BioFire Defense’s COVID-19 Test Gets FDA’s 510(k) Clearance

The FDA has granted 510(k) clearance to BioFire Defense's COVID-19 Test 2, which it developed in collaboration with the U.S. Army's Warfighter Protection and Acute Care Project Management Office.

The in vitro diagnostic test is used in conjunction with BioFire’s FilmArray device to analyze nasopharyngeal swabs from symptomatic individuals to detect the SARS-CoV-2 virus in approximately 45 minutes.

The test, which was evaluated in three U.S. clinical study sites from July through October 2020, previously received the FDA’s Emergency Use Authorization.