First Blood Test to Evaluate Potential Concussions Approved
WEDNESDAY, Feb. 14, 2018 -- The first blood test designed to help doctors evaluate whether a suspected brain injury is a concussion has been approved by the U.S. Food and Drug Administration.
Traditional concussion evaluation includes a CT scan of the head to detect any brain tissue damage. But many people who have such a scan do not have brain lesions that are detectable, the FDA said Wednesday in a news release.
The new test -- dubbed the Brain Trauma Indicator -- is designed to help determine the need for such scans after head injuries, reducing unnecessary CT testing and associated radiation exposure, the agency said.
"Today's action supports the FDA's Initiative to Reduce Unnecessary Radiation Exposure from Medical Imaging -- an effort to ensure that each patient is getting the right imaging exam, at the right time, with the right radiation dose," said agency Commissioner Dr. Scott Gottlieb.
There were some 2.8 million emergency department visits in the United States in 2013 for evaluation of potential concussions, the FDA said, citing statistics from the U.S. Centers for Disease Control and Prevention. Most people with concussion symptoms -- such as impaired thinking or memory, movement, sensation or emotional function -- have a negative CT scan, the FDA said.
The new test measures levels of certain proteins that are released from the brain into the blood within 12 hours of a head injury. Results, available within four hours, can help doctors decide whether to perform a CT scan.
The test was evaluated in a multi-center study of nearly 2,000 blood samples from adults with suspected concussions. The test correctly predicted the presence of brain lesions 97.5 percent of the time, the FDA said.
The test is produced by Banyan Biomarkers Inc., in Alachua, Fla.
Learn more from the FDA.
Posted: February 2018