Yesterday FDA announced that it would be permitting the marketing of the Banyan Brain Trauma Indicator, the first blood test to evaluate mild traumatic brain injury (mTBI) in adults. The test was developed as a result of a partnership between bioMerieux and Banyan Biomarkers last year, and the agency’s swift review and authorization happened in less than six months, thanks to its Breakthrough Devices Program.
“The FDA’s review team worked closely with the test developer and the U.S. Department of Defense to expedite a blood test for the evaluation of mTBI that can be used both in the continental U.S. as well as foreign U.S. laboratories that service the American military.” – Jeff Shuren, M.D., CDRH
The test measures levels of UCH-L1 and GFAP, proteins that the brain releases into the blood, measuring them within 12 hours of head injury. According to FDA, the levels of these proteins following an mTBI or concussion might help indicate which patients have intracranial lesions that will be visible by a CT scan. The current standard of care in treating patients with a suspected head injury is to use the 15-point Glasgow Coma scale, which is followed by a CT scan of the head. In just three to four hours, the Brain Trauma Indicator provides results that may help prevent patients from undergoing unnecessary neuroimaging and resulting radiation exposure.