Abbott (NYSE:ABT) announced that it received FDA clearance for the first commercially available laboratory traumatic brain injury (TBI) blood test.
The test, now widely available to U.S. hospitals, runs on the Abbott Alinity i laboratory instrument. It provides clinicians with an objective way to quickly assess mild TBIs, otherwise known as concussions.
Abbott said in a news release that its Alinity i TBI lab test offers a new reliable result in 18 minutes. This helps clinicians quickly assess concussion and triage patients. For those with negative results, it rules out the need for a CT scan and can eliminate hospital wait time.
The company designed the test to measure two biomarkers in the blood. In elevated concentrations, these biomarkers closely correlate to brain injury.
“People sometimes minimize a hit to the head, thinking it’s no big deal. Others wonder if a visit to the doctor or emergency room for a possible concussion will provide them with meaningful answers or care,” said Dr. Beth McQuiston, M.D., medical director in Abbott’s diagnostics business. “Now that this test will be widely available in labs across the country, medical centers will be able to offer an objective blood test than can aid in concussion assessment. That’s great news for both doctors and people who are trying to find out if they have suffered a traumatic brain injury.”
Abbott and the need to test for TBI efficiently
TBIs, caused by a bump, blow or whiplash to the head, can lead to the risk of short- and long-term effects. These effects can last anywhere a few days post-injury but they can also prove permanent. Those who sustain TBI are more likely to have another one, Abbott said.
Misdiagnosis or lack of diagnosis only exacerbates these effects. Tools that can aid in the evaluation of concussion can get people the required answers and treatment, Abbott explained.
The company said the newly cleared test complements its i-STAT TBI plasma test. It holds FDA clearance and marks the first rapid blood test for concussion. Alinity i now allows for running a TBI blood test on Abbott’s high throughput Alinity i laboratory instrument. Hospitals and laboratories across the U.S. already use the Alinity i instrument, the company said.
Alinity i works when a patient arrives at the hospital with a suspected TBI within 12 hours of injury. The patient provides a blood sample from the arm, which is then sent to the lab for preparation and running on Alinity i. Abbott said the platform provides results in as little as 18 minutes before sharing with the treating healthcare provider for evaluation.
The test covers patients 18 years of age or older with suspected mild traumatic brain injury. It already has CE mark approval. Abbott said it’s offered the test outside the U.S. since 2021.
