FDA Approves First Blood Test to Evaluate Potential Concussions
WEDNESDAY, Feb. 14, 2018 -- The first blood test designed to help health care professionals evaluate mild traumatic brain injury has been approved by the U.S. Food and Drug Administration.
The new test -- called the Brain Trauma Indicator -- measures levels of UCH-L1 and GFAP proteins that are released from the brain into the blood within 12 hours of a head injury. Results, available within four hours, can help health care professionals determine the need for a computed tomography scan.
The test was evaluated in a multi-center study of 1,947 individual blood samples from adults with suspected concussions. The test correctly predicted the presence of intracranial lesions 97.5 percent of the time, the FDA said.
"Today's action supports the FDA's Initiative to Reduce Unnecessary Radiation Exposure from Medical Imaging -- an effort to ensure that each patient is getting the right imaging exam, at the right time, with the right radiation dose," FDA Commissioner Scott Gottlieb, M.D., said in an agency news release. "A blood-testing option for the evaluation of mild traumatic brain injury/concussion not only provides health care professionals with a new tool, but also sets the stage for a more modernized standard of care for testing of suspected cases."
The test is produced by Banyan Biomarkers Inc., in Alachua, Fla.
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Posted: February 2018