concussion

The FDA reviewed a novel blood test, called the Banyan Brain Trauma Indicator, to assist in the evaluation of adults with a suspected concussion.

Mild traumatic brain injury or concussions are the results of a sudden blow to the head or a penetrating head injury that disrupts the brain’s normal functioning. Concussions often result in impaired thinking, memory, movement, sensation, or emotions. Current assessments of concussions involve the use of the 15-point Glasgow Coma Scale, which evaluates neurological function by assessing eye, verbal, and motor responses. In addition, computed tomography (CT) scans are employed to detect brain tissue damage or intracranial lesions.

The majority of patients with concussion symptoms have negative CT scans, which leads to unnecessary radiation exposure and health costs. Health care providers agree that an alternative, blood-testing option, would prevent unnecessary neuroimaging tests, radiation exposure, and health care costs. The United States Food and Drug Administration (FDA) has recently reviewed and approved marketing of a novel concussion blood test, called the Banyan Brain Trauma Indicator, for use within the next six months.

The Brain Trauma Indicator test works by measuring levels of proteins, including UCH-L1 and GFAP, which are released from the brain into the blood after a head injury. A prospective clinical study of 1,947 adults with suspected concussions demonstrated that the blood test predicted the presence of intracranial lesions on a CT scan with a 97.5% accuracy. Additionally, the indicator predicted the absence of a lesion on CT scans with a 99.6% accuracy. The findings demonstrate that the indicator can be employed as a useful tool in optimizing patient care by re-evaluating the necessity of a CT scan.

Written by Haisam Shah, BSc

Reference: FDA authorizes marketing of first blood test to aid in the evaluation of concussion in adults. U.S. Food and Drug Administration News Release. (2018). https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm596531.htm

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