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BioMérieux Gets CE Mark for Coronavirus Serology Tests

NEW YORK — BioMérieux said on Thursday that it has received CE marking for its two SARS-CoV-2 serology tests.

According to the company, the tests are designed to detect immunoglobulin M and immunoglobulin G antibodies, respectively, against SARS-CoV-2 and have demonstrated over 99 percent specificity. They run on the BioMérieux's Vidas immunoanalyzers and provide results in less than 30 minutes.

Marcy l'Étoile, France-based BioMérieux said it plans to submit the tests to the US Food and Drug Administration for Emergency Use Authorization.