New Test Finds CNS Infections Fast

FilmArray Meningitis/Encephalitis Panel, from BioFire Diagnostics, received FDA marketing approval

/ Author:  / Reviewed by: Jennifer Gershman, PharmD, CPh

(RxWiki News) A new test for meningitis and encephalitis could bring the time needed for results down from three days to one hour.

The FilmArray Meningitis/Encephalitis (ME) Panel, approved for marketing Thursday by the US Food and Drug Administration (FDA), uses a small sample of cerebrospinal fluid (CSF) to look for meningitis and encephalitis. This new test, from BioFire Diagnostics L.L.C. in Salt Lake City, looks for 14 pathogens that can indicate these two conditions, according to the FDA.

Testing for multiple pathogens at one time could help doctors make diagnoses sooner than they can with current testing methods, which can take up to three days to bring results. The FilmArray ME Panel could give results in about an hour.

“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,” said Alberto Gutierrez, director of the Office of In Vitro Diagnostics and Radiological Health at the FDA’s Center for Devices and Radiological Health, in a press release.

Meningitis and encephalitis are potentially deadly infections of the membranes near the brain and spinal cord. Yeast, bacterial, and viral pathogens can cause these conditions. Fast treatment is critical.

The FDA noted that the FilmArray ME Panel "does not detect all causes of central nervous system infections or provide information about which antimicrobial drugs may be most effective for treating bacterial infections."

The FDA assessed the effectiveness of this new test with the CSF samples of more than 1,500 patients showing symptoms of meningitis or encephalitis. The FilmArray ME Panel's accuracy was on par with current testing methods. Two smaller studies showed similar results.

Review Date: 
October 9, 2015
Last Updated:
October 12, 2015