Cerebrospinal fluid test for detecting multiple pathogens gains FDA allowance

The FDA recently allowed marketing of the first cerebrospinal fluid nucleic acid-based panel for concurrent detection of multiple pathogens responsible for central nervous system infections.

The FilmArray Meningitis/Encephalitis Panel, manufactured by BioFire Diagnostics, tests cerebrospinal fluid (CSF) specimens from patients with symptoms of meningitis or encephalitis. The panel is intended as a diagnostic aid for these diseases when used in combination with clinical and laboratory data.

The FDA’s de novo classification process reviewed the panel, and test efficacy was determined through a prospective study of cerebrospinal fluid specimens from 1,560 patients with suspected meningitis/encephalitis. The FDA said it evaluated two additional studies with 575 samples, and results showed that the panel worked effectively when compared with other methods and expected results.

“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, PhD, director of the office of in vitro diagnostics and radiological health at the FDA’s Center for Devices and Radiological Health, said in a press release.

According to the release, the FilmArray ME Panel cannot determine all causes of central nervous system infections. It also is incapable of determining which antimicrobial drugs to prescribe for optimal treatment.