The agency cleared BioFire's FilmArray ME panel through its de novo classification process, which it reserves for low- to moderate-risk devices with no market precedent. Regulators based their decision on three studies including one with 1,560 patients suspected of having meningitis and encephalitis, which found that FilmArray performed as well as traditional testing methods to pinpoint the infections.
BioFire's test could offer an advantage over current screening methods, which sometimes take as many as three days to deliver results. Testing for CNS viral infections is even more complicated, the agency said, as many hospitals have to ship specimens and tests to labs for processing. The nucleic acid-based panel screens for 14 bacterial, viral and yeast pathogens that cause central nervous system (CNS) infections by using a small sample of spinal fluid, providing results in about an hour, the FDA said in a statement.
"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.
But FilmArray ME is not a completely surefire way of screening for CNS infections. The test does not pinpoint all causes of the infections or give information about which drugs would work best at treating bacterial infections, the FDA pointed out. The agency is recommending that doctors still carry out bacterial and fungal cultures of spinal fluid along with FilmArray to reduce false negative and false positive results.
The FDA blessing marks a victory for BioFire, which has been working hard to chalk up regulatory wins since selling out to BioMérieux last year for $450 million plus debt. In May 2014, the company nabbed an FDA OK for its innovative GI panel. Months later, the company scored the FDA's emergency authorization for two of its rapid Ebola tests amid the global outbreak.