Traumatic Brain Injury Biomarkers Point to Recovery
U.S. Army Medical Materiel Development Activity
Press Release — FOR IMMEDIATE RELEASE
FORT DETRICK, MD – In January 2021, the FDA cleared Abbott's i-STAT™ TBI Plasma test for patients suspected of having a mild traumatic brain injury. This first-ever TBI blood test on a deployable device measures the protein biomarkers glial fibrillary acidic protein (GFAP) and ubiquitin carboxyl-terminal hydrolase L1 (UCH-L1) that appear in the bloodstream soon after a brain injury. The blood test is currently in clinical implementation and operational assessments at Army deployed units as well as medical treatment facilities. The Analyzer Traumatic Brain Injury (ATBI) Program is assessing the degree to which the i-STAT™ TBI test may avoid unnecessary evacuations and computed tomography (CT) scans.
Now, in a study published in The Lancet Neurology (https://www.thelancet.com/journals/laneur/article/PIIS1474-4422(22)00256-3/fulltext), researchers from the Transforming Research and Clinical Knowledge in TBI (TRACK-TBI) Network, a consortium of 18 Level I trauma centers throughout the U.S., have demonstrated that levels of GFAP and UCH-L1 may also predict the longer-term (6-month) course of recovery and functional outcome of TBI.
“A rapid TBI blood test that indicates prognosis for recovery could be a powerful triage tool for clinicians to manage the more severely injured head trauma patients, particularly in a deployed environment where evacuations are limited,” said Lt. Col. Stuart Hobbs, Product Manager for the ATBI Program that is developing the TBI plasma and whole blood assays for military use.
Additionally, this TBI blood test offers another research tool to identify and follow biomarker levels in patients with evidence of bleeding in the brain as they receive investigative drug treatments for TBI as part of the Traumatic Brain Injury Drug Therapy (TBI-DT) development effort. The blood biomarkers will be used on the i-STAT™ Alinity™ as well as on the Alinity i core laboratory instrument.
“These tools are intended to help Warfighters receive the care they need in a timely manner, and aid in clinical decisions, but currently there are no FDA approved drugs specifically for treatment of TBI,” said Dr. Krista Caudle, TBI-DT Product Manager. This new study adds to our confidence that these biomarkers will have utility for predicting which patients may benefit most from a given therapeutic approach.
The drug trials are led by The University of California at San Francisco, with TRACK-TBI Network clinical sites, and a public-private partnership with Abbott.
About US Army Medical Materiel Development Activity
The TBI blood biomarkers were developed with continued support from the U.S. Army Medical Research and Development Command (USAMRDC), and managed by the U.S. Army Medical Materiel Development Activity's (USAMMDA's) Warfighter Brain Health (WBH) Project Management Office.
The USAMMDA is a subordinate command of the U.S. Army Medical Research and Development Command, under the Army Futures Command. As the premier developer of world-class military medical capabilities, USAMMDA is responsible for developing and delivering critical products designed to protect and preserve the lives of Warfighters across the globe. These products include drugs, vaccines, biologics, devices and medical support equipment intended to maximize survival of casualties on the battlefield.