FDA approves TBI blood test that could reduce need for head CTs by 1/3
A blood test administered within 12 hours of a suspected traumatic brain injury (TBI) could help clinicians identify injuries like hemorrhage and contusion before having to resort to CT imaging, according to the preliminary results of a study published this week in the Lancet Neurology.
Jeffrey Bazarian, MD, MPH, a co-leader of the paper and a professor at the University of Rochester School of Medicine in New York, said in a release the initial results of his team’s study were overwhelmingly positive—the test correctly identified 99.6 percent of patients who didn’t have a TBI after presenting to the emergency department and undergoing a CT.
“Based on the results of this multicenter study, routine use of the new biomarker test in emergency departments could reduce head CT scans by a third in acutely head-injured patients thought to be in need of CT scanning, avoiding unnecessary CT-associated costs and radiation exposure, with a very low false-negative rate,” he said.
Based on those early results, Bazarian said the test has received FDA approval for commercial use in the U.S. It’s the first blood-based brain biomarker test of its kind to gain approval for use in the country.
For their research, Bazarian and his colleagues conducted a prospective study of nearly 2,000 adults who’d presented to emergency departments between December 2012 and March 2014 in the U.S. and Europe with head trauma. Participants all received the blood test within 12 hours, the results of which were then compared to their CT results.
A significant majority—98 percent—had a mild TBI, the researchers said. The biomarker test was positive in 97.6 percent of patients with a traumatic injury as shown on a CT, with a negative predictive value of 99.6 percent.
“Our results suggest that patients with mild TBI who have no other indication for a CT and who have a negative test can safely avoid a CT scan,” Bazarian said. “Those patients with a positive test have a 10 percent chance of an intracranial lesion, and most clinicians would get a CT scan of their head to determine if an intracranial injury exists, and define it further. The extent to which these biomarker results can be applied to patients presenting with more severe injury requires further confirmation.”
The researchers said that further study is what will confirm their preliminary findings and solidify the test’s usefulness in clinical practice.
After graduating from Indiana University-Bloomington with a bachelor’s in journalism, Anicka joined TriMed’s Chicago team in 2017 covering cardiology. Close to her heart is long-form journalism, Pilot G-2 pens, dark chocolate and her dog Harper Lee.