March 19, 2021 – On Wednesday, the U.S. Food and Drug Administration (FDA) granted marketing authorization of the BioFire Respiratory Panel 2.1 (RP2.1), a diagnostic test to detect and identify multiple respiratory viral and bacterial nucleic acids in nasopharyngeal swabs (NPS) obtained from individuals suspected of COVID-19 and other respiratory tract infections.
The FDA granted the marketing authorization to BioFire Diagnostics LLC (Salt Lake City, UT).
The diagnostic test, which was granted Emergency Use Authorization (EUA) in May 2020, was granted marketing authorization using the De Novo premarket review pathway, a regulatory pathway for low- to moderate-risk devices of a new type.
This is the first SARS-CoV-2 diagnostic test that will be permitted to be marketed beyond the public health emergency.
The BioFire RP2.1 is for use only in individuals suspected of respiratory tract infections, including COVID-19.