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U.S. Army Medical Materiel Development Activity

US Army Announces Award to Validate TBI Point-of-care Device

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


FORT DETRICK, Md. – The U.S. Army Medical Materiel Development Activity today announced the award of U.S. Army funds to Abbott Point of Care, Inc. to conduct a Phase III clinical trial to validate a rapid blood test for traumatic brain injury on Abbott's portable device, the i-STAT Alinity.

Finding a solution for the diagnosis and evaluation of mild TBI in our wounded Service Members has been a top priority for the Department of Defense for well over a decade.

"Traumatic brain injury is a significant health issue affecting both active Service Members and Veterans, and we are committed to developing solutions that detect, protect, prevent and treat people impacted by brain injury," said Krista Caudle, Ph.D., product manager for the Neurotrauma and Psychological Health Project Management Office at USAMMDA.

According to the Defense and Veterans Brain Injury Center, over 380,000 Service Members have been diagnosed with TBI since 2000. Approximately 82 percent of these TBI cases are classified as mild TBI or a concussion. Service Members can experience a TBI from combat injuries, as well as from everyday activities such as sporting events or training accidents.

The U.S. Food and Drug Administration clearance of the Banyan Biomarkers, Inc. Brain Trauma Indicator™ benchtop assay, also funded by USAMMDA, laid the regulatory groundwork and will serve as a predicate for the i-STAT TBI assay. After an injury, this assay can identify two brain-specific protein markers that rapidly appear in the blood. This blood test provides medical personnel with objective markers of injury to the brain, as opposed to relying only on a description of the incident and symptoms, and may reduce the need for computed tomography scans.

"Having a portable technology will give clinicians an objective measure of a Soldier's brain injury in a matter of minutes and could impact the care that they receive when they are evaluated and treated," said Caudle.

The TBI assay for whole blood on the i-STAT point-of-care device has logistical advantages in forward Roles of Care because it does not require the spin down of blood. Additionally, it provides a rapid clinical reading within 15 minutes.

"The development of a whole blood TBI assay to modernize a multifunctional device that is already fielded, such as the i-STAT, minimizes additional logistical burden and provides a vital readiness capability to the Warfighter," said Caudle. "This test holds promise to change the practice of medicine for brain injury. We are looking forward to executing our plan to bring this capability to the Service Members in a prolonged field care setting."

This effort began as an idea developed between scientists at the Walter Reed Army Institute of Research, a subordinate command of the U.S. Army Medical Research and Materiel Command, and the University of Florida. Since then, the effort has grown to include partnerships with industry as well as academic institutions such as the Transforming Research and Clinical Knowledge in Traumatic Brain Injury Trial Network.

The biomarker effort has been funded by the U.S. Army and the Defense Health Program and also leverages investments by the National Institute of Neurological Disorders and Stroke.

USAMMDA is a subordinate command of the U.S. Army Medical Research and Materiel Command, under the Army Materiel 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.

Last Modified Date: 04/30/2019