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FDA Permits Marketing of Blood Test for Concussion

FDA news release; 2018 Feb 14

The US Food and Drug Administration (FDA) has permitted marketing of the first blood test to evaluate mild traumatic brain injury (mTBI), commonly referred to as concussion, in adults. The FDA reviewed and authorized for marketing the Banyan Brain Trauma Indicator in <6 months as part of its Breakthrough Devices Program. The FDA is permitting marketing of the Brain Trauma Indicator to Banyan Biomarkers, Inc., with headquarters in San Diego, CA, and Alachua, FL.

Most patients with a suspected head injury are examined using a neurological scale, called the 15-point Glasgow Coma Scale, followed by a computed tomography, or CT scan, of the head to detect brain tissue damage, or intracranial lesions, that may require treatment. However, a majority of patients evaluated for mTBI/concussion do not have detectable intracranial lesions after having a CT scan. Availability of a blood test for concussion will help health care professionals determine the need for a CT scan in patients suspected of having mTBI and help prevent unnecessary neuroimaging and associated radiation exposure to patients.


US Food and Drug Administration. FDA authorizes marketing of first blood test to aid in the evaluation of concussion in adults. FDA Web site. February 14, 2018. Accessed February 14, 2018.