NEW YORK (GenomeWeb) – BioMérieux today announced that BioFire's FilmArray Gastrointestinal Panel has received 510(k) clearance for marketing by the US Food and Drug Administration.
The 22-target panel is for diagnosing infectious diarrhea and includes bacteria, viruses, and parasites in one test. According to BioMérieux, the test is the most comprehensive gastrointestinal panel to be cleared by FDA and contains several pathogens that have received FDA clearance for the first time.
BioMérieux acquired the test as part of its €357 million ($495 million) buy of BioFire Diagnostics at the start of the year. BioFire submitted its 501(k) application to FDA for the GI panel in February.
The panel runs on the FilmArray system, a closed system that integrates sample preparation, amplification, and detection, and is performed directly from stool in Cary Blair transport media. It takes two minutes to set up and about one hour to produce results, BioMérieux said.
Randy Rasmussen, CEO of BioFire Diagnostics and corporate VP of molecular biology at BioMérieux, said in a statement that the test is a "game-changer in the diagnosis of infectious diarrhea. ... 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."
BioFire anticipates CE-IVD marking for the panel in late spring. The firm now has three panels that have received FDA clearance, including the Respiratory Panel and the Blood Culture Identification Panel. It also has begun studies for its Meningitis-Encephalitis Panel and expects to submit the test to FDA for clearance in 2015, BioMérieux said.