FDA approves blood test developed by Abbott, USAMMDA for traumatic brain injury

The U.S. Food and Drug Administration recently approved a blood test that the U.S. Army Medical Materiel Development Activity at Fort Detrick worked on with Abbott Point of Care, which can more quickly detect signs of traumatic brain injury.

The i-STAT Alinity, a device created by Abbott, can test blood samples on a specific kind of 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 quickly be evacuated from areas of combat and transported to a hospital for a CT scan, USAMMDA product manager Damien Hoffman said during an interview on Tuesday.

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 health care company.

An Abbott representative on Friday provided a statement from Dr. Chris Davlantes, the senior director of global medical and scientific affairs for Abbott’s Point of Care Business:

“The Abbott i-STAT TBI test cleared for use with whole blood will be available commercially this summer. This new clearance will enable testing to be performed in an array of new healthcare settings beyond hospital emergency departments, like urgent care clinics and nursing homes. This is an important step toward a future where testing could be done outside traditional healthcare settings, such as on the sidelines of sporting events.”

From 2016 to 2022, the Department of Defense saw between 16,000 and 21,000 incidents of traumatic brain injury each year, according to data available on the Military Health System‘s website.

More specifically, in 2022, the Department of Defense had about 20,500 incidents of traumatic brain injury, including mild, moderate, severe and penetrating injuries. In 2023, the department had about 14,700 traumatic brain injury incidents.

The majority of those injuries were mild traumatic brain injuries, or concussions, during both 2022 and 2023.

“There are no other blood tests that are FDA-approved that the DoD [Department of Defense] uses for traumatic brain injury. Right now, what’s used are subjective tests,” Hoffman said. “The device and the cartridge have been a major development in this space.”

Right now, he said, one of the only objective measures to detect traumatic brain injuries is CT scans, but the tests are costly and can’t be done close to the front lines.

Hoffman said the Alinity and cartridge blood test could help prevent unnecessary evacuations for CT scans by quickly detecting signs of traumatic brain injury without having to transport individuals.

Hoffman said the journey to this achievement for USAMMDA started about a decade ago around 2013, when the project was transitioned to the agency.

USAMMDA received the project from the Combat Casualty Care Research Program, according to an email from USAMMDA spokesperson Caree Vander Linden.

Years later in 2018, biotechnology company 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.

Test results for the Banyan test are available within three to four hours, according to a news release from the University of Florida announcing the approval.

However, Hoffman said, Banyan’s test wouldn’t fit the Department of Defense’s needs since armed forces require technology that can deliver results quickly enough to determine if an individual has to be evacuated. Additionally, the department would need a test that could easily be used on the front lines.

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

Abbott got FDA approval for plasma tests on the Alinity in 2021, and this past March, the FDA approved the Alinity and the cartridge developed with USAMMDA for traumatic brain injury blood testing.

Hoffman said he and other USAMMDA staff members did durability testing for the device and in the transit case it would be delivered in. Those tests included dropping the device and case from forklifts or exposing them to extreme temperatures.

He said some devices and cartridges were sent to labs within the U.S. Central Command, which gave feedback on what aspects of the test worked and what needed to be improved.

Now that the device and cartridge have FDA approval, Hoffman said, the next step is to deploy it, so it can be used.

Of the thousands of Department of Defense personnel who experience traumatic brain injuries every year, Hoffman said, “some of those personnel — this device will touch or could touch and inform their care for the better of the patient, whether it’s preventing them from getting a CT or removed from their battle buddies, evacuated for care that they could’ve received locally.”