The Food and Drug Administration gave a green light Wednesday for the first time to a blood test that doctors can use to help rule out concussions.
The Brain Trauma Indicator, marketed by Banyan Biomarkers Inc., measures the levels of two proteins — called UCH-L1 and GFAP — whose elevated presence suggests a certain type of brain damage normally only visible on a CT scan. The test takes three to four hours, and doctors could use it to determine which patients need a CT scan to confirm the damage and which patients can rest easy.
In a press release, FDA Commissioner Scott Gottlieb said that this product could save the health care system money by preventing unnecessary neuroimaging tests. Additionally, by sparing some patients CT scans, it would reduce the radiation exposure associated with those scans.
“A blood test to aid in concussion evaluation is an important tool for the American public and for our Service Members abroad who need access to quick and accurate tests,” said Dr. Jeffrey Shuren, director of the FDA’s Center for Devices and Radiological Health, in a statement. “The FDA’s review team worked closely with the test developer and the U.S. Department of Defense to expedite a blood test for the evaluation of mTBI that can be used both in the continental U.S. as well as foreign U.S. laboratories that service the American military.”
Other companies have similar tests in the works. Abbott, with funding from the Department of Defense is developing a blood test that searches for the same two proteins, Scientific American reported last year. Hundreds of patents have been filed in recent years describing various methods to test for concussion.