FDA Approves First Objective Blood Test for Concussion Evaluation

The U.S. Food and Drug Administration (FDA) recently approved the first blood test to evaluate concussions in adults. The Banyan Brain Trauma Indicator (Banyan Biomarkers; Alachua, Fla.) improves upon current diagnosis by introducing an objective measurement for diagnosis of mild traumatic brain injury and potentially cuts back on the number of unnecessary CT scans and related radiation exposure.

Current practice uses a 15-point neurological scale, called the Glasgow Coma Scale, followed by CT scans of the head to assess damage to brain tissue. However, Banyan Biomarkers says that the vast majority — more than 90 percent — of patients presenting to the emergency department with suspected concussion have a negative CT scan.

“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., in a statement. The “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.”

The Banyan Brain Trauma Indicator is a novel enzyme linked immunosorbent assay that assesses two brain-specific protein biomarkers — Ubiquitin Carboxy-terminal Hydrolase-L1 (UCH-L1) and Glial Fibrilliary Acidic Protein (GFAP). These markers are released from the brain into blood and measured within 12 hours of head injury. Test results are within 3 to 4 hours.

The FDA approval was based on a trial that compared blood samples from 1,947 from adults with suspected concussion to CT scan results. The Brain Trauma Indicator was able to predict the presence of intracranial lesions on a CT scan 97.5 percent of the time and identify those who did not have intracranial lesions on a CT scan 99.6 percent of the time.

The test was developed with support from the U.S. Department of Defense with the intent that the test be used both in the United States, as well as in foreign U.S. laboratories that service the American military. The test received rapid review through the FDA’s Breakthrough Devices Program, but required the De Novo premarket review pathway, for novel low- to moderate-risk devices unlike any prior legally marketed device.

Takeaway: This approval marks a breakthrough for advancing the objective diagnosis of concussion.