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

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.

Advertisement

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.

 

More articles on spine:
CNS past president Dr. Nathan Selden joins Cerebrotech’s scientific advisory board: 5 key notes
Drs. Joseph Zabramski, William Hunter & more: 12 spine surgeons in the headlines this week
Where non-operative spine specialists fit in the future: What surgeons need to know

At the Becker's 23rd Annual Spine, Orthopedic and Pain Management-Driven ASC + The Future of Spine Conference, taking place June 11-13 in Chicago, spine surgeons, orthopedic leaders and ASC executives will come together to explore minimally invasive techniques, ASC growth strategies and innovations shaping the future of outpatient spine care. Apply for complimentary registration now.

Advertisement

Next Up in Spine

Advertisement

Comments are closed.