NEWS RELEASE

Department of Defense
United States Army Medical Research and Development Command
Congressionally Directed Medical Research Programs

Released: April 22, 2024

FORT DETRICK, Md. This month, the FDA announced clearance of Abbott Laboratories' i-STAT® TBI cartridge to evaluate a suspected traumatic brain injury by detecting biomarkers in a blood sample with results after 15 minutes of the testing. CDMRP-funded awards contributed to the early research and development of this test now cleared for patients over 18 years old.

"CDMRP funds innovative and impactful research that seeks to transform health care for Service Members, their Families, Veterans, and the American public," Col. Sarah Goldman, director of CDMRP, said. "CDMRP is directed by Congress to facilitate research for traumatic brain injuries, seeking to improve the way we prevent, diagnose, and treat these injuries."

Recognizing the historical prevalence of combat-related head injuries and the occurrence of TBI in the early years of the Iraq war, Ronald Hayes, Ph.D., and Dr. Kevin Wang, Ph.D., of University of Florida and co-founders of Banyan Biomarkers, Inc., first developed the protein-based platform to identify the biomarkers of brain injury with funding from the Peer Reviewed Medical Research Program, and the Traumatic Brain Injury and Psychological Health Research Program.

Along with CDMRP, the Walter Reed Army Institute of Research and the U.S. Army Medical Material Development Activity, also within the U.S. Army Medical Research and Development Command, contributed to the research and development.

First developed for use with plasma, the liquid portion of blood, the i-STAT could evaluate for TBI within 12 hours of a suspected brain injury. Since the test required processing blood into plasma, which requires additional resources and time, the test was not ideal for use in resource- limited military environments.

Now, the i-STAT TBI cartridge is cleared for use with whole blood collected within the first 24 hours after a suspected injury. The non-invasive diagnostic test requires a small blood sample to detect protein biomarkers released from the brain into the bloodstream after a possible injury. Levels of these proteins can assist in determining the need for a CT-scan.

"The i-STAT TBI cartridge is in fact a 'game changer' as it no longer requires the extra step of centrifugation of the blood collection step to obtain plasma, thus significantly simplifying the workflow required for this point-of-care test," Wang said.

This simplified process enables testing outside of the clinical setting, such as potentially helping to triage injured Service Members in operational environments.

The i-STAT TBI cartridge works on Abbott's hand-held i-STAT Alinity® instrument and produces lab-quality results within 15 minutes. Tests like this can help rule out the need for diagnostic imaging of the head and help health practitioners on site to determine appropriate next steps for care.

"These critically important financial supports [from CDMRP] resulted in proof-of-principle data for Banyan to submit to the FDA, thus securing the Investigative Device Exemption and setting the stage of the pivotal trial, ALERT-TBI" Wang said.

The ALERT-TBI trial of approximately 2,000 subjects with suspected mild TBI successfully demonstrated that the blood-based biomarker test accurately predicted CT-scan-detectable brain injuries within 12 hours after injury, according to Wang.

Between 2000 and 2023, nearly 500,000 Service Members experienced a mild TBI, according to a Department of Defense report. In 2020, there were approximately 214,000 TBI-related hospitalizations for U.S. civilians.

In FY24, the CDMRP received over $1.5 billion in congressional appropriations for research dedicated to enhancing the lives of Service Members and their Families, Veterans, and the American public. This funding targets critical gaps in research by focusing on innovative, high impact projects that will lead to cures or improvements in patient care, or breakthrough technologies and resources for clinical benefits.

Ronald Hayes, Ph.D. died in November 2023. His legacy continues through the improved care of civilians and Service Members provided by this brain injury diagnostic test.

For more information about the Congressionally Directed Medical Research Programs, our research programs, please visit the website at https://cdmrp.health.mil..

Point of Contact:

CDMRP Public Affairs
usarmy.detrick.medcom-cdmrp.mbx.cdmrp-public-affairs@health.mil

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