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# FDA Authorizes Concussion Blood Test
- URL: https://www.fdaweb.com/fda-authorizes-concussion-blood-test/
- Published: 2018-02-15T12:00:00.000Z
- Updated: 2026-09-14T23:22:53.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5140774

FDA has authorized marketing of the Banyan Biomarkers Banyan Brain Trauma Indicator, a blood test used to evaluate mild traumatic brain injury (concussion). An agency [news release](https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm596531.htm?ref=fdaweb.com) says that most patients with a suspected head injury are examined using a neurological scale (Glasgow Coma Scale) followed by a CT head scan to detect brain tissue damage or intracranial lesions that may require treatment.

“However,” it says, “a majority of patients evaluated for a concussion do not have detectable intracranial lesions after having a CT scan. Availability of a blood test for concussion will help healthcare professionals determine the need for a CT scan in patients suspected of having a mild traumatic brain injury and help prevent unnecessary neuroimaging and associated radiation exposure to patients.”

The indicator works by measuring levels of UCH-L1 and GFAP proteins that are released from the brain into blood and measured within 12 hours of head injury. It can help predict which patients may have intracranial lesions visible by CT scan and which won’t.

FDA says the test was reviewed under the *de novo* premarket review pathway by evaluating data from a multi-center prospective clinical study of 1,947 individual blood samples from adults with suspected concussion and reviewed the product’s performance by comparing the blood test results with CT scan results. The test was able to predict the presence of intracranial lesions on a CT scan 97.5% of the time and predict those who did not have intracranial lesions on a CT scan 99.6% of the time, it says.