Finally, Actual Data for the FDA-Approved Biomarkers of Traumatic Brain Injury

In February, the FDA approved the first blood biomarker test for diagnosis of traumatic brain injury (TBI); it measures ubiquitin C-terminal hydrolase-L1 (UCH-L1) and glial fibrillary acidic protein (GFAP). Data submitted to the FDA have now been published.

The prospective industry-funded study enrolled adults at emergency departments in the U.S. and Europe who had a head computed tomography (CT) scan for suspected TBI, initial Glasgow coma scale (GCS) score of 9–15, and blood obtained within 12 hours of injury. CT evidence of injury included intracranial injuries, but also skull and facial fractures, or even scalp injury alone. The biomarker test was considered positive if levels of one or both proteins were above prespecified thresholds.

Of…