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.
Testing for multiple pathogens using current practices has not always been possible because it can be difficult to obtain enough cerebrospinal fluid from a patient, the agency noted.
"Testing one sample for many pathogens and potentially having test results sooner should allow physicians to use this information, along with other clinical findings and test results, to provide improved diagnosis and treatment for these very serious illnesses," Alberto Gutierrez, director of the Office of In Vitro Diagnostics and Radiological Health at the FDA's Center for Devices and Radiological Health, said in a statement.
The one-hour assay detects a total of 14 pathogens: six bacteria, seven viruses, and one type of yeast.
Specifically, the bacterial pathogens identified are Escherichia coli K1, Haemophilus influenzae, Listeria monocytogenes, Neisseria meningitides, Streptococcus agalactiae, and Streptococcus pneumoniae. Viruses identified are cytomegalovirus, enterovirus, herpes simplex virus 1, herpes simplex virus 2, human herpesvirus 6, human parechovirus, and varicella-zoster virus. The yeast pathogen is Cryptococcus neoformans/gattii.
Back-up cultures will still be required to rule out false positive and false negative results, and to perform drug susceptibility testing, the FDA noted.
BioMérieux noted that it has also seen favorable adoption of FilmArray by clinical labs, with 1,900 systems installed and a year-over-year doubling of sales reported at the end of June this year.
The ME panel will be commercially available in the US next month, and CE-marked shortly thereafter.