BioFire Diagnostics wins FDA clearance for innovative GI panel

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

BioFire Diagnostics won 510(k) clearance for its gastrointestinal panel for infectious diarrhea, following in the footsteps of the company's acquisition by French diagnostic giant bioMérieux.

BioFire's FilmArray device includes several molecular diagnostic panels, two of which have already been cleared by the FDA: respiratory and blood culture. Its GI panel tests for common pathogens such as viruses, bacteria and parasites, and uses a closed-system that combines sample preparation, amplification and detection. The system also decreases testing time, as it takes two minutes to set up and produces results in about an hour.

The company plans to secure a CE mark for its FilmArray GI test in late spring 2014, and is also moving forward with development for another panel. BioFire initiated studies for its Meningitis-Encephalitis panel, and expects to submit the product for FDA clearance in 2015, the company said in a statement.

"We view this panel as a game-changer in the diagnosis of infectious diarrhea, delivering accurate and timely results," BioFire Diagnostics CEO and bioMérieux Corporate Vice President of Molecular Biology Randy Rasmussen said in a statement. "The breadth of pathogens on our GI Panel provides physicians with the underlying causes of gastrointestinal infectious disease, which aids with treatment decisions for their patients."

BioMérieux purchased Salt Lake City-based BioFire in mid-January for $450 million, and submitted the company's FilmArray diagnostic system's new gastrointestinal panel to the FDA for clearance one month later. BioFire kept its name and senior management in the process, and moved forward with development of its FilmArray tests.

Both sides stood to benefit from the deal, as bioMérieux could build its stateside presence and ramp up its position in infectious disease testing. The French diagnostic giant gained access to BioFire's manufacturing facilities, and planned on using the company's Salt Lake City headquarters as its molecular biology hub. BioFire in turn would be able to capitalize on bioMérieux's extensive commercial network in North America and Europe.

"They are committed to leaving us the way we are going and supporting us," Eric Gorrell, BioFire's general counsel and head of investor relations, told FierceDiagnostics at the time the deal was announced. "We will become their hub, the center of excellence for molecular biology for the entire bioMérieux family."

BioFire launched 20 years ago, and was most recently known as Idaho Technology. The company counts the U.S. Department of Defense as one of its many biodefense customers, and previously scored a diagnostics license with Roche ($RHHBY).

- read the release