The FDA has approved the first blood test that helps doctors diagnose traumatic brain injuries in the U.S. Banyan Biomarkers, the test’s maker, can commercialize its test and the approval now gives the company an inside track on the goal to find a better way to diagnose concussions.
The test doesn’t detect concussions and it won’t immediately change how patients with concussions are treated, but experts in the field hope it accelerates the development of such tests and technology.
The procedure detects proteins that are present in brain cells that leak into the bloodstream following injuries to the head. The company says the test can detect those proteins within 12 hours of trauma. It’s designed to help doctors determine which patients may have brain bleeding or other injury.
Patients who test positive on the test would then have a CT scan performed to confirm the results and to determine if additional treatment is needed. The test will first be used in emergency rooms but the company’s hope is that it will eventually be used on the football field as well as the battlefield.
The test “sets the stage for a more modernized standard of care for testing of suspected cases,” FDA Commissioner Dr. Scott Gottlieb said in a statement.
The ultimate goal, according to experts in the field, is to develop a blood test that could detect concussions and brain injuries, similar to blood tests that hospitals currently use to detect heart attacks.