioFire Defense.
bioMérieux is currently making every effort to scale up supply of the BIOFIRE® COVID-19 test at multiple production facilities in Salt Lake City (Utah, USA). The initial test kits are committed to the DoD for redistribution. Test kits will be available for commercial distribution in the United States under the EUA as well as internationally where regulatory approval allows. bioMérieux expects to have maximum production capability within a few weeks to address the needs of the thousands of labs and healthcare professionals using one of the nearly 11 000 BIOFIRE® systems worldwide.
“In the face of this unprecedented global health crisis, bioMérieux is now launching a second diagnostic test for the detection of SARS-CoV2. True to our commitment to public health we are making every effort to provide a comprehensive diagnostic approach that meets the highest performance and quality standards to help physicians mount an effective response to the ongoing COVID-19 pandemic”, said Dr. Mark Miller, Executive Vice President and Chief Medical Officer of bioMérieux.
bioMérieux has also received authorization to sell the BIOFIRE® COVID-19 test External Control Kit. This positive control material may be used for quality control and laboratory verification of the test.
About bioMérieux’s commitment to fight COVID-19 pandemic
bioMérieux already launched the SARS-COV-2 R-GENE® test. This real-time PCR test running on open platforms has been validated by the French Reference Center for respiratory infectious diseases, highlighting its excellent performance. It is produced and available in France and is expected to be rapidly CE-marked and submitted to the FDA for an EUA (Emergency Use Authorization) as well.
bioMérieux is also developing an expanded version of its BIOFIRE® FILMARRAY® Respiratory Panel 2, which will be called the BIOFIRE® Respiratory Panel 2.1 (RP2.1). This new panel will include SARS-CoV-2 in addition to the 21 other common respiratory pathogens and will deliver results in approximately 45 minutes. It will also be available on the FILMARRAY® 2.0 and FILMARRAY® TORCH platforms.
About Emergency Use Authorization
The BIOFIRE® COVID-19 test has not been FDA cleared or approved. This test has been authorized by FDA under an EUA for use by authorized laboratories only for the detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens.
This test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics 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 the BIOFIRE® FILMARRAY® solution
The BIOFIRE® FILMARRAY® is an FDA-cleared and CE-marked multiplex PCR closed and fully-automated system that integrates sample preparation, amplification, and detection. A BIOFIRE® FILMARRAY® test requires only two minutes of hands-on time and has a total run time of about 45 to 75 minutes, depending on the panel.
The BIOFIRE® FILMARRAY® range has the largest infectious disease pathogen menu commercially available, composed of:
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BIOFIRE® Respiratory Panel (RP, RP2 and RP2plus), identifying between 20 and 22 respiratory viruses and bacteria performed directly on nasopharyngeal swabs in transport media.
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BIOFIRE® RP EZ, identifying 11 viral and 3 bacterial pathogens associated with respiratory infections. FDA-cleared and CLIA-waived for use in the US only.
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BIOFIRE® Pneumonia (PN) and Pneumonia plus (PNplus) Panel, identifying 33 to 34 targets (18 bacteria, 8 to 9 viruses, 7 resistant genes to antibiotics) in sputum (including endotracheal aspirate) and bronchoalveolar lavage (including mini-BAL). 15 of the bacterial targets are reported with semi-quantitative information about the abundance of organism in a given sample.
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BIOFIRE® Blood Culture Identification (BCID) Panel, identifying 27 of the most common causes of bloodstream infections and associated antimicrobial resistances directly from positive blood culture.
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BIOFIRE® Gastrointestinal (GI) Panel, identifying 22 of the most common viral, bacterial, and parasitic causes of infectious diarrhea directly from stool in Cary Blair transport media.
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BIOFIRE® Meningitis/Encephalitis (ME) Panel, identifying 14 bacterial, viral, and fungal causes of meningitis and encephalitis directly from cerebrospinal fluid.
Reference: https://www.biomerieux.com/en/biomerieux-receives-emergency-use-authorization-biofirer-covid-19-test
LabCorp Developing Options to Prioritize COVID-19 Testing for Inpatient Population in Support of Guidance from the White House Coronavirus Task Force
23 March 2020 - Company also preparing to support faster point-of-care testing for COVID-19 in hospitals once available
BURLINGTON, N.C., Mar. 23, 2020 -- LabCorp, a leading global life sciences company that is deeply integrated in guiding patient care, today announced that it is exploring all options to prioritize COVID-19 testing for the hospital inpatient population who are being treated for what the physician suspects may be the COVID-19 virus. The company anticipates finalizing options through the week and will subsequently work with hospitals to begin implementation.
LabCorp continues to add capacity to perform testing for patients who should be tested in accordance with Centers for Disease Control and Prevention (CDC) and other health authority guidelines.
“LabCorp colleagues around the world are working tirelessly alongside our industry partners and governmental and health authorities to increase testing and capacity,” said Adam Schechter, president and CEO of LabCorp. “We are aligned with the Administration’s guidance and are actively encouraging all healthcare providers to follow the guidance to prioritize testing for patients who are hospitalized and being treated for suspected COVID-19. We are exploring all options to make this happen and will continue to do all we can to help fight this unprecedented health crisis.”
LabCorp is also preparing to help hospitals for whom it provides technical support services to perform on-site serological and molecular tests for COVID-19, including Cepheid’s recently announced Xpert Xpress SARS-CoV-2 molecular test, once available. LabCorp remains in close contact with manufacturers that are developing additional test options, and will work with healthcare providers to help them prepare to use these tests when they become available.
LabCorp continues to play a vital role in supporting the public response to COVID-19 and has moved quickly to increase its testing capacity by adding staff, equipment and more high-throughput testing. On Friday, March 20,LabCorp announced that it has the ability to perform more than 20,000 COVID-19 tests per day. This represents a significant increase in capacity since the company released its COVID-19 test on March 5, 2020. The company is working continuously to support the needs of healthcare workers, patients, government, clients and other organizations, and expects capacity to continue to increase.
LabCorp is now performing COVID-19 testing in three of its largest labs in the country.
About LabCorp
LabCorp (NYSE: LH), an S&P 500 company, is a leading global life sciences company that is deeply integrated in guiding patient care, providing comprehensive clinical laboratory and end-to-end drug development services. With a mission to improve health and improve lives, LabCorp delivers world-class diagnostics solutions, brings innovative medicines to patients faster, and uses technology to improve the delivery of care. LabCorp reported revenue of more than $11.5 billion in 2019. To learn more about LabCorp, visit www.LabCorp.com, and to learn more about Covance Drug Development, visit www.Covance.com.
Cepheid Receives Emergency Use Authorization from FDA for Rapid SARS-CoV-2 Test
21 March 2020 - First Rapid, Point-of-Care and Near-Patient Molecular Test for Detection of Virus that Causes COVID-19
SUNNYVALE, Calif., March 21, 2020 -- Cepheid today announced it has received Emergency Use Authorization (EUA) from the U.S. Food & Drug Administration (FDA) for Xpert® Xpress SARS-CoV-2, a rapid molecular diagnostic test for qualitative detection of SARS-CoV-2, the virus causing COVID-19. The test has been designed to operate on any of Cepheid's more than 23,000 automated GeneXpert® Systems worldwide, with a detection time of approximately 45 minutes.
"During this time of increased demand for hospital services, Clinicians urgently need an on-demand diagnostic test for real-time management of patients being evaluated for admission to health-care facilities. An accurate test delivered close to the patient can be transformative — and help alleviate the pressure that the emergence of the 2019-nCoV outbreak has put on healthcare facilities that need to properly allocate their respiratory isolation resources," said Dr. David Persing, MD, Ph.D., Chief Medical and Technology Officer at Cepheid. "By leveraging the design principles of our current Xpert Xpress Flu/RSV cartridge technology, in which multiple regions of the viral genome are targeted to provide rapid detection of current and potential future variants of SARS-CoV-2, we have developed a test that provides reference lab-quality results in multiple settings where actionable treatment information is needed quickly."
"Cepheid currently has nearly 5,000 GeneXpert® Systems in the US capable of point-of-care testing and for use in hospitals," said Cepheid President Warren Kocmond. "Our automated systems do not require users to have specialty training to perform testing — they are capable of running 24/7, with many systems already doing so today."
The test will begin shipping next week. For more information about Cepheid's Xpert Xpress SARS-CoV-2 test, please visit www.cepheid.com/coronavirus.
About Cepheid
Based in Sunnyvale, Calif., Cepheid is a leading molecular diagnostics company that is an operating company within Danaher Corporation's (NYSE: DHR) Diagnostics platform. Cepheid is dedicated to improving healthcare by developing, manufacturing, and marketing accurate yet easy-to-use molecular systems and tests. By automating highly complex and time-consuming manual procedures, the company's solutions deliver a better way for institutions of any size to perform sophisticated genetic testing for organisms and genetic-based diseases. Through its strong molecular biology capabilities, the company is focusing on those applications where accurate, rapid, and actionable test results are needed most, such as managing infectious diseases and cancer. For more information, visit http://www.cepheid.com.
New Studies Find Bio-Rad’s QX200 Droplet Digital PCR System Can Detect COVID-19 with Greater Sensitivity and Precision than Other Existing Molecular Tests
19 March 2020
HERCULES, Calif., 19 March 2020 – Bio-Rad Laboratories, Inc., a global leader of life science research and clinical diagnostic products, today announced that in two studies published this month, ahead of peer-review, researchers in China reported that Bio-Rad’s QX200 Droplet Digital PCR (ddPCR) System showed superior sensitivity and precision for clinical detection of SARS-CoV-2 (the virus that causes COVID-19) compared to existing test methods that are performed using qPCR.
In the first study, clinicians in Wuhan, China observed that a subset of infected individuals who tested negative for COVID-19 using qPCR tested positive using ddPCR. The findings suggest that ddPCR can reduce false negative results of COVID-19 without any increase to false positive results, and could be a powerful complement to the current standard of testing.
The second study, led by the National Institute of Metrology and provincial CDCs in China, also concluded that Droplet Digital PCR significantly improves diagnostic detection accuracy of SARS-CoV-2 from 28.2% to 87.4%, thereby reducing false negatives. Furthermore, they found that Droplet Digital PCR is more sensitive and suitable for low virus load specimens from patients under isolation and observation even without any clinical symptoms.
"Bio-Rad is working to make ddPCR-based tests available for COVID-19 detection and is partnering with Biodesix in Colorado to bring an Emergency Use Authorization (EUA) test online," said Norman Schwartz, Bio-Rad President and Chief Executive Officer. "By more quickly identifying those who test positive for the virus, individuals can be quarantined and receive treatment as quickly as possible, helping to contain the spread of COVID-19."
About Bio-Rad
Bio-Rad Laboratories, Inc. is a global leader in developing, manufactu