Bazarian called the test "a huge step" toward devising a blood test that can detect brain injuries including concussions. When compared to a CT scan, the Brain Trauma Indicator was 97.5 per cent as effective in detecting concussion and 99.6 per cent in ruling out concussion, according to the online article published on Feb 14. 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 FDA reviewed and authorized for marketing the Banyan Brain Trauma Indicator in fewer than six months as part of its Breakthrough Devices Program", the FDA said in a statement.
"A blood-testing option for the evaluation of [mild traumatic brain injury]/concussion not only provides health care professionals with a new tool, but also sets the stage for a more modernized standard of care for testing of suspected cases", FDA Commissioner Scott Gottlieb said in a press release. The blood test can accurately and quickly identify patients with brain tissue damage, or intracranial lesions, following a head injury without the need for an expensive and time-consuming CT scan. The test should be performed within 12 hours of injury; results are available in 3-4 hours, the FDA said. A blow to the head can cause the proteins to leak into the bloodstream.
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In 2013, there were around 2.8 million visits to the emergency room for evaluations of possible concussions, according to statistics from the US Centers for Disease Control and Prevention. It's created to help doctors quickly determine which patients with suspected concussions may have brain bleeding or other brain injury.
The development of the new blood test, as well as the clinical trials reviewed by the FDA, were largely underwritten by the U.S. Army Medical Research and Materiel Command. Of these cases, concussion-related head injuries contributed to the deaths of almost 50,000 patients.
The test doesn't detect concussions and the approval won't immediately change how patients with suspected concussions or other brain trauma are treated. Most people who present with concussion symptoms, like impaired memory, problems with movements or sensations, or compromised emotional function, turn out to have negative CT scans, the FDA said.
"I think there will be some off-label usage" in children with TBI, said Nordhoff, referring to physicians' legal use of products in different ways or on different populations than those for which the products have been approved by the FDA.