The U.S. Food and Drug Administration has announced approval of Banyan Biomarkers, Inc.’s Banyan BTI (Brain Trauma Indicator) under the FDA’s De Novo premarket review pathway. According to the press release, Banyan BTI is the first in vitro diagnostic blood test for the evaluation of mild traumatic brain injuries (mTBI), commonly referred to as concussions, authorized for marketing by the FDA.

According to Banyan Biomarkers, more than 90 percent of patients presenting to the emergency department with mTBI receive a negative CT scan. Banyan BTI purports to identify two brain-specific protein biomarkers that rapidly appear in the blood after a brain injury, providing information to assess patients with suspected mTBI. According to the FDA, availability of a blood test for concussions will help health care professionals determine the need for a CT scan in patients suspected of having mTBI and help prevent unnecessary neuroimaging and associated radiation exposure to patients.

With respect to approval of Banyan BTI, FDA Commissioner Scott Gottlieb, M.D. stated:

“A blood-testing option for the evaluation of mTBI/concussion not only provides health care 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.”