NEW YORK (GenomeWeb) – BioMérieux said today that the FilmArray Meningitis/Encephalitis (ME) panel from its subsidiary BioFire Diagnostics has received CE marking.
The FilmArray ME Panel received a de novo clearance from the US Food and Drug Administration in October. The panel is cleared for use on the FilmArray and FilmArray 2.0 systems, and uses PCR and high-resolution melt analysis to test cerebrospinal fluid for the 14 most common pathogens (six bacteria, seven viruses, and one yeast) responsible for community-acquired meningitis or encephalitis in about an hour.
"In Europe, the ME Panel brings a unique opportunity to test simultaneously and rapidly for most bacteria, viruses, and fungi found in those pathologies that can be extremely severe and sometimes lethal," François Simon, head of the Department of Virology, Bacteriology and Hygiene at Hospital Saint-Louis-Lariboisière-Fernand Widal in Paris, said in a statement.
"Such an approach will positively impact the management of those patients by helping clinicians and biologists speed the diagnosis of these potentially severe conditions and make much faster decisions on appropriate therapy to prevent complications," Simon said.