Eurofins Viracor Invests in Innovation with the Launch of Coronavirus (COVID-19) SARS-CoV-2 inSIGHT™ T Cell Immunity Testing
LUXEMBOURG--(BUSINESS WIRE)--Regulatory News:
As one of the first commercial labs to deliver COVID-19 testing, Eurofins Viracor, Inc. continues to invest in innovation with the launch of Coronavirus SARS-CoV-2 inSIGHT™ T Cell Immunity testing. Viracor’s inSIGHT™ T Cell Immunity test delivers a deeper understanding of a patient's response to viral antigens and gives healthcare providers critical insight to aid in treatment decisions. The test measures CD4+ and CD8+ T Cells independently to evaluate cell- mediated immunity to Coronavirus SARS-CoV-2 that causes COVID-19.
Utilizing flow cytometry and intracellular cytokine staining, SARS-CoV-2 inSIGHT™ testing could be an important tool for evaluating an individual’s immunological memory to the SARS-CoV-2 virus and even indicate a level of protection from further infection with the virus. The ability to determine the proportion of antigen specific T cells that respond to stimulation with SARS-CoV-2 spike (S) and nucleocapsid (N) proteins can assist even the most critical and immunocompromised patients, such as transplant recipients, those battling cancer and more. Results for this live cell test, collected in a sodium heparin test tube, can be available in 3 to 4 business days from receipt of specimen.
SARS-CoV-2 inSIGHT™ testing joins a robust menu of COVID-19 testing, including the recently-launched cPASS™ Coronavirus SARS-CoV-2 Neutralizing Antibody test. If SARS-CoV-2 inSIGHT™ is used in combination with the cPass™ Coronavirus SARS-CoV-2 Neutralizing Antibody test, the results from the two tests could help physicians evaluate two areas of our adaptive immune system that can give indication of immunity. When neutralizing antibody response begins to diminish months after exposure to the virus or vaccine, the presence of T cell immunity may signify long-term immunity.
A leader in infectious disease testing for over 35 years, Viracor has launched molecular and serological tests to aid in the evaluation of naturally infected or vaccinated individuals. Available testing includes RT-PCR, IgG, IgM and Neutralizing Antibody testing to help identify individuals with active or prior COVID-19 cases. Furthermore, Viracor's SARS-CoV-2 RT-PCR assay offers the best sensitivity of the 117 laboratories that have submitted results to FDA's SARS-CoV-2 Reference Panel, with a limit of detection of 180 NAAT Detectable Units/mL1,2. To see the full list of available testing, visit https://www.eurofins-viracor.com/clinical/our-testing/.
1 This test has not been cleared or approved for diagnostic use by the U.S. Food and Drug Administration. This test has been authorized by FDA under an EUA for use by authorized laboratories. This test has been authorized only for the detection of RNA from SARS-CoV-2 virus and diagnosis of SARS-CoV-2 virus infection, not for any other viruses or pathogens. This test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of in vitro diagnostic tests for detection of SARS-CoV-2 virus and/or diagnosis of SARS-CoV-2 virus infection under section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.
Notes to Editors:
For more information, please visit www.eurofins.com
With over 30 years of specialised expertise in infectious disease, immunology and allergy testing for immunocompromised and critical patients, Viracor Eurofins is committed to delivering results to medical professionals, transplant teams, reference laboratories and biopharmaceutical companies faster, when it matters most. Eurofins Viracor is passionate about delivering value to its clients by providing timely, actionable information, never losing sight of the connection between the testing it performs and the patients it ultimately serves.
Eurofins Viracor is a subsidiary of Eurofins Scientific (EUFI.PA), a global leader in bio-analytical testing, and one of the world leaders in genomic services. For more information, please visit https://www.eurofins.com/ and https://www.eurofins-viracor.com/.
About Eurofins – the global leader in bio-analysis
Eurofins is Testing for Life. Eurofins is the global leader in food, environment, pharmaceutical and cosmetic product testing and in agroscience Contract Research Organisation services. Eurofins is one of the market leaders in certain testing and laboratory services for genomics, discovery pharmacology, forensics, advanced material sciences and in the support of clinical studies, as well as having an emerging global presence in Contract Development and Manufacturing Organisations. The Group also has a rapidly developing presence in highly specialised and molecular clinical diagnostic testing and in-vitro diagnostic products.
With over 50,000 staff across a decentralised and entrepreneurial network of more than 800 laboratories in over 50 countries, Eurofins offers a portfolio of over 200,000 analytical methods to evaluate the safety, identity, composition, authenticity, origin, traceability and purity of a wide range of products, as well as providing innovative clinical diagnostic testing services and in-vitro diagnostic products.
The Group’s objective is to provide its customers with high-quality services, innovative solutions and accurate results on time. Eurofins is ideally positioned to support its clients’ increasingly stringent quality and safety standards and the increasing demands of regulatory authorities as well as the requirements of healthcare practitioners around the world.
In 2020, Eurofins reacted quickly to meet the global challenge of COVID-19, by creating the capacity to help over 20 million patients monthly who may have been impacted by the pandemic with our testing products and our services and directly supporting healthcare professionals working on the front line to fight the virus. The Group has established widespread PCR testing capabilities and has carried out over 25 million tests in its own laboratories, is supporting the development of a number of vaccines and has established its SAFER@WORK™ testing, monitoring and consulting programmes to help ensure safer environments during COVID-19.
Eurofins has grown very strongly since its inception and its strategy is to continue expanding its technology portfolio and its geographic reach. Through R&D and acquisitions, the Group draws on the latest developments in the field of biotechnology and analytical chemistry to offer its clients unique analytical solutions.
Shares in Eurofins Scientific are listed on the Euronext Paris Stock Exchange (ISIN FR0014000MR3, Reuters EUFI.PA, Bloomberg ERF FP).
Until it has been lawfully made public widely by Eurofins through approved distribution channels, this document contains inside information for the purpose of Regulation (EU) 596/2014 of the European Parliament and of the Council of 16 April 2014 on market abuse, as amended.
This press release contains forward-looking statements and estimates that involve risks and uncertainties. The forward-looking statements and estimates contained herein represent the judgment of Eurofins Scientific’s management as of the date of this release. These forward-looking statements are not guarantees for future performance, and the forward-looking events discussed in this release may not occur. Eurofins Scientific disclaims any intent or obligation to update any of these forward-looking statements and estimates. All statements and estimates are made based on the information available to the Company’s management as of the date of publication, but no guarantees can be made as to their completeness or validity.
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