FDA has recently granted market clearance to the FilmArray Gastrointestinal (GI) panel from BioFire, Salt Lake City. The 22-target panel is the most comprehensive gastrointestinal test to be cleared by the agency and contains several pathogens receiving clearance for the first time. The test allows a syndromic approach to the diagnosis of infectious diarrhea by including bacteria, viruses, and parasites in a single panel. The closed system also avoids cross-contamination by integrating sample preparation, amplification, and detection. The FilmArray panel is performed directly from stool in Cary Blair transport media and takes only two minutes to set up, producing results in about an hour. BioFire anticipates CE IVD marking of the FilmArray GI panel in late spring of 2014. For more information, visit BioFire Diagnostics.
May 10, 2019
August 3, 2022