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BioMérieux's BioFire SARS-CoV-2 Respiratory Panel Wins FDA Emergency Use Authorization

NEW YORK – The US Food and Drug Administration on Friday granted BioFire Diagnostics' Respiratory Panel 2.1 Emergency Use Authorization.

The panel, which uses PCR and takes about 45 minutes to run, is designed to detect and differentiate between nucleic acids from SARS-CoV-2 and 20 other viral and bacterial respiratory pathogens — including various influenza A subtypes, respiratory syncytial virus, and Bordetella pertussis — in nasopharyngeal swabs from individuals suspected of having COVID-19.

It runs on BioFire's FilmArray 2.0 and FilmArray Torch systems and can be performed by labs CLIA-certified to perform high- or moderate-complexity tests. The company said it has nearly 12,000 FilmArray systems installed worldwide.

Marcy-l'Étoile, France-based BioMérieux, BioFire's parent company, said it plans to submit the panel to the FDA for de novo clearance. It is also pursuing rapid CE mark certification for an expanded panel, called Respiratory 2.1plus, that also includes the detection of MERS-CoV.

BioFire said it is currently ramping up production of the RP2.1 panel at its facility in Salt Lake City. In March, the company received EUA for a coronavirus assay called BioFire COVID-19 test. BioMérieux also launched the Argene SARS-CoV-2 R-Gene test that month.

BioFire's RP2.1 is the second respiratory panel to obtain FDA emergency authorization for SARS-CoV-2 testing, following Qiagen's QiaStat-Dx Respiratory SARS-CoV-2 panel in March.




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