BioMérieux Receives FDA Clearance for Its Revised BioFire Gastrointestinal Panels
Announced on 9 November 2026, the clearance covers not a new product but revised versions of the BioFire FilmArray Gastrointestinal Panels. These versions incorporate a reconfigured test for norovirus GI/GII and optimized algorithms for detecting the Campylobacter bacterium which, according to BioMérieux, enhance the specificity of the tests and the reliability of each result.
Two Panels Detecting 22 and 11 Pathogens in About One Hour
The BioFire FilmArray Gastrointestinal 1.1 (GI1.1) Panel and its GI1.1 Panel Mid variant detect respectively 22 and 11 bacteria, viruses and parasites among the most common causes of gastroenteritis, from a single stool sample. Running on the BioFire FilmArray 2.0 and Torch instruments, they require two minutes of preparation for a result in about one hour.
The press release recalls that diarrhoeal diseases are among the leading causes of death in children under 60 months of age, with approximately 1.7 billion cases recorded each year worldwide according to the WHO. Since gastroenteritis symptoms are often non-specific, diagnostic tests become, according to the company, all the more essential.
Dr Charles K. Cooper, Executive Director of Medical Affairs, highlighted the case of norovirus, which “remains one of the leading causes of acute gastroenteritis worldwide and can spread rapidly within communities and healthcare facilities”.
According to him, these tests make it possible to “accelerate clinicians' informed decision-making” and to “support infection control measures”.
The GI1.1 Panel Sold Worldwide, the Mid Mainly in the United States
BioMérieux specified that the GI1.1 Panel will be marketed worldwide, while the GI1.1 Panel Mid will be available primarily in the United States. In addition to the FDA 510(k) clearance, the former has obtained CE marking under the European IVDR regulation on in vitro diagnostic medical devices, enabling its deployment on European markets.
Jennifer Zinn, Executive Director of Clinical Operations, placed these updates within an approach of “continuous improvement of the performance of technologies in our portfolio of solutions”. The group relies, she said, “on robust post-market surveillance and on advances from our R&D to continuously evolve” its gastrointestinal tests.
