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Army Announces FDA Clearance of Field Deployable TBI Blood Test

Military personnel standing in the snow preparing to fire a missile Soldiers from 1st/120th Field Artillery, Wisconsin National Guard, prepare to fire a M-777 Howitzer during Winter Strike 21 at Camp Grayling Maneuver Center, Michigan in Jan. 2021. Soon the Army should have a field-deployable means to detect and evaluate soldiers for TBI (Photo by: Air National Guard photo by Master Sgt. Dan Heaton).

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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 in January.

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 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.

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.

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Traumatic Brain Injury (TBI) is structural alteration of the brain or physiological disruption of brain function caused by an external force.  TBI, particularly mild TBI or concussion, is the most common traumatic injury in the U.S. military. This analysis provides the estimated rates of incident TBIs among service members before their first-ever deployment as well as separately among service members during deployments/ after deployments. It also mentions factors that may explain why the TBI incidence rates among the previously deployed were higher than those of the never-deployed group. Moreover, it describes the demographic and military traits of service members diagnosed as TBI cases (before/after deployment). Categorization of person time during surveillance period included four categories: Group 1 (Never deployed/TBI before first-ever deployment), Group 2 (Currently deployed or within 30 days of return), Group 3 (previously deployed but not currently deployed nor within 30 days of return) and Censored after Diagnosis of TBI. From 2001-2016, 276,858 active component service members received first-time diagnoses of TBI. The crude overall incidence rate of TBI among deployed service members was 1.5 times that of service members assigned to Group 1 and 1.2 times that of service members in Group 3 during the surveillance period.  Total TBI cases by group were Group 1 42.8%, Group 2 13.2% and Group 3 44.0%. Incidence rates by group (per 100,000 person-years) were Group 1 1,141.3, Group 2 1,690.5, and Group 3 1,451.2. Learn more at www.Health.mil/MSMR and see fact sheets at www.Health.mil/AFHSB

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