BioMérieux's BioFire sets course for GI panel FDA clearance

BioFire's FilmArray system with multi-PCR capability--Courtesy of BioFire

Just a month out from being bought by French giant bioMérieux, BioFire Diagnostics took its FilmArray diagnostic system's new gastrointestinal option to the FDA for clearance, which the newly united outfits expect to gain before a summer rollout this year.

Salt Lake City-based BioFire's FilmArray system is a multiplex PCR device that combines several molecular diagnostic panels. Cleared already by the FDA are its respiratory and blood culture panels, and BioFire hopes to add the gastrointestinal option with its most recent 510(k) application. The GI panel tests for common pathogens such as viruses, bacteria and protozoa that cause infectious diarrhea, according to the company, and can do so in about two minutes of hands-on time with a turnaround of about an hour.

BioFire is similarly looking to have the GI panel CE marked before this year's launch.

BioMérieux picked up BioFire in mid-January for $450 million, also acquiring in the deal about $35 million in net financial debt. But BioFire held onto its name and senior management in the process, moving forward with its FilmArray tests all the same. The stateside site became bioMérieux's hub for molecular biology here, with the added benefit of offsetting manufacturing costs and giving it a wider berth for R&D.

"We are thrilled to submit our GI panel to the FDA and believe that this panel will deliver the rapid, comprehensive results that our customers need to aid in timely diagnosis of infectious diarrhea," BioFire CEO Randy Rasmussen said in a statement. "The submission highlights our continued work to expand the menu of tests for our FilmArray platform."

Known previously as Idaho Technology, BioFire launched 20 years ago and has been a rising player in infectious diseases with biodefense customers such as the U.S. Department of Defense and a previous diagnostics license with Roche ($RHHBY).

- here's the release

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