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BioFire Gets 510(k) Clearance for Reduced Time-to-Result Respiratory Panel

NEW YORK (GenomeWeb) – BioMérieux today said that the US Food and Drug Administration has given 510(k) clearance to its BioFire Diagnostics business for the FilmArray Respiratory Panel 2 (RP2), which tests for 17 viruses and four bacteria that are responsible for respiratory tract infections.

The panel will be commercially available in the US by mid-June, the firm said.

BioMérieux noted that FilmArray RP2 advances BioFire's existing FilmArray Respiratory Panel by reducing the assay time to less than 45 minutes from about an hour, while also improving overall sensitivity and enhancing several assays. The panel consists of an additional pathogen, Bordetella parapertussis, a cause of whooping cough. Clinicians often miss B. parapertussis because, upon clinical presentation, it's difficult to differentiate from other viral infections, and there has been a deficiency of reliable diagnostic tests, BioMérieux said.

In April, BioFire received CE marking for the FilmArray Respiratory Panel 2 plus, which tests for one more pathogen than FilmArray RP2 — the Middle East respiratory syndrome coronavirus. BioFire has submitted a de novo application to the FDA for clearance of the FilmArray RP2 plus.

Randy Rasmussen, CEO of BioFire Diagnostics, said in a statement that a growing body of evidence "strongly supports the added medical value of rapid syndromic infectious disease testing."

Judy Daly, director of microbiology laboratories at Primary Children's Medical Center in Salt Lake City, Utah, the principal investigator at an FDA clinical study site for FilmArray RP2, said that the panel "enables us to provide faster, more accurate, and more comprehensive results, and helps improve detection of respiratory pathogens and clinical actionability.”

The FilmArray RP2 panel is compatible with BioFire's FilmArray 2.0 and FilmArray Torch systems.

BioMérieux said that it will continue to make the current-generation FilmArray RP panel commercially available.


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