Thermo Fisher Scientific to Acquire PPD, Inc., a Leading Clinical Research Organization
15 April 2021 - Further expands service offering to pharma and biotech customers - Establishes Thermo Fisher as a global leader in the attractive and high growth clinical research services industry - Adds highly complementary services for the company's fastest growing end market - Offers both meaningful cost and revenue synergies which will further accelerate growth - Expected to be immediately and significantly accretive to Adjusted Earnings Per Share (EPS) after close
WALTHAM, Mass. and WILMINGTON, N.C., April 15, 2021 -- Thermo Fisher Scientific Inc. ("Thermo Fisher"), the world leader in serving science, and PPD, Inc. ("PPD"), a leading global provider of clinical research services to the pharma and biotech industry, today announced that their boards of directors have approved a definitive agreement under which Thermo Fisher will acquire PPD for $47.50 per share for a total cash purchase price of $17.4 billion plus the assumption of approximately $3.5 billion of net debt. This represents a premium of approximately 24% to the unaffected closing price of PPD's common stock on the Nasdaq as of Tuesday, April 13, 2021, or 32% to the 60-day VWAP inclusive of that date.
PPD provides a broad range of clinical research and laboratory services to enable customers to accelerate innovation and increase drug development productivity. A leader in the growing $50 billion clinical research services industry, PPD has more than 26,000 colleagues operating in nearly 50 countries. In 2020, the company generated revenue of $4.7 billion. Upon close of the transaction, PPD will become part of Thermo Fisher's Laboratory Products and Services Segment.
"Pharma and Biotech is our largest and fastest growing end market, and our customers value us as a strategic partner and an industry leader. The acquisition of PPD is a natural extension for Thermo Fisher and will enable us to provide these customers with important clinical research services and partner with them in new and exciting ways as they move a scientific idea to an approved medicine quickly, reliably and cost effectively," said Marc N. Casper, chairman, president and chief executive officer, Thermo Fisher Scientific. "Longer term, we plan to continue to invest in and connect the capabilities across the combined company to further help our customers accelerate innovation and drive productivity, while driving further value for our shareholders."
David Simmons, chairman and chief executive officer, PPD, said, "This is a very exciting announcement for our shareholders and will provide customers with an even better opportunity to bring meaningful innovation to the market faster and more efficiently. Thermo Fisher is a world-class company with a very similar culture and values and will provide a great foundation for our colleagues to continue to deliver for our customers and to develop their own skills and careers."
Casper added, "Both companies have complementary mission-driven cultures, and I can't wait to welcome PPD's colleagues from around the world to Thermo Fisher once the transaction is completed."
Benefits of the Transaction
Establishes Thermo Fisher as One of the Global Leaders in the Attractive, High Growth Clinical Research Services Industry
PPD serves a $50 billion industry forecasted to grow long-term in the mid-single digits, driven by scientific breakthroughs, the continued expected robust funding for drug discovery and the need for strategic suppliers for the pharma and biotech industry to help them bring safe and effective medicines to the patients that need them. PPD has invested significantly in its capabilities and is one of the leading global players providing services to both emerging biotech customers and to all of the top pharma companies in the world.
Combination Further Enhances Thermo Fisher's Value Proposition for Pharma and Biotech Customers by Adding Highly Complementary Services
Thermo Fisher is a leading supplier to the pharma and biotech industry, supporting research and development, clinical trials and production. PPD enhances Thermo Fisher's offering, bringing a proven drug development platform, excellent patient recruitment capabilities, strong laboratory services and a complementary reputation for excellent quality and service. These combined capabilities further enhance Thermo Fisher's value proposition to pharma and biotech customers and allow them to more efficiently access these services, which are key enablers of their success.
Creates Meaningful Benefits for Customers
In the near-term, Thermo Fisher's access to key decision makers in pharma and biotech companies will increase the opportunities for PPD to win additional work from existing and new customers as the pandemic has further highlighted the need for these customers to develop strategic relationships with their key suppliers. The combined company's extensive capabilities and knowledge in serving the pharma and biotech industry will enable new solutions for customers that create the potential to reduce the time and cost of the drug development process.
Delivers Attractive Financial Benefits
The transaction is expected to be immediately and significantly accretive to Thermo Fisher's adjusted EPS, adding $1.40 in the first 12 months after close. Thermo Fisher expects to realize total synergies of approximately $125 million by year three following close, consisting of approximately $75 million of cost synergies and approximately $50 million of adjusted operating income benefit from revenue-related synergies.
Approvals and Financing
The transaction, which is expected to be completed by the end of 2021, is subject to the satisfaction of customary closing conditions, including the receipt of applicable regulatory approvals.
In addition to board approval, shareholders holding in aggregate approximately 60% of the issued and outstanding shares of common stock of PPD have approved the transaction by written consent. No further action by other PPD shareholders is required to approve the transaction.
Thermo Fisher has obtained committed bridge financing with respect to a portion of the purchase price. To fund the transaction, Thermo Fisher intends to use proceeds from debt financing and cash on hand.
Advisors
Barclays Capital, Inc. and Morgan Stanley & Co. LLC are serving as financial advisors to Thermo Fisher, and Cravath, Swaine & Moore LLP and Arnold & Porter Kaye Scholer LLP are serving as legal counsel. For PPD, J.P. Morgan Securities LLC is serving as exclusive financial advisor, while Simpson, Thacher & Bartlett LLP is serving as legal counsel.
Conference Call and Webcast
Thermo Fisher will host a conference call and webcast at 8:30 a.m. Eastern Time today to provide more information on this announcement. The webcast and accompanying slides can be accessed in the Investors section of www.thermofisher.com. An audio archive of the call will be available in that section of the website until April 29, 2021.
ALM-Update: Corona-Maßnahmen konsequent beibehalten und die besorgniserregenden Varianten (B.1.1.7) mehr beachten
13 April 2021
13 April 2021 -- Eine weiterhin steigende Positivrate und die starke Verbreitung der Varianten – insbesondere der Variante B.1.1.7 – das zeigen die aktuellen Ergebnisse der Datenauswertung der Akkreditierten Labore in der Medizin – ALM e.V. Die Zahl der SARS-CoV-2-Neuinfektionen ist in der KW 14 (Ostern und Ferien) auf 128.063 (Vorwoche: 118.945) gestiegen. Die britische Variante B.1.1.7 wird bundesweit mittlerweile bei deutlich über 80 Prozent der diagnostizierten SARS-CoV-2-Fälle nachgewiesen. Die Positivrate stieg in der KW 14 auf 12,8 Prozent (Vorwoche: 11,3 Prozent). Insgesamt wurden 1.002.082 SARS-CoV-2-PCR-Tests angefordert (KW 13: 1.050.115). An der Auswertung des ALM e.V. nehmen 177 Labore (+ 1) aus dem ambulanten und stationären Bereich teil.
BD MAX™ Molecular Multi-Drug Resistant Tuberculosis Test To Be Included In WHO Updated Consolidated Guidelines On Tuberculosis
13 April 2021 - WHO Rapid Communication cites high accuracy for the detection of TB, rifampicin and isoniazid resistance on respiratory samples
FRANKLIN LAKES, N.J., April 13, 2021 -- BD (Becton, Dickinson and Company), a leading global medical technology company, today announced that its BD MAX™ Molecular Multi-Drug Resistant Tuberculosis (MDR-TB) Assay was included in the moderate complexity automated NAAT class of molecular diagnostic technologies that were recognized for high diagnostic accuracy for tuberculosis testing by the World Health Organization (WHO) in advance of an update to its guidelines for TB diagnostic tests.
Laboratorians and clinicians can use the BD MAX™ MDR-TB Assay to simultaneously detect bacteria that cause tuberculosis (TB) and determine if the bacteria contain mutations associated with resistance to two important first-line drugs, isoniazid (INH) and rifampicin (RIF), enhancing the information available to direct the optimal treatment for their patients.
"BD is keenly focused on the fight against antimicrobial resistance and we believe the BD MAX™ MDR-TB Assay will make a real impact on the detection of MDR-TB and better inform which treatment regimen to use for TB patients," said Dave Hickey, president of Life Sciences for BD. "This recognition by WHO is a significant milestone for this product and furthers BD's commitment in the fight to end TB. We look forward to WHO releasing its updated guidelines later this year."
The BD MAX™ MDR-TB Assay is an in vitro diagnostic device with CE mark available in Europe and other countries around the world. The PCR-based molecular diagnostic test is an integrated diagnostic test intended to help in the detection and diagnosis of TB, and INH and RIF resistance in a single assay.
Every year, about 10 million people develop TB and 1.4 million die from the disease. Until the global COVID-19 pandemic, TB was the leading cause of death from a single infectious agent. With proper detection and treatment, TB is curable. Multidrug-resistant TB (MDR-TB), defined as resistance to both isoniazid and rifampicin, remains a critical hurdle in the fight to eradicate tuberculosis as patients with this type of TB will not benefit from those key medicines and could spread the resistant forms of the disease to others.1 Additionally standard testing that only detects RIF resistance can miss cases of TB infection resistant to INH further delaying appropriate treatment and cure for those in need.
BD has a long history in TB diagnostics, having launched the first automated liquid culture system, the BD BACTEC™ MGIT™ Automated Mycobacterial Detection System for comprehensive testing for TB, drug susceptibility and monitoring patients' response to treatment. The BD MAX™ MDR-TB Assay complements this technology enabling clinicians to rapidly test for TB and multidrug resistance as a first-line test and then use the BD BACTEC™ MGIT™ System for broader drug susceptibility testing and patient monitoring.
BD offers a free on-demand webinar featuring Dr. Daniela Maria Cirillo, president of the European Society of Mycobacteriology and head of the Emerging Bacterial Pathogen Research unit at San Raffaele Scientific Institute in Milan. The webinar explores the importance of laboratory diagnostics to stop TB, as well as how the STOP TB Partnership and the ongoing work of the European Society of Mycobacteriology are working to help fight TB. View the on-demand webinar at labroots.com (https://www.labroots.com/webinar/importance-laboratory-diagnostics-fight-tuberculosis).
For more information on BD's role in TB diagnostics please visit: https://www.bd.com/en-us/company/global-health/infectious-diseases/tuberculosis. For more information on BD's molecular platform visit: https://advancing-diagnostics.eu/.
About BD MAX™ SYSTEM
The BD MAX™ System is a molecular diagnostic platform already in use at thousands of laboratories worldwide. The system is fully automated, reducing the opportunity for human error and increasing the speed to result, and can process 24 samples simultaneously, and up to several hundred samples per 24-hour period. Each unit is capable of performing assays for respiratory infections, enterics, hospital acquired infections, and sexually transmitted infections.
About BD
BD is one of the largest global medical technology companies in the world and is advancing the world of health by improving medical discovery, diagnostics and the delivery of care. The company supports the heroes on the frontlines of health care by developing innovative technology, services and solutions that help advance both clinical therapy for patients and clinical process for health care providers. BD and its 70,000 employees have a passion and commitment to help enhance the safety and efficiency of clinicians' care delivery process, enable laboratory scientists to accurately detect disease and advance researchers' capabilities to develop the next generation of diagnostics and therapeutics. BD has a presence in virtually every country and partners with organizations around the world to address some of the most challenging global health issues. By working in close collaboration with customers, BD can help enhance outcomes, lower costs, increase efficiencies, improve safety and expand access to health care. For more information on BD, please visit bd.com.
FDA Authorizes New High-Throughput, Automated System for Leading COVID-19 Test
12 April 2021 - The Amplitude Solution with the TaqPath COVID-19 High-Throughput Combo Kit enables laboratories to rapidly scale high-sensitivity PCR testing capacity as schools and employers seek increased testing to support reopening strategies
WALTHAM, Mass., April 12, 2021 -- Thermo Fisher Scientific Inc., the world leader in serving science, today announced that the U.S. Food and Drug Administration (FDA) has granted Emergency Use Authorization (EUA) for the Thermo Fisher Scientific Amplitude Solution with the TaqPath COVID-19 High-Throughput Combo Kit.
The Amplitude Solution enables clinical and public health laboratories to scale gold standard PCR testing and process up to 8,000 samples in a single day with minimal staffing resources and a secured supply of kits, reagents and consumables to meet their testing needs. The Amplitude Solution has been implemented globally including labs in Europe and Japan.
"While COVID-19 cases globally may be decreasing in some areas as vaccines become more widely available, there continues to be a demand for frequent routine testing to control future outbreaks," said Mark Stevenson, executive vice president and chief operating officer of Thermo Fisher Scientific. "For population-wide testing programs, lab-based PCR is the best fitting technology, providing confidence in results, capacity to process thousands of samples a day, and consistent, reliable turnaround times. The Amplitude Solution can help support a systematic testing strategy by enabling labs to quickly scale their testing and begin processing high-volume samples, even with limited personnel."
The Amplitude Solution is a molecular diagnostic testing system that helps clinical labs expand testing capacity by combining Thermo Fisher's extraction and real-time PCR instruments with liquid handling products from Tecan Group. The modular system utilizes a high-throughput version of Thermo Fisher's Applied Biosystems TaqPath COVID-19 Combo Kit, which received EUA in March 2020, to process samples in four steps with minimal hands-on time and laboratory space requirements. The kit's multi-gene target design and updated interpretive software may help labs detect SARS-CoV-2 variants.
For more information on the Amplitude Solution, please visit www.thermofisher.com/amplitude.
Testing with the Amplitude Solution with the TaqPath COVID-19 High-Throughput Combo Kit is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. 263a, to perform high-complexity tests, or by similarly qualified non-U.S. laboratories.
The Amplitude Solution with the TaqPath COVID-19 High-Throughput Combo Kit has not been FDA cleared or approved and is only authorized for the duration of the EUA granted under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.
About Thermo Fisher Scientific
Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $30 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, improving patient diagnostics and therapies or increasing productivity in their laboratories, we are here to support them. Our global team of more than 80,000 colleagues delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services and Patheon. For more information, please visit www.thermofisher.com.
World's fastest marathoner Eliud Kipchoge uses Abbott's Libre Sense at NN Mission Marathon qualifier race for the Olympic Games
12 April 2021 - Abbott, Eliud Kipchoge and the NN Running Team collaborate in a partnership to track glucose levels during training and marathons. Kipchoge and NN Running Team members will wear Abbott's Libre Sense Glucose Sport Biosensor in upcoming competition at the NN Mission Marathon, the fastest way to the Tokyo Games. Built upon the company's world-leading continuous glucose monitoring technology, Abbott's Libre Sense is the world's first glucose biosensor designed for athletes to help sports performance.
ABBOTT PARK, Ill., April 12, 2021 -- Abbott announced today it is teaming up with Eliud Kipchoge, who is considered the world's fastest marathon runner, and the NN Running Team to support their athletic performance training program. Kipchoge and three NN Running Team members are training with Abbott's Libre Sense Glucose Sport Biosensor to monitor their glucose levels to help them achieve optimal athletic performance. The NN Mission Marathon, a qualifying race for the Olympic Games, in Enschede, the Netherlands on April 18, will be the first time Kipchoge and the NN Running Team will use Abbott's biosensor in a competitive marathon.
"Using Abbott's Libre Sense has transformed my training program. I am learning how my glucose levels relate to my running performance and have already started to see how quickly small adjustments can make a big difference," said Eliud Kipchoge, the world's fastest marathon runner. "I am honored to work on this project, which hopefully will help athletes around the world to better understand the relationship between nutrition and performance to help them improve."
Kipchoge is celebrated as the greatest marathon runner in history as a three-time Olympic medal winner and the first person in history to run a marathon in under two hours. To maintain elite performance, Kipchoge and the NN Running Team continually seek to innovate across all aspects of their training program, evaluating everything from race planning, nutrition and hydration to clothing and footwear. As the first product of its kind, Abbott's biosensor empowers the runners to tap into real-time molecular data to monitor their glucose levels and help them design personalized nutrition plans.
"We've utilized our breakthrough sensing technology to help world-class athletes like Eliud and everyday athletes alike live up to their optimal potential," said Duncan Williams, divisional vice president, Biosensor Technology, Abbott. "Libre Sense will help make glucose monitoring commonplace in athletic performance training and enable athletes to fuel their peak performance."
Abbott's Libre Sense, CE Marked in September 2020, is an over-the-counter product made available in Europe that is designed to provide continuous glucose monitoring via a mobile appiii and wrist readersiv to athletes. Athletes wear the small round biosensor (approximately the size of a two Euro coin) on the back of their upper arm. Worn for up to 14 days, the biosensor provides real-time glucose values through a mobile app developed by Supersapiens, a sports technology company focused on improving athletic performance. Abbott's biosensor and Supersapiens app are designed to help athletes understand the efficacy of their nutrition choices in training and competition.
Abbott is providing Kipchoge and the NN Running Team members with Abbott's biosensors for training, as well as collaborating to develop personalized insights into their athletic performance. Kipchoge and the NN Running Team will provide key learnings, share their experiences and educate athletes worldwide to better understand the link between nutrition and performance.
To prepare for the NN Mission Marathon, their last competitive marathon before the Olympic Games, Eliud and the NN Running Team have been training in Kenya using Libre Sense for the past month.
"After training with Abbott's biosensor, we've been able to quickly develop new insights into high-performance, endurance training nutrition and hydration. For example, we are exploring a shift in timing of pre-race and race-time carbohydrate fueling to net maximum benefits," said Valentijn Trouw, performance director of NN Running Team and Global Sports Communications. "Abbott's biosensor enables us to build personalized nutrition plans based on glucose data in order to deliver peak athletic performance and a competitive advantage. The NN Mission Marathon will be an excellent opportunity to show how important glucose insights can make a real difference in performance."
To see Kipchoge and the NN Running Teams training sessions in Kenya with the Abbott biosensor, click here.
About Abbott Libre Sense Glucose Sport System
The Abbott Libre Sense Glucose Sport Biosensor is intended for athletes (aged 16+ years) to measure glucose. Athletes are defined as individuals who perform exercise and train with the purpose of improving fueling and performance. The biosensor allows athletes to correlate their glucose levels and their athletic performance. The biosensor is not intended for use in the diagnosis, treatment, or monitoring of a disease.
The product is available across eight European countries: Austria, France, Germany, Ireland, Italy, Luxembourg, Switzerland and the United Kingdom.
For more information about Abbott's biosensor, visit LibreSense.com. For more information about the app, visit Supersapiens.com.
About Abbott
Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 109,000 colleagues serve people in more than 160 countries.
Expediting the Diagnosis of Heart Attack with Atellica VTLi Patient-Side Analyzer for Industry First Fingerstick High-Sensitivity Troponin I at Point-of-Care
11 April 2021 - Expediting triage times for patients presenting with heart attack symptoms enhances patient care and helps against Emergency Department overcrowding – a patient safety issue and a world-wide public health problem that contributes to cardiac deaths. The Siemens Healthineers Atellica VTLi Patient-Side Analyzer is offering clinicians the first high-sensitivity troponin I test from a fingerstick sample. With the ability to aid in diagnosing a heart attack quickly and accurately in eight minutes, clinicians can improve outcomes for patients and healthcare providers.
11 April 2021 -- Siemens Healthineers announced today the company's Atellica VTLi Patient-Side Immunoassay Analyzer2 has obtained CE mark and is expected to be available later this spring. The Atellica VTLi analyzer provides lab standard, high-sensitivity cardiac troponin I (hs-cTnI) test results to clinicians in eight minutes using a patient's fingerstick blood sample. With this industry first technology, Siemens Healthineers is helping to improve the patient care paradigm with its disruptive technology, providing hs-cTnI results at the patient’s side to help clinicians properly diagnose and treat heart attacks with confidence.
“Siemens Healthineers is among the best-in-class with cardiac disease state solutions, immunoassays, and critical care diagnostics. Now we are raising the bar as the first company to offer a true point-of-care high-sensitivity cardiac troponin I test with results comparable to laboratory performance using just a fingerstick sample. Healthcare providers have been waiting decades for hs-cTnI at the point of care and now the wait is over. This new technology further expands Siemens Healthineers' broad cardiac portfolio throughout the entire patient care continuum,” said Christoph Pedain, PhD, Head of Point of Care Diagnostics, Siemens Healthineers.
Globally, millions of patients present annually to the emergency room with symptoms that may be related to a heart attack. Responsible for an estimated 31 percent of all deaths worldwide, cardiovascular disease is the leading cause of death.3 Fast triage for patients presenting with symptoms can help save lives. Clinicians primarily rely on the central laboratory for critical blood test results before they can make care decisions for their patients. This process can take an hour or more to get results. The substantial reduction in turnaround time achieved when introducing the wireless, handheld Atellica VTLi analyzer may offer clinicians a fast pathway to help diagnose and treat their patients, helping to accelerate care, improve patient outcomes, and reduce the strain felt in overcrowded EDs.
When a patient presents at the hospital with symptoms of a potential heart attack, securing favorable outcomes depends on the speedy availability of test results, and the confidence care providers have in them. “In today’s busy emergency departments across the globe, there is a demand by clinicians for the rapid measurement of cardiac troponin, using guideline-recommended, high-sensitivity assays, to quickly and accurately rule in and rule out myocardial injury and myocardial infarction in patients presenting with symptoms suggestive of ischemia," said Dr. Fred Apple, PhD, Medical Director of clinical laboratories, clinical chemistry, point-of-care testing, and clinical and forensic toxicology laboratories at Hennepin County Medical Center. "The Siemens Healthineers Atellica VTLi point-of-care assay technology, utilizing whole blood with result turn-around times in as fast as eight minutes, provides a high-sensitivity cardiac troponin I measurement that is equivalent to the diagnostic and analytical accuracy of instruments found in the central laboratory. I believe this POC system could easily integrate into existing hospital and clinic workflows, with the potential to impact patient care and clinical outcomes, with operational and financial efficiencies.”
The Atellica VTLi system has wireless capability that easily integrates and directly connects to data management systems, including the Siemens Healthineers POC Ecosystem Solution, and the laboratory and hospital information systems. Together, this offering provides the laboratory centralized control over decentralized point-of-care testing.
The Atellica VTLi immunoassay analyzer is the resulting innovation stemming from Siemens Healthineers' acquisition of Minicare BV, which was completed on July 2, 2019.
Reference: https://www.corporate.siemens-healthineers.com/press/releases/atellica-vtli
DiaSorin to acquire Luminex Corporation for USD 37.00 per share or approximately USD 1.8 billion
11 April 2021 - Provides access to proven Luminex multiplexing technology and molecular testing solution to be used in unique testing panels, generating critical mass in the molecular diagnostics space. Sets the ground for new partnerships and business development opportunities through life science offerings. Broadens DiaSorin’s presence in the U.S. Accelerates Luminex technology and solutions' penetration outside the U.S. by leveraging DiaSorin’s international commercial footprint. Creates significant value and is expected to be immediately accretive to DiaSorin earnings per share post closing.
Saluggia (Italy), April 11, 2021 -- DiaSorin S.p.A. today announced that its Board of Directors has unanimously approved and signed a definitive merger agreement for DiaSorin to acquire Luminex Corporation for a price of USD 37.00 per share in an all-cash transaction. This corresponds to a total equity value of approximately USD 1.8 billion on a fully diluted basis and an enterprise value of approximately USD 1.8 billion.
The cash consideration represents a c.23.1% premium to Luminex shareholders based on the unaffected closing stock price of Luminex on 24 February 2021 (the date prior to press rumors regarding a potential sale of the company) and a c.30.6% and c.47.5% premium, based on, respectively, the 30-day and 90-day volume-weighted average closing stock price before 24 February 2021.
Luminex develops, manufactures and sells proprietary biological testing technologies and products with leading applications throughout the Diagnostics and Life Science industries. Luminex is a leader in multiplexing technology, one of the fastest growing markets in the molecular space, with more than 900 active clients. With its first-class technology and extensive Life Science solutions supporting clinical and pharmaceutical research and development, Luminex is highly complementary to DiaSorin’s growing diagnostics segment.
The acquisition will broaden DiaSorin’s positioning in the molecular diagnostics space and strengthen its existing value proposition in line with its strategic priorities. Through the acquisition, DiaSorin will gain access to Luminex’s molecular diagnostics multiplexing technology and a portfolio that will strengthen its existing offering while expanding its presence in the U.S. The acquisition will also provide access to Luminex’s applications throughout the Life Science industry, supporting access to academic and scientific research to shape market intelligence on future market trends, engaging with biopharma companies to drive opportunities for long-term partnerships (e.g. vaccine development, biological drugs) and access to clinical multiplexing assays for future Value Based Care projects based on diagnostic algorithms, as defined at the 2019 DiaSorin Investor Day.
Following the acquisition, the combined entity will have combined 2020 revenues of approximately € 1.25 billion, adjusted EBITDA of approximately € 472 million, and positive Net Financial Position of approximately € 335 million.
Reference: https://www.luminexcorp.com/wp-content/uploads/2021/04/DiaSorin-to-acquire-Luminex-Corporation24.pdf
BGI’s Detection Kit for Neutralization Antibody of SARS-CoV-2 Obtains CE Mark
9 April 2021
9 April 2021 -- The Detection Kit for Neutralization Antibody of SARS-CoV-2 (Competitive ELISA) has recently got the CE Mark. It was developed by BGI PathoGenesis Pharmaceutical Technology Co., Ltd., a subsidiary of BGI Genomics.
The positive conversion rate of neutralizing antibody is one of the important indicators for clinical research and vaccine efficacy monitoring to evaluate the level of effective antibodies generated after vaccination. BGI‘s new CE marked kit can detect the neutralizing antibody of SARS-CoV-2 in human serum or plasma samples after inoculation, helping to evaluate the positive conversion rate of a COVID-19 vaccine and providing scientific data support for the monitoring and evaluation of vaccines, and helps continuously optimize vaccine clinical research data.
Last month, BGI’s Rapid Identification Kit for B.1.1.7 lineage and B.1.351 lineage of SARS-CoV-2 (Fluorescence RT-PCR), and the Detection Kit for six mutations in S gene of SARS-CoV-2 (ARMS-PCR) also got the CE Mark.
Hologic to Acquire Mobidiag, Innovator in Near-Patient, Acute Care Diagnostic Testing, for Approximately $795 Million
8 April 2021 - Transaction Will Accelerate Global Growth of Mobidiag’s Differentiated Molecular Platform, which Offers Ease of Use, Multiplex Capability and Rapid Turnaround Time
MARLBOROUGH, Mass., 8 April 2021 -- Hologic, Inc., a global leader in women's health, announced today that it has signed a definitive agreement to acquire Mobidiag Oy, a privately held, commercial-stage Finnish-French developer of innovative molecular diagnostic tests and instrumentation, for an enterprise value of approximately $795 million. This includes a cash payment of approximately $714 million (€600 million) for Mobidiag’s equity, and net debt of approximately $81 million.
“Acquiring Mobidiag will further strengthen our international and diagnostics businesses by enabling us to expand into the large, fast-growing acute care adjacency with a near-patient testing solution that offers ease of use, multiplex capability and rapid turnaround time,” said Jan Verstreken, group president, international at Hologic. “We believe that Mobidiag has developed a differentiated platform that addresses many of the historical challenges of multiplexed point-of-care molecular testing.”
“We are very excited to join Hologic’s diagnostic business,” said Tuomas Tenkanen, Mobidiag’s chief executive officer. “Hologic’s commercial expertise and scale will drive broader market adoption of our products, and their established U.S. regulatory and market development capabilities will accelerate the introduction of our products and maximize their potential in the United States.”
Mobidiag develops and markets PCR (polymerase chain reaction)-based tests for acute care conditions such as gastrointestinal and respiratory infections, antimicrobial resistance management, and healthcare associated infections. The Amplidiag and Novodiag platforms are automated instruments that deliver rapid turnaround times ranging from 50 minutes to two hours.
The Novodiag platform combines real-time PCR and microarray capabilities to provide high-level multiplexing. Multiplexing enables multiple pathogens to be identified in a single sample, streamlining workflows for laboratories and providing rapid results to physicians. For example, gastrointestinal infections commonly present with similar or identical symptoms but can be caused by more than 25 organisms. Highly multiplexed assays allow clinicians to identify which organism is responsible for an infection quickly, accurately and efficiently.
“One of our key goals is to use our strong cash flow to create a larger, faster growing company for a post-pandemic world,” said Steve MacMillan, Hologic’s chairman, president and chief executive officer. “Mobidiag provides an exceptional new growth platform, which will generate long-term value by enabling us to enter the acute care market, which is expected to roughly double in the next five years, with a differentiated, highly competitive solution.”
Mobidiag generated approximately $42 million (€35 million) of revenue in calendar 2020. Hologic intends to invest in assay development to drive growth of the Novodiag platform. As a result, the acquisition is expected to be approximately $0.10 dilutive to Hologic’s non-GAAP earnings per share in fiscal 2022, slightly dilutive in 2023, and accretive thereafter. Hologic expects to finance the transaction with cash on hand and borrowing on its existing line of credit.
The acquisition is expected to close early in the fourth quarter of fiscal 2021, subject to receipt of certain required regulatory approvals and other customary closing conditions.
About Hologic, Inc.
Hologic, Inc. is an innovative medical technology company primarily focused on improving women's health and well-being through early detection and treatment. For more information on Hologic, visit www.hologic.com.
Hologic and The Science of Sure are trademarks and/or registered trademarks of Hologic, Inc. and/or its subsidiaries in the United States and/or other countries.
About Mobidiag
Mobidiag is a commercial stage, fast-growing Finnish-French biotechnology company that develops and markets innovative molecular diagnostic solutions for gastrointestinal infections, antimicrobial resistance management, healthcare associated infections (HAIs), respiratory infections and sepsis. Based on well-established qPCR and microarray technologies, Mobidiag offers a broad range of tests and automated platforms. These include a comprehensive range of fast, reliable and cost-effective molecular diagnostic solutions for the detection of infectious diseases adapted to laboratories of all sizes. They allow detection of most clinically relevant bacteria, parasites, viruses and markers for antibiotic resistance.
Non-GAAP Financial Measures
This press release discusses non-GAAP diluted EPS, which is a non-GAAP financial measure. Hologic’s definition of non-GAAP diluted EPS may differ from similarly titled measures used by others. Hologic defines its non-GAAP EPS presented in this press release to primarily exclude the amortization of intangible assets, acquisition- and integration-related charges, and income taxes related to such adjustments.
Non-GAAP diluted EPS adjusts for specified items that may be non-cash, or can be highly variable or difficult to predict. In the context of forward-looking statements, the non-GAAP financial measures facilitate period-to-period comparisons by excluding the effects of events that have occurred in the past or may occur in the future and have accounting consequences that can mask underlying operational trends, such as acquisitions, restructurings, debt extinguishment and impairments.
This non-GAAP financial measure should be considered supplemental to, and not a substitute for, financial information prepared in accordance with GAAP. Because non-GAAP financial measures exclude the effect of items that will increase or decrease Hologic’s reported results of operations, management encourages investors to review Hologic’s consolidated financial statements and publicly filed reports in their entirety.
Future GAAP EPS may be affected by changes in ongoing assumptions and judgments, and may also be affected by non-recurring, unusual or unanticipated charges, expenses or gains, which are excluded in the calculation of Hologic’s non-GAAP EPS as described in this press release.
When Hologic provides its expectations for non-GAAP EPS on a forward-looking basis, a reconciliation of the differences between these non-GAAP expectations and the corresponding GAAP measures are not available without unreasonable effort because Hologic has not estimated the fair value of the assets and liabilities expected to be acquired in the transaction. Nor has Hologic determined the fair value of acquired intangible assets and related annual amortization expense that would be required to provide the corresponding GAAP measure. The variability of the items that have not yet been determined may have a significant, and potentially unpredictable, impact on Hologic’s future GAAP results.
QIAGEN erweitert Test-Portfolio um Antigen-Schnelltests für den deutschen Markt
8 April 2021 - QIAGEN-Initiative ermöglicht Unternehmen, mehr Arbeitskräfte in höherer Frequenz zu testen. Mehrere Millionen Tests pro Monat lieferbar. Zulassung für die Nutzung durch Fachpersonal erteilt. Zulassung für Selbsttestung ohne Fachpersonal für April erwartet.
Hilden, 8. April, 2021 – QIAGEN hat heute angekündigt, mehrere Millionen Antigen Schnelltests für Unternehmen in Deutschland ab sofort liefern zu können um die Wirtschaft bei ihrer Selbstverpflichtung zum Testen von Mitarbeitern im Kampf gegen SARS-CoV-2 unterstützen zu können.
QIAGEN aktiviert sein Fachwissen und seine Schlagkraft im Vertrieb von Diagnostika-Produkten und bezieht die zugelassenen und qualitativ hochwertigen Tests von dem deutschen Hersteller möLab GmbH, um ab dem 6. April die Coronavirus-Testkapazitäten von Unternehmen in Deutschland deutlich zu erweitern.
„Mit der Initiative möchten wir Unternehmen dabei unterstützen, ihren Mitarbeiterinnen und Mitarbeitern mindestens zwei Coronavirus-Tests pro Woche anbieten zu können,“ sagte Kai te Kaat, Vice President, Leiter Programmmanagement Life Sciences bei QIAGEN. „Für die erfolgreiche Umsetzung der Selbstverpflichtung der Spitzenverbände der Wirtschaft braucht es einen gemeinsamen Kraftakt. Wir freuen uns, einen weiteren Beitrag leisten zu können, dass Wirtschaft und Gesellschaft am Laufen bleiben.“
Der von QIAGEN vertriebene immunochromatographischer Schnelltest wird von medizinischem Fachpersonal durchgeführt und liefert innerhalb von 15 Minuten ein Ergebnis. Eine Zulassung zur Eigenanwendung für Laien wurde bereits beantragt und wird für April erwartet.
Der Test ist beim Bundesinstitut für Arzneimittel und Medizinprodukte gelistet und nutzt sowohl einen einfachen Nasen- als auch einen tieferen Nasen-Rachen-Abstrich. Er hat eine Sensitivität von 97,25 % und eine Spezifität von 99,9 % und wird vom Paul-Ehrlich-Institut in Deutschland empfohlen.
Zusätzliche Informationen zu QIAGENs Antigen-Schnelltest finden Sie hier.
Weitere Informationen zu QIAGENs Engagement im Kampf gegen das Coronavirus finden Sie hier.
Über QIAGEN
QIAGEN N.V., eine niederländische Holdinggesellschaft, ist der weltweit führende Anbieter von Komplettlösungen zur Gewinnung wertvoller molekularer Erkenntnisse aus biologischen Proben. Die Probentechnologien von QIAGEN ermöglichen die Aufreinigung und Verarbeitung von DNS, RNS und Proteinen aus Blut, Gewebe und anderen Stoffen. Testtechnologien machen diese Biomoleküle sichtbar und bereit zur Analyse. Bioinformatik-Lösungen und Wissensdatenbanken helfen bei der Interpretation von Daten zur Gewinnung relevanter und praktisch nutzbarer Erkenntnisse. Automationslösungen integrieren diese zu nahtlosen und kosteneffizienten molekularen Test-Workflows. QIAGEN stellt seine Lösungen mehr als 500.000 Kunden aus den Bereichen Molekulare Diagnostik (Gesundheitsfürsorge) und Life Sciences (akademische Forschung, pharmakologische F&E und industrielle Anwendungen, hauptsächlich Forensik) zur Verfügung. Zum 31. Dezember 2020 beschäftigte QIAGEN weltweit rund 5.600 Mitarbeiter an über 35 Standorten 1.200 hiervon am Standort in Hilden. Weitere Informationen über QIAGEN finden Sie unter http://www.qiagen.com.
ALM-Update: Auch über die Osterfeiertage, weiterhin deutliche Zunahme der Positivrate an SARS-CoV-2-PCR-Tests
7 April 2021
7 April 2021 -- Auch wenn das Bild der Coronatestungen über die Osterfeiertage gesondert betrachten werden sollte, setzt sich der Trend der vergangenen Wochen fort: Die Zahl der SARS-CoV-2-Neuinfektionen bleibt weiterhin hoch und die britische Variante B.1.1.7 hat sich durchgesetzt – ihr Anteil liegt bundesweit bei über 80 Prozent der diagnostizierten Fälle, regional teilweise noch deutlich darüber. Die Positivrate stieg in der KW 13 auf 11,3 Prozent (Vorwoche: 9,5). Dabei wurden in der Karwoche erwartungsgemäß weniger SARS-CoV-2-PCR-Tests angefordert. Im Vergleich zur Vorwoche ging die Zahl der PCR-Tests um rund 18 Prozent auf 1.050.115 zurück. Insgesamt wurden 118.945 Menschen positiv auf das Vorliegen einer Coronainfektion getestet (Vorwoche: 121.982). Das zeigt die Auswertung der Akkreditierten Labore in der Medizin – ALM e.V., an der 176 (+ 1) Labore aus dem ambulanten und stationären Bereich teilgenommen haben.
Grifols advances in the execution of its expansion plan with the acquisition of 7 plasma centers in the U.S.
7 April 2021 - The seven plasma centers acquired from Kedrion obtain roughly 240,000 liters of plasma per year. The USD 55 million transaction will be financed with Grifols’ own resources. Grifols’ acquisitions of plasma centers in 2021 provide the company with immediate access to approximately 1.4 million liters per year and move forward with the execution of its plasma expansion plan. This transaction is aligned with the plasma-supply expansion and diversification strategy of the company, an industry leader with the world’s largest network of plasma centers: 351 centers in the U.S. and Europe. The company remains firmly committed to further increasing its plasma supply to meet current and expected strong increases in demand for plasma-based therapies.
Barcelona, April 7, 2021 -- Grifols, a global leader in the development of plasma-derived medicines with a track record of more than 100 years dedicated to enhancing people’s health and well-being, closed the acquisition of seven U.S. plasma donation centers from Kedrion for USD 55.2 million. The operation received regulatory clearances and will be financed with Grifols’ own resources, without issuing debt.
Grifols will gain immediate access to the plasma obtained in these centers, which obtain approximately 240,000 liters per year. The seven newly acquired centers are authorized by the U.S. Food and Drug Administration (FDA) and European healthcare authorities.
This acquisition reflects Grifols’ commitment to enlarge its plasma supply through organic and inorganic growth.
Since January 2021, Grifols’ efforts to accelerate the execution of its strategic expansion plan have enabled it to instantly leverage approximately 1.4 million more liters of plasma yearly. At the same time, the company continues its efforts to open new centers.
In this regard, in March 2021, Grifols acquired 25 plasma centers from BPL Inc., which obtain approximately 1 million liters of plasma per year.
As part of its organic efforts, the company plans on opening between 15 and 20 new plasma centers in 2021. Additionally, Grifols will open several plasma centers in Egypt during the year1, following the strategic alliance signed with the Egyptian government in November 2020.
This most recent acquisition advances Grifols’ strategy to reinforce and diversify its access to plasma. An industry leader, the company boasts a robust network of 351 plasma centers, with 296 in the United States and 55 in Europe across Germany, Austria and, recently Hungary.
The transaction reinforces the company’s efforts to strengthen its plasma center network, which represents a significant competitive advantage. Grifols remains committed to increasing the availability of its life-enhancing plasma-derived products for patients who need them and doing its utmost to respond to expected strong demand.
bioMérieux announces the CE marking of 3 dengue immunoassays on VIDAS®
7 April 2021 - bioMérieux, a world leader in the field of in vitro diagnostics, announces the CE marking of its innovative and fully-automated assays to diagnose dengue infection: VIDAS® DENGUE NS1 Ag VIDAS® Anti-DENGUE IgM VIDAS® Anti-DENGUE IgG
7 April 2021 -- Dengue is a viral disease transmitted to humans by certain types of mosquitoes. With 100 to 400 million people affected each year, it is the most common arthropod-borne viral infection worldwide. The global incidence of this infection has grown over 8 fold during the last 20 years, with the greatest burden observed in Asia (75%) followed by Latin America and Africa.
Dengue often presents non-specifically and with fever, thereby leading to a high risk of misdiagnosis in the absence of laboratory confirmation, especially in countries where many other infectious diseases are circulating. “Presenting in different forms, from mild to life-threatening, a dengue diagnosis and optimal patient management both rely on rapid and reliable diagnostics. In line with our goal of addressing major global health issues, it is important for us to provide these easy, automated, and high-quality tests for diagnosing dengue virus infection.” said Mark Miller, Executive Vice President, Chief Medical Officer, bioMérieux.
Diagnostic testing for dengue relies on several laboratory methods, mainly manual, which each have their own advantages and limitations. If molecular assays are not available or the patient presents later during the course of the disease, serological methods are particularly well suited.
VIDAS® DENGUE NS1 Ag, Anti-DENGUE IgM and Anti-DENGUE IgG are the new automated assays intended as an aid in the diagnosis of dengue infection.
These VIDAS® DENGUE assays can be used independently to detect the viral antigen (NS1) and antibodies (IgM and IgG) produced by the host in response to the infection. These 3 serological tests are recommended by international guidelines.
Performed on the VIDAS® family platforms, VIDAS® DENGUE assays provide reliable results with improved quality compared to the existing manual methods. The performance level responds to the medical need for an early and accurate diagnosis of dengue.
The test process is fully automated, from sample identification to the result report. Based on the single test concept and the “load & go” system, the VIDAS® DENGUE panel is easy to use and accessible to all laboratories. Capitalizing on bioMérieux’s expertise in infectious diseases, VIDAS® DENGUE assays enable clear-cut results with no equivocal zone and an objective interpretation thanks to the automation.
“This new VIDAS® DENGUE solution is cost-effective and suitable for low- and middle-income countries where VIDAS® is widely available. It broadens our immunoassay offer against vector borne-diseases that will be further extended to chikungunya” said Pierre Boulud, Chief Operating Officer, Clinical Operations, bioMérieux.
Reference: https://www.biomerieux.com/en/biomerieux-announces-ce-marking-3-dengue-immunoassays-vidasr
QIAGEN Adds to COVID-19 Portfolio With New Ultra-Fast Sequencing Solution for High-Throughput Genomic Surveillance
6 April 2021 - QIAseq DIRECT SARS-CoV-2 Kit halves both library preparation times and plasticware use. Kit supports analysis of over 6,000 samples simultaneously on highest-throughput sequencers. Integrates with QIAGEN Digital Insights cloud solutions to support variant detection and reporting including clade and lineage annotations across sequencing platforms.
GERMANTOWN, Md. & HILDEN, Germany, 6 April 2021 -- QIAGEN N.V. today announced the launch of QIAseq DIRECT SARS-CoV-2 Kit, a viral genome enrichment and library preparation solution that significantly reduces library turnaround times and plastics use compared with ARTIC project protocols (primer-based approaches for next-generation sequencing (NGS)). The lab and bioinformatic protocols of the ARTIC network, an initiative funded by the Wellcome Trust, are considered the gold standard in NGS-based characterization of SARS-CoV-2 genomes.
High-throughput NGS is increasingly being used to conduct genomic surveillance and research on new and potentially dangerous COVID-19 variants that continue to emerge. These viral mutations have become an area of intense concern particularly with regard to vaccine efficacy. As a result, sequencing laboratories worldwide have come under intense pressure to provide results as quickly as possible.
QIAseq DIRECT SARS-CoV-2 supports sample multiplexing with up to 768 Dual Molecular Indices - unique markers tagged to molecules in a sample to eliminate errors from downstream analysis - in a library preparation workflow from extracted viral RNA that reduces turnaround time to as little as four hours. This also increases the amount of samples per sequencer to over 6,000 samples on the highest-throughput instruments. The kit also cuts plastics usage by 50%, drastically reduces hands-on time, requires no fragmentation or ligation reactions and can be readily automated with robotic liquid handlers. The viral enrichment approach delivers superior uniformity of coverage across the SARS-CoV-2 genome as well as deeper sequencing performance compared with the most widely used amplicon-based options.
“QIAseq DIRECT SARS-CoV-2 is a powerful solution that will increase the efficiency and output of NGS at a time when global expectations to perform could not be higher,” said Thomas Schweins, Senior Vice President of the Business Area Life Sciences of QIAGEN. “This kit is an important extension of our QIAseq range, that allows for more accurate detection and quantification of molecular variants, while drastically reducing the time and workflow steps needed for library preparation, increasing lab efficiency and throughput.”
An additional pressure point for laboratories is the analysis and interpretation of the large and rapidly collected viral datasets. The QIAseq DIRECT SARS-CoV-2 kit is supported by the new QIAGEN Digital Insights CoV-2 Insights Service, a cloud-based solution tailored to viral genome analysis, characterization and reporting. The service is designed for large-scale surveillance applications and is available globally. It offers Whole Genome Sequencing variant analysis, identification and standardized reporting of community-based standards essential for high-throughput genomic surveillance, as well as fast and easy set up.
QIAGEN has built up one of the most comprehensive SARS-CoV-2 research and testing portfolios. It includes sample preparation innovations like QIAprep&, syndromic testing solution QIAstat-Dx, high throughput PCR with NeuMoDx, QIAreach digital Antibody and Antigen tests and T-Cell research solutions based on QIAGEN’s QuantiFERON IGRA technology. The company continues to add novel solutions to support laboratories combatting the pandemic and to provide experts with tools to learn more about the virus and drive research forward.
About QIAGEN
QIAGEN N.V., a Netherlands-based holding company, is the leading global provider of Sample to Insight solutions that enable customers to gain valuable molecular insights from samples containing the building blocks of life. Our sample technologies isolate and process DNA, RNA and proteins from blood, tissue and other materials. Assay technologies make these biomolecules visible and ready for analysis. Bioinformatics software and knowledge bases interpret data to report relevant, actionable insights. Automation solutions tie these together in seamless and cost-effective workflows. QIAGEN provides solutions to more than 500,000 customers around the world in Molecular Diagnostics (human healthcare) and Life Sciences (academia, pharma R&D and industrial applications, primarily forensics). As of December 31, 2020, QIAGEN employed approximately 5,600 people in over 35 locations worldwide. Further information can be found at http://www.qiagen.com.
Quest Diagnostics Sells Ownership Interest in Q² Solutions to IQVIA
1 April 2021
SECAUCUS, N.J. and RESEARCH TRIANGLE PARK, N.C., April 1, 2021 -- Quest Diagnostics, the world's leading provider of diagnostic information services, today announced the sale of its minority share in Q2 Solutions to IQVIA, a leading global provider of advanced analytics, technology solutions, and clinical research services to the life sciences industry, for $760 million in an all-cash transaction.
Q2 Solutions is a leading global clinical laboratory services organization that provides comprehensive testing, project management, supply chain, biorepository, biospecimen and consent tracking solutions for clinical trials. IQVIA and Quest established Q2 Solutions as a joint venture in 2015. IQVIA previously owned a 60 percent majority share and Quest Diagnostics owned a 40 percent minority share.
"Divesting from Q2 Solutions supports our vision to be focused on empowering better health with diagnostic information services," said Steve Rusckowski, Quest Diagnostics Chairman, CEO and President. "We are proud of our contributions to the growth of Q2 Solutions, and are confident that IQVIA has the strategic vision and agility to lead Q2 Solutions on the next phase of its journey as a global leader in central lab services."
Under a multi-year agreement, Quest will remain the strategic preferred laboratory provider for Q2 Solutions' clients, providing a range of complementary lab testing capabilities to augment Q2 Solutions' core offerings and extend its industry leading suite of services.
About Quest Diagnostics
Quest Diagnostics empowers people to take action to improve health outcomes. Derived from the world's largest database of clinical lab results, our diagnostic insights reveal new avenues to identify and treat disease, inspire healthy behaviors and improve health care management. Quest annually serves one in three adult Americans and half the physicians and hospitals in the United States, and our approximately 50,000 employees understand that, in the right hands and with the right context, our diagnostic insights can inspire actions that transform lives. www.QuestDiagnostics.com.
Quidel’s Sofia® SARS Antigen Test receives Emergency Use Authorization for screening use with serial tests
1 April 2021 - Easy-to-use test that provides results in 15 minutes is now available without a prescription
SAN DIEGO, 1 April 2021 -- Quidel Corporation (“Quidel”), a leading provider of rapid diagnostic testing solutions, cellular-based virology assays and molecular diagnostic systems, announced today that it has received an Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA), allowing the company to market its Sofia® SARS Antigen FIA for the qualitative detection of the nucleocapsid protein antigen from SARS-CoV-2 from anterior nares swab specimens directly from individuals who are either suspected of COVID-19 by their healthcare provider within the first five days of the onset of symptoms, or are individuals without symptoms or other epidemiological reasons to suspect COVID-19 tested twice over two (or three) days with at least 24 hours (and no more than 36 hours) between tests. Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, that meet the requirements to perform moderate, high or waived complexity tests. This test is authorized for use at the Point of Care (POC), i.e., in patient care settings operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation.
The Sofia® SARS Antigen FIA shows excellent performance within the first five days of the onset of symptoms, with positive results agreeing with PCR 96.7% of the time, and negative results agreeing 100% of the time, delivering confidence to physicians, healthcare workers and other customers within the professional segment. This new intended use allows the Sofia® SARS Antigen FIA to be used among asymptomatic individuals and run without a prescription provided that individuals test twice within 24-36 hours. Routine testing by rapid antigen tests has shown to be effective in diagnosing COVID-19.1 As with all antigen tests, performance may decrease as days since symptom onset increases due to lower viral loads later in the patient’s disease course. Similarly, the inability to synchronize asymptomatic individuals with onset of infection may impact performance as specimens may be tested when viral loads are below the assay’s limit of detection. Clinical studies in asymptomatic patients undergoing serial testing are ongoing to establish the clinical performance.
“Quidel’s goal throughout this pandemic has been to develop the most innovative and sensitive testing technologies on the market and to make our COVID-19 tests as widely available as possible,” said Douglas Bryant, president and CEO of Quidel Corporation. “FDA’s authorization opens the door to true democratization of the benefits of serial testing for both individuals experiencing symptoms and screening of people who may not have symptoms but are actively shedding the virus. Broadscale application of our Sofia® rapid antigen test for COVID-19 screening will catch asymptomatic cases early and limit virus spread.”
About Quidel Corporation
Quidel Corporation is a leading manufacturer of diagnostic solutions at the point of care, delivering a continuum of rapid testing technologies that further improve the quality of health care throughout the globe. An innovator for over 40 years in the medical device industry, Quidel pioneered the first FDA-cleared point-of-care test for influenza in 1999 and was the first to market a rapid SARS-CoV-2 antigen test in the U.S. Under trusted brand names Sofia®, Solana®, Lyra®, Triage® and QuickVue®, Quidel’s comprehensive product portfolio includes tests for a wide range of infectious diseases, cardiac and autoimmune biomarkers, as well as a host of products to detect COVID-19. With products made in America, Quidel’s mission is to provide patients with immediate and frequent access to highly accurate, affordable testing for the good of our families, our communities and the world. For more information about Quidel, visit quidel.com.
EUROIMMUN Launches SARS-CoV-2 NeutraLISA Assay to Determine the Neutralizing Capacity of Anti-SARS-CoV-2 Antibodies
1 April 2021 - CE marked assay based on well-established ELISA technology expands EUROIMMUN’s offerings for labs that seek to understand immune response to COVID-19
WALTHAM, Mass., April 1, 2021 – EUROIMMUN, a PerkinElmer, Inc. Company, today announced the launch of the SARS-CoV-2 NeutraLISA™ assay, a surrogate neutralization test intended for the detection of neutralizing antibodies against SARS-CoV-2, the pathogen causing COVID-19. The CE marked assay adds to the Company’s broad portfolio of COVID-19 diagnostics and is currently available in more than 30 countries that accept the CE mark.
In COVID-19, antibodies that target the viral receptor binding domain (RBD) in the S1 domain of the SARS-CoV-2 spike protein have been shown to exhibit a virus-neutralizing capacity, which predominately are IgG antibodies.
SARS-CoV-2 enters a human host cell through interaction of its RBD with the host cell ACE2 receptor. However, if the RBD is blocked by specific antibodies formed during immune response, the virus cannot continue to infect and proliferate within the human body. This is why many leading COVID-19 vaccine developments are also based on this protein domain.
The EUROIMMUN SARS-CoV-2 NeutraLISA imitates this natural process by determining the inhibitory effect of antibodies capable of hampering the interaction between biochemically produced RBD and ACE2. Unlike standard neutralization tests, which can be labor-intensive and require handling of the live virus in a specialized high-safety laboratory setting, the SARS-CoV-2-NeutraLISA assay is based on well-established ELISA technology and uses non-pathogenic viral proteins. As such, the assay can be processed in common lab settings either manually or automatically.
“In addition to disturbing or altogether inhibiting the pathogen from binding to a host cell, neutralizing antibodies may last for years in the human body and can potentially prevent SARS-CoV-2 infection and reinfection,” said Dr. Wolfgang Schlumberger, CEO of EUROIMMUN. “The SARS-CoV-2 NeutraLISA assay supplements EUROIMMUN’s existing CE-marked QuantiVac™ ELISA and SARS-CoV-2 Interferon-gamma Release Assay which is expected to be available with CE mark soon. In combination, the assays make a powerful trio to help evaluate the immune response to SARS-CoV-2 induced through natural infection or vaccination with S1/RBD-based vaccines from multiple angles.”
EUROIMMUN offers a comprehensive COVID-19 product portfolio, including real-time PCR tests, an antigen detection assay for acute diagnostics, multiple antibody tests and a dried blood spot solution to support assessment of the immune response. In addition, EUROIMMUN offers the Interferon-gamma Release Assay to evaluate specific T-cell response, currently available for research use only, and provides automation systems for small, medium and high sample throughput workflows.
About PerkinElmer
PerkinElmer enables scientists, researchers and clinicians to address their most critical challenges across science and healthcare. With a mission focused on innovating for a healthier world, we deliver unique solutions to serve the diagnostics, life sciences, food and applied markets. We strategically partner with customers to enable earlier and more accurate insights supported by deep market knowledge and technical expertise. Our dedicated team of about 14,000 employees worldwide is passionate about helping customers work to create healthier families, improve the quality of life, and sustain the wellbeing and longevity of people globally. The Company reported revenue of approximately $3.8 billion in 2020, serves customers in 190 countries, and is a component of the S&P 500 index. Additional information is available through 1-877-PKI-NYSE, or at www.perkinelmer.com.
Sysmex launches Plasma-SeqSensei™ liquid biopsy RUO kits in EMEA
1 April 2021 - Sysmex Europe GmbH, together with Sysmex Inostics GmbH, announced today that they will launch the Plasma-SeqSensei™ Liquid Biopsy Research Use Only (RUO) kits for colorectal cancer (CRC), non-small cell lung cancer (NSCLC), melanoma and thyroid cancer.
1 April 2021 -- Liquid biopsy detects material in body fluids to assess the extent of disease, most often used for the detection of cancerous material in plasma. Though several molecular techniques are used, next generation sequencing is considered to be the most important method to detect minute amounts of circulating tumour DNA (ctDNA). In contrast to tissue biopsy, which is not always obtainable and much more invasive, liquid biopsy is well-suited for clinical research purposes due to its less invasive nature, high concordance to tissue samples in many cancers and real-time information available.
Due to a unique technology developed at Johns Hopkins University, Plasma-SeqSensei™ kits can reduce sequencing errors by >100 fold after refining the previously published methods and therefore detect very small amounts of mutant DNA down to seven mutant molecules per sample. It solves one of the key weaknesses to date which has been the inability to detect very low levels on analyte, missing over 40% of the samples with metastatic disease.
Sysmex is launching four reagent kits with a highly convenient software to enable the use of this highly sensitive technology for RUO purposes in four different types of cancers, namely CRC, NSCLC, melanoma (skin cancer) and thyroid cancer. The liquid biopsy market is expected to grow rapidly by >40% per year to 1B USD over the next three to five years.
About Sysmex Inostics GmbH
Sysmex Inostics (President and CEO: Bhuwnesh Agrawal), a subsidiary of Sysmex Corporation, is a molecular diagnostic company that is a pioneer in blood-based cell-free tumour DNA (ctDNA) mutation detection in oncology utilising highly sensitive technologies such as BEAMing (digital PCR) and SafeSEQ (NGS). With more than 10 years’ experience in liquid biopsy, Sysmex Inostics is a trusted partner to leading pharmaceutical companies, advancing their efforts to bring the most effective personalized cancer therapies to global markets, from discovery through companion diagnostics.
LGC launches SARS-CoV-2 quality solution for antigen testing
1 April 2021
1 April 2021 -- LGC has released ACCURUN® SARS-CoV-2 Antigen Reference Material Kit, a new quality measurement tool to support SARS-CoV-2 antigen testing. It is formulated for use with test methods that detect the nucleocapsid (NP) protein of SARS-CoV-2 virus – the target for the majority of the SARS-CoV-2 antigen assays currently on the market.
The product comprises purified recombinant SARS-CoV-2 NP protein in simulated viral transport media. Offering both positive and negative materials, the kit is designed to support assay installation and monitoring of day-to-day assay performance, providing a complete quality solution for SARS-CoV-2 antigen testing.
Clinical laboratories are increasingly adopting antigen tests as a first line SARS-CoV-2 screening tool. While less accurate than amplification-based molecular tests, most antigen tests offer high specificity paired with a less complex, cost-effective design – making them more amendable to rapid, repeat testing of large populations in a point-of-care environment.
Bharathi Anekella, Executive Vice President and General Manager, LGC Clinical Diagnostics, stated, “We anticipate the demand for SARS-CoV-2 antigen testing to continue to be strong for the coming year, as it has become a preferred testing method for rapid large-scale screening, including back-to-work and back-to-school programs. Adding a quality solution like ACCURUN SARS-CoV-2 Antigen Reference Material Kit to the testing workflow offers a way to increase confidence in the results produced by these types of rapid diagnostics.”
To learn more about ACCURUN SARS-CoV-2 Antigen reference materials, as well as the complete line of SARS-CoV-2 Quality Solutions, please visit the SeraCare website.
Philips and NHS implement the first regional data integration hub for UK’s National COVID-19 Chest Imaging Database
31 March 2021 - Cheshire and Merseyside consortium (NHS) is the first region to have achieved this milestone for the UK’s National COVID-19 Chest Imaging Database (NCCID). The deployment of a single SMART box server has provided access to 15 years of imaging data across 2.5 million people in the region, the largest single data source for NCCID. Data integration capabilities as a result of this deployment will allow Cheshire and Merseyside to validate the use of AI technology across a variety of conditions.
Amsterdam, the Netherlands and Guildford, United Kingdom, 31 March 2021 – Royal Philips, today announced it has supported the NHS’ Cheshire and Merseyside consortium to become the first regional hub supplying the United Kingdom’s National COVID-19 Chest Imaging Database (NCCID). The NCCID is a centralized database containing X-Ray, CT and MRI images from hospital patients across the country. It aims to support a better understanding of the COVID-19 virus and develop AI-powered technology which will enable the best care for patients hospitalized with a severe infection. This first regional hub is integrating data across 13 NHS trusts in the consortium. The deployment of a single centralized and secure server has provided access to 15 years of imaging data across 2.5 million people in the region, the largest single data source for NCCID.
The Cheshire and Merseyside consortium engaged with Philips to help with enabling access to the entire region’s imaging data through a single hub. Philips’ advanced data integration solution for radiology, Philips Global worklist, was used to enable easy integration with the NCIDD’s secure central SMART Box server that will be required to support mass data collection, management and de-identification and can facilitate multiple trials/research projects simultaneously.
“One of the findings coming out of the end of this project will definitely be to focus on regional hubs that will be able to coordinate and better centralize the data, a hub just like Cheshire and Merseyside,” said Prof Mark-Halling Brown, Head of Scientific Computing at Royal Surrey NHS Foundation Trust. “It can take many months or even years to set up SMART boxes at individual trusts, so doing it regionally is the only way to scale up nationally."
“Most District General Hospitals average 250,000 to 350,000 imaging exams per year,” said Steve Sparks, Professional Services Manager Radiology Informatics at Philips UK&I. “With a single regional SMART box we have been able to gain access to the images from the 13 Trusts within the Cheshire and Merseyside consortium.”
Save Radiologists’ time, increase the safety and consistency of care
The NCCID database is developed in collaboration with NHSX, an organization driving the digital transformation of the NHS, The British Society of Thoracic Imaging (BSTI) and The Royal Surrey NHS Foundation Trust. The database is being used for the validation of AI products for use in the NHS, aiding the diagnosis and treatment of COVID-19 in the UK population. This data has the potential to enable quicker patient assessment when arriving at hospital’s emergency departments, save Radiologists’ time, increase the safety and consistency of care across the country, and ultimately save lives. It is being made available to researchers, clinicians, technology companies and all those wanting to investigate the disease and develop solutions that can support the COVID-19 patient care pathway.
The SMART box server technology will also enable Cheshire and Merseyside to participate in research into many areas requiring large volumes of clinical imaging data. The COVID-19 pandemic has highlighted the potential for medical imaging systems powered by AI. The NHS AI Lab, created last year within NHSX, is developing a National Medical Imaging Platformwith the purpose of creating a pipeline for patient data to be used within AI technology across conditions other than COVID-19. The NCCID is one workstream taken forward by the NHS AI Lab at NHSX, which will accelerate the safe, ethical, and effective adoption of AI in the healthcare sector. The power of large-scale data collection has already been demonstrated in various studies, including breast cancer screening studies such as OPTIMAM. Setting up regional hubs, such as the SMART box deployment in Cheshire and Merseyside, will aid the creation of these large-scale National databases and AI technology to help combat a variety of conditions.
Comprehensive portfolio for COVID-19 high-quality care
Philips has a comprehensive portfolio of products, services and solutions to support the delivery of high-quality care to COVID-19 patients worldwide. Solutions include secure, connected and intelligent approaches to diagnosis, treatment and predictive monitoring in the hospital, plus screening, remote patient monitoring and care at home. Philips’ telehealth and AI-enabled data analytics can help support workflows, facilitate remote collaboration and optimize resources. Philips’ COVID-19-related solutions are designed for rapid deployment and scalability.
About Royal Philips
Royal Philips is a leading health technology company focused on improving people's health and well-being, and enabling better outcomes across the health continuum – from healthy living and prevention, to diagnosis, treatment and home care. Philips leverages advanced technology and deep clinical and consumer insights to deliver integrated solutions. Headquartered in the Netherlands, the company is a leader in diagnostic imaging, image-guided therapy, patient monitoring and health informatics, as well as in consumer health and home care. Philips generated 2020 sales of EUR 19.5 billion and employs approximately 82,000 employees with sales and services in more than 100 countries. News about Philips can be found at www.philips.com/newscenter.
Abbott's BinaxNOW™ Rapid Antigen Self Test receives FDA Emergency Use Authorization for asymptotic, over-the-counter, non-prescription, multi-test use
31 March 2021 - FDA Emergency Use Authorization permits asymptomatic, non-prescription, over-the-counter self use for people with or without symptoms. The BinaxNOW COVID-19 Self Test is identical to the professional-use test, used since August 2020, bringing the most studied and widely used rapid antigen test to retail shelves across the country. BinaxNOW Self Test will be available nationwide and in large quantities at major food, drug and mass merchandiser retailers nationally and will be priced affordably, similar to common over-the-counter (OTC) tests. Together with vaccines, serial testing of asymptomatic people will help restore a sense of safety in everyday settings where people gather. Asymptomatic multi-test authorization also applies to BinaxNOW professional-use test.
ABBOTT PARK, Ill., March 31, 2021 -- Abbott announced today it has received U.S. Food and Drug Administration (FDA) Emergency Use Authorization (EUA) for over-the-counter, non-prescription, asymptomatic use of its BinaxNOW™ COVID-19 Ag Self Test for detection of COVID-19 infection. This new indication allows individuals with or without symptoms to have access to this test without a prescription. Abbott will begin shipping to major food, drug and mass merchandiser retailers in the coming weeks and expect the test to be available through some of their online store websites.
The test can be used on children as young as two years old when samples are collected by an adult and for all people aged 15 years or older, bringing the country's most extensively studied and widely used rapid antigen test to nearly everyone in the U.S. The test will come in a two-count box to meet serial (frequent) testing requirements.
Using the test will be simple, even for people who have never tested themselves. People will only need to perform a minimally invasive nasal swab (not the deep nasopharyngeal swab) and all materials required to perform the test (swab, test card, and reagent solution) will come in the box.
"We've now accomplished what we set out to do when we launched BinaxNOW, which is to bring an accurate, affordable and readily available test to the American people that they can have on hand, whether they want to test frequently or in certain circumstances," said Robert B. Ford, president and chief executive officer, Abbott. "Together with vaccines, the BinaxNOW Self Test will help Americans get back to doing what they want and need to do – like going to work and school or seeing friends and family – with greater confidence."
Abbott launched the BinaxNOW professional test nationwide in August 2020 and scaled up production at its new U.S. manufacturing facilities to produce 50 million tests per month. The U.S. Department of Health and Human Services (HHS) purchased the company's first 150 million tests, sending them to K-12 schools, nursing homes, historically black colleges and universities and underserved communities, where they remain in use today and serve as a powerful tool to help prevent the virus from spreading. Since its approval, BinaxNOW has also been used by workplaces, K-12 schools and universities and other organizations throughout the country.
The BinaxNOW Self Test is the same technology as the existing BinaxNOW test that has been available since August 2020 but is indicated by the FDA for serial asymptomatic testing, meaning that people should test themselves frequently.
The advantages of serial (frequent) testing with BinaxNOW
Serial testing makes it possible for people to know their infection status when it matters most. And because rapid antigen testing is less expensive, people can test themselves with greater regularity, which is important for those who may be concerned that they were recently exposed or may be attending a large event in close confines.
When combined with vaccines and other public health precautions, serial testing can restore a sense of safety and let Americans get back to celebrating life's big milestones or everyday moments, such as weddings, birthdays and graduation parties, traveling, dinner with friends, and countless other cherished moments that were once taken for granted.
With results in just 15 minutes, the BinaxNOW Self Test lets people who test positive immediately isolate so that they do not infect others, rather than waiting days for results from a lab or send-away at-home tests. BinaxNOW is proven to be high quality, with a complaint rate for the 150 million professional tests distributed to HHS of 0.0034% as of March 24. That is 1 out of every 29,511 tests, affirming Abbott's decades of leadership in infectious disease detection and commitment to studying real-world performance of its products.
Abbott to bring massive scale and experience to over-the-counter COVID-19 testing
Abbott's manufacturing scale and existing retail distribution partnerships with the nation's largest food, drug and mass merchandiser retailers are unmatched by any rapid-test maker. Abbott expects the BinaxNOW Self Test to be priced affordably – similar to common OTC tests – to make it more accessible and affordable for Americans to test themselves, whether regularly or for life's important moments.
Digitally verified results remain important in many settings
Abbott's earlier innovations in rapid testing remain as important as ever, especially for people who need to show digitally verified proof of a negative COVID-19 test before returning to work, school, travel, and congregate-care living environments.
As part of this authorization, the BinaxNOW COVID-19 Ag Card test for professional use will no longer require a prescription, meaning that states, workplaces, schools and other organizations no longer need to work through a medical provider to generate a prescription before the test can be administered. For congregate environments using the professional-use version of BinaxNOW, a CLIA certificate is still required.
Abbott continues to deploy its NAVICA system so that individuals can obtain digitally verified test results. Users can download the NAVICA app, take a BinaxNOW Home Test or BinaxNOW professional-use test at a NAVICA-enabled testing site, and display negative results through an encrypted NAVICA Pass. This solution supports organizations – such as employers, K-12 schools, universities, sports and entertainment venues, and nursing homes – to take ownership of their testing solutions and make informed decisions about who enters their facilities.
BinaxNOW performance in the field
Today, BinaxNOW demonstrates overall performance of 84.6% positive agreement (sensitivity) and 98.5% negative agreement (specificity) in people seven days or less post-symptom onset at all Ct counts. In our studies, it further shows performance of 95.6% positive agreement (sensitivity) in people seven days or less post-symptom onset with Ct counts of 33 or below.
Ct counts are the number of times a PCR instrument must cycle through to amplify enough genetic material of the SARS CoV-2 virus for it to be detectable. The greater the amount of virus present (viral load), the fewer cycles required to detect the virus.
In a recent study published by Pilarowski et al. in the peer-reviewed journal Clinical Infectious Diseases, researchers in California assessed BinaxNOW in a community-based setting in people of all ages with and without symptoms. They demonstrated high sensitivity and specificity for BinaxNOW, including in asymptomatic people and in children. Among 102 people who were asymptomatic or whose symptom onset was greater than 7 days before testing, sensitivity for a Ct cutoff of 30 was 100% and specificity was 98.9%. As Ct counts increased to 35 (therefore reflecting less viral load) performance remained high in asymptomatic people of all ages, showing 97.5% sensitivity and 99.7% specificity.
As part of its Emergency Use Authorization for self-testing, Abbott has committed to complete a post-authorization study to determine serial testing performance in people without symptoms.
About BinaxNOW™ COVID-19 Ag Card Self Test Card
The BinaxNOW COVID-19 Ag Card Self Test is a lateral flow immunoassay intended for the qualitative detection of nucleocapsid protein antigen from SARS-CoV-2. This test is authorized for home use with self-collected observed direct anterior nasal (nares) swab samples from individuals aged 15 years or older or adult collected nasal swab samples from individuals aged two years or older with or without symptoms or other epidemiological reasons to suspect COVID-19 infection, when tested twice over three days with at least 36 hours between tests.
Individuals who test negative and continue to experience COVID-like symptoms should seek follow up care from their healthcare provider. Individuals who test positive should take precautions, isolate and seek follow-up care from their healthcare provider. BinaxNOW COVID-19 Ag Card Self Test is only for use under the Food and Drug Administration's Emergency Use Authorization.
About Abbott
Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 109,000 colleagues serve people in more than 160 countries.
Trinity Biotech Announces the Submission of TrinScreen™ HIV to the World Health Organisation for Approval
30 March 2021
DUBLIN, Ireland, March 30th, 2021 -- Trinity Biotech plc has submitted its new HIV screening product, TrinScreen™ HIV, to the World Health Organisation (WHO) for approval.
This product, once approved, will allow the Company to build on its strong presence in HIV testing in Africa, with the Company having been the main confirmatory test provider over many years with its UniGold™ HIV test.
It is expected that the WHO will take a number of months to consider the submission. The Company intends to use that time to prepare for automated manufacturing of the test at the Company’s facility in Ireland.
Test Overview
The product is designed to test for the presence of HIV antibodies from a finger stick sample of blood, in less than 12 minutes. The test has been designed to maximise assay sensitivity and ease of use in the field. A high assay sensitivity indicates the potential risk of a false negative result is very low - a critical parameter in screening programmes where the objective is to identify those with HIV infection. Ease of use in the field allows for broad dissemination of testing which is of critical importance in the African HIV testing market.
Performance Evaluation
As part of the WHO approval process the product has already undergone an evaluation sponsored by the WHO with 1,200 clinical samples at an independent laboratory. The results of this evaluation were excellent. In addition to this, the full submission for pre-qualification also includes the data from a multicentre clinical evaluation which concluded in Africa in 2020.
Comments
Commenting, Ronan O’Caoimh, Chief Executive Officer stated, “We are excited to have submitted our new HIV screening product, TrinScreen HIV, to the WHO for approval. The development of this product has been a strategic priority for Trinity Biotech over several years. It is very positive to see this project reach such a key milestone, especially given the challenges caused by COVID-19 to the clinical evaluation process. Trinity Biotech has already earned a strong reputation in the HIV testing market in Africa with our HIV confirmatory test, Uni-Gold HIV. We expect that on approval by the WHO of TrinScreen HIV, Trinity Biotech will be ideally positioned to take a significant share of the HIV screening market in Africa given the excellent clinical performance of the product and our existing strong reputation in the HIV testing market in Africa.”
About Trinity Biotech
Trinity Biotech develops, acquires, manufactures and markets diagnostic systems, including both reagents and instrumentation, for the point-of-care and clinical laboratory segments of the diagnostic market. The products are used to detect infectious diseases and to quantify the level of Haemoglobin A1c and other chemistry parameters in serum, plasma and whole blood. Trinity Biotech sells direct in the United States, Germany, France and the U.K. and through a network of international distributors and strategic partners in over 75 countries worldwide. For further information please see the Company's website:www.trinitybiotech.com.
ALM-Update: SARS-CoV-2-Pandemie bleibt sehr dynamisch
30 March 2021
30 March 2021 -- Wie seit einigen Wochen beobachtet und vorhergesehen, nehmen die SARS-CoV-2-Neuinfektionen weiterhin deutlich zu – und der Anteil der britischen Variante B.1.1.7 ebenso, mancherorts liegt er bei deutlich über 80 Prozent der diagnostizierten Fälle. Für die Osterfeiertage bedeutet das: „Wir alle sollten uns und unsere Mitmenschen weiterhin diszipliniert vor Ansteckungen schützen“, sagt Dr. Michael Müller. Der 1. Vorsitzende des ALM e.V. rät weiterhin und besonders jetzt zur Beachtung der bekannten und auch gegenüber den Varianten wirksamen wesentlichen Maßnahmen: Kontaktreduzierung, Hygiene, Abstand halten, Maske tragen. Die Auswertung der Akkreditierten Labore in der Medizin – ALM e.V., an der 175 Labore aus dem ambulanten und stationären Bereich teilgenommen haben, zeigen für die KW 12 eine Positivrate von 9,5 Prozent (Vorwoche: 8,3 Prozent). Insgesamt fielen in der vergangenen Woche von den durchgeführten 1.279.394 (Vorwoche: 1.196.364) SARS-CoV-2-PCR-Tests 121.787 Tests positiv aus (Vorwoche: 98.762). Das ist eine Steigerung um 23 Prozent.
Reference: https://www.synlab.de/human/news-artikel/alm-update-sars-cov-2-pandemie-bleibt-sehr-dynamisch-1356
QIAGEN Receives FDA Emergency Use Authorization for NeuMoDx Multiplex Test Expanding COVID-19 Portfolio
29 March 2021 - NeuMoDx™ Flu A-B/RSV/SARS-CoV-2 Vantage Test receives Emergency Use Authorization by FDA. The 4-plex test utilizes the high-throughput, automated testing capabilities of the NeuMoDx systems, which has a growing and comprehensive assay menu for respiratory, blood-borne virus, transplant, and reproductive health disease areas. Test adds to QIAGEN’s expanding portfolio of PCR testing solutions for COVID-19 testing.
GERMANTOWN, Md. & HILDEN, Germany, 29 March 2021 -- QIAGEN N.V. today announced the Emergency Use Authorization by the U.S. FDA for the NeuMoDx™ Flu A-B/RSV/SARS-CoV-2 VantageAssay that will help healthcare professionals quickly identify and differentiate individuals suspected by a healthcare provider of respiratory viral infection consistent with COVID-19.
As restrictions are eased and social distancing measures are reduced, respiratory viral infections are likely to increase. Clinical signs and symptoms of respiratory viral infection due to SARS-CoV-2, influenza or RSV can be similar. This makes it essential to correctly identify them in order to treat and manage patients accordingly, especially in the COVID-19 pandemic. This polymerase chain reaction (PCR) multiplex test will be an important tool now and in upcoming winter seasons for simultaneous qualitative detection and differentiation of influenzas A and B, respiratory syncytial virus (RSV) and SARS-CoV-2 infections within 80 minutes.
QIAGEN launched the NeuMoDx™ Flu A-B/RSV/SARS-CoV-2 Vantage Test in the European Union and other markets that accept CE-IVD in November 2020 and will now begin commercialization of the test in the U.S.
QIAGEN’s new respiratory test takes advantage of the NeuMoDx 96 and NeuMoDx 288 molecular systems’ automated three-step workflow. Coupled with additional system features – like processing capacity, true random access, and continuous loading of samples, reagents and consumables while the system is running – the NeuMoDx™ Flu A-B/RSV/SARS-CoV-2 VantageAssay will be a powerful diagnostic tool for the flu season and COVID-19 pandemic.
“The authorization of this new test will become a pivotal tool for the detection and differentiation of SARS-CoV-2 from influenza like illnesses, or ILls,” said Jean-Pascal Viola, Senior Vice President, Head of the Molecular Diagnostics Business Area and Corporate Business Development at QIAGEN. “This test will play an important role in differentiating between ILI’s while the burden of COVID-19 continues. With its ease of use and true random access, the NeuMoDx will help laboratories maintain throughput for this increased testing volume while continuing routine testing. Also, with the continued ramp up of our manufacturing capacity, the NeuMoDx will be ready to answer the needs of molecular diagnostic laboratories for 2021 and beyond.”
The new 4-plex test joins a growing menu of assays on the NeuMoDx platform, which includes tests for blood-borne viruses, sexual and reproductive health, transplant and immunocompromised disease areas. More tests are in development and expected to launch in the coming months, including VZV, adenovirus and others.
QIAGEN fully acquired NeuMoDx in September 2020 and made it one of its five growth drivers for the company to continue growing on a standalone basis – the others being Sample Prep, QIAcuity, QFT and QIAstat-Dx. The NeuMoDx™ Flu A-B/RSV/ SARS-CoV-2 VantageTest strengthens QIAGEN’s footprint in PCR, the gold standard in coronavirus testing.
QIAGEN has a broad portfolio of testing and research solutions for COVID-19, ranging from fast singleplex and multiplex PCR tests to fast syndromic solutions (QIAstat-Dx), providing customers with a broad variety of PCR-based testing options. Furthermore, the portfolio includes RNA extraction kits and instruments as well as testing components and enzymes used by third parties for their own PCR test kits. QIAGEN’s COVID-19 portfolio also includes the QIAreach Antibody and Antigen tests, as well as SARS-CoV-2 T-Cell tests based on the QuantiFERON IGRA technology. In October 2020, the company also launched QIAprep& which streamlines PCR workflows by integrating sample preparation and real-time PCR detection into a single kit. QIAGEN also provides NGS solutions for research into mutations of COVID-19, dPCR solutions for wastewater testing and bioinformatics with QDI.
Further information on QIAGEN’s response to the coronavirus outbreak can be found here.
For more information on the NeuMoDx platform and NeuMoDx™ Flu A-B/RSV/SARS-CoV-2 Vantage Test,please visit http://qiagen.com/NeuMoDx
About QIAGEN
QIAGEN N.V., a Netherlands-based holding company, is the leading global provider of Sample to Insight solutions that enable customers to gain valuable molecular insights from samples containing the building blocks of life. Our sample technologies isolate and process DNA, RNA and proteins from blood, tissue and other materials. Assay technologies make these biomolecules visible and ready for analysis. Bioinformatics software and knowledge bases interpret data to report relevant, actionable insights. Automation solutions tie these together in seamless and cost-effective workflows. QIAGEN provides solutions to more than 500,000 customers around the world in Molecular Diagnostics (human healthcare) and Life Sciences (academia, pharma R&D and industrial applications, primarily forensics). As of December 31, 2020, QIAGEN employed more than 5,600 people in over 35 locations worldwide. Further information can be found at http://www.qiagen.com.
BGI Obtains CE Mark for Two SARS-CoV-2 Mutant Detection Kits
29 March 2021
29 March 2021 -- BGI Genomics Co. LTD., today announces that its Rapid Identification Kit for B.1.1.7 lineage and B.1.351 lineage of SARS-CoV-2 (Fluorescence RT-PCR*), and the Detection Kit for six mutations in S gene of SARS-CoV-2 (ARMS-PCR*) get the CE Mark.
The two kits developed by BGI PathoGenesis Pharmaceutical Technology Co., Ltd., a subsidiary of BGI Genomics, enable rapid identification and monitoring of new variants. The Rapid Identification Kit for B.1.1.7 lineage and B.1.351 lineage of SARS-CoV-2 (Fluorescence RT-PCR) can identify the B.1.1.7 and B.1.351 lineages, whereas the Detection Kit for 6 mutations in S gene of SARS-CoV-2 (AMRS-PCR) enables the identification of wild-type and mutant coronavirus virus strains by detecting spike protein mutations (N501Y, A570D, HV69-70del, K417N, K417T and E484K).
B.1.1.7, B.1.351 and B.1.1.28 variants have been found in many countries. They have N501Y mutations in the receptor-binding domain (RBD) of the spike protein on the surface of the virus, making it easier to bind to the angiotensin-converting enzyme 2 (ACE2) receptor on the human cell surface. The RBD mutations in these variants also include A570D, HV69-70del, K417N, K417T and E484K mutations.
Since the outbreak of COVID-19, the evolution of SARS-CoV-2 has been one of the focuses of public attention. These two CE marked kits will facilitate the rapid identification and global surveillance of new SARS-CoV-2 variants.
*RT-PCR: reverse transcriptase—polymerase chain reaction
*ARMS-PCR: amplification refractory mutation system—polymerase chain reaction
Augsburg: Corona-Tests mit neuer Lolli PCR-Methode
29 March 2021
29 March 2021 -- SYNLAB startet ein medizinisches Pilotprojekt und testet in den nächsten Wochen Kindertagesstätten und Grundschulen in Augsburg. Es gibt aktuell keine zufriedenstellende Teststrategie für Kinder, daher starten das Gesundheitsamt Augsburg und SYNLAB nach Ostern ein neues Verfahren. Bei den sogenannten Lolli-Tests lutschen Kinder zwei Mal pro Woche 30 Sekunden lang zu Hause an einem Abstrich-Tupfer. Das ist eine für Kinder einfache und nicht invasive Probenentnahme. Die Proben werden im Poolingverfahren im SYNLAB Labor in Augsburg getestet. Im Falles eines positiven Ergebnis innerhalb eines Pools erfolgt eine Testung der einzelnen Proben.
Ziel ist es Alternativen zu Antigentests zu entwickeln, die mit einer Sensitivität von häufig unter 60% Infektionen übersehen. Mit dem Pilotprojekt will SYNLAB eine deutlich sensitivere und gleichzeitig kostengünstige Alternative zum Antigen-Schnelltestverfahren für Kinder etablieren, damit Infektionsketten schneller durchbrechen und dabei unterstützen Kindertagesstätten und Grundschulen offen zu halten.
Reference: https://www.synlab.de/human/news-artikel/augsburg-corona-tests-mit-neuer-lolli-pcr-methode-1355
Labcorp Appoints Johnson & Johnson Executive Kathryn Wengel to the Board of Directors
26 March 2021 - Healthcare Veteran Brings Significant Global Industry Experience
BURLINGTON, N.C., Mar. 26, 2021-- Labcorp, a leading global life sciences company, today announced the appointment of Kathryn Wengel, current Executive Vice President and Chief Global Supply Chain Officer at Johnson & Johnson, as an independent member of Labcorp’s Board of Directors, effective immediately. In connection with this appointment, the Labcorp Board will expand from 9 to 10 directors.
“I am pleased to welcome a renowned healthcare industry veteran like Kathy to the Labcorp Board,” said Adam Schechter, chairman and CEO of Labcorp. “Kathy brings a wealth of experience managing complex healthcare organizations and developing globally diverse teams. We look forward to benefitting from her unique perspective as the Board works with management to advance Labcorp’s role in healthcare and improving the health and lives of patients around the world. Kathy’s appointment is also aligned with the Labcorp Board’s commitment to bring diverse perspectives to the boardroom that will best position us to deliver for our patients, customers, and shareholders."
Ms. Wengel brings significant healthcare and operations experience and global business expertise, with more than three decades of experience in leadership positions within Johnson & Johnson. She currently serves on Johnson & Johnson’s Executive Committee as Executive Vice President and Chief Supply Chain Officer. Ms. Wengel is responsible for all aspects of the development and implementation of Johnson & Johnson’s global Supply Chain, as well as its Quality & Compliance, Procurement, Environmental Health and Safety, Sustainability and Engineering & Property Services functions.
“I’ve long admired Labcorp for its innovation, leadership and commitment to patients and their health, as most recently demonstrated by the essential role the Company has played in combating the COVID-19 pandemic over the last year,” said Wengel. “I’m honored to join Labcorp’s board, and I look forward to working with Adam and the entire Labcorp team to deliver on its important mission and the best interests of patients, clients, and shareholders.”
As Executive Vice President, Chief Global Supply Chain Officer, Ms. Wengel leads a team of more than 56,000 people globally across Johnson & Johnson’s three business segments: Pharmaceuticals, Medical Devices and Consumer Health. Prior to this role, she served in a variety of leadership positions with increasing responsibilities since joining Johnson & Johnson in 1988. In 2009, she co-led the design of Johnson & Johnson’s enterprise Supply Chain and Quality operating model and subsequently served as the company’s first Chief Quality Officer. She also serves as an executive sponsor for both Johnson & Johnson’s Women’s Leadership and Inclusion Initiative and its Women in Science, Technology, Engineering, Math, Manufacturing and Design program.
In addition to her role at Johnson & Johnson, Ms. Wengel serves as Chairman of the Board of GS1 Global, an organization that sets and maintains standards regarding the exchange of critical business data for global commerce. Ms. Wengel is also a member of the Executive Committee of the National Association of Manufacturers (NAM) in the US. She also serves on the Executive Advisory Board for Gartner’s Supply Chain practice and is a member of Supply Chain 50. In 2019, Ms. Wengel was recognized with the Distinguished Service Award by the Council of Supply Management Professionals (CSCMP) and was inducted into the Supply Chain Hall of Fame.
Ms. Wengel holds a Bachelor of Science in Engineering, Civil Engineering & Operations from Princeton University.
About Labcorp
Labcorp is a leading global life sciences company that provides vital information to help doctors, hospitals, pharmaceutical companies, researchers, and patients make clear and confident decisions. Through our unparalleled diagnostics and drug development capabilities, we provide insights and accelerate innovations to improve health and improve lives. With over 70,000 employees, we serve clients in more than 100 countries. Labcorp (NYSE: LH) reported revenue of $14 billion in FY2020. Learn about Labcorp at www.Labcorp.com.
Roche commences tender offer for all shares of GenMark Diagnostics, Inc. for $24.05 per share in cash
25 March 2021
Basel, 25 March 2021 – Roche today announced that it has commenced a cash tender offer for all of the outstanding shares of common stock of GenMark Diagnostics, Inc. (NASDAQ: GNMK) at a price of $24.05 per share. The tender offer is being made pursuant to the previously announced merger agreement dated as of March 12, 2021 among Roche Holdings, Inc., an indirect wholly owned subsidiary of Roche Holding Ltd, Geronimo Acquisition Corp., a wholly owned subsidiary of Roche Holdings, Inc., and GenMark.
The tender offer period will expire at 12:00 midnight, Eastern Time, at the end of the day on Wednesday, April 21, 2021, unless the offer is extended.
Roche has filed a tender offer statement on Schedule TO with the United States Securities and Exchange Commission (SEC). Geronimo Acquisition Corp. is the acquirer in the tender offer. The Offer to Purchase contained within the Schedule TO sets out the terms and conditions of the tender offer.
GenMark has also filed a Solicitation/Recommendation Statement with the SEC on Schedule 14D-9, which includes the unanimous recommendation of the GenMark board of directors that GenMark stockholders tender their shares in the tender offer. Closing of the tender offer is conditioned upon customary closing conditions, including the expiration or termination of the applicable waiting period under the Hart-Scott-Rodino Antitrust Improvements Act, and there being validly tendered and not validly withdrawn a majority of the outstanding shares of GenMark common stock. The offer is not subject to any financing condition. Following successful completion of the tender offer, any shares not acquired in the tender offer will be acquired in a second step merger at the same price of $24.05 per share. The closing of the transaction is expected to take place in the second quarter of 2021.
The complete terms and conditions are set out in the Offer to Purchase, which was filed with the SEC today, March 25, 2021. GenMark stockholders may obtain copies of all of the offering documents, including the Offer to Purchase, free of charge at the SEC’s website (www.sec.gov) or by directing a request for the Solicitation/Recommendation Statement on Schedule 14D-9 to GenMark’s website at www.genmarkdx.com or the Offer to Purchase and the other related materials to MacKenzie Partners, Inc., the Information Agent for the offer, toll free at (800) 322-2885 (or please call (212) 929-5500 if you are located outside the U.S. or Canada) or via email at tenderoffer@mackenziepartners.com.
Before making any decision with respect to the Offer, investors are urged to read the Offer to Purchase and related documents, as well as the Solicitation/Recommendation Statement, because they contain important information about the Offer.
About GenMark Diagnostics
GenMark Diagnostics is a leading provider of multiplex molecular diagnostic solutions designed to enhance patient care, improve key quality metrics and reduce the total cost-of-care. Utilizing GenMark’s proprietary eSensor® detection technology, GenMark’s eSensor XT-8® and ePlex® systems are designed to support a broad range of molecular diagnostic sample-to-answer tests with compact, easy-to-use workstations and self-contained, disposable test cartridges. GenMark’s ePlex: The True Sample-to-Answer Solution™ is designed to optimize laboratory efficiency and address a broad range of infectious disease testing needs, including respiratory, bloodstream and gastrointestinal infections.
About Roche
Roche is a global pioneer in pharmaceuticals and diagnostics focused on advancing science to improve people’s lives. The combined strengths of pharmaceuticals and diagnostics under one roof have made Roche the leader in personalised healthcare – a strategy that aims to fit the right treatment to each patient in the best way possible.
Roche is the world’s largest biotech company, with truly differentiated medicines in oncology, immunology, infectious diseases, ophthalmology and diseases of the central nervous system. Roche is also the world leader in in vitro diagnostics and tissue-based cancer diagnostics, and a frontrunner in diabetes management.
Founded in 1896, Roche continues to search for better ways to prevent, diagnose and treat diseases and make a sustainable contribution to society. The company also aims to improve patient access to medical innovations by working with all relevant stakeholders. More than thirty medicines developed by Roche are included in the World Health Organization Model Lists of Essential Medicines, among them life-saving antibiotics, antimalarials and cancer medicines. Moreover, for the twelfth consecutive year, Roche has been recognised as one of the most sustainable companies in the Pharmaceuticals Industry by the Dow Jones Sustainability Indices (DJSI).
The Roche Group, headquartered in Basel, Switzerland, is active in over 100 countries and in 2020 employed more than 100,000 people worldwide. In 2020, Roche invested CHF 12.2 billion in R&D and posted sales of CHF 58.3 billion. Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan. For more information, please visit www.roche.com.
Reference: https://www.roche.com/media/releases/med-cor-2021-03-25.htm
Thermo Fisher Scientific Completes FDA Listing and Launches the Applied Biosystems QuantStudio 5 Dx Real-Time PCR System for In Vitro Diagnostic Use
25 March 2021 - Innovative qPCR platform simplifies molecular diagnostic workflows for infectious disease, oncology and COVID-19 testing
CARLSBAD, Calif., March 25, 2021 -- Thermo Fisher Scientific today announced the completion of the U.S. Food and Drug Administration (FDA) listing for the Applied Biosystems QuantStudio 5 Dx Real-Time PCR System. The innovative product enables clinical laboratories and assay developers to meet testing demands and enhance their molecular diagnostics workflows.
Clinical diagnostic and hospital laboratories across the United States have ramped up PCR testing over the last year in response to the global COVID-19 pandemic. These laboratories are now seeking solutions to continue to screen for COVID-19 after emergency use authorizations (EUAs) for SARS-CoV-2 assays expire.
"The COVID-19 pandemic has increased testing demands for laboratories exponentially, with a significant portion of the testing globally conducted on Thermo Fisher PCR instruments," said Mark Smedley, president of Genetic Sciences for Thermo Fisher Scientific. "As our customers' testing requirements grow, we are continuously innovating to meet their needs with our molecular diagnostic products. With the launch of the IVD QuantStudio 5 Dx, we can continue to support our customers around the world."
The high-performing qPCR system's simplified, efficient workflow minimizes steps to deliver quality results in as little as 30 minutes. The system has high sensitivity and specificity and offers up to six channels for multiplexing. The cost-effective and complete solution, including simplified software, enhanced security and a simple-to-use interface, comes in a compact footprint that can fit in any lab.
"Thermo Fisher is a valued partner, supporting us in the development of clinical trial assays and companion diagnostics," said Michael Sloan, global vice president of commercial operations at Almac Diagnostic Services. "Thermo Fisher's QuantStudio qPCR systems offer a seamless integration into our assay development workflows. Both the QuantStudio Dx and QuantStudio 5 Dx offer the flexibility of customizable solutions and provide high-quality data output for molecular diagnostic testing."
The QuantStudio 5 Dx Real-Time PCR System is listed with the FDA, includes the CE-IVD Mark under the self-certification process in the European Union, and has been certified and approved by the National Medical Products Administration (NMPA) in China. The system is currently registered in more than 50 countries.
For more information, please visit www.thermofisher.com/quantstudio5dx.
About Thermo Fisher Scientific
Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $30 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, improving patient diagnostics and therapies or increasing productivity in their laboratories, we are here to support them. Our global team of more than 80,000 colleagues delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services and Patheon. For more information, please visit www.thermofisher.com.
Grifols Procleix UltrioPlex E and Procleix Babesia assays receive CE mark
25 March 2021 - Procleix UltrioPlex E Assay enhances blood safety by detecting the presence of HIV-1, HIV-2, HBV, HCV, and HEV in a single, simultaneous test, improving overall laboratory efficiencies. Procleix Babesia Assay detects the Babesia pathogen responsible for one of the most frequent causes of non-viral transfusion-transmitted infections (TTI). The CE mark for these two assays is an important step forward for the Grifols Procleix portfolio and is another example of the company’s commitment to transfusion safety.
Barcelona, Spain, March 25, 2021 -- Grifols, a global leader in the development of plasma-derived therapies and in the development of innovative diagnostic solutions, today announced it has obtained the CE mark for its Procleix UltrioPlex E and Procleix Babesia assays.
The Procleix UltrioPlex E Assay is a nucleic acid test (NAT) designed to improve blood safety by detecting the presence of human immunodeficiency virus type 1 (HIV-1), HIV type 2 (HIV-2), hepatitis B virus (HBV), hepatitis C virus (HCV), and hepatitis E virus (HEV) in a single, simultaneous test from human serum or plasma. It was first commercially launched in August 2020 in Japan and represents a significant advance in streamlining a laboratory’s NAT testing operations by allowing for an increased screening of viruses from a single-donor specimen without the need for any additional equipment. The Procleix UltrioPlex E Assay also helps produce less waste with higher results throughput and greater walk-away time for laboratory staff when compared with running current screening solutions separately.
The Procleix Babesia Assay detects Babesia, a tick-borne parasite that infects the host’s red blood cells and is responsible for one of the most frequent causes of non-viral TTI. It is the first Procleix assay to use a whole blood specimen and, most importantly, target a parasite instead of a virus. The detection of ribosomal RNA, which is present in thousands of copies per parasite, allows equivalent sensitivity in individual samples and pooled lysates. Screening of donated whole blood to detect the presence of the four most common Babesia species is currently mandated in certain parts of the United States where the pathogen represents a serious threat to the safety of the blood supply.
“We are excited to announce the CE mark of two additional assays, as part of our Procleix portfolio for screening blood and plasma, demonstrating Grifols’ continued commitment to transfusion safety,” said David Dew, President, Grifols Diagnostic Commercial Division. “Certification of the Procleix UltrioPlex E and Procleix Babesia assays enhances the competitiveness of our Procleix portfolio and enables blood banks in Europe to increase transfusion safety.”
The Procleix UltrioPlex E and Procleix Babesia assays will be available in all markets accepting the CE mark after completion of any additional registration and notification requirement.
About Procleix UltrioPlex E Assay
The Procleix UltrioPlex E Assay is a nucleic acid test (NAT) that uses Transcription-Mediated Amplification (TMA) to detect the presence of specific nucleic acid sequences for HIV-1, HIV-2, HBV, HCV, and HEV in serum or plasma of donated blood. Because of the high sensitivity and specificity of the amplification technology, detection of the targeted pathogens can be achieved within the early stages of infection, thereby helping in preventing infected blood or blood components to be transfused even when the donor does not exhibit symptoms and traditional screening techniques are not able to detect the presence of the pathogen, or the antibodies against it. The assay runs on the Procleix Panther System, a fully automated NAT instrument launched by Grifols in the EU market in 2012, and currently widely adopted in laboratories globally.
About Procleix Babesia Assay
The Procleix Babesia Assay is a nucleic acid test (NAT) that uses Transcription-Mediated Amplification (TMA) to detect the presence of specific ribosomal RNA sequences of at least four clinically relevant species of Babesia parasites (B. microti, B. duncani, B. divergens, and B. venatorum) in whole blood specimens from blood donors. Because of the high sensitivity and specificity of the amplification technology, detection of the pathogen can be achieved within the early stages of infection, thereby helping in preventing infected blood or blood components to be transfused even when the donor does not exhibit symptoms and traditional screening techniques are not able to detect the presence of the pathogen, or the antibodies against it. The assay runs on the Procleix Panther System, a fully automated NAT instrument launched by Grifols in the EU market in 2012, and currently widely adopted in laboratories globally.
bioMérieux announces the CE marking of TB IGRA® test on VIDAS®
24 March 2021 - Today marks World Tuberculosis (TB) Day and bioMérieux, a world leader in the field of in vitro diagnostics, announces the CE marking of its innovative and fully-automated test VIDAS® TB IGRA (Interferon-Gamma Release Assay) to diagnose latent TB infection.
24 March 2021 -- Tuberculosis continues to be a major global health problem. With 10 million new active cases and 1.4 million related deaths worldwide in 2019, TB remains an important cause of mortality from a single infectious disease.
It is estimated that a fourth of the global population is infected with Mycobacterium tuberculosis, the bacteria responsible for TB disease. In most cases (90-95%), people with healthy immune systems can control the infection without developing the active disease: this is called “Latent Tuberculosis Infection” (LTBI). The remaining infected people (5-10%), will develop active TB disease (aTB), making them sick as well as infectious to others.
“Despite all efforts, tuberculosis has not been eradicated and remains a significant health problem for a large proportion of the world’s population, especially in low- and middle-income countries. Diagnosing people who have latent TB infection is an important tool for global TB control. Detecting and then following or treating people with latent TB infection can help in preventing their progression to active disease, which would make them sick and also infectious to others.” said Mark Miller, Executive Vice President and Chief Medical Officer, bioMérieux.
There is no single gold standard for diagnosing LTBI. Current diagnostic tools for LTBI include a detailed clinical history of exposure to TB, the tuberculin skin test (TST) or an IGRA test, which are indirect diagnostic methods based on the host immune response to the pathogen.
Despite their improved performances over TST, current IGRA tests are cumbersome, consist of many manual steps, and can negatively impact the lab workflow. There is a need for improved TB-IGRA tests having complete automation, standardization of each step, faster time to results, more accurate and reliable clinical performances and increased ease-of-use for any lab without specialized expertise.
VIDAS® TB-IGRA is the new fully automated assay intended as an aid in the diagnosis of infection with Mycobacterium tuberculosis.
Performed on the VIDAS® 3 platform, VIDAS® TB-IGRA provides reliable test results and improves current workflow compared to existing TB-IGRA solutions.
The complete test process is fully automated from sample to result interpretation, including the stimulation step. Only one whole blood sample tube is needed with no manual sample preparation. Thanks to this simplified “load & start” process, laboratories will now be able to easily manage TB-IGRA testing in-house and deliver faster results to clinicians without additional cost.
In addition to full automation, VIDAS® TB-IGRA demonstrated strong clinical performances. Clinical trials conducted on populations coming from different areas around the world demonstrated a better sensitivity in an active TB population compared to an existing test (97% vs 80,6%), a high specificity of 97.5% in populations at very low risk of being TB infected and a strong agreement with the comparative assay on populations at mixed risk levels of TB infection. Furthermore, significantly fewer indeterminate results (0,1% vs 1,3%) were observed.
“For more than 55 years, bioMérieux has been driven by a pioneering spirit and unrelenting commitment to improve public health worldwide. It is a great achievement for us to provide laboratories with a fully automated assay with high performances to detect latent tuberculosis. As we commemorate World Tuberculosis Day today, the launch of VIDAS® TB-IGRA reaffirms our commitment to help end tuberculosis by detecting infected individuals” declared Alexandre Mérieux, Chief Executive Officer, bioMérieux.
VIDAS® TB-IGRA will be gradually deployed in countries that recognize CE marking. Hospitals and private laboratories will be able to run the test on bioMérieux’s VIDAS® 3 system, which allows for higher automation and traceability. bioMérieux is planning a submission for FDA clearance in the near future.
Reference: https://www.biomerieux.com/en/biomerieux-announces-ce-marking-tb-igrar-test-vidasr
BGI Detection Kit for 6 Mutations in S Gene of SARS-CoV-2
24 March 2021
24 March 2021 -- Here in BGI, we work night and day looking for solutions, using cutting-edge technology and our team expertise to bring health to the people. In response to the new COVID-19 mutants, BGI monitors the emergence of additional SARS-CoV-2 variants of concern and develops a variety of identification kits for B.1.1.7, B.1.351, and P1.
Reference: https://www.bgi.com/global/company/news/6-mutations/
ALM-Update: SARS-CoV-2-Infektionen nehmen weiter deutlich zu
23 March 2021
23 March 2021 -- Die SARS-CoV-2-Neuinfektionen nehmen wieder deutlicher und schneller zu. Das bestätigen auch die Zahlen der Akkreditierten Labore in der Medizin – ALM e.V. aus der vergangenen Kalenderwoche. So zeigt die Auswertung der Daten der nun 175 Labore aus dem ambulanten und stationären Bereich eine erneut deutlich gestiegene Positivrate von 8,3 Prozent (Vorwoche 7,2 Prozent). Insgesamt fielen in der KW 11 von den durchgeführten 1.196.364 (Vorwoche: 1.090.422) SARS-CoV-2-PCR-Tests 98.762 positiv aus (Vorwoche: 77.646). „Neben dem forcierten Impfen und der konsequenten Umsetzung der Nationalen Teststrategie mit breiter und niedrigschwelliger Testung nach den RKI-Kriterien bleiben die bekannten allgemeinen Maßnahmen mit Kontaktreduktion, Abstand halten, Maske tragen, Lüften in Innenräumen und der Nutzung der Corona-Warn-App weiterhin das wirksame Mittel gegen die Ausbreitung von SARS-CoV-2. Jede und jeder von uns kann hier einen Beitrag leisten“, sagt Dr. Michael Müller, 1. Vorsitzender des ALM e.V.
Roche launches new high throughput configurations for cobas pro integrated solutions to increase testing efficiency
23 March 2021 - With eight new configurations, cobas pro® integrated solutions offers labs greater flexibility to ramp up their testing capacity to adapt to evolving testing needs. This will allow a greater number of patient samples to be processed faster. By consolidating up to four analytical units on a single platform, testing efficiency in high-volume labs is increased.
Basel, 23 March 2021 – Roche announced today the launch of eight new configurations for cobas pro integrated solutions, in countries accepting the CE mark. As a result, this analyser can deliver up to 4,400 tests per hour, doubling its previous testing capacity. This makes it the ideal choice for labs seeking greater flexibility in ramping up their testing capacity, to adapt to evolving clinical chemistry and immunochemistry testing needs.
Today, the importance of accurate and timely diagnostic testing can be felt across the globe. Growing testing demands put laboratories under significant pressure to increase their testing volumes and operational efficiency, with fewer resources. At the same time, clinicians and patients rely on accurate and timely results to make informed decisions. To overcome these challenges, labs require reliable diagnostic solutions that ensure simplified testing, allowing for earlier diagnosis and improved patient care.
“We are excited to release eight new high throughput configurations for cobas pro integrated solutions which have been designed to address the individual needs of healthcare professionals to maximise throughput and efficiency,” said Thomas Schinecker, CEO Roche Diagnostics. “By building on a system with proven reliability and performance, we continue to simplify laboratory operations so that patients can benefit from shorter time to results and faster treatment decisions.”
cobas pro integrated solutions now offers the possibility to add two additional analytical units of cobas c 503 and/or cobas e 801, consolidating up to four analytical units on a single platform and thus serving the needs of high throughput labs. Labs can now benefit from eight new configurations, allowing them to better tailor their instrumentation to their individual needs. As a result, cobas pro integrated solutions can deliver up to 4,400 tests per hour, doubling its previous testing capacity. Running more tests across a broad range of disease areas including cardiology, oncology and infectious diseases, enables labs to further extend their value for physicians and patients. Furthermore, by consolidating a greater number of samples on a single platform and offering the industry’s broadest clinical chemistry and immunochemistry assay menu of over 230 diagnostic tests, this analyser helps to simplify sample processing and laboratory workflows.
About cobas pro integrated solutions
Launched in 2018, cobas pro integrated solutions is a scalable and modular solution designed to achieve mid-to-high volume clinical chemistry and immunochemistry testing needs. It aims to increase efficiency with fast analytical units, intelligent sample routing, and short assay incubation times, with 93% of Roche immunoassays having reaction times of 18 minutes or less. This analyser features automated maintenance and cobas® AutoCal, an automated calibration procedure, to save hands-on time. Additionally, it incorporates cobas® SonicWash, an ultrasonic probe cleaning to ensure sample integrity.
cobas pro integrated solutions provides fully standardised results and operation to cobas® pure integrated solutions. Together, they deliver a seamless experience and the highest level of standardisation using the same reagents and assay menu, delivering consistent results and operation, and therefore allow for flexible staff assignment and minimal training needs. It makes these systems also ideal candidates for integrated health networks and lab chains.
cobas pro integrated solutions is fully compatible with the cobas® mobile solution, a tablet that integrates multiple Roche applications, allowing laboratory professionals to interact with the analyser from anywhere in the lab.
With cobas pro integrated solutions, the required sample volume per test has been reduced on average by 43% compared to previous generation systems. Additionally, the plastic generated per test result has been reduced by up to 78% due to smaller reagent pack sizes with a higher number of tests per pack.
About Roche
Roche is a global pioneer in pharmaceuticals and diagnostics focused on advancing science to improve people’s lives. The combined strengths of pharmaceuticals and diagnostics under one roof have made Roche the leader in personalised healthcare – a strategy that aims to fit the right treatment to each patient in the best way possible.
Roche is the world’s largest biotech company, with truly differentiated medicines in oncology, immunology, infectious diseases, ophthalmology and diseases of the central nervous system. Roche is also the world leader in in vitro diagnostics and tissue-based cancer diagnostics, and a frontrunner in diabetes management.
Founded in 1896, Roche continues to search for better ways to prevent, diagnose and treat diseases and make a sustainable contribution to society. The company also aims to improve patient access to medical innovations by working with all relevant stakeholders. More than thirty medicines developed by Roche are included in the World Health Organization Model Lists of Essential Medicines, among them life-saving antibiotics, antimalarials and cancer medicines. Moreover, for the twelfth consecutive year, Roche has been recognised as one of the most sustainable companies in the Pharmaceuticals Industry by the Dow Jones Sustainability Indices (DJSI).
The Roche Group, headquartered in Basel, Switzerland, is active in over 100 countries and in 2020 employed more than 100,000 people worldwide. In 2020, Roche invested CHF 12.2 billion in R&D and posted sales of CHF 58.3 billion. Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan. For more information, please visit www.roche.com.
Reference: https://www.roche.com/media/releases/med-cor-2021-03-23b.htm
Thermo Fisher Scientific to Offer Integrated COVID-19 Testing to School Districts Nationwide
23 March 2021 - Increased testing capacity and an extensive network of testing laboratories combined with support from Color, a leading software and logistics provider, will enable safe, sustainable in-person instruction
WALTHAM, Mass., March 23, 2021 -- Thermo Fisher Scientific Inc., the world leader in serving science today announced the launch of a nationwide testing program designed to support U.S. efforts to return to in-person classroom instruction. This program, developed in partnership with Color Health, Inc., a California-based leader in distributed healthcare services, along with leading providers of laboratory testing, aims to support schools as the Biden Administration provides $10 billion in funding to conduct COVID-19 testing.
The Biden Administration has identified COVID-19 testing in schools as a critical proactive step in the recovery from the pandemic and has proposed a two-pronged strategy that includes both funding for states to administer testing programs and a soon-to-be-awarded federal hub and spoke based program to expand capacity for schools and underserved populations.
Since the start of the pandemic, Thermo Fisher has supported governments and laboratory partners with COVID-19 testing ramp-up, including equipping a network of labs with capacity to deliver accurate PCR-based individual and pooled testing. Testing programs for this initiative can include PCR-based testing as well as rapid antigen, depending on the school and/or district.
Thermo Fisher's partnership with Color draws on Color's experience serving school districts, major employers, universities, and public health departments to provide critical testing programs. Color's scaled easy-to-use school testing model will provide both convenient sample collection and a seamless result-reporting platform.
"The $10 billion allocation is a critical first step to returning students to school in April, and what happens next is even more critical – helping schools take advantage," said Mark Stevenson, executive vice president and chief operating officer of Thermo Fisher Scientific. "This program is possible because our industry has already established a strong testing infrastructure during the pandemic and now it's time to make that available where it's needed most urgently."
According to Othman Laraki, chief executive officer of Color, "As we have seen throughout the COVID-19 pandemic, one of the most daunting obstacles has been the ability to effectively address the logistical and accessibility challenges for the last mile of healthcare. This initiative allows us to link individuals in need of COVID-19 tests with available lab capacity near their school or home."
For more information on setting up a testing program for your school district, visit www.thermofisher.com/safeschools or email safeschools@thermofisher.com.
About Thermo Fisher Scientific
Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $30 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, improving patient diagnostics and therapies or increasing productivity in their laboratories, we are here to support them. Our global team of more than 80,000 colleagues delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services and Patheon. For more information, please visit www.thermofisher.com.
https://clinical.r-biopharm.com/news/quality-controls-for-sars-cov-2-rapid-tests-and-rt-pcr/
23 March 2021 - Lenco Diagnostic Laboratories among first to offer Beckman Coulter’s semi-quantitative antibody test; Lab expects clinicians will use assay to monitor patients’ COVID-19 recovery and assess immune response over time. Assay available to ship in the U.S. and countries accepting the CE Mark.
BREA, CALIF., MAR. 23, 2021 — Beckman Coulter, a clinical diagnostics leader, today announced that its Access SARS-CoV-2 IgG II antibody assay received U.S. Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration. The semi-quantitative assay measures a patient’s level of antibodies in response to a previous SARS-CoV-2 infection and provides a qualitative and numerical result of antibodies in arbitrary units (AU).
Lenco Diagnostic Laboratories, one of New York City’s largest privately-owned, full-service reference labs, is among the first to offer the test in its facilities across Brooklyn, NYC, and the tri-state metropolitan area. Lenco conducted an independent verification of the assay’s performance and is highly satisfied with the quality of the results.
“To help in the fight against COVID-19, it is important that we partner with a company that has the reputation, quality, and testing accuracy like Beckman Coulter in meeting the needs of the people of New York,” said Robert Boorstein, M.D., Ph.D., medical director, Lenco Diagnostics Laboratories. “This next step in COVID-19 antibody testing creates a pathway in helping us establish a quantitative baseline of different antibody levels and determine how a patient’s immune response to COVID-19 is affected over time. We expect that clinicians will find this assay useful for monitoring the progress of a patients’ COVID-19 recovery and assessing the immune response over time.”
The Access SARS-CoV-2 IgG II assay measures IgG antibodies directed to the receptor-binding domain of the spike protein of the coronavirus. The test has a confirmed 100% negative percent agreement (specificity) and a 98.9% positive percent agreement (sensitivity) at >/= 15 days post symptom onset. The Access SARS-CoV-2 IgG II assay can be used in Random Access Mode (RAM) and seamlessly integrates into existing workflows without batch processing.
“Effective and high-quality diagnostic solutions are essential in the fight against COVID-19,” said Shamiram R. Feinglass, MD, M.P.H, chief medical officer at Beckman Coulter. “Antibody assays like our Access SARS-CoV-2 IgG II test can help researchers quantitatively determine the levels of IgG antibodies and enable them to assess the relative changes of an individual’s immune response to the SARS-CoV-2 virus over time. This information is essential because it helps continually inform therapeutics and vaccine development.”
The Access SARS-CoV-2 IgG II antibody assay is now available in the U.S. and countries accepting the CE Mark. Results of the new test are delivered on Beckman Coulter’s award-winning immunoassay analyzers, including the DxI 800 high-throughput analyzer, capable of processing up to 4,800 samples per day. The IgG II antibody assay is the latest addition to Beckman Coulter’s full suite of testing solutions that provide clinicians valuable information in their fight against COVID-19. Beckman Coulter also recently launched an automated SARS-CoV-2 antigen test in the U.S. under Policy C of the FDA’s emergency use authorization (EUA) program. For more information on Beckman Coulter’s antibody assays, as well as its full suite of COVID-19 diagnostic solutions, visit www.BeckmanCoulter.com/Coronavirus.
About Beckman Coulter
Beckman Coulter is committed to advancing healthcare for every person by applying the power of science, technology and the passion and creativity of our teams to enhance the diagnostic laboratory’s role in improving healthcare outcomes. Our diagnostic systems are used in complex biomedical testing, and are found in hospitals, reference laboratories and physician office settings around the globe. Beckman Coulter offers a unique combination of people, processes and solutions designed to elevate the performance of clinical laboratories and healthcare networks. We do this by accelerating care with a menu that matters, bringing the benefit of automation to all, delivering greater insights through clinical informatics and unlocking hidden value through performance partnership. An operating company of Danaher Corporation since 2011, Beckman Coulter is headquartered in Brea, Calif., and has more than 11,000 global associates working diligently to make the world a healthier place.
Quality controls for SARS-CoV-2 rapid tests and RT-PCR
22 March 2021
22 March 2021 -- We complement our control reagent portfolio with new controls including SARS-CoV2 positive and negative controls, as well as all-encompassing validation and verification kits for respiratory and SARS-CoV-2 pathogens. Our portfolio includes control material for RT-PCR as well as for quick tests. These quality controls are cross-platform compatible, mimic patient samples and safe to use.
Microbix quality assessment products advantages:
- Liquid material is in ready to use aliquots and swabs
- Stable for up to two years
- Compatible with immunoassays and nucleic acid tests
- Commutable and cross-platform compatible
- ONBOARDx™ (RUO): designed to meet the instrument/device sample adequacy requirements if needed
- Special SARS-CoV-2 controls
PROCEEDx™
A sample that is used to ensure whether a device complies with its specification or imposed condition (fault insertion). Intended for use in internal processes.
REDx™
Ensures day-to-day consistency of an analytical process and assists in determining reliable patient test results.
ONBOARDx™
All-encompassing validation and verification kit for instrument/kit/assay qualification and operator training. Contains PROCEEDx™ material and is intended for use in internal processes.
Reference: https://clinical.r-biopharm.com/news/quality-controls-for-sars-cov-2-rapid-tests-and-rt-pcr/
BGI Rapid Identification Kits for SARS-CoV-2 Variants in Use in Angola
20 March 2021
On March 18, 2021, BGI announced the donation of 40,000 Rapid Identification Kits for SARS-CoV-2 variants to the Ministry of Health of Angola, to support the local fight against the pandemic. The kits arrived earlier this month in Luanda, the capital of Angola.
At the online ceremony, Silvia Lutucuta, the Minister of Health of Angola, said: “In the face of new challenges brought by the COVID-19 variants, BGI once again lent a helping hand and provided Identification Kits for SARS-CoV-2 variants to Angola. On behalf of the Angolan government, we express our heartfelt thanks.”
On July 16, 2020, the Angolan government commissioned BGI to build Huo-Yan Laboratories in four cities with a total daily testing capacity of 6,000 samples to fight against the pandemic. In the second half of 2020, four laboratories were opened successively. The 18 local laboratory experts were trained by BGI.
Angolan Minister of Health Silvia Lutucuta (top right), and Gong Tao, Chinese Ambassador to Angola (bottom left), attend the ceremony onsite in Angola. Li Ning, Vice President of BGI (top left, second from left) attended online.
Recently, three SARS-CoV-2 variants–the lineage B.1.1.7 first identified in England, and the lineages B.1.351 and P1 initially discovered in South Africa and Brazil have gained global attention.
In response to the new COVID-19 mutants, BGI monitors the emergence of additional SARS-CoV-2 variants of concern and develops a variety of identification kits for B.1.1.7, B.1.351, and P1. We have also developed a new NGS-based Genome Analysis Solution, which can detect mutations in new variants with high-quality genome sequencing results.
BGI provides a full range of COVID-19 nucleic acid detection kits, antibody detection kits and antigen detection kits together with identification kits. The series of product and applications can meet the clinical needs of various scenarios and contribute to the global COVID-19 prevention and control work.
Illumina Announces Board Changes
18 March 2021 - Jay Flatley to step down from the Board; John W. Thompson to be appointed new Chair
SAN DIEGO, 18 March 2021 -- Illumina, Inc. (the “Company”) today announced that Jay Flatley has decided to step down from the Board of Directors and John W. Thompson will be appointed as the Company’s new Chair of the Board. These changes will be effective as of the Company’s Annual Shareholder Meeting on May 26, 2021. This is part of a thoughtful, long-term succession planning process.
“It has been a tremendous honor to work with the Illumina team during the past 22 years to create an industry leader. Having witnessed the impact of our technology on patients’ lives and the passion of our employees, I am deeply grateful for my time at this incredible Company,” said Mr. Flatley. “I am excited about the future of Illumina – the potential for improving human health through our next-generation sequencing and technology remains enormous. Illumina has significant opportunities ahead and I am confident that John, Francis and the entire Illumina leadership team will continue the Company’s strong legacy of innovation and execution for long-term success.”
“It has been a privilege to work closely with Jay since I joined Illumina eight years ago. On behalf of our Board and the Company, I would like to thank Jay for his vision, partnership and dedication to continued growth and innovation. The entire Illumina team wishes Jay all the best as he embarks on his new chapter,” said Francis deSouza, Chief Executive Officer. “John’s extensive leadership and operating experience, his proven track record as the Chair of Microsoft’s Board, as well as his tenure as our Lead Independent Director, uniquely position him to serve as Illumina’s next Chair. He is an outstanding choice to lead our talented Board.”
“I am honored to be selected as Illumina’s next Chair of the Board,” said Mr. Thompson. “I look forward to working with Francis and the Board to support the next phase of Illumina’s evolution to benefit patients, employees, customers and shareholders.”
Mr. Flatley led Illumina as CEO from 1999 until mid-2016, served as Executive Chair from mid-2016 through 2019, and currently serves as Chair of the Board. Over the course of Mr. Flatley’s tenure, Illumina established its mission to “Unlock the Power of the Genome” and launched a myriad of products that made sequencing faster, more cost-effective and more accessible. As a pioneer of the genome sequencing market, Mr. Flatley spearheaded Illumina’s acquisition of Solexa and the underlying technology for the Company’s sequencing technology, transforming Illumina into the leading global provider of next-generation sequencing solutions.
Mr. Thompson has been a Director on Illumina’s Board since 2017. He brings extensive executive leadership experience having served in chief executive officer roles at Virtual Instruments and Symantec. He also brings 28 years of leadership experience at IBM where he held senior roles in sales, marketing, software development and served as General Manager of IBM Americas. He has served as Microsoft’s Chair of the Board since 2014 and as a director since 2012. He currently serves as a director on the boards of two privately held companies, Rubrik and Seismic Software. He has also served on the boards of Symantec, NIPSCO (Northern Indiana Public Service Company), Fortune Brands, Seagate Technologies, and United Parcel Service (UPS). Mr. Thompson is a member of the board of trustees for the Wetlands America Trust and was formerly a member of the national board of Teach for America.
Mr. Thompson received a bachelor’s degree in business administration from Florida A&M University and a master’s degree in management science from MIT’s Sloan School of Management. He has received honorary doctorate degrees from the University of Notre Dame, Mendoza College of Business and Florida A&M University.
About Illumina
Illumina is improving human health by unlocking the power of the genome. Our focus on innovation has established us as the global leader in DNA sequencing and array-based technologies, serving customers in the research, clinical, and applied markets. Our products are used for applications in the life sciences, oncology, reproductive health, agriculture, and other emerging segments. To learn more, visit www.illumina.com.
BIOFIRE® Respiratory 2.1 (RP2.1) Panel with SARS-CoV-2 obtains De Novo FDA Authorization
18 March 2021
Marcy l’Étoile, France, 18 March 2021 – bioMérieux, a world leader in the field of in vitro diagnostics, today announced that BioFire Diagnostics, its subsidiary specialized in molecular syndromic infectious disease testing, has received U.S. Food and Drug Administration (FDA) De Novo authorization for the BIOFIRE® RP2.1 Panel.
This panel allows for the detection of 22 viral and bacterial pathogens responsible for respiratory infections, including SARS-CoV-2 (the cause of COVID-19 disease). The panel is the first SARS-CoV-2 diagnostic test of any kind that has been granted De Novo status by U.S. FDA, having gone through the normal U.S. FDA review pathway outside of the Emergency Use Authorization (EUA) track.
This De Novo authorization will be concurrent with the revocation of the U.S. FDA EUA that was obtained on May 1st, 2020 for this panel. The BIOFIRE® RP2.1 Panel EUA and De Novo kits are identical with the exception of changes to the labeling.
The De Novo application was supported by a multicenter prospective clinical study in which the performance of the BIOFIRE® RP2.1 Panel SARS-CoV-2 assay was evaluated in over 500 specimens against a combined reference of three independent molecular SARS-CoV-2 assays, each with U.S. FDA EUA designation. The BIOFIRE® RP2.1 Panel SARS-CoV-2 assay demonstrated positive percent agreement (PPA) of 98.4% and negative percent agreement (NPA) of 98.9%.
Pierre Boulud, Chief Operating Officer, Clinical Operations of bioMérieux said: “The De Novo authorization of the BIOFIRE® RP2.1 Panel demonstrates how BioFire is dedicated to responding to a rapidly-evolving global pandemic with urgency and accuracy. This is the first U.S. FDA De Novo authorized Covid-19 test.”
The BIOFIRE® RP2.1 Panel allows healthcare providers to quickly identify common respiratory pathogens found in patients presenting with acute respiratory tract infection, using one simple test. The BIOFIRE® RP2.1 Panel yields results in approximately 45 minutes using nasopharyngeal swab (NPS) samples in transport media or saline. It runs on the fully automated BIOFIRE® FILMARRAY® 2.0 and BIOFIRE® Torch Systems with only 2 minutes of sample preparation time.
About bioMérieux's global response to COVID-19
bioMérieux provides several SARS-CoV-2 diagnostic solutions:
- ARGENE® SARS-CoV-2 R-GENE® and SARS-CoV-2 RESPI R-GENE®: these tests are available in certain international markets outside of the US and rely on real-time PCR technology and can be used with most commercially available amplification PCR-platforms. The SARS-CoV-2 RESPI R-GENE® allows the simultaneous (multiplex) detection of SARS-CoV-2, influenza viruses A and B and two other respiratory pathogens (RSV and hMPV).
- BIOFIRE® COVID-19 test: this fully automated SARS-CoV-2 test provides results from a patient sample in 45 minutes. It is suitable for use in emergency situations for critically ill patients. The BIOFIRE® COVID-19 test was developed with funding from the U.S. Department of Defense (DoD) and is produced in Utah (USA).
- BIOFIRE® Respiratory 2.1 plus Panel: this test is available in certain international markets outside of the US and includes the detection of MERS-Coronavirus in addition to the other pathogens of the BIOFIRE® RP2.1 Panel in approximately 45 minutes.
- BIOFIRE® Respiratory 2.1-EZ Panel: this panel identifies 19 pathogens associated with respiratory infections, including SARS-CoV-2 in approximately 45 minutes, and is used in point of care and near patient (e.g. CLIA-waived) settings. Available in the US only.
- EMAG® and easyMAG®: equipment and associated reagents are pivotal for the extraction of nucleic acids prior to the amplification and detection of specific gene sequences. These systems are in high demand as a means of preparing nucleic acids from clinical specimens.
- VIDAS® anti-SARS-CoV-2 IgM and anti-SARS-CoV-2 IgG: these two serology tests detect antibodies as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection.
Beckman Coulter Offers $4/High-throughput Antigen Test to Support U.S. Government Initiative to Expand COVID-19 Testing
18 March 2021 - Company ready to support the $12 billion expansion in COVID-19 testing as vaccinations increase. Company able to support testing for schools and underserved congregate settings, directly through existing and new coordinating centers by supplying 25 million tests per month. The test is specifically designed to support high-throughput automated testing screening.
BREA, CALIF., MAR. 18, 2021 — Beckman Coulter, a clinical diagnostics leader, today announced their commitment to support the U.S. government’s plan to invest more than $12 billion to expand COVID-19 testing with their high-throughput, high-quality lab antigen test, Access SARS-CoV-2 Ag*, ideal for mass screening testing.
Beckman Coulter announced in December that their $4 antigen test will be available to all customers and has a confirmed 93% positive predictive agreement (PPA) and 100% negative predictive agreement (NPA). Results can be delivered in as little as 30 minutes on Beckman Coulter’s immunoassay analyzers, including the DxI 800 high-throughput analyzer that can process up to 200 samples every 60 minutes.
“We support the U.S. government’s goal to expand screening because this is the right way to open up our schools, our economy and get people back to work in tandem with the massive vaccination drive that is underway,” said Julie Sawyer Montgomery, president of Beckman Coulter Diagnostics. “The key to saving lives while vaccines are being put into arms is still masking, social distancing, regular testing, tracing and isolation. Our antigen assay makes the regular testing part of this equation a reality by enabling institutions and communities to implement low-cost, frequent, mass COVID-19 testing with automation, ease of handling and speed to enable scalability.”
Beckman Coulter’s antigen test can be used for testing in high-risk settings, such as nursing homes, hospitals, universities and other group settings where repeat testing, coupled with relevant clinical information, could identify those with a SARS-CoV-2 infection to minimize transmission.
“We are offering our solution at $4 per test because it’s only with affordable and regular testing that we can address disparities and promote equity in COVID-19 testing, which is vital to address COVID-19-related health gaps and advance health equity among high-risk and underserved populations, including racial and ethnic minority groups and people living in rural areas,” said Shamiram R. Feinglass, M.D., MPH, chief medical officer for Beckman Coulter.
While point of care (POC) antigen tests have a purpose in diagnosing COVID-19, they are difficult and resource intensive to scale to address high-volume testing needs. Only Beckman Coulter’s $4 SARS-CoV-2 antigen test makes large-scale, serial testing programs feasible and affordable.
“A point of care test that delivers a result in 15 minutes for a single individual cannot perform as efficiently when it’s asked to deliver results for hundreds or thousands of people; the workflow breaks down with too many manual handling steps in the process,” said Dr. Feinglass. “Furthermore, a hospital is compelled to report positive results to the regulatory bodies, and some point of care tests require cumbersome manual recording of patient data into their EMR.”
Ideal for implementing as part of a large-scale community, workplace or school screening program, Access SARS CoV-2 Antigen test samples are collected with a nasopharyngeal or nasal swab and can be stored at room temperature for up to 24 hours and 48 hours refrigerated (2-8 degrees Celsius) with one freeze/thaw cycle.
The assay also provides ultimate flexibility in scaling to address the needs of small or low volume to moderately-sized laboratories that operate a desktop analyzer, to large laboratories with automated, high-throughput analyzers for mass testing. Whether on a desktop with an Access 2 or on a high-throughput analyzer like the DxI 800, results are immediately delivered electronically to physicians, patient portals and health agencies, allowing clinicians to initiate proper treatment quickly, isolate patients, and start tracing, helping to minimize the spread of COVID-19.
Learn more about Beckman Coulter’s affordable, reliable and designed for high-throughput antigen solution at www.beckmancoulter.com/accessantigen.
Beckman Coulter’s Suite of COVID-19 Testing Solutions
Beckman Coulter offers a menu that matters for COVID-19, including the $4 Access SAR-CoV-2 Antigen assay, as well as three antibody assays: Access SARS-CoV-2 IgM, Access SARS CoV-2 IgG and the semi-quantitative SARS-CoV-2 IgG II. Beckman Coulter is also developing a SARS-CoV-2 quantitative IgG assay based on WHO reference ranges.
The company also has an interleukin 6† (IL-6) assay, which can be used to aid physicians in identifying a severe inflammatory response and determining the risk of intubation with mechanical ventilation in COVID-19 patients. Beckman Coulter also offers a biomarker that measures monocyte distribution width (MDW), which can be used as an aid in the early detection of sepsis in adult patients presenting to the emergency department. Earlier this year, the company received government funding to develop a machine learning algorithm to help accurately predict and detect sepsis in COVID-19 patients leveraging its MDW test. Additionally, in mid-October, Beckman Coulter was awarded funding by for a multi-center clinical trial to validate the ability of MDW to aid in the rapid detection of Multisystem Inflammatory Syndrome in Children (MIS-C), a severe COVID-19 complication.
All of Beckman Coulter’s assay to address COVID-19 can be performed in automated or high-throughput immunoassay formats, as well as with Beckman Coulter’s Access 2 analyzer, a compact, tabletop analyzer enabling high-quality serology testing to be carried out in small hospitals and clinics. Additionally, all of the assays seamlessly integrate into laboratory workflows making it easy to add these tests to routine blood tests performed during inpatient and wellness testing.
About Beckman Coulter
Beckman Coulter is committed to advancing healthcare for every person by applying the power of science, technology and the passion and creativity of our teams to enhance the diagnostic laboratory’s role in improving healthcare outcomes. Our diagnostic systems are used in complex biomedical testing, and are found in hospitals, reference laboratories and physician office settings around the globe. Beckman Coulter offers a unique combination of people, processes and solutions designed to elevate the performance of clinical laboratories and healthcare networks. We do this by accelerating care with a menu that matters, bringing the benefit of automation to all, delivering greater insights through clinical informatics and unlocking hidden value through performance partnership. An operating company of Danaher Corporation since 2011, Beckman Coulter is headquartered in Brea, Calif., and has more than 11,000 global associates working diligently to make the world a healthier place.
Quidel Corporation applauds Biden administration plan to expand COVID-19 testing
18 March 2021
SAN DIEGO, 18 March 2021 -- Quidel Corporation (“Quidel”), a provider of rapid diagnostic testing solutions, cellular-based virology assays and molecular diagnostic systems, today announced its support for the Biden Administration’s plan to expand COVID-19 testing in schools, underserved communities, rural areas and other settings that have been gravely impacted by the pandemic.
“Quidel applauds the Biden Administration’s urgent and comprehensive approach to bringing the benefits of rapid, routine and equitable coronavirus testing to America’s classrooms, underserved communities and rural areas,” said Douglas Bryant, president and CEO of Quidel Corporation. “Frequent testing has proven to be a critical tool for both empowering people to take charge of their own health and allowing large institutions, businesses, sports and entertainment venues and enumerable other aspects of society to reopen safely and remain so.”
“Our mission at Quidel has always been to democratize access to frequent, affordable and highly accurate COVID-19 testing, and we expect the Administration’s American Rescue Plan for testing will turbocharge efforts all across the diagnostics industry to get everyone screened so the virus and any variants can be stopped, tracked and traced in real time,” Mr. Bryant noted. “We are approaching the inflection point where frequent at-home, in-school and on-site testing of asymptomatic people at scale can give us greater peace of mind to see our families, dine out and travel.”
Quidel recently received Emergency Use Authorization (EUA) from the FDA for its QuickVue® At-Home COVID-19 Test, an easy-to-use test that provides results to symptomatic patients in ten minutes with a doctor’s prescription. The company is seeking an EUA for over-the-counter (OTC) sale of the QuickVue® At-Home COVID-19 Test to symptomatic and asymptomatic consumers without a prescription. Quidel is currently building out a new manufacturing facility in Carlsbad, CA dedicated to the production of Quidel’s popular QuickVue® line of products. The 128,000 square foot facility will be the company’s highest-volume production plant in the world and is expected to produce 600 million QuickVue® rapid antigen tests for the detection and diagnosis of COVID-19 infections.
Visit www.quickvueathome.com for more information.
About Quidel Corporation
Quidel Corporation is a leading manufacturer of diagnostic solutions at the point of care, delivering a continuum of rapid testing technologies that further improve the quality of health care throughout the globe. An innovator for over 40 years in the medical device industry, Quidel pioneered the first FDA-cleared point-of-care test for influenza in 1999 and was the first to market a rapid SARS-CoV-2 antigen test in the U.S. Under trusted brand names Sofia®, Solana®, Lyra®, Triage® and QuickVue®, Quidel’s comprehensive product portfolio includes tests for a wide range of infectious diseases, cardiac and autoimmune biomarkers, as well as a host of products to detect COVID-19. With products made in America, Quidel’s mission is to provide patients with immediate and frequent access to highly accurate, affordable testing for the good of our families, our communities and the world. For more information about Quidel, visit quidel.com.
BD Statement On U.S. Government Plan To Invest $10 Billion In Covid-19 Testing In Schools
17 March 2021
FRANKLIN LAKES, N.J., March 17, 2021 – BD (Becton, Dickinson and Company), a leading global medical technology company, today issued the following statement regarding the U.S. government’s plan to invest $10 billion in COVID-19 testing in American schools:
Dave Hickey, president of Life Sciences for BD said, “Committing $10 billion for COVID-19 testing in America’s schools is a critical investment in getting all schools open and back to in-person learning.
“As a manufacturer of both PCR and antigen tests, BD understands the strengths of both approaches to testing. For testing programs administered by health care providers in schools, antigen tests are ideal because they are easy to use, low cost, don’t require sophisticated lab equipment or personnel, can be performed in a CLIA waiver point-of-care setting and most importantly, can provide a test result in 15 minutes when students are suspected of COVID-19, which allows for immediate isolation and other protective measures to minimize the spread of COVID-19.
“In addition, some antigen tests, like the one used on the BD Veritor™ Plus System provide additional benefits, including a definitive positive or negative digital readout and enabling data transfer to the cloud for ease of reporting test results to public health officials. The ease of use and immediate results provided by antigen tests would allow our educators to focus on teaching, not testing.”
About BD
BD is one of the largest global medical technology companies in the world and is advancing the world of health by improving medical discovery, diagnostics and the delivery of care. The company supports the heroes on the frontlines of health care by developing innovative technology, services and solutions that help advance both clinical therapy for patients and clinical process for health care providers. BD and its 70,000 employees have a passion and commitment to help enhance the safety and efficiency of clinicians' care delivery process, enable laboratory scientists to accurately detect disease and advance researchers' capabilities to develop the next generation of diagnostics and therapeutics. BD has a presence in virtually every country and partners with organizations around the world to address some of the most challenging global health issues. By working in close collaboration with customers, BD can help enhance outcomes, lower costs, increase efficiencies, improve safety and expand access to health care. For more information on BD, please visit bd.com.
Roche launches cobas pure integrated solutions analyser to help simplify operations in small to medium sized labs
17 March 2021 - cobas® pure integrated solutions brings together three diagnostic technologies on a single platform to optimise space and resources in small to medium laboratory settings. With a footprint of just two square meters, this new analyser provides small to medium sized labs with access to more than 230 diagnostic tests across a wide-range of disease areas including infectious diseases, oncology and cardiology. Through automation of manual tasks, Roche’s new solution is designed to simplify workflows and improve the productivity of lab personnel whilst also supporting the delivery of better patient care.
Basel, 17 March 2021 – Roche announced today the launch of cobas pure integrated solutions in countries accepting the CE mark. This new compact analyser combines three technologies1 on a single platform helping to simplify daily operations in labs with limited space and resources.
Now more than ever, diagnostic laboratories have proven to be a critical component of our global healthcare system. Medical and laboratory professionals play a key role in delivering optimal patient care, yet they are under significant pressure to deliver accurate and timely results with less resources.
Built on the latest technology, cobas pure integrated solutions provides labs with an integrated system that focuses on the automation of manual tasks. This reduces the hands-on maintenance time of technicians to just 5 minutes per day which is 80% less than previous generation systems. This can help to improve the productivity of lab personnel whilst also supporting fast delivery of patient results and clinical decision-making.
With a footprint of just two square meters, cobas pure integrated solutions is up to 30% smaller in footprint than previous generation systems. It is able to perform up to 870 tests per hour whilst providing small to medium sized labs with access to the full clinical chemistry and immunochemistry assay menu from Roche which includes over 230 diagnostic tests across a wide-range of disease areas such as infectious diseases, oncology and cardiology. cobas pure integrated solutions will enable small to medium sized labs to make better use of their space and expand their offering of high medical value tests for the benefit of patients.
“During these challenging times, providing accurate and timely testing has never been more vital. Roche continues to invest heavily in laboratory innovation to help meet the changing demands of healthcare systems,” said Thomas Schinecker, CEO Roche Diagnostics. “With the launch of cobas pure integrated solutions, we seek to simplify complex workflows in small to medium sized labs so that laboratory professionals can focus on providing clinicians with the information they need to make reliable and timely clinical decisions for patients.”
Furthermore, to ensure simple and effective work across healthcare networks, cobas pure integrated solutions provides fully standardised results and operation to cobas® pro integrated solutions – Roche’s latest analyser designed for larger labs. Standardisation enables labs to do more work on fewer instruments, through consolidation of workflows, systems and reagents. This results in improved speed and accuracy of care as well as optimised patient management. In addition, cobas pure integrated solutions is fully compatible with the cobas® mobile solution, a tablet that integrates multiple Roche applications, allowing laboratory professionals to interact with the analyser from anywhere in the lab.
About the cobas pure integrated solutions
cobas pure integrated solutions is the newest member of the cobas family of systems and combines clinical chemistry, immunoassay and ISE diagnostic testing on a single platform for low to mid volume testing needs. In addition, cobas pure integrated solutions comes with a number of innovations including automated maintenance, automated calibration and completely ready to use reagents that help simplify the overall operation of the lab.
With cobas pure integrated solutions, the required sample volume per test has been reduced on average by 43% compared to previous generation systems. Additionally, the plastic generated per test result has been reduced by up to 78% due to smaller reagent pack sizes with higher number of tests per pack.
To learn more about cobas pure integrated solutions system, please visit: https://diagnostics.roche.com/global/en/products/systems/cobas-pure-integrated-solutions.html
To learn more about cobas pro integrated solutions, please visit: https://diagnostics.roche.com/global/en/products/systems/cobas-pro-integrated-solutions.html
To learn more about the cobas mobile solution, please visit: https://diagnostics.roche.com/global/en/products/instruments/cobas-mobile-solution.html
About Roche
Roche is a global pioneer in pharmaceuticals and diagnostics focused on advancing science to improve people’s lives. The combined strengths of pharmaceuticals and diagnostics under one roof have made Roche the leader in personalised healthcare – a strategy that aims to fit the right treatment to each patient in the best way possible.
Roche is the world’s largest biotech company, with truly differentiated medicines in oncology, immunology, infectious diseases, ophthalmology and diseases of the central nervous system. Roche is also the world leader in in vitro diagnostics and tissue-based cancer diagnostics, and a frontrunner in diabetes management.
Founded in 1896, Roche continues to search for better ways to prevent, diagnose and treat diseases and make a sustainable contribution to society. The company also aims to improve patient access to medical innovations by working with all relevant stakeholders. More than thirty medicines developed by Roche are included in the World Health Organization Model Lists of Essential Medicines, among them life-saving antibiotics, antimalarials and cancer medicines. Moreover, for the twelfth consecutive year, Roche has been recognised as one of the most sustainable companies in the Pharmaceuticals Industry by the Dow Jones Sustainability Indices (DJSI).
The Roche Group, headquartered in Basel, Switzerland, is active in over 100 countries and in 2020 employed more than 100,000 people worldwide. In 2020, Roche invested CHF 12.2 billion in R&D and posted sales of CHF 58.3 billion. Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan. For more information, please visit www.roche.com.
Reference: https://www.roche.com/media/releases/med-cor-2021-03-17.htm
Vela Diagnostics receives CE-IVD approval for automated Flu A/B & RSV Extension Kit
17 March 2021 - The ViroKey™ Flu A/B & RSV RT-PCR Extension Kit is now CE certified
Singapore, Mar 17 2020 – Vela Diagnostics announced today that its ViroKey™ Flu A/B & RSV RT-PCR Extension Kit (for use only with ViroKey™ SARS-CoV-2 RT-PCR Test v2.0), has received the CE mark for in vitro diagnostic use.
The ViroKey™ Flu A/B & RSV RT-PCR Extension Kit detects Influenza A, Influenza B and RSV by targeting the matrix protein gene in the RNA of the respective viruses. The ViroKeyTM SARS-CoV-2 RT-PCR Test v2.0 detects SARS-CoV-2 by targeting conserved regions of the SARS-CoV-2 RNA—the ORF1a and N genes.
The tests are optimized on a workflow consisting of the Sentosa™ SX101 instrument for automated sample extraction and PCR setup, in conjunction with the Sentosa™ SA201 instrument. The automated workflow enables high throughput testing with significantly reduced hands-on time. Up to 46 samples (and two controls) can be tested—to detect up to four viruses—in a single run. The PCR is set up as two separate reactions; one to detect SARS-CoV-2, and the other for the Flu A/B and RSV triplex. This prevents masking of low positive results, resulting in higher sensitivity of detection.
“The flu season and the recent appearance of a new SARS-CoV-2 variant makes pandemic management all the more challenging, especially when these viral infections cause similar symptoms in patients. With the ViroKey™ Flu A/B & RSV RT-PCR Extension Kit, we can distinguish across the four viruses in patients with flu-like symptoms, thus enabling clinicians to prescribe the appropriate treatment protocol at the soonest,” said Managing Director, Andreas Goertz.
The ViroKeyTM SARS-CoV-2 RT-PCR Test v2.0 received the CE mark in July 2020.
About Vela Diagnostics
Vela Diagnostics is a leading provider for integrated IVD system solutions, from sample to result. VELA’s test solutions utilize the automated Sentosa™ platform, providing the unique ability to leverage one system for NGS and PCR testing in infectious disease and oncology.
All Sentosa™ products listed above are by Vela Diagnostics. For more information, visit www.veladx.com.
ALM-Update: SARS-CoV-2-PCR-Positivrate steigt wieder deutlich an
16 March 2021
16 March 2021 -- Deutlich steigende Zahlen an SARS-CoV-2-Infizierten und eine Bestätigung der erneut zunehmende Infektionsdynamik von COVID-19 ist durch die Analyse der Akkreditierten Labore in der Medizin – ALM e.V. aus der vergangenen Kalenderwoche erkennbar. So zeigt die Auswertung der Daten von nunmehr 173 (171) Laboren bei steigenden an SARS-CoV-2-PCR-Testzahlen (1.084.771; Vorwoche: 1.021.024) eine im Vergleich zur Vorwoche von 6,4 auf nun 7,2 Prozent gestiegene Positivrate. Insgesamt fielen 20 Prozent mehr SARS-CoV-2-PCR-Tests (77.660) positiv aus als in der Vorwoche (64.981). „Wir in den Laboren sind besorgt angesichts dieser Entwicklung, denn auch der Anteil der Varianten, insbesondere von B.1.1.7, nimmt weiter zu. Deswegen gilt unverändert und gerade jetzt: Wir sollten die Ergebnisse und die Situation ernst nehmen“, sagt Dr. Michael Müller, 1. Vorsitzender des ALM e.V. Nina Beikert, Vorständin im fachärztlichen Verband bestätigt: „Bis zu einer echten Entspannung wird es noch einige Zeit dauern. Wir sind deshalb auf ein gutes Konzept und wirksame Maßnahmen zur Pandemieeindämmung angewiesen.“
Roche launches SARS-CoV-2 variant test to help monitor emerging coronavirus mutations
16 March 2021 - The cobas SARS-CoV-2 Variant Set 1 Test is designed to detect key spike mutations in virus variants associated with increased human-to-human transmission. Accurate detection and differentiation of SARS-CoV-2 mutations can help assess the spread of circulating variants and monitor their potential impact on therapeutics, vaccines and public health interventions. Periodic assessments against emerging variants have shown that Roche’s current diagnostic tests for detecting active SARS-CoV-2 infections remain accurate and effective. The test runs on widely used high-throughput systems and is for research purposes only.
Basel, 16 March 2021 -- Roche today announced the launch of the cobas® SARS-CoV-2 Variant Set 1 Test to detect and differentiate mutations found in variants that originated in the UK (B.1.1.7), South Africa (B.1.351), and Brazil (P.1). This research use only laboratory test can be used to help scientists track mutation prevalence and to assess any potential impact on diagnostics, vaccines and therapeutics, providing crucial insight for healthcare systems in making appropriate measures to combat COVID-19.
Variants of B.1.1.7, B.1.351 and P.1 lineage gained prominence in late 2020, with each carrying a number of genomic mutations. Among them, mutations E484K, N501Y and del 69-70 are located in the spike protein, the region that enables the virus to attach to and enter the human cell. Studies have suggested that these mutations may be linked to increased disease transmissibility, and possibly decreased therapeutic and vaccine efficacy.
“Viruses naturally evolve over time. While most mutations do not have a clinical impact, some variants need to be tracked carefully as they seem to spread more easily and quickly,” said Thomas Schinecker, CEO Roche Diagnostics. “Continued surveillance is essential for public health. Our latest solution provides laboratories a fast and efficient way to investigate these variants found in infected individuals and the potential impact on existing therapies, vaccines and tests.”
The cobas SARS-CoV-2 Variant Set 1 Test runs on the widely available, high-volume cobas® 6800/8800 Systems. Pre-optimised assay design, ready-to-use test cassettes and predefined software parameters enable laboratories to reduce testing complexity and increase walkaway time.
It is important to note that Roche has confirmed its existing diagnostic tests to detect SARS-CoV-2 are not affected by known mutations and remain accurate and effective in detecting active infections. The company is conducting assessments on a regular basis and will continue to monitor as new variants arise.
About SARS-CoV-2 Variants B.1.1.7, B.1.351 and P.1
First reported in the UK in December 2020, B.1.1.7 variant has quickly become the dominant circulating variant and has since been found in countries worldwide.1 B.1.1.7 carries a large number of mutations, eight of which are accumulated in the spike region. Preliminary studies have suggested that two such spike mutations, N501Y and del 69-70, are associated with increased transmissibility of the disease.2,3 Another variant, B.1.351, which arose independently from B.1.1.7, was reported in South Africa in December 2020. In addition to having mutation N501Y, B.1.351 carries another spike mutation E484K, which appears to evade the body’s immune response, possibly diminishing vaccine efficacy.4 Variant P.1, a close relative to B.1.351, has several defining mutations including N501Y and E484K in the spike region. P.1 has been circulating in the Amazon region as of late 2020 and is thought to evade immunity generated after infection by other variants.
About cobas SARS-CoV-2 Variant Set 1 Test
cobas SARS-CoV-2 Variant Set 1 Nucleic Acid test for use with the cobas 6800/8800 Systems is an automated, multiplex, real-time reverse transcription polymerase chain reaction (RT-PCR) assay for the rapid in vitro qualitative detection and discrimination of select SARS-CoV-2 mutations E484K, N501Y and del 69-70. The test contains the respective primers and probes provided in the ready-made 384-test cassette. Automated data management is performed by the cobas 6800/8800 software, which assigns test results for all tests. Results can be reviewed directly on the system screen, and printed as a report. Roche is committed to providing additional variant tests as needed based on regular assessments of the infectious disease landscape.
About cobas 6800/8800 Systems
When every moment matters, the fully automated cobas 6800/8800 Systems offer the fastest time to results with the highest throughput and the longest walk-away time available among automated molecular platforms. With proven performance, absolute automation and unmatched flexibility delivering unparalleled throughput 24/7— cobas 6800/8800 Systems are designed to ensure a lab’s long-term sustainability and success now, more than ever. Learn more now: www.cobas68008800.com.
About Roche’s response to the COVID-19 pandemic
As a leading healthcare company we are doing all we can to support countries in minimising the impact of COVID-19. We have developed a growing number of diagnostic solutions that help to detect and diagnose the infection in patients, as well as providing digital support to healthcare systems, and we continue to identify, develop and support potential therapies which can play a role in treating the disease.
We understand the impact of COVID-19 goes beyond those who contract it, which is why we are working with healthcare providers, laboratories, authorities and organisations to help make sure that patients continue to receive the tests, treatment and care they need during these challenging times. As we learn from the pandemic, we are partnering with governments and others to make healthcare stronger and more sustainable in the future.
Our diagnostics solutions:
Reliable, high-quality testing is essential to help healthcare systems overcome this pandemic. Our portfolio includes:
- a high-volume molecular test to detect SARS-CoV-2, the virus that causes COVID-19, (FDA Emergency Use Authorisation (EUA) and available in countries accepting the CE Mark)
- a SARS-CoV-2 laboratory-based antibody test, aimed at detecting the presence of antibodies in the blood targeting the nucleocapsid (FDA EUA and CE Mark)
- an IL-6 test to assist in identifying severe inflammatory response in patients with confirmed COVID-19 (FDA EUA and CE Mark)
- Roche v-TAC, which could help simplify the screening, diagnosis and monitoring of patients with respiratory compromise in the current COVID-19 pandemic
- a SARS-CoV-2 rapid antibody test to help determine at the point of care whether a person has been exposed to the virus (CE Mark)
- a rapid antigen test to support in the detection of SARS-CoV-2 at the point of care within 15 minutes (CE Mark)
- a high-volume molecular test to simultaneously detect and differentiate between SARS-CoV-2 and influenza A/B, as the symptoms are similar for both (FDA EUA and CE Mark)
- a second SARS-CoV-2 antibody test, aimed at measuring the spike protein to support vaccination development and complement our existing portfolio
- a point-of-care molecular PCR test that simultaneously detects and differentiates between SARS-CoV-2 and influenza A/B infections to support urgent triage and diagnosis (FDA EUA and CE Mark)
Our research into therapies
Roche is committed to improving the treatment of COVID-19. We are actively involved in understanding the potential of our existing portfolio and are exploring the potential of our investigational molecules.
In August we signed a collaboration agreement with Regeneron on developing and manufacturing and significantly increasing global supply of an investigational antibody combination for COVID-19 if it proves safe and effective in clinical trials and regulatory approvals are granted. We are also partnering with Atea to jointly develop AT-527, an orally administered direct-acting antiviral (DAA) currently in Phase 2 clinical trials. If approved, Atea will distribute AT-527 in the United States and Roche will be responsible for global manufacturing and distribution outside the United States.
At the beginning of the pandemic, on 19 March, we announced the initiation of COVACTA - a global Phase III randomised, double-blind, placebo-controlled clinical trial to evaluate the safety and efficacy of intravenous Actemra©/RoActemra© (tocilizumab) plus standard of care in hospitalised adult patients with severe COVID-19 pneumonia compared to placebo plus standard of care. On 29 July we announced that COVACTA did not meet its primary endpoint of improved clinical status in patients with COVID-19 associated pneumonia or the key secondary endpoint of reduced mortality.
Separately, we have studied Actemra©/RoActemra© in the EMPACTA study in COVID-19 associated hospitalised pneumonia in patients that are often underrepresented in clinical trials. On 18 September we announced that the phase III EMPACTA study showed Actemra/RoActemra plus standard of care reduced the likelihood of progression to mechanical ventilation or death in hospitalised patients with COVID-19 associated pneumonia compared to placebo plus standard of care. However, there was no statistical difference in mortality between patients who received Actemra/RoActemra or placebo.
Actemra©/RoActemra© is also being studied in combination with the investigational antiviral remdesivir in hospitalised patients with severe COVID-19 pneumonia in the REMDACTA trial in partnership with Gilead, announced 28 May. Actemra©/RoActemra© is not approved by any health authority for use in COVID-19 pneumonia. Roche has further initiated an internal early research programme focused on the development of medicines for COVID-19 and is engaged in multiple research collaborations.
In these exceptional times, Roche stands together with governments, healthcare providers and all those working to overcome the pandemic.
About Roche
Roche is a global pioneer in pharmaceuticals and diagnostics focused on advancing science to improve people’s lives. The combined strengths of pharmaceuticals and diagnostics under one roof have made Roche the leader in personalised healthcare – a strategy that aims to fit the right treatment to each patient in the best way possible.
Roche is the world’s largest biotech company, with truly differentiated medicines in oncology, immunology, infectious diseases, ophthalmology and diseases of the central nervous system. Roche is also the world leader in in vitro diagnostics and tissue-based cancer diagnostics, and a frontrunner in diabetes management.
Founded in 1896, Roche continues to search for better ways to prevent, diagnose and treat diseases and make a sustainable contribution to society. The company also aims to improve patient access to medical innovations by working with all relevant stakeholders. More than thirty medicines developed by Roche are included in the World Health Organization Model Lists of Essential Medicines, among them life-saving antibiotics, antimalarials and cancer medicines. Moreover, for the twelfth consecutive year, Roche has been recognised as one of the most sustainable companies in the Pharmaceuticals Industry by the Dow Jones Sustainability Indices (DJSI).
The Roche Group, headquartered in Basel, Switzerland, is active in over 100 countries and in 2020 employed more than 100,000 people worldwide. In 2020, Roche invested CHF 12.2 billion in R&D and posted sales of CHF 58.3 billion. Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan. For more information, please visit www.roche.com.
Reference: https://www.roche.com/media/releases/med-cor-2021-03-16b.htm
Kostenlose Antigen-Schnelltests im Rahmen der neuen Coronavirus-Testverordnung
12 March 2021 - SYNLAB bietet Ihnen ab sofort an allen Laborstandorten kostenlose PoC-Antigen-Tests im Rahmen der neuen Coronavirus-Testverordnung an.
12 March 2021 -- Seit dem 08. März hat jeder Bürger mit Wohnsitz in Deutschland Anspruch auf einen Schnelltest pro Woche. Das Testergebnis liegt in der Regel innerhalb von 15 bis 30 Minuten vor. Die kostenlosen Tests richten sich nur an Personen, die keine SARS-CoV-2-Symptome vorweisen.
Zu jedem Antigen-Schnelltest erhalten Sie einen Befund, den Sie über unsere App abrufen können. Personen mit einem positiven Schnelltest-Ergebnis sind verpflichtet, anschließend einen PCR-Test machen zu lassen. Diesen Test können Sie ebenfalls über uns beauftragen.
Bitte vereinbaren Sie vorab einen Termin über unser Terminbuchungstool an einem unserer Standorte und bringen Sie Ihren Personalausweis mit.
Abbott announces its pandemic defense coalition: a global network of experts collaborator designed to help prevent future pandemics, currently searching for COVID-19 variants
11 March 2021 - The Abbott Pandemic Defense Coalition is a first-of-its-kind global scientific network dedicated to the early detection of, and rapid response to, future pandemic threats. The coalition builds on Abbott's decades of leadership in virus surveillance and helps to analyze virus samples for unknown diseases and detect mutations and variants including for COVID-19. Abbott is bringing together global collaborators specializing in identification of unknown diseases, surveillance, virus sample collection, testing and sequencing. Abbott will rapidly develop tests that can be used to help identify, isolate and contain outbreaks when potential new virus threats are identified.
ABBOTT PARK, Ill., March 11, 2021 -- Abbott today announced the formation of the Abbott Pandemic Defense Coalition, a first-of-its-kind global scientific and public health partnership dedicated to the early detection of, and rapid response to, future pandemic threats. By connecting global centers of excellence in laboratory testing, genetic sequencing and public health research, the program will identify new pathogens, analyze potential risk level, rapidly develop and deploy new diagnostic testing and assess public health impact in real time.
The coalition is designed to help the global scientific and health community identify new viral threats, take quick action when one is discovered, and help prevent future pandemics. The sequences of the viruses that are found will be published in a public database so that health officials and laboratories can work together to identify if it's a novel strain, or a virus that has previously been detected. This program expands upon the viral surveillance and discovery work that Abbott has performed over the last three decades.
"We cannot fight what we cannot see coming. This program establishes a global network of 'eyes on the ground' that are always looking for threats, which helps the global health community to stay one step ahead of the next viral threat, and allows us to utilize Abbott's expertise and technology to quickly develop tests to address them," said Gavin Cloherty, Ph.D., head of infectious disease research at Abbott. "The COVID-19 pandemic has demonstrated a clear need for advanced surveillance and viral sequencing – and the critically important role of testing. Understanding what pathogenic threats are emerging will help us test, diagnose and hopefully help prevent the next pandemic."
Abbott is helping look for COVID-19 variants and ensuring COVID-19 tests are effective
Abbott is playing an important role in helping to monitor for new variants or mutations to the virus that causes COVID-19. The company is collecting virus samples from around the world and looking for any changes (mutations) to the virus's genetic sequencing.
With decades of experience in viral surveillance, Abbott specifically designs its tests, including COVID-19 tests, with viral evolution in mind. As new strains are discovered, Abbott vigorously analyzes them so it can ensure its diagnostic tests can detect them. The coalition provides the network to collaborate with other leading institutions on this effort.
A global force of scientific experts focused on outsmarting viruses
The new Abbott Pandemic Defense Coalition consists of global collaborators specializing in virus identification, surveillance, sample collection, testing and data analytics. The process to identify potential new viral threats begins with physicians across the network identifying patients with unknown conditions that they cannot treat or diagnose. Next, patient samples are tested by our partners on a global scale, followed by genetic sequencing and analyses to spot trends and identify peculiarities that may indicate an emerging threat or outbreak. If a potential threat is discovered, Abbott will quickly develop diagnostic testing to assist in containment efforts.
Abbott's growing network of partners includes organizations in strategic geographic locations:
- Colombia/Wisconsin One-Health Consortium at the Universidad Nacional de Colombia, Medellin, Colombia
- Faculty of Medicine, Siriraj Hospital, Mahidol University, Bangkok, Thailand
- Institut de Recherche en Santé, de Surveillance Epidémiologique et de Formations (IRESSEF), Dakar, Senegal
- KRISP, Genomic Centre of the University of KwaZulu-Natal, Durban, South Africa
- Rush University System for Health, Chicago, U.S.
- The University of the West Indies, Mona Campus, Jamaica
- Universidade de São Paulo, São Paulo, Brazil
- YRG Care, Chennai, India
Abbott is in talks with additional non-governmental organizations, governments and research centers of excellence regarding participation and collaboration.
"In a sophisticated network like the Abbott Pandemic Defense Coalition, we have access to best-in-class science and technology that makes data collection, analysis and sharing efficient and effective," said Professor Souleymane Mboup, president of Institut de Recherche en Santé, de Surveillance Epidemiologique et de Formations (IRESSEF) of Dakar, Senegal. "The key here is collaboration; no single lab or organization in any one country would be able to conduct testing and analysis of this breadth and scale but connecting global centers of excellence makes it possible for us all to assist in identifying the next potential threats to public health."
A history of hunting viruses around the globe – and a future dedicated to further advancing this vital work
As a leader in blood screening and infectious disease testing, Abbott created its Global Viral Surveillance Program more than 25 years ago to monitor HIV and hepatitis viruses and identify mutations, which helps ensure the company's diagnostic tests remain up to date and enable researchers to proactively evaluate and solve infectious disease challenges. This surveillance program will now be a part of the Abbott Pandemic Defense Coalition.
Through its surveillance efforts, the company recently announced the discovery of a high prevalence of HIV Controllers – a group of people living with controlled HIV without antiretroviral medications in the Democratic Republic of Congo, which could hold the key to a cure. Abbott also announced the finding of a new strain of HIV in 2019.
And looking ahead, Abbott will focus on testing and digital solutions accessible to more people in more places for many of the world's most pressing health challenges, including infectious diseases. This work also is an important part of Abbott's 2030 sustainability strategy which includes a focus on transforming the care of infectious diseases. Across its business and through collaboration, Abbott will create new technologies to detect and monitor infectious diseases such as COVID-19, HIV, malaria and hepatitis, as well as tomorrow's pandemic threats.
About Abbott
Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 109,000 colleagues serve people in more than 160 countries.
Roche awarded WHO prequalification for the HIV and HCV tests on the cobas 6800/8800 Systems
11 March 2021 - For patients living in areas with limited healthcare resources, WHO prequalification ensures access to the highest quality diagnostics. Access to broader reliable diagnostic solutions helps healthcare communities working to expedite and increase disease elimination programs. Roche’s Global Access Program provides innovative diagnostic solutions improving disease and patient management for those most in need.
Basel, 11 March 2021 -- Roche today announced that the cobas® HIV-1 and cobas® HCV Tests for use on the cobas® 6800/8800 Systems have been awarded World Health Organization (WHO) prequalification. WHO prequalification helps regulators and procurers in low and middle-income countries to identify products that meet high quality standards and are safe and suitable for their intended use. This is of benefit to healthcare professionals and patients, for whom quality assured IVDs are essential for effective diagnosis and monitoring of therapeutic efficiency. Increased access to diagnostic testing and monitoring for HIV and hepatitis C virus (HCV) provides broader reliable solutions to patients living in remote settings. Without accurate diagnosis, appropriate disease management may be delayed.
For people who can not easily access healthcare facilities, the ability to simplify blood collection and sample transportation on a stable device improves access to reliable diagnostics. The cobas HIV-1 Test can be used in conjunction with the first-of-its-kind cobas® Plasma Separation Card to process dried plasma spot samples collected in remote areas, where access to testing facilities can be difficult.
“We are focusing on improving patient and disease management where it is needed most. Sustainable solutions can help healthcare providers more efficiently work towards eliminating infections,” said Thomas Schinecker, CEO Roche Diagnostics. “Since we launched the Global Access Program in 2014, access to innovative diagnostics solutions has improved in countries with high disease burdens. There is still more work that needs to be done and with the WHO prequalification more people around the world will have access to high-quality diagnostics.”
Roche is committed to helping countries scale up HIV elimination programs and reach the WHO 2030 goals of 95% of people living with HIV knowing their HIV status; 95% of HIV-positive people on treatment; and 95% of people on treatment having suppressed viral loads. Roche also strives to help reach the 2030 hepatitis elimination targets of 90% reduction in new chronic hepatitis B and C cases; 65% reduction in hepatitis-related deaths and 80% of eligible people with chronic hepatitis B and C infections receiving treatment.
About the Global Access Program
In 2014, Roche announced the Global Access Program for increased access to HIV diagnostics. Roche partnered with national governments, local healthcare facilities, communities and international agencies, including UNAIDS, Clinton Health Access Initiative (CHAI), Unitaid, the U.S. President’s Emergency Plan for AIDS Relief (PEPFAR), Global Fund and Center for Disease Control and Prevention (CDC), to establish programs that would go beyond providing diagnostic tests.
Since its inception, the program has expanded substantially in menu and geographic footprint to provide increased access to diagnostics at affordable pricing for qualifying organizations in eligible countries with the highest disease burden. The Global Access Program includes diagnostic solutions for HIV, Mycobacterium tuberculosis (MTB), Hepatitis B and C (HBV and HCV), and Human Papillomavirus (HPV) to help towards implementation of elimination programs in efforts to eradicate disease and in line with the WHO 2030 elimination goals.
About the cobas Plasma Separation Card
According to the WHO, plasma is the preferred sample type for viral load diagnostic testing to ensure accurate results versus potential excessive quantification of the viral load result in whole blood. In the size of a simple credit card, the cobas Plasma Separation Card is a stable and easy-to-use sample collection device for HIV plasma viral load testing. By providing a small amount of a patient’s blood from a fingertip, this specially designed card simplifies blood collection and sample transportation - even in areas of extreme heat and humidity - as it is sent by post to the testing laboratory, no refrigeration required. The card is the only CE-marked plasma sample collection device which meets the WHO sensitivity standard of < 1000 cp/mL and fundamentally changes the way plasma samples are taken and processed allowing for reliable quantitative testing for determining HIV viral load.
About the cobas® Systems
When every moment matters, the fully automated cobas 6800/8800 Systems offer the fastest time to results with the highest throughput and the longest walk-away time available among automated molecular platforms. With proven performance, absolute automation and unmatched flexibility delivering unparalleled throughput 24/7, cobas® Systems are designed to ensure a lab’s long-term sustainability and success … now, more than ever.
Learn more now: http://diagnostics.roche.com.
About Roche
Roche is a global pioneer in pharmaceuticals and diagnostics focused on advancing science to improve people’s lives. The combined strengths of pharmaceuticals and diagnostics under one roof have made Roche the leader in personalised healthcare – a strategy that aims to fit the right treatment to each patient in the best way possible.
Roche is the world’s largest biotech company, with truly differentiated medicines in oncology, immunology, infectious diseases, ophthalmology and diseases of the central nervous system. Roche is also the world leader in in vitro diagnostics and tissue-based cancer diagnostics, and a frontrunner in diabetes management.
Founded in 1896, Roche continues to search for better ways to prevent, diagnose and treat diseases and make a sustainable contribution to society. The company also aims to improve patient access to medical innovations by working with all relevant stakeholders. More than thirty medicines developed by Roche are included in the World Health Organization Model Lists of Essential Medicines, among them life-saving antibiotics, antimalarials and cancer medicines. Moreover, for the twelfth consecutive year, Roche has been recognised as one of the most sustainable companies in the Pharmaceuticals Industry by the Dow Jones Sustainability Indices (DJSI).
The Roche Group, headquartered in Basel, Switzerland, is active in over 100 countries and in 2020 employed more than 100,000 people worldwide. In 2020, Roche invested CHF 12.2 billion in R&D and posted sales of CHF 58.3 billion. Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan. For more information, please visit www.roche.com.
Reference: https://www.roche.com/media/releases/med-cor-2021-03-11b.htm
Luminex Submits Joint SARS-CoV-2 and Flu/RSV Respiratory Panel to FDA for Emergency Use Authorization
10 March 2021
AUSTIN, Texas, March 10, 2021 -- Luminex Corporation today announced that it has submitted an Emergency Use Authorization application to the U.S. Food and Drug Administration for the company's new multi-analyte respiratory panel combining Flu A/B and respiratory syncytial virus (RSV) targets with the SARS-CoV-2 target. The ARIES® Flu A/B & RSV+SARS-CoV-2 Assay can be run on all Luminex ARIES® Systems. This submission represents completion of a key milestone in a Luminex funding award from the Biomedical Advanced Research and Development Authority (BARDA), which helped support the rapid development and validation of the assay.
Respiratory infections such as COVID-19 and influenza can be challenging to differentiate and diagnose because they often have overlapping symptoms. Luminex designed the combined assay to quickly deliver clear answers about these infections from a single test and, thereby, help clinical-care teams treat patients more effectively. The ARIES® Flu A/B & RSV+SARS-CoV-2 Assay can be run on six-unit and 12-unit ARIES® Systems with minimal hands-on time, producing results in approximately two hours. The ARIES® System is an FDA-cleared, sample-to-answer, automated molecular diagnostics platform designed for use in moderate and high complexity labs.
Importantly, the ARIES® Flu A/B & RSV+SARS-CoV-2 Assay is expected to detect new variants of the coronavirus. An in silico analysis of molecular probes used in the assay compared to SARS-CoV-2 sequences available in the GISAID database as of February 11, 2021, determined that key sequences still match and should yield a positive result. The analysis included variants originally detected in the United Kingdom (B.1.1.7), South Africa (B.1.351 or 20H/501Y.V2), Brazil (P.1 lineage or 20J/501Y.V3), and California (one of five reoccurring mutations that constitute the B.1.429 lineage and CAL20C).
"We are grateful to BARDA for supporting development of this important new assay, and are pleased to have fulfilled our commitment to file for EUA so quickly," said Nachum "Homi" Shamir, Chairman, President and CEO of Luminex. "It is critical to continue expanding the number of FDA-authorized assays that include SARS-CoV-2 detection for a broad range of clinical uses, and we're proud to have developed a single assay that provides answers about some of the most common respiratory infections – including SARS-CoV-2 - in just two hours."
BARDA is part of the US Department of Health and Human Services and is tasked with protecting the country against emerging infectious diseases and other threats. Through public-private partnerships, BARDA supports the development of vaccines, drugs, and diagnostics. Luminex developed the original ARIES® SARS-CoV-2 Assay with financial support from BARDA earlier this year.
Since the COVID-19 pandemic began, Luminex has expanded capacity for SARS-CoV-2 testing across its diagnostic platforms. The company previously launched the NxTAG CoV Extended Panel under an EUA from the FDA and an Authorization for Import or Sale with Conditions from Health Canada, and also received FDA EUA for its ARIES® SARS-CoV-2 Assay. It also received an EUA from the FDA for its xMAP® SARS-CoV-2 Multi-Antigen Immunoglobulin G (IgG) Assay, a serology test that can be run on any of Luminex's xMAP-based, high-throughput, gold-standard multiplex platforms.
This project has been funded in whole or in part with Federal funds from the Department of Health and Human Services; Office of the Assistant Secretary for Preparedness and Response; Biomedical Advanced Research and Development Authority, Division of Research Innovation and Ventures under Contract No. 75A50121P00025.
About Luminex Corporation
At Luminex, our mission is to empower labs to obtain reliable, timely, and actionable answers, ultimately advancing health. We offer a wide range of solutions applicable in diverse markets including clinical diagnostics, pharmaceutical drug discovery, biomedical research, genomic and proteomic research, biodefense research, and food safety. We accelerate reliable answers while simplifying complexity and deliver certainty with a seamless experience. To learn more about Luminex, please visit us at luminexcorp.com. To learn more about Luminex's COVID-19 Testing and Research Solutions, please visit: https://www.luminexcorp.com/solutions/.
ALM-Update: SARS-CoV-2-PCR-Positivrate stagniert bei ca. 6,4 Prozent
10 March 2021
10 March 2021 -- Die aktuelle Datenauswertung der ALM zeigt, dass die AHA-Regeln weiterhin konsequent eingehalten werden müssen, was die positiven Schnell- und Selbsttests durch die PCR-Diagnostik bestätigen. Weiterhin leicht steigende Zahlen an in Anspruch genommenen SARS-CoV-2-PCR-Tests, eine Positivrate auf etwa gleichbleibendem Niveau und die erwartete weitere usAbreitung der Variante B.1.1.7. Das ist das Ergebnis der wöchentlichen Datenerhebung der Akkreditierten Labore in der
Medizin – ALM e.V., an der wieder 171 Labore der ambulanten und stationären Versorgung teilgenommen haben. Wegen des Feiertags in Berlin gingen die Zahlen erst im Laufe des heutigen Dienstags ein. In der KW 09 wurden insgesamt 1.020.839 SARS-CoV-2-PCR-Tests durchgeführt, 3 Prozent mehr als in der Woche zuvor (991.290). Die Positivrate blieb in der KW 09 auf annährend gleich hohem Niveau bei 6,4 Prozent (Vorwoche: 6,5 Prozent). Insgesamt fielen 64.979 (Vorwoche: 64.644) SARS-CoV-2-PCR-Tests positiv aus.
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Thermo Fisher Scientific Launches Customizable TaqMan SARS-CoV-2 Mutation Panel
10 March 2021 - Panel designed to provide surveillance of ongoing mutations of virus that causes COVID-19
CARLSBAD, Calif., March 10, 2021 -- Thermo Fisher Scientific, the world leader in serving science, today announced the launch of its Applied Biosystems TaqMan SARS-CoV-2 Mutation Panel, a customizable menu of 22 verified real-time PCR assays for identification of SARS-CoV-2 mutations. These assays enable surveillance of variants that are causing COVID-19 infections in specific regions globally and allow laboratories to choose which mutations to track.
SARS-CoV-2 has mutated countless times, with some variants potentially impacting efficacy of treatments and vaccines, stressing the importance of continued surveillance of viral changes. The TaqMan SARS-CoV-2 Mutation Panel is designed to be highly scalable, being able to run a few or hundreds of samples to identify one or many mutations. This provides laboratories with the ability to meet various levels of testing need with real-time PCR instruments they already use.
"With an evolving virus, having up to date, reliable and accurate information is critical in fighting back," said Mark Smedley, president of the genetic sciences business of Thermo Fisher Scientific. "With this panel, we're empowering researchers and clinicians by putting another tool in their hands to monitor changes in the virus so they can make informed and effective decisions for overall public health."
The TaqMan SARS-CoV-2 Mutation Panel provides results in about an hour and is based on gold standard TaqMan SNP genotyping assay technology, which can help to detect and distinguish mutations efficiently.
About Thermo Fisher Scientific
Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $30 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, improving patient diagnostics and therapies or increasing productivity in their laboratories, we are here to support them. Our global team of more than 80,000 colleagues delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services and Patheon. For more information, please visit www.thermofisher.com.
BD Announces Collaboration with ImageMover for Rapid Antigen Test Reporting
9 March 2021 - Reporting app helps facilitate SARS-CoV-2 testing and result reporting from BD Veritor™ Plus System
FRANKLIN LAKES, N.J., March 9, 2021 -- BD (Becton, Dickinson and Company), a leading global medical technology company, today announced an agreement with ImageMover, a software platform that automates and simplifies medical data collection and management, to offer a companion mobile app that enables more streamlined reporting of SARS-CoV-2 antigen testing results performed on the BD Veritor™ Plus System at everyday testing locations, such as schools and businesses. The ImageMover app is available immediately for BD Veritor™ Plus System customers.
COVID-19 testing in everyday settings presents challenges in managing test subject demographics and results. The ImageMover app enables organizations performing point-of-care testing to efficiently capture required demographic details of those being tested, upload COVID-19 test results, report results to appropriate stakeholders and automate reporting to federal and state agencies. While the BD Veritor™ Plus System has built-in functionality to allow for data sharing to electronic health records through the BD Synapsys™ Informatics platform, that functionality requires an information technology infrastructure common to diagnostic testing locations in health care facilities such as hospitals, doctor's offices and urgent care centers. The addition of the ImageMover app provides the benefits of seamless and secure data sharing for everyday locations that don't have a health care information technology platform in place.
"The ImageMover app helps resolve a major administrative reporting burden for 'return to normal' testing and further strengthens the advantages of using a digitally read test like the BD Veritor™ Plus System," said Dave Hickey, president of Life Sciences for BD. "From handheld portability to a simple workflow to a definitive digital readout of results that eliminates human subjectivity and now an automated reporting tool, the BD Veritor™ Plus System provides the simplicity needed for novice testers."
The ImageMover app coordinates with the BD Veritor™ Plus System to upload testing results for streamlined reporting and significantly reduced manual documentation. The app is compliant with patient privacy requirements under the Health Insurance Portability and Accountability Act of 1996 (HIPAA).
"ImageMover has pioneered a highly secure mobile solution for managing the end-to-end workflow for point-of-care COVID-19 test administration and result management," said Laura Brown, chief clinical officer at ImageMover. "Now, organizations without sophisticated information systems can more easily manage the data associated with testing from anywhere and across any care setting with the BD Veritor™ Plus System. With ImageMover, these non-acute organizations now have a solution that automatically submits test results to public health authorities. In addition, we securely share test subject results with the individuals directly. We are excited to partner with BD to increase access to a comprehensive testing solution for organizations struggling with point-of-care testing today."
For traditional acute care settings, the optional BD Synapsys™ Informatics solution will continue to deliver automated result reporting, provide streamlined CARES Act and other Health & Human Services-mandated reporting functionality, and offer analytics and reports to support clinical and operational decision-making.
The ImageMover app differs from BD's previously announced collaboration with Scanwell Health, which was created to develop a lateral flow antigen test to be paired with the Scanwell Health mobile app for at-home use. The Scanwell Health app is expected to provide step-by-step instructions on how to collect and transfer a nasal swab sample, perform the test and use the mobile device's camera to analyze and interpret results in the home. The ImageMover app still requires the use of the BD Veritor™ Plus System to read the results of the test, but it provides a more streamlined reporting tool for testing locations that don't have a health care IT infrastructure.
BD has been on the forefront of the COVID-19 response providing innovative solutions for immunology research, molecular- and antigen-based diagnostics, devices that aid in therapeutics and injection devices for vaccine administration. For more information about the BD Veritor™ Plus System, please visit bdveritor.com
About the BD Veritor™ Plus System for Rapid Detection of SARS-CoV-2 Assay
The BD Veritor™ Plus System for Rapid Detection of SARS-CoV-2 Assay has not been cleared or approved by FDA but has been authorized by FDA under an Emergency Use Authorization (EUA) for use by authorized laboratories. This product has been authorized only for the detection of proteins from SARSCoV-2, not for any other viruses or pathogens, and this product is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the declaration is terminated or authorization is revoked sooner.
About BD
BD is one of the largest global medical technology companies in the world and is advancing the world of health by improving medical discovery, diagnostics and the delivery of care. The company supports the heroes on the frontlines of health care by developing innovative technology, services and solutions that help advance both clinical therapy for patients and clinical process for health care providers. BD and its 70,000 employees have a passion and commitment to help enhance the safety and efficiency of clinicians' care delivery process, enable laboratory scientists to accurately detect disease and advance researchers' capabilities to develop the next generation of diagnostics and therapeutics. BD has a presence in virtually every country and partners with organizations around the world to address some of the most challenging global health issues. By working in close collaboration with customers, BD can help enhance outcomes, lower costs, increase efficiencies, improve safety and expand access to health care. For more information on BD, please visit bd.com.
About ImageMover
ImageMover is a medical software company that innovates seamless point-of-care medical workflow software solutions for healthcare professionals and patients. The company's solutions employ an exclusive approach to securely capture and integrate medical data to simplify communication and enhance patient care. For more information, visit http://imagemovermd.com/ or email Info@ImageMoverMD.com.
PerkinElmer Launches Comprehensive Solutions for Detecting SARS-CoV-2 Mutations
9 March 2021 - Company expands SARS-CoV-2 assay portfolio with RT-PCR and next generation sequencing solutions to identify mutations associated with SARS-CoV-2 variants
WALTHAM, Mass., March 9, 2021 -- PerkinElmer, Inc. today announced the launch of two Research Use Only (RUO) solutions, PKamp™ VariantDetect™ SARS-CoV-2 RT-PCR Assay and Next Generation Sequencing-based NEXTFLEX® Variant-Seq™ SARS-CoV-2 Kit. Using nucleic acid extracted from samples that previously tested positive, laboratories can use these assays to identify genomic mutations reported in relation to SARS-CoV-2 variants.
Public health agencies such as the U.S. Food and Drug Administration (FDA) have alerted clinical laboratories and the healthcare community about SARS-CoV-2 viral mutations. Upon detecting a positive case using a first-tier diagnostic assay, second-tier assays such as the PerkinElmer PKamp VariantDetect and NEXTFLEX Variant-Seq kits provide further information about mutations in the sample. The PKamp VariantDetect SARS-CoV-2 RT-PCR assay can detect mutations associated with B.1.1.7, B.1.351 and P.1 variants, which are the predominant variant strains known today. The NEXTFLEX Variant-Seq SARS-CoV-2 WGS workflow can detect all SARS-CoV-2 genetic changes relative to the strain originally identified in Wuhan, China.
“While continuing to rely on gold-standard RT-PCR tests for COVID-19 diagnosis, we must understand emerging variants to effectively limit the spread of the virus,” said Masoud Toloue, Ph.D., senior vice president, diagnostics, PerkinElmer. “The second-tier assays made available today are the outcome of a product development engine primed to continue producing assays that will help labs outpace the virus.”
PerkinElmer continues to work on the frontlines of improving COVID-19 testing. The PerkinElmer® New Coronavirus Nucleic Acid Detection Kit is the most sensitive molecular test for COVID-19 on the market, according to comparative data released by a FDA Reference Panel, and can be used to test symptomatic or asymptomatic individuals, individually or in pools of up to five samples. The Company’s comprehensive SARS-CoV-2 offerings also include high throughput RNA extraction, RT-PCR, antigen testing, workflow automation, ELISA, chemiluminescence, time-resolved fluorescence and lateral flow based serology testing.
About PerkinElmer
PerkinElmer enables scientists, researchers, and clinicians to address their most critical challenges across science and healthcare. With a mission focused on innovating for a healthier world, we deliver unique solutions to serve the diagnostics, life sciences, food, and applied markets. We strategically partner with customers to enable earlier and more accurate insights supported by deep market knowledge and technical expertise. Our dedicated team of about 14,000 employees worldwide is passionate about helping customers work to create healthier families, improve the quality of life, and sustain the wellbeing and longevity of people globally. The Company reported revenue of approximately $3.8 billion in 2020, serves customers in 190 countries, and is a component of the S&P 500 index. Additional information is available through 1-877-PKI-NYSE, or at www.perkinelmer.com.
Sysmex Presents Academic Report on Creating a Simple Method of Diagnosing Alzheimer’s Disease Using Blood
8 March 2021 - Presenting the most recent data at the 15th international conference on Alzheimer’s & Parkinson’s diseases (AD/PD 2021)
8 March 2021 -- Sysmex Corporation (HQ: Kobe, Japan; Chairman and CEO: Hisashi Ietsugu; "Sysmex") will present the most recent data on using blood as a method of diagnosing Alzheimer’s disease at the 15th International Conference on Alzheimer’s & Parkinson’s Diseases (AD/PD 2021), held virtually from March 9 to 14, 2021. Sysmex is conducting this development in collaboration with Eisai Co., Ltd. (HQ: Tokyo, Japan; CEO: Haruo Naito; "Eisai").
In February 2016, Sysmex and Eisai signed a non-exclusive comprehensive agreement aimed at the creation of new diagnostics in the field of dementia. By leveraging each other’s technologies and knowhow, we aim to discover next-generation diagnostic drugs that will enable the early diagnosis, selection of treatment options, and regular monitoring of the effects of treatment for dementia. Sysmex and Eisai are pursuing joint development aimed at creating a simple method of diagnosing Alzheimer’s disease using blood. At AD/PD 2021, Sysmex will announce the most recent data regarding prediction of amyloid positivity by incorporating the APOE4 status into plasma Aβ ratio measurement on the HISCLTM automated immunoassay system.
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Asset in Development, Session Name |
Topic/Planned Date and Time (Eastern Standard Time) |
Presenter (Affiliation) |
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AD Diagnostics “Amyloid, Tau, and Synapse PET Imaging” |
A Fully Automated Plasma Aβ Assay Incorporating APOE4 Status Shows High Performance to Predict Amyloid Positivity Determined by Centiloids of Amyloid PET Session time: March 12 (Fri.) 10:00-12:00 Oral presentation: 11:15-11:30; live Q&A session: 16:30-17:00 |
Kazuto Yamashita (Sysmex) |
Sysmex is working to create new diagnostic technologies for the prevention and treatment of dementia. We aim to contribute to the advancement of healthcare and improve the quality of life for patients and their families.
Grifols fosters world’s first scientific journal specialized in blood plasma
8 March 2021 - Plasmatology aims to become the reference publication for plasma science, bringing together the discipline’s knowledge, research and scientific advances that until now lacked a specialized journal. The prestigious Publisher SAGE Publications, specializing in scientific journals, independently edits the new international, open access, peer-reviewed online publication, which debuts March 9.
Barcelona, Spain, March 8, 2021 -- Grifols, a global leader in plasma-derived therapies with a more than 100-year track record of contributing to the health and well-being of people, today announced it’s fostering the first scientific journal dedicated to the science of plasma, coinciding with the 70th anniversary of the international presentation of the plasmapheresis technique.
This procedure, which separates plasma from the other blood components that are then reinfused into the donor, was developed by Josep Antonio Grifols i Lucas in 1951 in Barcelona and today continues to be the gold standard for plasma collection globally.
Plasmatology, which begins publishing March 9, aspires to become the scientific reference in its field, featuring all relevant research related to plasma science, from basic research to clinical application.
The publication is edited independently, with its editorial committee and director answering only to the prestigious publisher SAGE Publications , a longtime publisher of respected scientific journals covering different medical disciplines, life sciences, engineering, the humanities and other areas.
The international, open access, peer-reviewed journal will publish manuscripts evaluated and vetted by independent experts. Researchers can send their work – original articles, case studies, technical essays, reviews, editorials and comments – to the editorial board for its consideration. All content will be indexed in PubMed Central, as well as other scientific data bases.
Grifols, as part of its longstanding commitment to the scientific community, will provide the journal with an educational grant during the next two years to establish the publication as a global source for the scientific knowledge and research accomplishments in plasma science.
According to Víctor Grifols Deu, co-CEO of Grífols, “At Grifols we’re celebrating the creation of Plasmatology and we believe without a doubt it will accelerate the knowledge and research of proprietary plasma therapeutics.”
Raimon Grifols Roura, co-CEO of Grifols, added: “In addition it’s particularly gratifying that the birth of the publication coincides with the 70th anniversary of the development of plasmapheresis by my uncle Josep Antoni Grifols i Lucas. The company’s commitment to research and scientific publishing forms part of his legacy.”
Abbott receives FDA EUA for laboratory PCR assay that detects and differentiates SARS-COV-2, FLU A, FLU B AND RSV in one test - and FDA EUA for asymptotic usage of alinity m COVID-19 test
5 March 2021 - Abbott's Alinity™ m Resp-4-Plex assay will allow healthcare workers to test for four viruses in one test, a critically important tool as flu presents with similar symptoms. The test helps save on much-needed testing supplies since it allows for testing for all four viruses with one swab. Assay will run on Abbott's most advanced molecular PCR platform, the Alinity m system, which provides fast results in high volumes. Abbott also received updated EUA for asymptomatic usage of its Alinity m SARS-CoV-2 assay.
ABBOTT PARK, Ill., March 5, 2021 -- Abbott today announced U.S. Food and Drug Administration (FDA) Emergency Use Authorization (EUA) for the company's Alinity™ m Resp-4-Plex molecular assay to detect and differentiate SARS-CoV-2, influenza A, influenza B and respiratory syncytial virus (RSV) in one test. This is an important tool because these viruses have similar symptoms but require different treatment approaches. This test is CE Marked and available in countries outside the U.S.
The Alinity m Resp-4-Plex test can be conducted with one swab specimen (anterior nasal or nasopharyngeal) collected by a healthcare provider or an anterior nasal swab specimen self-collected at a healthcare location from individuals suspected by their provider of respiratory viral infection consistent with COVID-19. Test will run on Abbott's Alinity m system — the company's most advanced high-volume laboratory molecular instrument. Alinity m uses Polymerase Chain Reaction (PCR) technology, which is known for its high sensitivity in detecting infectious diseases. To help fight the pandemic, Abbott has accelerated placements of the Alinity m system in hospital labs, academic centers and labs that are critical to patient care.
"Abbott has been developing and introducing tests that have been playing a critical role in fighting the pandemic. The need for a combination of testing methods in different settings has never been more clear," said Andrea Wainer, executive vice president, Rapid and Molecular Diagnostics, Abbott. "This newest test will allow for fast and efficient diagnosis and triage of patients who present with respiratory symptoms so they can be given the right care."
Advanced technology's role in the fight
The Alinity m Resp-4-Plex assay will be a critical tool in detecting these four prevalent respiratory viruses. The advanced technology of the Alinity m system provides automation and on-demand access, meaning an urgent test can be run at any time. This flexibility and efficiency allow for the testing of multiple diseases while still producing fast results in high volumes. This assay's ability to detect and differentiate these viruses simultaneously with only one swab will also ease the resource strain on collection devices, which have been in high demand throughout the COVID-19 pandemic.
Expanding Alinity m SARS-CoV-2 to asymptomatic cases
Abbott is also announcing that the EUA for the company's Alinity m SARS-CoV-2 test has been updated to include an asymptomatic claim – detecting COVID-19 in individuals who do not have symptoms. A recent study found that more than 60% of COVID-19 infections present as asymptomatic cases, which is why it's critical to catch those cases before they spread. With the recent update to the Alinity m SARS-CoV-2 test EUA, the assay can now be used to detect individuals who are infected with SARS-CoV-2, but do not have symptoms or other reason to suspect COVID-19 infection. The Alinity m SARS-CoV-2 test EUA was also updated to include a pooling claim, which allows up to five samples to be tested at the same time. The updated Alinity m SARS-CoV-2 test, Alinity m Resp-4-Plex assay, and Abbott's existing testing technologies will now all be available to support front-line healthcare workers.
About Alinity m
Assays available for use on the Alinity m system worldwide include: SARS-CoV-2, HCV (hepatitis C), HBV (hepatitis B), HIV-1 (human immunodeficiency virus type 1), STI (CT/NG/TV/MG) and HR HPV. The easy-to-use system will help to improve laboratory workflow and efficiency with its large capacity and fast turnaround time, being able to run up to 1,080 tests in a 24-hour period based on laboratory practice and workflow. Alinity m systems are designed to be more efficient – running more tests in less time and minimizing human errors – while continuing to provide quality results. The availability of the Alinity m system and tests varies by geography. More information is available at molecular.abbott.
About Abbott
Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 109,000 colleagues serve people in more than 160 countries.
Illumina and R-Pharm Secure Registration for Two Complete IVD Sequencing Platforms in Russia
5 March 2021
SAN DIEGO, 5 March 2021 -- Illumina, Inc.’s NextSeq™ 550Dx platform and associated reagent kits received medical device registration in Russia, as have reagents for the MiSeq™Dx which was approved previously as a medical device. Both of these in vitro diagnostic (IVD)-ready solutions are available to customers and third-party developers to create diagnostic solutions using the technology. These registrations will catalyze the expansion of sequencing-based clinical diagnostics across the country.
Sequencing platforms, and the reagents that drive them, must be approved separately in Russia by the medical device regulatory agency, Roszdravnadzor. Illumina’s strategic partner in Russia and CIS, R-Pharm, led the regulatory process and this is the first approval of complete sets of sequencing instruments plus reagents.
“Having the two IVD-platforms available to assay developers to expand the clinical use of Next Generation Sequencing-based (NGS) molecular diagnostics will be a great boost to testing for genetic diseases and oncology in Russia,” said Paula Dowdy, Senior Vice President and General Manager of Illumina, Europe Middle East and Africa. “The NextSeq 550Dx is ideal for high throughput sequencing at large, federal hospitals, and the desktop MiSeqDx is well suited to the laboratory facilities of standard clinical centers.”
“These registrations are a significant step in bringing NGS technologies closer to patients, many of whom live near the smaller municipal and regional clinics. Bringing NGS diagnostics, with accurate and validated results, will be a huge benefit to patients,” said deputy Director General of the Dmitry Rogachev National Medical Research Center of Pediatric Hematology, Oncology and Immunology, Professor Mikhail Maschan.
Director of the Tomsk National Research Medical Center, correspondent member of the Russian Academy of Sciences, Vadim Stepanov, said: “Genetics and molecular biology are the core of clinical science because the majority of diseases originate from genetic mechanisms in cells, tissues and organs. Registration of Illumina’s products as medical devices allows to add the most modern technologies to clinical practice.”
“We are pleased that our partnership with Illumina, a global leader in human genome sequencing, will help Russian patients benefit from improved diagnosis and precision healthcare,” said Alexey Repik, R-Pharm Chairman of the Board.
About R-Pharm
R-Pharm Group introduces comprehensive solutions for the healthcare system and focuses on research, development, manufacturing and commercialization of pharmaceuticals, laboratory equipment and medical devices. R-Pharm's mission is to increase the accessibility of advanced diagnostics, preventative care and therapy methods in Russia and abroad. More than 4500 employees of the group in 70 branches and 30 countries of the world do their best to provide as many people as possible with the necessary means to improve and prolong their lives. To learn more, visit www.rpharm.com.
About Illumina
Illumina is improving human health by unlocking the power of the genome. Our focus on innovation has established us as the global leader in DNA sequencing and array-based technologies, serving customers in the research, clinical, and applied markets. Our products are used for applications in the life sciences, oncology, reproductive health, agriculture, and other emerging segments. To learn more, visit www.illumina.com.
BioGX Sample-Ready™ technology launches into Space yet again, aboard the International Space Station
4 March 2021
BIRMINGHAM, ALABAMA, 03 March 2021 – BioGX Sample-Ready™ lyophilized qPCR technology was selected by the NASA WetLab-2 program in 2016 to conduct genetic analysis in a microgravity environment aboard the International Space Station (ISS). Five years and several launches later, the collaboration is still going strong with a track record of success.
The International Space Station (ISS) is the world’s leading laboratory for cutting-edge research and innovation. “We are proud to be NASA’s partner in their quest for high-performing, innovative molecular chemistries. Our outer space innovations find their way in creating best in class molecular diagnostics solutions for any lab setting, here on earth” said Shazi Iqbal, Ph.D., CEO of BioGX.
BioGX support was essential for the successful launch of the latest One-Step Gene sampling tool for genetic analysis on the ISS. At the core of this technology is a microscopic probe for rapid and single-step purification of RNA from biological specimens using a pin interface with the Cepheid SmartCycler instrument that is currently on the ISS. The One-Step Gene Sampler was developed in a collaboration between Dr. Gergana G. Nestorova (Louisiana Tech University, Ruston, LA), Dr. Niel Crews (nou Systems Inc, Huntsville, AL), and the WetLab-2 team at NASA ARC. The latest batch of BioGX Sample-Ready™ lyophilized reagents and the One-Step Gene Sampler were launched on Space-X21 in December,2020 and are scheduled for testing this month.
“BioGX worked with us to develop a custom-designed lyophilized mixture for the reverse-transcription PCR experiment in orbit. The company provides our reagents in a ready-to-use format, customized in SmartCycler tubes that require only the addition of water before the actual genomic experiment in orbit. The reverse-transcription PCR reagents supplied by BioGX provide excellent sensitivity and reproducibility. Due to the constraints of performing experiments in space, the traditional liquid suspension format of PCR reagents is not appropriate for delivery to the ISS. Therefore, the lyophilization method developed by BioGX is essential for the preparation of PCR reagents for launch and storage in orbit.” said Dr. Gergana G. Nestorova of Louisiana Tech University, Ruston, LA.
About BioGX
BioGX is a leading global provider of lyophilized real-time PCR reagents for molecular diagnostics. BioGX, Inc., headquartered in Birmingham, Alabama, and its wholly owned subsidiary BioGX B.V., based in Amsterdam, The Netherlands, (collectively “BioGX”), operates in a cGMP compliant environment certified to ISO 13485 medical device development and manufacturing standards. The proprietary Sample-Ready™ technology is at the core of all product offerings for Clinical, Food Safety, Pharma QC and Water Quality molecular testing. BioGX B.V.’s 50+ molecular diagnostic products are marketed and sold in several countries through its Global Distribution Network.
Luminex Receives FDA Emergency Use Authorization and CE Mark for Expanded NxTAG® Respiratory Panel Test Including SARS-CoV-2
4 March 2021 - Provides labs with high throughput, syndromic respiratory testing capabilities
AUSTIN, Texas, March 4, 2021 -- Luminex Corporation today announced that it has received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) for a new expanded version of its NxTAG® Respiratory Pathogen Panel (RPP) that includes the SARS-CoV-2 virus for high-throughput respiratory testing. The new test is a combination of the company's original NxTAG RPP, an FDA-cleared in vitro diagnostic for syndromic respiratory infection testing, and SARS-CoV-2.
Respiratory infections such as COVID-19 and influenza can be challenging to differentiate and diagnose because they often have overlapping symptoms. NxTAG RPP is a multiplex, high-throughput test designed to enable simultaneous detection of the most common respiratory pathogens for a fast, syndromic testing approach. Following the addition of the SARS-CoV-2 virus target, the panel now includes 19 viral and 2 bacterial targets, combining the most common respiratory pathogens in one panel to help facilitate the rapid identification of various individual and co-occurring infectious pathogens.
NxTAG RPP provides scalable throughput, allowing clinical labs to run up to 96 samples at a time—generating results in approximately four hours with minimal hands-on time. The test runs on Luminex's easy-to-use, compact MAGPIX® System and is designed for use in high-complexity molecular laboratories.
Importantly, the NxTAG RPP + SARS-CoV-2 Assay is expected to detect new variants of the coronavirus. An in silico analysis of molecular probes used in the assay compared to SARS-CoV-2 sequences available in the GISAID database as of February 11, 2021, determined that key sequences still match and should yield a positive result. The analysis included variants originally detected in the United Kingdom (B.1.1.7), South Africa (B.1.351 or 20H/501Y.V2), Brazil (P.1 lineage or 20J/501Y.V3), and California (one of five reoccurring mutations that constitute the B.1.429 lineage and CAL20C).
"Given the emergence of new respiratory pathogens and new variants of these pathogens, it will be increasingly challenging to identify and distinguish the presence and co-existence of SARS-CoV-2, influenza, and other common respiratory pathogens. As a highly accurate, low-cost, multiplex test, our NxTAG RPP + SARS-CoV-2 test delivers an ideal solution for this challenge," said Nachum "Homi" Shamir, Chairman, President and CEO of Luminex. "Clinical laboratories using the assay will be able to scale-up their testing for both COVID-19 and the flu with one high-capacity diagnostic platform that can provide much-needed information for appropriate patient treatment. This is especially important given that the symptoms for the flu, COVID-19, and other respiratory illnesses can be very similar, but their treatment may be very different."
A version of the assay, which also detects Legionella pneumophila and the 2009 H1N1 Flu A subtype, also just received a CE Mark, and was commercialized last month in Europe.
Since the COVID-19 pandemic began, Luminex has expanded capacity for SARS-CoV-2 testing across all of its molecular platforms. The company previously launched the NxTAG CoV Extended Panel under an EUA from the FDA and an Authorization for Import or Sale with Conditions from Health Canada, and also received FDA EUA for its ARIES® SARS-CoV-2 Assay. In August, the company announced it received an EUA from the FDA for its xMAP® SARS-CoV-2 Multi-Antigen Immunoglobulin G (IgG) Assay, a new serology test that can be run on any of Luminex's xMAP-based, high-throughput, gold-standard multiplex platforms. The test detects IgG antibodies, which are an important component of an adaptive immune response and typically reflect sustained immunity to a given pathogen.
The NxTAG CoV Extended Panel and the ARIES® SARS-CoV-2 Assay have each been funded with $642,450 of Federal funds, approximately 36% each of the expected overall cost of development, from the Department of Health and Human Services; Office of the Assistant Secretary for Preparedness and Response; Biomedical Advanced Research and Development Authority, Division of Research Innovation and Ventures under Contract Nos. 75A50120C00037 (NxTAG CoV Extended Panel) and 75A50120C00043 (ARIES® SARS-CoV-2 Assay). Luminex financed the remaining $1,118,663 of each program, constituting 64% each of the total program costs.
About Luminex Corporation
At Luminex, our mission is to empower labs to obtain reliable, timely, and actionable answers, ultimately advancing health. We offer a wide range of solutions applicable in diverse markets including clinical diagnostics, pharmaceutical drug discovery, biomedical research, genomic and proteomic research, biodefense research, and food safety. We accelerate reliable answers while simplifying complexity and deliver certainty with a seamless experience. To learn more about Luminex, please visit us at luminexcorp.com.
Der Corona-Selbsttest zum Gurgeln (logo! ZDF-Kindernachrichten)
4 March 2021
4 March 2021 -- logo-Reporterin Maral war zu Gast in der SYNLAB-Teststation in Augsburg um den Corona-Selbsttest mit Rachen-Spülwasser zum Gurgeln zu testen.
Zum Videobeitrag: https://www.zdf.de/kinder/logo/selbsttest-corona-maral-100.html
Antibiotic Induced Hearing Loss update new clinical guidance in the UK supports assay
3 March 2021
3 March 2021 -- genedrive plc, the near patient molecular diagnostics company, provides an update on its Antibiotic Induced Hearing Loss (“AIHL”) assay. As announced on the 3 December 2020, an 11 month implementation trial at Manchester University NHS Foundation Trust and and Liverpool Women’s Hospital successfully concluded in November 2020. The results of the study will be published in a peer reviewed journal. The study’s primary outcomes were very positive, showing genedrive’s utility as the world’s first rapid genetic test in an emergency care neonatal setting. In excess of 750 babies were tested and 160 hospital staff were trained to provide rapid testing in this critical care setting.
Since completion of the trial, there has been new clinical guidance in the UK on the importance of the management of specific genetic mutations and their role in hearing loss as a result of antibiotics (“ototoxicity”). Government and Society guidance are considered a key factor influencing the speed and extent of future adoption. The Company and Inspiration Healthcare Group plc (AIM: IHC), the distribution partner for the AIHL assay, believe this will lead to increased demand for the genedrive AIHL test in the UK. This new government guidance reminds healthcare professionals about the impact of antibiotic related ototoxicity and to consider the need for genetic testing prior to initiation of treatment. genedrive’s assay is the only commercial point of care test available for the testing of MT-RNR1, the most important mutation contributing to AIHL in infants.
The launch of the genedrive AIHL assay remains on track for summer 2021 and the Company is enthusiastic about both the commercial prospects and the clinical benefits of this novel test to prevent potential irreversible hearing loss and this test becoming a standard of care. The Company is executing initial stage key opinion leader engagement in the UK alongside Inspriration Healthcare in preparation for commercial launch.
David Budd, CEO of genedrive plc, said: “We had the privilege of working with Manchester University NHS Foundation Trust and Liverpool Women’s Hospital throughout 2020 on the first deployment globally of a point of care test system to screen for MT-RNR1 – a mitochondrial mutation closely associated with ototoxicity in infants. Despite the emergence of COVID-19, our clinical partners showed huge dedication in keeping this important project on-track, becoming the first in the world to generate valuable information on the utility of this approach in an emergency care setting. As we see updated guidance and greater awareness to the requirement for genetic testing, we only expect increased interest in our novel assay.”
Reference: https://www.genedrive.com/news/index.php
BGI Donates COVID-19 Testing Kits to Bosnia and Herzegovina
3 March 2021
3 March 2021 -- BGI on Tuesday held an online signing ceremony with the Ministry of Health and Social Welfare of the Republic of Srpska, Bosnia and Herzegovina, and its Public Health Institute, to donate 5,000 COVID-19 test kits and help fight against the local pandemic. The Mammoth Foundation provided full supports for this donation.
Dr. Alen Šeranić, the Minister of Health and Social Welfare of the Republic of Srpska, Bosnia and Herzegovina, Mr. Branislav Zeljković, the Director of the Public Health Institute, and Dr. Li Ning, Vice President of BGI, jointly signed the agreement of donation.
Dr. Nina Sajić, the advisor in the Cabinet of the Serbian member of the Presidency of Bosnia and Herzegovina, Mr. Xie Yu, Economic and Commercial Counsellor, Embassy of China to Bosnia and Herzegovina, Dr. Yin Ye, Chief Executive Officer of BGI Genomics and Mr. Wang Kai, Secretary-General of Mammoth Foundation attended the signing ceremony.
Dr. Yin Ye, CEO of BGI Genomics, said that BGI is proud to do its part in Bosnia and Herzegovina. BGI has a motto, “Omics for All”, and hopes to use its research and expertise to improve people’s welfare.
Dr. Seranic and Dr. Sajic, in their expression of appreciation and gratitude, said that BGI’s donation will be a strong support to the fight against the pandemic in the country. They expected to discuss cooperation further.
Mr. Xie Yu, Economic and Commercial Counsellor from the Embassy of China, praised the donation and said it is a reflection of friendship and mutual support between the peoples of the two countries.
Since the outbreak of the COVID-19 pandemic, the order of BGI’s testing kits have covered over 180 countries and regions. More than 80 Huo-Yan laboratories have been established. Besides, BGI joins forces with the Mammoth Foundation to donate COVID-19 test kits and equipment. It’s dedicated to making contributions in the global fight against the pandemic.
Reference: https://www.bgi.com/global/company/news/bgi-donates-covid-19-testing-kits-to-bosnia-and-herzegovina/
Quidel receives Emergency Use Authorization for QuickVue® At-Home COVID-19 Test
1 March 2021 - Easy-to-use at-home test provides results in ten minutes with a doctor’s prescription
SAN DIEGO, 1 March 2021 -- Quidel Corporation (“Quidel”), a leading provider of rapid diagnostic testing solutions, cellular-based virology assays and molecular diagnostic systems, announced today that it has received an Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA), allowing the company to market its new QuickVue® At-Home COVID-19 Test for the qualitative detection of the nucleocapsid protein antigen from SARS-CoV-2. This test is authorized for prescription home use with self-collected (unobserved) anterior nares (NS) swab specimens directly from individuals aged 14 years and older who are suspected of COVID-19 by their healthcare provider within the first six days of the onset of symptoms. This test is also authorized for prescription home use with adult-collected anterior NS samples directly from individuals aged 8 years or older who are suspected of COVID-19 by their healthcare provider within the first six days of the onset of symptoms.
Quidel has provided rapid COVID-19 testing through doctors and health care providers throughout the pandemic, manufacturing and shipping millions of Sofia® tests last year. Now, Quidel’s QuickVue® At-Home COVID-19 Test will allow patients with a prescription to easily perform the test themselves and get results in 10 minutes. The QuickVue® At-Home COVID-19 Test shows excellent performance, with positive results agreeing with PCR 84.8% of the time, and negative results agreeing 99.1% of the time, delivering confidence to patients running the test and facilitating informed discussions with doctors.
“Quidel’s employees have truly risen to the challenge of the SARS pandemic. Our mission is to provide greater access to frequent, affordable and highly accurate diagnostic testing, and ultimately to enable individuals to take charge of their own health and help them make prudent decisions to protect themselves and their loved ones,” said Douglas Bryant, president and CEO of Quidel Corporation. “This is an important first step in a two-step process that, once additional ongoing studies are completed, will further expand access to frequent testing at home.”
The QuickVue® At-Home COVID-19 Test employs the same Quidel lateral flow technology used for decades by healthcare professionals and features the same SARS CoV-2 rapid antigen test strip and reagent solution that received an EUA from the FDA for use in professional settings in December 2020. Quidel’s contract with the National Institutes of Health’s Rapid Acceleration of Diagnostics initiative was expanded in late 2020 to include the QuickVue At-Home COVID-19 test, which expedited its emergency use authorization.
Quidel recently started the buildout of a new manufacturing facility in Carlsbad, CA. The 128,000 square foot facility is expected to be the company’s highest-volume production facility and begin operations in the second half of 2021, initially with a mission to produce more than 50 million QuickVue® rapid antigen tests per month, or 600 million tests per year at full capacity.
“The flexibility of our QuickVue® At-Home COVID-19 Test for meeting the urgent testing needs of individuals at home will save time and enable doctors and telemedicine providers to determine appropriate treatments without exposing their staff and other patients to heightened risk of infection,” Mr. Bryant noted. “We hope to bring the benefits of this technology to more broadly serve consumers, school systems, businesses and remote communities in the near future.”
Quidel’s QuickVue® brand launched in 1986 with visually read rapid diagnostics focusing on women’s health and respiratory diseases. In 1999, QuickVue® Influenza A+B was the first visually read rapid test approved by the FDA for professional use. QuickVue® was also the first flu test cleared by the FDA for use in CLIA-Waived point-of-care facilities like doctors’ offices, urgent care clinics and pharmacies. Today, QuickVue® is a market leading platform in the professional segment for visually diagnosing Influenza, respiratory syncytial virus, Strep A and a variety of other illnesses. Since the launch of the QuickVue® brand into the professional segment, more than 150 million QuickVue® diagnostic tests have been sold.
The QuickVue At-Home COVID-19 Test is intended for self-use and/or, as applicable for an adult lay user testing another person aged 8 years or older in a non-laboratory setting. The QuickVue At-Home COVID-19 Test is only for use under the Food and Drug Administration’s Emergency Use Authorization. The QuickVue® At-Home Covid-19 Test has not been FDA cleared or approved. The test has been authorized only for the detection of proteins from SARS-CoV-2, not for any other viruses or pathogens, and is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostic tests for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Federal Food, Drug and Cosmetic Act, 21 U.S.C. § 360bbb-3(b)(1), unless the declaration is terminated or authorization is revoked sooner.
About Quidel Corporation
Quidel Corporation is a leading manufacturer of diagnostic solutions at the point of care, delivering a continuum of rapid testing technologies that further improve the quality of health care throughout the globe. An innovator for over 40 years in the medical device industry, Quidel pioneered the first FDA-cleared point-of-care test for influenza in 1999 and was the first to market a rapid SARS-CoV-2 antigen test in the U.S. Under trusted brand names Sofia®, Solana®, Lyra®, Triage® and QuickVue®, Quidel’s comprehensive product portfolio includes tests for a wide range of infectious diseases, cardiac and autoimmune biomarkers, as well as a host of products to detect COVID-19. With products made in America, Quidel’s mission is to provide patients with immediate and frequent access to highly accurate, affordable testing for the good of our families, our communities and the world. For more information about Quidel, visit quidel.com.
Grifols acquires 25 U.S.-based plasma centers from BPL ensuring one million additional liters for fractionation
1 March 2021 - Grifols will immediately increase its plasma supply following the acquisition of these 25 plasma centers, which obtain a run-rate of 1 million liters of plasma per year. The USD 370 million transaction will be financed from Grifols’ own resources. This acquisition promotes the global expansion and plasma-supply diversification strategy of the company, an industry leader with 344 plasma centers worldwide: 289 in the U.S. following this transaction and 55 in Europe. Grifols remains committed to increasing its supply of plasma and plasma-derived therapies to ensure patients continue to receive the treatments and healthcare they need.
Barcelona, March 1, 2021 -- Grifols, a global leader in the development of plasma-derived therapies dedicated for more than 100 years to enhancing people’s health and well-being, finalized a USD 370 million transaction to acquire 25 U.S.-based plasma donation centers from BPL Plasma Inc., a subsidiary of Bio Products Laboratory Holdings Limited. The transaction has received the applicable regulatory clearances and will be financed with Grifols’ own resources, without issuing debt.
In accordance with the company’s strategic plan to advance its plasma-collection leadership, this transaction expands, reinforces and diversifies Grifols’ already-robust network of centers and capacity to supply life-enhancing plasma-derived medicines to patients.
In parallel, the transaction also builds on its network of plasma centers, which represents an important competitive advantage. Grifols remains committed to increasing the availability of its essential plasma-derived products to meet growing demand.
Grifols was able to limit its net plasma supply impact by roughly 15% in 2020 despite of COVID-19-related constraints. In 2021, the company is ready for a rebound in its plasma-collection levels in the wake of wider vaccination deployments and the ease of COVID-19 constraints. Grifols is also advancing on the execution of its expansion plan, comprising organic and inorganic growth.
As part of its organic efforts, the company plans to open between 15 and 20 new plasma centers in 2021. Thanks to its agile management, Grifols will open several plasma centers in Egypt in 2021, following the strategic alliance signed with the Egyptian government in November 2020.
Grifols now operates 344 plasma centers worldwide: 289 in the U.S. and 55 in Europe across Germany, Austria and, recently Hungary. The 25 centers acquired from BPL are authorized by the U.S. Food and Drug Administration (FDA) and the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA).
Grifols retained the legal services of Osborne Clarke, S.L.P. for this transaction.
Expanding its plasma supply to ensure patients’ access to treatments
Plasma-derived medicines are used to treat or prevent serious disorders or diseases in a range of therapeutic areas, including pulmonology, hematology, immunology and neurology.
Grifols is making every effort to increase its supply of plasma and plasma-based therapies to ensure patients continue to receive the treatments and healthcare they need. The company also joined global appeals to mobilize all qualified individuals to donate plasma, including both patients recovered from COVID-19 and those unaffected by the virus, given its critical role in the production of life-saving plasma-derived medicines.
Roche SARS-CoV-2 Rapid Antigen Test receives special approval for at-home patient self-testing using nasal swabs in Germany
26 February 2021 - Special approval from German Federal Institute for Drugs and Medical Devices (BfArM) enables home use of a SARS-CoV-2 Rapid Antigen Test using a simple nasal swab. The test will be widely available in pharmacies across Germany.
Basel, 26 February 2021 -- Roche today announced it has been granted special approval by the German Federal Institute for Drugs and Medical Devices (BfArM) to offer the SARS-CoV-2 Rapid Antigen Test using a simple nasal swab for patient self-testing in Germany.
The test is a reliable rapid test for the qualitative detection of a specific SARS-CoV-2 antigen in nasal swab samples.This rapid antigen test collects the sample from the front area of the nose instead of the nasopharynx, resulting in a simplified and more comfortable sampling procedure. By following simple instructions, patients can perform the test at home with results ready after only 15 minutes. The test will be made available in pharmacies and requires no prescription.
The German Federal Institute for Drugs and Medical Devices’ special approval of our test provides people in Germany with a reliable option to test themselves in the comfort of their own home,” said Thomas Schinecker, CEO Roche Diagnostics. “Regular self-testing at home can reduce pressure on healthcare systems. It can quickly identify people with the highest potential to be infectious so they can take immediate action to manage their infection, seek medical advice and protect others.”
This test is part of a partnership with SD Biosensor Inc., with whom Roche has also launched a SARS-CoV-2 Rapid Antibody Test in July and two SARS-CoV-2 Rapid Antigen Tests for professional use in September 2020 and February 2021. Those tests will continue to play an important role in this pandemic and remain available for healthcare professional testing.
Roche continues to expand its comprehensive COVID-19 portfolio to support healthcare systems in diagnosing SARS-CoV-2 infection.
About the SARS-CoV-2 Rapid Antigen Test for at-home patient self-testing
The SARS-CoV-2 Rapid Antigen Test for self testing is a rapid chromatographic immunoassay for the qualitative detection of the nucleocapsid protein of SARS-CoV-2 present in human nasal specimens. In a self-testing clinical study, the SARS-CoV-2 Rapid Antigen Test showed a sensitivity of 82.5% and a specificity of 100.0% when compared to RT-PCR testing. The relative sensitivity was 91.2% for samples with a high viral load ( Ct ≤30). Patients suspected of COVID-19 followed written and illustrated instructions to sample and test themselves. Most study participants considered the procedures easy to perform.
About antigen testing
An antigen test detects proteins which are structural or functional components of a pathogen and are very specific to that pathogen. In this case, the test would provide a qualitative “yes/no” answer on the presence of the antigen in the patient sample and can be offered as a rapid strip test that is performed at the point of care. If the target antigen (nucleocapsid protein) is present in sufficient concentrations in the sample, it will bind to specific antibodies and generate a visually detectable signal on the test strip, typically with results ready in 15 minutes. A rapid antigen test can reliably detect individuals with a high viral load allowing healthcare professionals to quickly identify those patients at the greatest risk of spreading the infection.
About Roche’s response to the COVID-19 pandemic
The COVID-19 pandemic continues to evolve globally with varying developments from country to country and we are partnering with healthcare providers, laboratories, authorities and organisations to help make sure that patients receive the tests, treatment and care they need. This new test is an additional step in Roche’s fight against the COVID-19 pandemic, which has already included:
- Launching COVID-19 diagnostic tests for active infection and the detection of antibodies in patients who have been exposed to the virus,
- Investigating treatments from our existing portfolio to better understand their potential to treat patients with COVID-19,
- Increasing manufacturing and supply chain capacity to meet product demand across our portfolio within the wider context of COVID-19 treatment, and
- Ensuring the supply of our existing medicines and diagnostics to patients around the world under exceptional conditions.
Reliable, high-quality testing is essential to help healthcare systems overcome this pandemic. On 13 March 2020 we received FDA Emergency Use Authorization for a high-volume molecular test to detect SARS-CoV-2, the virus that causes COVID-19, which is also available in countries accepting the CE Mark. On 3 May 2020, Roche announced that its COVID-19 antibody test, aimed at detecting the presence of antibodies in the blood, also received FDA Emergency Use Authorization and is available in markets accepting the CE mark. Also in June of last year we received an FDA EUA for the Elecsys® IL-6 test to assist in identifying severe inflammatory response in patients with confirmed COVID-19, as well as launching Roche v-TAC, which could help simplify the screening, diagnosis and monitoring of patients with respiratory compromise in the current COVID-19 pandemic. In July of 2020, we added a Rapid Antibody Test, with SD Biosensor as manufacturing partner, to the portfolio, that allows the detection of antibodies against COVID-19 at the point of care, a Rapid Antigen Test in September and a lab-based Antigen Test in December. Roche is working closely with governments and health authorities around the world, and has significantly increased production to help ensure availability of tests globally.
Roche is actively involved in understanding the potential of the existing portfolio and is researching options for the future. Roche has an ongoing clinical trial program evaluating the role of Actemra©/RoActemra© (tocilizumab) in COVID-19 pneumonia. On 29 July 2020 Roche announced that the COVACTA trial did not meet its primary endpoint of improved clinical status in patients with COVID-19 associated pneumonia, or the key secondary endpoint of reduced patient mortality. The study was the first global, randomised, double-blind, placebo-controlled phase III trial investigating Actemra/RoActemra in this setting. Roche remains committed to continuing the Actemra/RoActemra clinical trial programme in COVID-19 to further explore Actemra/RoActemra in other treatment settings, including in combination with an antiviral. In addition to COVACTA, Roche has initiated several studies to further investigate Actemra/RoActemra as a potential treatment for patients with COVID-19 associated pneumonia, including two phase III clinical trials, REMDACTA and EMPACTA, as well as the phase II MARIPOSA trial. Roche has further initiated an internal early research programme focused on the development of medicines for COVID-19 and is engaged in multiple research collaborations. On 19 August 2020, Roche announced a partnership with Regeneron to develop, manufacture and distribute REGN-COV2, Regeneron’s investigational antiviral antibody combination, to people around the globe. On 18 October 2020, Roche announced a collaboration with Atea Pharmaceuticals to develop a potential oral treatment for COVID-19 patients.
In these exceptional times, Roche stands together with governments, healthcare providers and all those working to overcome the pandemic.
About SD Biosensor
SD Biosensor is a global in-vitro diagnostic company focused on the development of immunoassay and molecular diagnostic products at the POC. Founded in 2010, SD Biosensor has continued to research and develop products that can aid in the fast and accurate diagnosis of patients across the testing journey. Through these innovative products, they are striving to become a leading global in vitro diagnostics company.
About Roche
Roche is a global pioneer in pharmaceuticals and diagnostics focused on advancing science to improve people’s lives. The combined strengths of pharmaceuticals and diagnostics under one roof have made Roche the leader in personalised healthcare – a strategy that aims to fit the right treatment to each patient in the best way possible.
Roche is the world’s largest biotech company, with truly differentiated medicines in oncology, immunology, infectious diseases, ophthalmology and diseases of the central nervous system. Roche is also the world leader in in vitro diagnostics and tissue-based cancer diagnostics, and a frontrunner in diabetes management.
Founded in 1896, Roche continues to search for better ways to prevent, diagnose and treat diseases and make a sustainable contribution to society. The company also aims to improve patient access to medical innovations by working with all relevant stakeholders. More than thirty medicines developed by Roche are included in the World Health Organization Model Lists of Essential Medicines, among them life-saving antibiotics, antimalarials and cancer medicines. Moreover, for the twelfth consecutive year, Roche has been recognised as one of the most sustainable companies in the Pharmaceuticals Industry by the Dow Jones Sustainability Indices (DJSI).
The Roche Group, headquartered in Basel, Switzerland, is active in over 100 countries and in 2020 employed more than 100,000 people worldwide. In 2020, Roche invested CHF 12.2 billion in R&D and posted sales of CHF 58.3 billion. Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan. For more information, please visit www.roche.com.
Reference: https://www.roche.com/media/releases/med-cor-2021-02-26c.htm
Vela Diagnostics adds two SARS-CoV-2 assays for virus genotyping, and variant identification to its COVID-19 testing solutions
26 February 2021 - The ViroKey™ SQ FLEX SARS-CoV-2 Genotyping Assay and ViroKey™ SARS-CoV-2 ID RT-PCR Test are added to our COVID-19 portfolio offering
Singapore, February 26 2021 – Vela Diagnostics announced that it has added ViroKey™ SQ FLEX SARS-CoV-2 Genotyping Assay and ViroKey™ SARS-CoV-2 ID RT-PCR Test to its portfolio offering.
The ViroKey™ SQ FLEX SARS-CoV-2 Genotyping Assay (RUO) harnesses next-generation sequencing (NGS) technology to sequence the whole SARS-CoV-2 genome. The accompanying Sentosa™ SQ Reporter software calls out mutations and classifies them by lineage, thereby aiding in the research and understanding of the molecular epidemiology of the COVID-19 pandemic. According to WHO, whole-genome sequencing is essential for improving effectiveness/sensitivity of molecular diagnostics, serological assays, vaccine design and anti-viral therapy, and aiding investigation of transmission routes and outbreak clusters.
“We offer a highly automated workflow which requires less than 2 hours of hands-on time from sample to report generation. With this ease-of-use, laboratories can very quickly adopt an NGS solution that would become an important tool in this pandemic situation,” said Managing Director, Andreas Goertz.
The ViroKey™ SARS-CoV-2 ID RT-PCR Test (RUO) is able to quickly identify variants present in positive samples. Variants include the B.1.1.7 (UK), B.1.351 (South Africa) and P.1 (Brazil) lineages.
“Identification of variants that may cause more severe disease or be more contagious is critical in our global response to the pandemic. Such variants may lead to more cases of COVID-19, putting a strain on healthcare systems and potentially leading to more deaths. As such, they need to be identified promptly for measures to be taken,” says Vice President, Jim Mismas.
“With emerging variants, like the recent B.1.526 from New York, that may weaken vaccine effectiveness, the need for mutation identification becomes clear. We are now able to offer options for quick detection of known variants of concerns, and all future variants for better pandemic management,” says Director of Business Development, Scott Cassidy.
The variant identification test can be used in conjunction with the ViroKey™ SARS-CoV-2 RT-PCR Test v2.0, which has received FDA Emergency Use Authorization, CE-IVD and TGA approval, and HSA Provisional Authorization.
About Vela Diagnostics
Vela Diagnostics is a leading provider for integrated IVD system solutions, from sample to result. VELA’s test solutions utilize the automated Sentosa™ platform, providing the unique ability to leverage one system for NGS and PCR testing in infectious disease and oncology.
Thermo Fisher Scientific Completes Acquisition of Mesa Biotech
26 February
WALTHAM, Mass., Feb. 26, 2021 -- Thermo Fisher Scientific Inc., the world leader in serving science, today announced it has completed its previously announced acquisition of Mesa Biotech, Inc., a privately held point-of-care molecular diagnostic company.
"Mesa Biotech is an important part of our strategy to expand the benefits of molecular diagnostics at the point of care, starting with COVID-19 testing," said Mark Stevenson, executive vice president and chief operating officer of Thermo Fisher Scientific. "By combining Thermo Fisher's operational excellence, access to raw materials and existing distribution and sales channels with Mesa's innovative platform, we can rapidly scale manufacturing volume, drive cost efficiencies and bring much-needed diagnostics to market faster and at greater scale."
Mesa Biotech has developed the Accula System, an affordable, easy-to-use, point-of-care PCR-based testing platform for infectious disease diagnosis. The platform enables rapid, highly accurate testing at physician offices, pharmacies and other settings, providing results in 30 minutes. Beyond COVID-19 testing, Mesa Biotech's existing platform includes tests for flu, respiratory syncytial virus (RSV), and Strep A.
"The Accula System complements our existing offerings and immediately provides our clinical customers with more options and flexibility for COVID-19 testing. And, as the point-of-care diagnostic market expands globally, we're well-positioned to deliver a broader menu of tests to meet increasing demand," Stevenson continued.
The Accula Flu A/Flu B, RSV and Strep A tests have 510(k) clearance and Clinical Laboratory Improvements Amendments (CLIA) waivers from the U.S. Food and Drug Administration (FDA). The Flu A/Flu B and RSV assays have also received CE-IVD Mark approval. Additionally, the Accula System has received Emergency Use Authorization (EUA) from the FDA for SARS-CoV-2 in vitro diagnostic testing*.
Mesa Biotech will become part of the Life Sciences Solution Segment and is expected to add revenue of approximately $200 million in 2021.
About Thermo Fisher Scientific
Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $30 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, improving patient diagnostics and therapies or increasing productivity in their laboratories, we are here to support them. Our global team of more than 80,000 colleagues delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services and Patheon. For more information, please visit www.thermofisher.com.
EMA issues advice on casirivimab and imdevimab antibody cocktail for the treatment of mild-to-moderate COVID-19
26 February 2021 - CHMP has completed a review of available data for investigational antibody cocktail casirivimab and imdevimab (REGN-COV2) to be considered for the treatment of confirmed COVID-19. CHMP scientific opinion supports national decision making within EU states on the use of the antibodies before a formal authorisation is granted during a public health emergency. Roche and Regeneron are collaborating on developing and manufacturing casirivimab and imdevimab; Roche will be responsible for distribution in Europe and other countries outside the US.
Basel, 26 February 2021 -- Roche confirmed today that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a scientific opinion supporting the use of the investigational antibody cocktail, casirivimab and imdevimab, as a treatment option for patients with confirmed COVID-19 who do not require oxygen supplementation and who are at high risk of progressing to severe COVID-19.
The CHMP’s scientific opinion (under Article 5(3) of Regulation 726/2004) provides a harmonised, EU-level opinion on the efficacy, quality and safety of casirivimab and imdevimab. This review took place in parallel to the EMA’s ongoing rolling review process, which is used to speed up the formal marketing application assessment of a promising medicine during a public health emergency. Under Article 5(3), the CHMP assessed available data in patients with COVID-19, including data from the REGN-COV2 2067 trial, as well as supportive data from other settings.
“This advice by the CHMP regarding casirivimab and imdevimab is an important step towards addressing the COVID-19 pandemic in the EU,” said Levi Garraway, M.D., Ph.D., Chief Medical Officer and Head of Global Product Development. “Initial data showed that patients treated with this investigational antibody cocktail saw a reduction in both viral loads and medically-attended visits. Together with our partner Regeneron, we will continue working with the EMA, governments and other health authorities across the globe to bring this antibody cocktail to as many patients as possible.”
Roche and Regeneron are collaborating to develop, manufacture and distribute casirivimab and imdevimab, to people around the globe, with the aim of having more than two million doses available in 2021. Regeneron will be responsible for distributing the antibody cocktail in the US and Roche will be responsible for distribution outside the US, with the first Roche-manufactured doses already being distributed. Casirivimab and imdevimab could provide a much-needed treatment option for infected individuals already experiencing symptoms of COVID-19, and may be able to prevent infection in people exposed to the virus, and hopefully help slow the spread of the global pandemic.
The investigational antibody cocktail of casirivimab and imdevimab continues to be evaluated in clinical trials in multiple settings for COVID-19: in non-hospitalised and certain hospitalised patients, including the open-label RECOVERY trial of hospitalised patients in the UK, and a trial for the prevention of COVID-19 in household contacts of infected individuals. As of February 2021, approximately 23,000 people have participated in casirivimab and imdevimab clinical trials. Lower doses of casirivimab and imdevimab are also being studied with the aim of increasing the number of patients who could potentially be treated if the cocktail is approved.
In these exceptional times, Roche stands together with society, governments, healthcare providers and all those working to overcome the pandemic.
About the CHMP’s review under Article 5(3) of Regulation 726/2004
The intent of the Article 5(3) referral procedure is for the CHMP to develop a harmonised scientific opinion at the EU level on the quality, safety and efficacy of a medicine based on the currently available data. The scientific opinions can then be considered by EU member states when making decisions on the use of medicines at a national level before a formal authorisation is issued.
The review under Article 5(3) of Regulation 726/2004 was requested by the EMA’s Executive Director following preliminary discussions with the COVID-19 EMA pandemic task force (COVID-ETF), which brings together experts from across the European medicines regulatory network to advise on the development, authorisation and safety monitoring of medicines and vaccines for COVID-19.
About casirivimab and imdevimab
Casirivimab and imdevimab is a cocktail of two monoclonal antibodies (also known as REGN10933 and REGN10987, respectively) and was designed by Regeneron scientists to block infectivity of SARS-CoV-2, the virus that causes COVID-19. They evaluated thousands of fully-human antibodies produced by the company's proprietary VelocImmune® mice, which have been genetically modified to have a human immune system, as well as antibodies identified from humans who have recovered from COVID-19.
The two potent, virus-neutralising antibodies that form casirivimab and imdevimab are believed to bind non-competitively to the critical receptor binding domain of the virus's spike protein, which is hypothesised to diminish the ability of mutant viruses to escape treatment and to protect against spike variants that may arise in the human population, as detailed in recent Science publications.
Casirivimab and imdevimab have not been approved by any health authority. In November 2020, the antibody cocktail was authorised by the U.S. Food and Drug Administration (FDA) under an Emergency Use Authorization (EUA) for the treatment of mild to moderate COVID-19 in adults and paediatric patients (12 years of age and older weighing at least 40 kg) with positive results of direct SARS-CoV-2 viral testing, and who are at high risk for progressing to severe COVID-19 and/or hospitalisation. The US EUA is temporary and does not take the place of the formal biologics license application (BLA) submission, review and approval process.
Casirivimab and imdevimab’s development, manufacturing and clinical trials have been funded in part by the Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response at the U.S. Department of Health and Human Services under OT number: HHSO100201700020C.
About Roche’s response to the COVID-19 pandemic
As a leading healthcare company we are doing all we can to support countries in minimising the impact of COVID-19. We have developed a growing number of diagnostic solutions that help to detect and diagnose the infection in patients, as well as providing digital support to healthcare systems, and we continue to identify, develop and support potential therapies which can play a role in treating the disease.
We understand the impact of COVID-19 goes beyond those who contract it, which is why we are working with healthcare providers, laboratories, authorities and organisations to help make sure that patients continue to receive the tests, treatment and care they need during these challenging times. As we learn from the pandemic, we are partnering with governments and others to make healthcare stronger and more sustainable in the future.
Our diagnostics solutions:
Reliable, high-quality testing is essential to help healthcare systems overcome this pandemic. Our portfolio includes:
- a high-volume molecular test to detect SARS-CoV-2, the virus that causes COVID-19, (FDA Emergency Use Authorisation (EUA) and available in countries accepting the CE Mark)
- a SARS-CoV-2 laboratory-based antibody test, aimed at detecting the presence of antibodies in the blood targeting the nucleocapsid (FDA EUA and CE Mark)
- an IL-6 test to assist in identifying severe inflammatory response in patients with confirmed COVID-19 (FDA EUA and CE Mark)
- Roche v-TAC, which could help simplify the screening, diagnosis and monitoring of patients with respiratory compromise in the current COVID-19 pandemic
- a SARS-CoV-2 rapid antibody test to help determine at the point of care whether a person has been exposed to the virus (CE Mark)
- a rapid antigen test to support in the detection of SARS-CoV-2 at the point of care within 15 minutes (CE Mark)
- a high-volume molecular test to simultaneously detect and differentiate between SARS-CoV-2 and influenza A/B, as the symptoms are similar for both (FDA EUA and CE Mark)
- a second SARS-CoV-2 antibody test, aimed at measuring the spike protein to support vaccination development and complement our existing portfolio
- a point-of-care molecular PCR test that simultaneously detects and differentiates between SARS-CoV-2 and influenza A/B infections to support urgent triage and diagnosis (FDA EUA and CE Mark)
Our research into therapies:
Roche is committed to improving the treatment of COVID-19. We are actively involved in understanding the potential of our existing portfolio and are exploring the potential of our investigational molecules.
There have been/are a number of clinical trials with an external 3rd party as the sponsor exploring the efficacy and safety of Actemra (tocilizumab) for the treatment of COVID-19 associated pneumonia. COVACTA and EMPACTA, sponsored by Roche, are the first global phase III, multi-centre, randomised, placebo-controlled studies evaluating Actemra in this setting.
We continue to evaluate the data from the global COVACTA study, which did not meet its primary endpoint as announced on 29 July 2020, in conjunction with results from the global EMPACTA study of Actemra in COVID-19 pneumonia, which met its primary endpoint as announced on 17 September 2020, as well as additional data sources that are in the public domain to determine whether a population can be defined based on patient and disease characteristics in which Actemra on top of usual care may provide a favourable benefit risk profile.
Roche remains committed to continuing the Actemra clinical trial programme in COVID-19 to further explore Actemra in other treatment settings, including in combination with an antiviral.
In August 2020 we signed a collaboration agreement with Regeneron on developing, manufacturing and significantly increasing global supply of an investigational antibody cocktail for COVID-19 if it proves safe and effective in clinical trials and regulatory approvals are granted.
In October 2020 we signed an agreement with Atea to jointly develop AT-527, an orally administered direct-acting antiviral (DAA) currently in phase II clinical trials. AT-527 has the potential to be the first novel oral antiviral to treat COVID-19 patients outside the hospital setting, as well as in the hospital, and may also be used in post-exposure prophylactic settings.
About Roche
Roche is a global pioneer in pharmaceuticals and diagnostics focused on advancing science to improve people’s lives. The combined strengths of pharmaceuticals and diagnostics under one roof have made Roche the leader in personalised healthcare – a strategy that aims to fit the right treatment to each patient in the best way possible.
Roche is the world’s largest biotech company, with truly differentiated medicines in oncology, immunology, infectious diseases, ophthalmology and diseases of the central nervous system. Roche is also the world leader in in vitro diagnostics and tissue-based cancer diagnostics, and a frontrunner in diabetes management.
Founded in 1896, Roche continues to search for better ways to prevent, diagnose and treat diseases and make a sustainable contribution to society. The company also aims to improve patient access to medical innovations by working with all relevant stakeholders. More than thirty medicines developed by Roche are included in the World Health Organization Model Lists of Essential Medicines, among them life-saving antibiotics, antimalarials and cancer medicines. Moreover, for the twelfth consecutive year, Roche has been recognised as one of the most sustainable companies in the Pharmaceuticals Industry by the Dow Jones Sustainability Indices (DJSI).
The Roche Group, headquartered in Basel, Switzerland, is active in over 100 countries and in 2020 employed more than 100,000 people worldwide. In 2020, Roche invested CHF 12.2 billion in R&D and posted sales of CHF 58.3 billion. Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan. For more information, please visit www.roche.com.
Reference: https://www.roche.com/media/releases/med-cor-2021-02-26b.htm
EMA issues advice on Regenerons's antibody cocktail (Casirivimab with Imdevimab) for certain COVID-19 patients
26 February 2021 - EU member states can utilize the positive CHMP opinion when making national decisions about use of the antibody cocktail, prior to a potential future EMA market authorization. Regeneron has collaborated with Roche to develop and manufacture the antibody cocktail; Roche is responsible ex-U.S. and has already begun distribution in the EU.
TARRYTOWN, N.Y., Feb. 26, 2021 -- Regeneron Pharmaceuticals, Inc. today announced the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion for the company's investigational COVID-19 antibody cocktail (casirivimab with imdevimab). The CHMP recommends that the antibody cocktail, known as REGEN-COVTM in the U.S., can be used to treat confirmed COVID-19 in patients who do not require supplemental oxygen and who are at high risk of progressing to severe COVID-19.
"Today's endorsement by the EU's leading scientific body for medicines helps bring our antibody cocktail one step closer to even more COVID-19 patients who could benefit from it," said George D. Yancopoulos, M.D., Ph.D., President and Chief Scientific Officer at Regeneron. "Our collaborator Roche is already in active discussions with a number of European countries following release of our data in non-hospitalized patients that showed the antibody cocktail significantly reduced virus levels within days of treatment, which was associated with significantly fewer medical visits. This is supported by preclinical data that show that our antibody cocktail effectively neutralizes emerging strains of the virus, which are becoming increasingly common in Europe and around the world."
The CHMP recommendation provides a harmonized, European Union (EU)-level opinion on the efficacy, quality and safety of the antibody cocktail, which can be used by EU member states when making decisions on the possible use of the antibody cocktail at a national level prior to a market authorization. Under Article 5(3) of Regulation EC 726/2004, the CHMP assessed available data in non-hospitalized patients ("outpatients") with COVID-19 as well as supportive data from other settings.
The CHMP's review took place in parallel to the EMA's ongoing rolling review process, which is used to speed up the formal marketing application assessment of a promising medicine during a public health emergency. Once finalized it will be the basis for an EU marketing authorization for the antibody cocktail. Regeneron, together with Roche, continues to work closely with the EMA as it undertakes its rolling review.
Regeneron is collaborating with Roche to increase global supply of the antibody cocktail. Regeneron is responsible for development and distribution of the treatment in the U.S., and Roche is primarily responsible for development and distribution outside the U.S., with the first Roche-manufactured doses already being distributed. The companies share a commitment to making the antibody cocktail available to COVID-19 patients around the globe and will support access in low- and lower-middle-income countries through drug donations to be made in partnership with public health organizations.
The development and manufacturing of REGEN-COV have been funded in part with federal funds from the Biomedical Advanced Research and Development Authority (BARDA), part of the U.S. Department of Health and Human Services, Office of the Assistant Secretary for Preparedness and Response, under OT number: HHSO100201700020C.
About the Antibody Cocktail
The antibody cocktail, known as REGEN-COV (casirivimab with imdevimab) in the U.S., consists of two monoclonal antibodies (also known as REGN10933 and REGN10987) and was designed specifically to block infectivity of SARS-CoV-2, the virus that causes COVID-19. The two potent, virus-neutralizing antibodies that form the cocktail bind non-competitively to the critical receptor binding domain of the virus's spike protein, which diminishes the ability of mutant viruses to escape treatment and protects against spike variants that have arisen in the human population, as detailed in Science.
In November 2020, REGEN-COV received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) for the treatment of mild to moderate COVID-19 in adults, as well as in pediatric patients at least 12 years of age and weighing at least 40 kg, who have received positive results of direct SARS-CoV-2 viral testing and are at high risk for progressing to severe COVID-19 and/or hospitalization. The clinical evidence from Regeneron's outpatient trial suggests that monoclonal antibodies such as casirivimab and imdevimab have the greatest benefit when given early after diagnosis and in patients who are seronegative and/or who have high viral load. The criteria for 'high-risk' patients are described in the Fact Sheet for Healthcare Providers. In the U.S., REGEN-COV is not authorized for use in patients who are hospitalized due to COVID-19 or require oxygen therapy, or for people currently using chronic oxygen therapy because of an underlying comorbidity who require an increase in baseline oxygen flow rate due to COVID-19.
REGEN-COV continues to be evaluated in clinical trials in multiple settings for COVID-19: in non-hospitalized and certain hospitalized patients, including the open-label RECOVERY trial of hospitalized patients in the UK, and a trial for the prevention of COVID-19 in household contacts of infected individuals. As of February 2021, approximately 23,000 people have participated in clinical trials involving REGEN-COV. Lower doses of REGEN-COV are also being studied with the aim of increasing the number of patients who could potentially be treated if the cocktail is approved.
REGEN-COV was invented using Regeneron's VelocImmune® technology that utilizes a proprietary genetically engineered mouse platform endowed with a genetically-humanized immune system to produce optimized fully-human antibodies. When Regeneron's co-Founder, President and Chief Scientific Officer George D. Yancopoulos was a graduate student with his mentor Frederick W. Alt in 1985, they were the first to envision making such a genetically humanized mouse, and Regeneron has spent decades inventing and developing VelocImmune® and related VelociSuite® technologies. Dr. Yancopoulos and his team have used VelocImmune technology to create multiple antibodies including Dupixent® (dupilumab), Libtayo® (cemiplimab-rwlc), Praluent® (alirocumab), Kevzara® (sarilumab), Evkeeza™ (evinacumab-dgnb) and Inmazeb™ (atoltivimab, maftivimab, and odesivimab-ebgn).
About Regeneron
Regeneron is a leading biotechnology company that invents life-transforming medicines for people with serious diseases. Founded and led for over 30 years by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to nine FDA-approved treatments and numerous product candidates in development, all of which were homegrown in our laboratories. Our medicines and pipeline are designed to help patients with eye diseases, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, pain, infectious diseases and rare diseases.
Regeneron is accelerating and improving the traditional drug development process through our proprietary VelociSuite® technologies, such as VelocImmune®, which uses unique genetically humanized mice to produce optimized fully human antibodies and bispecific antibodies, and through ambitious research initiatives such as the Regeneron Genetics Center, which is conducting one of the largest genetics sequencing efforts in the world.
Corona-Test: Von der Probenentnahme bis zur Sequenzierung im Labor (Jena TV)
24 February 2021
24 February 2021 -- Dr. Martin Roskos, CMO der SYNLAB Holding Deutschland GmbH bietet einen Blick hinter die Kulissen des SYNLAB-Labors in Jena, das täglich hunderte Corona-Proben mit der PCR-Methode untersucht und die Viren in positiven Abstrichen auch sequenziert. In diesem Interview mit Jena TV erklärt Dr. Martin Roskos den Ablauf eines Corona PCR-Tests von der Probenentnahme bis zur Untersuchung und ggf. anschließenden Sequenzierung der Probe im Labor.
Quest Diagnostics Introduces New COVID-19 Semi-quantitative Serology Test Service
24 February 2021
SECAUCUS, N.J., Feb. 24, 2021 -- Quest Diagnostics, the world's leading provider of diagnostic information services, today introduced a new COVID-19 testing service that aids in providing insight into an individual's immune response as a result of a recent or prior infection with SARS-CoV-2, the virus that causes COVID-19, or to immune response observed in connection with COVID-19 vaccination.
As many as 40 percent of individuals infected with SARS-CoV-2 do not experience symptoms and may not realize they are or have been infected. Serology testing can inform if an individual's immune system has produced antibodies in response to infection, even in asymptomatic individuals, about two weeks following suspected infection. According to the U.S. Food and Drug Administration, serology tests can help to identify individuals who have "developed antibodies that may protect from future infection as well as identify those still at risk."
The new Quest Diagnostics test service provides a positive/negative result as well as a numerical result that may provide the basis for assessing relative changes in antibody blood levels. In addition, the new service can aid in assessing blood levels of antibodies produced to structural proteins of the SARS-CoV-2 spike protein. Because currently available vaccines in the United States contain mRNA that encodes the spike protein, the test may aid in indicating an immune response resulting from a recent or prior infection or vaccination. The test will not differentiate between immune response mounted in response to infection or vaccination.
"We believe that SARS CoV-2 semi-quantitative serology testing will be an important clinical tool to assess if an individual has mounted an immune response from recent or prior infection or from vaccination," said Jay G. Wohlgemuth M.D., Senior Vice President and Chief Medical Officer for Quest Diagnostics. "These insights may aid clinical management of certain patients at high risk of severe COVID-19 disease or who may be at risk for vaccination, such as people with a history of severe vaccine allergy or women who are pregnant. While the science is evolving, many individuals may have an interest in understanding their immune response status over time and post-vaccination."
"Importantly, we also believe semi-quantitative testing will improve public health surveillance as researchers across the United States seek to better understand the contributions of vaccination and prior infections on herd immunity," Dr. Wohlgemuth added.
In its commitment to advancing COVID-19 science and public health response, Quest Diagnostics currently provides COVID-19 semi-qualitative antibody testing services and variant genomic sequencing services to aid public health monitoring by the Centers for Disease Control and Prevention.
The new semi-quantitative testing service is the latest addition to the company's existing menu of COVID-19 qualitative IgG and IgG/IgM test services. These services aid in identifying a relative level of adaptive immune response to recent or prior infection with SARS-CoV-2. The Quest Diagnostics menu of serology testing services are based on several FDA emergency use authorized tests from leading manufacturers.
While there is no recommended minimum interval between infection and vaccination, current evidence suggests that the risk of SARS-CoV-2 reinfection is low in the first few months after initial infection but may increase with time due to waning immunity. Based on available science, it is unclear how long an individual will sustain an effective immune response to SARS-CoV-2 following infection or vaccination. However, research of other coronaviruses, including SARS, and the low rate of known SARS-CoV-2 re-infections, suggests those with antibodies may be at lower risk of symptomatic infection. A study recently published in the New England Journal of Medicine found no symptomatic infections in individuals with antibodies to SARS-CoV-2 over six months. Another study suggests COVID-19 antibodies may remain stable for more than 8 months.
According to the CDC, vaccination should be offered to persons regardless of history of prior symptomatic or asymptomatic SARS-CoV-2 infection. The CDC also advises that while vaccine supply remains limited, persons with recent documented acute SARS-CoV-2 infection may choose to temporarily delay vaccination up to 90 days, if desired, recognizing that the risk of reinfection, and therefore the need for vaccination, might increase with time following initial infection. Pre-vaccination testing can help tell whether antibodies are present in an individual patient regardless of the cause of their presence.
Ordering a Test
Serology testing employs a blood specimen. Quest Diagnostics operates more than 2,200 patient service centers across the United States that perform blood draws for COVID-19 antibody testing consistent with health and safety guidelines from the Centers for Disease Control and Prevention (CDC). Healthcare providers can also collect blood specimens in their offices for patients for testing by Quest Diagnostics. For more information on visiting our patient service centers, refer more about our Peace of Mind program.
Only a healthcare provider can order a Quest Diagnostics serology antibody test. Assuming a provider places an order for testing, patients may schedule appointments ahead of time through the Quest Diagnostics MyQuest patient portal or at www.QuestDiagnostics.com.
About COVID-19 Testing at Quest Diagnostics
Quest Diagnostics empowers people to take action to improve health outcomes. Derived from the world's largest database of clinical lab results, our diagnostic insights reveal new avenues to identify and treat disease, inspire healthy behaviors and improve health care management. Quest annually serves one in three adult Americans and half the physicians and hospitals in the United States, and our 50,000 employees understand that, in the right hands and with the right context, our diagnostic insights can inspire actions that transform lives. For more information about the latest developments with our COVID-19 testing, visit: newsroom.questdiagnostics.com/COVIDTestingUpdates
About Quest Diagnostics
Quest Diagnostics empowers people to take action to improve health outcomes. Derived from the world's largest database of clinical lab results, our diagnostic insights reveal new avenues to identify and treat disease, inspire healthy behaviors and improve health care management. Quest annually serves one in three adult Americans and half the physicians and hospitals in the United States, and our 50,000 employees understand that, in the right hands and with the right context, our diagnostic insights can inspire actions that transform lives. www.QuestDiagnostics.com
PerkinElmer Changes COVID-19 Rapid Testing Landscape with Highly Sensitive Point of Care Antigen Test for Mass Screening Financial Information
23 February 2021 - Company expands portfolio of SARS-CoV-2 testing solutions with rapid antigen test benchmarked against gold standard RT-PCR
WALTHAM, Mass., Feb. 23, 2021 -- PerkinElmer, Inc. today announced the launch of the PerkinElmer® COVID-19 Antigen Test for the qualitative detection of SARS-CoV-2 nucleocapsid protein antigen in nasal (NS) or nasopharyngeal (NP) swab specimens. The lateral flow immunoassay test can be used to screen or to aid in diagnoses of COVID-19 in asymptomatic or symptomatic individuals. A positive or negative result can be obtained in as little as 15 minutes to facilitate immediate isolation or treatment decisions.
This latest addition to the Company’s portfolio of SARS-CoV-2 testing solutions is available in more than 30 countries that accept the CE mark. The in vitro diagnostic device is ideally suited for professional use point-of-care (POC) clinical and non-clinical settings such as healthcare centers, travel hubs, businesses and educational institutions. Clinical studies in symptomatic and asymptomatic populations, including individuals with low viral load, have shown sensitivity of greater than 97% amongst all NS and NP samples. Specificity of the test across 202 negative samples was 100%, which means no false positives were identified.
“While RT-PCR tests remain the gold standard in COVID-19 diagnostics, there is an unmet need in the market for a highly reliable antigen test that can support the reopening strategies of organizations worldwide,” said Masoud Toloue, Ph.D., Senior Vice President, Diagnostics, PerkinElmer. “Sensitivity and reliability matters, especially in this challenging environment. Just like with our RT-PCR test, significant talent and effort was put behind developing a lateral flow antigen test that sets the benchmark for rapid testing, and may help facilitate the safe return of in-person education, commerce and everyday life.”
PerkinElmer continues to work on the frontlines of improving COVID-19 testing. The Company’s comprehensive SARS-CoV-2 offerings span high throughput RNA extraction, RT-PCR, automation, ELISA, chemiluminescence, time-resolved fluorescence and lateral flow based serology testing.
Based on comparative data released by the U.S. Food and Drug Administration, the PerkinElmer® New Coronavirus Nucleic Acid Detection Kit has the lowest limit of detection among authorized COVID-19 molecular diagnostic tests reported, deeming it the most sensitive assay. This RT-PCR assay originally obtained FDA EUA in the spring of 2020 and recently received EUA to test individuals without symptoms or other reasons to suspect COVID-19 infection.
About PerkinElmer
PerkinElmer enables scientists, researchers, and clinicians to address their most critical challenges across science and healthcare. With a mission focused on innovating for a healthier world, we deliver unique solutions to serve the diagnostics, life sciences, food, and applied markets. We strategically partner with customers to enable earlier and more accurate insights supported by deep market knowledge and technical expertise. Our dedicated team of about 14,000 employees worldwide is passionate about helping customers work to create healthier families, improve the quality of life, and sustain the wellbeing and longevity of people globally. The Company reported revenue of approximately $3.8 billion in 2020, serves customers in 190 countries, and is a component of the S&P 500 index. Additional information is available through 1-877-PKI-NYSE, or at www.perkinelmer.com
BD Announces Collaboration for At-Home Rapid Test for COVID-19
22 February 2021 - Aims to Pair BD Antigen Test with Scanwell Health Mobile App
FRANKLIN LAKES, N.J., Feb. 22, 2021 -- BD (Becton, Dickinson and Company), a leading global medical technology company, and Scanwell Health, a leader in smartphone-enabled at-home medical tests, today announced a collaboration to create an at-home rapid test for SARS-CoV-2 using a BD antigen test and the Scanwell Health mobile app.
As part of the collaboration, BD plans to produce a lateral flow antigen test and pair it with the Scanwell Health mobile app. The app is expected to provide step-by-step instructions on how to collect and transfer a nasal swab sample and use the mobile device's camera to analyze and interpret results. The test result will be displayed onscreen, and the companies are also planning to develop functionality to assist in automated reporting to public health agencies. This approach is intended to provide an efficient and scalable rapid antigen home testing solution.
"Testing at home before going out into the public is a critical safeguard to help stop the spread of COVID-19," said Dave Hickey, president of Life Sciences for BD. "BD and Scanwell Health are bringing the best of our innovations together to develop a reliable test with a convenient and simple user experience. We see the development of an at-home lateral flow rapid antigen test as a complementary solution to our best-in-class BD Veritor™ system."
Stephen Chen, founder and CEO of Scanwell Health said, "Partnering with an industry leader like BD creates a unique opportunity to help millions of people test for the SARS-CoV-2 virus from the safety and comfort of their homes. Scanwell's innovative computer vision technology closely mirrors that of point-of-care and laboratory diagnostic systems. We're excited to leverage our experience in building FDA-cleared apps to bring this solution to market."
BD has been on the forefront of the COVID-19 response providing innovative solutions for immunology research, molecular- and antigen-based diagnostics, devices that aid in therapeutics and injection devices for vaccine administration.
About BD Veritor™ Plus System for Rapid Detection of SARS-CoV-2
The BD Veritor™ Plus System for Rapid Detection of SARS-CoV-2 Assay has not been cleared or approved by FDA. The test has been authorized by FDA under an EUA for use by authorized laboratories. The test has been authorized only for the detection of proteins from SARS-CoV-2, not for any other viruses or pathogens; and, the test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner. For more information on the BD Veritor™ system, please visit bdveritor.com
About BD
BD is one of the largest global medical technology companies in the world and is advancing the world of health by improving medical discovery, diagnostics and the delivery of care. The company supports the heroes on the frontlines of health care by developing innovative technology, services and solutions that help advance both clinical therapy for patients and clinical process for health care providers. BD and its 70,000 employees have a passion and commitment to help enhance the safety and efficiency of clinicians' care delivery process, enable laboratory scientists to accurately detect disease and advance researchers' capabilities to develop the next generation of diagnostics and therapeutics. BD has a presence in virtually every country and partners with organizations around the world to address some of the most challenging global health issues. By working in close collaboration with customers, BD can help enhance outcomes, lower costs, increase efficiencies, improve safety and expand access to health care. For more information on BD, please visit bd.com or connect with us on LinkedIn at www.linkedin.com/company/bd1/ and Twitter @BDandCo.
About Scanwell Health
Scanwell Health empowers health care consumers and companies through at-home medical testing with instant results. Scanwell pairs proven diagnostics with patented computer vision technology to put testing into the hands of people, enabling quick detection of acute illnesses and convenient monitoring of chronic diseases. The company is the first and only to receive FDA 510(k) clearance for an over-the-counter diagnostic smartphone application. Learn more at scanwellhealth.com.
Reference: https://news.bd.com/2021-02-22-BD-Announces-Collaboration-for-At-Home-Rapid-Test-for-COVID-19
Luminex Receives BARDA Funding to Support Development and Validation of Test Combining SARS-CoV-2 and Flu/RSV Respiratory Panel
19 February 2021 - ARIES® Assay will simultaneously detect influenza A/B, RSV, and SARS-CoV-2 in a single test, and could help accelerate testing and reduce supply pressures
AUSTIN, Texas, Feb. 19, 2021 -- Luminex Corporation today announced that it has received $11.3 million in funding from the Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response at the U.S. Department of Health and Human Services. These funds will support the rapid development and validation of a respiratory panel combining Flu A/B & respiratory syncytial virus (RSV) targets with the SARS-CoV-2 target that can be run on all ARIES® Systems. These 6- and 12-cassette systems are automated molecular diagnostic platforms used in moderate- and high-complexity labs with a number of FDA cleared tests already available for use on them. The systems produce results in less than two hours with minimal hands-on time required.
Clinical labs already challenged by continued COVID-19 testing are now under additional pressure to simultaneously meet the testing demand associated with seasonal flu and RSV, whenever these pathogens are in circulation at the same time. These respiratory illnesses can cause symptoms similar to COVID-19, making it difficult for physicians to distinguish between them. A single test that can simultaneously detect these pathogens would allow clinical labs to get more complete answers quickly, while using fewer reagents and other consumables, easing pressure on an already stressed supply chain.
"We believe that this targeted multiplex assay will play a pivotal role in helping healthcare professionals efficiently and effectively manage individuals with respiratory illness symptoms for years to come," said Nachum "Homi" Shamir, Chairman, President and CEO of Luminex. "We are grateful to BARDA for its continued support as we seek to streamline respiratory testing with a single assay for the most common pathogens. This will allow laboratories, most of which are already operating in resource-constrained environments, to run one test instead of two or more without sacrificing clinical results."
Luminex developed the original ARIES® SARS-CoV-2 (EUA) Assay with financial support from BARDA in 2020.
Luminex will submit the targeted multiplex respiratory panel, the ARIES® Flu A/B & RSV+SARS-CoV-2 Assay, to the FDA for Emergency Use Authorization as soon as possible, and eventually plans to submit the panel for 510(k) clearance as well.
About Luminex Corporation
At Luminex, our mission is to empower labs to obtain reliable, timely, and actionable answers, ultimately advancing health. We offer a wide range of solutions applicable in diverse markets including clinical diagnostics, pharmaceutical drug discovery, biomedical research, genomic and proteomic research, biodefense research, and food safety. We accelerate reliable answers while simplifying complexity and deliver certainty with a seamless experience. To learn more about Luminex, please visit us at luminexcorp.com. To learn more about Luminex's COVID-19 Testing and Research Solutions, please visit: https://www.luminexcorp.com/solutions/.
First shipments to US of Genedrive® 96 SARS-CoV-2 Kit
17 February 2021
17 February 2021 -- genedrive plc, the near patient molecular diagnostics company, announces the first shipments to the United States of its Genedrive® 96 SARS-CoV-2 Kits. Following the Company’s announcement on 28th January 2021 confirming genedrive’s distribution agreement with Beckman Coulter Life Sciences (“Beckman Coulter”), genedrive can confirm that it has completed its commercial and technical training with the Beckman Coulter sales representatives and has now shipped its first 96 SARS-CoV-2 Kits to the USA. This shipment will allow Beckman Coulter to commence initial sales activities and prepare the market for wider commercial rollout. This shipment coincides with the formal launch of the Genedrive® 96 SARS-CoV-2 Kit by Beckman Coulter today.
To learn more about the partnership or to request a quote, Beckman Coulter customers can visit: https://www.beckman.com/reagents/genomic/viral-detection/genedrive-96-sars-cov-2
David Budd, CEO of genedrive plc, said: “This is an important milestone for genedrive as the first shipments of our Genedrive 96 SARS-CoV-2 Kit are exported to the US. We are very optimistic about the US market for Covid PCR testing and it has market drivers that are favorable to the adoption of the genedrive assay: efficiency, ease of use, automation friendly, and scalability.”
Reference: https://www.genedrive.com/news/index.php
Labcorp Adds High Sensitivity Antigen Test to Screen for Active COVID-19 Infection
17 February 2021 - Antigen Test Is the Latest Offering by Labcorp to Fight COVID-19 at Every Stage, from Diagnostic Testing to Clinical Trials and Vaccination Services
BURLINGTON, N.C., Feb. 17, 2021 -- Labcorp, a leading global life sciences company, today announced the availability of a new laboratory-based antigen test that will help doctors determine if an individual is actively infected with COVID-19.
Developed by DiaSorin, the antigen test is available to patients through a doctor’s order and allows for testing to determine if individuals are still infected with and could spread COVID-19. The test is performed by a doctor or other healthcare provider using a nasal or nasopharyngeal swab to collect a sample and is then picked up and processed by Labcorp. Results are available on average within 24-48 hours from time of pick up.
“This new high-sensitivity antigen test is another example of Labcorp’s commitment to providing people with the information they need to make important health decisions,” said Dr. Brian Caveney, chief medical officer and president, Labcorp Diagnostics. “PCR tests are still considered the gold standard in diagnosing COVID-19, as they are able to detect the smallest traces of the virus. However, an antigen test is an additional tool to help individuals know if they could still be carrying the virus or if they are safe to resume work and life activities.”
According to the Centers for Disease Control and Prevention (CDC), antigen tests can be used in a variety of testing strategies to respond to the COVID-19 pandemic and are helpful in determining whether a person diagnosed with COVID-19 remains infectious.
Labcorp continues to recommend that individuals follow health guidelines, including wearing a mask in public, socially distancing, frequently washing hands and avoiding large groups, and receiving a COVID-19 vaccine as availability increases and the CDC guidance expands to more eligible groups. For more information about Labcorp’s COVID-19 response and testing options, visit Labcorp’s COVID-19 microsite.
The DiaSorin LIAISON® SARS-CoV-2 Ag antigen test has been made available to the U.S. market following notification to the U.S. Food and Drug Administration (FDA) on October 26, 2020 pursuant to the FDA’s Policy for Diagnostic Tests for Coronavirus Disease-2019 during the Public Health Emergency (Revised) and published May 11, 2020.
About Labcorp
Labcorp is a leading global life sciences company that provides vital information to help doctors, hospitals, pharmaceutical companies, researchers, and patients make clear and confident decisions. Through our unparalleled diagnostics and drug development capabilities, we provide insights and accelerate innovations to improve health and improve lives. With over 75,000 employees, we serve clients in more than 100 countries. Labcorp reported revenue of $14 billion in FY2020. Learn about Labcorp at www.Labcorp.com.
FDA Grants Emergency Use Authorization for New COVID-19, Flu A, Flu B Combo Kit
16 February 2021 - One multiplex real-time PCR diagnostic kit can simultaneously detect and differentiate SARS-CoV-2, influenza A and influenza B
CARLSBAD, Calif., Feb. 16, 2021 -- The U.S. Food and Drug Administration (FDA) has granted emergency use authorization (EUA) for the Applied Biosystems TaqPath COVID-19, Flu A, Flu B Combo Kit from Thermo Fisher Scientific, the company announced today.
The TaqPath COVID-19, Flu A, Flu B Combo Kit is a real-time PCR test for the detection and differentiation of RNA from the SARS-CoV2, influenza A and influenza B viruses in nasopharyngeal and nasal swabs.
"Understanding that the flu season would overlap with surges in COVID-19 infections, Thermo Fisher worked rapidly to develop a new multiplex real-time PCR diagnostic kit for detecting and differentiating SARS-CoV-2, influenza A and influenza B. These are illnesses which can present with similar clinical symptoms, but for which patient management, including quarantining measures, greatly differs," said Mark Smedley, president of Genetic Sciences for Thermo Fisher Scientific. Thermo Fisher. "This new kit offers clinical and public health laboratories a single test to help diagnose and monitor the spread of COVID-19 and the flu."
The TaqPath COVID-19, Flu A, Flu B Combo Kit helps labs expand their existing COVID-19 testing menu for respiratory samples while maintaining low operational costs and workflow simplicity. The kit includes Applied Biosystems Pathogen Interpretive Software to automatically convert genetic analysis data into a readable report, helping reduce risk of user interpretation error. For more information on the kit, visit thermofisher.com/covid19flu.
Testing with the TaqPath COVID-19, Flu A, Flu B Combo Kit is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. 263a, to perform high-complexity tests, or by similarly qualified non-U.S. laboratories.
The TaqPath COVID-19, Flu A, Flu B Combo Kit has not been FDA cleared or approved and is only authorized for the duration of the EUA granted under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.
About Thermo Fisher Scientific
Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $30 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, improving patient diagnostics and therapies or increasing productivity in their laboratories, we are here to support them. Our global team of more than 80,000 colleagues delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services and Patheon. For more information, please visit www.thermofisher.com.
Two COVID-19 Nucleic Acid Detection Kits of BGI Get CE Mark
10 February 2021
10 February 2021 -- BGI Genomics announces its Rapid Identification Kit for B.1.1.7 lineage (N501Y and P681H) of SARS-CoV-2 (ARMS-PCR = amplification refractory mutation system-polymerase chain reaction) and Rapid Nucleic Acid Detection Kit for 2019-nCoV (PCR fluorescent probe method) have been CE marked. Both kits are manufactured by BGI PathoGenesis Pharmaceutical Technology Co. Ltd., a subsidiary of BGI Genomics.
The Rapid Identification Kit is a qualitative in vitro nucleic acid amplification assay to identify the B.1.1.7 lineage (N501Y and P681H) of SARS-CoV-2 in throat swab specimens or sputum that have been confirmed by RT-PCR to be SARS-CoV-2 positive. The kit will be able to identify mutant strains quickly and effectively, thus facilitating the global pandemic prevention and control.
The second kit obtaining the CE mark this time is the Rapid Nucleic Acid Detection Kit for 2019-nCoV (PCR fluorescent probe method). Compared with the kit which got CE mark last April, the new detection kit follows an optimized reaction procedure and can assist healthcare
and medical institutions in different countries to effect timely and effective prevention in a shorter period of time.
In December 2020, the United Kingdom reported a new strain of SARS-CoV-2 lineage B.1.1.7, with data indicating that the new variant was highly infectious. The World Health Organization has recommended all countries should increase surveillance of new variants of COVID-19 to better understand the spread of the virus.
To date, BGI’s COVID-19 detection reagent has covered the nucleic acid detection kit, the antibody detection kit, the antigen detection kit and the mutant identification kit, which can meet the clinical needs of different applications.
Reference: https://www.bgi.com/global/company/news/two-covid-19-nucleic-acid-detection-kits-of-bgi-get-ce-mark/
Forscher haben Virus-Mutationen im Blick (MDR)
10 February 2021 - Video-Beitrag der MDR mit Dr. Martin Roskos, CMO der SYNLAB Deutschland zu Coronavirus-Mutationen
10 February 2021 -- Das Coronavirus mutiert 23 Mal pro Jahr. Bisher bereiten Varianten aus Brasilien, Großbritannien und Südafrika große Sorgen. Um sie schneller zu lokalisieren, werden seit Januar mehr Abstriche auf Mutationen untersucht. Sehen Sie jetzt den aktuellen Video-Beitrag der MDR mit Dr. Martin Roskos, CMO der SYNLAB Deutschland.
Reference: https://www.synlab.de/human/news-artikel/forscher-haben-virus-mutationen-im-blick-mdr-1334
Thermo Fisher Scientific Partners with Mindray on Clinical Chemistry Analyzers for use with Drugs of Abuse Immunoassays
9 February 2021
FREMONT, Calif., Feb. 9, 2021 -- Thermo Fisher Scientific, the world leader in serving science, today announced a partnership with Mindray, a leading global developer, manufacturer and supplier of medical devices, to make available to customers two clinical chemistry analyzers in the United States (U.S.) and Canada for drug screening in clinical and drug court laboratories.
"Systematically and reliably testing for drugs of abuse is key to helping addicted individuals rehabilitate, ensuring prescribed drugs are not abused and ultimately, helping to combat this crisis," said Stefan Wolf, president of the clinical diagnostics business at Thermo Fisher Scientific. "Through this exclusive partnership with Mindray we are able to address the needs of our customers in commercial labs, hospitals and the criminal justice field. Now we can better cater to the needs of those laboratories seeking to expand or increase their testing volumes, and laboratories working to consolidate and centralize their testing sites with these two medium- to high-throughput instruments."
To provide access to drug testing, Thermo Fisher and Mindray have entered into an agreement to offer the FDA-cleared and Health Canada–approved BS-480 (400 tests/hour) and BA-800M (800 tests/hour) analyzers to toxicology labs. Thermo Fisher will also provide an extensive menu of wet lab–validated Thermo Scientific DRI and CEDIA drugs of abuse immunoassay reagents with the instruments to enable the screening of urine samples for the presence of a given drug or a class of drugs.
Taken together, the world-class DRI and CEDIA drugs of abuse immunoassay reagents, validated on Mindray's instruments, bring a combination of performance and reliability from a single source in a cost-effective, plug-and-play solution. The solution streamlines the drug screening workflow and automates it to reduce risk of human error. The instruments also come with onboard software that has many advanced features, including sample/reagent probe collision protection, sample aggregate detection and a five-minute daily push-button self-service maintenance program.
Thermo Fisher began distributing, installing, training and servicing Mindray BS-480 and BA-800M instruments in the U.S. and Canada last month.
About Thermo Fisher Scientific
Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $30 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, improving patient diagnostics and therapies or increasing productivity in their laboratories, we are here to support them. Our global team of more than 80,000 colleagues delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services and Patheon. For more information, please visit www.thermofisher.com.
Siemens Healthineers and Sysmex Extend Hemostasis Agreement
9 February 2021 - Together, the companies will continue to provide one of the largest portfolios of hemostasis testing systems and reagents that caters to laboratories' diverse needs. As part of the agreement Siemens Healthineers will distribute the new Sysmex CN Systems.
Erlangen, Germany, 9 February 2021 -- Siemens Healthineers and Sysmex Corporation announced the renewal of the companies' long-standing global supply, distributorship, sales and service agreement for a broad portfolio of hemostasis products including a multi-year extension. Additionally, the companies’ agreement includes the future distribution of Sysmex's CN-Series automated blood coagulation analyzers, the CN-3000 and CN-6000, by Siemens Healthineers bringing the next generation of fully-automated solutions for mid- and high-volume coagulation testing to laboratories. The companies plan for Siemens Healthineers to start commercialization of the Sysmex CN Systems in various countries later this year.
A broad menu of both routine and specialty coagulation assays from Siemens Healthineers can be performed on these newest additions to the Sysmex family portfolio of hemostasis analyzers, which offer laboratories a compact and comprehensive hemostasis testing solution. The Sysmex CN Systems are designed to integrate with Atellica® Data Manager and Aptio® Automation to further streamline hands-free workflow and to automate sample processing, including sample preparation as well as storage, refrigeration and retrieval, if needed.
"Siemens Healthineers and Sysmex have built a solid hemostasis partnership for more than 25 years since initially signing the global alliance agreement in 1995," said Deepak Nath, PhD, President of Laboratory Diagnostics for Siemens Healthineers. "Together we are able to deliver both quality and comprehensive hemostasis testing solutions to laboratories of all sizes across the world."
Siemens Healthineers and Sysmex provide hemostasis products used to test for blood clotting disorders, preoperative bleeding risk management, and the monitoring of patients on anticoagulant therapy medications.
About Siemens Healthineers AG
Siemens Healthineers AG is shaping the future of Healthcare. As a leading medical technology company headquartered in Erlangen, Germany, Siemens Healthineers enables healthcare providers worldwide through its regional companies to increase value by empowering them on their journey towards expanding precision medicine, transforming care delivery, improving the patient experience, and digitalizing healthcare. Siemens Healthineers is continuously developing its product and service portfolio, with AI-supported applications and digital offerings that play an increasingly important role in the next generation of medical technology. These new applications will enhance the company’s foundation in in-vitro diagnostics, image-guided therapy, and in-vivo diagnostics. Siemens Healthineers also provides a range of services and solutions to enhance healthcare providers’ ability to provide high-quality, efficient care to patients. In fiscal 2020, which ended on September 30, 2020, Siemens Healthineers, which has approximately 54,000 employees worldwide, generated revenue of €14.5 billion and adjusted EBIT of €2.2 billion. Further information is available at www.siemens-healthineers.com.
Reference: https://www.siemens-healthineers.com/press-room/press-releases/partnerschaft-sysmex
Thermo Fisher Scientific Launches CE-IVD-Marked High Throughput COVID-19 Diagnostic Assay for Use On Its Automated Amplitude Platform
8 February 2021 - Applied Biosystems TaqPath COVID-19 High Throughput Combo Kit also receives Interim Order Authorization from Health Canada
CARLSBAD, Calif., Feb. 8, 2021 -- Thermo Fisher Scientific, the world leader in serving science, today launched its CE-IVD-Marked, Applied Biosystems TaqPath COVID-19 HT Kit that is compatible with the Amplitude platform. The high-throughput solution enables clinical and public health laboratories to efficiently test up to 8,000 COVID-19 samples a day with fewer staffing requirements and a reliable supply of kits, reagents and consumables.
The highly automated Amplitude platform is a molecular diagnostic system that allows labs to increase their COVID-19 testing capacity by combining Thermo Fisher's extraction and real-time PCR instruments with liquid handling products from Tecan Group. The system leverages a high-throughput version of Thermo Fisher's TaqPath COVID-19 CE-IVD RT-PCR Kit, which received CE-IVD Mark in March 2020.
The high throughput diagnostic assay, compatible with the Amplitude platform, also received Interim Order Authorization from Health Canada on January 21. Thermo Fisher has secured a contract with a large provincial authority in Canada for Amplitude systems to help fight the pandemic.
"Accurate and reliable testing that can scale is essential in addressing the spread of any disease, especially COVID-19," said Mark Smedley, president of the genetic sciences business of Thermo Fisher Scientific. "The Amplitude platform embodies our goal of empowering public health and clinical lab professionals to generate accurate results at higher volumes and use them to make informed health care decisions that lead to the management of a pandemic that is still raging around the world."
With the Amplitude platform, customers receive a reliable supply agreement and up-front monthly delivery of reagents to ensure that COVID-19 testing needs are met. Thermo Fisher now has capacity to produce more than 20 million tests per week and continues to work closely with laboratories, governments, academic institutions and other stakeholders to ensure each has a reliable supply of tests and materials.
About Thermo Fisher Scientific
Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $30 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, improving patient diagnostics and therapies or increasing productivity in their laboratories, we are here to support them. Our global team of more than 80,000 colleagues delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services and Patheon. For more information, please visit www.thermofisher.com.
FDA grants Breakthrough Device Designation for Roche's Elecsys Growth Differentiation Factor-15 (GDF-15) assay to help identify patients suitable for innovative treatment addressing unintentional weig
8 February 2021 - FDA BDD acknowledges the importance of GDF-15 testing in identifying eligible cachexic patients with solid tumours to be treated with Pfizer's investigational drug PF-06946860. Unintentional weight loss (cachexia) is a highly prevalent complication of cancer, affecting more than half of all cancer patients worldwide, potentially leading to significant functional impairment and increased risk of death. Successful cachexia treatment can potentially contribute to improved cancer treatment worldwide.
Basel, 8 February 2021 -- Roche announced today that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation to their Elecsys® GDF-15 assay as a companion diagnostic (CDx) in cancer treatment. This in vitro diagnostic immunoassay is intended for measurement of Growth Differentiation Factor-15 (GDF-15) in cachectic patients 18 years of age and older with solid tumours for treatment with Pfizer Inc.'s investigational drug PF-06946860.
Cachexia is a metabolic disorder and comorbidity that occurs with several chronic diseases including cancer, heart failure, chronic obstructive pulmonary disease (COPD), and chronic kidney disease (CKD). It impacts more than 30 million people globally. Cachexia manifests as marked involuntary body weight loss, muscle atrophy, and reduced appetite, progressing to significant functional impairment and increased risk of death. Elevated GDF-15 is associated with cachexia in cancer patients. Cachexia is a highly prevalent complication of cancer, affecting between 50 to 80% of all cancer patients. This range depends on the tumour type, the patient response to tumour progression and on individual body type.
“We are pleased to partner with Pfizer to address this unmet medical need in oncology through strong companion diagnostics”, said Thomas Schinecker, CEO Roche Diagnostics. “The FDA BDD grant for the Elecsys GDF-15 assay shows the importance of these strong partnerships. The ability to detect elevated GDF-15 in patients who are experiencing weight loss may provide a precision-medicine approach to identifying patients likely to respond to a GDF-15 therapeutic treatment.”
About Elecsys GDF-15
Elecsys GDF-15 is a quantitative serologic, two-incubation step electrochemiluminescence immunoassay (ECLIA) using the sandwich test format for the detection of GDF-15 in human serum. The Elecsys GDF-15 assay is indicated as an aid in identifying cachectic patients 18 years of age and older with solid tumours for treatment with PF-06946860. The electrochemiluminescence immunoassay “ECLIA” is intended for use on cobas e immunoassay analyzers. GDF-15 has CE approval in several intended uses in cardiology including risk prediction of major bleeding events of atrial fibrillation patients, risk stratification of patients with acute coronary syndrome or chronic heart failure.
About Cachexia
Cachexia impacts more than 30 million people globally but is poorly understood due to its complexity. It has traditionally been seen as a complication of chronic diseases or end stages of cancer. The burden cachexia poses on patients, their caregivers and loved ones, as well as the healthcare system, is significant. Cancer cachectic patients experience numerous complications including, but not limited to, reduced effectiveness of chemotherapy, reduced mobility and reduced functionality of muscle-dependent systems, such as the respiratory and cardiovascular systems, leading to decreased quality of life and survival.
About Roche
Roche is a global pioneer in pharmaceuticals and diagnostics focused on advancing science to improve people’s lives. The combined strengths of pharmaceuticals and diagnostics under one roof have made Roche the leader in personalised healthcare – a strategy that aims to fit the right treatment to each patient in the best way possible.
Roche is the world’s largest biotech company, with truly differentiated medicines in oncology, immunology, infectious diseases, ophthalmology and diseases of the central nervous system. Roche is also the world leader in in vitro diagnostics and tissue-based cancer diagnostics, and a frontrunner in diabetes management.
Founded in 1896, Roche continues to search for better ways to prevent, diagnose and treat diseases and make a sustainable contribution to society. The company also aims to improve patient access to medical innovations by working with all relevant stakeholders. More than thirty medicines developed by Roche are included in the World Health Organization Model Lists of Essential Medicines, among them life-saving antibiotics, antimalarials and cancer medicines. Moreover, for the twelfth consecutive year, Roche has been recognised as one of the most sustainable companies in the Pharmaceuticals Industry by the Dow Jones Sustainability Indices (DJSI).
The Roche Group, headquartered in Basel, Switzerland, is active in over 100 countries and in 2020 employed more than 100,000 people worldwide. In 2020, Roche invested CHF 12.2 billion in R&D and posted sales of CHF 58.3 billion. Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan. For more information, please visit www.roche.com.
Reference: https://www.roche.com/media/releases/med-cor-2021-02-08.htm
Dev Kurdikar Named President of BD Diabetes Care
8 February 2021
FRANKLIN LAKES, N.J., Feb. 8, 2021 – BD (Becton, Dickinson and Company), a leading global medical technology company, today announced the appointment of Dev Kurdikar, 52, to the position of worldwide president, BD Diabetes Care, effective Feb. 10.
In his new role, Kurdikar will have responsibility for driving global strategic, operational and commercial performance across a portfolio of solutions that aims to minimize the burdens and complications for people with diabetes.
“Dev has spent his career in the health care industry, in roles that have spanned operations, finance, strategy and general management,” said Alberto Mas, executive vice president and president of the BD Medical Segment. “This cross functional experience, coupled with a hands-on and authentic leadership style, has enabled him to build high-performing teams and a winning culture. His bold and strategic approach and the demonstrated ability to iterate, try new things and embrace change make him well suited to lead the Diabetes Care business.
Most recently, Kurdikar served as CEO and president for Cardiac Science, a global manufacturer of automated external defibrillators (AEDs). Previously, he was the general manager for the men’s health business within American Medical Systems (AMS) and held positions of increasing responsibility and leadership with Baxter, including vice president of the Infusion Systems business in the U.S. and vice president of Marketing/Strategy for enterprise-wide commercial initiatives.
Kurdikar earned an MBA with an emphasis in Finance & Strategy from Washington University in Missouri and a Ph.D. in Chemical Engineering from Purdue University in Indiana. He is currently a member of the Board of Directors of LMG Holdings.
About BD
BD is one of the largest global medical technology companies in the world and is advancing the world of health by improving medical discovery, diagnostics and the delivery of care. The company supports the heroes on the frontlines of health care by developing innovative technology, services and solutions that help advance both clinical therapy for patients and clinical process for health care providers. BD and its 70,000 employees have a passion and commitment to help enhance the safety and efficiency of clinicians' care delivery process, enable laboratory scientists to accurately detect disease and advance researchers' capabilities to develop the next generation of diagnostics and therapeutics. BD has a presence in virtually every country and partners with organizations around the world to address some of the most challenging global health issues. By working in close collaboration with customers, BD can help enhance outcomes, lower costs, increase efficiencies, improve safety and expand access to health care. For more information on BD, please visit bd.com.
Reference: https://news.bd.com/2021-02-08-Dev-Kurdikar-Named-President-of-BD-Diabetes-Care
Sysmex and Siemens Healthineers Extend Long-standing Global Alliance in Hemostasis Testing
3 February 2021
3 February 2021 -- Sysmex Corporation (HQ: Kobe, Japan; Chairman and CEO: Hisashi Ietsugu) and Siemens Healthcare Diagnostics Inc. (HQ: NY, U.S.A.; hereinafter, "Siemens Healthineers") today announced that, on February 2, 2021, the two companies agreed to extend their long-standing alliance on global supply, distribution, and sales and service for hemostasis products through at least 2023. The agreement enables global laboratory customers to continue to benefit from the world’s largest portfolio of hemostasis systems and reagents.
For more than 20 years since signing the global alliance agreement on hemostasis products in 1995, the two companies have built a solid partnership. The extension of the agreement will continue to allow Sysmex and Siemens Healthineers to mutually supply hemostasis systems and reagents, respectively, on a global basis, thus achieving the world’s most extensive product portfolio that caters to laboratory customers' diverse needs.
The renewed agreement contains a partial review of the list of products and territories for mutual supply. Sysmex hopes that it will reinforce the sales of Sysmex's CN-Series automated blood coagulation analyzer and allow the two companies to maintain the proven cooperative framework to offer ample solutions for hemostasis testing to customers the world over.
Sysmex and Siemens Healthineers will continue to harness each other's strengths to expand the hemostasis business, with a view toward contributing to the standardization and enhanced quality of hemostasis testing.
Quidel opens new manufacturing facility to mass produce QuickVue® rapid antigen tests for COVID-19
3 February 2021 - Carlsbad, CA facility aims to reach a run rate of 600 million QuickVue® tests per year by end of 2021. Future plans call for production of numerous popular QuickVue® diagnostic tests to serve the emerging at-home testing market,
SAN DIEGO, 3 February 2021 -- Quidel Corporation (“Quidel”), a leading provider of rapid diagnostic testing solutions, cellular-based virology assays and molecular diagnostic systems, today announced the opening of a new manufacturing facility in Carlsbad, CA that will be dedicated to the production of Quidel’s popular QuickVue® line of products. The 128,000 square-foot facility will be the company’s highest-volume production plant in the world and begins operations in the second half of 2021 with a mission to produce 600 million QuickVue® SARS rapid antigen tests per year for the detection and diagnosis of COVID-19 infections.
Quidel plans to install multiple manufacturing lines at the Carlsbad facility and hire approximately 400 new employees with a mission to scale Quidel’s operations from 50 million QuickVue® tests per year to 50 million tests per month at full capacity, including non-COVID-19 diagnostic assays currently in-market or under development. The company is actively hiring to fill open positions including engineers, chemists, technicians, manufacturing, purchasing, sourcing and support services.
“From the first days of the pandemic, Quidel has stepped up to meet the COVID-19 challenge head-on with innovative diagnostic technologies to detect coronavirus infections and expanded manufacturing to democratize access to affordable and high-quality testing,” said Douglas Bryant, president and CEO of Quidel Corporation. “The opening of our massive new QuickVue® manufacturing plant is our boldest move yet and is expected to provide Quidel with the scale necessary to serve the needs of communities and institutions for frequent testing now and for years to come.”
Quidel received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) for its QuickVue® SARS Antigen Test for COVID-19 in December. The company’s QuickVue® lateral-flow technology is visually read by the user and provides results in 10 minutes from nasal swab samples. Initial applications for QuickVue® COVID-19 tests range from hospitals and physician offices to schools and pharmacies. Quidel is seeking EUA for a new QuickVue® At-Home COVID-19 Test for over-the-counter sale directly to consumers.
Quidel’s new QuickVue® SARS Antigen test offers excellent performance for the detection of SARS-CoV-2, with positive results agreeing with PCR 96.6% of the time and negative results agreeing 99.3% of the time, thereby providing quick, reliable results to patients, their families and healthcare workers alike.
In the professional segment, Quidel has manufactured the QuickVue® line for over 30 years. Quidel was the first company to introduce a visually read flu test, the QuickVue® Influenza A/B Test, which received FDA approval in September of 1999. QuickVue® was also the first flu test cleared by the FDA for use in CLIA-Waived point-of-care facilities like doctors’ offices, urgent care clinics and pharmacies.
Today, Quidel’s QuickVue® diagnostic products that test for Influenza, RSV, Strep A, fecal occult blood, pregnancy, chlamydia, infectious mononucleosis, adenoviral conjunctivitis and H. pylori. Over the years, more than 150 million QuickVue® diagnostic testing units have been sold.
To learn more about our available positions, please visit: https://careers.quidel.com/
Background Information:
Throughout this pandemic, Quidel has been at the forefront of diagnostic innovation. From the company’s Lyra® PCR tests, to its Sofia® rapid antigen tests for COVID-19, to its Sofia® “ABC” combination test for the Influenza A+B and coronavirus, to its QuickVue SARS-CoV-2 test authorized for emergency use by the FDA in December, Quidel has significantly advanced the science and the scale of its operations.
Quidel was the first company to receive EUA from the FDA for a rapid point-of-care antigen test for COVID-19 and remains at the forefront of the battle against the coronavirus pandemic.
Sofia® 2 is Quidel’s best-selling cartridge-based, instrument-read rapid diagnostic system for infectious disease testing, which utilizes fluorescent chemistry design, an intuitive graphical user interface, and optics system to provide a highly accurate, objective and automated result in 15 minutes. The Sofia® 2 system also comes connected to Virena®, Quidel’s data management system, which provides aggregated, de-identified testing data to public health authorities in near real-time.
In 2020, Quidel quickly increased its production of Sofia® rapid antigen tests from approximately 500,000 units per week to a rate of over 2 million tests per week at the end of December. Quidel is building additional production lines with a goal to reach a run-rate of over 240 million Sofia® tests per year by the third quarter of 2021. In 2020, the company also increased the installed base of Sofia® diagnostic instruments to more than 65,000 point-of-care locations.
Quidel’s QuickVue® and Sofia® SARS Antigen test kits are made in the greater San Diego metropolitan area of California.
About Quidel Corporation
Quidel Corporation is a leading manufacturer of diagnostic solutions at the point of care, delivering a continuum of rapid testing technologies that further improve the quality of health care throughout the globe. An innovator for over 40 years in the medical device industry, Quidel pioneered the first FDA-cleared point-of-care test for influenza in 1999 and was the first to market a rapid SARS-CoV-2 antigen test in the U.S. Under trusted brand names Sofia®, Solana®, Lyra®, Triage® and QuickVue®, Quidel’s comprehensive product portfolio includes tests for a wide range of infectious diseases, cardiac and autoimmune biomarkers, as well as a host of products to detect COVID-19. With products made in America, Quidel’s mission is to provide patients with immediate and frequent access to highly accurate, affordable testing for the good of our families, our communities and the world. For more information about Quidel, visit quidel.com.
bioMérieux announces the CE marking of NEPHROCHECK® test on VIDAS®
3 February 2021
Marcy l’Etoile, France, February 3rd , 2021 – bioMérieux, a world leader in the field of in vitro diagnostics, today announced the CE marking of the innovative NEPHROCHECK® assay to detect kidney stress in patients at risk of acute kidney injury (AKI).
AKI is a common complication, affecting between 7 and 18% of all hospitalized patients and up to 50% of critically ill patients. The condition is associated with a 10-fold increase in hospital mortality and a higher rate of chronic kidney disease among post-op patients.
While a number of acute risk factors and patient characteristics have been identified which predispose patients to AKI, there is no reliable way for a clinician to establish a clear risk profile for any given patient. Delays in recognizing AKI can potentially lead to irreversible consequences. In many cases, adverse patient outcomes are avoidable if the condition is identified and managed in a timely fashion.
About NEPHROCHECK®
NEPHROCHECK® is an innovative test that detects kidney stress prior to actual damage, when a timely intervention can still make a difference. It is intended to be used in conjunction with clinical evaluation as an aid to support the risk assessment of moderate or severe AKI in acutely ill patients. With this early information, clinicians may either rule out kidney stress with confidence, or implement a series of protective measures for the kidneys.
The NEPHROCHECK® test relies on the detection of 2 innovative urinary biomarkers: TIMP-2 (tissue inhibitor of metalloproteinases-2) and IGFBP-7 (insulin-like growth factor-binding protein 7). Both proteins are produced by stressed kidney cells as an early warning signal, before the onset of AKI. Specific to kidney stress, they are not affected by any of the usual co-morbidities (such as sepsis, trauma, chronic kidney disease or cancer).
“As a predictive tool for AKI, NEPHROCHECK ® provides clinicians with high medical-value information and can lead to benefits in patient care and improved outcomes. The development of this test is consistent with our focus on improving care for individuals with acute medical and critical conditions. It complements our existing pioneering assays for these patients, such as procalcitonin (PCT),” said Mark Miller, Executive Vice President and Chief Medical Officer, bioMérieux.
“Considering the proportion of patients affected each year, AKI represents a significant burden on the functioning of intensive care units and has a huge economic impact on healthcare systems. Innovative assays like NEPHROCHECK® not only contribute to improved patient outcomes but could potentially help optimize hospital costs,” said Pierre Boulud, Chief Operating Officer, Clinical Operations of bioMérieux.
Effective immediately, VIDAS® NEPHROCHECK® is available in key European markets and will gradually be deployed in countries that recognize CE marking. Hospitals and private laboratories will be able to run the tests on bioMérieux’s VIDAS® 3 system, which allows for higher throughput, automation and traceability. bioMérieux is planning a submission for FDA clearance in the near future.
ABOUT VIDAS®
Launched 30 years ago, VIDAS® has transformed the field of immunoassays offering laboratories universal access to a simple, automated and robust technology providing fast and safe results. Today, VIDAS® is still the most widely used immunoassay system in clinical laboratories worldwide.
The VIDAS® menu comprises over 100 parameters, covering a wide range of pathologies, including infectious diseases and chronic diseases, as well as a range of tests dedicated to emergency and critical care. A number of these parameters are part of the bioMérieux full solution to address the global challenges of antimicrobial resistance (AMR) and sepsis. As it enters into its fourth decade, VIDAS® remains a major focus of the bioMérieux immunoassay strategy with ongoing research into new parameters and frequent launches that create value for labs and clinicians, ultimately bringing benefits for patients.
Reference: https://www.biomerieux.com/en/biomerieux-announces-ce-marking-nephrocheckr-test-vidasr
Sysmex establishes new subsidiary in Portugal
3 February 2021 - Increasing portuguese market presence by enhancing sales and after-sales support networks
3 February 2021 -- Sysmex Corporation (HQ: Kobe, Japan; Chairman and CEO: Hisashi Ietsugu) announced today the establishment of a new subsidiary, Sysmex Portugal, S.A. Going forward, Sysmex aims to increase its market presence by enhancing its sales and after-sales support networks in the country.
Since the 1979 creation of its public healthcare system, Portugal has maintained universal health insurance coverage, and its IVD market currently ranks 12th among European countries.1 Its per capita annual healthcare expenses are high, and demand for new testing in the life science field and elsewhere is expected to grow.
Sysmex first expanded to foreign markets in the early 1970s and, since establishing a UK subsidiary in 1991, has built direct sales and after-sales support networks outside of Japan. Now, 58 overseas affiliates (as of October 2020) deliver Sysmex products to over 190 countries and regions worldwide.
By building stable and long term relationships with customers, Sysmex hopes to develop insights into the needs of local customers to offer better solutions and to further increase its penetration into the IVD market, including hematology and urinalysis, while also expediting the market introduction of its products and services in the life science field.
Sysmex will remain committed to enhancing its global networks and offering a broad product line and attentive services and support, thus bringing greater trust and confidence to medical professionals.
LGC’s ValuPanel Reagents help public laboratories detect SARS-CoV-2 and influenza
2 February 2021
2 February 2021 -- LGC, Biosearch Technologies today announces the release of a new set of ValuPanel™ Reagents to help the efforts of public health laboratories to detect SARS-CoV-2, influenza A, and influenza B.
The CDC Influenza SARS-CoV-2 (Flu SC2) Multiplex ValuPanel Reagents - which are for research use only and not for use in diagnostic procedures - consists of probes and primers for multiplex RT-PCR detection and allows discrimination of SARS-CoV-2, influenza A, and influenza B from a single patient sample.
Mark Dearden, Managing Director, Genomics, LGC, said, “LGC was one of the first companies to support the initial US public health response to COVID-19, partnering with the CDC to provide oligonucleotides used to support the CDC 2019-nCoV Real-Time PCR Diagnostic Panel. The CDC Flu SC2 Multiplex ValuPanel has been added to our growing line of ValuPanel Reagents, which includes our US CDC 2019-nCoV ValuPanel, the Charité 2019-nCoV BHQ™/BBQ-650™ ValuPanel, and our recently-released Yale 2019-nCoV SalivaDirect™ ValuPanel.”
“In today’s crisis, LGC’s core purpose of Science for a Safer World could not be more relevant and important. We are involved in many aspects of the global response, doing everything we can to accelerate delivery and scale our capacity and output in order to deliver these critical testing supplies and help our customers ramp up their testing capability.”
The ValuPanel Reagents were designed to match the sequences and performance of the probes and primers from the CDC’s Flu SC2 Multiplex Assay, which was granted EUA in July 2020.
Each line of ValuPanel Reagents consists of separately delivered probes and primers, which allow assay flexibility and sizes that can help facilitate scale-up. The full portfolio offers additional components across the PCR workflow, including master mix and enzymes manufactured in an ISO13485-certified facility and extraction reagents.
LGC is the inventor of specific chemistries, such as Black Hole Quencher™ (BHQ™), BlackBerry™ Quencher (BBQ-650™) and other critical dyes and components for diagnostic kit developers. It has previously provided detection solutions for viruses including seasonal influenza, H1N1 (swine flu), Chikungunya, Zika, and Ebola and also has CDC-qualified lots of SARS-CoV-2 probe and primer kits available for sale. Each kit contains enough material for 1,000 reactions, equivalent to 1,000 tests.
LGC’s probes and primers are manufactured and shipped from a facility entirely separate from positive control production to protect the integrity of customer COVID-19 workflows.
Reference: https://www.lgcgroup.com/newsroom-and-blog/news-and-blog/reagents-detect-sars-cov-2-and-influenza/
Roche announces the upcoming launch of the SARS-CoV-2 Rapid Antigen Test Nasal allowing for patient self-collection
1 February 2021 - The SARS-CoV-2 Rapid Antigen Test Nasal uses a nasal swab to quickly and conveniently collect specimens from people suspected of having an active infection Nasal sampling allows for collection of the sample from the front area of the nose instead of the nasopharynx resulting on a less invasive testing experience for patients The test also provides patients with the option to self-collect their nasal sample
Basel, 01 February 2021 -- Roche today announced it has obtained the CE mark for its new SARS-CoV-2 Rapid Antigen Test Nasal. The test will be available in countries accepting the CE mark by mid-February 2021.
In comparison to the existing Roche SARS-CoV-2 Rapid Antigen Test, the SARS-CoV-2 Rapid Antigen Test Nasal collects the sample from the front area of the nose instead of the nasopharynx, resulting in a simplified and faster testing procedure. This testing method can help reduce overall patient discomfort, particularly in sensitive individuals such as children, elderly people and/or people with disabilities.
Besides being less invasive, the test also provides patients with the option to self-collect their nasal sample under the supervision of a healthcare professional. Through reduced physical contact, this method of testing can help to decrease the risk of exposure to the virus for healthcare professionals. Whether the test could also be used without supervision of a healthcare professional will depend on local regulatory requirements.
“Rapid testing continues to play an important role in the fight against COVID-19, especially in places when laboratory testing is not available and quick results are needed, such as nursing homes, healthcare facilities, and schools.” said Thomas Schinecker, CEO Roche Diagnostics. “The SARS-CoV-2 Rapid Antigen Test Nasal provides patients with a more comfortable testing experience.”
The launch is a partnership with SD Biosensor Inc., with whom Roche has also launched a SARS-CoV-2 Rapid Antibody Test in July and a SARS-CoV-2 Rapid Antigen Test in September 2020. SD Biosensor, is currently preparing to submit an Emergency Use Authorisation (EUA) to the U.S. Food and Drug Administration (FDA).
The test is the latest addition to Roche's comprehensive COVID-19 portfolio to support healthcare systems in diagnosing SARS-CoV-2 infection.
About the SARS-CoV-2 Rapid Antigen Test Nasal
The SARS-CoV-2 Rapid Antigen Test Nasal is a rapid chromatographic immunoassay for the qualitative detection of the nucleocapsid protein of SARS-CoV-2 present in human nasal specimens. In clinical studies, the SARS-CoV-2 Rapid Antigen Test Nasal showed a relative sensitivity of 90.6% (Ct value ≤ 30; 95 % CI: 75.0 % - 98.0 %) and a specificity of 98.6% for professionally collected samples. For self-collected samples a sensitivity of 84.4 % (Ct value ≤ 30; 95 % CI: 67.2 % - 94.7 %) and a specificity of 99.2% was detected. Overall the studies contained 468 symptomatic and asymptomatic individuals. This test is intended to detect antigen from SARS‑CoV‑2 in individuals suspected of COVID‑19 or with known or suspected exposure to SARS‑CoV‑2.
About antigen testing
An antigen test detects proteins which are structural or functional components of a pathogen and are thus very specific to that pathogen. In this case, the test would provide a qualitative “yes/no” answer on the presence of the pathogen in the patient sample and can be offered as a rapid strip test that is performed at the point of care. If the target antigen is present in sufficient concentrations in the sample, it will bind to specific antibodies and generate a visually detectable signal on the test strip, typically with results ready in 15 minutes. A rapid antigen test can reliably detect individuals with a high viral load allowing healthcare professionals to quickly identify those patients at greatest risk of spreading the infection.
About Roche’s response to the COVID-19 pandemic
The COVID-19 pandemic continues to evolve globally with varying developments from country to country and we are partnering with healthcare providers, laboratories, authorities and organisations to help make sure that patients receive the tests, treatment and care they need. This new test is an additional step in Roche’s fight against the COVID-19 pandemic, which has already included:
- Launching COVID-19 diagnostic tests for active infection and the detection of antibodies in patients who have been exposed to the virus,
- Investigating treatments from our existing portfolio to better understand their potential to treat patients with COVID-19,
- Increasing manufacturing and supply chain capacity to meet product demand across our portfolio within the wider context of COVID-19 treatment, and
- Ensuring the supply of our existing medicines and diagnostics to patients around the world under exceptional conditions.
Reliable, high-quality testing is essential to help healthcare systems overcome this pandemic. On 13 March 2020 we received FDA Emergency Use Authorisation for a high-volume molecular test to detect SARS-CoV-2, the virus that causes COVID-19, which is also available in countries accepting the CE Mark. On 3 May 2020, Roche announced that its COVID-19 antibody test, aimed at detecting the presence of antibodies in the blood, also received FDA Emergency Use Authorisation and is available in markets accepting the CE mark. Also in June of last year we received an FDA EUA for the Elecsys® IL-6 test to assist in identifying severe inflammatory response in patients with confirmed COVID-19, as well as launching Roche v-TAC, which could help simplify the screening, diagnosis and monitoring of patients with respiratory compromise in the current COVID-19 pandemic. In July of 2020, we added a Rapid Antibody Test, with SD Biosensor as manufacturing partner, to the portfolio, that allows the detection of antibodies against COVID-19 at the point of care, a Rapid Antigen Test in September and a lab-based Antigen Test in December. Roche is working closely with governments and health authorities around the world, and has significantly increased production to help ensure availability of tests globally.
Roche is actively involved in understanding the potential of the existing portfolio and is researching options for the future. Roche has an ongoing clinical trial program evaluating the role of Actemra©/RoActemra© (tocilizumab) in COVID-19 pneumonia. On 29 July 2020 Roche announced that the COVACTA trial did not meet its primary endpoint of improved clinical status in patients with COVID-19 associated pneumonia, or the key secondary endpoint of reduced patient mortality. The study was the first global, randomised, double-blind, placebo-controlled phase III trial investigating Actemra/RoActemra in this setting. Roche remains committed to continuing the Actemra/RoActemra clinical trial programme in COVID-19 to further explore Actemra/RoActemra in other treatment settings, including in combination with an antiviral. In addition to COVACTA, Roche has initiated several studies to further investigate Actemra/RoActemra as a potential treatment for patients with COVID-19 associated pneumonia, including two phase III clinical trials, REMDACTA and EMPACTA, as well as the phase II MARIPOSA trial. Roche has further initiated an internal early research programme focused on the development of medicines for COVID-19 and is engaged in multiple research collaborations. On 19 August 2020, Roche announced a partnership with Regeneron to develop, manufacture and distribute REGN-COV2, Regeneron’s investigational antiviral antibody combination, to people around the globe.
In these exceptional times, Roche stands together with governments, healthcare providers and all those working to overcome the pandemic.
About SD Biosensor
SD Biosensor is a global bio-diagnostic company that provides in vitro products engrafted with innovative technologies. Established in 2010, SD Biosensor has successfully launched diagnostics of blood glucose, glycated hemoglobin and cholesterols globally. Through these innovative products, they are striving to become a leading global in vitro diagnostic company.
About Roche
Roche is a global pioneer in pharmaceuticals and diagnostics focused on advancing science to improve people’s lives. The combined strengths of pharmaceuticals and diagnostics under one roof have made Roche the leader in personalised healthcare – a strategy that aims to fit the right treatment to each patient in the best way possible.
Roche is the world’s largest biotech company, with truly differentiated medicines in oncology, immunology, infectious diseases, ophthalmology and diseases of the central nervous system. Roche is also the world leader in in vitro diagnostics and tissue-based cancer diagnostics, and a frontrunner in diabetes management.
Founded in 1896, Roche continues to search for better ways to prevent, diagnose and treat diseases and make a sustainable contribution to society. The company also aims to improve patient access to medical innovations by working with all relevant stakeholders. More than thirty medicines developed by Roche are included in the World Health Organization Model Lists of Essential Medicines, among them life-saving antibiotics, antimalarials and cancer medicines. Moreover, for the twelfth consecutive year, Roche has been recognised as one of the most sustainable companies in the Pharmaceuticals Industry by the Dow Jones Sustainability Indices (DJSI).
The Roche Group, headquartered in Basel, Switzerland, is active in over 100 countries and in 2019 employed about 98,000 people worldwide. In 2019, Roche invested CHF 11.7 billion in R&D and posted sales of CHF 61.5 billion. Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan. For more information, please visit www.roche.com.
Reference: https://www.roche.com/media/releases/med-cor-2021-02-01.htm
Distribution agreement with Beckman Coulter Life Sciences for COVID-19 PCR Testing
28 January 2021
28 January 2021 -- genedrive plc, the near patient molecular diagnostics company, announces that it has entered into a distribution agreement with Beckman Coulter Life Sciences (“Beckman Coulter”) for its Genedrive® 96 SARS-CoV-2 Kit. The agreement enables Beckman Coulter to sell and distribute genedrive’s high-throughput COVID-19 PCR Kit in the United States and Europe for use on upper respiratory viral samples. The agreement is the result of the collaboration agreement announced in August 2020, under which the companies worked to develop and validate a fully automated PCR process for Beckman Coulter’s Biomek automated workstation in conjunction with its RNAdvance Viral XP extraction kit.
The Genedrive® 96 SARS-CoV-2 test is ideally suited for use on the high throughput robotic Biomek i7 instrument. The ready-to-go nature of the test removes many of the fluid dispensing steps required in competitor assays, increasing the overall throughput of the Biomek compared to using a liquid reagent based test formulation. Full automation of the overall PCR workflow can allow laboratories to run large numbers of tests over extended working hours or workstation platforms. Beckman Coulter estimates that this new turnkey solution could process circa 1,000 PCR samples per Biomek workstation installed during a standard 8-hour working day, using just a 0.5 full-time-equivalent in technician time for processing.
David Budd, CEO of genedrive plc, said: “We are very pleased to have the partnership of Beckman Coulter in accessing significant COVID testing opportunities throughout the United States and Europe, where the incidence of COVID continues to escalate and the need for high throughout testing solutions remains a priority. The combination of genedrive and Beckman Coulter products and expertise provides the Company with a new, innovative, and competitive solution, and a new sales channel for the American market, which we did not have previously.
“We are very pleased to now take our initial collaboration and development agreement to the commercial stage. Beckman Coulter is an important and significant company in these core geographies, well suited to promoting, selling, and supporting our products.”
The Companies are planning commercial introduction of the Genedrive kit from mid February, following commercial and technical training of the Beckman sale and support organisations.
Reference: https://www.genedrive.com/news/index.php
Ortho Clinical Diagnostics Announces Launch of Initial Public Offering
27 January 2021
Raritan, NJ, 27 January 2021 -- Ortho Clinical Diagnostics Holdings plc (“Ortho”), the world’s largest pure-play in vitro diagnostics company dedicated to improving and saving lives through innovative laboratory testing and blood-typing solutions, today announced the pricing of its initial public offering of 76 million ordinary shares at $17.00 per share. The gross proceeds raised from this offering are expected to be $1,292 million. Ortho’s ordinary shares are expected to begin trading on The Nasdaq Global Select Market on January 28, 2021, under the symbol “OCDX,” and the offering is expected to close on February 1, 2021, subject to customary closing conditions.
Ortho has granted the underwriters a 30-day option to purchase up to 11.4 million additional ordinary shares at the initial public offering price less underwriting discounts and commissions.
Ortho intends to use the net proceeds from the offering to redeem $160 million in aggregate principal amount of 7.375% senior notes due 2025 and $270 million in aggregate principal amount of 7.250% senior notes due 2028, in each case issued by certain of Ortho’s subsidiaries, repay borrowings under its dollar term loan facility, and for working capital and general corporate purposes, which may include further repayment of indebtedness.
The offering is being made through an underwriting group led by J.P. Morgan, BofA Securities, and Goldman Sachs & Co. LLC, who are acting as lead bookrunning managers, Barclays, Morgan Stanley, Citigroup, Credit Suisse, UBS Investment Bank, Evercore ISI and Piper Sandler, who are acting as joint bookrunning managers, and ING, Macquarie Capital, Nomura, TCG Capital Markets L.L.C., Drexel Hamilton, H.C. Wainwright & Co., Ramirez & Co., Inc. and Siebert Williams Shank, who are acting as co-managers.
A registration statement on Form S-1 relating to these securities has been declared effective by the Securities and Exchange Commission. This news release shall not constitute an offer to sell or a solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.
About Ortho Clinical Diagnostics
Ortho Clinical Diagnostics is a global leader of in vitro diagnostics dedicated to improving and saving lives through innovative laboratory testing and blood-typing solutions.
Because Every Test is a Life™, we never stop innovating to offer streamlined, sustainable laboratory solutions that deliver fast, accurate, reliable test results that support exceptional patient care.
As a trusted partner of hospitals, hospital networks, blood banks, and labs around the world, we proudly serve the clinical laboratory and transfusion medicine communities with customized solutions that enhance clinical outcomes, improve lab performance, overcome staffing challenges and better manage costs.
We are powered by Ortho Care™, our global, award-winning, holistic approach to service, which supports customers with best-in-class technical support, award-winning field support, and remote service and inventory support.
LGC launches SARS-CoV-2 molecular solution for Oral Fluid Testing
26 January 2021
26 January 2021 -- LGC has expanded its innovative portfolio of SARS-CoV-2 quality solutions with the release of AccuPlex™ SARS-CoV-2 in Synthetic Oral Fluid reference material. The product is designed to support development and testing efforts around novel saliva-based SARS-CoV-2 diagnostics. It serves as an ideal research tool for assay developers as well as a complete quality solution for clinical laboratories employing such tests.
LGC’s proprietary AccuPlex technology mimics wild-type pathogenic viruses, but is safe, non-infectious, and replication deficient. These materials serve as true, full-process, quality solutions that challenge the entire PCR test procedure, making them the preferred alternative to infectious materials. AccuPlex SARS-CoV-2 in Synthetic Oral Fluid can be utilized for oral fluid-based diagnostic development, as well as for assay verification at installation and day-to-day performance monitoring.
Michael Sweatt, Executive Vice President, Clinical Diagnostics, LGC, stated, “As the need for solutions for SARS-CoV-2 diagnostics evolves to include alternative sample types, we are pleased to offer innovative tools for both test manufacturers and clinical testing labs. This addition to our suite of AccuPlex SARS-CoV-2 quality solutions is just the latest innovation in our efforts to support novel diagnostics development and implementation in response to the COVID-19 pandemic.”
To learn more about AccuPlex SARS-CoV-2 in Synthetic Oral Fluid reference material, as well as the complete line of SARS-CoV-2 Quality Solutions, please visit the SeraCare website.
PerkinElmer Launches Industry-First GPCR TR-FRET Binding Assay and Beta-Arrestin Kits to Help Advance Therapeutics Discovery
26 January 2021 - New offerings join PerkinElmer’s leading GPCR Portfolio across characterization and screening assays, screening libraries and workflow optimization
WALTHAM, Mass., January 26, 2021 – PerkinElmer, a global leader committed to innovating for a healthier world, today announced the addition of new assay kits to help further GPCR (G Protein-Coupled Receptor) therapeutic discovery. The new PerkinElmer offerings extend the company’s leading GPCR analysis portfolio, which includes innovative assays, plate readers, automation technologies and software solutions combined with siRNA, shRNA, CRISPR, and cDNA/ORF libraries to help scientists more easily and accurately characterize receptors, screen compounds and streamline workflows.
The new assays, which enable researchers to use the preferred cell models of their choice, include the HTRF GTP Gi binding kit, the industry’s first TR-FRET based assay for GTP binding; the B-arr2 recruitment kit; and HTRF total kits for B-Arrestin 1, B-Arrestin 2 and AP2. These assays will help scientists continue to better understand the important role GPCRs play in disease by studying the interaction, expression and potential modulation of intracellular proteins involved in GPCR signaling mechanisms.
Further, when the new kits are leveraged as part of PerkinElmer’s comprehensive range of GPCR solutions, users can fully characterize the GPCRs being studied -- from ligand binding with the Tag-Lite® platform, and 2nd messenger with the cAMP and IP-One™ kits, to downstream GPCR signaling with hundreds of available assays. With the recent acquisition of Horizon Discovery, the PerkinElmer portfolio also includes siRNA, shRNA, CRISPR guide RNA, and cDNA/ORF libraries, such as ON-TARGETplus™, SMARTvector™ and Edit-R™ and screening services, which help researchers better explore the impact of gene modulation and editing on GPCR disease drivers.
“With GPCR-targeting drugs accounting for more than 30% of all FDA approved therapeutics and 20% of all drugs being studied, this area of research and development has been incredibly fruitful and holds immense potential for the future,” said Alan Fletcher, VP and GM of Life Sciences, PerkinElmer. “By adding these new assays to our already robust GPCR capabilities, we are giving researchers an end-to-end solution for continuing to unlock the role GPCRs play in disease so new and better therapeutics can be uncovered.”
About PerkinElmer
PerkinElmer enables scientists, researchers and clinicians to address their most critical challenges across science and healthcare. With a mission focused on innovating for a healthier world, we deliver unique solutions to serve the diagnostics, life sciences, food and applied markets. We strategically partner with customers to enable earlier and more accurate insights supported by deep market knowledge and technical expertise. Our dedicated team of about 14,000 employees worldwide is passionate about helping customers work to create healthier families, improve the quality of life, and sustain the wellbeing and longevity of people globally. The Company reported revenue of approximately $2.9 billion in 2019, serves customers in 190 countries, and is a component of the S&P 500 index. Additional information is available through 1-877-PKI-NYSE, or at www.perkinelmer.com.
Abbott's Panbio Rapid Antigen Test receives CE Mark for asymptomatic screening and self-administered sample collection with nasal swab
26 January 2021 - Panbio™ COVID-19 Ag Rapid Test Device supports mass testing in congregate populations of people (mass screening) who are asymptomatic. Frequent screening of asymptomatic and symptomatic people helps restore a sense of safety at workplaces, schools, travel and recreational settings, and other places where people gather in large numbers. Test is approved for use with a patient-friendly and minimally invasive nasal swab; patients can self-administer sample collection under a healthcare professional's supervision. Panbio COVID-19 Ag delivers results in as early as 15 minutes with no instrumentation, using proven Abbott lateral flow technology. Test performance in clinical study demonstrated 93.8% sensitivity and 100.0% specificity in asymptomatic people with high viral loads. Along with the test, Abbott will offer complementary digital solutions: the NAVICA™ mobile app to allow people to display negative results for proof of testing and Sympheos™ for surveillance management to understand epidemiological trends. Since August 2020 to date, Abbott has shipped 200 million Panbio rapid antigen tests to 120 countries worldwide.
ABBOTT PARK, Ill., Jan. 26, 2021 -- Abbott announced today it has received CE Mark for two new uses of its Panbio™ COVID-19 Ag Rapid Test Device for the detection of the SARS-CoV-2 virus: asymptomatic testing and self-swabbing.
Panbio COVID-19 Ag's label has been updated with clinical data on asymptomatic individuals, which enables mass testing (mass screening) of people who do not currently present symptoms of the disease. According to a recent study published in JAMA, at least 50% of COVID-19 infections are estimated to have originated from exposure to asymptomatic individuals.
The other update to the label allows self-collection of nasal specimens under the supervision of a healthcare worker. Self-swabbing with a patient-friendly nasal swab improves patient comfort and reduces the risk of accidental exposure to the virus for healthcare workers as they can maintain distance during the testing procedure.
"Rapid testing continues to be one of our most important tools for fighting this pandemic, and the ability to perform mass screening allows us to expand testing and reach more people in more places," said Robert B. Ford, president and chief executive officer, Abbott. "Now that Abbott's Panbio rapid antigen test has an asymptomatic indication, it becomes an even more valuable tool for enabling a safer return to work, school, travel and other activities of daily life."
Since last August to date, Abbott has shipped 200 million Panbio rapid antigen tests to 120 countries across Europe, the Americas, Asia and Africa. Healthcare professionals globally have seen the clinical utility of the test in detecting COVID-19 infections. In coordination with the Global Fund, the World Health Organization and the Bill & Melinda Gates Foundation, Abbott continues to make Panbio rapid antigen tests available to low- and middle-income countries.
Panbio COVID-19 Ag is not available in the U.S., where Abbott manufactures and sells the BinaxNOW™ COVID-19 Ag Card, which has received emergency use authorization (EUA) by the U.S. Food and Drug Administration (FDA). Abbott is in the process of pursuing FDA EUA of an asymptomatic indication for BinaxNOW.
Both Panbio and BinaxNOW rapid antigen tests use similar biologics and are highly portable, reliable and affordable.
Widespread, frequent and fast testing facilitates return to work
The large number of COVID-19 cases and fear of disease spread has resulted in a global economic recession, increased workplace absenteeism and the inability of employers to bring their employees back to the office. As a result, employers and governments around the world are looking for ways to ensure business continuity and restart their economies.
Frequent and fast screening of employees using rapid antigen tests such as Panbio COVID-19 Ag – along with preventative measures such as mask-wearing, social distancing, handwashing, disinfecting facilities and any other actions required by government – can support a safer return to work by quickly identifying and isolating infected and contagious individuals. Employees who test negative can be admitted to facilities and resume their work.
"Since October 2020, Abbott has used rapid antigen tests in a phased rollout of employee testing across multiple sites globally," said Mary Moreland, executive vice president, Human Resources, Abbott. "Our experience proves that testing helps our employees feel safer and more comfortable coming into the office during this time, so they can more effectively collaborate with each other and perform their duties."
Expanded rapid antigen testing plays critical role in restoring freedom of mobility
Beyond workplace screening, the ability to conduct mass screenings at ports of entry using the Panbio rapid antigen test will facilitate the resumption of global travel. A number of governments now mandate proof of a negative COVID-19 viral test before entering the country.
Additionally, various airlines and cruise ship companies require that passengers present negative test results before boarding. The International Air Transport Association (IATA) and the Airports Council International (ACI) have publicly called for a systematic approach to testing that is fast, accurate, affordable, easy-to-use, scalable and supported by public health authorities. Mass screening can help restore freedom of mobility across borders and will allow people to travel safely and with confidence.
"Being able to effectively screen asymptomatic people – along with other hygienic measures already in place – is the best way to ensure the safety of our passengers and all air transport workers," said Olivier Jankovec, director general, Airports Council International Europe. "Over 100 airports across Europe are already providing COVID-19 testing facilities in close cooperation with their health authorities. Rapid screening using high-quality and affordable antigen tests is a crucial part of resuscitating global travel until the vast majority of the world's travelers and crews are vaccinated."
Digital solutions facilitate return to daily life and understanding epidemiological trends
Digital health technologies play an important role in pandemic response. Integrated into testing strategies, digital technologies can support mass screening of people for safe entry into facilities and disease surveillance management to understand epidemiological trends. Abbott is offering two distinct digital solutions to support each of these functions.
Abbott's NAVICA mobile app for iPhone and Android devices allows people who test negative to display a temporary digital health certificate that is renewed each time a person is tested by a healthcare worker together with the date of the test result. Organizations using the NAVICA verifier app can scan and verify the information on a mobile device to manage safe entry into workplaces, airplanes and cruise ships, schools and universities, and other places where people come together in large numbers. NAVICA for use with Panbio Ag is soon to be available at no charge to customers outside the U.S.
In support of public health strategies, Abbott is offering Sympheos™, a web-based data collection and visualization tool, for use with Panbio Ag. Sympheos allows healthcare workers to log real-time test results on a smart phone, aggregate the collected data, and display it in a dashboard with heat maps, disease surveillance and testing trends. Sympheos data visualization may help health authorities better understand the epidemiological status of their epidemic and mobilize their COVID-19 response more effectively. Sympheos, which is available now to customers outside the U.S., can also be used to track in parallel other diseases such as malaria and HIV where there are high rates of co-infection.
Since the pandemic began, Abbott has developed the most advanced and comprehensive portfolio of COVID-19 tests across its testing platforms — from high-throughput molecular tests on its m2000™ RealTime and Alinity™ m lab-based systems; to serology tests on its Alinity™ i and ARCHITECT® i1000SR and i2000SR instruments; to rapid molecular tests on the ID NOW™ instrument; to rapid antigen test options on BinaxNOW™ (available in the U.S. only) and the Panbio™ COVID-19 Ag Rapid Test Device (available in countries outside the U.S.).
About Panbio COVID-19 Ag Rapid Test Device
Panbio COVID-19 Ag Rapid Test Device is a lateral flow assay for rapid, qualitative detection of SARS-CoV-2 virus. A nasal or nasopharyngeal swab is used for collection of specimens from individuals. Test results are delivered in as early as 15 minutes with no instrumentation.
Negative results must be combined with clinical observations, patient history and epidemiological information. Negative results do not preclude COVID-19 infection and cannot be used as the sole basis for treatment or other management decisions.
Clinical performance of Panbio COVID-19 Ag Rapid Test Device was determined by testing 483 asymptomatic people for SARS-CoV-2 antigen and comparing results against a PCR reference method.
Positive results (n=50) were stratified by cycle threshold (Ct) counts in order to understand the correlation between product performance and the amount of virus present in the clinical sample. A lower Ct value corresponds to a higher concentration of the virus.
Specificity of the test across 433 negative samples was 100.0%, which means no false positives were identified. Results for sensitivity were:
- 93.8% in 32 samples with Ct values less than or equal to 30
- 80.0% in 40 samples with Ct values less than or equal to 33
- 66.0% across all 50 positive samples (at all Ct counts)
There is a growing body of scientific literature and experience focused on the correlation between infectiousness, Ct counts and viral load. Specifically, scientific evidence suggests that at Ct counts in the 30s, the SARS-CoV-2 virus can't be replicated, meaning people are no longer infectious. This underscores the importance of frequent antigen testing to catch people with lower Ct counts while they are most contagious and need to self-quarantine.
Panbio COVID-19 Ag is CE-Marked for use with a nasal swab on asymptomatic and symptomatic people. Abbott has submitted documentation to the World Health Organization for Emergency Use Listing for the two new claims for asymptomatic testing and self-swabbing. Panbio COVID-19 Ag Rapid Test device is available in countries outside of the U.S. and subject to local regulatory and commercialization requirements.
About Abbott
Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 107,000 colleagues serve people in more than 160 countries.
Beckman Coulter brings the productivity and efficiency benefits of large volume hematology analyzers to small- and medium-sized labs
25 January 2021 - The new DxH 560 AL enables clinics and physician’s offices to continually load up to 50 samples per run, freeing up valuable time and resources. With less than a drop of blood, one of the lowest sample volumes on the market, the analyzer delivers high-quality results in 60 seconds or less.
BREA, CALIF., JAN. 25, 2020 — Beckman Coulter, a global leader in clinical diagnostics, announced today the launch of the DxH 560 AL, a tabletop analyzer geared to reduce the time and resource constraints faced by small to mid-sized laboratories. With the analyzer’s Auto-Loading functionality, closed tube aspiration and walkaway capabilities, users can continually add up to 50 samples, provide safety against blood-borne pathogens and spend less time on manual instrument tasks. Compactly designed, the DxH 560 AL uses ~30% less counter space than other analyzers in its class.
The DxH 560 AL delivers results in 60 seconds or less, and is the ideal instrument to use with difficult-to-draw patients (infants, oncology and elderly) as it only needs a 17 μL sample – less than a drop of blood, one of the smallest aspiration volumes on the market. The analyzer also provides industry-leading privacy and security features including customizable user login, paperless data management and fully traceable automated timeouts that guards patient electronic personal health information.
“With proven performance and low-cost to operate, the DxH 560 AL includes the analytical strengths and data management capabilities of high-throughput analyzers in a small footprint,” said Peter Soltani, Ph.D., senior vice president and general manager of hematology at Beckman Coulter. “The industry-leading functionality and auto-load capabilities of the DxH 560 AL enables smaller labs to reap the same efficiency and productivity benefits as their larger counterparts without blowing the budget.”
The DxH 560 AL is part of Beckman Coulter’s DxH 500 series of small footprint tabletop hematology analyzers, including the recently launched DxH 500 and the award winning DxH 520. The full DxH 500 series of analyzers include dynamic gating for its 5-part differential, eliminating rejected results and lowering manual interventions.
Beckman Coulter’s DxH 560 AL builds on the organization’s strength in hematology innovation and complements its broad spectrum of hematology analyzers, including the award winning DxH 690T for mid-volume, DxH 900 for high-volume and DxH connected workcell solutions for ultra-high-volume facilities. For more information on the DxH 560 AL, or the full DxH 500 series, visit https://www.beckmancoulter.com/en/products/hematology.
About Beckman Coulter
Beckman Coulter is committed to advancing healthcare for every person by applying the power of science, technology and the passion and creativity of our teams to enhance the diagnostic laboratory’s role in improving healthcare outcomes. Our diagnostic systems are used in complex biomedical testing, and are found in hospitals, reference laboratories and physician office settings around the globe. Beckman Coulter offers a unique combination of people, processes and solutions designed to elevate the performance of clinical laboratories and healthcare networks. We do this by accelerating care with a menu that matters, bringing the benefit of automation to all, delivering greater insights through clinical informatics and unlocking hidden value through performance partnership. An operating company of Danaher Corporation since 2011, Beckman Coulter is headquartered in Brea, Calif., and has more than 11,000 global associates working diligently to make the world a healthier place.
Roche renews partnership with Sysmex to deliver haematology testing solutions
25 January 2021 - This successful long-running partnership continues to evolve and bring haematology testing innovations to laboratories, globally. The new agreement aims to utilise the IT systems to lead to improved clinical decision making and customer experience. Blood disorders have a high impact, not only for patients but for society as a whole, accounting for a third of all central laboratory tests.
Basel, 25 January 2021 -- Roche today announced that, on 14 December, 2020, it signed a Global Business Partnership Agreement (GBP) with Sysmex. Under this new framework, the parties renewed their commitment to the long standing Distribution, Sales and Service (DSS) agreement, allowing Roche to continue to distribute Sysmex haematology products, including instruments and reagents. This GBP sees the introduction of an IT Solutions Collaboration Agreement. In the newly defined collaboration, the two companies have agreed to utilise their respective IT platforms to improve customer experience, in the short to mid-term, with a longer term ambition to use the IT systems to lead to improved clinical decision making. The GBP agreement will run until the end of 2030.
“Roche is committed to supporting improvements in haematology testing, which helps patients with the diagnosis and management of blood diseases, as diverse as anemia and leukaemia”, said Thomas Schinecker, CEO Roche Diagnostics. “Extending our longstanding partnership with Sysmex underscores our unique synergy and our objective to offer our customers high-quality haematology solutions to improve the testing efficiency in central laboratories in hospitals and commercial laboratories, ultimately benefiting the millions of patients living with blood disorders.”
The burden of blood disorders is very high, not only for patients but for society as a whole. Recent studies estimated that, in Europe, 80 million people suffer from haematological disorders and the economic impact of blood disorders in Europe amounts to EUR 23 billion per year, mostly in healthcare expenditure. Improved management is a key factor to counteract the rise of this economic burden for healthcare and society.
About the Roche and Sysmex partnership
In 1999, Sysmex and Roche entered into a Distributorship Sales and Service Agreement (DSS), under which Roche distributed Sysmex hematology products and provided services in overseas markets. This mutually beneficial arrangement has since advanced as demands for haematology testing have evolved, with greater focus on automation of manual processes and streamlining workflow, expanding the utility of haematological parameters so as to support diagnosis, monitoring and treatment across disease areas, beyond routine testing. In 2018, Roche and Sysmex entered into a non-exclusive collaboration agreement to offer Total Laboratory Solutions (TLS). This means that customers who want to purchase products for clinical chemistry, immunochemistry, and hematology testing from one vendor, could do so seamlessly with Roche and Sysmex.
The GBP agreement will allow Roche and Sysmex to deliver tailored haematology solutions to new and existing customers, while having the benefits of working with a single provider. Streamlining testing efficiency and effectiveness are an important part of a laboratory’s remit. Having the opportunity to integrate the technologies from two leading IVD companies, while simultaneously having a single service provider, can support laboratories to improve their testing solution and service delivery. Utilising a single service provider can simplify laboratory workflows, inventory management and service solutions, while maintaining access to high-quality, market-leading systems and solutions. The partnership will also strive to develop a joint framework to ensure and promote connectivity through standardisation of cybersecurity measures.
About Roche
Roche is a global pioneer in pharmaceuticals and diagnostics focused on advancing science to improve people’s lives. The combined strengths of pharmaceuticals and diagnostics under one roof have made Roche the leader in personalised healthcare – a strategy that aims to fit the right treatment to each patient in the best way possible.
Roche is the world’s largest biotech company, with truly differentiated medicines in oncology, immunology, infectious diseases, ophthalmology and diseases of the central nervous system. Roche is also the world leader in in vitro diagnostics and tissue-based cancer diagnostics, and a frontrunner in diabetes management.
Founded in 1896, Roche continues to search for better ways to prevent, diagnose and treat diseases and make a sustainable contribution to society. The company also aims to improve patient access to medical innovations by working with all relevant stakeholders. More than thirty medicines developed by Roche are included in the World Health Organization Model Lists of Essential Medicines, among them life-saving antibiotics, antimalarials and cancer medicines. Moreover, for the twelfth consecutive year, Roche has been recognised as one of the most sustainable companies in the Pharmaceuticals Industry by the Dow Jones Sustainability Indices (DJSI).
The Roche Group, headquartered in Basel, Switzerland, is active in over 100 countries and in 2019 employed about 98,000 people worldwide. In 2019, Roche invested CHF 11.7 billion in R&D and posted sales of CHF 61.5 billion. Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan. For more information, please visit www.roche.com.
Reference: https://www.roche.com/media/releases/med-cor-2021-01-25b.htm
QIAGEN confirms effectiveness of its SARS-CoV-2 PCR tests in the face of mutations of the coronavirus
20 January 2021 - QIAstat-Dx and NeuMoDx tests continue to detect all known viral variants extremely effectively. QIAGEN started cross-checking variants in May 2020 and continues to conduct biweekly assessments. QIAseq SARS-CoV-2 Primer Panel helps with sequencing RNA and identifying mutations.
Germantown, Maryland, and Hilden, Germany, January 20, 2021 – QIAGEN N.V. today announced its polymerase chain reaction (PCR) tests remain accurate and effective in detecting SARS-CoV-2 infections – and will continue to closely monitor their performance as global concerns mount regarding the detection of new viral variants by established testing methods.
QIAGEN has successfully assessed its SARS-CoV-2 PCR tests against genetic mutations of the virus uploaded to the GISAID and GenBank public databases since May 2020. A latest round of assessments conducted in January 2021 again confirmed that no recorded mutations affected the sensitivity of QIAGEN assays for detection of SARS-CoV-2. Surveillance of genetic variations will continue on a biweekly basis.
“We are pleased to report the known viral variants have had no impact on the effectiveness of our three SARS-CoV-2 PCR tests – PCR remains the gold standard for detecting RNA viruses like SARS-CoV-2,” said Davide Manissero, M.D., Chief Medical Officer - Infection and Immune Diagnostics at QIAGEN. “Further genomic sequencing of SARS-CoV-2 samples worldwide will vastly increase transparency and help us identify and respond to potentially dangerous mutations of the virus, while at the same time broadening the database we can use to verify if vaccines and tests continue to be effective.”
Variants with potentially increased transmissibility include VUI 202012/01 (first detected in the United Kingdom), 501Y.V2 (identified in South Africa), and B.1.1.28 P1 (most recently discovered in Brazil). As a virus encoded by RNA nucleotides, SARS-CoV-2 frequently mutates due to erroneous or ineffective replication of the virus genome. These mutations can sometimes produce viruses with altered properties or even entirely new strains.
To better identify potentially dangerous variants, countries like Germany and the U.S. are increasing the frequency of sequencing positive SARS-CoV-2 samples to monitor the occurrence of potential mutations. In August 2020, QIAGEN launched the QIAseq SARS-CoV-2 solution for comprehensive monitoring of sequence drift of the virus around the world. Consisting of a CoV-2 targeting panel, the QIAseq Fx UNGS library kit, and QDI bioinformatic analysis solution, this system allows for the identification of both known and novel variants in the CoV-2 genome.
A recent paper published by scientists from the Center of Genomics at the School of Medicine at the Loma Linda University in California measured performance variation across several SARS-CoV-2 whole genome sequencing technologies using clinical nasopharyngeal swab samples. Results demonstrated the QIAseq SARS-CoV-2 Primer Panel enabled preferential amplification of the SARS-CoV-2 genome by up to 100-fold compared to human or bacterial genomes in human samples. In comparison with RNA-seq metagenomics-based technologies, it achieved more than 100-fold higher coverage of the SARS-CoV-2 genome, depending on viral load and sequencing depth.
About QIAGEN
QIAGEN N.V., a Netherlands-based holding company, is the leading global provider of Sample to Insight solutions that enable customers to gain valuable molecular insights from samples containing the building blocks of life. Our sample technologies isolate and process DNA, RNA and proteins from blood, tissue and other materials. Assay technologies make these biomolecules visible and ready for analysis. Bioinformatics software and knowledge bases interpret data to report relevant, actionable insights. Automation solutions tie these together in seamless and cost-effective workflows. QIAGEN provides solutions to more than 500,000 customers around the world in Molecular Diagnostics (human healthcare) and Life Sciences (academia, pharma R&D and industrial applications, primarily forensics). As of September 30, 2020, QIAGEN employed more than 5,300 people in over 35 locations worldwide. Further information can be found at http://www.qiagen.com.
Reference: https://corporate.qiagen.com/newsroom/press-releases/2021/20210120_sars_cov_mutations
Labcorp Appoints Dr. Deborah Ann Sesok-Pizzini as Chief Medical Officer, Labcorp Diagnostics
19 January 2021 - Industry Leader Will Assume the Role Previously Held by Dr. Dot Adcock Who is Retiring in April
BURLINGTON, N.C., Jan. 19, 2021 -- Labcorp, a leading global life sciences company, announced today that Dr. Deborah Ann Sesok-Pizzini has been appointed Chief Medical Officer of Labcorp Diagnostics, following the retirement of Dr. Dot Adcock in April 2021. Dr. Sesok-Pizzini assumed the role starting on January 11, 2021.
Dr. Sesok-Pizzini joins Labcorp with over two decades of experience in healthcare. Prior to joining Labcorp, she held multiple appointments with The Children’s Hospital of Philadelphia, including Patient Safety Officer, Chief of the Division of Transfusion Medicine and Vice-Chief of Pathology and Laboratory Medicine. She was also a professor of clinical pathology and laboratory medicine at the Perelman School of Medicine at the University of Pennsylvania in Philadelphia, PA.
“We are thrilled to welcome Dr. Sesok-Pizzini to Labcorp,” said Dr. Brian Caveney, chief medical officer and president of Labcorp Diagnostics. “Her significant contributions to scientific communities and research, along with her esteemed career in healthcare and pathology, will provide invaluable expertise and insight to our leadership team. We are also extremely grateful to Dr. Dot Adcock for her dedication and years of stellar service to Labcorp and wish her the best in retirement.”
Dr. Sesok-Pizzini holds her doctorate from Pennsylvania State University and a MBA from Villanova University. She belongs to an extensive list of professional and scientific organizations and has authored dozens of articles, abstracts and publications related to her research.
“I am excited to be joining Labcorp Diagnostics and look forward to helping further the mission to improve health and improve lives,” said Dr. Sesok-Pizzini. “My top priority has always been the patient. I hope to use my experiences and education to provide insights that can be used to enhance the patient experience, enable health provider decisions and develop innovative testing solutions.”
About Labcorp
Labcorp is a leading global life sciences company that provides vital information to help doctors, hospitals, pharmaceutical companies, researchers, and patients make clear and confident decisions. Through our unparalleled diagnostics and drug development capabilities, we provide insights and accelerate innovations to improve health and save lives. With over 70,000 employees, we serve clients in more than 100 countries. Labcorp reported revenue of $11.5 billion in FY2019. Learn more about us at www.Labcorp.com.
PepTalk: The Protein Science and Production Week
19-21 January 2021
19-21 January 2021 -- PepTalk is celebrating its 20th year! This is a fully integrated virtual event that will continue to serve as a content hub for the latest research and biotherapeutics developments, provide a 1:1 networking platform, offer an interactive exhibit hall, live Q&A sessions, breakout groups, research posters, and so much more.
Dana Holzinger, Head of Product Management at PROGEN will be attending and presenting a poster focusing on 'Developing reliable AAV standards for ELISA'.
Download the full event guide from the PepTalk conference website for more information.
We look forward to meeting you virtually!
Reference: https://company.progen.com/news/article/view/peptalk-the-protein-science-and-production-week/
Thermo Fisher Scientific to Acquire Point-of-Care Molecular Diagnostics Provider Mesa Biotech
19 January 2021
WALTHAM, Mass., Jan. 19, 2021 -- Thermo Fisher Scientific Inc., the world leader in serving science, today announced it has entered into a definitive agreement to acquire Mesa Biotech, Inc., a privately held molecular diagnostic company, for approximately $450 million in cash. Under the terms of the agreement, Thermo Fisher will pay up to an additional $100 million in cash upon the completion of certain milestones following the close of the transaction.
Mesa Biotech has developed and commercialized a PCR-based rapid point-of-care testing platform available for detecting infectious diseases including SARS-CoV-2, Influenza A and B, respiratory syncytial virus (RSV) and Strep A. Mesa Biotech's patented technology expands the availability of gold standard nucleic acid PCR amplification to point-of-care diagnostics. The company is based in San Diego, California and has approximately 500 employees and revenues in 2020 of approximately $45 million.
Mesa Biotech's Accula™ Flu A/Flu B, RSV and Strep A tests have obtained 510(k) clearance and Clinical Laboratory Improvements Amendments (CLIA) waivers from the U.S. Food and Drug Administration (FDA). Additionally, the Accula System has received Emergency Use Authorization (EUA) from the FDA for SARS-CoV-2 in vitro diagnostic testing and is now available for use in patient care settings, providing results within 30 minutes, with higher accuracy than other rapid tests on the market.
"Mesa Biotech's innovative platform will enable us to accelerate the availability of reliable and accurate advanced molecular diagnostics at the point of care. Since the start of the pandemic, Thermo Fisher has acted quickly to provide support to the scientists and healthcare professionals at the frontlines of combating COVID-19," said Mark Stevenson, executive vice president and chief operating officer of Thermo Fisher Scientific. "The addition of Mesa Biotech's easy-to-use, rapid PCR-based test is highly complementary to our existing offering and will further help us meet the continuing demand for COVID-related testing while we work to rapidly scale and develop point-of care tests for other infectious diseases in the future."
Ingo Chakravarty, president and chief executive officer of Mesa Biotech said, "I am extremely proud of the remarkable accomplishments Mesa Biotech has achieved to date and excited about the prospects of becoming a part of Thermo Fisher. Mesa's innovative rapid PCR platform technology, combining PCR accuracy with mobility and test results in 30 minutes, has already played a meaningful role in the collective efforts combating the pandemic. Thermo Fisher's scale, innovation and global reach will allow us to more significantly amplify the impact our technology will have on human health, during the pandemic, and far beyond."
The transaction is expected to be completed in the first quarter of 2021, subject to customary closing conditions, including regulatory approval. Upon completion, the business will become part of Thermo Fisher's Life Sciences Solutions Segment.
About Thermo Fisher Scientific
Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $25 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, improving patient diagnostics and therapies or increasing productivity in their laboratories, we are here to support them. Our global team of more than 75,000 colleagues delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services and Patheon. For more information, please visit www.thermofisher.com.
SYNLAB bietet Genom-Sequenzierung von SARS-CoV-2 Varianten an
18 January 2021 - Angesichts der aktuellen Verbreitung neuer SARS-CoV-2 Varianten bieten wir die vollständige Genom-Sequenzierung des Virus in unserem Labor mittels Next Generation Sequencing (NGS) an. Darunter fallen auch die in Großbritannien (SARS-CoV-2 VOC 202012/01) sowie in Südafrika (SARS-CoV-2 501Y.V2) zirkulierenden Varianten.
Im Rahmen einer Verordnung des Bundesgesundheitsministeriums zur molekulargenetischen Surveillance des Coronavirus soll auf diese Weise die Voraussetzung dafür geschaffen werden, kurzfristig mehr Genomsequenzdaten der in Deutschland zirkulierenden Varianten von SARS-CoV-2 für Analysen zur Verfügung zu stellen.
Bei Interesse und allen weiteren Fragen zum Thema SARS-CoV-2-Sequenzierung wenden Sie sich bitte an unseren Chief Medical Officer (CMO), Dr. Martin Roskos telefonisch unter +49 3641 50740 oder senden Sie uns Ihre Anfrage über unser Kontakformular:
https://www.synlab.de/kontaktformular/anfrage-sars-cov-2-testung
Quest Diagnostics Granted CDC Contract to Sequence COVID-19 Gene Variants to Aid Public Health Response to COVID-19
18 January 2021 - Quest's genomic sequencing and infectious disease expertise will identify novel SARS-CoV-2 mutations, providing insights on prevalence and transmission in the United States
SECAUCUS, N.J., Jan. 18, 2021 -- Quest Diagnostics, the world's leading provider of diagnostic information services, today announced that it has entered into an agreement with the Centers for Disease Control and Prevention (CDC) to provide genomic sequencing to identify new mutations in, and patterns of transmission of SARS-CoV-2, the virus that causes COVID-19. Financial terms of the agreement are not disclosed.
The goal of the collaboration is to aid the CDC in conducting a large-scale longitudinal genomic survey of the SARS-CoV-2 virus using a random set of samples collected from Quest's labs across the United States. The company will perform the sequencing from its advanced diagnostics laboratory in San Juan Capistrano, Calif.
Viruses can mutate over time. In recent weeks, highly transmissible variants of the SARS-CoV-2 virus first discovered in the United Kingdom and South Africa have been identified in the United States.
Quest Diagnostics will sequence the viral genomes of random de-identified samples that test positive in the course of providing molecular diagnostic testing for SARS-CoV-2 for providers and patients, and provide the CDC with completed whole viral sequences. These data will be combined with the results of other data provided to the CDC by national, state, academic, and commercial labs to help meet the CDC survey's aims.
"Public and private collaboration is essential to mobilizing an effective response to COVID-19," said Jay G. Wohlgemuth, M.D., Senior Vice President and Chief Medical Officer. "Quest has the expertise in genomics and infectious diseases, as well as extensive COVID-19 testing data and access to patient samples. Our program will complement and extend the efforts of the CDC to discover and track new virus mutations and thereby improve public health response to the pandemic."
The CDC's survey aims to provide important baseline information for national and state-level surveillance, help define changes in transmission, identify new variants of the virus, and improve the public health response to the virus.
Quest Diagnostics and the CDC have a long history of collaboration to improve public health initiatives. Most recently, Quest joined the CDC's seroprevalence survey, which analyzes results of de-identified COVID-19 antibody tests to identify rates of COVID-19 prevalence in the United States. In addition, Quest is a member of the SARS-CoV-2 Sequencing for Public Health Emergency Response, Epidemiology and Surveillance (SPHERES) consortium, which launched in May 2020. Quest and the CDC are also long-time collaborators to identify trends in screening, diagnosis and treatment in viral hepatitis, HIV and sexually transmitted infections in the United States, based on insights revealed by analysis of Quest's national testing database.
About COVID-19 Testing at Quest Diagnostics
Quest Diagnostics is at the forefront of the response to the COVID-19 pandemic, working to broaden access to laboratory insights to help us all lead healthier lives. We provide both molecular diagnostic and antibody serology tests to aid in the diagnosis of COVID-19 and immune response. Through our team of dedicated phlebotomists, air fleet team, couriers and laboratory professionals, Quest Diagnostics works hard every day to help patients and communities across the United States access quality COVID-19 testing.
About Quest Diagnostics
Quest Diagnostics empowers people to take action to improve health outcomes. Derived from the world's largest database of clinical lab results, our diagnostic insights reveal new avenues to identify and treat disease, inspire healthy behaviors and improve health care management. Quest annually serves one in three adult Americans and half the physicians and hospitals in the United States, and our 47,000 employees understand that, in the right hands and with the right context, our diagnostic insights can inspire actions that transform lives. Learn more about Quest Diagnostics at www.QuestDiagnostics.com.
Grifols begins clinical trial of a new treatment that would provide immediate immunity against COVID-19
18 January 2021 - The treatment could be administered in primary care centers to people who test positive for COVID-19, avoiding hospitalization due to the progression of the disease and complementing the vaccine in the early phase after vaccination. The medicine, an anti-SARS-CoV-2 immunoglobulin, given subcutaneously, would provide immediate protection after exposure to the virus and could be used to protect the elderly and healthcare workers. It could also be given to immunocompromised patients for whom the vaccination isn’t indicated. The treatment is based on the Grifols immunoglobulin Gamunex®-C, and contains anti-SARS-COV-2 polyclonal antibodies from plasma donors who have recovered from COVID-19. The clinical trial to evaluate the safety and efficacy of the plasma-derived medicine will have doctors Oriol Mitjà and Bonaventura Clotet as the principal researchers and is expected to begin in early 2021.
Barcelona, Spain, January 18, 2021 -- Grifols, a global leader in the development of therapies with plasma-derived proteins with a track record of more than 100 years dedicated to enhancing people’s health and well-being, today announced it will begin a clinical trial in Spain to evaluate the safety and efficacy of a new COVID-19 drug based on the Grifols immunoglobulin Gamunex®-C and containing anti-SARS-CoV-2 polyclonal antibodies from plasma donors who have recovered from the disease.
The new drug would provide immediate post-exposure protection against the virus and would be especially useful as a complement to the vaccine in the early phase after vaccination. In addition, it could protect the elderly and healthcare workers as well as immunocompromised patients for whom vaccination isn’t recommended. It could also help contain outbreaks in places where the vaccination hasn’t begun or is still underway.
Grifols expects this clinical trial, led by the researchers Oriol Mitjà and Bonaventura Clotet, from Germans Trias i Pujol Hospital in Barcelona, to begin in February 2021, with the possibility of results in the spring.
About 800 patients, all asymptomatic but having tested positive for the virus in a diagnostic test, will participate in the clinical study, receiving subcutaneously Grifols’ immunoglobulin rich with anti-SARS-CoV-2 antibodies.
The Grifols immunoglobulin Gamunex®-C, whether administered intravenously, intramuscularly or subcutaneously, has proven to be safe and efficacious in the prevention of diverse infectious diseases in immunocompromised patients and has been used for this for more than 15 years.
According to Dr. Mitjà, “This treatment based on immunoglobulins would provide a combination of polyclonal antibodies that, compared with monoclonal antibodies, offers a greater diversity that could improve the degree of protection against the virus.”
Dr. Antonio Páez, Medical Director at Grifols, underscores that the potential treatment “is easy to refrigerate while its subcutaneous administration facilitates its distribution and use in any doctor’s office, avoiding hospitalization. If the new therapy’s efficacy is confirmed, it could be administered to people who test positive for the virus through PCR and antigen tests in hospitals and primary care offices.”
Grifols, a global leader in the production and distribution of immunoglobulins and hyperimmune immunoglobulins, currently has underway more than 25 research initiatives to treat different stages of COVID-19, from early exposure to the virus to severe cases requiring hospitalization and intensive care.
In October 2020, Grifols, together with other companies and various U.S. health agencies, began the clinical trial ITAC (Inpatient Treatment with Anti-Coronavirus Immunoglobulin) to evaluate the efficacy and safety of the anti-SARS-CoV-2 hyperimmune globulin in hospitalized and serious cases. Results are expected during the first half of 2021.
EUROIMMUN Launches SARS-CoV-2 Test System to Detect T-Cell Response
14 January 2021 - Novel test supports vaccine development studies critical to aiding researchers in understanding immunity levels and disease progression
WALTHAM, Mass., January 14, 2021 -- PerkinElmer today announced that its EUROIMMUN business has launched a SARS-CoV-2 Interferon Gamma Release Assay (IGRA) for Research Use Only (RUO) to determine the activity of T-cells reactive to SARS-CoV-2, the pathogen causing COVID-19.
Evidence suggests that both pillars of the immune system, antibody and T-cell response, are important in understanding immunity against SARS-CoV-2 reinfections. IgG antibodies against the S1 subunit of the SARS-CoV-2 spike protein and specific long-lived T-cells are suspected to play the most relevant roles in virus neutralization and sustained immunity.
This novel IGRA uses whole blood samples for determination of T-cell activity against SARS-CoV-2 through detection of interferon gamma, an important signaling molecule of the immune system which is released by the T-cells upon contact with the virus. The detection system is based on the well-established ELISA technology and can be processed manually or automatically in most laboratory settings. For this reason, the assay can be a helpful tool in research studies evaluating the cellular immune response in SARS-CoV-2 infected or vaccinated individuals.
“There are still a lot of open questions with respect to the COVID-19 disease progression and the development of long-term immunity after infection or vaccination,” said Dr. Wolfgang Schlumberger, CEO of EUROIMMUN. “In order to help answer these questions, both the IGRA and our Anti-SARS-CoV-2 QuantiVacTM ELISA (IgG) allow researchers to study the immune response to the coronavirus much more comprehensively and broadly to learn about vaccine efficacy from different angles.”
The IGRA for RUO is the latest addition to EUROIMMUN’s comprehensive SARS-CoV-2-specific product portfolio, which includes real-time PCR tests, an antigen detection assay and multiple antibody tests, a dried blood spot solution, as well as automation systems for small, medium and high sample throughput.
About PerkinElmer
PerkinElmer enables scientists, researchers and clinicians to address their most critical challenges across science and healthcare. With a mission focused on innovating for a healthier world, we deliver unique solutions to serve the diagnostics, life sciences, food and applied markets. We strategically partner with customers to enable earlier and more accurate insights supported by deep market knowledge and technical expertise. Our dedicated team of about 14,000 employees worldwide is passionate about helping customers work to create healthier families, improve the quality of life, and sustain the wellbeing and longevity of people globally. The Company reported revenue of approximately $2.9 billion in 2019, serves customers in 190 countries, and is a component of the S&P 500 index. Additional information is available through 1-877-PKI-NYSE, or at www.perkinelmer.com.
Thermo Fisher Scientific Extends SARS-CoV-2 GlobalAccess Sequencing Program to Support Research on New Virus Strains
14 January 2021 - Subsidized technology available as global bodies call for sequencing to confirm COVID-19 mutations
CARLSBAD, Calif., Jan. 14, 2021 -- As scientists continue to identify new strains of the SARS-CoV-2 virus, including the B.1.1.7 UK variant that studies suggest is more transmissible, genetic sequencing is being used to track these strains and new ones that are emerging, as well as to trace transmission patterns within communities. Today, Thermo Fisher Scientific announced an extension of its SARS-CoV-2 GlobalAccess Sequencing Program to provide additional units of the Ion Torrent Genexus System* and Ion GeneStudio S5* Series sequencers at a subsidized price to further support global COVID-19 research and surveillance.
Understanding the virus's genetic code and new variants is critical to assist with genetic tracing and transmission interruption efforts. Further research is also needed to determine how new strains affect people who are infected and vaccine effectiveness. Thermo Fisher's next-generation sequencing (NGS) technology offers researchers fast, real-time sequencing-data acquisition and easy data sharing across the global scientific community, as suggested by the U.S. Food and Drug Administration (FDA) and European Centre for Disease Prevention and Control (ECDC).
"As new strains of the virus have emerged and continue to spread, genetic sequencing provides unique insights on the epidemiology of infection and transmission patterns," said Garret Hampton, president of clinical next-generation sequencing and oncology at Thermo Fisher Scientific. "When we first launched the GlobalAccess Sequencing Program in May, our intention was to accelerate multi-institutional efforts to map coronavirus transmission and epidemiological studies. We are excited to continue our support of global research efforts to help track the growing presence of new strains across the globe."
With only five minutes of hands-on time required, the Genexus System is the world's first turnkey NGS solution that is designed to deliver results in a day in a decentralized laboratory setting. The platform's ease of use and automation has been developed to provide researchers – regardless of expertise level – access to the power of NGS technology. When combined with the Ion AmpliSeq SARS-CoV-2 Research Panel, the platform provides laboratories with a powerful, specimen-to-report workflow to carry out infectious disease studies using minimal amounts of sample.
About Thermo Fisher Scientific
Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $25 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, improving patient diagnostics and therapies or increasing productivity in their laboratories, we are here to support them. Our global team of more than 75,000 colleagues delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services and Patheon. For more information, please visit www.thermofisher.com/globalaccess.
PerkinElmer SARS-CoV-2 RT-PCR Assay Receives FDA EUA for Asymptomatic Testing
14 January 2021 - Gold-standard testing of individuals without COVID-19 symptoms key to controlling the spread
WALTHAM, Mass., Jan. 14, 2021-- PerkinElmer, Inc. announced today that its PerkinElmer® New Coronavirus Nucleic Acid Detection Kit received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) to test individuals without symptoms or other reasons to suspect COVID-19 infection.
According to a new model from The Journal of the American Medical Association’s Open Network developed by researchers from the Centers for Disease Control and Prevention, close to 60% of total COVID-19 transmissions come from those who have no symptoms, signaling that silent spreaders are the ones most often passing the virus around without knowing it.
For asymptomatic carriers, diagnostic testing is essential to identify infected individuals, and thereby provides a better chance of getting infectious individuals into isolation to avoid spreading the disease further. The ability to quickly identify asymptomatic individuals provides significant public health value. Moreover, based on comparative data released by the FDA, the PerkinElmer test kit has the lowest Limit of Detection (LoD) among the authorized COVID-19 molecular diagnostic tests reported, deeming it the most sensitive assay. PerkinElmer’s RT-PCR assay originally obtained FDA EUA in the spring of 2020.
“The data is clear – it’s imperative we have reliable and accurate testing for asymptomatic individuals, especially as we’re seeing new strains of the virus appear that are even more contagious,” said Masoud Toloue, Ph.D., Vice President & General Manager, Diagnostics, PerkinElmer. “PerkinElmer is in a unique position to help this cause, as we’re one of the few suppliers to have an EUA for asymptomatic testing, maintain the most sensitive test on the market along with a strong supply chain, and have the capability to do sample pooling to save time and resources for diagnostic laboratories.”
Previously, the FDA issued EUA to allow sample pooling with the PerkinElmer New Coronavirus Nucleic Acid Detection Kit to increase the number of individuals who can be tested without increasing resources. Additional testing mechanisms, including the use of saliva as a sample type, are also on the horizon. SARS-CoV-2 testing using saliva is less invasive, reduces the risk of exposure to healthcare workers involved in sample collection, and lessens the need for frequent replacement of personal protective equipment.
PerkinElmer continues to work on the frontlines of improving COVID-19 testing. The Company’s comprehensive SARS-CoV-2 offerings span high throughput RNA extraction, RT-PCR, automation, ELISA, chemiluminescence, time-resolved fluorescence and lateral flow based serology testing.
About PerkinElmer
PerkinElmer enables scientists, researchers, and clinicians to address their most critical challenges across science and healthcare. With a mission focused on innovating for a healthier world, we deliver unique solutions to serve the diagnostics, life sciences, food, and applied markets. We strategically partner with customers to enable earlier and more accurate insights supported by deep market knowledge and technical expertise. Our dedicated team of about 14,000 employees worldwide is passionate about helping customers work to create healthier families, improve the quality of life, and sustain the wellbeing and longevity of people globally. The Company reported revenue of approximately $2.9 billion in 2019, serves customers in 190 countries, and is a component of the S&P 500 index. Additional information is available through 1-877-PKI-NYSE, or at www.perkinelmer.com
BD Advances Immunology Research by Enabling Researchers to Investigate 30 Immune Markers in a Single Experiment
13 January 2021 - The BD® AbSeq Immune Discovery Panel enables researchers to execute single cell experiments with high efficiency
FRANKLIN LAKES, N.J. (Jan. 13, 2021) – BD (Becton, Dickinson and Company), a leading global medical technology company, today announced the commercial release of the BD® AbSeq Immune Discovery Panel (IDP), a state-of-the-art, pre-titrated antibody-oligo based discovery tool designed to investigate 30 immune markers in a single experiment.
The BD® AbSeq IDP builds upon the advances of the BD® AbSeq Assay, which analyzes protein expression at the single-cell level using next-generation sequencing. The BD® AbSeq IDP now offers researchers convenience, reliability and flexibility as both a multiomics-enabled and cost-efficient tool to aid in immune research and discovery.
Also built upon BD antibody-oligo based technology, the BD® AbSeq IDP consists of 30 different specificities targeting most major immune markers, conveniently grouped together in a single tube. The panel helps enable immune cell type identification and the analysis of their activation and suppression status. Further, it allows researchers to include additional immune markers of interest.
“Antibody panels can have a significant impact on both basic and translational science. A well-designed panel allows for rapid implementation and reduces delays in experimental set up,” says Professor Fabio Luciani, Associate Professor, School of Medical Sciences, University of New South Wales, Australia. “Combined with single-cell technologies, high-dimensional antibody panels with oligo barcodes are powerful tools to identify the broad spectrum of immune cells in disease samples, and they also inform on molecular and cellular profiles that possibly drive further understanding of the disease.”
The IDP is designed to work on the BD Rhapsody™ Single-Cell Analysis System, alongside RNA and multiplexing assays.
“The 30-plex BD® AbSeq IDP helps enable sequencing-based immune cell phenotyping, which fits well among a broad audience in immunology and immuno-oncology fields,” said Xuhuai Ji, PhD, Genomics Manager, The Human Immune Monitoring Center (HIMC), Stanford Medicine Institute for Immunity, Transplantation and Infection, Palo Alto, California. “This new approach makes it easier for researchers to start designing and begin their new projects on the BD Rhapsody™ Single-Cell Analysis System.”
The BD® AbSeq IDP offers immunology researchers multiple benefits:
- One-Tube Convenience: 30 pre-titrated antibodies against major immune markers in a single tube
- Ease of Use: Lyophilized format; simply reconstitute to stain samples
- Reliability: Accompanied by comprehensive performance test data
- Flexibility: A great backbone panel that allows easy addition of more antibodies of interest
- Multiomics Enabled: Works along with RNA and multiplexing assays
- Great Value: Manage your sequencing costs
“With the development and availability of the BD® AbSeq IDP, BD expands our commitment to single-cell research and delivers robust, easy-to-use tools that offer researchers valuable and deeper insights,” said Brian Lilhanand, leader for Single-Cell Multiomics at BD Biosciences for BD. “Single-cell analysis tools like the BD® AbSeq Assay and BD Rhapsody™ Single-Cell Analysis System have helped expand our customers' ability to study cells of interest and drive rapid advancements in immunology, including drug treatment response and cell therapy.”
About the BD Single-Cell Multiomics Portfolio
To further knowledge of the immune system, BD empowers immunology researchers with a range of tools for multiomic analysis. BD advances the future of immunology research with the BD® AbSeq Assay, an innovative product that leverages 40 years of BD leadership in immunology research. The BD® AbSeq Portfolio currently encompasses more than 450 different clones of both mouse and human specificities. In addition, BD also offers customers the option to conjugate their in-house antibodies of interest with oligos compatible with the BD Rhapsody™ Single-Cell Analysis System to generate custom BD® AbSeq Antibodies.
BD has continued to build on its BD Rhapsody™ Single-Cell Analysis System, a complete system of reagents, instruments, software and targeted gene panels to offer additional single-cell analysis capabilities. These include the BD Rhapsody™ Whole Transcriptome Analysis Amplification Kit designed to analyze the entire transcriptome, targeted RNA panels and VDJ CDR3 protocols that enable researchers to identify TCR and BCR sequence information. Importantly, all BD assays are multiomics enabled and allow researchers to simultaneously analyze protein and RNA information at the single-cell level.
More information on the new BD® AbSeq Immune Discovery Panel is available here.
About BD
BD is one of the largest global medical technology companies in the world and is advancing the world of health™ by improving medical discovery, diagnostics and the delivery of care. The company supports the heroes on the frontlines of health care by developing innovative technology, services and solutions that help advance both clinical therapy for patients and clinical process for health care providers. BD and its 65,000 employees have a passion and commitment to help enhance the safety and efficiency of clinicians' care delivery process, enable laboratory scientists to accurately detect disease and advance researchers' capabilities to develop the next generation of diagnostics and therapeutics. BD has a presence in virtually every country and partners with organizations around the world to address some of the most challenging global health issues. By working in close collaboration with customers, BD can help enhance outcomes, lower costs, increase efficiencies, improve safety and expand access to health care. For more information on BD, please visit bd.com.
Mesa Biotech Receives 510(k) Clearance and CLIA Waiver for Its Accula Strep A Molecular Point of Care Test
13 January 2021 - Accula Strep A Test Further Expands Company’s Commitment to Bring Routine Testing Closer to the Patient
SAN DIEGO, CA, December 9, 2020 -- Mesa Biotech, developers of an affordable, easy to use, handheld testing platform for infectious disease diagnosis, today announced it has received 510(k) clearance and Clinical Laboratory Improvements Amendments (CLIA) waiver from the US Food and Drug Administration (FDA) for its Accula™ Strep A test. The Strep A cassette, for the molecular detection of Group A Streptococcus bacterial nucleic acid by rapid PCR, is cleared for diagnosing both children and adults and provides laboratory quality results in 30 minutes at the point of care (POC).
Accula Strep A is the third molecular POC diagnostic on the Accula platform to receive FDA clearance and CLIA waiver, following the company’s commercially available tests for Flu A/Flu B and RSV. In addition, the company received Emergency Use Authorization (EUA) for its SARS-CoV-2 cassette earlier this year. The ergonomically designed, simple to use Accula test, fits in the palm of your hand and is visually read, using reverse transcription-polymerase chain reaction (RT-PCR) technology to detect Strep A via throat, nasal or nasopharyngeal swab samples.
With the addition of Strep A, we continue to deliver on our promise of bringing rapid, molecular diagnostics to the point of need,” said Bruce Cary, Ph.D., Co-founder and Chief Scientific Officer, Mesa Biotech, Inc. “The current pandemic has accentuated the need for PCR testing at the point of care and we are excited to be spearheading developments in this area.”
Group A streptococcus (GAS) is the most common bacterial cause of acute pharyngitis, an inflammation of the pharynx causing a sore throat and accounts for 15 to 30 percent of cases in children and 5 to 20 percent of cases in adults. It is estimated that 616 million people worldwide has a pharyngitis from a GAS infection annually and more than 18 million develop a severe GAS infection. According to Pediatrics, GAS is easily and frequently spread among families, school-aged children and other close contacts via respiratory secretions, and infection peaks in the late winter and early spring.
“It is important to diagnose and treat Strep A infections promptly as it is contagious and secondary complications can develop, especially in children,” said Hong Cai, Ph.D., Co-founder and Chief Technology Officer, Mesa Biotech, Inc. “Our Accula testing platform enables healthcare providers to reach a rapid diagnosis and administer the appropriate treatment, thus reducing the amount of time the patient is sick, preventing long-term health problems and helping prevent the spread of infection.”
About Mesa Biotech Inc.
Mesa Biotech designs, develops, manufactures and commercializes next generation Rapid PCR tests, bringing the superior diagnostic performance of nucleic acid PCR amplification to the point-of-care (POC). Mesa Biotech’s Accula™ SARS-CoV-2 test was among the first POC tests to obtain Emergency Use Authorization. The company’s Flu A/Flu B and RSV tests have obtained CE Mark in the EU and 510(k) clearance and Clinical Laboratory Improvements Amendments (CLIA) waiver from the U.S. Food and Drug Administration (FDA).
For more information visit http://www.mesabiotech.com.
Reference: https://www.mesabiotech.com/press-release/mesa-biotech-accula-strep-a-510k-clearance/
Abbott announces fulfillment of federal government purchase of 150 million BinaxNOW™ COVID-19 rapid tests and is now ready to support commercial distribution
12 January 2021 - Abbott will complete the U.S. government order for 150 million BinaxNOW COVID-19 tests this week and will supply 30 million additional tests through March via a new government order. Company is in final stages of completing its self-funded capacity expansion across U.S. manufacturing sites. Abbott has the most advanced and comprehensive COVID-19 rapid test portfolio available today, including ID NOW, BinaxNOW, the BinaxNOW at-home test and the NAVICA app. Workplaces, universities, schools and other qualified organizations that need frequent and affordable testing can now directly procure BinaxNOW tests from Abbott.
ABBOTT PARK, Ill., Jan. 12, 2021 — Abbott is announcing today the fulfillment of the federal government's order of 150 million BinaxNOW™ COVID-19 Ag tests. These rapid tests were distributed through the Department of Health and Human Services (HHS) to states, territories and targeted entities, such as nursing homes, assisted living facilities, home health and hospice agencies, historically black colleges and universities (HBCUs), and the Indian Health Service.
Abbott is also in the final stages of completing its self-funded investment in U.S. manufacturing capacity and is now ready to make tens of millions of BinaxNOW tests available per month for direct purchase to organizations including schools, workplaces and pharmacies.
"We've intentionally developed the most comprehensive COVID testing portfolio and the most advanced family of rapid tests to have the greatest impact we can," said Robert B. Ford, president and chief executive officer, Abbott. "We're pleased to take this next step in making BinaxNOW and NAVICA available to support the opening of organizations, and get them to more places where people need them, such as schools and universities, workplaces and pharmacies."
The University of Wisconsin System will be the first customer in the U.S. to secure BinaxNOW at scale, procuring 480,000 tests over six months for use at its universities and branch campuses.
"The University of Wisconsin System strives to be a national leader in combating COVID-19 and our robust testing strategy is one of our most effective means to do it," said Tommy Thompson, president, University of Wisconsin System. "We will continue to be aggressive in acquiring and implementing tests at our universities and our partnership with Abbott is key to making this happen."
At the size of a credit card and with no equipment required, Abbott's BinaxNOW COVID-19 test—sold directly to qualified organizations for $5 per test—is already the country's most widely available and mass-produced rapid test, providing results in 15 minutes and detecting the virus when people are most infectious and therefore at the greatest risk of spreading it to others. An at-home, virtually and digitally guided version of the test is also available at $25 per test.
Abbott will continue supplying HHS with a total of 30 million tests between now and March 2021. A breakdown of the initial 150 million tests shipped to states, territories and targeted entities via HHS orders can be found here.
BinaxNOW and NAVICA work together to help organizations perform testing at scale
The BinaxNOW test can be paired with the no-charge NAVICA™ app, which was developed by Abbott to allow people who test negative to display that result through a temporary digital health certificate. People who test negative on BinaxNOW can receive a QR code (similar to a mobile boarding pass used to board an airplane) and organizations can scan and verify the information to manage entry into facilities that accept NAVICA.
"Since October 2020, Abbott has been providing testing for U.S. employees using BinaxNOW and the NAVICA platform. Through the thousands of employees who have been tested, Abbott has gained important insights on managing workflow and how to use NAVICA to allow people to store, access and display their test results," said Mary Moreland, executive vice president, human resources, Abbott. "Our experience shows that large organizations can effectively manage a high-throughput, rapid testing program across multiple sites and in different occupational settings."
Since the pandemic began, Abbott has developed the most advanced and comprehensive portfolio of COVID-19 tests across its testing platforms—from high-throughput molecular tests on its m2000™ RealTime and Alinity™ m lab-based systems; to serology tests on its Alinity i™ and ARCHITECT® i1000SR and i2000SR instruments; to rapid molecular tests on the ID NOW™ instrument; to rapid antigen test options on BinaxNOW (available in U.S.) and the Panbio™ COVID-19 Ag Rapid Test Device (available in countries outside the U.S.).
The company will continue to study the role of testing as more becomes known about the long term efficacy of vaccines and how testing can be deployed to track outbreaks and more confidently return to group settings.
About the BinaxNOW COVID-19 Ag Card Rapid Test
The BinaxNOW COVID-19 Ag Card is an assay for the qualitative detection of specific antigens to COVID-19 in the human nasal cavity. A simple nasal swab is used to collect specimens from people suspected of having an active infection.
Under FDA EUA, the BinaxNOW COVID-19 Ag Card is for use by healthcare professionals and can be used in point-of-care settings that are qualified to have the test performed and are operating under a CLIA (Clinical Laboratory Improvement Amendments) Certificate of Waiver, Certificate of Compliance or Certificate of Accreditation. Within these settings, the test can be performed by doctors, nurses, school nurses, medical assistants and technicians, pharmacists, employer occupational health specialists and more with minimal training and a patient prescription.
About Abbott
Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 107,000 colleagues serve people in more than 160 countries.
Regeneron announces U.S. government agreement to purchase additional COVID-19 antibody cocktail doses
12 January 2021 - New agreement covers 1.25 million additional doses of the casirivimab and imdevimab antibody cocktail, bringing total potential U.S. supply to over 1.5 million doses. Doses are being supplied for use pursuant to the FDA Emergency Use Authorization for high-risk patients with mild to moderate COVID-19 in order to reduce the risk of progression to severe COVID-19 and/or hospitalization.
TARRYTOWN, N.Y., Jan. 12, 2021 -- Regeneron Pharmaceuticals, Inc. today announced that the U.S. Department of Health and Human Services (HHS) and the Department of Defense (DOD) will purchase additional supply of the casirivimab and imdevimab antibody cocktail for use in non-hospitalized COVID-19 patients to meet the federal government's Operation Warp Speed goals. The government has said it will provide these doses at no cost to patients, though healthcare facilities may charge fees related to administration.
Under the new agreement, the government will purchase all finished doses of the casirivimab and imdevimab antibody cocktail delivered by June 30, 2021, up to 1.25 million doses. Under a previous agreement, Regeneron is already supplying doses to treat approximately 300,000 people, bringing the total potential purchase to over 1.5 million doses.
"COVID-19 continues to sicken hundreds of thousands of Americans every day and the people of Regeneron are committed to help," said Leonard S. Schleifer, M.D., Ph.D., President and Chief Executive Officer of Regeneron. "Tackling the COVID-19 pandemic will require a combination of public health measures, vaccines and therapeutics. We are pleased to work with the U.S. government to supply our antibody cocktail as an important weapon in this fight."
The U.S. government has said it will continue to coordinate allocation of the antibody cocktail to state and territorial health departments. Patients, caregivers and healthcare providers can find sites with COVID-19 antibody treatments through these links to the HHS or National Infusion Center Association locator tools.
"Patients in our antibody cocktail outpatient clinical trial experienced significant reductions in virus levels and required fewer medical visits for COVID-19, suggesting the therapy can help reduce the current burden on hospitals and healthcare systems," said George D. Yancopoulos, M.D., Ph.D., President and Chief Scientific Officer of Regeneron. "Additionally, as expected, the virus continues to mutate, with the possibility of developing resistance to any one antibody. The Regeneron cocktail of two antibodies, each targeting a different site on the virus, reduces the possibility of the virus becoming resistant."
The casirivimab and imdevimab antibody cocktail continues to be evaluated in clinical trials for the treatment of COVID-19 in certain hospitalized and non-hospitalized patients, including the open-label RECOVERY trial of hospitalized patients in the UK, and a trial for the prevention of COVID-19 in household contacts of infected individuals. To date, nearly 15,000 people have participated in casirivimab and imdevimab clinical trials.
The development and manufacturing of the antibody cocktail has been funded in part with federal funds from the Biomedical Advanced Research and Development Authority (BARDA), part of HHS, Office of the Assistant Secretary for Preparedness and Response, under OT number: HHSO100201700020C.
Details of the New Agreement
The current authorized dose for emergency use in non-hospitalized patients is 2,400 mg (1,200 mg casirivimab and 1,200 mg imdevimab) administered as a one-time infusion. Regeneron is evaluating the safety and efficacy of a lower 1,200 mg dose (600 mg casirivimab and 600 mg imdevimab) of the antibody cocktail in this 'outpatient' setting.
Under the agreement, the government will acquire doses at the lowest authorized dose. The government is obligated to purchase all finished doses supplied by June 30, up to 1.25 million doses total (an agreement value of up to $2.625 billion), and may accept doses after this date at its discretion. A number of factors may impact available finished supply by June 30, including manufacturing considerations and authorized dose levels. Regeneron expects to supply approximately 750,000 finished doses by the end of June based on the 2,400 mg dose level, with the vast majority supplied in the second quarter. Regeneron expects to fulfill the entire 1.25 million targeted doses if the 1,200 mg dose is authorized.
About the Regeneron Antibody Cocktail for COVID-19
Casirivimab and imdevimab is a cocktail of two monoclonal antibodies (also known as REGN10933 and REGN10987, respectively) and was designed specifically to block infectivity of SARS-CoV-2, the virus that causes COVID-19. The two potent, virus-neutralizing antibodies that form the cocktail bind non-competitively to the critical receptor binding domain of the virus's spike protein, which diminishes the ability of mutant viruses to escape treatment and protects against spike variants that have arisen in the human population, as detailed in Science.
In November 2020, the casirivimab and imdevimab antibody combination received Emergency Use Authorization (EUA) from the FDA for the treatment of mild to moderate COVID-19 in adults, as well as in pediatric patients at least 12 years of age and weighing at least 40 kg, who have received positive results of direct SARS-CoV-2 viral testing and are at high risk for progressing to severe COVID-19 and/or hospitalization. The clinical evidence from Regeneron's outpatient trial suggests that monoclonal antibodies such as casirivimab and imdevimab have the greatest benefit when given early after diagnosis and in patients who are seronegative and/or who have high viral load. The criteria for 'high-risk' patients are described in the Fact Sheet for Healthcare Providers. In the U.S., casirivimab and imdevimab are not authorized for use in patients who are hospitalized due to COVID-19 or require oxygen therapy, or for people currently using chronic oxygen therapy because of an underlying comorbidity who require an increase in baseline oxygen flow rate due to COVID-19.
Regeneron is collaborating with Roche to increase global supply of casirivimab and imdevimab. Regeneron is responsible for development and distribution of the treatment in the U.S., and Roche is primarily responsible for development and distribution outside the U.S. The companies share a commitment to making the antibody cocktail available to COVID-19 patients around the globe and will support access in low- and lower-middle-income countries through drug donations to be made in partnership with public health organizations.
About Regeneron
Regeneron is a leading biotechnology company that invents life-transforming medicines for people with serious diseases. Founded and led for over 30 years by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to eight FDA-approved treatments and numerous product candidates in development, all of which were homegrown in our laboratories. Our medicines and pipeline are designed to help patients with eye diseases, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, pain, infectious diseases and rare diseases.
Regeneron is accelerating and improving the traditional drug development process through our proprietary VelociSuite® technologies, such as VelocImmune, which uses unique genetically-humanized mice to produce optimized fully-human antibodies and bispecific antibodies, and through ambitious research initiatives such as the Regeneron Genetics Center, which is conducting one of the largest genetics sequencing efforts in the world.
For additional information about the company, please visit www.regeneron.com.
Ortho’s VITROS® SARS-CoV-2 Antigen Test for Accurate, Mass-Scale COVID-19 Testing is the First Widely-Available High-Volume Test to Receive FDA Emergency Use Authorization
12 January 2021 - Ortho’s VITROS® SARS-CoV-2 Antigen Test is the first high-volume COVID-19 antigen test to receive Food and Drug Administration (FDA) Emergency Use Authorization (EUA). With utility for mass-scale testing and same-day results for labs, Ortho’s latest COVID-19 solution can run up to 130 tests per hour. The test is run on Ortho’s high-volume VITROS® Systems, which are installed in over 5,600 laboratories around the world with 1,500 installed in the U.S.
12 January 2021 — Ortho Clinical Diagnostics, a global leader of in vitro diagnostics, today announced that its VITROS® SARS-CoV-2 Antigen Test, designed to detect active infection, has become the first high-volume COVID-19 antigen test to receive Food and Drug Administration (FDA) Emergency Use Authorization (EUA). U.S. distribution of the test commenced in November 2020 under an FDA Emergency Use Notification (EUN); the test was also granted CE Mark in November 2020.
Ortho’s antigen test comes at a critical time—a recent Rockefeller Foundation report estimates that the U.S. will need to increase coronavirus testing capacity by nearly 10-fold— from 21 million to 193 million tests per month—in order to reopen schools safely and protect nursing homes.
With utility for mass-scale testing and same-day results for labs, Ortho’s latest COVID-19 solution can run up to 130 tests per hour and immediately help hospitals and reference labs address testing backlogs, supply shortages, and delayed results.
“As the pandemic continues to devastate our communities and economy, laboratory professionals have been working under extraordinary circumstances to deliver critical COVID-19 testing data to patients, clinicians and communities,” said Chris Smith, chairman and chief executive officer, Ortho Clinical Diagnostics. “Even as vaccine inoculation programs roll out, mass-scale testing remains an essential tool in fighting COVID-19. Ortho’s accurate, high-volume COVID-19 antigen test can play a pivotal role in the global response to this virus.”
About the VITROS® SARS-CoV-2 Antigen Test
The VITROS® SARS-CoV-2 Antigen Test produces accurate, clinically reliable results on Ortho’s high-volume VITROS® Systems, which are installed in over 5,600 laboratories around the world. More than 1,500 VITROS analyzers are operational across the U.S.—including more than 500 located in rural regions, where coronavirus testing needs are especially urgent.
These analyzers normally run a broad menu of over 150 different tests from blood and body fluid samples, but now are also able to run samples derived from swabs. Additional analyzers are available for shipment and can be installed rapidly to further increase capacity since they don’t require an external water source to operate.
Ortho’s COVID-19 antigen test is an alternative to real-time polymerase chain reaction (PCR) testing, which although highly sensitive, can be expensive and require long processing times during testing surges. Roughly one-third of individuals who underwent a PCR test waited more than four days for a result—including 10% who waited more than 10 days, according to an article published by researchers from Harvard, Northeastern, Northwestern, and Rutgers.
Other COVID-19 diagnostic testing platforms, including rapid antigen tests, have limited capacity to run multiple tests simultaneously or require short time windows to read results, making it challenging to test more than a handful of patients at a time.
Ortho is currently able to deliver 5 million tests per month and can scale up to 15 million tests per month in February.
About Ortho’s VITROS® COVID-19 Testing Solutions
Ortho’s new SARS-CoV-2 Antigen Test is the latest addition to the company’s COVID-19 solutions, which include two COVID-19 antibody tests—Total and IgG—both of which have FDA EUA and CE Mark.
Because Ortho’s VITROS Systems are already installed worldwide, reporting times may be further improved because lab staff require no additional training, and the instruments are already connected to existing laboratory information systems and software. These systems are self-contained and do not require an external water source to run.
Abbott receives FDA 510(K) clearance for the first rapid handheld blood test for concussions
11 January 2021 - The test to help evaluate mild traumatic brain injury (TBI), commonly known as concussion, produces a result within 15 minutes after a plasma sample is inserted and will run on Abbott's i-STAT™ Alinity™ handheld device. Having a blood test available could help eliminate wait time in the emergency room and could reduce the number of unnecessary CT scans by up to 40%. The test simultaneously measures biomarkers UCH-L1 and GFAP, proteins found in the blood after a concussion or head trauma. Building on this initial clearance, Abbott is also working on a test that would use whole blood on i-STAT at the point of care, and developing a test for its Alinity™ i and ARCHITECT® core laboratory instruments under FDA breakthrough designation.
ABBOTT PARK, Ill., Jan. 11, 2021 -- Abbott has received 510(k) clearance for the first rapid handheld traumatic brain injury (TBI) blood test, which will help clinicians assess individuals with suspected mild TBIs, including concussions. The test will run on Abbott's handheld i-STAT™ Alinity™ platform. Tests results are available within 15 minutes after plasma is placed in the test cartridge.
TBIs, including concussions, are an alteration in brain function caused by an external force. This test measures specific proteins present in the blood after a TBI. A negative result on this test can be used to rule out the need for a head CT scan, a common tool used to diagnose concussion. For those who test positive, this test result complements CT scans to help clinicians evaluate whether someone has a TBI.
"Healthcare providers have been waiting for a blood test for the brain and now we have one," said Beth McQuiston, M.D., medical director for Abbott's diagnostics business. "You can't treat what you don't know and now physicians will be equipped with critical, objective information that will help them provide the best care possible, allowing patients to take steps to recover, prevent reinjury and get back to doing the things they care about most."
The test requires a small blood sample drawn from the arm, from which plasma is extracted with a centrifuge and applied to the test's cartridge. The cartridge is then inserted into the handheld instrument.
Abbott is also working on a whole blood test, which would eliminate the need for separation of plasma and could be used at the patient's side in a healthcare setting. Our vision for the future is that we'd have a 15-minute, portable test that can be used outside the traditional healthcare setting where people experience head injuries and need a quick evaluation, like sporting events.
Abbott has also received FDA breakthrough designation – which speeds assessment of tests through increased FDA interaction – for a TBI test that would run on its Alinity™ i and ARCHITECT® core laboratory instruments. This is part of Abbott's strategy to ensure that its tests are available both in the lab and in other settings where people need immediate answers and care.
The need for immediacy and accuracy in diagnosing TBI
Nearly 5 million people go to the emergency room for a TBI in the U.S. each year.
"Evaluating brain injuries is complex – and research shows that we only catch about half of those who show up to the hospital with a suspected TBI," said Geoffrey Manley, M.D., Ph.D., vice chair of neurological surgery at the University of California, San Francisco. "And beyond those who go to the hospital for a suspected TBI, many more never do. A test like this could encourage more people to get tested after a head trauma, which is important, because not receiving a diagnosis can be dangerous and may prevent people from taking the necessary steps to recover safely."
Survivors of TBI may experience impairment of memory, movement, sensation (e.g., vision and hearing), and emotional functioning (e.g., personality changes, psychological symptoms). Effects of TBI can last anywhere from a few days post-injury or may be permanent. People who sustain a TBI are more likely to have another one – similarly to how a sprained ankle or torn ligament is more susceptible to future injury.
These effects are worsened by misdiagnosis or lack of diagnosis. Abbott's blood test will give healthcare professionals an objective tool for evaluating people suspected of having an injury to the brain.
About the i-STAT Alinity TBI plasma test
The i-STAT Alinity TBI plasma test simultaneously measures biomarkers glial fibrillary acidic protein (GFAP) and ubiquitin carboxyl-terminal hydrolase L1 (UCH-L1) in blood plasma, two complementary biomarkers that, in elevated concentrations, are tightly correlated to brain injury. It provides test results with 95.8% sensitivity and greater than 99% negative predictive value.
The TBI blood test was developed in collaboration with the U.S. Department of Defense (DoD) – which has been dedicated to developing a solution for the objective detection and evaluation of TBI for more than a decade. The DoD, through U.S. Army Medical Research and Development Command's (USAMRDC) U.S. Army Medical Materiel Development Activity (USAMMDA), played a critical role in developing the test run on Abbott's i-STAT Alinity platform. The Transforming Research and Clinical Knowledge in Traumatic Brain Injury (TRACK-TBI) research team were the first to demonstrate how this TBI blood test can be used for the benefit of TBI patients in clinical care.
About Abbott
Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 107,000 colleagues serve people in more than 160 countries.
PerkinElmer to Acquire Oxford Immunotec Global PLC Financial Information
7 January 2021 - PerkinElmer to acquire Oxford Immunotec for USD 22.00 per share in cash. Transaction expected to be completed in the first half of 2021.
WALTHAM, Mass. & LONDON, Jan. 7, 2021 -- PerkinElmer, Inc. (“PerkinElmer”) and Oxford Immunotec Global PLC ("Oxford Immunotec" or the “Company”) are pleased to announce they have reached an agreement on terms under which PerkinElmer will acquire Oxford Immunotec (the “Acquisition”). It is intended that the Acquisition will be implemented by means of a U.K. High Court of Justice-sanctioned scheme of arrangement under Part 26 of the U.K. Companies Act 2006 between Oxford Immunotec and its shareholders (the “Scheme”).
Under the terms of the Acquisition, Oxford Immunotec shareholders will be entitled to receive USD 22.00 in cash for each outstanding ordinary share (“Oxford Immunotec Share”). The terms of the Acquisition value the Company’s entire issued and to be issued ordinary share capital at approximately USD 591 million, and the terms of the Acquisition represent a premium of approximately 28.3% to the closing price per share of USD 17.15 on January 5, 2021 (being the last practicable date prior to the date of this announcement (the “Announcement”)) and 53.5% to the 90 trading day volume-weighted average price per Oxford Immunotec Share of USD 14.34 for the period from October 8, 2020 to January 5, 2021 (being the last practicable date prior to the date of this Announcement). In addition, the terms of the Acquisition represent a premium of 99.2% to the Company’s enterprise value calculated using the 90-day volume weighted average price for the period from October 8, 2020 to January 5, 2021.
Through this Acquisition, PerkinElmer will grow its portfolio of advanced infectious disease testing solutions to include tuberculosis detection to better serve customers around the world. Moreover, the deal will enable PerkinElmer to combine its channel expertise and leading workflow and testing capabilities with Oxford Immunotec’s leading proficiencies in T cell immunology with its proprietary test kits for latent tuberculosis.
In terms of financial impact, PerkinElmer expects the Acquisition to be modestly accretive to non-GAAP earnings in year-one following the close, and PerkinElmer anticipates Oxford Immunotec’s sales growth will exceed that of its Diagnostics franchise for the foreseeable future.
Headquartered in Abingdon, UK, Oxford Immunotec is recognized as a global leader of proprietary test kits for latent tuberculosis. Its Interferon Gamma Release Assay (IGRA) offering identifies individuals who are infected with tuberculosis. Oxford Immunotec had approximately 275 global employees as of September 30, 2020 and reported total revenue from continuing operations of $73.7 million and $39.2 million as of the fiscal year ended December 31, 2019 and the nine months ended September 30, 2020, respectively.
Commenting on the Acquisition, Prahlad Singh, PhD, President and Chief Executive Officer of PerkinElmer, said: “Tuberculosis remains one of the leading infectious causes of death, with close to one quarter of the world’s population infected. We believe Oxford Immunotec’s diagnostic testing solution plays an important role in slowing the spread and saving lives. Oxford Immunotec’s highly sensitive test and their team’s passion for solving complex health issues make it a natural fit with PerkinElmer’s mission and together, we believe will accelerate development of robust solutions to help detect infectious disease.”
PerkinElmer's comprehensive global diagnostics portfolio includes solutions focused on:
1) Immunodiagnostics, in areas of immunology and infectious disease;
2) Reproductive Health, with a focus on newborn and prenatal testing; and
3) Applied Genomics, which includes fully automated sample to answer solutions around genomics and molecular testing.
Commenting on the Acquisition, Peter Wrighton-Smith, PhD, Chief Executive Officer of Oxford Immunotec, said: “We are delighted to be joining the PerkinElmer family. We believe this transaction is great for our shareholders, our employees and our customers. Access to PerkinElmer’s global reach and automation experience will enable us to accelerate our growth journey and make a growing impact in the field of infectious disease.”
The Board of Directors of each company has approved the transaction, which is expected to close in the first half of calendar 2021, subject to approval of Oxford Immunotec’s shareholders, court approval of the Scheme and other customary closing conditions. Upon the closing of the transaction, Oxford Immunotec will become a privately held company and Oxford Immunotec’s ordinary shares will no longer be listed on any public market.
Guggenheim Securities, LLC is acting as financial advisor to PerkinElmer. Wilmer Cutler Pickering Hale and Dorr LLP is acting as legal counsel to PerkinElmer as to matters of U.S. law and Hogan Lovells International LLP is acting as legal counsel to PerkinElmer as to matters of English law.
An affiliate of Perella Weinberg UK Limited (“Perella Weinberg Partners”) is acting as financial advisor to Oxford Immunotec. Covington & Burling LLP is acting as legal counsel to Oxford Immunotec.
About Oxford Immunotec
Oxford Immunotec is a global, high-growth diagnostics company. Oxford Immunotec’s vision is to bring energy and invention to a world in need of diagnostic truth. Oxford Immunotec is uniquely placed as the only company in the world offering regulated ELISPOT assays for T cell measurement, with approval around the globe. Oxford Immunotec’s leading product, the T-SPOT®.TB test, is used for diagnosing infection with Tuberculosis, the world’s largest cause of death from infectious disease. Oxford Immunotec has manufactured in excess of 20 million clinical T cell tests for TB infection. The T-SPOT.TB test has been approved for sale in over 50 countries, including the United States, where it has received pre-market approval from the Food and Drug Administration, Europe, where it has obtained a CE mark, as well as Japan and China. The Company is headquartered near Oxford, U.K. and in Marlborough, MA. Additional information can be found at www.OxfordImmunotec.com.
About PerkinElmer
PerkinElmer enables scientists, researchers and clinicians to address their most critical challenges across science and healthcare. With a mission focused on innovating for a healthier world, we deliver unique solutions to serve the diagnostics, life sciences, food and applied markets. PerkinElmer strategically partners with customers to enable earlier and more accurate insights supported by deep market knowledge and technical expertise. It has a dedicated team of about 14,000 employees worldwide who are passionate about helping customers work to create healthier families, improve the quality of life, and sustain the wellbeing and longevity of people globally. PerkinElmer reported revenue of approximately $2.9 billion in 2019, serves customers in 190 countries, and is a component of the S&P 500 index. Additional information is available through 1-877-PKI-NYSE, or at www.perkinelmer.com.
Labcorp Awarded CDC Contract to Study Variants of COVID-19 Virus and Improve Public Health Response
7 January 2021 - Genomic Sequencing Aims to Help Define Changes in Transmission and Identify New Mutations
BURLINGTON, N.C., Jan. 7, 2021 -- Labcorp, a leading global life sciences company, today announced that it has been awarded a contract from the Centers for Disease Control and Prevention (CDC) to provide genomic sequencing of samples of SARS-CoV-2, the virus that causes COVID-19.
This sequencing will aid the CDC in its goal of conducting a large-scale longitudinal genomic survey of the virus using a random set of samples collected from across the United States. The survey aims to provide important baseline information for national and state-level surveillance, help define changes in transmission, identify new variants of the virus, and improve the public health response to the virus. Through this program, the CDC aims to more than double the rate of genomic samples sequenced per week.
Labcorp will sequence the genomes of random de-identified samples that test positive for SARS-CoV-2 and will provide the CDC with completed sequences. This sequencing data will be combined with the results of similar efforts undertaken by national, state, academic, and private labs to help meet the CDC’s target goal.
“Better decision making starts with better data, and we are eager to help the CDC in its effort to improve the nation’s understanding of this virus and how to effectively fight it,” said Dr. Marcia Eisenberg, chief scientific officer at Labcorp. “This sequencing survey is a critical project to ensure our knowledge of COVID-19 improves even as the virus may mutate and change.”
About Labcorp
Labcorp is a leading global life sciences company that provides vital information to help doctors, hospitals, pharmaceutical companies, researchers, and patients make clear and confident decisions. Through our unparalleled diagnostics and drug development capabilities, we provide insights and accelerate innovations to improve health and save lives. With over 70,000 employees, we serve clients in more than 100 countries. Labcorp (NYSE: LH) reported revenue of $11.5 billion in FY2019. Learn more about us at www.Labcorp.com.
Trinity Biotech Announces CE Mark of its Covid-19 IgG ELISA Antibody Test
5 January 2021
DUBLIN, Ireland, January 5th, 2021 -- Trinity Biotech plc has achieved CE Mark approval and registration for its Covid-19 IgG ELISA antibody test, the Captia™ SARS-CoV-2 IgG ELISA.
Trinity Biotech has launched the test in countries throughout the European Union as well as other countries that recognise the CE Mark designation. This is in addition to our launch of the product in the US following submission under the FDAs Emergency Use Authorisation pathway.
Test Overview
The test uses a recombinant form of coronavirus spike protein to detect IgG antibodies which are the focus for SARS-CoV-2 vaccine development. The detection of IgG antibodies indicates either past exposure to the virus or the desired immune response following vaccination.
Trinity Biotech expects that the antibody test will have a number of uses, including:
- Assessing if an individual has previously had a SARS-CoV-2 infection and may now be assumed immune.
- Monitoring individuals in the weeks and months following vaccination, to assess the degree to which their immune system builds an antibody response to the virus.
- Assisting governments manage the prevalence of Covid-19 immunity in the population.
- Screening people prior to vaccination to avoid vaccinating individuals who already have a circulating antibody response, particularly in an environment where vaccine supply is constrained.
The instrumentation platforms that perform this type of ELISA test are available in virtually all clinical testing laboratories. Trinity Biotech have significant capacity for ELISA manufacture within their current operations and intend to leverage their existing distribution network to optimise the commercialisation of the test kit.
Performance Evaluation
A study of healthcare workers using the Trinity Biotech ELISA took place between June and October 2020. In addition to extensive internal testing, eighty-eight participants provided appropriate samples for calculation of the Sensitivity and Specificity at ≥14 days post Day 0 (date of oro/nasopharyngeal swab). Participants were tested with a PCR test and the Trinity Biotech ELISA.
Sensitivity: 95.9%
Specificity: 100.0%
A high Specificity value indicates the potential risk of a false positive result as low - this is a critical parameter when determining immune status and minimising the risk of an individual being incorrectly determined as having immunity.
About Trinity Biotech
Trinity Biotech develops, acquires, manufactures and markets diagnostic systems, including both reagents and instrumentation, for the point-of-care and clinical laboratory segments of the diagnostic market. The products are used to detect infectious diseases and to quantify the level of Haemoglobin A1c and other chemistry parameters in serum, plasma and whole blood. Trinity Biotech sells direct in the United States, Germany, France and the U.K. and through a network of international distributors and strategic partners in over 75 countries worldwide. For further information please see the Company's website: www.trinitybiotech.com
Illumina and Helix Collaborate to Assess Prevalence of New SARS-CoV-2 UK Variant (B.1.1.7) in the US and Develop National Surveillance Infrastructure
5 January 2021 - With support from the Centers for Disease Control and Prevention (CDC), Illumina and Helix have already identified more than 50 cases of the new variant in the US
SAN DIEGO, 5 January 2021 -- Illumina, Inc. and Helix today announced a collaboration to augment national surveillance infrastructure in the US to track the emergence and prevalence of novel strains of SARS-CoV-2 with support from the CDC. The combination of Illumina’s sequencing technology and expertise and Helix’s national COVID-19 testing footprint will significantly expand the country’s existing surveillance efforts to detect and characterize emerging variants of SARS-CoV-2.
The collaboration has already demonstrated results – identifying 51 of the first 54 cases of B.1.1.7, the highly transmissible variant first found in the UK, reported in the US. Over the past several weeks, Helix has analyzed recent positive samples and identified those with ‘S gene dropout’ on their diagnostic PCR assay, indicating the potential presence of the emerging B1.1.7 variant in different regions in the US. Illumina then sequenced a subset of these ‘S gene dropout’ samples using Illumina’s COVIDSeq Test, which identified the B.1.1.7 variant in 4 samples from California and Florida.
“Genomic surveillance is essential in fighting the pandemic. Illumina is pleased to partner with the CDC and Helix to provide accurate sequencing that can contribute to rapidly scaling genomic surveillance in the US to better understand the presence of B.1.1.7 and other variants as they emerge in our communities,” said Dr. Phil Febbo, M.D., Chief Medical Officer of Illumina.
“Having a robust surveillance effort in place is critical to understanding how the SARS-CoV-2 virus is evolving, and how our public health response needs to adapt,” said Dr. James Lu, M.D., Ph.D., co-founder and President of Helix. “By bringing together the strengths of Helix, Illumina, and the CDC, we were able to quickly evaluate the prevalence of this new variant and take learnings from this effort to better and more proactively characterize future strains that will emerge.”
Helix and Illumina are expanding the scope of their collaboration to examine a higher volume of samples on an ongoing basis for both the presence of B.1.1.7 and new strains. This will empower public and private entities to react quickly to any potential changes in pathogenicity of the virus or effectiveness of diagnostics, therapeutics, and vaccines.
About Illumina
Illumina is improving human health by unlocking the power of the genome. Our focus on innovation has established us as the global leader in DNA sequencing and array-based technologies, serving customers in the research, clinical, and applied markets. Our products are used for applications in the life sciences, oncology, reproductive health, agriculture, and other emerging segments. To learn more, visit www.illumina.com.
About Helix
Helix is the leading population genomics company operating at the intersection of clinical care, research, and genomics. Its end-to-end platform enables health systems, life sciences companies, and payers to advance genomic research and accelerate the integration of genomic data into clinical care. Powered by one of the world’s largest CLIA / CAP next-generation sequencing labs and its proprietary Exome+® assay, Helix supports all aspects of population genomics including recruitment and engagement, clinically actionable disease screening, return of results, and basic and translational research. In response to the COVID-19 public health crisis, Helix has launched a sensitive and scalable end-to-end COVID-19 test system to meet the needs of health systems, employers, governments, and other organizations across the country. Learn more at www.helix.com.
Quidel receives Emergency Use Authorization for moderately complex Solana® SARS molecular test for COVID-19 diagnosis
23 December 2020 - Proprietary RT-HDA Assay Yields Accurate Results from up to 11 Samples in 25 Minutes. Simplified Process Requires No Sample Extraction and Minimal Hands-on Time.
SAN DIEGO, 23 December 2020 -- Quidel Corporation (“Quidel”), a leading provider of rapid diagnostic testing solutions, cellular-based virology assays and molecular diagnostic systems, announced today that it has received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) to market its Solana® SARS-CoV-2 Assay, an isothermal Reverse Transcriptase - Helicase-Dependent Amplification (RT-HDA) assay intended for the qualitative detection of nucleic acid from SARS-CoV-2 in nasopharyngeal (NP) and nasal (NS) swab specimens in viral transport media from patients suspected of COVID-19 by their healthcare provider. Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, to perform high and moderate complexity tests.
The Solana® SARS CoV-2 offers a number of advantages over competing laboratory-based molecular diagnostic test protocols for COVID-19, including: a simple workflow with no sample extraction; a medium volume throughput design that is ideal for batch testing and improved laboratory efficiency; and a fast, 25-minute run time for up to 11 samples. The assay consists of two main steps: (1) specimen preparation, and (2) amplification and detection of target sequences specific to SARS-CoV-2 using Quidel’s proprietary isothermal Reverse Transcriptase – Helicase-Dependent Amplification (RT-HDA) in the presence of target-specific fluorescence probes. The Solana® instrument objectively measures and interprets a fluorescent signal, reports the test results to the user on its display screen, and can print out the results via an integrated printer.
Quidel’s Solana® bench-top instrument is designed for maximum space efficiency and ease of use. The small-profile instrument features an interactive touchscreen and barcode scanner for easy data entry, Ethernet and USB ports for data transfer and printing and compatibility with Dymo Label Writer systems. Solana® also comes with access to Quidel’s proprietary Virena® data management and surveillance ecosystem, which provides aggregated, de-identified testing data to public health authorities in near real time.
“With so many of our nation’s laboratories overwhelmed by demand for COVID-19 tests and under pressure to produce more timely results, there is a compelling societal need for the throughput and quick runtime offered by our new Solana® molecular testing technology,” said Douglas Bryant, president and CEO of Quidel Corporation. “Joining our Lyra® and Lyra® Direct assays for SARS-CoV-2, we now offer another molecular weapon in the fight against COVID-19 to quickly diagnose symptomatic patient populations. The Solana® SARS-CoV-2 Assay nicely complements our Sofia® and QuickVue® tests that are run at the point-of-care, for pre-symptomatic, asymptomatic and symptomatic patients. We are pleased to bring the benefits of our proprietary RT-HDA technology to detect COVID-19 to the marketplace and further democratize access to testing across the country. Solana® is a powerful diagnostic solution at a critical time.”
Solana® is an established Quidel brand with more than 1,000 instruments and ten different 510(k) cleared Solana® diagnostic assay applications in the market. In addition to laboratories, Solana® is ideal for use in small- to medium-sized hospitals that cannot afford the space requirements or expense of traditional diagnostic machinery. Solana® also eliminates the need for healthcare facilities to send patient test samples out for processing -- saving time and costs while reducing the backlog at central laboratories.
“We are proud of the commitment demonstrated by our Quidel team since the first day we started developing our PCR, rapid antigen and HDA tests for COVID-19,” Mr. Bryant added. “Our people have worked around the clock to create these life-saving diagnostic innovations and their ability to speed and scale production has been extraordinary.”
Solana® is a bench top instrument that combines Quidel’s proprietary helicase-dependent amplification (HDA) with fluorescence detection to deliver molecular results faster than ever before. Isothermal amplification eliminates thermal cycling, operating at one temperature in one tube to reduce the time to result to as little as 25 minutes. Solana®’s simplified workflow also avoids the need for specialized molecular operator training, making Solana easily adoptable in CLIA certified settings.
In addition to the Solana® SARS CoV-2 assay, Quidel’s Solana® instrument can run a suite of diagnostic assays and panels including Bordetella, C. Difficile, GAS, GBS, HSV 1+2/VSV, Influenza A+B, Respiratory Viral Panel, RSV + hMPV, Strep, and Trichomonas.
Background Information:
Quidel Corporation operates at the forefront of the battle against the coronavirus pandemic. Quidel received Emergency Use Authorization (EUA) from the FDA for its Lyra® SARS-CoV-2 Assay, a real-time RT-PCR test intended for the qualitative detection of nucleic acid from COVID-19 on March 17, 2020. Lyra® is a leading molecular test for COVID-19.
On May 8, 2020, Quidel was first to market in the U.S. with a rapid antigen test that delivers results in 15 minutes. Quidel's Sofia® SARS Antigen FIA set the bar for antigen test accuracy, proving to be in agreement with PCR results 96.7% of the time.
Quidel developed the first visually read lateral flow flu test, the QuickVue® Influenza A/B Test, which received FDA approval in September of 1999. QuickVue® was also the first flu test cleared by the FDA for use in CLIA-Waived point-of-care facilities like doctors’ offices, urgent care clinics and pharmacies.
QuickVue® is a market leading platform for visually diagnosing Influenza, respiratory syncytial virus (RSV), Strep A and a variety of other illnesses. Since its FDA approval in 1999, more than 150 million QuickVue® units have been sold.
Sofia® 2 is Quidel’s best-selling cartridge-based, instrument read rapid diagnostic system for infectious disease testing, which utilizes fluorescent chemistry design, an intuitive graphical user interface, and optics system to provide a highly accurate, objective and automated result in 15 minutes. The Sofia® 2 system also comes connected to Virena®, Quidel’s data management system, which provides aggregated, de-identified testing data to public health authorities in near real time.
Quidel recently doubled its production of Sofia® rapid antigen tests to the current rate of approximately two million tests per week. The company is building additional production lines that we expect will more than double current capacity once again. Our goal is to reach a run-rate of over 240 million tests per year by the third quarter of 2021.
About Quidel Corporation
Quidel Corporation is a leading manufacturer of diagnostic solutions at the point of care, delivering a continuum of rapid testing technologies that further improve the quality of health care throughout the globe. An innovator for over 40 years in the medical device industry, Quidel pioneered the first FDA-cleared point-of-care test for influenza in 1999 and was the first to market a rapid SARS-CoV-2 antigen test in the U.S. Under trusted brand names Sofia®, Solana®, Lyra®, Triage® and QuickVue®, Quidel’s comprehensive product portfolio includes tests for a wide range of infectious diseases, cardiac and autoimmune biomarkers, as well as a host of products to detect COVID-19. With products made in America, Quidel’s mission is to provide patients with immediate and frequent access to highly accurate, affordable testing for the good of our families, our communities and the world. For more information about Quidel, visit quidel.com.
Sysmex Obtains Marketing Approval for the HISCLTM IFN-λ3 Assay Kit, a Test Kit to Assist in Determining Exacerbation Risk in Novel Coronavirus (SARS-CoV-2)-Positive Patients
23 December 2020 - TARGET MARKET: JAPAN
23 December 2020 -- Sysmex Corporation obtained marketing approval on December 22, 2020 for the HISCL IFN-λ3 reagent, an interferon-λ3 kit.
The new product can be used in combination with the HISCL-5000/HISCL-800 Automated Immunoassay Systems to measure the serum level of interferon-λ3 (IFN-λ3) to provide information to assist in determining the exacerbation risk in SARS-CoV-2-positive patients.
Respiratory infections are diseases caused by pathogens infecting the respiratory system including the nasal cavity, pharynx, trachea, bronchi, and alveoli. These pathogens include viruses, bacteria, fungi, and parasites; the viruses include coronaviruses and influenza.
It has been reported that patients infected with SARS-CoV-2 experience cold symptoms, such as fever, as well as symptoms of respiratory infection, such as dysgeusia and dysosmia. Ninety percent of patients recover and experience mild or moderate symptoms, whereas 10% develop severe symptoms that require oxygen inhalation or ventilators. Severely affected patients have a characteristic clinical course in which they experience seemingly mild symptoms in the early stages of the disease, but then rapidly worsen to the point where oxygen ventilators are required.
Through joint research, Sysmex and the National Center for Global Health and Medicine have identified IFN-λ3, which is a useful biomarker for discriminating patients who are at high risk of worsening symptoms. It has been found that the blood level of IFN-λ3 rises rapidly several days before severe symptoms become apparent. IFN-λ3 has also been reported to be clinically useful for predicting the onset of severe symptoms resulting from the novel coronavirus disease (COVID-19) and for assisting with follow-up.
On December 22, 2020, Sysmex obtained marketing approval for the interferon-λ3 kit, the HISCL IFN-λ3 Assay Kit. This product can be used in combination with HISCL-5000/HISCL-800 Automated Immunoassay Systems to measure IFN-λ3 in serum, and thereby assist in determining the exacerbation risk in SARS-CoV-2-positive patients. A rapid reaction time of 17 minutes and an hourly throughput of 200 tests (in the case of HISCL-5000) ensure fast and efficient testing.
In clinical settings, being able to predict if a condition is likely to become more severe helps doctors focus on providing the most comprehensive treatment for high-risk patients. This means that limited medical resources can be allocated more efficiently, leading to a reduction in the psychological stress not only on patients and their families, but also on healthcare professionals.
Development of therapies which utilize the IFN-λ3 test results of patients under treatment as an indicator of exacerbation will, if successful, help to reduce disease severity and mortality, making more effective treatment a feasible prospect in the future.
Sysmex will contribute to research on COVID-19 and the establishment of its diagnosis and treatment through a variety of tests, including PCR, antigen, antibody, and cytokine tests, as well as existing hematology and hemostasis tests. We will also continue to investigate the clinical usefulness of other promising biomarkers.
Walgreens and Labcorp Make Pixel by Labcorp™ At-Home COVID-19 Collection Kit Available Through Walgreens Find Care®
21 December 2020 - Kit Can Allow More People to Get Tested, Helping Reduce the Spread of the Virus and Improving the Health of Communities
DEERFIELD, Ill. & BURLINGTON, N.C., Dec. 21, 2020 -- Labcorp, a leading global life sciences company that is focused on advancing health and guiding patient care decisions, and Walgreens today announced that the Pixel by Labcorp™ At-Home COVID-19 Collection Kit is now available from Labcorp through Walgreens Find Care®, a digital health platform available on the Walgreens app and Walgreens.com. Walgreens currently offers COVID-19 testing in more than 1,100 drive-thru locations across the country.
Using Walgreens Find Care®, customers can connect to the Pixel by Labcorp website to request the test after completing a short COVID-19 survey to determine eligibility. The kit will be shipped via FedEx Express Overnight to the customer’s home, where they can self-administer the test collection using a short nasal swab and send their sample back to Labcorp. Once processed by Labcorp, test results are accessed by the customer via the Pixel by Labcorp site. If a COVID-19 test is positive, a healthcare staff member will contact individuals directly by phone or mail to discuss next steps. Pixel by Labcorp has contracted with a physician network to provide independent physician services for testing. The Pixel by Labcorp At-Home COVID-19 Collection Kit is not a substitute for visits to a healthcare professional and is for use by adults 18 and older.
“Labcorp and Walgreens share a common goal of helping customers find easy and safe ways to get COVID-19 test results and make informed health decisions,” said Amy Summy, executive vice president and chief marketing officer, Labcorp. “We’re excited to expand our collaboration and make our popular and easy-to-use Pixel by Labcorp At-Home COVID-19 Collection Kit available to even more customers.”
Walgreens Find Care® helps patients manage their healthcare from the comfort of their own home, including accessing convenient in-person and virtual doctor visits for a range of services, such as scheduling a test in any of the Labcorp patient service centers nationally. In addition, Walgreens Find Care® can be used to book appointments for a range of services like urgent care, telehealth, for physician second opinions, mental health, and even optical services. The platform offers an integrated healthcare and pharmacy experience to empower people to get care when and how they need it from local and national providers they trust, all through the convenience of the Walgreens mobile app or online at Walgreens.com/findcare.
Currently through Walgreens Find Care®, patients can access more than 40 trusted providers that together offer more than 60 services and treat more than 100 conditions. The launch of additional features and providers on Walgreens Find Care® coincided with guidance from the Centers for Disease Control and Prevention (CDC) to use telehealth to help address medical needs while supporting social distancing, an important step in managing the impact of COVID-19.
“The expanded collaboration between Labcorp and Walgreens reflects both companies' shared objective to provide health services that help our communities,” said Giovanni Monti, senior vice president of healthcare services, Walgreens Boots Alliance. “We are committed to working together to make it even easier for our customers to get safe access to COVID-19 testing.”
Labcorp’s COVID-19 PCR test has not been FDA cleared or approved and has been authorized by the FDA under an emergency use authorization only for the detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens. The test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostic tests for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.
About Labcorp
Labcorp is a leading global life sciences company that provides vital information to help doctors, hospitals, pharmaceutical companies, researchers, and patients make clear and confident decisions. Through our unparalleled diagnostics and drug development capabilities, we provide insights and accelerate innovations to improve health and save lives. With over 70,000 employees, we serve clients in more than 100 countries. Labcorp (NYSE: LH) reported revenue of $11.5 billion in FY2019. Learn more about us at www.Labcorp.com or follow us on LinkedIn and Twitter @Labcorp.
About Walgreens
Walgreens (www.walgreens.com) is included in the Retail Pharmacy USA Division of Walgreens Boots Alliance, Inc. (Nasdaq: WBA), a global leader in retail and wholesale pharmacy. As America’s most loved pharmacy, health and beauty company, Walgreens purpose is to champion the health and wellbeing of every community in America. Operating more than 9,000 retail locations across America, Puerto Rico and the U.S. Virgin Islands, Walgreens is proud to be a neighborhood health destination serving approximately 8 million customers each day. Walgreens pharmacists play a critical role in the U.S. healthcare system by providing a wide range of pharmacy and healthcare services. To best meet the needs of customers and patients, Walgreens offers a true omnichannel experience, with platforms bringing together physical and digital, supported by the latest technology to deliver high-quality products and services in local communities nationwide.
Q BioMed Technology Partner Mannin Research Inc. Announced as Member of Canadian National COVID-19 Consortium
21 December 2020 - Group Secures $5.1M to Expand Platform for COVID Research
NEW YORK, December 21, 2020 – Q BioMed, Inc. is pleased to announce that its technology partner Mannin Research Inc. (MRI), a private Canadian biotechnology company, is a member of the Canadian national COVID Cloud consortium.
The platform will be used by MRI to help understand, predict, and treat COVID-19 with molecular precision.
MRI is developing a host-directed approach to treating patients with COVID-19 suffering from Acute Respiratory Distress Syndrome (ARDS). MRI is contributing to the development of the COVID-19 platform so as to provide information that will improve the effectiveness of its novel therapeutic for COVID-19 patients, code named MAN-19.
The Canadian national consortium will expand development of a software platform for genomics and health data and apply it to COVID-19 research and drug development utilizing $5.1M CAD in co-funding by Canada’s Digital Technology Supercluster and aims to increase Canada’s capacity to harness exponentially growing volumes of genomics and biomedical data to advance precision health. With a global death count of over 1.4 million people and record numbers of cases nationally, solutions that can help Canada respond to ongoing challenges of the pandemic are urgently needed.
The consortium is a collaboration between BioSymetrics, Centre of Genomics and Policy at McGill University, DNAstack, FACIT, Genome BC, Mannin Research, McMaster University, Microsoft Canada, Ontario Genomics, Ontario Institute for Cancer Research, Roche Canada, Sunnybrook Research Institute, and Vector Institute. It leverages past work of partners to address needs of infectious disease research with guidance from domain experts.
“We are very proud to contribute to such an important effort in Canada, as it will have an impact not only on Canadian’s healthcare but on COVID-19 patients around the world, as we learn more about the disease and ways we can treat patients with it”, said George N. Nikopoulos, President and CEO of Mannin Research Inc.
For more information, visit dnastack.com/solutions/covid-cloud.
About Mannin Research Inc.
Mannin Research is a research-stage biotechnology company focused on the discovery, development, and commercialization of first-in-class therapeutics for vascular diseases. Mannin Research main platform is built on the expertise in activation of Angiopoietin-Tie2 signalling pathway, a major regulator of vascular endothelium with a broad range of therapeutic applications.
Acute respiratory distress syndrome (ARDS) is a major severe complication of viral respiratory infections and the primary cause of mortality of COVID-19 patients. It is associated with profound vascular inflammation leading to pulmonary edema and hypoxemic respiratory failure. In the face of the global COVID-19 pandemic, Mannin Research is developing novel therapeutics to stabilize lung endothelial barrier integrity and reduce vascular leakage. These therapeutics offer novel virus-independent, host-directed strategies to support patients with critical respiratory illness and prevent negative outcomes.
About Digital Technology Supercluster
The Digital Technology Supercluster solves some of industry's and society's biggest problems through Canadian-made technologies. We bring together private and public sector organizations of all sizes to address challenges facing Canada's economic sectors including healthcare, natural resources, manufacturing and transportation. Through this 'collaborative innovation' the Supercluster helps to drive solutions better than any single organization could on its own. The Digital Technology Supercluster is led by industry leaders such as D-Wave, Finger Food Advanced Technology Group, LifeLabs, LlamaZOO, Lululemon, MDA, Microsoft, Mosaic Forest Management, Sanctuary AI, Teck Resources Limited, TELUS, Terramera, and 1Qbit. Together, we work to position Canada as a global hub for digital innovation. A full list of Members can be found here.
About the COVID-19 Program
The COVID-19 Program aims to improve the health and safety of Canadians and support Canada's ability to address issues created by the COVID-19 outbreak. In addition, the program will build expertise and capacity to anticipate and address issues that may arise in future health crises, from healthcare to a return to work and community. More information can be found here.
Please visit www.QBioMed.com for more information on our various pipeline products.
About Q BioMed Inc.
Q BioMed Inc. is a biotech acceleration and commercial stage company. We are focused on licensing and acquiring undervalued biomedical assets in the healthcare sector. Q BioMed is dedicated to providing these target assets; strategic resources, developmental support, and expansion capital to ensure they meet their developmental potential, enabling them to provide products to patients in need.
Beckman Coulter Launches one of the First High-Quality, High-Throughput COVID-19 Antigen Test Ideal for Mass Testing in the U.S.
18 December 2020 - The Access SARS-CoV-2 Antigen assay is offered to healthcare providers at $4, making reliable and frequent mass testing affordable. Assay’s limit of detection is 2 to 200 times lower therefore more sensitive than most point-of-care (POC) antigen tests. Test runs on Beckman Coulter’s analyzers capable of processing up to 200 samples per hour, enabling high throughput screening in just 30 minutes and addressing the scalability constraints of POC tests. Company is submitting for EUA and can ship up to 25 million tests per month.
BREA, CALIF., DEC. 18, 2020 — Beckman Coulter, a leader in clinical diagnostics, today announced the launch of a new test that addresses the three main barriers currently facing schools, businesses, hospitals and communities with the rollout of mass COVID-19 testing. The new Access SARS-CoV-2 Antigen assay is one of the first cost-effective high-quality, high-throughput COVID-19 test available in the U.S. with the volume, workflow and scalable flexibility needed to help fight the COVID-19 pandemic.
The Access SARS-CoV-2 Antigen assay has proven 93% Positive Percent Agreement (PPA) within seven days post symptom onset and 100% Negative Percent Agreement (NPA). Additionally, the assay and has a limit of detection of 33 TCID50/mL, which is 2 to 200 times lower and therefore more sensitive than the reported limits of detection for most of the available point-of-care (POC) antigen tests. Results of the Beckman Coulter antigen test can be delivered in as little as 30 minutes on the organizations’ immunoassay analyzers, including the DxI 800, a high-throughput analyzer capable of processing 200 samples per hour.
According to the Rockefeller Foundation, 4.3 million COVID-19 tests per day are recommended to help minimize infection spread and save lives. New York University economist Paul Romer suggested recently that number could be significantly higher. Currently, only about 1.8 million RT-PCR tests are performed daily in the U.S.
While several point of care (POC) antigen tests are now available to help increase testing beyond current levels, POC tests come with workflow challenges when scaled to large patient populations. Beckman Coulter’s SARS CoV-2 Antigen test is designed to address these challenges. The organization can deliver up to 25 million tests per month, and the assay separates sample collection and processing, enabling test providers to leverage the existing infrastructure and workflows.
Additionally, Beckman Coulter’s new assay is priced at $4 to all healthcare providers, including public and private institutions, governments and non-profits to enable frequent testing.
Beckman Coulter’s new antigen test is appropriate for many of the same populations as RT-PCR tests—individuals who are suspected of COVID-19 infection by their healthcare providers for various reasons, including known exposure or working in high-risk environments. According to the CDC, antigen tests can be used in high-risk settings, such as nursing homes, hospitals, universities and other group settings where repeat testing, coupled with relevant clinical information could identify COVID-19 infection to minimize transmission. In addition, the FDA recently stated that it is now allowing antigen and molecular diagnostic tests to be used off-label in testing asymptomatic patients, as directed by a prescriber for prescription-use tests.
The Beckman Coulter antigen test can be a reliable alternative for laboratories to manage test demand and decrease their testing turnaround times. Moreover, while POC antigen tests have a purpose in diagnosing COVID-19, they are difficult and resource intensive to address high-volume testing needs.
Dr. Feinglass added, “A point-of-care test that delivers a result in 15 minutes for a single individual cannot perform as efficiently when it’s asked to deliver results for larger populations; the workflow breaks down with too many manual steps in the process. Furthermore, a hospital must report positive results to regulatory bodies, and many POC tests require cumbersome manual recording of patient data into their EMR.”
In contrast to the cumbersome workflow of POC antigen tests, the Beckman Coulter antigen test samples are collected with a nasopharyngeal swab at the point of care and can be stored at room temperature for up to 24 hours and refrigerated for 48 hours while transporting to the laboratory for processing. The ability to separate the sample collection from sample processing allows for flexibility to meet the needs of all Beckman Coulter customers from small laboratories that operate a desktop analyzer, to large laboratories that implement automated, high-throughput analyzers for mass testing.
Whether on a desktop or high-throughput analyzer, results are delivered electronically to physicians, patient portals and health agencies, allowing clinicians to initiate proper treatment, isolate patients, and start contact tracing, helping to minimize the spread of COVID-19.
Nicholas Decker, MLS (ASCP) laboratory director at Memorial Healthcare, “RT-PCR is a great tool; however, it is not one-size fits all. Affordable antigen testing is battle tested and has the ability to turn a laboratory into a well-rounded partner for our providers and patients.”
Beckman Coulter is filing for Emergency Use Authorization of the assay with the U.S. Food and Drug Administration (FDA) and can immediately begin shipping 18 million tests per month, and ramp to 25 million tests per month by March 2021 to its customer base throughout the U.S. and Puerto Rico under Policy C. The test will be made available to markets accepting the CE Mark in January 2021.
To learn more about the $4 Access SARS-CoV-2 Antigen assay including how to place an order, or for the latest information on Beckman Coulter’s response to COVID-19, visit www.beckmancoulter.com/antigenassay.
About Beckman Coulter’s Suite of COVID-19 Testing Solutions
Beckman Coulter’s suite of COVID-19 assays includes the $4 Access SAR-CoV-2 Antigen assay, as well as two qualitative antibody assays: Access SARS-CoV-2 IgM and Access SARS CoV-2 IgG assay, and a SARS-CoV-2 semi-quantitative IgG assay. The company also has an interleukin 6 (IL-6) assay, can be used to aid physicians identifying a severe inflammatory response and determining the risk of intubation with mechanical ventilation in COVID-19 patients.
All of Beckman Coulter’s assay to address COVID-19 can be performed in automated or high-throughput immunoassay formats, as well as with Beckman Coulter’s Access 2 analyzer, a compact, table-top analyzer enabling high-quality serology testing to be carried out in small hospitals and clinics. Additionally, all of the assays seamlessly integrate into laboratory workflows making it easy to add these tests to routine blood tests performed during inpatient and wellness testing.
About Beckman Coulter
Beckman Coulter is committed to advancing healthcare for every person by applying the power of science, technology and the passion and creativity of our teams to enhance the diagnostic laboratory’s role in improving healthcare outcomes. Our diagnostic systems are used in complex biomedical testing, and are found in hospitals, reference laboratories and physician office settings around the globe. Beckman Coulter offers a unique combination of people, processes and solutions designed to elevate the performance of clinical laboratories and healthcare networks. We do this by accelerating care with a menu that matters, bringing the benefit of automation to all, delivering greater insights through clinical informatics and unlocking hidden value through performance partnership. An operating company of Danaher Corporation since 2011, Beckman Coulter is headquartered in Brea, Calif., and has more than 11,000 global associates working diligently to make the world a healthier place.
Quest Diagnostics and The Commons Project to Deliver Convenient Access to Lab Data -- Including COVID-19 Test Results -- Through the CommonHealth App
17 December 2020 - Android device users can now securely collect, store and share personal health data, including COVID-19 test results, from a single app Collaboration to include a privacy preserving way for individuals traveling internationally to confirm their vaccination information and COVID-19 status
SECAUCUS, N.J., Dec. 17, 2020 -- Quest Diagnostics, the world's leading provider of diagnostic information services, and The Commons Project, a non-profit public trust dedicated to building and operating global digital platforms and services for public good, today announced a collaboration that will give individuals more control over how and when they can access their data.
With the new collaboration, Quest Diagnostics also joins a handful of industry members of the Commons Project Foundation, which is focused on enabling people to access digital versions of their COVID-19 test results and vaccination records in order to more safely open international borders and resume economic activity.
Through the new collaboration, individuals can elect to access their Quest Diagnostics laboratory testing data through CommonHealth, the privacy-preserving Android app. The solution makes it easier for patients to access and review all their health data on a single, secure app.
"As patients navigate their health during the pandemic, and beyond, it is more important than ever to have their health data in one place," said Cathy Doherty, Senior Vice President and Group Executive, Clinical Franchise Solutions and Marketing for Quest Diagnostics. "By making Quest Diagnostics lab results accessible via CommonHealth, more individuals will have convenient access to their most critical and up-to-date health information, for better health decisions powered by diagnostic insights."
Approximately 55 percent of people in the United States are Android users. CommonHealth – available as a free download via Google Play – is the first and the only platform designed to allow users of the Android operating system to manage their medical records on Android-enabled devices and smartphones.
"As we expand our network with digital solutions that help people better manage their health, we need trusted members to help provide secure lab results and vaccination data in a timely and accurate way," said Dr. Brad Perkins, CMO, The Commons Project. "Our collaboration with Quest unlocks access to the world's largest database of clinical lab results for more than half the population that uses Android devices, putting them in control of their private health data."
CommonHealth aggregates health information, such as lab test results and vaccine information, from more than 320 U.S. hospitals and allows users to download, store, manage and share with other apps and services they trust. In doing so, Quest Diagnostics and The Commons Project intend to accelerate a shared vision to improve people's lives by giving them greater insight and control over their health data.
Quest's Commitment to Consumer Empowered Health
Quest Diagnostics has long been at the forefront of the movement for consumer empowerment in healthcare. The company was among the first diagnostic information services providers to offer free access to test results online and other channels. Its mobile app and patient portal, called MyQuest, provides its more than 14 million users a way to securely access and track their test results and other health data. The company's QuestDirect service provides dozens of tests for conditions ranging from heart health and sexually transmitted diseases. For added convenience, the company now offers at-home self-collection devices for tests including COVID-19 infection, diabetes, and hormones. Through its collaborations with Safeway and Walmart, Quest Diagnostics operates approximately 200 patient service centers in retail store locations, for the utmost in convenient access. Quest Diagnostics also provides next-generation sequencing and genotyping services for Ancestry.
About Quest Diagnostics
Quest Diagnostics empowers people to take action to improve health outcomes. Derived from the world's largest database of clinical lab results, our diagnostic insights reveal new avenues to identify and treat disease, inspire healthy behaviors and improve health care management. Quest annually serves one in three adult Americans and half the physicians and hospitals in the United States, and our 47,000 employees understand that, in the right hands and with the right context, our diagnostic insights can inspire actions that transform lives. www.QuestDiagnostics.com
About The Commons Project
The Commons Project is a non-profit public trust building global digital services and platforms for the common good. Founded with support from the Rockefeller Foundation and based in Switzerland, it was established to build and operate the shared platforms and services that neither governments nor tech companies are well-positioned to create. The Commons Project's public trust governance structure is designed to ensure that people's interests are served above all.
BD Surpasses 1 Billion Injection Device Orders in Support of COVID-19 Vaccination Efforts Around the World
16 December 2020
FRANKLIN LAKES, N.J., Dec. 16, 2020 -- BD (Becton, Dickinson and Company), a leading global medical technology company, today announced that it has received pandemic orders for needles and syringes totaling more than 1 billion injection devices to support global COVID-19 vaccination planning efforts.
This milestone reflects commitments from governments across the world, including the United States, Australia, Belgium, Canada, Germany, Netherlands, Saudi Arabia, Spain and the United Kingdom, among several others, as well as non-governmental organizations supporting vaccine deployment for developing countries.
Shipments are already underway and more than 300 million injection devices have been delivered around the world to date, with the remaining orders to be delivered between now and the end of 2021 to support vaccine administration. These devices are being shipped to governments or appointed distribution partners where they will then be distributed to health care facilities based on each country's individual distribution and allocation strategy. BD continues to be in discussions with governments and non-governmental organizations on the need to place orders immediately for delivery later in calendar year 2021 and 2022.
"This milestone is more than just a number – it represents hundreds of millions of people around the world, such as frontline workers and at-risk loved ones who will now be able to receive a vaccination the moment vaccines are available," said Rick Byrd, president of Medication Delivery Solutions for BD. "We recognize our manufacturing and supply chain teams who are working around the clock to make and deliver these essential devices throughout the world. From our decades of immunization experience, we also know our work doesn't stop at delivery. We are equally committed to providing resources to ensure health care communities globally have the right training tools and support on injection techniques to implement these campaigns."
The company continues to closely plan supply capabilities to ensure maximum volumes can be dedicated to COVID-19 efforts while minimizing disruption for routine health care and annual flu vaccination and childhood immunization programs.
In addition to supporting immediate efforts for COVID-19 vaccination readiness, BD is also working on multiple fronts to help ensure the global community is prepared for future pandemic vaccination efforts by:
- Partnering with the U.S. government on a $70 million capital project to further expand BD's operations and manufacturing capacity in Nebraska. The new capacity is expected to be online in summer 2021 and once completed, the federal government will have priority access to hundreds of millions of injection devices to support vaccination efforts for COVID-19 and future pandemics.
- Investing approximately $1.2 billion over a 4-year period to expand and upgrade manufacturing capacity and technology for pre-fillable syringes and advanced drug delivery systems to allow for continued growth of new injectable drugs and vaccines, but also provide surge capacity for increased pre-fillable syringe demand during times of pandemic response.
- Actively engaging with med-tech associations and research groups to address challenges, solutions and further innovation in support of a more sustainable future vaccine ecosystem.
BD is the largest manufacturer of injection devices in the world, producing billions of syringes and needles annually through its global manufacturing network. Learn more about BD's vaccination preparedness efforts at bd.com/vaccination.
In addition to ramping up manufacturing of needles and syringes, BD has been working closely with governments and multilateral organizations around the world to expand access to diagnostic testing and support treatment of COVID-19 patients. The company has supplied health care providers globally with millions of products used in of the fight against COVID-19, including swabs for flu and COVID-19 testing, rapid molecular diagnostic tests on the BD MAX™ System, 15-minute point-of-care antigen testing on the BD Veritor™ Plus System, infusion pumps, infusion sets and catheters. BD Biosciences instruments are also being used by researchers around the world to better understand the human immune response to COVID-19.
About BD
BD is one of the largest global medical technology companies in the world and is advancing the world of health by improving medical discovery, diagnostics and the delivery of care. The company supports the heroes on the frontlines of health care by developing innovative technology, services and solutions that help advance both clinical therapy for patients and clinical process for health care providers. BD and its 65,000 employees have a passion and commitment to help enhance the safety and efficiency of clinicians' care delivery process, enable laboratory scientists to accurately detect disease and advance researchers' capabilities to develop the next generation of diagnostics and therapeutics. BD has a presence in virtually every country and partners with organizations around the world to address some of the most challenging global health issues. By working in close collaboration with customers, BD can help enhance outcomes, lower costs, increase efficiencies, improve safety and expand access to health care. For more information on BD, please visit bd.com.
EUROIMMUN Launches Novel ELISA for Detection of SARS-CoV-2 Antigen in Acutely Infected Patients
16 December 2020 - Automatable and reliable COVID-19 test rounds out Company’s menu of offerings for acute diagnostics of the virus
WALTHAM, Mass. – December 16, 2020 – EUROIMMUN, a PerkinElmer, Inc. Company, today announced the launch of the CE marked SARS-CoV-2 Antigen ELISA for specific determination of the SARS-CoV-2 protein. The assay adds to the Company’s broad product portfolio for COVID-19 diagnostics and supports the molecular PCR tests to aid in diagnosing acute SARS-CoV-2 infections.
The Antigen ELISA is a laboratory test able to be applied in semi quantitative automatable detection of the SARS-CoV-2 nucleocapsid protein on a large scale. It is validated for swab sample material from the upper respiratory tract and is useful for testing individuals with acute symptoms that point to COVID-19 or who have had suspected contact with SARS-CoV-2. Validation data revealed 93.6% positive agreement (sensitivity) and 100% negative agreement (specificity) between results obtained with the Antigen ELISA and those obtained with a real time PCR test for detecting the virus. Based on the well-known ELISA technology, the SARS-CoV-2 Antigen assay can be performed in most diagnostic laboratory settings and automatically processed on all open ELISA platforms.
“Infection numbers are continuously increasing, and there is enormous pressure to provide sufficient test capacities. The availability of gold-standard PCR testing, however, is often challenged in acute COVID-19 outbreak situations. That’s why a reliable and automatable antigen detection test as our new ELISA can be a valuable supplement to help rapid identification of acutely infected individuals,” says Dr. Wolfgang Schlumberger, CEO of EUROIMMUN.
The SARS-CoV-2 Antigen ELISA is available in countries that recognize CE marking. Validation of saliva specimens for use with this assay is currently in process.
The assay is the latest of the comprehensive EUROIMMUN COVID-19 product portfolio and the third test to support acute COVID-19 diagnostics following the two molecular diagnostic systems: EURORealTime SARS-CoV-2 and EURORealTime SARS-CoV-2/Influenza A/B.
About PerkinElmer
PerkinElmer enables scientists, researchers and clinicians to address their most critical challenges across science and healthcare. With a mission focused on innovating for a healthier world, we deliver unique solutions to serve the diagnostics, life sciences, food and applied markets. We strategically partner with customers to enable earlier and more accurate insights supported by deep market knowledge and technical expertise. Our dedicated team of about 14,000 employees worldwide is passionate about helping customers work to create healthier families, improve the quality of life, and sustain the wellbeing and longevity of people globally. The Company reported revenue of approximately $2.9 billion in 2019, serves customers in 190 countries, and is a component of the S&P 500 index. Additional information is available through 1-877-PKI-NYSE, or at www.perkinelmer.com.
Abbott's BinaxNOW COVID-19 rapid test receives FDA Emergency Use Authorization for first virtually guided, at-home rapid test using EMED'S digital health platform
16 December 2020 - First at-home, virtually guided service to bring rapid, reliable and affordable testing into the home where the result is delivered in minutes. Abbott and eMed™ expect to deliver and administer 30 million BinaxNOW™ tests in the first quarter of 2021, with an additional 90 million in the second quarter. $25 cost for the test and service is the lowest available for at-home testing, which supports the home user to ensure a successful testing process. BinaxNOW is a highly portable, easy-to-use, 15-minute antigen test with no instrument that detects the virus when people are most infectious, which is critically important in slowing the spread of the virus. Service uses Abbott's complementary NAVICA™ app to enable the testing process and display authenticated BinaxNOW test results verified by a trained guide - and supports consumer confidence in testing at home.
ABBOTT PARK, Ill.,, Dec. 16, 2020 -- Abbott announced today that the U.S. Food and Drug Administration (FDA) has issued Emergency Use Authorization (EUA) for virtually guided at-home use of its BinaxNOW™ COVID-19 Ag Card rapid test for detection of COVID-19 infection. Abbott is bringing BinaxNOW, the most affordable and widely distributed rapid test into the home, where the result is delivered in minutes without the need to send it out for processing. The $25 cost for the test and service is the lowest currently available for at-home testing.
To facilitate the delivery of the BinaxNOW test to the home and the guided collection and testing process, Abbott has partnered with digital health solutions provider eMed™. This agreement furthers Abbott's vision of making as many tests as possible available in a variety of different settings to improve accessibility, support consumer confidence in testing at home, and help people start returning to living their daily lives with more normalcy.
Abbott and eMed expect to deliver and administer 30 million BinaxNOW at-home tests in the first quarter of 2021, with an additional 90 million in the second quarter. Scale is critical to provide broad access to people who need testing and Abbott has scale for all its eight COVID-19 lab and rapid tests. In fact, since launching BinaxNOW in August, Abbott has ramped up capacity to 50 million tests a month in its U.S. facilities that are currently being distributed through the federal government and is expanding further so even more people have access to the tests.
"As the pandemic has evolved, the need for rapid testing has only grown. Unfortunately, we're still hearing that many people can't access testing as quickly as they need it," said Robert B. Ford, Abbott's president and chief executive officer. "That's why Abbott is bringing our rapid BinaxNOW test and NAVICA platform into homes through this partnership with eMed, which allows us to maintain the integrity of the testing process, get even closer to people who need testing and help provide the confidence we need to help get back to living with a bit more normalcy."
The eMed service offering costs $25 a test, and eMed takes care of determining eligibility, the guided self-collection process, public health reporting requirements and gets people their results through their NAVICA app in a matter of minutes.
The eMed offering could also remove some of the obstacles that individuals, governments and organizations face when seeking to provide or perform testing. These include mobility issues for people with disabilities or who may not have a reliable form of transportation, inconvenient testing windows for people who work non-traditional hours or have childcare or eldercare responsibilities, and discouragingly long lines at testing centers.
"COVID-19 is the greatest public health threat our nation has experienced in a century," said Dr. Patrice Harris, CEO of eMed. "This pandemic has had devastating effects in every region of our country but particularly on seniors, essential workers and communities of color. FDA's authorization of Abbott's BinaxNOW test for home use is a breakthrough in the battle against COVID-19. I am proud to lead eMed's partnership with Abbott to democratize access to frequent, affordable, at-home testing with results in 15 minutes. Together we can help to mitigate the spread, save lives and support our return to school, work and play."
Through eMed and the NAVICA app, people can use authenticated BinaxNOW results to enter into venues that accept the NAVICA digital certificate. The virtually guided process preserves the integrity of the testing process and state-mandated reporting obligations, while ensuring equitable access to people who need tests through the prescription process. Real-time data generated from at-home testing can also help federal and state public health authorities to better understand the extent of an outbreak and take appropriate steps to control its spread.
How the at-home digital health service works
A person can access the eMed service through Abbott's NAVICA app, which can be downloaded from the Apple and Android app stores. Once eligibility requirements are met, the test kit is shipped directly to the home user or a pick-up location, allowing a person to remain isolated until their status is known.
Once a BinaxNOW test kit arrives at the home, the home user logs into the eMed portal for their guided testing session and can expect results in approximately 20 minutes. The eMed certified guide is available to answer questions throughout the testing process.
BinaxNOW at-home performance data
In an interim, ongoing analysis of data collected in the U.S. from four investigational sites – where people tested themselves or a child – on a total of 52 people ranging from less than one-year-old to 63 years of age, which included analyses of people by days post-symptom onset and Ct counts, results showed that BinaxNOW for at-home use delivered the following performance as compared to lab-based molecular PCR tests:
- Overall performance of 91.7% positive agreement (sensitivity) and 100% negative agreement (specificity) in people seven days or less post-symptom onset at all Ct counts.
- Performance of 100% positive agreement (sensitivity) in people seven days or less post-symptom onset with Ct counts of 33 or below. These are people who are most likely to be infectious and spread the virus to others due to their lower Ct values.
- The performance of BinaxNOW in the at-home setting is similar to performance in the larger post-authorization study (see section below in release).
There is a growing body of scientific literature and experience focused on the correlation between infectiousness, Ct counts and viral load. Specifically, scientific evidence suggests that at Ct counts in the 30s, the SARS-CoV-2 virus can't be replicated, meaning people are no longer infectious. This underscores the importance of frequent antigen testing to catch people with lower Ct counts while they are most contagious and need to self-quarantine.
- A study by La Scola et. al. published in the European Journal of Microbiology & Infectious Diseases, shows the inability to culture virus at Ct counts greater than or equal to 34.
- A recent study from the University of California-San Francisco of BinaxNOW in a real-life setting, which showed performance of 93.3% sensitivity and 99.9% specificity at a Ct count of 30 and below.
Ct counts are the number of times a PCR instrument must cycle through to amplify enough genetic material of the SARS CoV-2 virus for it to be detectable. The greater the amount of virus present (viral load), the fewer cycles required to detect the virus. A person with a higher viral load (and lower Ct count) is more likely to be infectious.
Updated BinaxNOW professional use data
As part of its submission to the FDA for at-home use, Abbott also released the latest clinical data for its BinaxNOW COVID-19 Ag Card professional use product (not inclusive of at-home data) to show real-world evidence of clinical utility and efficacy.
In data collected from ten clinical sites in 460 people ranging from 6 to more than 60 years of age, which included analyses of people by days post-symptom onset and Ct counts, results showed that BinaxNOW delivered the following performance as compared to lab-based molecular PCR tests:
- Overall performance of 84.6% positive agreement (sensitivity) and 98.5% negative agreement (specificity) in people seven days or less post-symptom onset at all Ct counts.
- Performance of 95.6% positive agreement (sensitivity) in people seven days or less post-symptom onset with Ct counts of 33 or below. These are people who are most likely to be infectious and spread the virus to others due to their lower Ct values.
Abbott also conducted multiple culture studies that consistently showed that Ct counts less than or equal to 28 are required to grow the virus in a lab. Other independent third-party studies have identified that higher Ct counts are correlated with a lack of infectiousness, and a rapid antigen test with high performance at a Ct count of 33 or below is able to detect the virus in people who are infectious.
Abbott continues to study the BinaxNOW COVID-19 Ag Card, including in asymptomatic people.
About the BinaxNOW COVID-19 Ag Card Home Test and NAVICA App
The BinaxNOW™ COVID-19 Ag Card Home Test is a lateral flow immunoassay intended for the qualitative detection of nucleocapsid protein antigen from SARS-CoV-2. This test is authorized for prescription home use with self-collected observed direct anterior nasal (nares) swab samples from individuals aged 15 years or older who are suspected of COVID-19 by their healthcare provider within the first seven days of symptom onset or adult collected nasal swab samples from individuals aged four years or older who are suspected of COVID-19 by their healthcare provider within the first seven days of symptom onset. The BinaxNOW COVID-19 Ag Card Home Test is to be performed only with the supervision of a telehealth proctor.
Along with BinaxNOW, Abbott is also offering a mobile app at no charge called NAVICA, which will allow people to display their results obtained through a healthcare provider or through the eMed at-home service when entering facilities requiring proof of testing. The NAVICA app is optional and an easy-to-use tool that allows people to store, access and display their results with organizations that accept the results so people can move about with greater confidence. The NAVICA app is supported by Apple and Android digital wallets and is available from public app stores in the U.S.
About Abbott
Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 107,000 colleagues serve people in more than 160 countries.
About eMed
eMed is democratizing healthcare with a digital point-of-care platform that provides fast, easy and affordable at-home healthcare testing, supervised and guided online by eMed Certified Guides. We utilize quantitative medicine to deliver prescribed tests and treatments directly to patients, driving better and more cost-effective results.
bioMérieux announces the CE marking of its molecular biology ARGENE® test for the simultaneous detection of SARS-CoV-2, influenza viruses A and B, and RSV and hMPV viruses
16 December 2020
Marcy l’Etoile, France – December 16, 2020 – bioMérieux, a world leader in the field of in vitro diagnostics, has announced the expansion of its ARGENE® range for the real-time PCR (RT-PCR) detection of SARS-CoV-2: the SARS-COV-2 RESPI R-GENE® test has received CE marking and is now commercially available.
This high-throughput test, which can be used on molecular biology platforms in hospital laboratories and private laboratories, allows the simultaneous (multiplex) detection of SARS-CoV-2 and influenza viruses A and B. In addition, it includes a cellular control to check the quality of the sample, providing an important clinical advantage in the context of the pandemic and large-scale sample collection at many different sites. In a single kit, this new test comes with a second RT-PCR analysis performed from the same extraction, for the detection of two other pathogens that often circulate at the same time and are particularly implicated in respiratory diseases affecting children and seniors: RSV (human respiratory syncytial virus) and hMPV (human metapneumovirus). hMPV is more rarely included in testing panels.
“Infections caused by respiratory viruses often have similar symptoms, but patient management may differ. Multiplex tests have a key role to play with the onset of winter and the flu season. Although the circulation of flu viruses is low to date, in light of the COVID-19 pandemic, it is even more important to detect other diseases associated with respiratory disease early on, especially for high-risk patient groups. This makes it possible to adapt clinical management and limit the circulation of these viruses,” explained François Lacoste, Executive VP, R&D.
The SARS-COV-2 RESPI R-GENE® test will be available in Europe and in countries that recognize the CE marking.
Genedrive notifies FDA of its intent to distribute the SARS-CoV-2 PCR test in the USA
16 December 2020
16 December 2020 -- Genedrive plc, the near patient molecular diagnostics company, announces that it notified the Food and Drug Association (FDA) in the United States of its intention to import and distribute its Genedrive 96 SARS-CoV-2 Kit prior to an Emergency Use Authorization (EUA) determination, as described in the guidance on Policy for Coronavirus Disease-2019 Tests During the Public Health Emergency, Section IV.C.2.
Notification was made on 25 November and acknowledged on 15 December. The current claims of the product cover high throughput testing on a variety of third-party RT-PCR platforms for upper respiratory track specimens.
David Budd, CEO of genedrive plc, said: “genedrive submitted its application to the FDA in May of this year but owing to the volume of applications received we are still waiting for EUA review. However, in order to support the Beckman Biomek system’s transition into clinical use and exploit commercial opportunities, the product needs to be commercially available in the United States to end users. We are confident in the performance claims of our assay and have generated independent evaluation data in the United States at non-automated sites and our automated Biomek installations which confirm our product claims.”
In light of the increasing numbers of COVID-19 cases throughout the US and the need to expand capacity for COVID-19 testing during the public health emergency, the FDA has stated that it does not object to a commercial manufacturer’s development and distribution of SARS-CoV-2 test kits for specimen testing for a reasonable period of time, where the test has been validated and while the manufacturer has made an Emergency Use Authorization request, where the manufacturer gives appropriate notification of validation to FDA, and where the manufacturer provides instructions for use of the test and posts data about the test’s performance characteristics on the manufacturer’s website.
The product will bear a labelling stating that “validation of this test has not been reviewed by FDA. Review under the EUA program is pending”.
Reference: https://www.genedrive.com/news/index.php
Abbott receives CE Mark for its COVID-19 IgG quantitative antibody blood test
15 December 2020 - SARS-CoV-2 IgG II Quant antibody test measures levels of IgG antibodies to help measure and understand a person's immune response. The test specifically identifies levels of IgG antibodies that attach to the virus' spike protein which can be helpful to evaluate a person's immune response to vaccines. CE Mark test will be available for use on Abbott's ARCHITECT® and Alinity i™ platforms. Abbott plans to submit its test for U.S. Food and Drug Administration (FDA) emergency use authorization soon.
ABBOTT PARK, Ill., Dec. 15, 2020 -- Abbott announced today it received CE Mark for its new quantitative SARS-CoV-2 IgG (Immunoglobulin G) lab-based serology test. IgG antibody testing that gives a quantitative result (measuring the amount of antibodies) provides important insights to people as they recover from COVID-19 and helps evaluate a person's immune response to a vaccine.
Countries around the world are preparing for the authorization and the distribution of COVID-19 vaccines. As these vaccines become available, healthcare professionals and researchers will need to assess how individuals and communities are responding.
"Testing will continue to help both identify those who are infected as well as determine whether people have had a natural or vaccine-induced immune response," said John Hackett, Ph.D., divisional vice president of Applied Research and Technology for Abbott's diagnostics business. "Quantitative antibody testing can help provide greater understanding of a person's immune response."
The evolution of serology testing during COVID-19
During the early months of the pandemic, Abbott launched its first COVID-19 IgG antibody blood test, which detects the nucleocapsid protein of the virus. The qualitative test continues to provide a better understanding of people's immune response to the virus, including potential duration of the recovery process. The new quantitative antibody test expands on this knowledge by determining both the presence and level (or titer) of antibodies present in the blood.
Abbott's scientists designed its quantitative assay to detect the spike protein of the virus, which plays an important part in how the virus enters the cells. As the body develops an immune response, antibodies develop and bind to the spike portion of the virus in order to block the protein and ultimately prevent infection.
Several vaccines are designed with the spike protein to trigger that same immune response. Research has also shown a correlation between rising IgG levels that target the spike protein, such as those in Abbott's quantitative test, and rising levels of neutralizing antibodies, or the specific antibodies that block infections. Studies are underway to understand the relationship between the levels of antibodies a person has and potential immunity from the virus.
As we continue to learn more about the virus, antibody tests may help:
- Determine and monitor a person's immune response to vaccines, including research to determine how long a response may last
- Assess whether a person's antibody levels are a result of the body's natural response to fighting the virus, versus a vaccine-induced response
- Evaluate an individual's level of antibodies to help determine eligibility and potency for convalescent plasma donations
The quantitative IgG antibody test is the latest in Abbott's broad portfolio of tests to support the global healthcare community in the fight against COVID-19. Abbott's COVID-19 test portfolio includes molecular, antigen and serology tests. These tests can help healthcare professionals detect the virus at all stages of its life cycle, including tests that are done in the lab as well as rapid tests done at the point of care.
About the SARS-CoV-2 IgG II Quant antibody test
Abbott's quantitative IgG antibody test is designed to detect levels of IgG antibodies that attach to the virus' spike protein on the virus surface in serum and plasma from individuals who are suspected to have had COVID-19, or in serum and plasma of subjects that may have been infected by SARS-CoV-2.
A study to determine the clinical performance of Abbott's SARS-CoV-2 IgG II Quant test on its Alinity i instrument found it had 99.60% specificity (ability to exclude false positives) and 99.35% sensitivity (ability to exclude false negatives) in patients tested 15 days or more after symptoms began.
The quantitative IgG test will be available on both the Abbott ARCHITECT and Alinity i platforms. Abbott is also developing a test and plans to submit for U.S. Food and Drug Administration (FDA) emergency use authorization soon.
About Abbott
Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 107,000 colleagues serve people in more than 160 countries.
EUROIMMUN Receives CE Mark for New PCR Test to Differentiate Between COVID-19 and Flu
14 December 2020 - Company expands testing portfolio for acute diagnostics of COVID-19
WALTHAM, Mass., December 14, 2020 – EUROIMMUN, a PerkinElmer, Inc. Company, today announced the launch of the CE marked EURORealTime SARS-CoV-2/Influenza A/B for direct detection of SARS-CoV-2, influenza virus type A and influenza virus type B. It expands the testing portfolio for acute COVID-19 diagnostics by supporting differential diagnostics between SARS-CoV-2 infections and the common flu. It is available in countries accepting the CE mark.
PCR technology is considered the gold standard for direct pathogen detection. The new EURORealTime test allows fast detection and differentiation of genetic material from SARS-CoV-2, influenza virus type A and influenza virus type B using throat swab samples of patients with acute symptoms, which can be indicative for COVID-19 or flu. Validation efforts revealed very high agreement of results obtained with the EURORealTime test and those obtained with reference PCR tests for SARS-CoV-2 and influenza A/B. No cross-reactions with other common respiratory pathogens were detected. The assay is compatible with common real-time PCR thermal cyclers, while the EURORealTime Analysis Software allows for reliable and standardized evaluation of the test results.
“As the flu season overlaps with the second wave of COVID-19, there is an increasing need to be able to quickly distinguish between SARS-CoV-2 and influenza infections. Individuals with these viral diseases can present with very similar symptoms which makes it difficult to differentiate between them. Here, direct pathogen detection plays a major role in rapid and correct identification of these infections as it is essential for proper subsequent patient management,” says Dr. Wolfgang Schlumberger, CEO of EUROIMMUN. “The combination of the three pathogens within this single multiparametric assay means saving valuable time and resources in the laboratories.”
The EURORealTime SARS-CoV-2/Influenza A/B assay adds to the Company’s broad product portfolio of COVID-19 diagnostics and is the second molecular assay for direct pathogen detection following the CE-marked and FDA-EUA approved EURORealTime SARS-CoV-2 assay. The EURORealTime SARS-CoV-2/Influenza A/B assay complements PerkinElmer’s PKamp™ Respiratory SARS-CoV-2 RT-PCR Panel that previously received the CE mark.
About PerkinElmer
PerkinElmer enables scientists, researchers and clinicians to address their most critical challenges across science and healthcare. With a mission focused on innovating for a healthier world, we deliver unique solutions to serve the diagnostics, life sciences, food and applied markets. We strategically partner with customers to enable earlier and more accurate insights supported by deep market knowledge and technical expertise. Our dedicated team of about 14,000 employees worldwide is passionate about helping customers work to create healthier families, improve the quality of life, and sustain the wellbeing and longevity of people globally. The Company reported revenue of approximately $2.9 billion in 2019, serves customers in 190 countries, and is a component of the S&P 500 index. Additional information is available through 1-877-PKI-NYSE, or at www.perkinelmer.com.
Roche launches laboratory SARS-CoV-2 antigen test to support high-volume testing of suspected COVID-19 patients
11 December 2020 - The Elecsys® SARS-CoV-2 Antigen test is an automated laboratory assay intended as an aid in the diagnosis of active SARS-CoV-2 infection. Roche will be able to ramp up to a double-digit million number of tests per month, by early 2021. The test is the latest addition to Roches comprehensive COVID-19 portfolio and can help in the management of patients for optimal care delivery.
Basel, 11 December 2020 -- Roche announced today that it has launched a high-throughput SARS-CoV-2 antigen test as an aid in the diagnosis of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) infections, in markets accepting the CE Mark. Roche has also filed for Emergency Use Authorisation (EUA) from the U.S. Food and Drug Administration.
The Elecsys® SARS-CoV-2 Antigen test is a highly accurate laboratory immunoassay for the in vitro qualitative detection of the nucleocapsid antigen of SARS‑CoV‑2. In clinical studies, the Elecsys SARS-CoV-2 Antigen test showed a 94.5% sensitivity across 200 PCR confirmed symptomatic individuals and a 99.9% specificity across 2747 PCR negative symptomatic and screening individuals. It is planned to ramp up production to have a double-digit million number of tests per month, in early 2021, depending on the demand of healthcare systems, globally. The test is performed by healthcare professionals and uses nasopharyngeal or oropharyngeal swab samples from patients with symptoms suggestive of COVID-19, or people with either known or suspected exposure to SARS-CoV-2. A widely available, laboratory-based automated antigen assay allows for cost and error reduction due to removal of manual handling as well as fast turn-around times and high test throughput.
“Healthcare systems remain under significant pressure to deliver robust testing options, with a sufficient number of tests available”, said Thomas Schinecker, CEO Roche Diagnostics. “The launch of our high-throughput antigen test will provide additional testing capacity to reliably support healthcare systems in diagnosing SARS-CoV-2 infection, as a supplement to PCR testing.”
About the Elecsys SARS-CoV-2 Antigen test
Roche’s Elecsys SARS-CoV-2 Antigen test is an immunoassay intended for the qualitative detection of SARS-CoV-2 present in the respiratory tract including nasopharynx and oropharynx. The Elecsys SARS-CoV-2 Antigen test is performed by healthcare professionals and could be used as an alternative or in conjunction with PCR testing. This is highly beneficial where reliable laboratory PCR testing is limited or not available. In symptomatic individuals, a positive result with the Elecsys SARS-CoV-2 Antigen test indicates an active SARS-CoV-2 infection with a likelihood of 94.5%. A negative result may require to be confirmed with a PCR test or repeated (antigen test) after one to two days, if other clinical indications point to a SARS-CoV-2 infection.
The Elecsys SARS-CoV-2 Antigen immunoassay runs on all cobas e immunochemistry analysers which are widely available around the world and allow for these test to be run alongside other COVID-19 infectious diseases diagnostic markers available from Roche, which run on the cobas e systems. These fully automated systems can provide test results in 18 minutes for a single test (excluding time for sample collection, transport, and preparation), with a throughput of up to 300 tests per hour from a single analyser, depending on the analyser.
About antigen testing
An antigen test detects proteins which are structural or functional components of a pathogen and are thus very specific to that pathogen. In this case, the test would provide a qualitative “yes/no” answer on the presence of the pathogen in the patient sample. If the target antigen is present in sufficient concentrations in the sample, it will bind to specific antibodies and generate a positive result, indicating an active infection.
In general, antigen tests have a high specificity, though are not as sensitive as PCR tests that amplify the target viral DNA or RNA sequence in order to generate a quantifiable signal to indicate the presence of the virus in a sample. Therefore, to make up for the potential decrease in sensitivity of an antigen test, negative results should be analysed together with additional patient factors, such as COVID-19 exposure history, clinical symptoms, additional test results to help guide the diagnosis and subsequent treatment of the patient.
| Detection of acute infections (SARS-CoV-2 PCR or Antigen) | Detection of immune response (SARS-CoV-2 Antibodies) |
|
| Laboratory setting | cobas® SARS-CoV-2 Test cobas® SARS-CoV-2 & Influenza A/B Test NEW: Elecsys® SARS-CoV-2 Antigen Test |
Elecsys® Anti-SARS-CoV-2 (N) immunoassay Elecsys® Anti-SARS-CoV-2 S Immunoassay |
| Point of Care setting (near patient) | SARS-CoV-2 Rapid Antigen Test cobas® Liat® SARS-CoV-2 Test |
SARS-CoV-2 Rapid Antibody Test |
About Roche’s response to the COVID-19 pandemic
As a leading healthcare company we are doing all we can to support countries in minimising the impact of COVID-19. We have developed a growing number of diagnostic solutions that help to detect and diagnose the infection in patients, as well as providing digital support to healthcare systems, and we continue to identify, develop and support potential therapies which can play a role in treating the disease.
We understand the impact of COVID-19 goes beyond those who contract it, which is why we are working with healthcare providers, laboratories, authorities and organisations to help make sure that patients continue to receive the tests, treatment and care they need during these challenging times. As we learn from the pandemic, we are partnering with governments and others to make healthcare stronger and more sustainable in the future.
Our diagnostics solutions:
Reliable, high-quality testing is essential to help healthcare systems overcome this pandemic. Our portfolio includes:
- a high-volume molecular test to detect SARS-CoV-2, the virus that causes COVID-19, (FDA Emergency Use Authorisation (EUA) and available in countries accepting the CE Mark)
- a SARS-CoV-2 laboratory-based antibody test, aimed at detecting the presence of antibodies in the blood targeting the nucleocapsid (FDA EUA and CE Mark)
- an IL-6 test to assist in identifying severe inflammatory response in patients with confirmed COVID-19 (FDA EUA and CE Mark)
- Roche v-TAC, which could help simplify the screening, diagnosis and monitoring of patients with respiratory compromise in the current COVID-19 pandemic
- a SARS-CoV-2 rapid antibody test to help determine at the point of care whether a person has been exposed to the virus (CE Mark)
- a rapid antigen test to support in the detection of SARS-CoV-2 at the point of care within 15 minutes (CE Mark)
- a high-volume molecular test to simultaneously detect and differentiate between SARS-CoV-2 and influenza A/B, as the symptoms are similar for both (FDA EUA and CE Mark)
- a second SARS-CoV-2 antibody test, aimed at measuring the spike protein to support vaccination development and complement our existing portfolio
- a point-of-care molecular PCR test that simultaneously detects and differentiates between SARS-CoV-2 and influenza A/B infections to support urgent triage and diagnosis (FDA EUA and CE Mark)
Our research into therapies:
Roche is committed to improving the treatment of COVID-19. We are actively involved in understanding the potential of our existing portfolio and are exploring the potential of our investigational molecules.
In August we signed a collaboration agreement with Regeneron on developing and manufacturing and significantly increasing global supply of an investigational antibody combination for COVID-19 if it proves safe and effective in clinical trials and regulatory approvals are granted. We are also partnering with Atea to jointly develop AT-527, an orally administered direct-acting antiviral (DAA) currently in Phase 2 clinical trials. If approved, Atea will distribute AT-527 in the United States and Roche will be responsible for global manufacturing and distribution outside the United States.
At the beginning of the pandemic, on 19 March on 19 March, we announced the initiation of COVACTA - a global Phase III randomised, double-blind, placebo-controlled clinical trial to evaluate the safety and efficacy of intravenous Actemra©/RoActemra© (tocilizumab) plus standard of care in hospitalised adult patients with severe COVID-19 pneumonia compared to placebo plus standard of care. On 29 July we announced that COVACTA did not meet its primary endpoint of improved clinical status in patients with COVID-19 associated pneumonia or the key secondary endpoint of reduced mortality.
Separately, we have studied Actemra©/RoActemra© in the EMPACTA study in COVID-19 associated hospitalised pneumonia in patients that are often underrepresented in clinical trials. On 18 September we announced that the phase III EMPACTA study showed Actemra/RoActemra plus standard of care reduced the likelihood of progression to mechanical ventilation or death in hospitalised patients with COVID-19 associated pneumonia compared to placebo plus standard of care. However, there was no statistical difference in mortality between patients who received Actemra/RoActemra or placebo.
Actemra©/RoActemra© is also being studied in combination with the investigational antiviral remdesivir in hospitalised patients with severe COVID-19 pneumonia in the REMDACTA trial in partnership with Gilead, announced 28 May. Actemra©/RoActemra© is not approved by any health authority for use in COVID-19 pneumonia. Roche has further initiated an internal early research programme focused on the development of medicines for COVID-19 and is engaged in multiple research collaborations.
In these exceptional times, Roche stands together with governments, healthcare providers and all those working to overcome the pandemic.
About Roche
Roche is a global pioneer in pharmaceuticals and diagnostics focused on advancing science to improve people’s lives. The combined strengths of pharmaceuticals and diagnostics under one roof have made Roche the leader in personalised healthcare – a strategy that aims to fit the right treatment to each patient in the best way possible.
Roche is the world’s largest biotech company, with truly differentiated medicines in oncology, immunology, infectious diseases, ophthalmology and diseases of the central nervous system. Roche is also the world leader in in vitro diagnostics and tissue-based cancer diagnostics, and a frontrunner in diabetes management.
Founded in 1896, Roche continues to search for better ways to prevent, diagnose and treat diseases and make a sustainable contribution to society. The company also aims to improve patient access to medical innovations by working with all relevant stakeholders. More than thirty medicines developed by Roche are included in the World Health Organization Model Lists of Essential Medicines, among them life-saving antibiotics, antimalarials and cancer medicines. Moreover, for the twelfth consecutive year, Roche has been recognised as one of the most sustainable companies in the Pharmaceuticals Industry by the Dow Jones Sustainability Indices (DJSI).
The Roche Group, headquartered in Basel, Switzerland, is active in over 100 countries and in 2019 employed about 98,000 people worldwide. In 2019, Roche invested CHF 11.7 billion in R&D and posted sales of CHF 61.5 billion. Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan. For more information, please visit www.roche.com.
Reference: https://www.roche.com/media/releases/med-cor-2020-12-11.htm
Direct from Saliva PCR Test for COVID-19 Enables Fast, Low-Cost Results for High-Frequency Surveillance Testing at Colleges and Universities
10 December 2020
CARLSBAD, Calif., Dec. 10, 2020 -- Thermo Fisher Scientific announced today the availability of a new direct from saliva PCR test for COVID-19 to enable widespread, high-frequency surveillance testing. The Applied Biosystems TaqCheck SARS-CoV-2 Fast PCR Assay uses raw saliva samples and simplifies lab workflows using instruments that are widely available globally to deliver reliable data quickly.
The company also introduced the Safe Campus Reopening Program to subsidize the cost of the test for U.S. colleges, universities and post-secondary institutions. Availability of this program coincides with recent guidance issued by the Centers for Disease Control and Prevention (CDC) that calls for expanded COVID-19 surveillance using PCR-based tests with turnaround times within 24-48 hours.
By performing the test directly from raw saliva and eliminating the need for equipment, materials, time and labor associated with nucleic acid extraction, the TaqCheck SARS-CoV-2 Fast PCR Assay helps labs meet the CDC turnaround time recommendations.
"Thermo Fisher scientists are continually working to answer the call as public and private institutions take proactive measures to protect their communities," said Mark Smedley, president of Genetic Sciences for Thermo Fisher Scientific. "The TaqCheck Fast PCR Assay breaks new ground and provides global communities access to affordable surveillance testing that is easy-to-implement and delivers trusted quality and reliability so they can manage the spread of COVID-19 and return to a sense of normalcy."
Direct from saliva PCR testing is already being implemented at the University of Illinois Urbana-Champaign (UIUC) to reduce the cost and complexity of on-campus testing. With its raw saliva direct to PCR protocol and comprehensive on-campus surveillance program, UIUC is currently processing more than 10,000 samples a day in as little as four hours.
UIUC is currently collaborating with Thermo Fisher to determine how the TaqCheck SARS-CoV-2 Fast PCR Assay could further improve UIUC's existing workflow. "The new assay produced highly correlative results with UIUC's current direct PCR testing and reduced thermocycling time by one-third," said Dr. Leyi Wang, clinical assistant professor who leads UIUC's COVID-19 data analysis and validation studies.
The TaqCheck Fast PCR Assay is ideal for institutions of higher learning with existing laboratories. Universities that do not have labs on campus can also benefit by partnering with third-party testing providers. These reference labs can leverage the assay's workflow to support significant increases in testing volume.
The TaqCheck SARS-CoV-2 Fast PCR Assay is available globally for research use only. Thermo Fisher plans to seek emergency use authorization (EUA) in the U.S. and CE-IVD in Europe in early 2021.
For more information on the TaqCheck SARS-CoV-2 Fast PCR Assay and Thermo Fisher's Safe Campus Reopening Program, please visit www.thermofisher.com/taqcheck.
About Thermo Fisher Scientific
Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $25 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, improving patient diagnostics and therapies or increasing productivity in their laboratories, we are here to support them. Our global team of more than 75,000 colleagues delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services and Patheon. For more information, please visit www.thermofisher.com.
New Quest Diagnostics Health Trends™ Survey Reveals COVID-19 Testing Hesitancy Among Americans, With 3 of 4 Avoiding a Test When They Believed They Needed One
9 December 2020 - Nationwide survey believed to be the first to reveal insights into U.S. consumer behaviors and attitudes toward COVID-19 testing and health effects since fall-winter COVID-19 wave began. Medical treatment delays and worsening chronic conditions during pandemic may lead to surge in non-COVID-19 health conditions, with nearly one-third (31%) of those living with a chronic health condition saying their health has gotten worse since pandemic began. Parents and women suffer disproportionate health impacts amid pandemic.
SECAUCUS, N.J., Dec. 9, 2020 -- A new Quest Diagnostics Health Trends™ study finds that three in four Americans who believed they needed a COVID-19 test (74%) chose not to get one, or delayed getting one, primarily due to concerns about exposure to the SARS-CoV-2 virus (30%).
The nationally representative survey was conducted online by The Harris Poll on behalf of Quest Diagnostics between November 10-12, 2020, among 2,050 U.S. adults. This survey is believed to be the first to evaluate attitudes about COVID-19's impact on medical care and testing since the recent fall-winter wave of COVID-19 cases began to sweep across the United States.
The findings suggest large numbers of Americans are putting off medical care they may need – including COVID-19 diagnostic lab tests as well as preventative and chronic care – due to fears and other barriers, with likely long-term consequences for patients and the U.S. healthcare system.
Among the key findings:
- Of those Americans who believed they needed a COVID-19 test, 74% chose not to get or delayed getting one. The primary reason was concern about exposure to the virus (30%); with others citing that they thought it was very unlikely they had COVID-19 (21%); concerns over having to quarantine while waiting for results or if they were positive (15%); and cost (15%). Lab testing for COVID-19 is an important tool in preventing COVID-19 disease spread, given that as many as 40% of infected individuals may lack symptoms and not know they are infected and able to pass the infection to others
- A larger proportion of Hispanic/Latinx adults (83%) vs. Whites (non-Hispanic) (72%) and Blacks (72%) chose to avoid or delayed getting a diagnostic COVID-19 test when they believed they needed one.
- Black Americans, who are overrepresented among America's essential workforce, who have been disproportionately affected by the pandemic and are more likely to be in essential jobs that put them at exposure risk, found greater access to testing even more important: specifically, 73% of Blacks compared to 55% of Whites feel greater access is "absolutely essential" or "very important" to slow the pandemic.
"Our Health Trends data show that while most Americans understand the vital role testing plays in helping to control the COVID-19 pandemic, people are scared of exposure to the virus. This fear keeps them from getting tested when they believe they needed it, and out of the doctor's office for routine care and treatment," said Harvey W. Kaufman, M.D., Senior Medical Director, Head of the Health Trends Research Program for Quest Diagnostics. "Those who are concerned about exposure should discuss their concerns with their healthcare provider or local health department, so that they can access a test, if appropriate, and other important health care services."
Delayed Health Care during Pandemic Could Lead to Surge of Chronic Disease and Non-COVID-19 Health Conditions and Emergencies
In the meantime, while they await a vaccine, Americans revealed deep concerns about undiagnosed and worsening chronic health conditions during the pandemic. Worries about exposure to the virus are at the top of the list of reasons why U.S. adults have avoided or delayed in-person health care (53%), but many of them also recognize that forgoing this care has now led to other health problems, like greater stress about a health condition (31%), delayed treatment (23%) or diagnosis (18%) and worsening symptoms (17%).
At the same time, Americans' reluctance to maintain routine or preventive medical visits due to the pandemic could lead to a wave of non-COVID-19 health conditions once the pandemic abates or a vaccine is distributed.
According to the findings:
- The majority of U.S. adults (60%) have skipped or delayed some in-person medical treatments or appointments during the COVID-19 pandemic, in particular, Hispanic/Latinx adults (67%) (compared to 59% White and 58% Black). About one in five Americans (22%) skipped or delayed blood work or lab testing specifically.
- Over a third of Americans do not plan to resume attending in-person medical treatments and appointments until the pandemic is under better control (39%) or until a vaccine is available (33%).
- One in two Americans (51%) said that only a severe illness or injury would motivate them to seek in-person medical care during the COVID-19 pandemic.
- Nearly one in three Americans who have a chronic health condition (31%) said their condition had gotten worse since the pandemic began and two in five Americans (41%) are somewhat/very concerned that they may currently have an undiagnosed health condition.
- Current attitudes toward delaying care are also supported by Quest Diagnostics lab data. According to other Health Trends™ research, the rate of cancer diagnoses across six common cancer types decreased by 46% between March 1 and April 18, 2020, during the COVID-19 pandemic. And the rate of diabetes (hemoglobin A1c) testing declined by as much as 66% during approximately the first two months of the pandemic, compared with the previous year.
Women and Parents Have Borne the Brunt of the Pandemic's Impact
More women than men say COVID-19 has negatively impacted their mental (49% of women vs. 36% of men), financial (42% vs. 37%) and physical health (33% vs. 26%).
Meanwhile, parents of children under 18 years of age are more likely to have delayed in-person medical treatment or appointments during the pandemic: 71% have delayed an appointment, compared to 54% of those who don't have children under age 18. Specifically, parents are more likely than those without children under age 18 to have delayed or skipped:
- An annual physical exam (31% vs. 22%)
- Blood work/lab testing (30% vs. 18%)
- Preventative vaccinations or screenings (24% vs. 12%)
Dr. Kaufman continued, "With a vaccine likely not making its way to the general public until spring at the earliest, the healthcare community needs to do a better job of helping Americans get back to routine care now. Early diagnosis can save lives and putting off preventative care and chronic disease treatment could make the difference between life and death. Chronic diseases take a toll on the body each day. Delays in diagnosis and treatment will cause, for many people, irreversible damage, require more aggressive and less effective treatments, and contribute to a higher death rate. As Benjamin Franklin advised, 'An ounce of prevention is worth a pound of cure.'"
Methodology
On behalf of Quest, The Harris Poll conducted an online survey of 2,050 adults 18 years and older across the United States from November 10-12, 2020. The survey sample included 337 Hispanic/Latinx, 265 Black and 1,278 White adults. Harris weighted figures for age by sex, region, education, household size, marital status and household income by race/ethnicity where necessary to make them representative of their actual proportions in the population. The Harris Poll is one of the longest running surveys in the U.S. tracking public opinion, motivations and social sentiment since 1963 that is now part of Harris Insights & Analytics, a global consulting and market research firm that delivers social intelligence for transformational times.
About Quest Diagnostics Health Trends™
Quest Diagnostics Health Trends™ is a series of scientific reports that provide insights into health topics, based on analysis of objective clinical laboratory data, to empower better patient care, population health management and public health policy. The reports are based on the Quest Diagnostics database of 48 billion de-identified laboratory test results, believed to be the largest of its kind in healthcare. Health Trends has yielded novel insights to aid the management of allergies and asthma, prescription drug monitoring, diabetes, Lyme disease, heart disease, influenza and workplace wellness. Quest Diagnostics also produces the Drug Testing Index (DTI)™, a series of reports on national workplace drug positivity trends based on the company's employer workplace drug testing data.
About COVID-19 testing at Quest Diagnostics
Quest Diagnostics is at the forefront of the response to the COVID-19 pandemic, working to broaden access to laboratory insights to help us all lead healthier lives. We provide both molecular diagnostic and antibody serology tests to aid in the diagnosis of COVID-19 and immune response. Through our team of dedicated phlebotomists, air fleet team, couriers and laboratory professionals, Quest Diagnostics works hard every day to help patients and communities across the United States access quality COVID-19 testing.
About Quest Diagnostics
Quest Diagnostics empowers people to take action to improve health outcomes. Derived from the world's largest database of clinical lab results, our diagnostic insights reveal new avenues to identify and treat disease, inspire healthy behaviors and improve health care management. Quest annually serves one in three adult Americans and half the physicians and hospitals in the United States, and our 47,000 employees understand that, in the right hands and with the right context, our diagnostic insights can inspire actions that transform lives. www.QuestDiagnostics.com
LabCorp Receives FDA Authorization to Make At-Home COVID-19 Collection Kits Available Through Retail
9 December 2020 - Pixel by LabCorp™ COVID-19 Test Home Collection Kit is first to receive FDA authorization for over-the-counter purchase
BURLINGTON, N.C., Dec. 9, 2020 -- LabCorp, a leading global life sciences company that is focused on advancing health and guiding patient care decisions, today announced that the U.S. Food and Drug Administration (FDA) granted Emergency Use Authorization (EUA) for the Pixel by LabCorp™ COVID-19 Test Home Collection Kit to become the first to be available over the counter without requiring a prescription. The kit is currently available through the Pixel by LabCorp website, and this approval will enable LabCorp to potentially distribute the kit through retail channels.
This authorization is the latest example of LabCorp’s commitment to increase access to COVID-19 testing. The kit allows consumers to self-collect their sample in the privacy of their own home, which helps minimize transmission of the virus. Users then send the sample for processing at LabCorp .
“With the first over-the-counter at-home collection kit ever authorized by the FDA for COVID-19, we are empowering people to learn about their health and make confident decisions,” said Dr. Brian Caveney, chief medical officer and president of LabCorp Diagnostics . “With this authorization, we can help more people get tested, reduce the spread of the virus and improve the health of our communities.”
Upon purchase, users register their Pixel by LabCorp COVID-19 collection kit at the Pixel by LabCorp website and follow the instructions included. Test results are securely delivered to the consumer via the Pixel by LabCorp portal. A healthcare provider will counsel consumers who test positive to assist with healthcare treatment and actions. The Pixel by LabCorp COVID-19 collection kit is not a substitute for visits to a healthcare professional and is for use in adults 18 and older.
Retailers interested in selling Pixel by LabCorp COVID-19 collection kits can contact the company at PixelPartners@LabCorp.com.
LabCorp’s COVID-19 PCR test has not been FDA cleared or approved, has been authorized by FDA under an Emergency Use Authorization (EUA), and has been authorized only for the detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens. The test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostic tests for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.
About LabCorp
LabCorp, an S&P 500 company, is a leading global life sciences company that is deeply integrated in guiding patient care, providing comprehensive clinical laboratory and end-to-end drug development services. With a mission to improve health and improve lives, LabCorp delivers world-class diagnostics solutions, brings innovative medicines to patients faster, and uses technology to improve the delivery of care. LabCorp reported revenue of more than $11.5 billion in 2019. To learn more about LabCorp , visit www.LabCorp.com.
Roche partners with Moderna to include SARS-CoV-2 antibody test in ongoing COVID-19 vaccine trials
9 December 2020 - Moderna’s vaccine triggers an antibody response to the SARS-CoV-2 spike protein. The Elecsys Anti-SARS-CoV-2 S test can quantitatively measure the level of antibodies against SARS-CoV-2 in vaccine trial participants and could help to establish correlation to protection from COVID-19. Emergency Use Authorisation by the US FDA for the Elecsys Ab test was granted on 25 Nov, 2020.
Basel, 9 December 2020 -- Roche today announced a partnership with Moderna Inc. to utilise the Elecsys® Anti-SARS-CoV-2 S antibody test in Moderna’s mRNA-1273 vaccine research trials. This will facilitate the quantitative measurement of SARS-CoV-2 antibodies and help to establish a correlation between vaccine-induced protection and levels of anti-receptor binding domain (RBD) antibodies. Significantly, Moderna’s vaccine triggers antibody response specifically to the RBD of the SARS-CoV-2 spike protein. This follows the recent announcement that Roche has received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) for the Elecsys® Anti-SARS-CoV-2 S antibody test.
“Roche values the collaboration with Moderna, which has already included the successful use of our qualitative Elecsys Anti-SARS-CoV-2 test, targeting the nucleocapsid protein, in an earlier part of the studies”, said Thomas Schinecker, CEO Roche Diagnostics. “We are pleased to see that our quantitative Elecsys SARS-CoV-2 S test, which targets the spike protein, is now also being used as part of the Moderna vaccine trials, which could ultimately help to end this pandemic.”
Measuring the quantitative levels of anti-RBD SARS-CoV-2 antibodies using Roche’s test will help Moderna to gain valuable insights into the correlation between protection from vaccination and antibody levels. This could play a role in assessing if, or when, an individual needs revaccination, or in helping to answer other clinically relevant questions.
To enhance our understanding of vaccines against SARS-CoV-2 there would be a benefit in knowing the starting levels of antibodies a person has, prior to vaccination, in order to evaluate any change in antibody levels that the vaccine induces. This is particularly relevant in the case of antibodies directed against the SARS-CoV-2 spike protein, since these antibodies have been shown to have potent antiviral activity and correlate to potential immunity. Measuring antibody levels can also play a role in establishing vaccine efficacy in the prevention of infection and/or the development of severe COVID-19.
This partnership with Moderna, started by using the Elecsys Anti-SARS-CoV-2 test for qualitative determination of anti-N SARS-CoV-2 antibodies. This has been part of Moderna’s vaccine trials for baselining and assessing natural infection in trial participants.
About potential SARS-COV-2 vaccines
Candidate vaccines, such as Moderna’s mRNA-1237, aim to induce an antibody response against the SARS-CoV-2 spike protein. Any potential vaccine for SARS-CoV-2 would work (amongst other mechanisms) by triggering the immune response to develop neutralising antibodies in the person receiving the vaccine. In doing so, the vaccine trains the body’s immune system to recognise and fight an exposure to SARS-CoV-2, in a controlled way, without being exposed to the actual virus.
About Elecsys Anti-SARS-CoV-2 S test
Elecsys® Anti-SARS-CoV-2 S is an immunoassay for the quantitative, in vitro determination of antibodies to SARS-CoV-2 in human serum and plasma. Through a blood sample, the test can measure the quantity of antibodies to the spike protein of the coronavirus. Specifically, the test targets antibodies which are directed against the particular region of the viral spike protein responsible for binding to the host cell receptor, which is required for the virus to enter the host cell.
The presence and level of such antibodies could signal whether a person has been already infected and potentially developed immunity to the virus.
This plays an important part in characterising a vaccine-induced immune response.2 The majority of current candidate vaccines aim to induce an antibody response against the spike protein.
About Elecsys Anti-SARS-CoV-2 test
Elecsys Anti-SARS-CoV-2 is an immunoassay for the qualitative, in vitro detection of antibodies (including IgG) to SARS-CoV-2. The test can detect antibodies to the coronavirus, which could signal whether a person has been already infected and potentially developed immunity to the virus. This test can also help in the determination of seroprevalence (i.e. the frequency of individuals with antibody to the virus), in a given population, as well as a complement test to Nucleic Acid Amplification Tests (NAAT) for the diagnosis of SARS-CoV-2 infection.
Hospitals and reference laboratories can run both the tests on Roche’s cobas e analysers which are widely available around the world. These fully-automated systems can provide SARS-CoV-2 test results in approximately 18 minutes, with a test throughput of up to 300 tests/hour, depending on the analyser.
About Roche’s response to the COVID-19 pandemic
As a leading healthcare company we are doing all we can to support countries in minimising the impact of COVID-19. We have developed a growing number of diagnostic solutions that help to detect and diagnose the infection in patients, as well as providing digital support to healthcare systems, and we continue to identify, develop and support potential therapies which can play a role in treating the disease.
We understand the impact of COVID-19 goes beyond those who contract it, which is why we are working with healthcare providers, laboratories, authorities and organisations to help make sure that patients continue to receive the tests, treatment and care they need during these challenging times. As we learn from the pandemic, we are partnering with governments and others to make healthcare stronger and more sustainable in the future.
Our diagnostics solutions:
Reliable, high-quality testing is essential to help healthcare systems overcome this pandemic. Our portfolio includes:
- a high-volume molecular test to detect SARS-CoV-2, the virus that causes COVID-19, (FDA Emergency Use Authorisation (EUA) and available in countries accepting the CE Mark)
- a SARS-CoV-2 laboratory-based antibody test, aimed at detecting the presence of antibodies in the blood targeting the nucleocapsid (FDA EUA and CE Mark)
- an IL-6 test to assist in identifying severe inflammatory response in patients with confirmed COVID-19 (FDA EUA and CE Mark)
- Roche v-TAC, which could help simplify the screening, diagnosis and monitoring of patients with respiratory compromise in the current COVID-19 pandemic
- a SARS-CoV-2 rapid antibody test to help determine at the point of care whether a person has been exposed to the virus (CE Mark)
- a rapid antigen test to support in the detection of SARS-CoV-2 at the point of care within 15 minutes (CE Mark)
- a high-volume molecular test to simultaneously detect and differentiate between SARS-CoV-2 and influenza A/B, as the symptoms are similar for both (FDA EUA and CE Mark)
- a second SARS-CoV-2 antibody test, aimed at measuring the spike protein to support vaccination development and complement our existing portfolio
- a point-of-care molecular PCR test that simultaneously detects and differentiates between SARS-CoV-2 and influenza A/B infections to support urgent triage and diagnosis (FDA EUA and CE Mark)
Our research into therapies:
Roche is committed to improving the treatment of COVID-19. We are actively involved in understanding the potential of our existing portfolio and are exploring the potential of our investigational molecules.
In August we signed a collaboration agreement with Regeneron on developing and manufacturing and significantly increasing global supply of an investigational antibody combination for COVID-19 if it proves safe and effective in clinical trials and regulatory approvals are granted. We are also partnering with Atea to jointly develop AT-527, an orally administered direct-acting antiviral (DAA) currently in Phase 2 clinical trials. If approved, Atea will distribute AT-527 in the United States and Roche will be responsible for global manufacturing and distribution outside the United States.
At the beginning of the pandemic, on 19 March on 19 March, we announced the initiation of COVACTA - a global Phase III randomised, double-blind, placebo-controlled clinical trial to evaluate the safety and efficacy of intravenous Actemra©/RoActemra© (tocilizumab) plus standard of care in hospitalised adult patients with severe COVID-19 pneumonia compared to placebo plus standard of care. On 29 July we announced that COVACTA did not meet its primary endpoint of improved clinical status in patients with COVID-19 associated pneumonia or the key secondary endpoint of reduced mortality.
Separately, we have studied Actemra©/RoActemra© in the EMPACTA study in COVID-19 associated hospitalised pneumonia in patients that are often underrepresented in clinical trials. On 18 September we announced that the phase III EMPACTA study showed Actemra/RoActemra plus standard of care reduced the likelihood of progression to mechanical ventilation or death in hospitalised patients with COVID-19 associated pneumonia compared to placebo plus standard of care. However, there was no statistical difference in mortality between patients who received Actemra/RoActemra or placebo.
Actemra©/RoActemra© is also being studied in combination with the investigational antiviral remdesivir in hospitalised patients with severe COVID-19 pneumonia in the REMDACTA trial in partnership with Gilead, announced 28 May. Actemra©/RoActemra© is not approved by any health authority for use in COVID-19 pneumonia. Roche has further initiated an internal early research programme focused on the development of medicines for COVID-19 and is engaged in multiple research collaborations.
In these exceptional times, Roche stands together with governments, healthcare providers and all those working to overcome the pandemic.
About Roche
Roche is a global pioneer in pharmaceuticals and diagnostics focused on advancing science to improve people’s lives. The combined strengths of pharmaceuticals and diagnostics under one roof have made Roche the leader in personalised healthcare – a strategy that aims to fit the right treatment to each patient in the best way possible.
Roche is the world’s largest biotech company, with truly differentiated medicines in oncology, immunology, infectious diseases, ophthalmology and diseases of the central nervous system. Roche is also the world leader in in vitro diagnostics and tissue-based cancer diagnostics, and a frontrunner in diabetes management.
Founded in 1896, Roche continues to search for better ways to prevent, diagnose and treat diseases and make a sustainable contribution to society. The company also aims to improve patient access to medical innovations by working with all relevant stakeholders. More than thirty medicines developed by Roche are included in the World Health Organization Model Lists of Essential Medicines, among them life-saving antibiotics, antimalarials and cancer medicines.
Moreover, for the twelfth consecutive year, Roche has been recognised as one of the most sustainable companies in the Pharmaceuticals Industry by the Dow Jones Sustainability Indices (DJSI).
The Roche Group, headquartered in Basel, Switzerland, is active in over 100 countries and in 2019 employed about 98,000 people worldwide. In 2019, Roche invested CHF 11.7 billion in R&D and posted sales of CHF 61.5 billion. Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan. For more information, please visit www.roche.com.
Reference: https://www.roche.com/media/releases/med-cor-2020-12-09.htm
Ro and Quest Diagnostics Partner to Offer Lab Testing Through Ro's Vertically Integrated Primary Care Platform
8 December 2020 - Quest’s industry-leading lab expertise will support Ro’s expansion in the treatment and management of chronic and complex conditions requiring diagnostic data
NEW YORK, NY and SECAUCUS, NJ, December 8, 2020 -- Ro, the healthcare technology company, and Quest Diagnostics, the nation’s leader in diagnostic information services, today announced a strategic partnership to add diagnostic capabilities and lab testing to Ro's vertically integrated primary care platform. The partnership will support Ro’s expansion in the treatment and management of chronic and complex medical conditions facilitated on its platform.
Quest Diagnostics is the first diagnostic services provider to collaborate with Ro to help patients manage chronic conditions through virtual and in-home care. As the leading provider of diagnostic information services, Quest provides thousands of laboratory screening and diagnostic test services and operates 2,200 patient service centers where individuals can provide lab samples across the United States.
This partnership complements Ro’s recent acquisition of Workpath, a software platform that enables on-demand, in-home care. The acquisition allows Ro to seamlessly integrate virtual and in-person care and send healthcare professionals to a patient’s home for blood draws, vaccinations and more. All diagnostic tests for Ro patients will be processed by Quest Diagnostics, and patients will be able to have blood draws performed in their home through Ro’s integration with Workpath or at a Quest Diagnostics facility.
Initial Quest Diagnostics services offered through Ro will focus on hormone testing, including total testosterone and PSA. The addition of diagnostic testing services is expected to dramatically expand the range of services Ro can provide, for example treatment for hypothyroidism, STIs, diabetes, and hyperlipidemia.
“Seventy percent of medical decisions are based on lab results, and many patients need ongoing diagnostic data and provider guidance to manage their conditions,” said Melynda Barnes, MD, SVP of Medical Affairs and Research of Ro. “This partnership permits physicians and patients on Ro’s platform to have access to these critical diagnostic services, allowing for the treatment of increasingly complex conditions through Ro, and encourages ongoing patient-provider engagement.”
“At Quest Diagnostics, we recognize that healthcare is becoming more and more consumer-driven,” said Cathy Doherty, senior vice president and group executive, clinical franchise solutions and marketing, Quest Diagnostics. "Ro has created a virtual care model that does what any good healthcare provider does but few health technology companies do well: foster intimacy and trust with each patient. Through our industry-first relationship, Quest will add quality diagnostic insights to the proven Ro model, so more people can access care for a broader array of medical conditions when and where they need it most.”
Ro patients will be able to access and discuss their lab results and treatment plan with their provider at any time. With this partnership, Ro seamlessly connects a patient’s doctor, pharmacy, and diagnostics, facilitating end-to-end care from diagnosis to the delivery of medication to ongoing care.
About Ro
Ro is the healthcare technology company building a patient-centric healthcare system. Ro’s vertically integrated primary care platform powers a personalized, end-to-end healthcare experience from diagnosis, to delivery of medication, to ongoing care. With a nationwide provider network, in-home care API, and proprietary pharmacy distribution centers, Ro seamlessly connects telehealth, diagnostics, and pharmacy services to provide high-quality, affordable healthcare without the need for insurance. Since 2017, Ro has facilitated more than five million digital healthcare visits in nearly every county in the United States, including 98% of primary care deserts. Visit Ro.co for more information.
About Quest Diagnostics
Quest Diagnostics empowers people to take action to improve health outcomes. Derived from the world's largest database of clinical lab results, our diagnostic insights reveal new avenues to identify and treat disease, inspire healthy behaviors and improve health care management. Quest annually serves one in three adult Americans and half the physicians and hospitals in the United States, and our 47,000 employees understand that, in the right hands and with the right context, our diagnostic insights can inspire actions that transform lives. www.QuestDiagnostics.com
Quest’s Commitment to Consumer Empowered Health
Quest Diagnostics has long been at the forefront of the movement for consumer empowerment in healthcare. The company was among the first diagnostic information services providers to offer free access to test results online and other channels. Its mobile app and patient portal, called MyQuest, provides millions of people a way to securely access and track their test results and other health data. The company's QuestDirect service provides dozens of tests for conditions ranging from heart health and sexually transmitted diseases. For added convenience, the company now offers at-home self-collection devices for tests including COVID-19 active infection, diabetes, and hormones. Through its collaborations with Safeway and Walmart, Quest Diagnostics operates approximately 200 patient service centers in retail store locations, for the utmost in convenient access. Quest Diagnostics also provides next generation sequencing and genotyping services for Ancestry.
Reference: https://newsroom.questdiagnostics.com/press-releases?item=137231
Thermo Fisher Scientific Gains CE Mark Certification for New OmniPATH Combi SARS-CoV-2 IgG ELISA Test
8 December 2020 - Quantifying IgG is critical component to test population-wide vaccination effectiveness
DARTFORD, UK, December 8, 2020 -- Thermo Fisher Scientific, the world leader in serving science, has secured CE Mark certification for the Thermo Scientific OmniPATH Combi SARS-CoV-2 IgG ELISA test. The test is intended for the quantitative measurement of immunoglobulin G (IgG) antibodies raised against the spike protein of the SARS-CoV-2 virus to aid clinicians in identifying patients with an immune response pre- and post-vaccination.
The ability to quantify IgG is a critical component to understanding an individual’s immune response to the SARS-CoV-2 virus, especially as we start to vaccinate the population. Having quantitative data on neutralizing antibodies will enable better understanding of a person’s immune response following exposure to the COVID-19 virus and support monitoring of the effectiveness of vaccines as they become available.
Dr. Sarah Walker, Professor of Medical Statistics and Epidemiology at the University of Oxford and Chief Investigator of the National COVID-19 infection survey said: “Using this test within the COVID-19 Infection Survey allows us to answer vital questions about the role of previous infection and varying levels of antibody response in protecting people from getting infected again in the future. As we follow individuals over the course of a year, we are repeatedly testing them for both virus and antibodies.”
Thermo Fisher joined forces with the University of Oxford to harness their academic research capabilities in identifying the spike protein. This, coupled with Thermo Fisher’s manufacturing capability and immunoassay expertise, enabled the development of both a 96 and a 384 microplate assay format. The 384-well microplate assay is compatible with a newly developed automation system, designed by Thermo Fisher and enables the Oxford Univeristy to deliver COVID-19 testing capacity of up to 50,000 tests per day.
“Thermo Fisher Scientific is proud to have developed and delivered this CE marked product in collaboration with Oxford University,” said Mark Stevenson, executive vice president and chief operating officer at Thermo Fisher Scientific. “Combining the academic research capabilities of world recognized scientists at Oxford University with Thermo Fisher’s Dartford UK development and manufacturing facility has expanded our serology portfolio for improved COVID-19 epidemiological studies.”
Thermo Fisher’s new fully automated testing platform is already in use by Oxford University to provide weekly UK-wide data to the Office of National Statistics as part of the national COVID-19 Infection Survey. In addition, the equipment further enhances Oxford’s capacity to accurately quantify a patient’s vaccine response as part of the ongoing Oxford coronavirus vaccine clinical trial.
This new OmniPATH Combi SARS-CoV-2 IgG ELISA test assay is an extension of Thermo Fisher’s COVID-19 antibody test portfolio. In October, the company launched the OmniPATH COVID-19 Total Antibody ELISA test for qualitative detection of total antibodies to SARS-CoV-2, including immunoglobulin M (IgM), immunoglobulin A (IgA) and IgG.
About Thermo Fisher Scientific
Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding
$25 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, improving patient diagnostics and therapies or increasing productivity in their laboratories, we are here to support them. Our global team of more than 75,000 colleagues delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services and Patheon. For more information, please visit www.thermofisher.com.
Reference: https://thermofisher.mediaroom.com/press-releases?item=123524
LGC's Anti-SARS-CoV-2 controls kit now CE Marked
8 December 2020
8 December 2020 -- LGC is pleased to announce that the ACCURUN® Anti-SARS-CoV-2 Reference Material Kit is now CE marked for in vitro diagnostic use (CE-IVD).
With this change in regulatory status, the new product name is ACCURUN Anti-SARS-CoV-2 Controls Kit. Bearing the CE mark and IVD symbol signifies that the ACCURUN Anti-SARS-CoV-2 Controls Kit meets extensive design control requirements.
ACCURUN controls are specifically formulated to exhibit low-positive reactivity in true patient-like matrices, to test assay performance near critical signal cutoff boundaries. The ACCURUN Anti-SARS-CoV-2 Controls Kit is offered in two configurations, one designed for IgG-specific assays and the other for total antibody tests. Both products are designed to measure day-to-day assay performance and contain positive materials for antibodies against the SARS-CoV-2 virus as well as complementary negative materials.
Michael Sweatt, Executive Vice President, Clinical Diagnostics, LGC, stated, “We remain steadfast in our mission to supply the diagnostic community with dependable infectious disease quality solutions, ensuring clinical laboratories have the tools necessary to be able to report accurate and reliable patient results – during the COVID-19 pandemic and beyond.”
To learn more about the ACCURUN Anti-SARS-CoV-2 Controls Kits as well as the complete line of SARS-CoV-2 Molecular & Serology Quality Solutions, please visit the SeraCare website.
Reference: https://www.lgcgroup.com/newsroom-and-blog/news-and-blog/anti-sars-cov-2-controls-kit-ce-marked/
QIAGEN to launch QuantiFERON SARS-CoV-2 for research into causes, spread and control of COVID-19 through T-cell response
7 December 2020 - T-cell response has the potential to give a clearer picture of immunity and course of illness. T-cell response to SARS-CoV-2 may decline less rapidly than antibodies. Potentially vital tool for research into immune response and vaccination efficacy.
Hilden, Germany and Germantown, Maryland, December 7, 2020 – QIAGEN N.V. announced today the launch of its QuantiFERON SARS-CoV-2 RUO solution that can detect T-cell responses of the human immune system to the pathogen that causes COVID-19, which could help researchers find out more about immunity levels and disease progression.
Studies suggest that T-cell response to SARS-CoV-2 declines much more slowly than antibody response, which presents several benefits to researchers who want to push beyond the existing detection of active infections to screen for potential courses of the illness and long-term immune responses to it. QIAGEN’s QuantiFERON SARS-CoV-2 Research Use Only (RUO) solution could be a valuable tool in this research.
There is also growing evidence that T-cell response gives a reliable indication of how severe the course of an illness triggered by SARS-CoV-2 will be in infected patients, and how immune those who have recovered remain months – possibly even years – after having been infected.
QuantiFERON SARS-CoV-2 RUO is a flexible, modular system designed to meet a wide range of research demands. It is based on QIAGEN’s easy-to-use QuantiFERON technology, pioneered in the QuantiFERON-TB Gold Plus test for latent tuberculosis and recognized worldwide for its ability to detect interferon gamma that T-cells release upon contact with certain pathogens.
QuantiFERON SARS-CoV-2 RUO is a crucial addition to QIAGEN’s growing COVID-19 portfolio that already provides sample-preparation technology, infection testing with polymerase chain reaction (PCR) technology, antibody and antigen tests, enzymes and automation solutions.
“Research suggests that testing T-cell response could provide valuable insights into the novel coronavirus and how our immune system responds to it,” said Thierry Bernard, CEO of QIAGEN. “The more we know about the novel coronavirus, the better equipped the world will be to stop the pandemic,” he said. “We are excited about our QuantiFERON technology potentially helping researchers understand illness pathways and also immune responses that are crucial for vaccine development and deployment.”
QuantiFERON SARS-CoV-2 RUO will initially comprise a Starter Set and a Monitor Direct package for separate or combined research use. Both are made up of the QuantiFERON blood collection tubes with their proprietary stimulation principle and the QuantiFERON detection system to measure the resulting interferon-gamma. They use a tried-and-tested combination of flexible blood collection workflow with innovative CD4/CD8 T-cell technology. An additional component of the QuantiFERON SARS-CoV-2 RUO solution is also being developed in partnership with TScan Therapeutics, a US-based biopharmaceutical company, target specific so-called immunodominant SARS-CoV-2 epitopes they have identified.
About QIAGEN
QIAGEN N.V., a Netherlands-based holding company, is the leading global provider of Sample to Insight solutions that enable customers to gain valuable molecular insights from samples containing the building blocks of life. Our sample technologies isolate and process DNA, RNA and proteins from blood, tissue and other materials. Assay technologies make these biomolecules visible and ready for analysis. Bioinformatics software and knowledge bases interpret data to report relevant, actionable insights. Automation solutions tie these together in seamless and cost-effective workflows. QIAGEN provides solutions to more than 500,000 customers around the world in Molecular Diagnostics (human healthcare) and Life Sciences (academia, pharma R&D and industrial applications, primarily forensics). As of September 30, 2020, QIAGEN employed more than 5,300 people in over 35 locations worldwide. Further information can be found at http://www.qiagen.com.
Reference: https://corporate.qiagen.com/newsroom/press-releases/2020/20201207_qfn_sars_cov_2
Roche receives FDA Emergency Use Authorization for new test to measure the level of SARS-CoV-2 antibodies
2 December 2020 - Elecsys® Anti-SARS-CoV-2 S test specifically detects antibodies against the SARS-CoV-2 spike protein. The spike protein is the target of many COVID-19 vaccines in development. This test may help identify recovering patients who could potentially be serum and plasma donors for developing treatments for COVID-19.
Basel, 2 December 2020 -- Roche today announced that its Elecsys® Anti-SARS-CoV-2 S antibody test has received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA). The serology (blood) test can be used to measure the level of antibodies in people who have been exposed to the SARS-CoV-2 virus. The EUA in the United States follows the launch of the Elecsys® Anti-SARS-CoV-2 S antibody test for markets accepting the CE Mark announced on 18 September.
The new test targets antibodies that are directed against the region of the novel coronavirus known as the spike protein, specifically the area that enables the virus to bind to a host cell receptor, which is required for the virus to enter the host cell. Many current candidate vaccines aim to induce an antibody response against the SARS-CoV-2 spike protein. Tests that quantify antibodies to the spike protein could be used to measure the level of that response and track that measurement over time. The test provides a numerical result describing the concentration of antibodies from 0.40-250 U/mL as well as a qualitative result.
“Since the start of this pandemic, our focus has been to bring effective diagnostic testing solutions to the fight against COVID-19,” said Thomas Schinecker, CEO of Roche Diagnostics. “Antibody tests like these will play a critical role in measuring a person’s vaccine-induced immune response”.
In addition to its role in helping to measure a patient’s immune response, the test may help guide the allocation of plasma donations from recovered COVID-19 patients to current patients by identifying donors that have antibodies to SARS-CoV-2 virus. Convalescent plasma therapy is an investigational procedure that separates and removes the plasma from a patient’s blood. This plasma is then replaced with plasma from a donor to give the ill patient antibodies to help fight the virus.
The laboratory-based Elecsys Anti-SARS-CoV-2 S test runs on Roche’s widely available cobas e analyzers and is the latest addition to Roche’s growing diagnostic portfolio to help healthcare systems combat COVID-19 through testing in the laboratory and at the point of care. Currently, this portfolio includes molecular, serology and digital solutions that help healthcare professionals diagnose COVID-19 and provide optimal patient care during the initial stages of infection and the recovery phase, as well as following the resolution of infection.
About SARS-CoV-2
Coronaviruses (CoV) are a large family of viruses that cause illness ranging from the common cold to more severe diseases such as Middle East Respiratory Syndrome (MERS-CoV) and Severe Acute Respiratory Syndrome (SARS-CoV). The novel coronavirus (SARS-CoV-2) is a new strain which has not previously been identified in humans.
Signs of infection include respiratory symptoms such as cough, shortness of breath, difficulty breathing and fever. In more severe cases, pneumonia, severe acute respiratory syndrome, kidney failure and death can occur.
About the Elecsys® Anti-SARS-CoV-2 S test
The Elecsys® Anti-SARS-CoV-2 S test is an immunoassay for the in vitro determination of antibodies to SARS-CoV-2. Through a blood sample, the test can measure antibodies to the spike protein of the coronavirus, which could signal whether a person has been already infected. The test has both a high negative percent agreement (NPA) of 99.98% (N=5991) and positive percent agreement (PPA) of 96.6% (N=233), 15 days or later after diagnosis with a PCR test. With this test, Roche also showed titer development over time for patient samples ranging >100 days following a reactive PCR result, with no samples showing a decline of titers below the reactive range. Additionally, across panels of potentially cross-reactive samples (N=1100) from endemic human coronaviruses, infectious respiratory diseases, other infectious diseases, auto-immune and liver related diseases, the test demonstrated zero cross-reactivity. This test has been authorized only for the presence of antibodies against SARS-CoV-2, not for any other viruses or pathogens.
Clinical laboratories can run these tests on Roche’s cobas e analyzers which are widely available around the world. These fully automated systems can provide antibody test results in approximately 18 minutes, with a test throughput of up to 300 tests/hour, depending on the analyzer.
About Roche’s response to the COVID-19 pandemic
To address the global COVID-19 healthcare crisis, Roche has developed a growing number of diagnostic solutions that help detect and diagnose the infection in patients, as well as providing digital support to healthcare systems. Roche also continues to identify, develop and support potential therapies that can play a role in treating the disease.
Reliable, high-quality testing is essential to help healthcare systems overcome this pandemic. Roche continues to work with healthcare providers, laboratories, authorities and organizations to help make sure that patients continue to receive the tests, treatment and care they need during these challenging times.
The Roche portfolio of COVID-19 solutions includes:
- a high-volume molecular test to detect SARS-CoV-2, the virus that causes COVID-19, (FDA Emergency Use Authorization (EUA) and available in countries accepting the CE Mark)
- a SARS-CoV-2 laboratory-based antibody test, aimed at detecting the presence of antibodies in the blood targeting the nucleocapsid (FDA EUA and CE Mark)
- an IL-6 test to assist in identifying severe inflammatory response in patients with confirmed COVID-19 (FDA EUA and CE Mark)
- a high-volume molecular test to simultaneously detect and differentiate between SARS-CoV-2 and influenza A/B, as the symptoms are similar for both (FDA EUA and CE Mark)
- a second SARS-CoV-2 antibody test, aimed at measuring antibody response to the spike protein, to help assess a patient’s immune response and support the development of convalescent plasma therapy
- a point-of-care molecular PCR test that simultaneously detects and differentiates between SARS-CoV-2 and influenza A/B infections to support urgent triage and diagnosis (FDA EUA and CE Mark)
About Roche
Roche is a global pioneer in pharmaceuticals and diagnostics focused on advancing science to improve people’s lives. The combined strengths of pharmaceuticals and diagnostics under one roof have made Roche the leader in personalised healthcare – a strategy that aims to fit the right treatment to each patient in the best way possible.
Roche is the world’s largest biotech company, with truly differentiated medicines in oncology, immunology, infectious diseases, ophthalmology and diseases of the central nervous system. Roche is also the world leader in in vitro diagnostics and tissue-based cancer diagnostics, and a frontrunner in diabetes management.
Founded in 1896, Roche continues to search for better ways to prevent, diagnose and treat diseases and make a sustainable contribution to society. The company also aims to improve patient access to medical innovations by working with all relevant stakeholders. More than thirty medicines developed by Roche are included in the World Health Organization Model Lists of Essential Medicines, among them life-saving antibiotics, antimalarials and cancer medicines. Moreover, for the twelfth consecutive year, Roche has been recognised as one of the most sustainable companies in the Pharmaceuticals Industry by the Dow Jones Sustainability Indices (DJSI).
The Roche Group, headquartered in Basel, Switzerland, is active in over 100 countries and in 2019 employed about 98,000 people worldwide. In 2019, Roche invested CHF 11.7 billion in R&D and posted sales of CHF 61.5 billion. Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan. For more information, please visit www.roche.com.
Reference: https://www.roche.com/media/releases/med-cor-2020-12-02.htm
Abbott's FreeStyle Libre 2 now approved for adults and children with diabetes in Canada, featuring unsurpassed 14-day accuracy and optional alarms
2 December 2020 - FreeStyle Libre 2 system continuously measures glucose data every minute with customizable, optional real-time alarms to alert users when their glucose is high or low without scanning. Now for children (ages 4 and older) and adults with diabetes, this latest technology sustains excellent performance for up to 14 days, providing trends, insights and actionable data on a reader or with the FreeStyle LibreLink mobile app – all at the same price as the current FreeStyle Libre system. Latest sensor-based glucose monitoring technology will be available in the coming months to the more than 3.7 million Canadians with diabetes.
ABBOTT PARK, Ill., Dec. 2, 2020 -- Abbott today announced its next-generation, sensor-based glucose monitoring technology, FreeStyle Libre 2, received approval by Health Canada for adults and children (4 and older) with diabetes. With new features such as optional, real-time alarms1 that measure glucose levels every minute, FreeStyle Libre 2 gives users the option to be alerted in real-time of critical events such as hypoglycemia (low glucose levels) or hyperglycemia (high glucose levels). The wearable technology, which eliminates the need for painful fingersticks, also provides people with diabetes with excellent accuracy and actionable information to better manage their condition, and will be priced at the same cost as the current FreeStyle Libre system.
"For the millions of Canadians with diabetes, Abbott's next-generation FreeStyle Libre 2 system expands on the life-changing capabilities of our original FreeStyle Libre system with enhanced accuracy, optional alarms and now available for children," said Marie-Flore Nabor, general manager of Abbott's diabetes care business in Canada. "This latest technology will transform the way diabetes is currently managed. The FreeStyle Libre 2 is designed to simplify this often complicated-to-manage condition and is accessible and affordable to people with diabetes in Canada."
How FreeStyle Libre 2 Works
As the world leader in sensor-based glucose monitoring, Abbott continues to transform how people with diabetes test their glucose levels. Using Bluetooth technology, the FreeStyle Libre 2 system automatically alerts users when their glucose is high or low without needing to scan the sensor.
The FreeStyle Libre 2 sensor is worn on the back of the upper arm for up to 14 days and measures glucose every minute to help users and their healthcare providers make informed treatment decisions. With a one-second scan using FreeStyle LibreLink, a smartphone app, or handheld reader, users can see their glucose reading, trend arrow and eight-hour history. Users can also share data with their physicians or family members via the LibreLinkUp mobile app.
Abbott′s FreeStyle Libre 2 system utilizes the same proprietary wired enzyme technology as the FreeStyle Libre system, which was the first to remove painful fingersticks and is associated with better glucose control, decreased time in hypoglycemia and hyperglycemia, more time in optimal glucose range, and improved HbA1C. A real-world study published in the British Medical Journal shows that the use of FreeStyle Libre system over one year is often associated with improved quality of life and that work absenteeism rate and diabetes-related hospital admissions decreased by two thirds.
"Adding an alarm to this glucose sensing technology is definitely a major step to help people with diabetes live more confidently with less fear of high or low glucose levels," said Dr. Bruce Perkins, M.D., Director, Leadership Sinai Centre for Diabetes and Clinician-Scientist, University of Toronto. "We have seen from research with similar technologies that this kind of innovation can improve glucose level control, and even prevent emergency room visits and hospitalizations. For kids and adults alike, it means less pain from fingersticks, much greater insight into patterns, and much more reassurance."
Abbott′s FreeStyle Libre 2 system will be available for people with diabetes ages 4 and up in Canada in the coming months.
As the #1 sensor-based glucose monitoring system used worldwide,6 Abbott's FreeStyle Libre portfolio has changed the lives of more than 2.5 million people across more than 50 countries. Abbott has also secured partial or full reimbursement for the FreeStyle Libre system in 37 countries, including Canada where residents of Ontario and Quebec who manage diabetes with insulin are covered. Other countries include France, Germany, Japan, the United Kingdom, and the U.S.
About Abbott
Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 107,000 colleagues serve people in more than 160 countries.
Charnwood Lighthouse Lab Goes Live Processing Thousands of COVID-19 Tests per Day with PerkinElmer Solutions
30 November 2020 - UK’s newest Lighthouse Lab boosts the country’s COVID-19 testing capacity, while generating hundreds of new local jobs
WALTHAM, Mass., November 30, 2020 – PerkinElmer, Inc., announced today the Lighthouse Lab in Charnwood, Loughborough, England is now processing COVID-19 testing samples as part of the Company’s collaboration with the Department of Health and Social Care (DHSC) in support of the UK Government’s NHS Test and Trace program.
The facility, operated by PerkinElmer Genomics, began processing samples today, and with its team of 400 scientists, researchers, technicians and operations personnel, has the capacity to test up to 50,000 samples daily by early 2021.
The Lighthouse Lab at Charnwood Campus is the result of a collaboration between the DHSC and PerkinElmer, which has been engaged to equip, staff, and manage the facility using PerkinElmer’s proprietary COVID-19 kits, diagnostic equipment, and industry leading workflow solutions.
Commenting on the launch of the Lighthouse Lab, PerkinElmer’s Managing Director for UK & Ireland, Miles Burrows, said: “PerkinElmer’s ability to draw on expertise from our operations across the globe has enabled us to rapidly build a facility that will apply our best-in-class technologies to efficiently test individuals and identify those carrying the virus. In addition to assisting the DHSC to ramp up the nation’s testing capacity, this lab has created hundreds of new jobs locally. This has allowed us to develop and deploy a team who are ready to play such an essential role in managing this pandemic.”
This experienced team will enable the facility to operate 24 hours per day. The Lighthouse Lab in Charnwood has created opportunities for graduates and those who are pursuing careers in the life sciences to start their careers at the forefront of delivering the UK’s national testing program.
Health Minister Lord Bethell said: “I am delighted the new Lighthouse Lab in Charnwood is now up and running. The lab is part of Britain’s largest ever network of diagnostic testing facilities and will support our strategy to stop the spread of the virus by helping us boost testing capacity and speed-up turnaround times.
“I’d like to thank everyone involved in the Charnwood lab who will play such an integral role in helping people get their test results as quickly as possible. The sooner test results are received, the sooner we can take swift action to trace the contacts of those people who test positive, and the sooner those who test negative can get back to normal life.”
Charnwood is the second Lighthouse Lab to be brought online by PerkinElmer on behalf of the DHSC. In October, the global diagnostics and life sciences leader opened the first of its COVID-19 testing operations in Newport, South Wales, which processes thousands of test samples per day.
Interim Executive Chair of the National Institute for Health Protection Baroness Dido Harding said: “Testing capacity for those with COVID-19 symptoms has increased almost five-fold in six months, from 100,000 a day at the end of April to 500,000 a day by the end of October, but we are not stopping there.
“Charnwood Lighthouse Lab is an important part of our growing network of labs that are working together to extend and improve testing across the whole country. I would like to congratulate everyone involved for their hard work in getting the lab up and running so quickly.”
In addition to creating and operating facilities for the Lighthouse Lab network, PerkinElmer also supplies testing capabilities, equipment and reagents to NHS Trusts across the UK.
Gosia Khrais, the director for Charnwood Campus, said: “I would like to welcome Department of Health and Social Care and PerkinElmer as new occupiers on the site. The addition of the DHSC and PerkinElmer to the stronghold of science-driven organizations here is fantastic news for Charnwood and our local economy. It would not have happened without an effort of a number of stakeholders, our local Council and MP, as well as of the committed design and construction team that delivered this fast-paced project on time.”
PerkinElmer is utilizing its chemagic™ 360 instruments and JANUS® G3 PCR+ Workstations in these UK labs to automate PerkinElmer’s RNA extraction and RT-PCR tests. This total workflow solution enables rapid sample processing at higher volumes, helping to decrease turnaround time. PerkinElmer’s OneSource® services and PerkinElmer Genomics operations enable this turnkey approach to provide sample testing in order to meet the Government’s immediate and future COVID-19 testing requirements.
About PerkinElmer
PerkinElmer enables scientists, researchers, and clinicians to address their most critical challenges across science and healthcare. With a mission focused on innovating for a healthier world, we deliver unique solutions to serve the diagnostics, life sciences, food, and applied markets. We strategically partner with customers to enable earlier and more accurate insights supported by deep market knowledge and technical expertise. Our dedicated team of about 13,000 employees worldwide is passionate about helping customers work to create healthier families, improve the quality of life, and sustain the wellbeing and longevity of people globally. The Company reported revenue of approximately $2.9 billion in 2019, serves customers in 190 countries, and is a component of the S&P 500 index. Additional information is available through 1-877-PKI-NYSE, or at www.perkinelmer.com.
LGC’s high-throughput PCR testing system for SARS-CoV-2 detection, submitted for Emergency Use Authorisation, capable of processing up to 35,000 tests per day
30 November 2020
30 November 2020 -- LGC’s high-throughput (HTP) RT-PCR testing system for SARS-CoV-2 has been submitted to the FDA for Emergency Use Authorisation (EUA). Testing labs can now leverage LGC’s unrivalled expertise in automated sample preparation and high-throughput RT-PCR workflows in a ready-to-deploy solution.
As the need for SARS-CoV-2 testing for both diagnostic and screening applications continues to grow, many organisations are looking to expand or create testing capacity. LGC’s high-throughput RT-PCR workflow can expand capacity by running up to 35,000 tests per day with one scalable testing system.
Mark Dearden, Managing Director, LGC Genomics, said, “We are grateful that the FDA is reviewing our SARS-CoV-2 testing system. LGC has been involved in the response to the COVID-19 pandemic since January. We know that large-scale and frequent testing is a key epidemiological response to help manage the spread of the virus and to assess positivity rates in communities. The benefits of being able to deliver large-scale testing capacity in tandem with rapid result turnaround time can’t be underestimated. Our Biosearch Technologies’ SARS-CoV-2 Real-Time and End-Point RT-PCR Test is intended to support our clients in meeting the surging demand for SARS-CoV-2 detection.”
Dearden continued, “Limited supplies of instruments, reagents and laboratory technicians have made it challenging to deliver high volumes of testing in a timely manner. The creation of new facilities and conversion of research labs into testing labs introduces the complexities of creating new, regulatory-compliant workflows. Our solution can enhance testing strategies and ramp up throughput of testing per day. If used widely, our ability to support large-scale testing could lead to enhanced management of virus response, which ultimately could unlock safe returns to work and get economies moving once again.”
LGC’s technology can be applied for a wide range of use cases, from businesses and academic institutions who wish to test their staff and students regularly, to public health institutions and governments wishing to conduct mass testing.
LGC has a proven track record in supporting the scientific and healthcare community with diagnostics for public health diseases as well as public health emergencies such as influenza, H1N1 (swine flu), Zika, and Ebola.
Strategic alliance between Grifols and the Egyptian government to boost plasma-derived medicines self-sufficiency in the Middle East and Africa
24 November 2020 - Grifols and the National Service Projects Organization (NSPO) have reached a strategic agreement to develop the local plasma-derived therapies market through the opening of 20 plasma centers and construction of production facilities in Egypt, including a plasma fractionation plant and a protein purification plants. The agreement is a unique collaborative opportunity that will strengthen Egypt’s healthcare system and self-sufficiency, while reinforcing Grifols’ international expansion in the Middle East and Africa. Grifols and NSPO will incorporate a new company (joint venture) which will be owned by Grifols and NSPO on a 49%-51% basis, respectively.
Barcelona, November 24, 2020 -- Grifols, one of the world’s leading producers of plasma-derived medicines with a more than 100-year track record of contributing to the health and well-being of people around the world, and the Government of Egypt, through the National Service Projects Organization (NSPO), have signed a strategic agreement (Master Joint Venture Agreement) to further develop the Egyptian plasma-derivatives market and promote its self-sufficiency. The operation will ensure national security needs and help strengthen the healthcare system in Egypt.
Under this joint venture, owned by NSPO (51%) and Grifols (49%), the parties will join their industrial expertise and financial efforts for the development, construction and operation of 20 plasma collection centers throughout Egypt (with an initial capacity to collect 600,000 liters of plasma per year); manufacturing facilities, including a fractionation plant (with a capacity to fractionate up to 1 million liters of plasma per year) and a purification and fill-and-finish plant; a warehouse and an analysis laboratory. The plasma centers and manufacturing installations are expected to be operational at the end of 2025.
Through this agreement, Grifols will become a strategic ally of the Egyptian government, while building on its commitment to help countries reach higher levels of self-sufficiency in the manufacture and procurement of plasma-derived therapies for patients who need them.
The transaction supports Grifols’ globally focused, long-term sustainable growth strategy, whose core objectives include increasing the company’s supply of plasma and reinforcing its global expansion.
The transaction will allow Grifols to bolster its presence in the Middle East and Africa after establishing a solid presence in the United States and Europe and making important inroads in China, all core areas of its growth plan.
For Víctor Grífols Deu, co-CEO of Grifols, “we are extremely pleased to take part in a strategic alliance that will contribute to developing the healthcare system of Egypt. In addition to marking an important step forward in our sustainable growth strategy, it fulfills our objective to continue helping countries achieve self-sufficiency in plasma-derived medicines, essential for patients who need them”.
Grifols’ leadership in the production of plasma-derived medicines, technical expertise and reputation in developing and managing plasma centers and manufacturing facilities have been key factors behind this strategic alliance.
About the strategic alliance
Under the agreement (Master Joint Venture Agreement), Grifols and NSPO will incorporate a new company which will be owned by Grifols and NSPO on a 49%-51% basis, respectively. The board of directors will comprise an equal number of members appointed by both parties. This notwithstanding, the agreement provides for a vast list of matters which will require unanimous consent of both shareholders in order to be approved.
The project will be carried out in stages over a 5-year time period and the total expected capital expenditure for the project is estimated to be USD 300 million and is to be disbursed by the shareholders according to their percentage ownership, on a need-be basis. An initial joint investment of USD 20 million will be made upon the incorporation of the joint venture in order to support immediate operations.
At a first stage, through a contract manufacturing agreement and whilst the manufacturing facilities are pending to be finalized and fully up and running, Grifols will secure the processing of the plasma collected in Egypt into plasma-derived products to serve Egyptian national needs in the short term.
The plasma-centers will initially enable the collection of around 600,000 liters of plasma per year and the plant will have a fractionation capacity of up to 1 million liters per year. The plasma centers and manufacturing facilities are expected to be operational at the end of 2025. For Grifols, this project will free-up plasma and manufacturing capacity, it will bring diversification to its plasma procurement sources and will create expansion opportunities in certain territories
As part of the recognized value to be contributed by Grifols into the joint venture it includes its industry expertise and experience, as well as its intellectual property. The subscription to specific complementary agreements (Consultancy and Services Agreement, Technology and Know-How License Agreement and Contract Manufacturing Agreement) will allow Grifols to provide with any needed support, guidance, training, engineering services, manufacturing services, know-how and technology to support the execution of the project, in exchange of fees and royalties agreed upon between the parties.
Grifols will assume full supervision and management of the operation’s quality and safety to guarantee the infrastructures and processes adhere to the strictest quality and safety standards. The installations are expected to be authorized by international regulatory agencies, such as the European Medicines Agency (EMA) or the International Quality Plasma Program (IQPP) of the Plasma Protein Therapeutics Association (PPTA), among others.
BGI’s Nucleic Acid Detection Kit for Bloodstream Infection Pathogens Obtains CE Mark
26 November 2020
26 November 2020 -- The Nucleic Acid Detection kit for Bloodstream Infection Pathogens with Combinatorial Probe-Anchor Synthesis Technology developed by BGI Patho-Genesis Pharmaceutical Technology Co. LTD, a holding subsidiary of BGI Genomics, has recently got CE Mark.
The kit was developed on basis of metagenomic sequencing for detecting nucleic acid of agnostic pathogens in plasma using combinatorial Probe-Anchor Synthesis technology, intending to identify the causative pathogens of bloodstream infection aiding clinical diagnosis and differential diagnosis in combination with clinical manifestation, examination and other laboratory findings.
The kit is to construct the total Nucleic Acid library directly from clinical samples for high-throughput sequencing. The sequenced data can be analyzed using the bioinformatic software dedicated for bloodstream infection and comparing with the curated microbial genome reference database, enabling to unbiased detection of pathogens including bacteria, fungi,
viruses and parasites. Because of its fast speed and high accuracy with wide coverage of microbial spectrum in a single test, it has been used widely in clinical practices for identifying the causative pathogens of bloodstream infection.
Bloodstream infection is a serious systemic infectious disease. Pathogens invade the blood circulatory system and release toxins and metabolites, causing systemic infection, poisoning and inflammatory responses frequently in form of bacteremia, septicemia, sepsis, catheter-related bloodstream infection, and bacterial endocarditis with high fatality rate. Rapid and timely diagnosis is very important for life-saving treatment. BGI new CE marked detection kit detects plasma samples from patients based on metagenomic sequencing without the need for prior culture of microorganism.
Beckman Coulter launches its semi-quantitative SARS-CoV-2 IgG II antibody test
23 November 2020 - Access SARS-CoV-2 IgG II test is a semi-quantitative assay that measures patient’s relative level of antibodies in response to a previous SARS-CoV-2 infection. Assay is an added tool to assess relative changes of IgG levels over time to demonstrate the durability of an immune response to the SARS-CoV-2 virus.
BREA, CALIF., Nov. 23, 2020 — Beckman Coulter, a clinical diagnostics leader, today launched its Access SARS-CoV-2 IgG II assay that measures a patient’s relative level of antibodies in response to a previous SARS-CoV-2 infection. The new capabilities of this assay enable clinicians to establish a baseline to evaluate an individual’s immune response to the SARS-CoV-2 virus based on a numerical value and assess relative changes of an individual’s immune response to the virus over time. The assay may also help researchers as they begin to understand the levels of IgG antibodies needed to be considered protective.
The organization is filing for Emergency Use Authorization of the assay with the U.S. Food and Drug Administration (FDA) and will immediately begin shipping assays to its customer base throughout the U.S. under Policy D. Beckman Coulter is also planning to make the assay available to markets accepting the CE Mark before the end of the year.
“Having a clearer picture of the immune response to SARS-CoV-2 plays an important role in the fight against COVID-19, especially before a vaccine is widely available,” said Shamiram R. Feinglass, M.D., MPH, chief medical officer Beckman Coulter. “While it's unknown how long antibodies persist following infection, and if the presence of antibodies confers protective immunity, having a quantifiable baseline is a critical step towards furthering the understanding of the adaptive immune response to SARS-CoV-2 in individuals over time.”
Access SARS-CoV-2 IgG II semi-quantitative assay provides a numerical result in Arbitrary Units (AU) from 2.00- 450 AU/mL as well as a qualitative result and offers the same high level of quality as Beckman Coulter’s Access SARS-CoV-2 IgG and IgM serology tests already on the market. The assays use the receptor-binding domain (RBD) of the spike protein. Beckman Coulter selected the RBD of the spike protein as it is critical for viral entry into human cells and has been shown to be the target for neutralizing antibodies in a surrogate model. This selection is also aligned with the multiple vaccines in development that target or include the RBD of the spike protein, with the goal of producing protective antibodies.
The Access SARS-CoV-2 IgG II semi-quantitative assay is the latest addition to Beckman Coulter’s full suite of testing solutions designed to provide valuable information to clinicians in their fight against COVID-19. The next product expected from the organization is an automated SARS-CoV-2 antigen test which is currently under development. While point of care (POC) antigen tests have a purpose in diagnosing COVID-19, they are difficult and resource intensive to scale to address high volume testing needs. Beckman Coulter’s antigen test is being designed to provide ultimate flexibility in scaling to address the needs of small, moderately complex laboratories that operate a desktop analyzer, to large laboratories that implement automated, high-throughput analyzers for mass testing.
About the Access SARS-CoV-2 IgG II assay
The Access SARS-CoV-2 IgG II assay is a semi-quantitative and qualitative immunoassay that measures IgG antibodies directed to the receptor-binding domain of the spike protein of the novel coronavirus in response to a previous infection. The assay then provides a numerical result ranging from 2.00-450/mL as well as a qualitative result for SARS-CoV-2 IgG antibodies.
The test has a confirmed 96.0% positive percent agreement (PPA, sensitivity) at 8-14 days post symptom onset and 99.9% negative percent agreement (NPA, specificity) evaluated in a study with 1,448 samples from donors in the U.S.A. and France collected prior to December 2019. With this high NPA rate, false positive results are extremely low to ensure accurate and reliable test results. It uses immobilized virus antigens on magnetic particles to capture IgG antibodies from patient serum or plasma samples and reveals them using labelled anti-IgG antibodies.
The Access SARS-CoV-2 IgG II assay can be used can be used in Random Access Mode (RAM) and seamlessly integrated into existing workflows without batch processing. Results of the new Access SARS-CoV-2 IgG II test are delivered quickly on Beckman Coulter’s award-winning immunoassay analyzers, including the DxI 800 high-throughput analyzer, which is capable of processing 200 samples per hour. For more information on Beckman Coulter’s full suite of testing solutions or its commitment to the fight against COVID-19, visit www.BeckmanCoulter.com/Coronavirus.
About Beckman Coulter
Beckman Coulter is committed to advancing healthcare for every person by applying the power of science, technology and the passion and creativity of our teams to enhance the diagnostic laboratory’s role in improving healthcare outcomes. Our diagnostic systems are used in complex biomedical testing, and are found in hospitals, reference laboratories and physician office settings around the globe. Beckman Coulter offers a unique combination of people, processes and solutions designed to elevate the performance of clinical laboratories and healthcare networks. We do this by accelerating care with a menu that matters, bringing the benefit of automation to all, delivering greater insights through clinical informatics and unlocking hidden value through performance partnership. An operating company of Danaher Corporation (NYSE: DHR) since 2011, Beckman Coulter is headquartered in Brea, Calif., and has more than 11,000 global associates working diligently to make the world a healthier place.
Genedrive HCV ID Kit demonstrates high clinical accuracy in India study
20 November 2020 - Hepatitis C virus testing kit reveals 100% sensitivity and specificity when compared to Abbott Real time HCV test
20 November 2020 -- Genedrive plc (AIM:GDR), the near patient molecular diagnostics company, announces the publication of the study data for the ‘Evaluation of the Point of Care Molecular Diagnostic Genedrive HCV ID Kit for the detection of HCV RNA in clinical samples’.
The study was led by Dr Ekta Gupta at ILBS, New Delhi, India. The objective of the study was to determine the diagnostic accuracy of the Genedrive HCV ID Kit, as a confirmatory test for seropositive hepatitis C virus (HCV) patients in Indian demographic settings.
The diagnostic accuracy of the Genedrive HCV ID Kit was evaluated by comparing the test with the Abbott Real time HCV test on the lab-based Abbott m2000 platform in an Indian demographic and across a range of different genotypes, to ensure suitability for introduction of the product to the Indian population. In India the circulation of HCV genotype is predominantly genotypes 3 and 1 with live infections of HCV estimated at between 6-12 million.
150 HCV RNA positive and 170 HCV RNA negative samples were tested using both methods. The comparison revealed 100% sensitivity (95% CI 97.9 – 100%) and 100% specificity (95% CI 97.9 – 100%). The overall diagnostic accuracy was 100% (95% CI 98.9 – 100%).
Overall, the study demonstrates that the Genedrive HCV ID Kit is suitable for use in India and can be used for decentralised testing of HCV thereby reducing the loss of patients to follow up.
David Budd, CEO of genedrive plc, said: “These excellent clinical results for our HCV assay further validate the applicability of the test for a decentralised setting. India is a key target market for our assay and we are excited about the commercial prospects in the region.”
Reference: https://www.genedrive.com/news/index.php
Aptima HIV-1 Quant Dx Assay Receives Additional FDA Approval for Use as an Aid in the Diagnosis of HIV Infection
20 November 2020 - First FDA-Approved Assay for Both Qualitative Diagnosis and Quantitative Viral Load Monitoring
MARLBOROUGH, Mass., 20 November 2020 -- Hologic, Inc. announced today that the U.S. Food and Drug Administration (FDA) has approved a diagnostic claim for its HIV-1 (human immunodeficiency virus type 1) viral load monitoring assay. The Aptima® HIV-1 Quant Dx assay is now the first dual-claim assay for both diagnosis and viral load monitoring in the United States.
The AptimaHIV-1 Quant Dx assay, which was approved in late 2016 for viral load monitoring, is a molecular diagnostic test that runs on the fully automated, sample-to-result Panther® system. The assay utilizes a dual target approach against highly conserved regions in the HIV genome that is designed to deliver reliable, consistent qualitative and quantitative results across HIV-1 groups and subtypes. The Aptima HIV-1 Quant Dx assay is also CE IVD-marked for both diagnostic and viral load monitoring claims.
“This is an exciting new claim for our highly sensitive and reliable HIV test because it has the potential to improve patient care,” said Kevin Thornal, president of Diagnostic Solutions at Hologic. “A simultaneous viral load measurement with diagnosis will allow healthcare providers to guide treatment choices for patients to begin therapy immediately. The dual claim will also benefit our clinical laboratory customers, who continuously seek to consolidate their testing as much as possible onto one automated platform.”
Starting treatment at the time of diagnosis is expected to reduce the risk of HIV transmission to others and to maximize prospects for long-term good health.
There are approximately 1.2 million people living in the US with HIV, with 38,000 new infections in 2018.
For more information about Hologic’s U.S. virology portfolio, please visit: http://usaptimavirology.com.
About the Panther and Panther Fusion Systems
The Panther molecular diagnostics system is a best-in-class, fully automated, sample-to-result platform that can be used in low-, medium- or high-throughput laboratories. With a small footprint, adaptable workflow options and consolidated testing menu, it combines women’s health, sexually transmitted infection and viral load testing, which can all be done simultaneously. The Panther Fusion system provides an expanded in vitro diagnostics menu, as well as Open AccessTM functionality to run laboratory developed tests. Hologic’s Panther and Panther Fusion systems now offer 18 FDA-cleared assays and 20 CE-marked assays that detect more than 20 pathogens. More than 2,250 Panther systems have been installed in clinical diagnostic laboratories around the world.
About Hologic
Hologic, Inc. is an innovative medical technology company primarily focused on improving women’s health and well-being through early detection and treatment. For more information on Hologic, visit www.hologic.com.
Siemens Healthineers is the First Leading Diagnostics Company Offering a Quantitative COVID-19 Test to Measure Neutralizing Antibodies
18 November 2020 - The Siemens Healthineers SARS-CoV-2 IgG Antibody Test, available under CE Mark, has proven to measure neutralizing antibodies. The company has submitted to the FDA under EUA. As SARS-CoV-2 vaccines become available, Siemens Healthineers is ready with fully automated antibody tests that can be used to help inform whether broad vaccination programs are working. Reliable antibody tests are a valuable tool to measure the effectiveness of vaccines.
TARRYTOWN, N.Y., November 18, 2020 – Siemens Healthineers announced today its SARS-CoV-2 IgG Antibody Test (sCOVG)1 has proven to measure neutralizing antibodies and has achieved CE Mark. The test is an enhanced version of the assay which became available globally this summer, including in the U.S. It demonstrates the ability to detect neutralizing antibodies and reports quantitative results measuring the amount of neutralizing antibodies present in a patient's blood sample. The company has submitted an application to FDA under Emergency Use Authorization.
Neutralizing antibodies are critical in the fight against COVID-19 because they defend cells from infection by the virus. A virus typically produces an immune response of many antibodies that act as an army to help fight off the virus; however, only a small subset of those antibodies are capable of neutralization—blocking the virus from infecting additional cells. Those neutralizing antibodies develop either in response to natural infection or to vaccination, then subsequently bind to the virus and block infection. To measure a vaccine’s effectiveness, it is critical to identify both the presence of these neutralizing antibodies as well as quantitatively assess the likely level needed to protect against future encounters with the virus. The Siemens Healthineers' antibody test will make learning this information possible as vaccines are rolled out and exposure to COVID-19 is tested against immunization and the level of immunity a vaccine provides.
"At the onset of the pandemic, the scientific community had to learn about COVID-19 and how our immune systems would respond. We targeted the spike protein for our antibody tests, anticipating antibodies to this protein would eventually prove to be neutralizing," said Deepak Nath, PhD, President of Laboratory Diagnostics at Siemens Healthineers. "Adequate data is available now to confirm the spike protein antibodies are indeed neutralizing, especially those against the spike receptor binding domain. Healthcare providers can feel confident that our test will help them determine whether a patient's immune system is producing the right antibodies to stop or prevent COVID-19 infection."
The Siemens Healthineers SARS-CoV-2 IgG antibody tests are available on one of the largest installed bases of automated immunoassay analyzers worldwide, and the largest in the U.S. This includes the Atellica® Solution and ADVIA Centaur® XP and XPT families of analyzers and the Dimension Vista® and Dimension® EXL™ systems.
Siemens Healthineers has distinguished itself as a provider of quality assays to aid the COVID-19 pandemic. In addition to antibody, antigen, and molecular SARS-CoV-2 tests, Siemens Healthineers offers a broad diagnostics portfolio to aid in the prognosis, treatment and follow-up of COVID-19 patients. The company’s broad and differentiated menu includes hematology, coagulation, cardiac, respiratory, inflammation and infectious disease panels. Blood gas and imaging solutions from Siemens Healthineers deliver actionable results that aid clinicians in caring for COVID-19 patients.
Reference: https://www.siemens-healthineers.com/press-room/press-releases/covid-19-igg-quantitative.html
bioMérieux announces the expansion of the CE marking of its molecular biology ARGENE® SARS-CoV-2 diagnostic test to include saliva specimens
16 November 2020
Marcy l’Etoile, France – November 16, 2020 – bioMérieux, a world leader in the field of in vitro diagnostics, has announced the expansion of its ARGENE® range for the detection of SARS-CoV-2. As a complement to nasopharyngeal swab specimens, the singleplex SARS-CoV-2 R-GENE® real-time PCR test may now be used on saliva and oropharyngeal (throat) swab specimens for the detection of the virus that causes COVID-19. This development helps optimize laboratory workflows.
The CE-marked SARS-CoV-2 R-GENE® test covers the above three sample types. This allows bioMérieux to address the recommendation issued by the French National Authority for Health (HAS) on September 18, 2020, which encourages the preferential use of saliva swabs to test symptomatic individuals for whom it is difficult or impossible to use nasopharyngeal swabs.
“True to its commitment to combat the COVID-19 pandemic, bioMérieux has taken into account the needs of laboratories. Expanding the use of the ARGENE® molecular test to include saliva swab specimens will make the test more acceptable to many patients, and will make it easier to perform,” said François Lacoste, Executive Vice President, R&D.
The expansion of the CE marking to include saliva and oropharyngeal swab specimens has been declared to the French National Agency of Medicines and Health Products Safety (ANSM).This new type of specimen is now mentioned in the list of tests authorized by the French Directorate General of Health.
Moreover, the Company will soon release a high-throughput test for the simultaneous (multiplex) detection of influenza viruses A and B and SARS-CoV-2, including a cellular control to check the quality of the sample. It will be available in Europe and in countries that recognize CE marking. This new test will be part of the same test kit for the detection of two other disease agents that often circulate during the winter months, RSV (human respiratory syncytial virus) and HMPV (human metapneumovirus).
About the ARGENE® SARS-COV-2 R-GENE® test
As for all tests in the ARGENE® range, the SARS-COV-2 R-GENE® test is an open assay, meaning that it may be performed by any laboratory using PCR technology on most commercially-available nucleic acid extraction and amplification platforms. Results are delivered in 4 to 5 hours, and a large number of patient samples may be processed simultaneously. The entire ARGENE® range for the detection of SARS-CoV-2 is produced in France at the bioMérieux site in Verniolle (Ariège).
QIAGEN launches NeuMoDx multiplex test to complete range of SARS-CoV-2 testing solutions in Europe and other markets
16 November 2020 - Fast and easy-to-use respiratory PCR test comes onto market as flu season gains pace in Northern Hemisphere. CE-IVD marking in Europe granted for NeuMoDx™ Flu A-B/RSV/SARS-CoV-2 Vantage Test, has also been submitted to FDA for Emergency Use Authorization. Test adds to QIAGEN’s growing portfolio of PCR testing solutions for COVID-19 testing. QIAGEN also expands sample type claim for NeuMoDx™ SARS-CoV-2 test to include saliva from a dedicated collection kit in Europe.
Germantown, Maryland, and Hilden, Germany, November 16, 2020 – QIAGEN N.V. today announced the European launch of the NeuMoDx™ Flu A-B/RSV/SARS-CoV-2 Vantage Test that will help healthcare professionals quickly identify and differentiate between patients with common seasonal respiratory infections and COVID-19.
With the Northern Hemisphere in the grip of flu season, this multiplex polymerase chain reaction (PCR) test detects and differentiates influenzas A and B, respiratory syncytial virus (RSV) and SARS-CoV-2 infections within 80 minutes. These viruses produce similar respiratory symptoms, making it essential to provide differential diagnosis among them for patient treatment and management decisions, especially in the COVID-19 pandemic.
QIAGEN has launched NeuMoDx™ Flu A-B/RSV/SARS-CoV-2 Vantage in the European Union and other markets after CE-IVD registration, and has submitted an Emergency Use Authorization (EUA) request to the FDA.
QIAGEN’s new respiratory test takes advantage of the NeuMoDx 96 and NeuMoDx 288 molecular systems’ automated three-step workflow. Coupled with additional system features – like processing capacity, true random access, and continuous loading of samples, reagents and consumables while the system is running – the NeuMoDx™ Flu A-B/RSV/SARS-CoV-2 Vantage test will be a powerful diagnostic tool for the flu season and COVID-19 pandemic.
In addition, QIAGEN has expanded specimen types that can be used on the existing NeuMoDx™ SARS-CoV-2 test. CE-IVD approval has been obtained for the use of saliva samples collected with the NeuMoDx™ Saliva Collection Kit, which includes a collection vial, stabilization tube and pipette.
This kit allows for less invasive sample collection compared to commonly used nasal swabs. It reduces the burden on the supply of the nasal collection devices and increases laboratory testing capacity. This claim extension for the saliva collection kit is also in review with the FDA. The singleplex test was granted an EUA in March.
“Both launch and label extension expand the capabilities of our NeuMoDx systems in detection of COVID-19,” said Thierry Bernard, Chief Executive Officer of QIAGEN. “They add to our growing NeuMoDx testing menu, which in 2020 included launches for HIV-1, TV/MG, Strep A/C/G, HPV, BK virus, and Influenza A-B/RSV. We will launch additional assays in 2021 and continue to increase the value of the platform for lab customers beyond the pandemic.
QIAGEN fully acquired NeuMoDx in September and made it one of its five growth drivers that make the company strong enough to continue to grow on a standalone basis – the others being Sample Prep, QIAcuity, QFT and the QIAstat-Dx. The NeuMoDx™ Flu A-B/RSV/ SARS-CoV-2 Vantage Assay strengthens QIAGEN’s footprint in PCR, the gold standard in coronavirus testing.
QIAGEN now is the only company to be able to offer fast singleplex and multiplex PCR tests as well as a fast syndromic solution (QIAstat-Dx), providing customers with a broad variety of PCR-based testing options. Furthermore, the portfolio includes RNA extraction kits and instruments as well as testing components and enzymes used by third parties for their own PCR test kits. In October, QIAGEN also launched QIAprep& which streamlines PCR workflows by integrating sample preparation and real-time PCR detection into a single kit. The product has initially been launched for research use only and is planned to gain EUA and CE-IVD registration soon.
Further information on QIAGEN’s response to the coronavirus outbreak can be found here. For more information on the NeuMoDx platform and NeuMoDx™ Flu A-B/RSV/SARS-CoV-2 Vantage Assay please visit http://qiagen.com/NeuMoDx
About QIAGEN
QIAGEN N.V., a Netherlands-based holding company, is the leading global provider of Sample to Insight solutions that enable customers to gain valuable molecular insights from samples containing the building blocks of life. Our sample technologies isolate and process DNA, RNA and proteins from blood, tissue and other materials. Assay technologies make these biomolecules visible and ready for analysis. Bioinformatics software and knowledge bases interpret data to report relevant, actionable insights. Automation solutions tie these together in seamless and cost-effective workflows. QIAGEN provides solutions to more than 500,000 customers around the world in Molecular Diagnostics (human healthcare) and Life Sciences (academia, pharma R&D and industrial applications, primarily forensics). As of September 30, 2020, QIAGEN employed more than 5,300 people in over 35 locations worldwide. Further information can be found at http://www.qiagen.com.
Reference: https://corporate.qiagen.com/newsroom/press-releases/2020/20201116_neumodx_ce_multiplex
PerkinElmer SARS-CoV-2 RT-PCR Assay Receives CE Mark for Saliva and Sample Pooling to Test Symptomatic and Asymptomatic Individuals
12 November 2020 - Non-invasive sample collection and batch processing to test symptomatic and asymptomatic individuals – a breakthrough in COVID-19 testing
WALTHAM, Mass., Nov. 12, 2020 -- PerkinElmer, Inc. announced today that its PerkinElmer® SARS-CoV-2 Real-time RT-PCR Assay received CE-IVD marking for the use of saliva as specimen type and the option to pool up to five specimens collected from individuals suspected of COVID-19 or asymptomatic individuals.
SARS-CoV-2 testing using saliva is less invasive, reduces the risk of exposure to healthcare workers involved in sample collection and need for frequent replacement of personal protective equipment.
Labs in countries accepting CE mark now have the option to accept saliva specimens and implement sample pooling using the PerkinElmer SARS-CoV-2 Real-time RT-PCR Assay. Sample pooling using saliva specimens is a critical advancement made possible by PerkinElmer’s chemistry and stringent manufacturing systems. The PerkinElmer SARS-CoV-2 Real-time RT-PCR Assay is built on the most sensitive SARS-CoV-2 test with the lowest limitation of detection in the market, according to the FDA’s reference panel comparative data.
The assay originally obtained its CE mark in the spring of 2020.
“To strike the right balance between keeping the world economy moving while ensuring safe practices, governments and private organizations are working tirelessly to increase the number of times individuals are tested for COVID-19,” said Masoud Toloue, Ph.D., Vice President & General Manager, Diagnostics, PerkinElmer. “We expect our newly released saliva-based collection and asymptomatic test solution will play a large role in this effort.”
PerkinElmer continues to work on the frontlines of improving COVID-19 testing. The Company’s comprehensive SARS-CoV-2 offerings span high throughput RNA extraction, RT-PCR, automation, ELISA, chemiluminescence, time-resolved fluorescence and lateral flow based serology testing.
About PerkinElmer
PerkinElmer enables scientists, researchers, and clinicians to address their most critical challenges across science and healthcare. With a mission focused on innovating for a healthier world, we deliver unique solutions to serve the diagnostics, life sciences, food, and applied markets. We strategically partner with customers to enable earlier and more accurate insights supported by deep market knowledge and technical expertise. Our dedicated team of about 13,000 employees worldwide is passionate about helping customers work to create healthier families, improve the quality of life, and sustain the wellbeing and longevity of people globally. The Company reported revenue of approximately $2.9 billion in 2019, serves customers in 190 countries, and is a component of the S&P 500 index. Additional information is available through 1-877-PKI-NYSE, or at www.perkinelmer.com
BGI Gets CE Mark for HPV Testing Products
12 November 2020
12 November 2020 -- BGI Europe A/S, A wholly-owned subsidiary of BGI Genomics Co., LTD., today announces that its HPV testing products: Human Papillomavirus (HPV) Typing Kit (Combinatorial Probe-Anchor Synthesis Sequencing Method), and related Nucleic Acid Extraction Kit has been CE marked.
The GLOBOCAN 2018 estimates there are about 500,000 new cases of cervical cancer each year, accounting for 3.2 percent of all new cancer cases, making it the fourth most common malignancy in terms of morbidity and mortality among women. Persistent high-risk human papillomavirus (HPV) infection is the leading cause of cervical cancer and precancerous lesions.
BGI CE marked Human Papillomavirus (HPV) Typing Kit (Combinatorial Probe-Anchor Synthesis Sequencing Method) together with its applicable nucleic acid extraction kit, used for the precise typing of 17 types of high-risk and medium-risk HPV such as HPV 16, 18, 31, etc. is conducive to the early diagnosis and treatment of HPV infection as well as the prevention and control of cervical cancer.
The CE certification of the HPV test will further enhance the company’s core competitiveness in the field of tumor detection in the global market, which will have a positive impact on the company’s tumor prevention and control business.
Reference: https://www.bgi.com/global/company/news/bgi-gets-ce-mark-for-hpv-testing-products/
QIAGEN launches portable digital SARS-CoV-2 antigen test that can accurately analyze over 30 samples per hour
11 November 2020 - QIAreach™ SARS-CoV-2 Antigen Test, developed in partnership with Ellume, is an important step towards decentralized mass screening by processing samples in 2–15 minutes. Digital results for dozens of samples per hour and the ability to process antibody tests in parallel, setting new standards in scalability and flexibility. Test submitted to FDA for Emergency Use Authorization for US, CE-IVD marking for European Union and other markets expected by year’s end.
Hilden, Germany, and Germantown, Maryland, November 11, 2020 – QIAGEN has started commercialization of a portable digital test in the United States that can be used by laboratories to detect SARS-CoV-2 antigens in people with active infections in 2-15 minutes. A point of care (POC) claim will be added and EUA amended later this year.
The QIAreach™ SARS-CoV-2 Antigen Test, developed in partnership with the Australian digital diagnostics company Ellume, sets new standards in scalability, validation and flexibility by processing more than 30 swab samples per hour, providing digital test results that do not require subjective interpretation, and allowing antibody tests to run simultaneously with antigen tests. This flexibility will be particularly valuable when vaccines are introduced.
QIAGEN has begun marketing and distributing QIAreach™ SARS-CoV-2 Antigen Test in the United States after applying for FDA emergency use authorization (EUA) for symptomatic patients. CE-IVD registration for European Union and other markets is expected as early as by the end of the year.
“As existing approaches often lack scalability and accuracy, antigen testing is playing an increasingly important role in national testing strategies as a complementary tool to PCR, the gold-standard for detecting active COVID-19 infections,” said Thierry Bernard, Chief Executive Officer of QIAGEN. “QIAreach SARS-CoV Antigen is a fast, digital and easy to use test that makes use of sensitive nanoparticle technology from Ellume. In as little as two minutes it allows objective reading of test results that provide clear qualitative interpretation. And it addresses the growing need for higher throughput testing for SARS-CoV-2 antigen by processing up to eight tests per hub simultaneously.”
Testing of clinical samples have shown the QIAreach™ SARS-CoV-2 Antigen Test to have a sensitivity of 90% and a specificity of 100%. It is the second QIAGEN COVID-19 test to make use of the digital eHub and eStick system made by its partner Ellume. QIAGEN in August announced the QIAreach™ Anti-SARS-CoV-2 Antibody Test – and both tests can run on the digital platform interchangeably.
The portable system provides a true walkaway solution with random access and does not require maintenance or calibration. It contains a rechargeable battery for eight hours of remote use and can fully connect to laboratory information management systems (LIMS) with an optional use software. The eHub will also run the QIAreach QuantiFERON®-TB test, a novel test for the detection of latent tuberculosis infections in low resource and high burden settings that is currently in development.
QIAreach™ SARS-CoV-2 Antigen Test uses the rugged and portable eHub to analyze eight eSticks with nasopharangeal-swab samples from symptomatic people at once, each test running independently of the others. The easy-to-use eStick uses nanoparticle fluorescent detection technology to flag the SARS-CoV-2 nucleocapsid protein, an antigen present on the inside of the virus. The device can detect strong positive cases in as little as two minutes and negative cases in 15 minutes.
For more information on QIAreach™ SARS-CoV-2 Antigen Test please visit https://go.qiagen.com/QIAreach-SARS-CoV2-Antigen-Test-LearnMore. Further information on QIAGEN’s response to the coronavirus outbreak can be found here.
About QIAGEN
QIAGEN N.V., a Netherlands-based holding company, is the leading global provider of Sample to Insight solutions that enable customers to gain valuable molecular insights from samples containing the building blocks of life. Our sample technologies isolate and process DNA, RNA and proteins from blood, tissue and other materials. Assay technologies make these biomolecules visible and ready for analysis. Bioinformatics software and knowledge bases interpret data to report relevant, actionable insights. Automation solutions tie these together in seamless and cost-effective workflows. QIAGEN provides solutions to more than 500,000 customers around the world in Molecular Diagnostics (human healthcare) and Life Sciences (academia, pharma R&D and industrial applications, primarily forensics). As of September 30, 2020, QIAGEN employed more than 5,300 people in over 35 locations worldwide. Further information can be found at http://www.qiagen.com.
About Ellume
Ellume is an Australian-based digital diagnostics company that develops, manufactures and commercializes high-performance, connected products for health professionals and consumers. Our focus is on the detection of common illnesses which affect the global population and our products differ from conventional diagnostics through performance, digital connectivity, actionability and simplicity. Ellume has developed novel detection technology powered by our unique quantum dot nanoparticle, which integrates optics, electronics, biologics and software into an intuitive and high-performance digital platform. Further information can be found at www.ellumehealth.com
Reference: https://corporate.qiagen.com/newsroom/press-releases/2020/20201111_qiareach_antigen_eua
BD Announces Canadian Government Order of More Than 7 Million Portable, Rapid Point-of-Care Antigen Tests to Detect SARS-CoV-2 in 15 minutes
10 November 2020
MISSISSAUGA, ON, Nov. 10, 2020 -- BD (Becton, Dickinson and Company), a leading global medical technology company, today announced its rapid, point-of-care, SARS-CoV-2 antigen test for use on the BD Veritor™ Plus System has been authorized for use by Health Canada under Interim Order. This authorization has been accompanied by an order from the Canadian government for 7.6 million tests through March 2021 to support Canada's planning for an advanced COVID-19 testing strategy.
"The Government of Canada continues to work diligently to provide Canadians with access to effective and efficient COVID-19 testing solutions," said Minister of Public Services and Procurement Anita Anand. "This new agreement with BD is critical to assisting the provinces and territories in their respective efforts to reduce the spread of the virus. We will continue to support Canadians through the COVID-19 pandemic."
The new test delivers results in approximately 15 minutes on an easy-to-use, portable instrument, which is a critical improvement in turnaround time for COVID-19 diagnostics, because it provides real-time results and enables decision-making while the patient is still onsite. This test is designed to be performed at the point-of-care, reducing the burden on testing laboratories. The test uses a mid-nasal swab to collect patient samples, which is less invasive for the patient than nasopharyngeal sample collection.
"As the demands for SARS-CoV-2 testing are increasing in Canada, we are excited to bring another testing solution to the Canadian market," said Greg Miziolek, president of BD-Canada. "The ability to perform SARS-CoV-2 testing at the point-of-care and deliver results while the patient waits will be truly impactful to help relieve some of the pressures on the testing labs and quickly identify affected patients. We applaud the federal government for their proactive approach in planning for future needs with a centralized order for antigen detection tests. We look forward to partnering with Canada's provincial health authorities to optimize the deployment of the BD Veritor™ Plus System to meet regional and local public health needs."
The test, which received Health Canada authorization in early October, has been available in the United States since July through an Emergency Use Authorization from the U.S. Food and Drug Administration (FDA).
The test uses the BD Veritor™ Plus System, which is already in use in Canada to detect Influenza A+B, Respiratory Syncytial Virus (RSV), and Group A Strep. The BD Veritor™ Plus System, which has a slightly larger footprint than a mobile phone, offers an easy-to-use workflow that makes it an ideal solution for point-of-care settings. It also offers customers traceability and reporting capabilities through the optional BD Synapsys™ informatics solution.
BD has also been supporting SARS-CoV-2 molecular testing (RT-PCR) in Canadian labs on the BD MAX™ System.
For Product Enquiries and How to Order:
Individuals interested in placing an order or learning more about the BD Veritor™ System for Rapid Detection of SARS-CoV-2 should visit: https://go.bd.com/BDVeritorinCanada.html
About the BD Veritor™ System for Rapid Detection of SARS-CoV-2 Assay
The BD Veritor™ System for Rapid Detection of SARS-CoV-2 assay has been authorized by Health Canada under Interim Order. This test is only authorized for the duration of the Interim Order Respecting the Importation and Sale of Medical Devices for Use in Relation to COVID-19, unless the authorization is terminated or revoked sooner. The SARS-CoV-2 antigen assay has been authorized only for the detection of proteins from SARS-CoV-2, not for any other viruses or pathogens. The BD Veritor™ System for Rapid Detection of SARS-CoV-2 Assay is not authorized for use by consumers or for at-home use.
About BD
BD is one of the largest global medical technology companies in the world and is advancing the world of health by improving medical discovery, diagnostics and the delivery of care. The company supports the heroes on the frontlines of health care by developing innovative technology, services and solutions that help advance both clinical therapy for patients and clinical process for health care providers. BD and its 65,000 employees have a passion and commitment to help enhance the safety and efficiency of clinicians' care delivery process, enable laboratory scientists to accurately detect disease and advance researchers' capabilities to develop the next generation of diagnostics and therapeutics. BD has a presence in virtually every country and partners with organizations around the world to address some of the most challenging global health issues. By working in close collaboration with customers, BD can help enhance outcomes, lower costs, increase efficiencies, improve safety and expand access to health care. For more information on BD, please visit bd.com/en-ca.
LGC signs pre-let for new R&D facility at Oxford Technology Park
10 November 2020
10 November 2020 -- The Native Antigen Company, one of the world’s leading suppliers of infectious disease antigens and antibodies, has signed a pre-let for a new purpose-built R&D and manufacturing facility at the Oxford Technology Park. It follows the acquisition of The Native Antigen Company in July 2020 by LGC.
This new 49,000 sq ft two-storey building, which will be ready by the summer 2021, will accommodate a mixture of bespoke laboratory, office and logistics operations.
The Native Antigen Company’s building will be constructed alongside the landmark three storey 30,000 sq ft lab-enabled office building fronting Langford Lane and the Oxford London airport, offering suites from 4,000 sq ft for occupation summer 2021.
These new buildings will join the Premier Inn hotel and Beefeater restaurant opened in January 2020 and will be quickly followed by the next phase of flexible hi-tech buildings suitable for lab, R&D and light manufacturing.
“The site presents a perfect opportunity to expand our operations”, comments Nick Roesen, COO of The Native Antigen Company. “The location is right for us and was made very attractive with the ability to design the interior space to suit our business requirements. We are also excited about being part of a new science community at the Oxford Technology Park.”
“We are thrilled to be working with The Native Antigen Company and will enjoy growing the community around them.” remarks Angus Bates, Director at Hill Street Holdings, owners of the Oxford Technology Park. “Oxford is such an amazing place and we have been overwhelmed by the scale of demand for what we are building. Our approach is to build flexible spaces with the power, data and construction technology to cater for any form of requirement from science and technology companies. We have great plans for the next phases including smaller ‘grow on’ units as well as more large buildings.”
Bidwells and Benedicts are the letting agents for the Oxford Technology Park. Further information at https://oxfordtechnologypark.com/
Reference: https://www.lgcgroup.com/newsroom-and-blog/news-and-blog/new-facility-site-in-oxford/
Beckman Coulter launches its SARS-CoV-2 IgM antibody test in countries accepting CE Mark and will begin shipping to diagnostics labs
10 November 2020 - Assay has 99.9% specificity and 100% sensitivity at >18 days post symptom onset and positive PCR1 and confirmed 96.9% positive predictive value when disease incidence is as low as 3%. Beckman Coulter developed separate SARS-CoV-2 Immunoglobulin M (IgM) and SARS-CoV-2 Immunoglobulin G (IgG) antibody assays to better help clinicians determine a patient’s immune status in response to a recent or past infection. Additional COVID-19 testing solutions coming to market to guide clinical and public health decision making include a SARS-CoV-2 antigen and quantitative IgG assay.
HIGH WYCOMBE, ENGLAND, Nov. 10, 2020 — Beckman Coulter, a clinical diagnostics leader, today announced the launch of its Access SARS-CoV-2 Immunoglobulin M (IgM) assay in countries accepting the CE Mark. The new IgM antibody test demonstrated 99.9% specificity with 1,400 negative samples and 100% sensitivity at >18 days post symptom onset and positive PCR. Beckman Coulter’s IgM assay is part of a full suite of testing solutions the company is developing to inform clinical and public health decision making during the COVID-19 pandemic. Beckman Coulter is also developing a SARS-CoV-2 antigen test and quantitative IgG assay. Beckman Coulter’s antibody assays and its other planned SARS-CoV-2 offerings run on the organisation’s award-winning immunoassay analysers, including the DxI 800 high-throughput analyser, which is capable of processing 200 samples per hour.
“Our new SARS-CoV-2 IgM assay provides information about an individual’s immune status with a positive predictive value of 96.9% in a population with disease incidence as low as 3%,” said Julie Sawyer Montgomery, president of Beckman Coulter. “As COVID-19 outbreaks continue to grow in intensity in many of our communities, highly accurate tests such as this are critical for providing reliable information for both individual health decisions as well as population-based immunity monitoring.”
The full suite of testing solutions, including the IgM and IgG assays currently available and the antigen and quantitative IgG assay under development, provide valuable information in clinical decision making for patients suffering from COVID-19. The company developed separate SARS-CoV-2 IgM and SARS-CoV-2 IgG antibody assays to help clinicians determine a patient’s immune status in response to a recent or past infection. The Beckman Coulter IgM assay detects antibodies that may emerge earlier in the course of infection and then dissipate, while the IgG test detects antibodies associated with the longer-term immune response. Both IgM and IgG assays can identify antibodies in asymptomatic individuals. Since each person’s seroconversion process is different, the two tests can be used together to provide the most accurate view of their immune response.
Rob Young, UK General Manager for Beckman Coulter, added: “This latest addition to our already extensive offering, which spans serological, antigen, and other diagnostic solutions, brings greater visibility to help monitor the progression of COVID-19 in patients. We continue to innovate and provide a multitude of high-quality tests in high volumes to help clinicians identify patients with the virus and support efforts in fighting the disease.”
Around the world, diagnostic labs are under immense pressure to be more efficient when it comes to meeting testing demands. Beckman Coulter’s assays can be performed in automated or high-throughput immunoassay formats. The Access SARS-CoV-2 IgM test can also be run on Beckman Coulter’s Access 2 analyser, a compact, table-top analyser enabling high-quality serology testing to be carried out in small hospitals and clinics. Additionally, this test seamlessly integrates into laboratory workflows, making it easy to add serology testing to routine blood tests performed during inpatient and wellness testing.
About the Access SARS-CoV-2 IgM assay
The Access SARS-CoV-2 IgM Assay is a qualitative immunoassay that detects IgM antibodies. The test has confirmed 100% sensitivity at >18 days post symptom onset and post positive PCR and 99.9% specificity. The assay utilises an immunocapture format to bind patient IgM antibodies on the magnetic particle solid phase and a recombinant SARS-CoV-2 protein - enzyme conjugate to detect anti-SARS-CoV-2 IgM. The Access SARS-CoV-2 IgM assay can be used in Random Access Mode (RAM), which means that the antibody tests can be run along with other immunoassay tests. The assay can also be used with a variety of Beckman Coulter analysers, including the high-throughput DxI 800 designed for large labs, the DxI 600 for mid-sized labs and the DxC 600i and Access 2 analysers for smaller labs and healthcare clinics.
About Beckman Coulter
Beckman Coulter is committed to advancing healthcare for every person by applying the power of science, technology and the passion and creativity of our teams to enhance the diagnostic laboratory’s role in improving healthcare outcomes. Our diagnostic systems are used in complex biomedical testing, and are found in hospitals, reference laboratories and physician office settings around the globe. Beckman Coulter offers a unique combination of people, processes and solutions designed to elevate the performance of clinical laboratories and healthcare networks. We do this by accelerating care with a menu that matters, bringing the benefit of automation to all, delivering greater insights through clinical informatics and unlocking hidden value through performance partnership. An operating company of Danaher Corporation since 2011, Beckman Coulter is headquartered in Brea, Calif., and has more than 11,000 global associates working diligently to make the world a healthier place.
EUROIMMUN Launches Quantitative ELISA to Measure SARS-CoV-2 Antibodies Against Viral S1 Protein
9 November 2020 - Underscores importance of serological testing using the S1 subunit for worldwide seroprevalence and vaccine development
WALTHAM, Mass., Nov. 9, 2020 -- PerkinElmer, Inc., a global leader committed to innovating for a healthier world, announced today that EUROIMMUN, a PerkinElmer company, has launched the Anti-SARS-CoV-2 QuantiVacTM ELISA (IgG) to quantify IgG antibodies against the SARS-CoV-2 S1 antigen. The assay is available for countries accepting the CE mark, and the Company plans to file a request for this product with the U.S. Food and Drug Administration for Emergency Use Authorization (EUA).
This quantitative test kit applies a recombinant S1 subunit of the SARS-CoV-2 spike protein, enabling detection of IgG antibodies. These antibodies have been the focus of vaccine development programs as well as discussions about possible immunity in previously infected individuals. With this new ELISA assay, EUROIMMUN is providing a product to support careful evaluation of an important antibody subgroup enabling standard curve-based quantification of the anti-S1 IgG antibody concentration.
“The global research and medical community is focused on having an effective SARS-CoV-2 vaccine available as soon as possible, but to do so, it’s clear that the quantitative measurement of antibodies in clinical studies will play a huge part,“ said Dr. Wolfgang Schlumberger, CEO of EUROIMMUN. “The EUROIMMUN assays, especially the S1-based tests, are important tools for pharmaceutical laboratories conducting clinical trials. Our assays can help to identify individuals who have been exposed to SARS-CoV-2 and may play a critical role in accurate evaluation of antibody status before and after infection, in antibody therapies or in vaccination programs.”
The QuantiVac ELISA assay adds to the Company’s broad product portfolio of COVID-19 diagnostics and is based on the CE-marked and FDA EUA-approved semi quantitative/qualitative Anti-SARS-CoV-2 ELISA (IgG).
EUROIMMUN has increased its ELISA production for COVID-19 diagnostics to more than three million tests per week and can supply large numbers of dried blood spot collection sets for upcoming seroprevalence and vaccination development studies. Large international reference laboratories have implemented EUROIMMUN SARS-CoV-2 assays, and the tests are being applied in an increasing number of epidemiological studies worldwide.
About PerkinElmer
PerkinElmer enables scientists, researchers and clinicians to address their most critical challenges across science and healthcare. With a mission focused on innovating for a healthier world, we deliver unique solutions to serve the diagnostics, life sciences, food and applied markets. We strategically partner with customers to enable earlier and more accurate insights supported by deep market knowledge and technical expertise. Our dedicated team of about 13,000 employees worldwide is passionate about helping customers work to create healthier families, improve the quality of life, and sustain the wellbeing and longevity of people globally. The Company reported revenue of approximately $2.9 billion in 2019, serves customers in 190 countries, and is a component of the S&P 500 index. Additional information is available through 1-877-PKI-NYSE, or at www.perkinelmer.com.
Sysmex Presents Academic Report with a View to Creating a Simple Method of Diagnosing Alzheimer’s Disease Using Blood - CTAD
9 November 2020 - The content presented at the 13th clinical trials on Alzheimer’s disease (CTAD) Conference
9 November 2020 -- Sysmex Corporation (HQ: Kobe, Japan; Chairman and CEO: Hisashi Ietsugu; "Sysmex") and Eisai Co., Ltd. (HQ: Tokyo, Japan; CEO: Haruto Naito; "Eisai") announced that the most recent data from the project to develop a method of diagnosing Alzheimer’s disease (AD) using blood plasma was presented at the 13th Clinical Trials on Alzheimer's Disease (CTAD) conference, held virtually from November 4 to 7, 2020. Sysmex demonstrated on behalf of the two companies the performance of the amyloid beta (Aβ) in plasma measured on Sysmex's HISCLTM fully automated immunoassay analyzers in predicting amyloid pathology as defined by amyloid positron emission tomography (PET) imaging on the centiloid scale.
The total number of those living with dementia across the world is projected to reach 82 million in 2030 and 152 million in 2050, with the total global societal cost of dementia stemming from direct medical and social care costs and lower productivity being estimated to reach 2 trillion USD in 2030. In Japan, the number of those with dementia is thought to have reached approximately 4.62 million in 2012 and is projected to grow to 7.30 million in 2025, with the total societal cost of this disease being estimated to be equivalent to 4.1% of the gross domestic product (GDP) in 2025 (25.8 trillion yen). Of these sufferers, those living with AD are thought to account for more than 60% of those living with dementia.
It is conceivable that AD is a disease that results in synaptic dysfunction and neuronal cell death due to tau deposition in neurons triggered by Aβ aggregation on the outside of neurons. These brain changes cause cognitive impairment and psychological and behavioral symptoms, suggesting that the Aβ aggregation and accumulation inside the brain is caused by AD before the presence of cognitive impairment appears, thus, it is believed that early diagnosis and early intervention is more effective in therapies targeting Aβ. Currently, amyloid PET and Aβ ratio in cerebrospinal fluid (CSF) are used for detecting amyloid aggregates in the brain, but this puts significant burden on patients in terms of access, costs, and their physical wellbeing.
Sysmex and Eisai are working to create new diagnostic technologies for the prevention and treatment of dementia. Accordingly, the overarching aim is to contribute to the advancement of healthcare and improve the quality of life for those living with the disease and their families.
About the collaboration between Sysmex and Eisai
In February 2016, Sysmex and Eisai signed a comprehensive non-exclusive agreement aimed at the development of new diagnostic tests in the field of dementia. By leveraging each other’s technologies and knowledge, the objective has been to discover next-generation diagnostic reagents that will enable early diagnosis of dementia, selection of the most appropriate treatment options, and regular monitoring of the effects of such treatments. At the 12th CTAD held in December 2019, the two companies reported on the performance of the plasma Aβ ratio measured on a fully automated immunoassay system HISCL in predicting the amyloid PET scan results (sensitivity: 73%, specificity: 71% [AUC = 0.74]), thus demonstrating the potential to predict amyloid pathology in the brain using the plasma Aβ ratio.* This finding was expected to lead to the development of a simple method of diagnosing Alzheimer's disease using blood.
RECOVERY trial data monitoring committee recommends continuing evaluation of REGN-COV2 in all hospitalized patients
5 November 2020
5 November 2020 -- Regeneron announced today an update from the independent data monitoring committee (DMC) for the United Kingdom-based RECOVERY trial evaluating REGN-COV2 in hospitalized patients with COVID-19. The DMC reviewed available safety and efficacy data for the 15,545 total patients randomized, including the 325 patients who were in the arm randomized to receive either REGN-COV2 or control. The DMC advised that, in the light of these data and the available external information, they saw no cogent reason to modify the protocol or intake to the study and recommended continuing recruitment of eligible patients to all study arms.
The DMC letter is available here: https://www.recoverytrial.net/for-site-staff/site-set-up-1/data-monitoring-committee-correspondence.
About the Trial
The RECOVERY trial is conducted by the registered clinical trials units in the Nuffield Department of Population Health in partnership with the Nuffield Department of Medicine. The trial is supported by a grant to the University of Oxford from UK Research and Innovation/National Institute for Health Research (NIHR) and by core funding provided by NIHR Oxford Biomedical Research Centre, Wellcome, the Bill and Melinda Gates Foundation, the Department for International Development, Health Data Research UK, the Medical Research Council Population Health Research Unit and NIHR Clinical Trials Unit Support Funding.
The trial involves many thousands of doctors, nurses, pharmacists, and research administrators at 176 hospitals across the whole of the UK, supported by staff at the NIHR Clinical Research Network, NHS DigiTrials, Public Health England, Department of Health & Social Care, the Intensive Care National Audit & Research Centre, Public Health Scotland, the Secure Anonymised Information Linkage at University of Swansea, and the NHS in England, Scotland, Wales and Northern Ireland.
REGN-COV2's development and manufacturing has been funded in part with federal funds from the Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response at the U.S. Department of Health and Human Services under OT number: HHSO100201700020C. Regeneron has partnered with Roche to increase the global supply of REGN-COV2 beginning in 2021. If REGN-COV2 proves safe and effective in clinical trials and regulatory approvals are granted, Regeneron will manufacture and distribute it in the U.S. and Roche will develop, manufacture and distribute it outside the U.S.
BD Receives Order from Dutch Ministry of Health for More than Nine Million 15-minute COVID-19 Antigen Tests
2 November 2020 - The first shipment of 1.2 million SARS-CoV-2 Assays for use on the BD Veritor™ Plus System to be delivered in The Netherlands by mid-November
THE HAGUE, NETHERLANDS and FRANKLIN LAKES, N.J., Nov. 2, 2020 -- BD (Becton, Dickinson and Company), a leading global medical technology company, today announced the receipt of an order from the Dutch Ministry of Health for 9.2 million of its rapid, point-of-care, SARS-CoV-2 antigen tests for use on the BD Veritor™ Plus System, which detects SARS-CoV-2 in symptomatic patients in approximately 15 minutes. The first 1.2 million units will be delivered by mid-November.
This is the first government contract in Europe for this test, which was CE marked to the IVD Directive (98/79/EC) in September. The Dutch Ministry of Health increased its initial order by 8 million assays to improve testing capacity. BD expects the order to be fulfilled by June 2021.
"We're proud to be working with the Dutch Ministry of Health to expand rapid testing for SARS-CoV-2. This test will be critical to aid rapid diagnosis and decision making," says Fernand Goldblat, vice president and general manager, Integrated Diagnostic Solutions, Europe at BD. "This rapid game-changing test is the latest effort in BD's comprehensive response to address the world's critical health needs during the global pandemic."
The BD Veritor™ Plus System is a portable, easy-to-use device that makes it an ideal solution for point-of-care settings. The BD Veritor™ Plus System is already in use across Europe to detect Influenza A+B, Respiratory Syncytial Virus (RSV), and Group A Strep. The SARS-CoV-2 assay has been available in the United States since July through an Emergency Use Authorization by the U.S. Food and Drug Administration (FDA).
For Product Enquiries and How to Order:
All BD SARS-CoV-2 diagnostic products have regulatory authorizations in the markets where they are sold. European customers interested in BD diagnostic solutions for SARS-CoV-2 should visit bd.com/VeritorSystem-EU or contact BD's local customer service.
About BD Veritor™ System for Rapid Detection of SARS-CoV-2 Assay
The BD Veritor™ Plus System for Rapid Detection of SARS-CoV-2 Assay has been CE marked to the IVD Directive (98/79/EC), but has not been cleared or approved by FDA. The test has been authorized by FDA under an Emergency Use Authorization (EUA) for use by authorized laboratories. The test has been authorized only for the detection of proteins from SARS-CoV-2, not for any other viruses or pathogens; and, the test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner. The BD Veritor™ Plus System for Rapid Detection of SARS-CoV-2 Assay is not authorized for use by consumers or for at-home use.
About BD
BD is one of the largest global medical technology companies in the world and is advancing the world of health by improving medical discovery, diagnostics and the delivery of care. The company supports the heroes on the frontlines of health care by developing innovative technology, services and solutions that help advance both clinical therapy for patients and clinical process for health care providers. BD and its 65,000 employees have a passion and commitment to help enhance the safety and efficiency of clinicians' care delivery process, enable laboratory scientists to accurately detect disease and advance researchers' capabilities to develop the next generation of diagnostics and therapeutics. BD has a presence in virtually every country and partners with organizations around the world to address some of the most challenging global health issues. By working in close collaboration with customers, BD can help enhance outcomes, lower costs, increase efficiencies, improve safety and expand access to health care.
Hologic Awarded U.S. Government Contract to Expand COVID-19 Test Production Capacity
30 October 2020 - $119 Million Contract Will Support Scale Up to 13 Million Tests Per Month for U.S. Market
MARLBOROUGH, Mass., 30 October 2020 -- Hologic, Inc. announced today that it has been awarded a $119 million contract from the United States government to expand its production capacity for COVID-19 molecular tests. The contract will support capital and labor investments enabling Hologic to provide 13 million COVID-19 tests per month for the U.S. market by January of 2022.
Hologic’s Panther Fusion® SARS-CoV-2 Assay and Aptima® SARS-CoV-2 Assay received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration in March 2020 and May 2020, respectively. The tests run on the Company’s fully automated Panther Fusion® and Panther® systems, which provide initial results in approximately three hours and process more than 1,000 tests in 24 hours. More than 2,000 of these systems have been installed in clinical diagnostic laboratories around the world, including in all 50 U.S. states.
“Hologic has already made significant investments in our test production capacity, which have resulted in our contributing tens of millions of COVID tests to the United States supply,” said Kevin Thornal, president of the Diagnostic Solutions Division at Hologic. “Our manufacturing teams continue to innovate to increase our contribution, and we are very pleased to partner with the federal government to further our ability to meet the ongoing public health need.”
The Department of Defense Joint Rapid Acquisition Cell collaborated with the Department of the Air Force’s Acquisition COVID-19 Task Force and the Biomedical Advanced Research and Development Authority (BARDA), part of the HHS Office of the Assistant Secretary for Preparedness and Response, to award the contract with BARDA funding. BARDA is also separately supporting development of Hologic’s COVID-19 assays.
About the Panther and Panther Fusion Systems
The Panther molecular diagnostics system is a best-in-class, fully automated, sample-to-result platform that can be used in low-, medium- or high-throughput laboratories. With a small footprint, adaptable workflow options and consolidated testing menu, it combines women’s health, sexually transmitted infections and viral testing, which can all be done simultaneously. In addition, patient samples can be loaded onto the Panther system as they arrive in the laboratory, a capability known as “random access” that improves efficiency and workflow. Overall, the instrument’s high throughput and quick turnaround time enable more patients to get results sooner.
The Panther Fusion system adds PCR (polymerase chain reaction) chemistry and provides an expanded in vitro diagnostics menu, as well as Open Access functionality to run laboratory developed tests. Together, the Panther and Panther Fusion systems now offer 16 FDA-cleared assays and 20 CE-marked assays that detect more than 20 pathogens.
About Hologic
Hologic, Inc. is an innovative medical technology company primarily focused on improving women’s health and well-being through early detection and treatment. For more information on Hologic, visit www.hologic.com.
PerkinElmer COVID-19 Test Kit Receives FDA Emergency Use Authorization for Sample Pooling
29 October 2020 - Latest testing strategy to increase the sample processing efficiency
WALTHAM, Mass., Oct. 29, 2020 -- PerkinElmer, Inc. announced today that the U.S. Food and Drug Administration (FDA) has issued Emergency Use Authorization (EUA) to allow sample pooling with PerkinElmer® New Coronavirus Nucleic Acid Detection Kit to increase the number of individuals who can be tested without increasing resources. This validation of batch testing using the industry’s most sensitive assay to date according to the FDA Reference Panel leverages its proven ability to detect low amounts of viral genetic material.
Laboratories certified under the Clinical Laboratory Improvement Amendments (CLIA) can now use PerkinElmer’s real-time RT-PCR in vitro diagnostic assay for COVID-19 to pool multiple samples together using the resources needed for a single test. If a pooled test is negative, all the individual samples are considered negative. If the pooled test is positive, each of the individual samples in that pool should be tested again separately to determine which of the samples are positive. For sample pooling to be effective, screening using a highly sensitive test is integral.
From comparative data released by the FDA, the PerkinElmer New Coronavirus Nucleic Acid Detection Kit has the lowest Limit of Detection (LoD) among the authorized COVID-19 molecular diagnostic tests reported, deeming it the most sensitive assay that can detect 3-fold less viral material in samples compared to the assay in second place, and over 90-fold times less viral material in samples compared to the industry average.
“The FDA has recognized that there is great interest in sample pooling to test for COVID-19,” said Masoud Toloue, Ph.D., Vice President and General Manager, Diagnostics, PerkinElmer. “The ability to pool samples using a highly sensitive RT-PCR test offers diagnostic labs an efficient and accurate way to increase testing capacity.”
PerkinElmer has been on the front lines of improving COVID-19 test turnaround times enabled by increasing production capacity of viral RNA extraction, RT-PCR tests and live streaming availability status to meet evolving public health needs.
PerkinElmer is actively working with specialty and reference diagnostic labs, clinics, hospitals, pharmaceutical and biopharmaceutical labs, academia, and governmental and research institutes to battle the pandemic. PerkinElmer’s comprehensive SARS-CoV-2 offerings span high throughput RNA extraction, RT-PCR, automation, ELISA, chemiluminescence, time-resolved fluorescence and lateral flow based serology testing.
About PerkinElmer
PerkinElmer enables scientists, researchers, and clinicians to address their most critical challenges across science and healthcare. With a mission focused on innovating for a healthier world, we deliver unique solutions to serve the diagnostics, life sciences, food, and applied markets. We strategically partner with customers to enable earlier and more accurate insights supported by deep market knowledge and technical expertise. Our dedicated team of about 13,000 employees worldwide is passionate about helping customers work to create healthier families, improve the quality of life, and sustain the wellbeing and longevity of people globally. The Company reported revenue of approximately $2.9 billion in 2019, serves customers in 190 countries, and is a component of the S&P 500 index. Additional information is available through 1-877-PKI-NYSE, or at www.perkinelmer.com
Merck Collaborates with Mammoth Biosciences to Scale New SARS-CoV-2 Test
29 October 2020 - Life Science business to serve as contract manufacturer for Mammoth’s new DETECTR BOOST™ SARS-CoV-2 Reagent Kit — a high-throughput Covid-19 test to be made available in the United States. Mammoth recently secured funding from the National Institute of Health’s RADx program to scale its CRISPR-based testing workflow. Once approved, new test will help laboratories increase testing capacity and decrease turnaround time for results.
Darmstadt, Germany, October 29, 2020 — Merck, a leading science and technology company, today announced a collaboration with Mammoth Biosciences Inc., of South San Francisco, California, USA, for the development, scale-up and commercial production of Mammoth’s CRISPR-based SARS CoV-2 diagnostic test. Mammoth’s high-throughput systems will be compatible with both nasal swab and saliva samples and are targeting approximately 1,500 tests per 8-hour shift with minimal user interaction. Mammoth Biosciences plans to submit the assay for FDA Emergency Use Authorization later this year.
“This collaboration will allow us to help Mammoth with the development and production of their new SARS-CoV-2 test, which, once approved by the FDA, will increase testing capacity here in the U.S. at the scale needed to combat this pandemic,” said Jean-Charles Wirth, head of Applied Solutions, Life Science, at Merck. “Merck is helping to advance the future of testing at scale. This is an important step in detecting Covid-19 quickly.”
The Life Science business of Merck will serve as the contract manufacturer of the DETECTR BOOST™ SARS-CoV-2 Reagent Kit, which will use standard, automated liquid handling equipment to allow rapid processing of patient samples. With this new test, Clinical Laboratory Improvement Amendments labs in the U.S. will be able to significantly improve capacity to regularly perform testing. According to Mammoth, the new test is expected to use a CRISPR-based workflow that reduces the time required for testing while maintaining the gold standard accuracy of Polymerase Chain Reaction expected by lab operators.
“Leveraging the proven manufacturing and product leadership of the Life Science business of Merck is critical to Mammoth delivering a CRISPR-based diagnostic solution to labs,” said Janice Chen, Ph.D., co-founder and chief technology officer of Mammoth Biosciences. “We have the opportunity to make a tremendous positive impact on the pandemic by enabling the further scale-up of our nation’s testing capacity.”
Mammoth recently secured funding from the National Institute of Health’s RADx program to scale its CRISPR-based testing workflow.
The Applied Solutions business unit, part of the Life Science business of Merck, offers a broad range of products and services for clinical and diagnostic testing laboratories as well as the food and beverage industry. It provides technologies that streamline processes, lower costs and deliver consistent, reliable results. The production will take place at the business’ Life Science Center in St. Louis, Missouri, USA.
Merck is committed to the fight against Covid-19. The company’s products are being used by scientists around the world to develop more than 50 vaccine candidates, more than 35 testing solutions and more than 20 monoclonal antibodies, plasma products and antivirals to combat the virus.
About Merck
Merck, a leading science and technology company, operates across healthcare, life science and performance materials. Around 57,000 employees work to make a positive difference to millions of people’s lives every day by creating more joyful and sustainable ways to live. From advancing gene editing technologies and discovering unique ways to treat the most challenging diseases to enabling the intelligence of devices – the company is everywhere. In 2019, Merck generated sales of €16.2 billion in 66 countries.
Scientific exploration and responsible entrepreneurship have been key to Merck’s technological and scientific advances. This is how Merck has thrived since its founding in 1668. The founding family remains the majority owner of the publicly listed company. Merck holds the global rights to the Merck name and brand. The only exceptions are the United States and Canada, where the business sectors of Merck operate as EMD Serono in healthcare, MilliporeSigma in life science and EMD Performance Materials.
Reference: https://www.merckmillipore.com/DE/de/20201028_185118
PerkinElmer Launches Industry First No-Wash Immunoassay For Phospho Ubiquitin Ser65 to Help Drive Neuroscience Disease and Therapeutics Research Forward
26 October 2020 - New kit provides highly sensitive and efficient approach for studying mitophagy impairment in conditions such as Parkinson’s and Alzheimer’s
WALTHAM, Mass., October 26, 2020 – PerkinElmer, Inc., a global leader committed to innovating for a healthier world, today launched the life science industry’s first no wash Ubiquitin phosphorylation at Serine 65 immunoassay for studying defective mitophagy biological mechanisms that have been broadly associated with diseases such as Parkinson’s and Alzheimer’s. The new PerkinElmer Cisbio HTRF® Phospho-Ubiquitin (Ser65) Cellular Kit takes analysis efficiency and accuracy to the next level compared to existing techniques such as Western blot and is aimed at helping scientists discover new therapeutic candidates earlier in the disease cycle.
The innovative assay leverages TR-FRET technology to bring high sensitivity across a wide range of analytes and greater study specificity to the Phospho-Ubiquitin (Ser65) intersection point that has been shown to play a key role in mitophagy dysfunction and breakdowns in the complex network between neurons and glial cells which can lead to neurodegenerative disease.
Efficient and streamlined workflows and accelerated data delivery are also provided by the immunoassay’s mix and read method approach and compatibility with microplate readers such as PerkinElmer’s VictorTM Nivo® or EnVision® systems. Analysis can also be automated and run in high throughput formats.
“With over 70 Million people around the world living with Alzheimer’s and Parkinson’s and the sheer complexity of how neurodegenerative disease develops in the brain, it is critical that scientists have the tools they need to help unlock promising avenues of study such as modulating mitophagy impairment,” said Alan Fletcher, VP and GM of Life Sciences, PerkinElmer. “With this new immunoassay, researchers now have a more efficient and effective way to study a key biomarker which could lead to exciting new therapeutic candidates.”
The new PerkinElmer Cisbio HTRF Phospho-Ubiquitin (Ser65) Cellular Kit, joins PerkinElmer’s range of immunoassay kits and reagents for neuroscience applications across HTRF, Alpha, LANCE® and DELFIA®. For more information please visit: https://learn.cisbio.com/lp/guide-neurodegenerative-diseases-and-neuroinflammation-pathways; https://uk.cisbio.eu/dd/by-universe/neuroscience
About PerkinElmer
PerkinElmer enables scientists, researchers and clinicians to address their most critical challenges across science and healthcare. With a mission focused on innovating for a healthier world, we deliver unique solutions to serve the diagnostics, life sciences, food and applied markets. We strategically partner with customers to enable earlier and more accurate insights supported by deep market knowledge and technical expertise. Our dedicated team of about 13,000 employees worldwide is passionate about helping customers work to create healthier families, improve the quality of life, and sustain the wellbeing and longevity of people globally. The Company reported revenue of approximately $2.9 billion in 2019, serves customers in 190 countries, and is a component of the S&P 500 index. Additional information is available through 1-877-PKI-NYSE, or at www.perkinelmer.com.
Point-of-care solution to detect SARS-CoV-2 in saliva
22 October 2020
22 October 2020 -- genedrive plc, the near patient molecular diagnostics company, announces it has completed the assay design for the Company’s Point-of-Care (“POC”) solution for COVID-19 testing and is now generating very promising analytical data aligned to market requirements.
The Genedrive® SARS-CoV-2 Kit is being designed to detect SARS-CoV-2, the virus causing COVID-19, amplified directly from a saliva sample without the need to extract viral RNA. This expands the potential use areas of the product and importantly, allows for rapid testing to be performed while a patient is present. When running on the Genedrive® POC device the chemistry is detecting a positive SAR-CoV-2 sample in approximately 15 minutes, with fully negative samples taking just over 20 minutes to resolve. The limit of detection is in line with the UK’s MHRA Target Product Profile sensitivity requirements.
The Genedrive SARS-CoV-2 POC Kit follows a similar workflow that has already been validated in the Company’s Genedrive® HCV-ID Kit which received WHO pre-qualification earlier this year.
The Company is targeting the end of the calendar year for completion of preliminary product evaluations, with full release of the final CE Marked system in Q1 2021 allowing for thorough clinical testing requirements. Additionally, the Company is working to progress to a version 2 of the product, which would accept a similar freeze-dried PCR bead format previously developed for the high throughput Genedrive® 96 SARS-CoV-2 Kit. This will allow for lower production costs and highly scalable manufacturing capacity.
David Budd, Chief Executive Officer of genedrive plc, said: “Rapid testing for current infection is a cornerstone to any track and trace programme, to quickly accessing current infection, to limiting infection, and to giving assurance to people concerned about their status. We believe the Genedrive® POC solution can contribute significantly to the ongoing management of this global health crisis.”
Reference: https://www.genedrive.com/news/index.php
Complete molecular solution for SARS-COV-2
21 October 2020
21 October 2020 -- Launch Diagnostics has increased its molecular diagnostic solution for SARS-CoV-2 with the addition of the Bosphore Novel Coronavirus (2019-nCoV) Detection kit v4 which is capable of detecting three different genes of SARS-CoV-2 in a single mix and the Bosphore SARS-CoV/Flu/RSV Panel kit.
Both assays are compatible with many open system platforms.
The GenomEra is a sample to answer instrument and the GenomEra SARS-CoV-2 assay; requires no sample extraction and with a run time of only 70 minutes .
To complete the molecular portfolio, AmpliRun and AmpiRun Total molecular controls from Vircell are external quality controls for nucleic acid detection.
Reference: https://www.launchdiagnostics.com/complete-molecular-solution-for-sars-cov-2/
CerTest Biotec and BD Announce CE Mark for Combination COVID-19, Influenza, RSV Test on BD MAX™ Molecular Diagnostic System
21 October 2020
ZARAGOZA, Spain and FRANKLIN LAKES, N.J., Oct. 21, 2020 -- CerTest Biotec, along with BD (Becton, Dickinson and Company), a leading global medical technology company, today announced that the VIASURE SARS-CoV-2 (N1 + N2) Real Time PCR Detection Kit adapted for the BD MAX™ System has been CE marked to the IVD Directive (98/79/EC).
This kit allows BD MAX™ System users to run a single module that tests concurrently for COVID-19 and Influenza (Flu) and Respiratory Syncytial Virus (RSV).
"The new CerTest kit will provide rapid COVID-19 diagnostic capabilities that can be run individually or combined with detection of Flu A, Flu B and RSV A and B," said Nelson Fernandes, managing director of CerTest Biotec. "As we enter flu season, the ability to test for both COVID-19 and Flu at the same time will speed diagnosis and, ultimately, treatment."
The BD MAX™ System, a molecular diagnostic platform, is widely used in hundreds of laboratories across Europe. Each unit can return results in two to three hours and is capable of analyzing hundreds of samples over a 24-hour period.
"Together with CerTest, we can offer our customers in Europe a complete solution for COVID-19 diagnostics during the winter season," said Nikos Pavlidis, vice president of Molecular Diagnostics and Women's Health for BD. "By leveraging our significant installed base and the versatility of the BD MAX System, this test will greatly enhance capacity for SARS-CoV-2 and Influenza testing, enabling clinicians to rapidly diagnose patients and help reduce the spread of COVID-19."
The CerTest tests snaps into the test-specific position on the BD MAX™ ExK™ TNA extraction strip, supplied by BD.
VIASURE SARS-CoV-2 (N1+N2) Real Time PCR Detection Kit for the BD MAX™ System and the VIASURE Flu A, Flu B & RSV Real Time PCR Detection Kit for the BD MAX™ System are sold through BD's network and are not available for sale in the United States. To locate an authorized BD representative or request information, visit: www.bd.com or www.certest.es
About CerTest
CerTest Biotec is a European company established in 2002 for the development and manufacturing of in vitro diagnostic medical devices.
Today, CerTest is a global company structured around 5 business units offering one of the widest portfolios for human In Vitro Diagnostic. The company bases its future on a strong technical knowledge and expertise in the detection of human diseases.
CerTest last generation laboratories, state-of-the-art technical equipment and skilled professionals are the keys for providing reliable solutions for the medical diagnostic professional.
About BD
BD is one of the largest global medical technology companies in the world and is advancing the world of health by improving medical discovery, diagnostics and the delivery of care. The company supports the heroes on the frontlines of health care by developing innovative technology, services and solutions that help advance both clinical therapy for patients and clinical process for health care providers. BD and its 65,000 employees have a passion and commitment to help enhance the safety and efficiency of clinicians' care delivery process, enable laboratory scientists to accurately detect disease and advance researchers' capabilities to develop the next generation of diagnostics and therapeutics. BD has a presence in virtually every country and partners with organizations around the world to address some of the most challenging global health issues. By working in close collaboration with customers, BD can help enhance outcomes, lower costs, increase efficiencies, improve safety and expand access to health care. For more information on BD, please visit bd.com.
PerkinElmer Immunoassay Helps NIH NCATS Team Identify Therapeutic Compounds Capable of Disrupting the SARS-CoV-2 Spike Protein/ACE2 Interaction
20 October 2020 - Findings shared on open data portal to help in global pursuit of drug repurposing candidates for COVID-19
WALTHAM, Mass., Oct. 20, 2020 -- PerkinElmer, Inc., a global leader committed to innovating for a healthier world, today announced that a research team at the National Center for Advancing Translational Sciences (NCATS), an arm of the National Institutes of Health (NIH), is working with PerkinElmer’s AlphaLISA® immunoassay to help support the global search for effective COVID-19 therapeutics.
The NCATS research project is focused on studying small molecule drug compounds that are already approved and in use as treatments but could potentially be repurposed for COVID-19.
The goal of the project is to quickly and reliably identify which small molecule compounds can best disrupt key proteins that bind together to allow for SARS-CoV-2 infection -- the S1 spike protein and the host ACE2 receptor.
Using PerkinElmer’s AlphaLISA assay, the NCATS team has been able to efficiently and accurately screen 3,384 molecular entities and narrow them down to a field of 25 quality therapeutic compounds or “hits”. The whole process, from assay development and optimization through screening, has been achieved in just a few months.
The AlphaLISA technology is a homogeneous (no-wash) assay that works by generating a light emission in response to a biomolecular interaction which results in proximity of the bead-binding complex. The platform can be used to detect and quantitate biomolecules of almost any size in both simple and complex sample types. Its bead-based, luminescent, signal amplification provides increased sensitivity, a wide dynamic range and potential assay miniaturization.
Speaking to the aim and contribution of the NCATS project, Dr. Quinlin Hanson, co-leader of the research effort and a Postdoctoral Fellow at NCATS said, “Our immediate goal was to develop a sensitive and robust assay platform that scientists could use as a template for screening small molecule compounds that might lead to further drug development. To share our learnings and support collaboration, we’ve posted our work on the NCATS Open Data Portal. Now our team will conduct additional testing on select molecules and make that information available to the scientific community as well when ready.”
Commenting on the importance of leveraging innovative approaches to help tackle COVID-19, Alan Fletcher, Vice President and General Manager, Life Sciences, PerkinElmer, added, “COVID-19 is inspiring research teams around the world to work in new ways -- both individually and collectively -- to tackle this universal health crisis. The research being done by the NCATS team around therapeutic compounds and the SARS-COV-2 spike protein is an important contribution to discovery efforts and we are delighted that our AlphaLISA technology is playing a role.”
The AlphaLISA technology is part of PerkinElmer’s testing and analysis portfolio that helps scientists around the globe fight COVID-19. From virus detection and therapeutic and vaccine discovery analysis to hand sanitizer testing, PerkinElmer’s innovations include research and diagnostics kits, assay platforms, instrumentation, automation solutions, informatics and custom services.
For more information, visit www.perkinelmer.com.
About PerkinElmer
PerkinElmer enables scientists, researchers and clinicians to address their most critical challenges across science and healthcare. With a mission focused on innovating for a healthier world, we deliver unique solutions to serve the diagnostics, life sciences, food and applied markets. We strategically partner with customers to enable earlier and more accurate insights supported by deep market knowledge and technical expertise. Our dedicated team of about 13,000 employees worldwide is passionate about helping customers work to create healthier families, improve the quality of life, and sustain the wellbeing and longevity of people globally. The Company reported revenue of approximately $2.9 billion in 2019, serves customers in 190 countries, and is a component of the S&P 500 index. Additional information is available through 1-877-PKI-NYSE, or at www.perkinelmer.com.
Thermo Fisher Scientific Increases Availability of COVID-19 Testing with Sample Collection Kit from Everlywell
19 October 2020
WALTHAM, Mass., Oct. 19, 2020 -- Thermo Fisher Scientific Inc., the world leader in serving science, announced it has received an expansion of its Emergency Use Authorization (EUA) for the TaqPath COVID-19 Combo Kit to include an additional sample collection method provided by Everlywell, a leading digital health testing company. The TaqPath test is authorized for use with the Everlywell COVID-19 Test Home Collection Kit, which enables individuals to self-collect nasal swab specimens when determined by a healthcare provider to be appropriate based on results of a COVID-19 questionnaire.
Samples collected using the Everlywell self-collection kit may be processed by CLIA-certified laboratories running Thermo Fisher's TaqMan SARS-CoV-2 RNase P Assay Kit, and the results obtained through the Everlywell online platform. This more convenient home-collection sample processing experience is expected to increase access to highly accurate PCR-based testing and complement other defensive measures including good hygiene, social distancing and wearing a mask.
"As part of our commitment to keep our workplaces safe and healthy, Thermo Fisher launched its own pilot program to provide at-home collection kits and online access to test results for more than 10,000 colleagues across the country," said Mark Stevenson, executive vice president and chief operating officer at Thermo Fisher Scientific. "Now, leveraging Everlywell's capabilities, we can expand our own use and offer other organizations the confidence to move forward with return-to-workplace strategies that reduce the risk of spreading the virus."
Julia Cheek, chief executive officer and founder of Everlywell, said, "Everlywell is a leader in at-home collection laboratory testing, providing access to dozens of essential lab tests through our digital platform. Joining forces with Thermo Fisher, one of the world's foremost life sciences and diagnostic companies, will expand our COVID-19 testing infrastructure and help keep workplaces, schools, and organizations safe over the coming months."
She added, "Accurate, convenient diagnostic testing is foundational to our country's efforts to reduce the spread of the virus. We are proud to support Thermo Fisher in these efforts."
About Thermo Fisher Scientific
Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $25 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, improving patient diagnostics and therapies or increasing productivity in their laboratories, we are here to support them. Our global team of more than 75,000 colleagues delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services and Patheon. For more information, please visit www.thermofisher.com.
LabCorp Launches Quantitative Antibody Test to Assess Effectiveness of COVID-19 Vaccines in Clinical Trials
19 October 2020 - Quantitative Test is Used to Assess Immune Response and to Support Other Scientific Research
BURLINGTON, N.C., Oct. 19, 2020 -- LabCorp, a leading global life sciences company that is focused on advancing health and guiding patient care, today announced a test that provides a quantitative measurement of an individual’s SARS-CoV-2 IgG antibodies. LabCorp’s Cov2Quant™ IgG test, which is available only for use in clinical trials and research, was developed to specifically detect and quantify antibodies to SARS-CoV-2, the virus that causes COVID-19. The level of antibodies is an important indicator of the strength of a person’s immune response, which can help determine the effectiveness of vaccines and therapies. Other COVID-19 antibody tests available in the market are qualitative and detect the presence of antibodies, but do not provide information on the individual’s antibody levels.
Pharmaceutical companies will be able to use the test to help evaluate the performance of vaccine candidates in clinical trials. While the level of antibodies needed to be considered immune to SARS-CoV-2 is yet to be determined, ongoing vaccine trials and research should help answer this question. The test is also currently being utilized by the Centers for Disease Control and Prevention (CDC) for SARS-CoV-2 seroprevalence studies to understand the level of antibodies produced through natural exposure and infection with the virus.
“Medical science and technology are the best ways to mitigate COVID-19, and our development of this quantitative assay is an important step in helping to bring effective treatments and vaccines to patients,” said Dr. Paul Kirchgraber, CEO of LabCorp’s drug development business unit, Covance. “LabCorp’s quantitative antibody test represents a significant advancement by giving scientists and researchers a more precise, detailed picture of the level of immune response. This will aid the scientific community as it works to characterize the immune response to SARS-CoV-2.”
The Cov2Quant IgG test is a continuation of LabCorp’s innovations and commitment to help physicians, health systems and patients manage the pandemic. Others include: the first commercially available COVID-19 RT-PCR test (March 5); first FDA Emergency Use Authorization (EUA) for at-home collection (April 20); first online consumer-initiated antibody testing (May 5); first digital service for physician-initiated patient collection (LabCorp At Home, July 7); first FDA EUA for asymptomatic testing and matrixed pool testing (July 24); first combined test for multiple respiratory infections including COVID-19 and flu (September 8); and first FDA EUA for a heat extraction method that improves test efficiency and throughput and for the use of matrixed pooling on samples collected by individuals outside of a healthcare setting (October 2).
LabCorp has performed more than 17 million molecular tests since first making the COVID-19 test available in March and is now able to process 210,000 tests per day, with plans to increase capacity further. The company also has performed 3 million COVID-19 antibody tests with the capacity to perform 300,000 per day.
About LabCorp
LabCorp, an S&P 500 company, is a leading global life sciences company that is deeply integrated in guiding patient care, providing comprehensive clinical laboratory and end-to-end drug development services. With a mission to improve health and improve lives, LabCorp delivers world-class diagnostics solutions, brings innovative medicines to patients faster, and uses technology to improve the delivery of care. LabCorp reported revenue of more than $11.5 billion in 2019.
To learn more about LabCorp, visit www.LabCorp.com, and to learn more about LabCorp’s drug development business, Covance, visit www.Covance.com.
BD Announces Assay for Immune Assessment of COVID-19 Patients Now Available in Europe
16 October 2020 - BD Multitest™ 6-Color TBNK Reagent with BD Trucount™ Tubes brings time-tested immune assessment solution to European clinicians treating COVID-19 patients
EYSINS, Switzerland, Oct. 16, 2020 – BD (Becton, Dickinson and Company), a leading global medical technology company, today announced the CE mark and European availability of a product for assessing immune function in COVID-19 patients.
The BD Multitest™ 6-Color TBNK Reagent with BD Trucount™ Tubes has been CE marked with expanded clinical application for the identification and enumeration of T-cell subtypes in COVID-19 patients, an innovation in helping clinicians better understand patient immune response to COVID-19 disease. Data from the first global wave of COVID-19 have shown that patients typically exhibit a remarkable decrease of CD4 and/or CD8 lymphocyte counts with increasing disease severity.
Accurate counts of T-cell subsets may be critical in informing the clinical course of action because T-cells are essential for viral killing and antibody response. The BD Multitest™ 6-Color TBNK Reagent with BD Trucount™ Tubes leverages time-tested technology for immune assessment and enables clinicians to go beyond the complete blood count (CBC) to better understand the underlying mechanisms for severity in COVID-19 patients, especially those with co-morbidities. This test has been used for more than a decade to assess immune function in HIV patients and may now also help clinicians better understand COVID-19 patient immune response, and when used in conjunction with clinical findings and laboratory testing, inform patient treatment plans and prioritize precious resources.
“The availability of this product with the expanded clinical application in COVID-19 patients is an important step in helping clinicians better understand how patient immune systems are responding to COVID-19 infection,” said Puneet Sarin, worldwide president, Biosciences at BD, “BD is a trusted partner in immunology research and clinical care with a long history helping clinicians and patients better understand immune function to make patient care decisions. Bringing this expertise to clinicians treating COVID-19 patients presents a great opportunity to enable deeper immune assessment of patients, which could lead to improved uses of precious resources within a hospital while helping get patients on the right clinical path.”
The BD Multitest™ 6-Color TBNK Reagent with BD Trucount™ Tubes is used in conjunction with the BD FACSLyric™ and BD FACSCanto™ II Clinical Flow Cytometers and the BD FACSLyric™/BD FACSDuet™ Sample-to-Answer Solution, which enables automated processing of samples, removing any unnecessary exposure to lab personnel.
About the BD Multitest™ 6-Color TBNK Reagent with BD Trucount™ Tubes
The BD Multitest™ 6-Color TBNK Reagent with BD Trucount™ Tubes is CE marked and is only available in the EU for COVID-19 Clinical Application.
The BD Multitest™ 6-Color TBNK Reagent with optional BD Trucount™ Tubes is a 6-color direct immunofluorescence reagent for use with a suitably equipped BD flow cytometer to identify and determine the percentages and absolute counts of T, B and natural killer (NK) cells, as well as the CD4 and CD8 subpopulations of T cells in peripheral blood. The BD Multitest™ 6-Color TBNK Reagent with BD Trucount™ Tubes can be used with the BD FACS™ Loader and the BD FACS™ Universal Loader.
Clinical Application
Determining counts of CD3+CD4+ and/or CD3+CD8+ lymphocytes may be useful in the immunological assessment of SARS-CoV-2 infected individuals with COVID-19 disease. Individuals with COVID-19 disease typically exhibit a decrease of CD3+CD4+ and/or CD3+CD8+ lymphocyte counts with increasing disease severity. For more information, visit www.bdbiosciences.com/Covid19-Tcell.
About BD
BD is one of the largest global medical technology companies in the world and is advancing the world of health™ by improving medical discovery, diagnostics and the delivery of care. The company supports the heroes on the frontlines of health care by developing innovative technology, services and solutions that help advance both clinical therapy for patients and clinical process for health care providers. BD and its 65,000 employees have a passion and commitment to help enhance the safety and efficiency of clinicians' care delivery process, enable laboratory scientists to accurately detect disease and advance researchers' capabilities to develop the next generation of diagnostics and therapeutics. BD has a presence in virtually every country and partners with organizations around the world to address some of the most challenging global health issues. By working in close collaboration with customers, BD can help enhance outcomes, lower costs, increase efficiencies, improve safety and expand access to health care. For more information on BD, please visit bd.com.
LGC’s multi-allergen reference material kit awarded ISO 17034 accreditation
16 October 2020
16 October 2020 -- LGC is delighted that the production of its first ever multi-allergen reference material kit containing five common allergens (milk, egg, almond, hazelnut, walnut), traceable to the SI (International System of Units), has been confirmed within the scope of its ISO 17034 accreditation.
The reference material kit, announced recently and produced by the LGC’s NML Reference Materials team, in collaboration with the University of Manchester and Romer Labs, is a world first. It will help scientists and industry by supporting method development to determine ‘true’ allergen content, and assist laboratories in monitoring the performance of methods on a day-to day basis.
Gill Holcombe, Head of the Reference Material Production Team, LGC said, “We are delighted that the RM kit is recognised by ISO accreditation. It is a fact that not many allergen RMs have this accreditation and this is confirmation that the kit has been prepared according to very exacting requirements. We hope this will ultimately improve the safety of food products for allergen sufferers.”
Gill Holcombe continued, “I am grateful to the Food Standards Agency and BEIS for funding the research that contributed to development of the RM. Food allergy is a serious and growing problem, with up to 2 million people in the UK estimated to be affected. In the absence of a currently accepted cure, these individuals must avoid eating problem foods throughout their life. This can be difficult to achieve in practice, as allergens can sometimes find their way into foods unintentionally, e.g. through use of common utensils and processing lines. Even very small quantities (as little as 1/100 of a gram) of a food such as peanut can cause an unwanted reaction in a person with peanut allergy”.
ISO 17034:2016 covers the production of all reference materials, including certified reference materials. It is intended as part of the general quality assurance procedures of the reference material producer.
The reference material kit consists of:
- five well-characterised individual common allergen foods (skimmed milk powder, egg white powder, almond, hazelnut and walnut flours),
- chocolate paste with all five added allergen food ingredients (fortified at 10 mg/kg as protein) and
- chocolate paste with no added allergen food ingredients (blank).
The Allergen RM kit is available to purchase from LGC Standards (reference LGC746-KT).
The allergen foods are also available for purchase as individual items. Click here for detailed statements of measurement for the allergen foods in the kit. The statement of measurement of the RM kit gives a wealth of detail on the composition of the RM, ELISA responses and conversion factors.
Siemens Healthineers Launches Rapid Antigen Test for the Detection of SARS-CoV-2
14 October 2020 - The CLINITEST Rapid COVID-19 Antigen Test helps identify infected individuals in 15 minutes so they can isolate sooner and avoid spreading COVID-19. Easy-to-use test, which doesn't require specialized laboratory personnel or instruments, offers flexibility to test in locations that benefit from immediate results. Test to be launched in CE mark countries; plans to submit to FDA for Emergency Use Authorization.
Erlangen, Germany, Oct 14, 2020 -- As society continues to navigate through the COVID-19 pandemic, there is a critical public health need to get ahead of the spread with a fast and simple testing for all. To address this need Siemens Healthineers is launching a rapid and easy-to-use antigen test for the detection of SARS-CoV-2, the virus that causes COVID-19. The CLINITEST Rapid COVID-19 Antigen Test1 is a point-of-care cassette test that does not require laboratory instruments or specialized lab personnel to administer, and it delivers results in 15 minutes.
The CE marked test which has been developed and tested by a Siemens Healthineers partner demonstrated 96.72 % sensitivity and 99.22 % specificity based on a clinical study of 317 subjects. The study was performed using operators with varied credentials at six diverse sites including a hospital, a community clinic, a college campus, and an oncology unit. Siemens Healthineers intends to meet such testing demand as the pandemic evolves. There are plans to submit the test for FDA Emergency Use Authorization.
“There is a great public need for reliable tests that can quickly identify contagious individuals and help to minimize the spread of COVID-19, especially in high-traffic areas and where people commonly congregate,” said Christoph Pedain, PhD, Head of Point of Care Diagnostics at Siemens Healthineers. “With quality at the forefront of decision makers’ criteria to determine test reliability, it was critical the clinical study for this test assesses variable clinical conditions that can be expected when implementing a rapid antigen test. This rapid antigen test makes testing available to more people across a wider variety of settings—particularly in locations that need to test people quickly such as airports or that have limited access to laboratory resources such as schools.”
The CLINITEST Rapid COVID-19 Antigen Test is easy to administer for healthcare professionals and delivers results quickly using the nasopharyngeal swab method. Once a sample is collected, the swab is inserted into a tube with special liquid to extract the target molecule. This liquid is then dispensed onto a test cassette and, in 15 minutes, a positive or negative result is clearly indicated.
In addition to the CLINITEST Rapid COVID-19 Antigen Test, Siemens Healthineers offers an extensive diagnostics portfolio to aid in the prognosis, treatment and follow up of COVID-19 patients. This test adds to the 15 critical assays Siemens Healthineers offers to detect severe symptoms and better manage critical COVID-19 patients. The company’s broad and differentiated menu includes antibody and molecular SARS-CoV-2 tests, and hematology, coagulation, cardiac, respiratory, inflammation and infectious disease panels. Blood gas and imaging solutions from Siemens Healthineers deliver actionable results that aid clinicians in caring for COVID-19 patients.
About Siemens Healthineers AG
Siemens Healthineers AG is shaping the future of Healthcare. As a leading medical technology company headquartered in Erlangen, Germany, Siemens Healthineers enables healthcare providers worldwide through its regional companies to increase value by empowering them on their journey towards expanding precision medicine, transforming care delivery, improving the patient experience, and digitalizing healthcare. Siemens Healthineers is continuously developing its product and service portfolio, with AI-supported applications and digital offerings that play an increasingly important role in the next generation of medical technology. These new applications will enhance the company’s foundation in in-vitro diagnostic, image-guided therapy, and in-vivo diagnostics. Siemens Healthineers also provides a range of services and solutions to enhance healthcare providers ability to provide high-quality, efficient care to patients. In fiscal 2019, which ended on September 30, 2019, Siemens Healthineers, which has approximately 52,000 employees worldwide, generated revenue of €14.5 billion and adjusted profit of €2.5 billion. Further information is available at www.siemens-healthineers.com.
Reference: https://www.siemens-healthineers.com/press-room/press-releases/covid-19-poc-rapid-antigentest.html
Roche to launch laboratory SARS-CoV-2 antigen test to support high-volume testing of suspected COVID-19 patients
13 October 2020 - The Elecsys® SARS-CoV-2 Antigen test is an automated laboratory assay intended as an aid in the diagnosis of SARS-CoV-2 infection. This new solution will run on all Roche cobas e immunochemistry analysers which are widely available around the world, thus helping to increase testing capacity. In combination with other COVID-19 diagnostic tests, the Elecsys SARS-CoV-2 Antigen test can help in the management of patients for optimal care delivery.
Basel, 13 October 2020 -- Roche announced today that it intends to launch a high-volume SARS-CoV-2 Antigen test as an aid in the diagnosis of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) infection. The test is planned to be made available at the end of 2020 for markets accepting the CE Mark. Roche also intends to file for Emergency Use Authorisation (EUA) from the U.S. Food and Drug Administration (FDA).
The Elecsys® SARS-CoV-2 Antigen test is a highly accurate laboratory immunoassay for the in vitro qualitative detection of the nucleocapsid antigen of SARS-CoV-2. The test is performed by healthcare professionals and uses nasopharyngeal or oropharyngeal swab samples from patients with signs and symptoms suggestive of COVID-19, or people with either known or suspected exposure to SARS-CoV-2.
The Elecsys SARS-CoV-2 Antigen immunoassay runs on all cobas e immunochemistry analysers which are widely available around the world. These fully automated systems can provide test results in 18 minutes for a single test (excluding time for sample collection, transport, and preparation), with a throughput of up to 300 tests per hour from a single analyser, depending on the analyser. A laboratory based automated antigen assay allows for cost and error reduction due to removal of manual handling as well as fast turn-around times and high test throughput.
Thomas Schinecker, CEO Roche Diagnostics, stated, “We are aware that governments and healthcare systems are under intense pressure to increase SARS-CoV-2 testing capacity to effectively manage the spread of the virus. A high-volume antigen test is a valuable addition to the testing portfolio for helping diagnose SARS-CoV-2 infection. Being able to quickly and correctly identify if someone has a SARS-CoV-2 infection is critical to informing patient management decisions and containing the spread of COVID-19. Roche remains committed to supporting governments, healthcare professionals and patients to fight this pandemic with the help of our diagnostics solutions.”
The test will be another addition to the comprehensive Roche diagnostic portfolio of solutions to help healthcare systems combat COVID-19 through testing in the laboratory and at the point of care. These solutions include both tests to detect an acute SARS-CoV-2 infection and tests measuring the body’s immune response upon infection or vaccination.
About the Elecsys SARS-CoV-2 Antigen test
Roche’s Elecsys SARS-CoV-2 Antigen test is an immunoassay intended for the qualitative detection of a specific antigen of SARS-CoV-2 present in the respiratory tract including nasopharynx and oropharynx. The Elecsys SARS-CoV-2 Antigen test is performed by healthcare professionals and could be used as an alternative or in conjunction with PCR testing. This is highly beneficial where reliable laboratory PCR testing is not available or where there are challenges in testing capacity. A positive result with the Elecsys SARS-CoV-2 Antigen test most likely indicates an active SARS-CoV-2 infection. A negative result may require to be confirmed with a PCR test or repeated (antigen test) after one to two days, if other clinical indications point to a SARS-CoV-2 infection. Performance evaluations around sensitivity and specificity of the test are ongoing and will be shared at the time of launch.
About antigen testing
An antigen test detects proteins which are structural or functional components of a pathogen and are thus very specific to that pathogen. In this case, the test would provide a qualitative “yes/no” answer on the presence of the pathogen in the patient sample. If the target antigen is present in sufficient concentrations in the sample, it will bind to specific antibodies and generate a positive result.
In general, antigen tests have a high specificity, though are not as sensitive as PCR tests that amplify the target viral DNA or RNA sequence in order to generate a quantifiable signal to indicate the presence of the virus in a sample. Therefore, to make up for the potential decrease in sensitivity of an antigen test, negative results should be analysed together with additional patient factors, such as COVID-19 exposure history, clinical symptoms, additional test results to help guide the diagnosis and subsequent treatment of the patient.
About Roche’s response to the COVID-19 pandemic
As a leading healthcare company we are doing all we can to support countries in minimising the impact of COVID-19. We have developed a growing number of diagnostic solutions that help to manage, detect and diagnose current and/or previous infection in patients, as well as providing digital support to healthcare systems. We continue to identify, develop and support potential therapies which can play a role in treating the disease.
We understand the impact of COVID-19 goes beyond those who contract it, which is why we are working with healthcare providers, laboratories, authorities and organisations to help make sure that patients continue to receive the tests, treatment and care they need during these challenging times. As we learn from the pandemic, we are partnering with governments and others to make healthcare stronger and more sustainable in the future.
Our diagnostics solutions:
Reliable, high-quality testing is essential to help healthcare systems overcome this pandemic. Our portfolio includes:
- a high-volume molecular test to detect SARS-CoV-2, the virus that causes COVID-19, (FDA Emergency Use Authorisation (EUA) and available in countries accepting the CE Mark)
- a SARS-CoV-2 laboratory-based qualitative antibody test, aimed at detecting the presence of antibodies in the blood targeting the nucleocapsid protein (FDA EUA and CE Mark)
- an IL-6 test to assist in identifying severe inflammatory response in patients with confirmed COVID-19 (FDA EUA and CE Mark)
- Roche v-TAC, which could help simplify the screening, diagnosis and monitoring of patients with respiratory compromise in the current COVID-19 pandemic
- a SARS-CoV-2 rapid antibody test to help determine at the point of care whether a person has been exposed to the virus (CE Mark)
- a rapid antigen test to support in the detection of SARS-CoV-2 at the point of care within 15 minutes (CE Mark)
- a high-volume molecular test to simultaneously detect and differentiate between SARS-CoV-2 and influenza A/B, as the symptoms are similar for both (FDA EUA and CE Mark)
- a second SARS-CoV-2 antibody test, aimed at measuring the spike protein to support vaccination development and complement our existing portfolio (CE Mark)
Our research into therapies:
Roche is committed to improving the treatment of COVID-19. We are actively involved in understanding the potential of our existing portfolio and are exploring the potential of our investigational molecules.
Specifically, on 19 March, we announced the initiation of COVACTA - a global Phase III randomised, double-blind, placebo-controlled clinical trial to evaluate the safety and efficacy of intravenous Actemra©/RoActemra© (tocilizumab) plus standard of care in hospitalised adult patients with severe COVID-19 pneumonia compared to placebo plus standard of care. On 29 July we announced that COVACTA did not meet its primary endpoint of improved clinical status in patients with COVID-19 associated pneumonia or the key secondary endpoint of reduced mortality.
Separately, we have studied Actemra©/RoActemra© in the EMPACTA study in COVID-19 associated hospitalised pneumonia in patients that are often underrepresented in clinical trials. On 18 September we announced that the phase III EMPACTA study showed Actemra/RoActemra plus standard of care reduced the likelihood of progression to mechanical ventilation or death in hospitalised patients with COVID-19 associated pneumonia compared to placebo plus standard of care. However, there was no statistical difference in mortality between patients who received Actemra/RoActemra or placebo.
Actemra©/RoActemra© is also being studied in combination with the investigational antiviral remdesivir in hospitalised patients with severe COVID-19 pneumonia in the REMDACTA trial in partnership with Gilead, announced 28 May. Actemra©/RoActemra© is not approved by any health authority for use in COVID-19 pneumonia. Roche has further initiated an internal early research programme focused on the development of medicines for COVID-19 and is engaged in multiple research collaborations.
In August we signed a collaboration agreement with Regeneron on developing and manufacturing and significantly increasing global supply of an investigational antibody combination for COVID-19 if it proves safe and effective in clinical trials and regulatory approvals are granted.
In these exceptional times, Roche stands together with governments, healthcare providers and all those working to overcome the pandemic.
About Roche
Roche is a global pioneer in pharmaceuticals and diagnostics focused on advancing science to improve people’s lives. The combined strengths of pharmaceuticals and diagnostics under one roof have made Roche the leader in personalised healthcare – a strategy that aims to fit the right treatment to each patient in the best way possible.
Roche is the world’s largest biotech company, with truly differentiated medicines in oncology, immunology, infectious diseases, ophthalmology and diseases of the central nervous system. Roche is also the world leader in in vitro diagnostics and tissue-based cancer diagnostics, and a frontrunner in diabetes management.
Founded in 1896, Roche continues to search for better ways to prevent, diagnose and treat diseases and make a sustainable contribution to society. The company also aims to improve patient access to medical innovations by working with all relevant stakeholders. More than thirty medicines developed by Roche are included in the World Health Organization Model Lists of Essential Medicines, among them life-saving antibiotics, antimalarials and cancer medicines. Moreover, for the eleventh consecutive year, Roche has been recognised as one of the most sustainable companies in the Pharmaceuticals Industry by the Dow Jones Sustainability Indices (DJSI).
The Roche Group, headquartered in Basel, Switzerland, is active in over 100 countries and in 2019 employed about 98,000 people worldwide. In 2019, Roche invested CHF 11.7 billion in R&D and posted sales of CHF 61.5 billion. Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan. For more information, please visit www.roche.com.
Reference: https://www.roche.com/media/releases/med-cor-2020-10-13.htm
BioGX Announces FDA Emergency Use Authorization Submission of Extraction-Free Direct RT-PCR Test for COVID-19
12 October 2020 - World’s Simplest High-Throughput RT-PCR Test for COVID-19 has the potential to increase testing capacity by millions per week
Birmingham, AL, October 12, 2020 – BioGX, a molecular diagnostics solutions company, announced FDA Emergency Use Authorization (EUA) submission of an extraction-free, direct sample addition RT-PCR test for detection of SARS-CoV-2 viral RNA in patients suspected of COVID-19.
The Xfree™ COVID-19 Direct RT-PCR test (“Xfree COVID-19”) is a complete test in a single vial, lyophilized in the trusted BioGX Sample-Ready™ format. The user would simply Just Add Water™, the patient sample, and run the test on a validated real-time PCR instrument.
“Xfree is a breakthrough in COVID-19 RT-PCR testing. Direct addition of patient samples without any pre-processing or extraction not only overcomes critical reagents supply issues, but also significantly shortens the results turnaround time. The fast and simple workflow is designed to help laboratories increase their testing capacity without adding expert personnel or new automation”, said Shazi Iqbal, Ph.D., CEO of BioGX.
“We believe Xfree is a game-changer. Xfree converts the most ubiquitous real-time PCR instruments into high throughput Sample-to-Answer machines – potentially augmenting the COVID-19 PCR testing capacity by millions”, said Michael Vickery, Ph.D., EVP & CSO of BioGX.
Xfree™ COVID-19 clinical performance study by direct, extraction-free testing of 77 patient samples demonstrated 98% Positive Percent Agreement (PPA) and 100% Negative Percent Agreement (NPA) when compared to the highly sensitive extraction-based BD-BioGX SARS-CoV-2 BD MAX™ test (FDA-EUA). Comparison with extracted viral RNA using QIAamp® DSP Viral RNA extraction kit (CDC EUA method) demonstrated 100% PPA and 100% NPA for Xfree™ COVID-19.
A single 96-well plate instrument can generate up to 1,500 test results every 24 hours, while a 384-well plate instrument can generate up to 6,000 test results. “Our current production capacity for the Xfree COVID-19 is nearly 2 million tests per week and can readily scale to 4 million per week. With efficient and early planning, we were able to secure long-term supply of critical raw materials to avoid any potential supply disruptions”, said Shahin Iqbal, Ph.D., SVP of Global Operations.
The Xfree™ COVID-19 test is validated for use on QuantStudio™ 5 and CFX Touch™ real-time PCR instruments with the most common specimen types – nasopharyngeal and oropharyngeal (throat) swabs with collections in UTM, UVT, VTM and saline. In addition to extraction-free direct testing, Xfree™ the world with no refrigeration required. Customers can request information on Xfree™ COVID-19 by contacting BioGX at covid19@biogx.com.
About BioGX
BioGX is a leading global provider of lyophilized real-time PCR reagents for molecular diagnostics. BioGX, Inc., headquartered in Birmingham, Alabama, and its wholly owned subsidiary BioGX B.V., based in Amsterdam, The Netherlands, (collectively “BioGX”), operates in a cGMP compliant environment certified to ISO 13485 medical device development and manufacturing standards. The proprietary Sample-Ready™ technology is at the core of all product offerings for Clinical, Food Safety, Pharma QC and Water Quality molecular testing. BioGX B.V.’s 50+ molecular diagnostic products are marketed and sold in several countries through its Global Distribution Network.
Abbott receives FDA Emergency Use Authorization for its COVID-19 IgM antibody blood test
12 October 2020 - Data demonstrates highly reliable test results with 99.56% specificity and 95.00% sensitivity for patients tested 15 days after symptom onset. Availability of the new IgM blood test on the ARCHITECT® and Alinity™ platforms is part of Abbott's effort to offer tests across the disease progression of COVID-19. Abbott's IgM test will give a more complete picture of where patients are in their recovery.
ABBOTT PARK, Ill., Oct. 12, 2020 -- Abbott announced today that the U.S. Food and Drug Administration (FDA) issued Emergency Use Authorization (EUA) for the company's AdviseDx SARS-CoV-2 IgM (Immunoglobulin M) lab-based serology test for use on the ARCHITECT® and Alinity™ platforms. IgM antibody testing can play an important role in understanding if someone has developed antibodies in response to the virus, indicating a recent or prior infection.
The new IgM antibody test is Abbott's latest test to support in the fight against COVID-19. Since the start of the pandemic, Abbott has received emergency use authorization for seven tests, including molecular tests, a rapid antigen test and an IgG antibody test.
"Abbott has developed tests to detect the virus at each stage of infection so doctors and their patients are equipped with knowledge of how they are responding to the virus and progressing through recovery," said Robert B. Ford, president and chief executive officer, Abbott. "Antibody tests will continue to play an important role to better understand the virus, the prevalence of COVID-19 in an area and where a patient may be in their recovery."
Understanding a person's immune response with antibody tests
While molecular tests detect whether someone has the virus, antibody tests determine if someone had a previous infection by detecting antibodies, such as IgM and IgG.
Abbott first developed an IgG blood test, which often is the antibody that is longer-lasting in the body after infection. This test has been widely adopted and continues to play a key role in understanding if someone has recovered from the virus, as well as contact tracing and epidemiological studies.
The IgM antibody, in comparison, is most useful for determining a recent infection as these antibodies become undetectable weeks to months following infection. Having this more complete picture of where a patient is in their recovery can help healthcare providers determine if treatment, isolation or follow-up visits are needed.
Similar to Abbott's IgG blood test, the IgM test has demonstrated high reliability in both Abbott's research and external virology laboratory studies. Abbott's data demonstrated 99.56% specificity and 95.00% sensitivity for patients tested 15 days after symptom onset.
The IgM test is now available on Abbott's ARCHITECT and Alinity platforms.
About Abbott
Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 107,000 colleagues serve people in more than 160 countries.
Thermo Fisher Scientific Further Expands COVID-19 Test Portfolio with Two New Antibody Tests
12 October 2020
WALTHAM, Mass., Oct. 12, 2020 -- Thermo Fisher Scientific Inc., the world leader in serving science, today introduced two new SARS-CoV-2 antibody tests: the Thermo Scientific OmniPATH COVID-19 Total Antibody ELISA test, and the Thermo Scientific EliA SARS-CoV-2-Sp1 IgG test. These new tests for detecting COVID-19 antibodies expand the company's leading response to the pandemic, which ranges from molecular diagnostic tests and sample collection products, to personal protective equipment, to support of therapy and vaccine development and manufacturing.
"Thermo Fisher is committed to providing a range of innovative solutions, including new serology tests that complement our PCR-based tests," said Marc N. Casper, chairman, president and chief executive officer of Thermo Fisher Scientific. "The addition of COVID-19 antibody tests to our broad portfolio further enables our support of the pandemic response on multiple fronts."
OmniPATH COVID-19 Total Antibody ELISA test
The OmniPATH COVID-19 Total Antibody ELISA test, developed in conjunction with the Mayo Clinic and WuXi Diagnostics as previously announced, has been granted Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) for qualitative detection of total antibodies to SARS-CoV-2, including immunoglobulin M (IgM), immunoglobulin A (IgA) and immunoglobulin G (IgG).
EliA SARS-CoV-2-Sp1 IgG test
The EliA SARS-CoV-2-Sp1 IgG test is commercially available in accordance with the FDA's "Policy for Coronavirus Disease-2019 Tests During the Public Health Emergency (Revised)". The EUA is currently under review by the FDA. The EliA test is designed for automated processing of up to 60 results per hour on the Thermo Scientific Phadia 250 instrument. The EliA test is quantitative within markets that accept the CE mark and semi-quantitative in the U.S. Individual IgM and IgA EliA tests are also available now for research use only.
Both of these new antibody tests are designed to meet the need for open ELISA and automated workflows. This flexibility enables laboratories to run the tests at customizable speed and throughput while using automated instruments already in place, minimizing initial costs and reducing the time needed to begin testing. Additionally, these tests are now available in Europe and countries accepting the CE Mark.
About Thermo Fisher Scientific
Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $25 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, improving patient diagnostics and therapies or increasing productivity in their laboratories, we are here to support them. Our global team of more than 75,000 colleagues delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services and Patheon. For more information, please visit www.thermofisher.com.
Grifols underlines the importance of plasma in its Annual General Shareholders’ Meeting
9 October 2020 - The company makes a public appeal on the critical role of plasma and the need to increase donations in support of International Plasma Awareness Week, promoted by the Plasma Protein Therapeutic Association (PPTA). Grifols’ co-CEOs outline the company’s main non-financial performance indicators and ongoing efforts to combat COVID-19. Shareholders endorse the company’s management in 2019, which led to an upturn in revenues (13.6%) and net profits (4.8%) to EUR 5,100 million and EUR 625 million, respectively. Grifols continued to promote innovation and capital investments in 2019 as core drivers of its long-term and sustainable growth strategy, allocating a total of EUR 661 million toward. The company optimized its financial structure, lowering its average cost of debt and extending maturities following an effective refinancing process that was closed at the end of 2019.
Barcelona, October 9, 2020 -- Grifols, a global healthcare company dedicated to enhancing the health and well-being of patients worldwide through the development of life-saving plasma-derived medicines, clinical diagnostics and pharmaceutical specialties for hospital use, and a pioneer in the research and development of therapeutic alternatives that drive scientific and social progress, celebrated its telematic Annual General Shareholders’ Meeting on second call.
Due to the healthcare crisis generated by COVID-19 and supported by law, the 2020 General Shareholders Meeting was held exclusively by telematic means, without the physical presence of shareholders or their representatives, through remote connection and direct broadcasting, reaching a high participation.
Grifols’ General Shareholders’ Meeting related to the 2019 financial year was represented by 448 shareholders, who hold 313.608.974 Class A shares and represent 73.6% of stock capital with voting rights. The votes delegated to the Board represented 78.3% of quorum and 57.6% of share capital, confirming shareholders’ support of the Group’s management and business plan.
More than EUR 3,150 million allocated to innovation and capital investments over the last five years
Grifols’ revenues grew by 13.6% in 2019 to EUR 5,099 million, while its net profit increased by 4.8% to EUR 625 million. Both results highlight Grifols’ progress toward its long-term and sustainable growth strategy, which led to sales increases in its main divisions in all regions of operation.
Grifols’ operations in 2019 aimed to reinforce factors crucial to advancing its corporate growth plan, such as strategic investments to increase its access to plasma; efforts to strength the company’s global presence; optimization of its financial structure; and a renewed focus on innovation and capital investments as key drivers of its growth.
The strategic alliance with Shanghai RAAS, announced in 2019 and closed in 2020, has enabled Grifols to boost its commercial presence in China, one of the world’s fastest-growing markets for plasma-derived products and transfusion diagnostic solutions. In addition, the company also closed a transaction with GC Pharma (Green Cross Group) to acquire different assets in Canada, henceforth becoming the only large-scale manufacturer of plasma products in this country. Both transactions have significantly advanced Grifols’ international expansion efforts.
Another important achievement in 2019 was the optimization of Grifols’ financial structure. The company finalized a debt financing process, leading to a lower average cost of debt and longer maturities. The process was well accepted by the market and completed in record time. Grifols also reinforced its liquidity position in 2020 after signing an upsize of its multicurrency revolving credit facility. As of June 30, 2020, the company’s liquidity position stands at EUR 1,900 million. The optimization and reduction of debt levels remains a priority for Grifols' financial management.
In 2019, Grifols continued to promote innovation and capital investments as key drivers of its long-term and sustainable growth strategy, allocating a total of EUR 661 million. Over the last five years, the company has allotted more than EUR 3,150 million to these core areas.
In terms of R+D+i highlights in 2019, Grifols completed its AMBAR (Alzheimer Management By Albumin Replacement) clinical trial, designed to evaluate the efficacy and safety of plasma replacement therapy. This is a procedure combining periodic extractions of plasma through plasmapheresis with albumin and immunoglobulin infusions. As presented in several international conferences, AMBAR’s findings demonstrate a significant slowdown in disease progression in patients with mild to moderate Alzheimer’s. These positive results encourage Grifols to continue its research efforts on discovering the potential benefits of plasma protein replacement therapies.
Grifols also announced an agreement to acquire the remaining capital of Alkahest, Inc. for USD 146 million to promote the research and development of innovative therapies based on the human plasma proteome to treat age-related diseases.
Alkahest currently has four candidates in six phase-2 clinical trials, including therapies to treat neurogenerative disorders, cognitive decline, neuromuscular and ophthalmological diseases. Alkahest has developed a map of the human plasma proteome, facilitating the identification of plasma proteins and their recombinant analogues as potential therapeutic solutions.
More than EUR 1,200 million allocated to dividends over the last 5 years
Grifols shareholders approved the allocation of EUR 250 million to dividends (approximately EUR 0.36 gross per share) in 2019. This amount includes the preferred dividend of EUR 0.01 gross per share of each Class B share.
The dividend was distributed in two payments: one already paid in December 2019 for EUR 0.20 gross per share and a second payment of EUR 0.16 gross per share, which will be distributed from October 28, 2020 onwards.
The company maintains its pay-out of 40% of the group’s consolidated net profits. Grifols remains firmly committed to creating value for its shareholders, distributing more than EUR 1,200 million in dividends over the last five years.
Non-financial information and sustainability
Grifols’ non-financial and corporate sustainability performance indicators in 2019 were presented during the General Shareholders’ Meeting. This information forms part of the Integrated Annual Report (IAR), submitted by the company and approved by the Board of Directors reflecting on the company’s long-standing commitment to transparency.
This publication aims to offer Grifols’ main stakeholders a clear and comprehensive view of its social, environmental and economic performance and progress toward the objectives included in its Corporate Social Responsibility Policy.
The non-financial information contained in the IAR was prepared in alignment with Global Reporting Initiative (GRI) information requirements and recommendations, and verified by an external independent firm.
Research efforts in the fight against COVID-19
Grifols’ ongoing efforts to combat COVID-19 were also disclosed during the General Shareholders’ Meeting. The company is currently leading efforts in two of the three potential disease treatments for COVID-19. At the same time, it has joined efforts with other global authorities to increase the rate of diagnosis, which is vital to battling highly infectious diseases like COVID-19.
In terms of potential treatments, Grifols is leading the development of an anti-SARS-CoV-2 hyperimmune immunoglobulin using plasma from recovered COVID-19 donors. Following the approval of scientific protocols by the FDA and National Institute of Allergy and Infectious Diseases (NIAID), a multicenter, randomized and double-blind clinical trial will assess the safety and efficacy of this hyperimmune immunoglobulin, produced in Grifols’ Clayton plant (North Carolina, USA) among other manufacturers.
In parallel, the company is promoting and supporting several researchers and healthcare entities in the U.S., Spain and Germany in clinical trials using inactivated convalescent plasma, as well as other plasma-derived specialty products such as immunoglobulin, alpha-1 and antithrombin III.
With regard to diagnostic solutions, Grifols has developed a specific Transcription-Mediated Amplification (TMA) molecular test to detect the SARS-CoV-2 virus in plasma, blood and respiratory samples. This test offers the same or even greater sensitivity than other molecular tests including PCR- (polymerase chain reaction) based diagnostics.
An appeal on the importance of plasma in support of the PPTA’s International Plasma Awareness Week
Within the framework of Grifols’ efforts to combat COVID-19 and discover the therapeutic potential of plasma to treat this infectious viral disease, the company made a global appeal on the strategic importance of plasma to ensure the health and quality of lives of thousands of people worldwide. Similarly, Grifols added its voice to the plea made by the Plasma Protein Therapeutic Association (PPTA), urging global healthcare authorities to take decisive action to increase the volume of plasma donations.
Plasma plays an essential role in global healthcare. Therefore, Grifols recognizes the generosity and commitment of all plasma donors in making plasma-derived therapies possible.
Approval of agenda items
Key agenda items ratified by the shareholders include:
- Approval of individual and consolidated annual accounts
- Re-election of Víctor Grífols Deu, Thomas Glanzmann and Steve F. Mayer as members of the Board of Directors and approval of the appointment of James Costos
- Appointment and re-election of auditors
- Approval of the Annual Compensation of the Board in an advisory capacity
AMSP partners with bioMérieux to facilitate supply of high-quality COVID-19 diagnostics
8 October 2020
8 October 2020 -- bioMérieux and the Africa Medical Supplies Platform (AMSP), have announced a new partnership to facilitate the supply of high-quality diagnostic solutions from the bioMérieux Pandemic Response Portfolio to African Union Member States.
The AMSP portal is an online marketplace that enables the supply of COVID-19-related critical diagnostics and medical equipment and consumables in Africa and the Caribbean Community (CARICOM). It was developed under the leadership of the African Union Special Envoy, Strive Masiyiwa and powered by Janngo, on behalf of the Africa Centres for Disease Control and Prevention (Africa CDC). The platform was developed in partnership with African Export-Import Bank (Afreximbank) and the United Nations Economic Commission for Africa (ECA).
This partnership with bioMérieux aims to respond to supply shortages experienced by African Union Member States by guaranteeing efficient, uninterrupted and rapid access to bioMérieux high-quality diagnostic solutions dedicated to the COVID-19 pandemic.
Under the partnership, a portfolio of high-quality diagnostic solutions (molecular testing and serology testing) for COVID-19 from bioMérieux will be available at very competitive prices to each of the 55 African Union Member States.
“To effectively respond to the COVID-19 pandemic, Africa needs continuous and predictable supply of diagnostics and medical consumables, and the AMSP was created to close the supply gap. Through AMSP we are building partnerships and exploring all markets, and we are delighted to have bioMérieux join this very important partnership,” said Dr John Nkengasong, Director of Africa CDC.
“We are very proud of this collaboration with AMSP, as it is part of our public health efforts which consist of allowing low and middle-income countries to have access to high quality diagnostics solutions in an ethical and equitable manner. It overall contributes to a better health for patients and communities in these countries at an affordable cost,” said Mr. Sindé Chekete, Vice-President, bioMérieux Africa.
“With the AMSP, Africa is leading the way to ensure all of our governments get access to test kits and other urgent medical supplies they need, at fair prices. We have been working relentlessly to expand choice & quality of supplies and that is why this partnership with bioMérieux is very important to us,” said African Union Special Envoy, Strive Masiyiwa.
“As a global leader pioneering diagnostics, bioMérieux’s commitment to fight infectious diseases for almost 60 years is highly commendable and we are very proud to partner with them through the AMSP. They are joining world class healthcare manufacturers in our fight against the pandemic in Africa,” concluded Fatoumata Bâ, Founder & Executive Chair of Janngo and Managing Partner of Janngo Capital.
Abbott releases ID NOW™ COVID-19 interim clinical study results from 1,003 people to provide the facts on clinical performance and to support public health
7 October 2020 - Data show ID NOW performance of 95.0% sensitivity and 97.9% specificity within seven days of symptom onset. ID NOW is the most studied COVID-19 test available; interim post-authorization study evaluated 1,003 people. To date, Abbott has shipped more than 12 million ID NOW tests to all 50 states and provided more than 30 million rapid and lab-based COVID-19 tests in the U.S. since March.
ABBOTT PARK, Ill., Oct. 7, 2020 -- In a continuing effort to provide the facts about ID NOW to support public health interests, Abbott is sharing new interim clinical data results on its ID NOW COVID-19 rapid test. The results confirm the data submitted to the U.S. Food and Drug Administration (FDA) in March for Emergency Use Authorization (EUA) and the interim results that Abbott shared in its May 21 press release. The data also speak to the important role played by reliable point-of-care testing that is available in convenient and accessible locations where people can get immediate results.
"We recognize there is a lot of discussion about testing and ID NOW, and we want to make sure the public has the facts and real-world data," said Robert B. Ford, president and chief executive officer, Abbott. "The facts we're seeing from one of the largest clinical studies of any COVID-19 test, conducted at some of the nation's leading academic centers, show that ID NOW delivers effective, consistent and reliable performance."
"In the beginning of the pandemic, the scientific community had to rely on samples and modeling to predict test performance," said John Hackett, Ph.D., divisional vice president of Applied Research and Technology for Abbott's diagnostics business. "But now we have a significant body of real-world, clinical data that support the critical role ID NOW is playing in identifying infection rapidly in places where people show up for care."
"Tests are taken at a moment in time and they detect the virus once there's enough viral material in a person to be able to detect it," continued Dr. Hackett. "While there's no perfect test, to fight a pandemic, we need a combination of gold standard lab-based PCR and accurate, reliable rapid tests like ID NOW to help reduce risk in society and slow the spread of the virus."
Post-Authorization Study Data
Abbott has completed an interim analysis of its ID NOW post-authorization study. A total of 1,003 people were evaluated across two care environments: urgent care clinics (acute care) and hospitals and nursing homes (in-patient care). In these two care environments, the ID NOW delivered the following agreement to lab-based molecular PCR tests:
- Overall performance of 93.3% positive agreement (sensitivity) and 98.4% negative agreement (specificity). Further, in the 161 patients with high viral titers (Ct <33), and therefore most likely to transmit virus, ID NOW showed performance of 97.0% positive agreement (sensitivity).
- Performance of 95.0% positive agreement (sensitivity) and 97.9% negative agreement (specificity) in subjects within seven days post symptom onset. Further, in the 129 patients with high viral titers (Ct <33), and therefore most likely to transmit virus,
ID NOW showed performance of 98.4% positive agreement (sensitivity). - Performance of 94.6% positive agreement (sensitivity) and 97.6% negative agreement (specificity) in symptomatic subjects. Further, in the 136 patients with high viral titers (Ct <33), and therefore most likely to transmit virus, ID NOW showed performance of 97.8% positive agreement (sensitivity).
Updates to May 21 Interim Data (Previous Studies)
In addition to the post-authorization data, Abbott is providing an update to three studies that were covered in its May 21 interim study press release:
- Multi-Site Urgent Care. In a completed analysis from a multi-site urgent care clinical setting of 430 symptomatic patients with two or more symptoms, including 53 PCR positive subjects, ID NOW demonstrated performance of 96.2% in positive agreement (sensitivity) and 99.5% negative agreement (specificity) compared to lab-based molecular PCR tests.
- Everett Clinic. In a completed study at The Everett Clinic in Washington of 974 people, including 23 PCR positive subjects, in partnership with Yuan-Po Tu, M.D., ID NOW demonstrated 91.3% positive agreement (sensitivity) and 100% negative agreement (specificity) compared to lab-based molecular PCR tests.
- In-patient. In an in-patient care study (hospitals and nursing homes), a total of 518 symptomatic patients were evaluated, including 94 PCR positive subjects. ID NOW demonstrated 79.8% positive agreement (sensitivity) and 94.3% negative agreement (specificity) compared to lab-based molecular PCR tests.
- In the 494 subjects who reported days from symptom onset, the median number of days from symptom onset was 10 days with 71.1% of people presenting >7 days post symptom onset. In 45 patients with high viral titers (Ct <33), and therefore more likely to transmit virus, ID NOW showed performance of 100% positive agreement (sensitivity).
- In a further analysis of this data, the subset of 143 symptomatic patients within seven days of symptom onset were evaluated, of which 30 were PCR positive. ID NOW demonstrated 86.7% positive agreement (sensitivity) and 96.5% negative agreement (specificity) compared to lab-based molecular PCR testing.
Cycle times (Ct) are the number of times a PCR instrument must cycle through to amplify enough genetic material to be detected. So, the greater amount of virus present (viral load), the fewer cycles required to detect the virus. A person is more likely to be contagious the higher their viral load (and the lower their Ct count). The Centers for Disease Control and Prevention (CDC) shares available data on its website indicating that at a Ct of 33 and above, replication competent virus has not been reliably recovered and infectiousness is unlikely.
These findings are also consistent with a study published in the Annals of Internal Medicine, where researchers from Johns Hopkins found that even the most sensitive lab-based molecular tests can have false negatives when viral load levels are ramping down, near the end of the infection cycle, when viral load decreases and patients may no longer be infectious.
Abbott's Research Continues
Abbott has continued to study ID NOW in a variety of settings in people who are at different stages of infection with more than 1,000 people, making it the most studied rapid COVID-19 test on the market today. Abbott has shared this data with the FDA throughout the research process and will continue doing so.
About Abbott
Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 107,000 colleagues serve people in more than 160 countries.
Hologic Panther Platform and HIV-1 Quant Assay Used in “HIV Cure” Research
7 October 2020 - Two published studies demonstrate automated detection of viral loads as low as one copy per milliliter
Marlborough, Massachusetts, October 7, 2020 – Two studies in the current issue of the Journal of Clinical Microbiology demonstrated the utility of Hologic’s Panther® platform and Aptima® HIV-1 Quant assay in research related to potentially curing HIV-infected individuals. Hologic scientists collaborated on the studies1,2 with researchers at Vitalant Research Institute, the University of California, San Francisco, the University of California, San Diego, and the University of Pittsburgh.
There is an intense international research effort to discover strategies to effectively cure HIV-infected individuals by eliminating the virus, so that they can discontinue medication permanently. To achieve this, scientists need a way to confirm that HIV has been eliminated.
“This is a promising field of research, but measuring very low levels of virus in patients’ blood has presented a major challenge,” said Andrew Worlock, Ph.D., senior director of R&D at Hologic. “We developed a way to take advantage of the flexibility of our Panther instrument and the high sensitivity of our Aptima HIV-1 Quant assay to measure single copy levels of virus in large volumes of plasma, and to do it quickly and inexpensively.” Methods used in the studies are for research use only, and are not for use in diagnostic procedures.
The Panther molecular diagnostics system is a fully automated, high-volume platform that can process approximately 1,000 tests in a 24-hour period. It is used in clinical diagnostic laboratories to run tests for sexually transmitted diseases and respiratory infections – including SARS-CoV-2/COVID-19 – and to monitor viral loads in HIV-, HCV- or HBV-infected individuals. The Aptima HIV-1 Quant assay is performed on a blood sample and will quantitate viral loads down to 30 copies/milliliter (ml).
In the new studies, the investigators described an approach in which samples were run in replicate, meaning multiple aliquots were run from the same tube loaded on the Panther system. The results of individual replicates were then combined to give the result for a sample. With this approach, the researchers demonstrated that they could detect HIV-1 RNA in all antiretroviral therapy-suppressed participants when 45 replicate 0.5 ml aliquots of plasma were tested. When nine replicates were tested, 100% of participants with an HIV concentration in the range of five copies/ml were positive, and 70% were positive with concentrations as low as one copy/ml.
“By running replicates of plasma samples on the automated Panther system, we succeeded in quantifying HIV viral loads in individuals well below the detection limits typically achieved with viral load assays used for clinical diagnosis and monitoring,” said Michael Busch, Ph.D., from Vitalant Research Institute and UCSF, the senior author of one of the studies. “It really opens the door to automating quantitation of viral loads that were previously only detectable using highly laborious, ultrasensitive HIV RNA assays that required manual processes including ultracentrifugation of large volumes of plasma. This new approach should help lead to progress in evaluating promising new interventions in the HIV cure research field.”
About the Panther System
The Panther molecular diagnostics system is a best-in-class, fully automated, sample-to-result platform that can be used in low-, medium- or high-throughput laboratories. With a small footprint, adaptable workflow options and consolidated testing menu, it combines women’s health, sexually transmitted infections and viral load testing, which can all be done simultaneously. More than 2,000 Panther systems have been installed in clinical diagnostic laboratories around the world.
About Hologic
Hologic, Inc. is an innovative medical technology company primarily focused on improving women’s health and well-being through early detection and treatment. For more information on Hologic, visit www.hologic.com.
Vela Diagnostics Launches Test Kits to Differentiate Between Flu, RSV and SARS-CoV-2
5 October 2020 - The ViroKey™ Flu A/B & RSV RT-PCR Extension Kit is available for ordering now
Singapore, October 5 2020 – Vela Diagnostics announced today the release of the ViroKey™ Flu A/B & RSV RT-PCR Extension Kit for research use (RUO). This extension kit is intended for use with Vela Diagnostics’ automated PCR workflow with the ViroKey™ SARS-CoV-2 RT-PCR Test v2.0 which tests for the SARS-CoV-2 virus.
The concurrent use of ViroKey™ Flu A/B & RSV RT-PCR Extension Kit with ViroKey™ SARS-CoV-2 RT-PCR Test v2.0 allows the differentiation of four virus types – Influenza A, Influenza B, Respiratory Syncytial Virus (RSV) and SARS-CoV-2 – in nasopharyngeal and oropharyngeal swabs.
The ViroKey™ SARS-CoV-2 RT-PCR Test v2.0 has garnered Emergency Use Authorization (EUA) from the U.S. FDA, CE-IVD and Australian Therapeutic Goods Administration (TGA) approvals, as well as Provisional Authorisation from the Health Sciences Authority in Singapore.
The automated workflow comprises of the Sentosa™ SX101 instrument and the Sentosa™ SA201 RT-PCR instrument, or the ABI 7500 Fast Dx. This workflow enables minimal hands-on time and tests for up to 46 samples and two controls per run with a turnaround time expected at 4.5 hours.
“The release of our Flu and RSV extension test kit is timely. It is a challenge to differentiate between Flu, RSV and SARS-CoV-2 simply based on symptoms alone, and with the flu season expected in the coming month, this solution will aid in the research of those respiratory viruses,” said Sam Dajani, CEO and Chairman of the Board.
About Vela Diagnostics
Vela Diagnostics is a leading provider for integrated IVD system solutions, from sample to result. VELA’s test solutions utilize the automated Sentosa™ platform, providing the unique ability to leverage one system for NGS and PCR testing in infectious disease and oncology.
All Sentosa™ products listed above are by Vela Diagnostics. For more information, visit www.veladx.com.
QIAGEN to complement COVID-19 testing portfolio with novel kit that simplifies and accelerates PCR analysis for research applications
5 October 2020 - Innovative QIAprep& technology integrates sample preparation and detection steps in one single kit. Streamlined workflow with sample prep under two minutes cuts costs, plastic usage and time to result to under one hour. Compatible with standard lab automation equipment, any assay and transport media.
Hilden, Germany, and Germantown, Maryland, October 5, 2020 – QIAGEN today announced plans to launch a novel straightforward approach to viral RNA epidemiology that will significantly simplify and accelerate PCR analysis and remove key testing bottlenecks for SARS-CoV-2 and other RNA viruses.
QIAGEN’s innovative QIAprep& Viral RNA UM Kit combines a liquid-based sample preparation step completed in only two minutes with real-time PCR detection in a streamlined workflow that can be automated with standard lab equipment for any throughput, any assay and any reaction need from single to multiplex testing. The kit, which uses the most common transport media such as Universal Transport Media (UTMTM) as the starting material, includes both sample extraction components and optimized PCR reagents for only one procedure.
The streamlined workflow takes under one hour to deliver a result, compared to approximately three hours for standard extraction-based quantitative PCR processes and can handle up to 2,600 samples per eight-hour shift per cycler. As a result, labs can significantly accelerate the time to result and the frequency of viral testing. With only three small pipette tips needed per sample, the kit keeps plastic usage to a minimum, while providing significant cost savings by reducing reagent use and labor utilization.
Initial studies run by select public health research institutions have shown that the level of detection of the new QIAprep& Viral RNA UM Kit, when used with their assay, is similar to or better than regular PCR workflows, and that performance compares to standard public health protocols of the U.S. Centers of Disease Control (CDC), the World Health Organization (WHO) and others that use the gold standard for sample extraction.
“We are excited to launch the first integrated liquid-based sample preparation and amplification method for testing of viral RNA with any assay, including SARS-CoV-2,” said Dr. Thomas Schweins, Senior Vice President of the Life Sciences Business Area at QIAGEN. “Unlike other products, QIAprep& does not eliminate the sample preparation step at the expense of performance. Instead, it streamlines the gold standard in sample preparation set by QIAGEN to a process completed in under two minutes to enable an immediate, fast real-time PCR run on any cycler that delivers results in under one hour. We are planning to ramp up the production capacities later in 2020 to levels that ensure a guaranteed supply and address effectively the challenge of long PCR turnaround times that are slowing down the frequency of testing.”
The QIAprep& workflow is simple, swift and straightforward, consisting of only three steps: an aliquot is taken from a primary sample (nasopharyngeal, oropharyngeal or nasal swab) in transport media and added to a sample preparation buffer that is optimized to prepare the viral RNA template without degradation. This is next combined with the RT-qPCR reaction mix, which provides reliable and sensitive results for RNA viruses in UTM. The sample then undergoes a routine real-time PCR in a cycler using any assay. The output is finally interpreted, delivering a test result in under one hour from start to finish – including incubation and hands-on time.
“QIAprep& makes the most of our expertise in both sample preparation and PCR,” said Thierry Bernard, Chief Executive Officer of QIAGEN. “PCR is the gold standard for detection of SARS-CoV-2 and other RNA viruses, and QIAprep& makes it faster – without compromising performance. The launch of this new product will complement our efforts to build the broadest portfolio of COVID-19 testing solutions that addresses the varying needs for clinical and research applications in the fight against the pandemic.”
QIAGEN has been adding PCR tests on the QIAstat-Dx and NeuMoDx systems that differentiate COVID-19 from other respiratory infections, delivering research gene panels integrated with bioinformatics for analysis of the SARS-CoV-2 virus on any sequencer and scaling up production capacity for sample preparation kits and reagents sold to other companies for their own COVID-19 tests. QIAGEN is also developing novel easy-to-use solutions for antibody and antigen testing running on a portable device that provides highly accurate results in less than 15 minutes.
About QIAGEN
QIAGEN N.V., a Netherlands-based holding company, is the leading global provider of Sample to Insight solutions that enable customers to gain valuable molecular insights from samples containing the building blocks of life. Our sample technologies isolate and process DNA, RNA and proteins from blood, tissue and other materials. Assay technologies make these biomolecules visible and ready for analysis. Bioinformatics software and knowledge bases interpret data to report relevant, actionable insights. Automation solutions tie these together in seamless and cost-effective workflows. QIAGEN provides solutions to more than 500,000 customers around the world in Molecular Diagnostics (human healthcare) and Life Sciences (academia, pharma R&D and industrial applications, primarily forensics). As of June 30, 2020, QIAGEN employed more than 5,200 people in over 35 locations worldwide. Further information can be found at www.qiagen.com.
Reference: https://corporate.qiagen.com/newsroom/press-releases/2020/20201005_qiaprepandamp
CLEAR Adds LabCorp COVID-19 Test Results to “Health Pass” Mobile App
5 October 2020 - Eases the Ability to Safely Travel, Enter Workplaces, and Attend Public Events
NEW YORK & BURLINGTON, N.C., Oct. 5, 2020 -- CLEAR, the secure identity company, and LabCorp, a leading global life sciences company that is focused on advancing health and guiding patient care decisions, today announced a partnership to enable users of CLEAR’s Health Pass mobile app to securely link their LabCorp test results using their LabCorp Patient™ account. The partnership brings together LabCorp’s advanced testing capabilities, including its COVID-19 tests, with CLEAR’s safe and secure Health Pass technology.
Health Pass securely connects a person’s digital identity with their COVID-19-related information to help ease access into public spaces and restore peace of mind. To leverage the new combined offering, eligible Health Pass users must first provide consent, then log in to their LabCorp Patient account through the CLEAR app to link their accounts. In communicating an individual’s health status, Health Pass only displays a comprehensive red or green signal to employers and venue operators — never sharing or providing access to a user’s private health details.
Health Pass is already being used across multiple industries, including the National Hockey League’s Stanley Cup Playoffs, and allows users to easily share their COVID-19-related health information. The app links a user with real-time health surveys, temperature checks through integrated CLEAR hardware, and will now provide users the ability to access test results performed by LabCorp. LabCorp has performed over 15 million COVID-19 diagnostic tests which are available to individuals through healthcare providers, pharmacies, employer programs and to patients directly through Pixel by LabCorpTM.
“We are enabling people to securely share their LabCorp health information in convenient ways so they can return to work, travel, and enter public venues safely and with confidence,” said Adam Schechter, chairman and CEO of LabCorp. “We are excited to combine science and technology in ways that can improve how people live and work.”
“We are thrilled to join forces with LabCorp to help our partners create safer environments for their employees and communities,” said CLEAR CEO Caryn Seidman