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TBI blood test cleared by FDA

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A new blood test for traumatic brain injury (TBI) has been cleared by the U.S Food and Drug Administration (FDA).

U.S. Army officials, in partnership with Abbott, have announced today that Abbott’s i-STAT® TBI cartridge has received FDA clearance to be used with whole blood.

The device is able to run whole blood testing at the patient’s bedside, allowing clinicians to obtain lab quality results for patients suspected of concussion in 15 minutes. In addition, patients can be evaluated up to 24 hours after injury, a significant improvement from previously available tests.

Previously, tests to help with the assessment of concussion were only cleared for use with plasma or serum, requiring samples to be sent to a laboratory for processing and results.

U.S. Army Brig. Gen. Edward H. Bailey, commanding general of the U.S. Army Medical Research and Development Command (USAMRDC), stated: “TBIs are a major concern for Warfighter health, readiness, and resiliency. This milestone accomplishment demonstrates how Army medical developers can partner with industry to deliver solutions for frontline medical personnel caring for our injured service members.”

Nearly 500,000 U.S. troops worldwide experienced a TBI resulting from military training, deployment, or day-to-day activities—such as sporting events—between 2000 and 2023, according to DoD statistics. Developing a field-deployable solution for the detection and evaluation of TBIs among service members stationed at home and abroad is, therefore, a top priority for the U.S. military health system.

Abbott developed the i-STAT TBI blood test in collaboration with the U.S. Army Medical Materiel Development Activity (USAMMDA), part of USAMRDC. The command has been dedicated to developing a solution for detecting and evaluating TBIs for more than two decades.

U.S. Army Col. Andy Nuce, commander of USAMMDA, said the assay will enhance the ability of frontline medical staff to quickly assess service members with suspected TBIs. Since not all patients will require head CT scans, the new method will prevent unnecessary medical evacuations and improve TBI case management in the field.

“During future large-scale combat operations, enemy weapons and exposure to blast or concussive events will present challenges to frontline medical providers,” said Nuce.

“We are constantly working to investigate, develop, and field modern medical solutions to protect the Warfighters of 2030, 2040, and beyond.”

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