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Abbott, DoD Planning Clinical Study of Traumatic Brain Injury Test

NEW YORK (360Dx) — Abbott said today that it is preparing to launch a clinical study that will evaluate a point-of-care blood test for traumatic brain injury in partnership with the US Department of Defense and the National Institutes of Health.

According to Abbott, its test is designed to detect two proteins — GFAP and UCH-L1 — that are released into the bloodstream from the brain following an injury. Last month, the US Army awarded Abbott a contract worth more than $35.2 million to develop the assay, extending an $11.3 million contract that was awarded in 2017. 

Abbott said that the planned study will evaluate individuals with suspected traumatic brain injuries within 24 hours of injury, comparing results from the Abbott Park, Illinois-based company's test with traditional clinical assessments, computerized tomography scans, magnetic resonance imaging scans, and clinical outcomes.

The research will be performed by Abbott and the DoD in collaboration with scientists from the Transforming Research and Clinical Knowledge in Traumatic Brain Injury — or TRACK-TBI — network, which was launched by the NIH in 2014 to study traumatic brain injury patients across age and injury spectrums.

"Whether on the battlefield or in the emergency room, we need quick and accurate information to help assess a person who may have sustained brain injury," Geoffrey Manley, principal investigator of TRACK-TBI and a University of California, San Francisco researcher, said in a statement. "Our goal with this partnership is to validate the scientific rigor behind new technologies, like this blood test, and how they can help ensure the best care for our troops and patients."

Abbott is also developing a concussion assessment test designed to run on its handheld blood testing system i-STAT Alinity with other collaborators.