French diagnostics company bioMérieux (Euronext Paris:BIM) announced on Monday that it has received US Food and Drug Administration (FDA) 510(k) clearance for its BIOFIRE FILMARRAY Gastrointestinal 1.1 (GI1.1) Panel and GI1.1 Panel Mid, expanding its molecular diagnostic portfolio for gastrointestinal infections.

The GI1.1 Panel has also received CE marking under the In Vitro Diagnostic Regulation (IVDR), enabling commercialisation across European markets.

The updated PCR-based panels detect 22 and 11 common bacterial, viral and parasitic pathogens, respectively, from a single stool sample, delivering results in approximately one hour. The latest versions feature a redesigned norovirus GI/GII assay and a software-based improvement to Campylobacter detection, strengthening diagnostic specificity and result reliability.

Designed for use with bioMérieux's BIOFIRE FILMARRAY 2.0 and TORCH systems, the tests require approximately two minutes of hands-on preparation time.

The GI1.1 Panel will be commercialised globally, while the GI1.1 Panel Mid will initially be available in the United States. The FDA clearances and European IVDR certification support the company's expansion of its gastrointestinal diagnostic testing solutions across key markets.