Blood Test For Concussions Approved By FDA For First Time
Currently, most patients with suspected traumatic brain injury are evaluated using a neurological exam, followed by a CT scan. FDA Commissioner Scott Gottlieb said that the blood test could save the health care system money by preventing unnecessary scans.
Stat:
FDA Approves First Blood Test To Help Diagnose Concussions
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. (Swetlitz, 2/14)
CNN:
FDA Approves First Ever Blood Test For Concussion
Patients are currently diagnosed with concussion based on a combination of symptoms as well as imaging. However, CT scans don't always detect concussion. "Over 90% of CT scans (for concussion) are negative. And you get 200 times the radiation of a chest X-ray. It's expensive; it's not terrific," said Hank Nordhoff, chairman and CEO of Banyan Biomarkers, maker of the new test. It can help determine whether a patient further needs a CT scan, based on a physician's concerns. (Kounang, 2/14)
The New York Times:
First Blood Test To Detect Concussions Is Approved
“This is going to change the testing paradigm for suspected cases of concussion,” said Tara Rabin, a spokeswoman for the F.D.A. She noted that the agency had worked closely on the application with the Defense Department, which has wanted a diagnostic tool to evaluate wounded soldiers in combat zones. The Pentagon financed a 2,000-person clinical trial that led to the test’s approval. (Kaplan and Belson, 2/14)
San Francisco Chronicle:
First Blood Test To Detect Concussions Approved
Concussion-related brain damage has become a particularly worrisome public health issue in many sports, especially football, affecting the ranks of professional athletes on down to the young children in Pop Warner leagues. Those concerns have escalated so far that it has led to a decline in children participating in tackle sports. (Kaplan and Belson, 2/14)
