Army Announces FDA Clearance of Field-Deployable TBI Blood Test
U.S. Army Medical Materiel Development Activity
Press Release — FOR IMMEDIATE RELEASE
FORT DETRICK, MD – The U.S. Army Medical Materiel Development Activity, in partnership with Abbott, announced the U.S. Food and Drug Administration approval of the Abbott i-STAT™ Alinity™ Traumatic Brain Injury plasma assay, a rapid blood test for TBI on Friday.
Between 2000 and 2019, more than 400,000 Service Members experienced a TBI as a result of combat injuries and training accidents, as well as everyday activities such as sporting events.
Developing a field-deployable solution for the detection and evaluation of TBI among our wounded Service Members serving at home and deployed overseas has been a top priority for the Department of Defense for more than a decade.
"A rapid test for TBI is a critical addition to our downrange capability to care for the brain health of our most important weapon system, the Warfighter, and help maintain a high state of readiness across the Force," said Army Brig. Gen. Michael J. Talley, commanding general for the U.S. Army Medical Research and Development Command and Fort Detrick, Maryland.
The i-STAT Alinity TBI plasma assay can identify two brain-specific protein markers that rapidly appear in the blood following a TBI. This blood test will provide medical professionals with objective markers that indicate injury to the brain, as opposed to relying on subjective descriptions of the injury-causing incident, reduce the need for head Computed Tomography scans.
"A blood-based biomarker laboratory assay (blood test) for TBI will greatly enhance the ability of DOD medical personnel to objectively assess Service Members who have suffered a suspected TBI. The ability to avoid unnecessary evacuations for head CT scans could really impact the efficiency of TBI management," said Dr. Krista Caudle, product manager for USAMMDA's Warfighter Brain Health Project Management Office.
The goal for initial implementation of the laboratory assay is to assist with the management of patients with a suspected TBI, particularly focusing on the areas where Service Members would be required to be evacuated from the operational setting to obtain a CT scan of the head. The overall objective is to have a logistically suitable, whole-blood, point-of-care TBI biomarker test with rapid turnaround time.
"The laboratory assay for TBI product development program is an example of how USAMRDC and private industry can share a common vision and achieve a common goal. Over the years, the program progressed through basic science studies at Walter Reed Army Institute of Research and USAMRDC's Combat Casualty Care Research Program, then into product development and clinical trials in USAMMDA, and ultimately U.S. FDA clearance," said Caudle.
In 2002, the Congressionally Directed Medical Research Program's Peer Reviewed Medical Research Program funded a grant for pivotal research on blood-based biomarkers for brain injury to the Walter Reed Army Institute of Research and the University of Florida, establishing the first proteomics based platform to identify biochemical markers of acute brain injury.
The FDA-approved Banyan Biomarkers, Inc., Brain Trauma Indicator™, also funded by USAMMDA, laid the groundwork and served as a foundation for the i-STAT Alinity TBI plasma assay. The DOD partnered with Abbott to develop the TBI biomarkers into a field-deployable laboratory platform, which is an easy-to-use TBI cartridge utilized in the i-STAT Alinity device, the new version of the i-STAT 1 that is currently fielded by the U.S. Army. Recent user assessments have established preliminary suitability of the assay and device in operational laboratory settings for the Army. Future testing will confirm system suitability and enable fielding of this capability.
The laboratory assay for TBI point-of-care biomarker effort has been funded by the U.S. Army and is managed by USAMMDA's Warfighter Brain Health Project Management Office.
About US Army Medical Materiel Development Activity:
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.
About the Congressionally Directed Medical Research Programs:
CDMRP originated in 1992 via a Congressional appropriation to foster novel approaches to biomedical research in response to the expressed needs of its stakeholders-the American public, the military, and Congress. The CDMRP fills research gaps by funding high impact, high risk and high gain projects that other agencies may not venture to fund. While individual programs are unique in their focus, all of the programs managed by the CDMRP share the common goal of advancing paradigm shifting research, solutions that will lead to cures or improvements in patient care, or breakthrough technologies and resources for clinical benefit. The CDMRP strives to transform healthcare for Service Members and the American public through innovative and impactful research.
About Army Futures Command:
Army Futures Command leads the persistent modernization of the Army in order to provide future warfighters with the concepts, capabilities, and organizational designs needed to dominate a future battlefield. Headquartered in Austin, Texas, AFC has more than 26,000 people worldwide. The Army's six modernization priorities are the focus of our eight Cross Functional Teams: Long Range Precision Fires; Next Generation Combat Vehicle; Future Vertical Lift; Army Network; Air and Missile Defense; Soldier Lethality; Assured Positioning Navigation Timing; and, Synthetic Training Environment. The Artificial Intelligence Task Force and Army Applications Lab also support our efforts. Collaborating with entrepreneurs, scientists, industry, and academia, AFC strives to create the best solutions to keep Soldiers safe and America strong. For more information, visit https://armyfuturescommand.com/.