FDA clears first commercially available blood test for traumatic brain injury, reducing need for CT
The U.S. FDA has cleared the first commercially available blood test for traumatic brain injury, eliminating the need for CT scans to assess such patients.
Industry giant Abbott announced the breakthrough on Tuesday, noting that the product will be made widely available to U.S. hospitals. The Alinity i TBI lab test is able to reach a result in 18 minutes, helping physicians to quickly assess and triage concussion patients.
Abbott estimated that the test could reduce the number of unnecessary CT scans by up to 40%, dropping wait times while cutting costs to the healthcare system and patients.
“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,” neurologist Beth McQuiston, MD, medical director in Abbott's diagnostics business, said in a statement. “That's great news for both doctors and people who are trying to find out if they have suffered a traumatic brain injury.”
Concussion assessment has remained constant for decades, with doctors using the Glasgow Coma Scale, along with computed tomography, to detect any lesions or damage in brain tissue.
Abbott said its test works by measuring complementary biomarkers in blood plasma and serum. It has demonstrated 96.7% sensitivity and 99.4% negative predictive value in previous use cases. Alinity i TBI is meant for patients age 18 and older who present with a suspected mild TBI (registering 13-15 on the Glasgow scale) within 12 hours of the injury.
Regulators in Europe previously approved the lab test, with it available in markets outside of the U.S. since 2021, Abbott said.
Marty Stempniak has covered healthcare since 2012, with his byline appearing in the American Hospital Association's member magazine, Modern Healthcare and McKnight's. Prior to that, he wrote about village government and local business for his hometown newspaper in Oak Park, Illinois. He won a Peter Lisagor and Gold EXCEL awards in 2017 for his coverage of the opioid epidemic.