Breakthrough for Traumatic Brain Injury
DOD Finds Success with First Blood-test for Traumatic Brain Injury

News release:

Point of Contact:
Carey Phillips
Public Affairs Specialist
U.S. Army Medical Materiel Development Activity
(301) 619-7056
E-mail: carey.a.phillips2.civ@mail.mil

FOR IMMEDIATE RELEASE

FORT DETRICK, Md. – The U.S. Army Medical Materiel Development Activity today announced the U.S. Food and Drug Administration has approved Banyan Biomarkers to market their BTI™ brain trauma indicator assay.

Finding a solution for the diagnosis and evaluation of mild traumatic brain injury in our wounded Service Members has been a top priority for the Department of Defense for well over a decade now. According to the Defense and Veterans Brain Injury Center, over 375,000 Service Members have been diagnosed with TBI since 2000. Approximately 82 percent of those TBI cases are classified as mild TBI or a concussion. Not only can Service Members experience a TBI from combat injuries, but they can also occur from everyday activities like sporting events or training accidents.

"Getting approval for this assay is a monumental success for the TBI community," said Army Lt. Col. Kara Schmid, project manager for the Neurotrauma and Psychological Health Project Management Office at the USAMMDA. "There are blood tests for many diseases on the market, but this is the first one dedicated to traumatic brain injury. For the first time, medical personnel won’t have to rely only on a description of the incident and symptoms, but will have access to an objective marker of injury to the brain, all from a simple blood test."

This is the first FDA-authorized blood test for TBI and concussions. After an injury, the assay can identify two brain-specific protein markers that rapidly appear in the blood. Medical professionals can use this objective information to evaluate patients with suspected mild TBI, potentially reducing the need for CT scans.

"Currently, when a Service Member has a suspected mild TBI, they are assessed with a battery of objective and subjective questions and tests known as the Military Acute Concussion Evaluation. Better known as the MACE, this evaluation is part of a larger clinical practice guideline, which also contains clinical indicators that a medic or corpsman will assess to determine if the brain injury is more severe," said Army Col. Sidney Hinds, DOD Brain Health Research Program coordinator.

"However, in combat or austere environments in which transportation to definitive care may be prolonged, innovative technology to objectify more accurately the patient’s TBI status has been seen as a knowledge gap," said Hinds. "Determining whether or not a Service Member needs a CT scan to exclude intracranial hemorrhage or other ominous finding is a key military medical necessity."

"When we started this development effort, many people were skeptical that you could find brain proteins in the blood after a head injury, especially in those classified as mild TBI. This breakthrough is a testament to the hard work, dedication and determination of many people, over many years, working together from academia, industry and the DOD," said Schmid. "This test will open the doors to what blood based biomarkers can do for the evaluation of TBI. This test holds promise to change the practice of medicine for brain injury. We are very excited to bring this type of capability to the Service Members and the TBI community."

This effort started as an idea between scientists at the University of Florida and the Walter Reed Army Institute of Research. Since then, the effort has grown to include partnerships with industry, academia and the DOD to develop a product out of a spark of innovation. This effort has been funded by the U.S. Army and the Defense Health Program.

The U.S. Army Medical Research and Materiel Command partnered with Banyan Biomarkers, Inc., to find a solution to diagnose and evaluate mild TBI in Service Members. The Banyan BTI™ was reviewed by the FDA under the Breakthrough Device Program. The De Novo approval permits commercialization of the Banyan BTI™.

About USAMMDA
USAMMDA is the DOD's advanced development activity for products designed to protect and preserve the lives of Warfighters. USAMMDA develops new drugs, vaccines and medical support equipment that enhance readiness, ensures the provision of the highest quality medical care to the DOD and maximizes survival of medical casualties on the battlefield.