bioMérieux, a world leader in the field of in vitro diagnostics, today announced performance validation and the upcoming launch of VIDAS® anti-SARS-CoV-2 serology tests to detect antibodies in people who have been exposed to the SARS-CoV-2 that causes the COVID-19 disease.
Building on years of experience in developing immunoassays, bioMérieux worked closely with several hospitals to develop and validate the performances of two tests. VIDAS® anti-SARS-CoV-2 IgM and anti-SARS-CoV-2 IgG will identify in less than 30 minutes the presence of antibodies in people who have been infected with SARS-CoV-2. In this context, clinical specificity is particularly important to ensure that testing of uninfected individuals consistently shows a negative result. Both VIDAS® anti-SARS-CoV-2 IgM and anti-SARS-CoV-2 IgG demonstrated excellent clinical specificity data.
François Lacoste, Executive VP R&D at bioMérieux stated: “Thanks to the engagement and the experience of our research and development teams, bioMérieux is now going to launch two new serology assays to assess the immune response following SARS-CoV-2 infection. These tests will complement our three already launched molecular tests for the direct detection of the virus. Offering complementary testing solutions to laboratories is crucial to help overcome this pandemic. True to its commitment to serve public health, bioMérieux is one of the few players to propose a complete diagnostic solution for COVID-19 disease”.
Hospitals and private laboratories can run the tests on bioMérieux’s VIDAS® analyzers (MINI VIDAS®, VIDAS® and VIDAS® 3) which are widely available with more than 30 000 systems installed around the world.
bioMérieux aims to have the VIDAS® anti-SARS-CoV-2 serology tests available by mid-May as RUO (Research Use Only). They will be CE marked rapidly thereafter and bioMérieux will file a request for Emergency Use Authorization (EUA) to the US Food and Drug Administration.
Thanks to the expertise and a close collaboration between R&D, industrialization and manufacturing on the same site in France, bioMérieux is planning on an accelerated ramp-up to produce several million serology tests per month in the coming weeks.
About bioMérieux global response to COVID-19
bioMérieux already provides several solutions for the molecular detection of SARS-CoV-2: