The US Food and Drug Administration (FDA) approved a blood test in February for two biomarkers associated with bleeding after TBI; the test is intended to identify patients who do not need to undergo imaging for intracranial lesions. If performed within 12 hours of injury, the test is almost 100 percent accurate, the FDA said in its February 14 announcement. The assay was approved in less than six months under the FDA Breakthrough Devices Program, in part to help prevent unnecessary radiation exposure. The Brain Trauma Indicator was developed by Banyan Biomarkers, Inc., in partnership with the Department of Defense. It measures levels of two proteins — glial fibrillary acidic protein (GFAP) and ubiquitin C-terminal hydrolase-L1(UCH-L1) — both of which are released into the bloodstream after head trauma.
Approval was based on results from the prospective, multicenter ALERT-TBI clinical trial. The study enrolled patients at 24 clinical sites and compared the test’s results to head CT scans. The FDA evaluated data on 1,947 individual blood samples from adults with suspected mTBI/concussion, comparing tests results with CT findings. The test predicted patients with intracranial lesions (positive predictive evidence) with 97.5 percent accuracy, and patients without lesions (negative predictive evidence) 99.6 percent of the time. Test results were available within three to four hours.