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Clarity of Purpose: FDA-Approved mTBI Blood Test

Mar 07, 2018

The U.S. Food and Drug Administration (FDA) recently approved a blood test, known as the Brain Trauma Indicator (BTI). The blood test measures levels of proteins, known as UCH-L1 and GFAP, that are released from the brain into blood within 12 hours of a head injury. The protein levels help indicate if a patient has bleeding in or around the brain that can be detected on a computed tomography (CT) scan.

As experts in evaluating and treating patients with traumatic brain injuries (TBI), physiatrists see the potential value of this test. However, it is the position of the American Academy of Physical Medicine and Rehabilitation (AAPM&R) that the test should not be considered a diagnostic tool for concussion, including sport concussion.  While concussion may result in neuropathological changes, the acute signs and symptoms largely reflect a functional disturbance rather than a structural injury and as such, standard radiologic imaging studies, including CT scans, are normal in patients with a concussion[i]. Clinical diagnosis of a concussion requires evaluation by a medical professional, such as a physiatrist, with expertise in concussion. In more severe brain injuries where bleeding in or around the brain is suspected, the BTI can be used by health care professionals to help determine if a CT scan is necessary. While the test may inform a healthcare provider’s decision to perform a CT scan, it is not designed to diagnose a concussion.

The test only applies to the adult population, and must be utilized within 12 hours of a head injury, and takes approximately 3 to 4 hours for results to be available. The test has not been adequately tested in the pediatric population, a population of particular concern in concussion management. It is likely that the value of this test will be realized with use in rural areas where imaging may be unavailable or in military field evaluations.

The FDA is permitting marketing of the Brain Trauma Indicator to Banyan Biomarkers, Inc.

About AAPM&R

The American Academy of Physical Medicine and Rehabilitation (AAPM&R) is the national medical specialty organization representing more than 9,000 physicians who are specialists in physical medicine and rehabilitation (PM&R). PM&R physicians, also known as physiatrists, treat a wide variety of medical conditions affecting the brain, spinal cord, nerves, bones, joints, ligaments, muscles, and tendons. Physiatrists utilize cutting‐edge as well as time‐tested treatments to maximize function and quality of life.


[i] McCrory P, Meeuwisse W, Dvořák J, et al Consensus statement on concussion in sport – the 5th international conference on concussion in sport held in Berlin, October 2016. Br J Sports Med 2017;51:838-847.