The FDA yesterday informed Cellex that it is issuing emergency use authorization (EUA) for the company’s SARS-CoV-2 antibody test for detecting coronavirus. Cellex (Research Triangle Park, N.C.) is touting its rapid test as the first of its kind to receive authorization amid the coronavirus crisis. It is a lateral flow immunoassay designed for the qualitative […]
Bodysphere
Bodysphere touts 2-minute COVID-19 test
Update: Bodysphere issued a statement clarifying that, in the rush to get its kits on the front lines, it misinterpreted the test’s listing on the FDA registry website. The test has not yet been cleared by the FDA. Bodysphere announced today that it has begun distributing its 2-minute testing kit for diagnosing COVID-19 after receiving […]