A new type of blood test is being used to detect mild traumatic brain injury, Army researchers have announced.
It is the first blood test for use in evaluating mild TBI to be approved by the U.S. Food and Drug Administration, according to a Feb. 14 release from the Army Medical Materiel Development Activity.
“There are blood tests for many diseases on the market, but this is the first one dedicated to traumatic brain injury,” said Army Lt. Col. Kara Schmid, project manager for the Neurotrauma and Psychological Health Project Management Office at the USAMMDA at Fort Detrick, Maryland.
“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,” Schmid said. “This test holds promise to change the practice of medicine for brain injury.”
The goal is to have the blood test ready for fielding to the force in the next year to 18 months, Schmid told Military Times.
The blood test can help fill a critical need to quickly evaluate injured troops in remote locations, where there is a “knowledge gap” in assessing how severe the injury is, said Army Col. Sidney Hinds, coordinator of the DoD Brain Health Research Program.
The Defense Department has been working for more than a decade to find ways to diagnose and evaluate TBI in service members. TBI has been called the signature wound of the recent wars, with more than 375,000 cases diagnosed since 2000. More than four in five of those cases are considered to be mild TBI.
Of the 375,230 TBI cases, the Army has had 220,014 cases, with 50,937 in the Navy, 50,995 in the Air Force and 53,284 in the Marine Corps, according to DoD records.
The new blood test works by identifying two protein markers that are specific to the brain. After an injury, these rapidly appear in the blood. Medical professionals can then evaluate the patient and assess whether the patient needs a CT scan and other treatment.
Limited user testing will be done at three military treatment facilities in this fall, while two more configurations of the product are in development,Schmid said.
The current version of the analytical tool, also referred to as an assay, can be used in military hospitals with clinical laboratories. Deployed units would see future versions that are in the works for combat support hospitals and, potentially, battalion aid stations, Schmid said.
“We are currently developing a configuration of the assay that could be supported, logistically, at the point of injury,” Schmid said.
However, she added, decisions to deploy it will depend on several factors including approved uses for it, and what providers are available to use it at the point of injury.
The U.S. Army Medical Research and Materiel Command worked with Banyan Biomarkers, Inc. to develop the technology, and Banyan Biomarkers received FDA approval to market the brain trauma indicator, or BTI. The effort has also included scientists at the Walter Reed Army Institute of Research, the University of Florida and partnerships with industry and academia.
“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,” Schmid said. “This test will open the doors to what blood based biomarkers can do for the evaluation of TBI.”