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Abbott Gains FDA Clearance for Lab-Based TBI Test

NEW YORK – Abbott announced on Tuesday that its laboratory-based test for traumatic brain injuries has received clearance from the US Food and Drug Administration. 

The test runs on Abbott's Alinity I instrument and returns results in 18 minutes, with a negative result ruling out a CT scan, the firm said in a statement. The assay measures two blood biomarkers — ubiquitin C-terminal hydrolase L1 and glial fibrillary acidic protein — that correlate to brain injury in elevated concentrations. It can be used when a patient arrives at the hospital with a suspected mild TBI within 12 hours of the injury, Abbott noted. 

The firm added that the test has nearly 97 percent sensitivity and 99 percent negative predictive value. It previously received clearance in the EU and has been available outside the US since 2021. Abbott's other blood-based TBI test, the I-Stat TBI Plasma test, received FDA clearance in 2021. A study from the University of California, San Francisco published last year found that the I-Stat test was able to predict patients who were most likely to die from their injuries or experience severe disability six months after the injury. 

"Now that this test will be widely available in labs across the country, medical centers will be able to offer an objective blood test that can aid in concussion assessment," Beth McQuiston, medical director for Abbott's diagnostics business, said in a statement. 

The US Department of Defense awarded the company $35.2 million in 2019 to develop a TBI assay. The agency has been collaborating with Abbott since 2014 to work on portable blood tests to help evaluate potential concussions.

Banyan Biomarkers received marketing approval from the FDA for a blood test using the same biomarkers to evaluate mild TBIs in 2018, but an Abbott spokesperson noted via email that the Alinity I test is the first commercially available lab test and will mark "the first time people will have access to a concussion blood test in the [emergency room]."