FDA Approves Blood Test to Assess Concussion
The Brain Trauma Indicator blood test was approved by the FDA to evaluate mild TBI.
The Food and Drug Administration (FDA) has approved the Brain Trauma Indicator (Banyan Biomarkers), the first blood test to evaluate mild traumatic brain injury (mTBI) in adults.
Currently computed tomography (CT) scan is used routinely in the evaluation of TBI, however, a majority of patients evaluated for mTBI do not have detectable intracranial lesions after having the scan. The Brain Trauma Indicator works by measuring Ubiquitin Carboxy-terminal Hydrolase-L1 (UCH-L1) and Glial Fibrilliary Acidic Protein (GFA) within 12 hours of head injury; these two brain-specific protein biomarkers rapidly appear in the blood after a brain injury. Blood levels of these biomarkers can help predict which patients may have detectable intracranial lesions and whether a CT needs to be performed; test results are available within 3 to 4 hours.
The FDA's marketing authorization was supported by data from a multi-center, prospective clinical study involving 1947 blood samples from adults with suspected mTBI/concussion. The FDA reviewed the product's performance by comparing blood test results with CT scan results. The Brain Trauma Indicator was able to predict the presence of intracranial lesions on a CT scan 97.5% of the time and those who did not have visual lesions on a CT scan 99.6% of the time. The data supported use of this tool into routine care for ruling out the need for a CT scan in at least one-third of patients with suspected mTBI.
FDA Commissioner Scott Gottlieb, MD, stated, “A blood-testing option for the evaluation of mTBI/concussion not only provides healthcare professionals with a new tool, but also sets the stage for a more modernized standard of care for testing of suspected cases. In addition, availability of a blood test for mTBI/concussion will likely reduce the CT scans performed on patients with concussion each year, potentially saving our healthcare system the cost of often unnecessary neuroimaging tests.”
FDA authorizes marketing of first blood test to aid in the evaluation of concussion in adults [press release]. Silver Spring, MD: US FDA. Published February 14, 2018. Accessed February 16, 2018.