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Abbott Traumatic Brain Injury Test Nabs FDA Clearance

NEW YORK – Abbott announced Monday that its I-Stat TBI cartridge has received clearance from the US Food and Drug Administration. 

The 15-minute test can be used at the patient's bedside to help evaluate patients with a suspected mild traumatic brain injury up to 24 hours after their injury, Abbott said in a statement. It runs on Abbott's portable I-Stat Alinity instrument and measures two biomarkers that may indicate a possible brain injury, ubiquitin C-terminal hydrolase L1 (UCH-L1) and glial fibrillary acidic protein (GFAP), in whole-blood samples. 

"When you look at all the other diseases, or other organs in the body, they all have blood tests to help assess what's happening," Beth McQuiston, medical director in Abbott's diagnostics division, said in a statement. "Now, we have a whole-blood test that can help assess the brain right at the patient's bedside — expanding access to more health providers and therefore patients." 

Abbott has received FDA clearance for other TBI tests, such as the I-Stat TBI Plasma assay and the Architect and Alinity I lab tests, that use plasma and serum, which require a laboratory to process and test samples. It has long been investigating the use of GFAP and UCH-L1 biomarkers for evaluating brain injuries, with multiple published studies describing their performance and utility.