Abbott (NYSE:ABT) announced today that it received FDA 510(k) clearance for its rapid handheld traumatic brain injury (TBI) blood test.
According to a news release, the test is designed to help clinicians assess individuals with suspected mild TBIs, including concussions.
The test runs on Abbott’s handheld i-STAT Alinity platform, with results provided within 15 minutes after the plasma is placed in the test cartridge. A negative test can be used to rule out the need for a head CT scan, while a positive test complements CT scans to help a clinician’s evaluation, the company said.
Abbott’s test requires a small blood sample drawn from the arm, from which plasma is extracted with a centrifuge, then applied to the test’s cartridge before the cartridge is inserted into the i-STAT Alinity instrument.
“Healthcare providers have been waiting for a blood test for the brain and now we have one,” Abbott diagnostic business medical director Dr. Beth McQuiston said in the release. “You can’t treat what you don’t know and now physicians will be equipped with critical, objective information that will help them provide the best care possible, allowing patients to take steps to recover, prevent reinjury and get back to doing the things they care about most.”
The company said it is also working on a whole blood test that would eliminate the need for separating plasma and provide an option at the patient’s side in a healthcare setting. Abbott is envisioning a portable test with the same result turnaround time that can be used outside a traditional healthcare setting to evaluate head injuries quickly, like at sporting events.
Abbott also received FDA breakthrough device designation for a TBI test to run on its Alinity i and Architect core laboratory instruments to widen the range of settings in which its diagnostics are available.
