The FDA has approved the first blood test to help diagnose concussions, clearing a path to the market for a diagnostic that could reduce the use of expensive brain imaging technologies that expose patients to radiation.
The approval goes to San Diego diagnostics developer Banyan Biomarkers. The company’s test, called Banyan BTI (short for brain trauma indicator), measures the levels of two proteins that the brain releases into the blood in the hours following a head injury. The company developed the test with partial support from a contract with the U.S. Army.
The current standard for concussion diagnosis involves a neurological assessment that measures a patient’s eye, verbal, and motor responses. That assessment is followed by a computed tomography (CT) scan. Banyan says that measuring the levels of the two brain proteins can help clinicians determine whether or not to proceed with a CT scan. The company’s test returns results within four hours.
Banyan’s test was evaluated in a study that enrolled more than 2,000 adult patients in the U.S. and Europe suspected to have a concussion. Blood test results were compared to CT scans. The FDA says the Banyan test was able to predict the presence of brain injury on a CT scan 97.5 percent of the time. For those who did not have a brain injury, the Banyan test was correct 99.6 percent of the time. Using the test could rule out the need for CT scans in at least one-third of suspected concussion patients, the FDA says.
Banyan is conducting more studies to determine if its tests could be used to monitor a patient’s recovery from injury. The company is also studying how its tests could be used to assess other brain conditions.
The FDA reviewed the Banyan test under its “Breakthrough Devices Program,” which was added under the 21st Century Cures Act, a wide-ranging 2016 law that includes provisions for speeding up the review of medical devices and drugs to bring new products to the market faster.
Because Banyan BTI is the first blood test for brain injury that the FDA has approved for sale, its approval creates a new classification for these types of diagnostics. That means going forward, the Banyan test will be the basis upon which the FDA reviews new blood tests for brain injury developed by Banyan or other companies.