CHICAGO — The first blood test to help doctors diagnose traumatic brain injuries has won U.S. government approval.
After deliberations that took less than six months, the FDA approved the marketing of the Banyan Brain Trauma Indicator to aid the evaluation of concussions in adults.
The move means Banyan Biomarkers can commercialize its test, giving the company an early lead in the biotech industry's race to find a way to diagnose concussions.
The test doesn't detect concussions and the approval won't immediately change how patients with suspected concussions or other brain trauma are treated. But Wednesday's green light by the Food and Drug Administration "is a big deal because then it opens the door and accelerates technology," said Michael McCrea, a brain injury expert at Medical College of Wisconsin.
The test detects two proteins present in brain cells that can leak into the bloodstream following a blow to the head. Banyan's research shows the test can detect them within 12 hours of injury. It's designed to help doctors quickly determine which patients with suspected concussions may have brain bleeding or other brain injury.
Patients with a positive test would need a CT scan to confirm the results and determine if surgery or other treatment is needed. The test will first be used in emergency rooms, possibly as soon as later this year, but Banyan's hope is that it will eventually be used on battlefields and football fields.
FDA Commissioner Dr. Scott Gottlieb said the test fits with the agency's goals for delivering new technologies to patients and reducing unnecessary radiation exposure.
The test "sets the stage for a more modernized standard of care for testing of suspected cases," Gottlieb said in a statement.