BioMérieux Announces Upcoming Launch of VIDAS Anti-SARS-CoV-2 Serology Tests

BioMérieux (Marcy-l'Étoile, France) has 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.

The VIDAS anti-SARS-CoV-2 IgM and anti-SARS-CoV-2 IgG can identify in less than 30 minutes the presence of antibodies in people who have been infected with SARS-CoV-2. BioMérieux has worked closely with several hospitals to develop and validate the performances of two tests, and both VIDAS anti-SARS-CoV-2 IgM and anti-SARS-CoV-2 IgG have demonstrated excellent clinical specificity data.

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 the company will file a request for Emergency Use Authorization (EUA) to the US Food and Drug Administration. BioMérieux plans an accelerated ramp-up to produce several million serology tests per month in the coming weeks.

“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,” said François Lacoste, Executive VP R&D at BioMérieux. “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.”

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