BioFire Diagnostics, LLC, a wholly owned subsidiary of bioMerieux, Inc., has submitted the FilmArray Gastrointestinal (GI) Panel to the United States Food and Drug Administration (FDA) for 510(k) clearance. The comprehensive FilmArray GI Panel tests for more than 20 common bacteria, viruses, and parasites that cause infectious diarrhea.
The submission of the FilmArray GI Panel comes after the successful completion of a clinical study that included more than 1,500 prospective samples. The study was conducted at several hospital-based clinical laboratories in the U.S. BioFire anticipates commercial release of the FilmArray GI Panel in early summer 2014, pending FDA clearance. Concurrently, the FilmArray GI Panel will receive CE marking.
Current diagnostic practice for infectious gastroenteritis requires choosing among multiple tests that can be laborious to perform and do not cover the breadth of pathogens that cause gastrointestinal illness. These tests are often carried out in a stepwise fashion, and the process can take too long to aid in timely pathogen-specific treatment decisions. The FilmArray is a closed system that integrates sample preparation, amplification, and detection. With a run time of about an hour and only two minutes of hands-on time, the panel is a comprehensive 23-target test that is performed directly from stool in transport media.
“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,” says Randy Rasmussen, CEO of BioFire Diagnostics. “This submission highlights our continued work to expand the menu of tests for our FilmArray platform.”
