FDA Green Lights Banyan Biomarkers’ First Blood Test to Help Diagnose Concussions

SAN DIEGO--(BUSINESS WIRE)-- Banyan Biomarkers, 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 BTI^TM (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

“The impact of traumatic brain injuries is felt within each branch of the service and throughout the Department of Defense, and were even considered the ‘signature wound’ from recent conflicts,” said Lt. Col. Kara Schmid, Project Manager for the Neurotrauma and Psychological Health Project Management Office for the U.S. Army Medical Materiel Development Activity. “Finding solutions for the diagnosis and evaluation of mild TBI has been a top priority for over a decade now. Obtaining FDA authorization for the first objective blood-based biomarkers of mild TBI is a huge success for the TBI community. This assay will provide a remarkable capability for the way we evaluate and care for our service members with TBI.”

Currently, the CT scan is routinely used to assist physicians in the evaluation of TBI. However, the use of CT scans is highly variable especially in the face of significant trauma with minimal symptoms. Lacking an approved biomarker to guide decision making, the default for physicians was to obtain a CT scan. More than 90 percent of patients presenting to the emergency department with mild TBI or concussion, have a negative CT scan.

“Brain biomarkers will change the practice of emergency care for mild TBI and will greatly assist a large number of patients. The impact will be improved medical care by reducing radiation exposure to the patient and improving efficiency in the emergency department,” stated Andy Jagoda, MD, Professor and Chair in the Department of Emergency Medicine at the Icahn School of Medicine at Mount Sinai.

The FDA granting of the De Novo request for Banyan BTI also creates a classification regulation for devices of this type and permits this diagnostic test to serve as a predicate device. The FDA granting was supported by a prospective multi-center pivotal study. The study called ALERT-TBI, enrolled 2,011 patients at 24 independent clinical sites in the United States and European Union and compared the test’s results to head CT scans of patients presenting to emergency departments with suspected head injury. The study showed that Banyan BTI achieved high sensitivity and high NPV (negative predictive value) for ruling out the need for a head CT scan and provides objective data for healthcare providers to aid in the evaluation of patients with suspected TBI. The company is engaged in additional studies to determine if the biomarkers have applications in monitoring recovery after injury as well as their application in other degenerative conditions of the brain.

The development of Banyan BTI^TM was supported by the U.S. Army Medical Research and Materiel Command under Contract No. W81XWH-10-C-0251. Any views, opinions, conclusions, and/or findings contained in this press release are those of Banyan Biomarkers, Inc. and should not be construed as an official Department of the Army position, policy, or decision, unless so designated by other documentation.

¹ CDC https://www.cdc.gov/traumaticbraininjury/severe.html
² CDC www.cdc.gov/traumaticbraininjury/get_the_facts.html

About Banyan Biomarkers

Banyan Biomarkers, Inc. has developed the first blood test, Banyan BTI™, that can be used by physicians to objectively aid in the evaluation of patients with suspected traumatic brain injury (TBI), also known as concussions. Banyan BTI consists of two test kits (Banyan UCH-L1^® Kit and Banyan GFAP^® Kit) that measure two specific protein biomarkers that rapidly appear in the blood after a brain injury. To learn more about the Company and Banyan BTI, visit www.banyanbio.com.

Banyan Biomarkers, Banyan, Brain Trauma Indicator, BTI, Banyan UCH-L1, Banyan GFAP, and the brain and tree logos are the trademarks and copyrights of Banyan Biomarkers, Inc.

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