Nov. 10, 2026—BioMérieux’s BioFire FilmArray Gastrointestinal 1.1 Panel has obtained FDA 510(k) clearance and IVDR CE marking, and its Gastrointestinal 1.1 Panel Mid also received 510(k) clearance. The PCR panels test 22 and 11, respectively, of the most common bacteria, viruses, and parasites associated with gastroenteritis. The new versions include a redesigned norovirus genogroups I and II assay and a software-based improvement for Campylobacter detection.
The panels use a stool sample from individuals presenting with signs or symptoms of gastrointestinal infection and are designed for use on the company’s BioFire FilmArray 2.0 and Torch systems. They require about two minutes of hands-on time for setup, with an approximate run time of one hour.