FDA approves FilmArray ME Panel for diagnosis of meningitis and encephalitis- BioFire Diagnostics

The FDA has allowed marketing of the first cerebrospinal fluid (CSF) nucleic acid-based test for simultaneous detection of multiple pathogens that can cause central nervous system infections such as meningitis and encephalitis. The FDA reviewed data for the FilmArray ME Panel, from Bio-Fire Diagnostics, through the de novo classification process, a regulatory pathway for some low- to moderate-risk devices that are novel and not substantially equivalent to any legally-marketed device.

The FilmArray ME Panel is designed to simultaneously test for 14 bacterial, viral and yeast pathogens using a small sample of CSF and can provide results in about an hour, which may enable clinicians to make informed treatment decisions earlier. Currently, testing CSF for multiple organisms is not always possible because it can be difficult to obtain enough fluid from each patient to run multiple tests. Identification of the cause of bacterial central nervous system infections may sometimes take up to three days using current methods. Testing for viral infections may take even longer because many hospital laboratories do not perform such tests and specimens must then be shipped to specialized laboratories for testing.