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BioMérieux's BioFire Unit Submits Meningitis/Encephalitis Panel for FDA Clearance

NEW YORK (GenomeWeb) – BioMérieux said today that its BioFire subsidiary has submitted a de novo classification request to the US Food and Drug Administration for the FilmArray Meningitis/Encephalitis (ME) panel.

FilmArray ME tests cerebrospinal fluid for the most common bacteria, viruses, and fungi responsible for community-acquired meningitis or encephalitis. The panel takes about an hour to run on BioFire's FilmArray molecular testing platform, a fully automated system that combines highly multiplexed PCR and melt curve analysis.

BioFire made the de novo submission after successfully completing a clinical study that included more than 1,500 prospective samples analyzed at 11 different sites across the US, including a representative mix of pediatric and adult patients. At the Association for Molecular Pathology annual meeting in November, Paul Schreckenberger, a clinical researcher at Loyola Medicine who led one of the FilmArray ME test sites, shared some early positive data from his group's evaluation of the panel.

If the panel gains FDA clearance, it will be the fourth clinical diagnostic panel to run on the FilmArray system, joining FDA-cleared and CE-marked respiratory, blood culture identification, and gastrointestinal panels.