FDA approves marketing of BioFire COVID-19 test

2020 07 16 23 29 1615 Laboratory Scientist Biosafety 400

The U.S. Food and Drug Administration (FDA) announced it has granted marketing approval for the BioFire Respiratory Panel 2.1 (RP2.1), a diagnostic test for the simultaneous qualitative detection and identification of multiple respiratory viral and bacterial nucleic acids in nasopharyngeal swabs obtained from individuals suspected of COVID-19 and other respiratory tract infections.

The diagnostic test had emergency use authorization and received approval for marketing through the FDA's "de novo" pathway, a regulatory pathway for low- to moderate-risk devices of a new type. The de novo request was based on additional data showing validation beyond what is needed for emergency use authorization.

The RP2.1 test is the first SARS-CoV-2 diagnostic test allowed to be marketed beyond the public health emergency, according to FDA's news release.

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