An FDA press release issued on 2/14 announced, “FDA authorizes marketing of first blood test to aid in the evaluation of concussion in adults.” Unfortunately, this headline does not accurately represent the approval, which is best captured by the release’s subtitle, “New quick testing option to help reduce need for CT scans, radiation exposure for patients.” According to the FDA release and underlying test data (Papa et al., 2016) two blood biomarkers, Glial Fibrillary Acidic Protein (GFAP) and Ubiquitin C-terminal Hydrolase (UCH-L1) in combination show high sensitivity in detecting intracranial brain lesions in children and adults with traumatic brain injury. The approval from the FDA arises from their initiative “Reduce Unnecessary Radiation Exposure from Medical Imaging.”
In short, the combined use of these biomarkers helps to predict whether a patient in the ER who has experienced a traumatic head injury would benefit from a CT scan to detect whether there is a lesion in the brain. Although the use of these biomarkers may help reduce the number of unnecessary CT scans, it does not diagnose whether a concussion has occurred, particularly a sports-related concussion.
Read the full article here – https://www.fda.gov/newsevents/newsroom/pressannouncements/ucm596531.htm