FDA clears 1st nucleic acid-based test for central nervous system infections for marketing

Spine

The FDA has approved marketing for the first "cerebrospinal fluid nucleic acid-based test for simultaneous detection of multiple pathogens that can cause central nervous system infections," according to HHS.

Called the FilmArray Meningitis/Encephalitis Panel, the fluid is intended to test for 14 bacterial, viral and yeast pathogens with a CSF sample. The test should be able to yield results in an hour.

 

The FDA emphasizes this test is not a replacement for standard CSF bacterial and fungal cultures, but rather an addition.

 

BioFire Diagnostics in Salt Lake City manufactures the FilmArray ME Panel.

 

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