SAN DIEGO--(BUSINESS WIRE)--Banyan Biomarkers, Inc., a pioneer in developing biomarkers for traumatic brain injury (TBI), today announced that the U.S. Food and Drug Administration (FDA) has granted the De Novo request for the commercialization of Banyan BTITM (Brain Trauma Indicator), an in vitro diagnostic blood test to aid in the evaluation of patients with suspected TBI, also known as concussion. The FDA, in keeping with its commitment to address urgent medical concern of brain injuries, reviewed the test under the Breakthrough Devices Program, which is intended to facilitate the development and expedite the review of innovative breakthrough technologies. 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, providing objective information to assess patients with suspected mild TBI. The goal of the study was to identify patients with head trauma who could safely forego the need for a CT scan thereby avoiding unnecessary radiation to the brain and reduce costs of care.

“With extensive clinical research and scientific validation, Banyan BTI has shown that these two specific protein biomarkers, which are released from the brain and circulate in the blood after a brain injury, can provide objective data to healthcare providers when evaluating patients with a traumatic brain injury,” said Henry L. Nordhoff, Chairman and CEO of Banyan Biomarkers. “Receiving marketing authorization from the FDA for the first blood test for TBI is a significant milestone that will transform how brain injury is managed. We are honored to have as our partner, the U.S. Department of Defense and the U.S. Army Medical Research and Materiel Command, for supporting the research and development of a diagnostic test that now provides objective quantifiable information to physicians, to eliminate unnecessary CT scans, and guide patient care.”

Automobile accidents, falls, sports-related injuries, assaults, and, in the military, improvised explosive devices (IEDs) and combat wounds are common causes of TBI. The U.S. Center for Disease Control estimates there are more than 2.5 million emergency room visits in the United States as a result of head injuries and TBI is an economic burden of more than $76 billion annually on the healthcare system.1 Traumatic brain injury is the leading cause of disability and the number one cause of death for young adults.2

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