bioMérieux receives FDA clearance for updated BIOFIRE GI panels
The panels feature a redesigned norovirus assay and improved Campylobacter detection, testing stool samples in about an hour with roughly two minutes of setup.
bioMérieux has received U.S Food and Drug Administration (FDA) 510(k) clearance and IVDR CE marking for the BIOFIRE FILMARRAY Gastrointestinal 1.1 (GI1.1) Panel, and FDA clearance for the BIOFIRE FILMARRAY Gastrointestinal 1.1 (GI1.1) Panel Mid.
These PCR molecular panels include a redesigned norovirus GI/GII assay and a software-based improvement for Campylobacter detection. bioMérieux reports they can simultaneously detect 22 and 11 pathogens, respectively, directly from stool samples of individuals presenting with signs and/or symptoms of gastrointestinal infection. Designed for use on bioMérieux’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 about one hour.
The BIOFIRE FILMARRAY GI1.1 Panel will be deployed across all regions, while the BIOFIRE FILMARRAY GI1.1 Panel Mid will be initially available in the United States.
