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Abbott receives FDA clearance for first time commercially available lab-based blood test to help evaluate concussions

Press releases may be edited for formatting or style | March 08, 2023 Alzheimers/Neurology CT X-Ray
ABBOTT PARK, Ill., March 7, 2023 /PRNewswire/ -- Abbott (NYSE: ABT) has received U.S. Food and Drug Administration clearance for what will be the first commercially available laboratory traumatic brain injury (TBI) blood test, making it widely available to hospitals in the United States. The test, which runs on Abbott's Alinity® i laboratory instrument, will provide clinicians with an objective way to quickly assess individuals with mild TBIs, also known as concussions.

Abbott's Alinity i TBI lab test offers a new reliable result in 18 minutes to help clinicians quickly assess concussion and triage patients. For those with negative results, it rules out the need for a CT scan and can eliminate wait time at the hospital. The test measures two biomarkers in the blood that, in elevated concentrations, are tightly correlated to brain injury.

For decades, standard concussion assessment has remained the same, with doctors leveraging the Glasgow Coma Scale, a subjective doctor assessment, and CT scans to detect brain tissue damage or lesions. Having a blood test available could help reduce the number of unnecessary CT scans by up to 40%, potentially reducing costs to the healthcare system and the patient as well as the amount of time they spend in the emergency department.
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Millions of people in the U.S. suffer a concussion each year, but more than half of people who suspect they have a concussion never get it checked.

"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 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."

TBIs are caused by a bump, blow or whiplash to the head and can pose risk of both short- and long-term effects. People who experience a TBI may experience impairment of memory, movement, sensation (e.g., vision and hearing), and emotional functioning (e.g., personality changes, psychological symptoms). Effects of TBI can last anywhere from a few days post-injury or may be permanent. People who sustain a TBI are more likely to have another one – similarly to how a sprained ankle or torn ligament is more susceptible to future injury.

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