For the first time in the U.S., a blood test will be available to help doctors determine if people who’ve experienced a blow to the head could have a traumatic brain injury such as brain bleeding or bruising.
Until this point, physicians have relied on subjective markers – mainly patient-reported symptoms such as headaches, nausea, or light sensitivity – to make an educated “guess” on which individuals have brain trauma and require a head CT scan. Particularly among athletes who may hide symptoms in order to keep playing, a subjective assessment is not always reliable. The new test provides an objective indicator of injury that can potentially be obtained quickly and easily in busy emergency departments.
In February 2018, the U.S. Food and Drug Administration approved the test as part of a fast track program to get breakthrough technologies to patients more quickly. Called the Banyan Brain Trauma Indicator®, the test aids in the evaluation of patients with a suspected traumatic brain injury or concussion, also known as a mild traumatic brain injury.
Today, the major study that led to approval of the test was published in The Lancet Neurology. The clinical trial included close to 2,000 individuals presenting with a head injury to 22 emergency departments in the U.S. and Europe. Banyan Biomarkers, Inc., the company that developed the test, is working with its commercial partners to make the test available in hospitals and emergency departments.
“Many concussion patients don’t seek medical care for their injury, a decision due in part to the perception that emergency departments have nothing to offer in terms of diagnosis,” said lead study author Jeffrey J. Bazarian, M.D., M.P.H., professor of Emergency Medicine at the University of Rochester Medical Center. “The results of this study show that we now have something to offer—a brain biomarker blood test. The ability of this test to predict traumatic injuries on head CT scan will soon allow emergency physicians to provide patients with an unbiased report on the status of their brain.”