The FilmArray Meningitis/Encephalitis (ME) Panel tests CSF for various pathogens — like bacteria, viruses, or yeast — in patients at risk of meningitis or encephalitis. According to the FDA, which made the announcement yesterday on its website, FilmArray is designed to be used as a diagnostic tool in conjunction with other clinical and laboratory tools.

The test claims to be able to identify 16 targets with 200 µl of CSF and with only 2 minutes of hands-on time. Within an hour, it can produce results, “which may enable clinicians to make informed treatment decisions earlier” for a population that needs to be treated quickly, according to the FDA.

“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, who works in diagnostics at the Center for Devices and Radiological Health at the FDA.

According to the drug agency, the bacterial and yeast pathogens that are identifiable by the test include Escherichia coli K1, Haemophilus influenzae, Listeria monocytogenes, Neisseria meningitidis, Streptococcus agalactiae, Streptococcus pneumoniae, and Cryptococcus neoformans/gattii. And identifiable viruses include Cytomegalovirus, Enterovirus, Herpes simplex virus 1, Herpes simplex virus 2, Human herpesvirus 6, Human parechovirus, and Varicella zoster virus.

But the FDA added that the FilmArray Panel is limited in that it doesn’t detect all the causes of an infection, and it doesn’t note which antimicrobial drugs should be used to treat the infection.

“Physicians should continue to perform standard CSF bacterial and fungal cultures in conjunction with the FilmArray ME Panel because false negative and false positive results are possible with the FilmArray ME Panel, and bacterial growth is needed for drug susceptibility testing when results are positive,” they added. “False negative results could potentially occur when the concentration of organisms in the CSF specimen is below the limit of detection for the FilmArray ME Panel.”

The permission to market was granted by the de novo classification process, which the FDA uses for devices that have a low to medium risk and are different from any other products on the market. The drug agency analyzed data from a trial in which CSF samples were taken from more than 1,500 patients and the FilmArray ME Panel was used in conjunction with other methods. In addition, two separate studies looked at clinical CSF samples that had already been determined to contain microorganisms or bacteria and viruses.

“Study results demonstrated high agreement between the FilmArray ME Panel, comparator methods and expected results,” wrote the FDA.

FilmArray also has a respiratory panel that can be used to detect bacteria.

The FilmArray ME Panel is manufactured by BioFire Diagnostics, in Salt Lake City, Utah.