First Concussion-Detecting Blood Test Approved by the FDA
The U.S. Food and Drug Administration has now approved a blood test that can quickly and reliably detect signs of a concussion.
The Brain Trauma Indicator, marketed by Banyan Biomarkers Inc., measures the levels of two proteins — called UCH-L1 and GFAP — whose elevated presence suggests a certain type of brain damage normally only visible on a CT scan. Test results currently can be available within three to four hours.
Concussion-related brain damage has become a particularly worrisome public health issue in many sports, especially football, affecting the ranks of professional athletes on down to the young children in Pop Warner leagues. Those concerns have escalated so far that it has led to a decline in children participating in tackle sports.
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.In a large prospective study of 1947 individual blood samples from adults suspected of having mTBI/concussion, the Brain Trauma Indicator was able to predict the presence of intracranial lesions on CT 97.5% of the time and the absence of intracranial lesions on CT 99.6% of the time.
“Helping to deliver innovative testing technologies that minimize health impacts to patients while still providing accurate and reliable results to inform appropriate evaluation and treatment is an FDA priority. Today’s action supports the FDA’s Initiative to Reduce Unnecessary Radiation Exposure from Medical Imaging—an effort to ensure that each patient is getting the right imaging exam, at the right time, with the right radiation dose,” said FDA Commissioner Scott Gottlieb, M.D. “A blood-testing option for the evaluation of mTBI/concussion not only provides healthcare professionals with a new tool, but also sets the stage for a more modernized standard of care for testing of suspected cases. In addition, availability of a blood test for mTBI/concussion will likely reduce the CT scans performed on patients with concussion each year, potentially saving our health care system the cost of often unnecessary neuroimaging tests.”
