The first blood test to help doctors diagnose traumatic brain injuries has won US government approval.
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.