FDA Approves Blood Test Developed by Abbott, USAMMDA for Traumatic Brain Injury

The U.S. Food and Drug Administration recently approved a blood test the U.S. Army Medical Materiel Development Activity at Fort Detrick worked on with Abbott Point of Care, which can detect signs of traumatic brain injury more quickly than a previous test by UF startup Banyan Biomarkers. Banyan’s biomarkers are used in the new device.

The i-STAT Alinity, a device created by Abbott, can test blood samples on a specific cartridge that USAMMDA developed and can deliver results in about 15 minutes. The device detects if a blood sample has elevated levels of specific biological markers, which indicate a brain bleed or injury.

If the sample has those elevated biological markers, the person can be transported from areas of combat to a hospital for a CT scan, USAMMDA product manager Damien Hoffman said.

USAMMDA develops new vaccines, drugs, devices, and other medical support equipment and leads medical product development for the U.S. Army. Abbott Point of Care is a division of Abbott Laboratories, a medical devices and healthcare company.

In 2018, UF startup Banyan Biomarkers received FDA approval for a blood test that detects the presence of two specific biomarkers — UCH-L1 and GFAP — to determine if a person has a mild brain injury. Banyan’s technology, which provides results in 3-4 hours, was discovered by a team of UF researchers, including Drs. Kevin Wang (Department of Psychiatry) and Ron Hayes (Department of Neuroscience) in the College of Medicine.

In 2019, Abbott received licensure from Banyan to use the company’s biomarkers on Abbott’s i-STAT Alinity device.

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