FDA Clears BioFire Diagnostics' FilmArray Meningitis/Encephalitis Panel | GenomeWeb

NEW YORK (GenomeWeb) – BioMérieux subsidiary BioFire Diagnostics has received de novo clearance by the US Food and Drug Administration for its PCR-based panel to detect pathogens causing meningitis and encephalitis.

The FilmArray ME panel is the first nucleic acid-based test to detect multiple pathogens from a single sample of cerebrospinal fluid, the FDA wrote in a separate press statement.

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