BioMérieux submitted updated gastrointestinal FilmArray PCR panels to FDA for 510(k) review, aiming to strengthen norovirus detection and improve specificity. The company filed both the FilmArray Gastrointestinal 1.1 Panel and the Mid version, with each designed for rapid results from a single stool sample. BioMérieux said the GI1.1 Panel tests for 22 pathogens, while the GI1.1 Panel Mid covers 11, with results available in about an hour. It also stated the tests are intended for use on the FilmArray 2.0 and Torch systems, requiring roughly two minutes of hands-on setup. The filing targets an operational bottleneck in gastroenteritis management—pathogen identification quickly enough to guide infection prevention and treatment—particularly as epidemiology evolves.
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