Salt Lake City firm submits gastrointestinal test for FDA approval
Salt Lake City-based BioFire Diagnostics announced Wednesday that it has submitted a new gastrointestinal test to the U.S. Food and Drug Administration for clearance. The FilmArray GI Panel tests for more than 20 common bacteria, viruses and parasites that lead to infectious diarrhea.
The panel already has completed a clinical study that included more than 1,500 prospective samples. It is expected to be made available this summer.
In the U.S., about 76 million cases of foodborne disease are estimated each year, resulting in about 5,000 deaths.