Eurofins BioPharma Services recently launched a validated antibody assay against the SARS-CoV-2 virus; Surrogate Virus Neutralization Test (sVNT). 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. Fast and automatable, the fully validated sVNT assay is amenable to high-throughput testing at a lower analytical cost requiring no extended validation timelines for our clients.
Additionally, Eurofins was granted an Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) for SARS-CoV-2 RT-PCR testing in support of clinical trials for COVID-19 vaccine and therapeutics development. The FDA developed a reference panel for RT-PCR testing to assess the performance of molecular tests. Data from the FDA SARS-CoV-2 Reference Panel demonstrates that Eurofins truly offers best in class solutions in the laboratory services marketplace, outperforming well-respected In Vitro Diagnostic (IVD) reagent kit manufacturers and other Laboratory Developed Tests (LDT) in house.
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 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 monitoring surveillance for COVID-19 testing solutions. Eurofins has the capacity to handle variable sample numbers and large volumes to meet the needs of clients.