CLN Article

FDA Authorizes First Blood Test to Aid in Evaluating Concussions

Regulatory Roundup: April 2018

The Food and Drug Administration (FDA) has permitted marketing of Banyan Biomarkers’ Brain Trauma Indicator, the first blood test to evaluate the severity of mild traumatic brain injury (mTBI) in adults. Most patients with a suspected head injury are examined using a neurological scale followed by a computed tomography (CT) scan of the head to detect intracranial lesions that may require treatment such as neurosurgical intervention. However, a majority of patients evaluated for mTBI do not have CT-detectable intracranial lesions. Banyan Biomarkers’ test will help healthcare professionals determine the need for CT scanning in patients suspected of having mTBI, thereby helping protect patients from unnecessary neuroimaging and radiation exposure. However, the test is not intended to diagnose or rule out concussions.

The Brain Trauma Indicator works by measuring within 12 hours of head injury proteins known as UCH-L1 and GFAP that are released from the brain into the bloodstream. Blood levels of these proteins after mTBI help predict which patients might or might not have intracranial lesions visible by CT scan. Test results are available within 3 to 4 hours. FDA reviewed and authorized this test for marketing in less than 6 months as part of its Breakthrough Devices Program. The agency evaluated the test by comparing its results with CT scan results for 1,947 individual blood samples from adults with suspected mTBI. The Brain Trauma Indicator predicted the presence and the absence of intracranial lesions on a CT scan 97.5% and 99.6% of the time, respectively.