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 development and 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.