“Food and Drug Administration authorizes marketing of first blood test to aid in the evaluation of concussion in adults,” read the headline on the FDA’s website this Valentine’s Day. On a day that promotes love and caring, the FDA announced approval for the use of the BTI (Brain Trauma Indicator), a blood test that can provide earlier detection of mTBI/concussions and, therefore, provide early caring and treatment for the patient.
The BTI is a product of the Breakthrough Devices Program of the 21st Century Cures Act. The research that developed into this product was completed by Banyan Biomarkers, Inc., in partnership with the U.S. Department of Defense and the U.S. Army Medical Research and Materiel Command. Specifically, “Banyan BTI identifies two brain-specific protein biomarkers (Ubiquitin Carboxy-terminal Hydrolase-L1 or UCH-L1 and Glial Fibrilliary Acidic Protein or GFAP) that rapidly appear in the blood after a brain injury.” A clinical study of the product, in which about 2,000 adults were tested, had over a 97% success rate.
The Banyan Indicator also has an additional benefit: reduced radiation exposure. The FDA states that, “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… [a] priority.” As testing is now, patients undergo an evaluation on a neurological scale (Glasgow Coma Scale), followed by a CT scan. However, even the FDA acknowledges that “there are both benefits and risks associated with the use of CT.” Beyond the reported risk of cancer through CT scans, under rare circumstances they can cause such effects as skin erythema (reddening), skin tissue injury, and birth defects following in-utero exposure. (More so, a CT scan can sometimes show no brain dysfunction when TBI is present.)
The BTI is not without concerns. Could there be false positives or negatives? What will it cost, especially compared to a CT scan? However, these are similar to the concerns given to all medical equipment and medications. A quick and easy evaluation and diagnosis of a brain injury, through only a blood test, would be beneficial for patients and doctors’ alike.