Eurofins Scientific : Bioanalytical Services launches Surrogate Virus Neutralizing antibody detection assays against the SARS-CoV-2 (COVID-19)

Thursday, January 7, 2021

Eurofins Bioanalytical Services, a member of Eurofins BioPharma Services, Laboratory Testing division, announces the launch of a Surrogate Virus Neutralization Test (sVNT) antibody assay against the SARS-CoV-2-virus. An alternative to conventional testing with a live virus, this assay is the first neutralizing antibody serology test authorized by the FDA as emergency use authorization (EUA). This innovative assay detects the presence of neutralizing/blocking antibodies against SARS-CoV-2 virus, that block the interaction between the receptor-binding domain (RBD) of the viral spike glycoprotein with the ACE2 cell surface receptor.

Current testing methods, such as PCR, determine whether someone is actively infected by confirming the presence of viral material or IgG/IgM antibodies that detect (binding and blocking) induced immune response from exposure to the virus. Being an ELISA methodology, the in-house, fully validated surrogate virus neutralization test (sVNT) is amenable to high-throughput testing, at a lower analytical cost and requires no extended validation timelines for our client base. It also removes the obstacle faced by many COVID-19 development programs, by eliminating the requirement for a biosafety level 3 containment.

The advantage over historic antibody IgG/IgM tests is that this new gold standard assay tests for neutralizing antibodies (versus binding antibodies), by confirming neutralizing function without the need for a secondary antibody and is isotype and species independent.

Eurofins BioPharma Services' scientific expertise and breadth of testing capabilities places the company at the forefront in supporting clients' mission to accelerate COVID-19 therapeutic/vaccine developmentand put an end to this crisis. Combined with the multi-continent footprint and global logistics of specimen management experience of our Eurofins Central Laboratory division, we can provide region specific solutions, while still retaining our Center of Excellence in St. Charles, MO.

Eurofins Bioanalytical Services is a leader in bioanalytical solutions for biologics, providing nearly 20 years of industry-leading scientific expertise. As a division of the Eurofins Scientific Group, our sole focus is in pre-clinical and clinical laboratory analysis. With state-of-the-art, testing facilities in St. Charles, MO, USA, Eurofins Bioanalytical Services develops, transfers and validates large molecule PK/TK, immunogenicity and biomarker assays to our client's specifications. With industry-leading capacity, capabilities range from a single plate to large multinational Phase III and IV clinical trials, in a broad range of therapeutic indications, including vaccines and COVID-19. Eurofins has the capacity to handle variable sample numbers and large volumes to meet the needs of clients.

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About Eurofins - the global leader in bio-analysis

Eurofins is Testing for Life. Eurofins is a 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 for over 10 million patient tests per month to support efforts to identify and suppress the virus. The Group has established widespread PCR testing capabilities and has carried out over 10 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).