"So this blood test precedes a CT scan unless you're showing signs of extreme trauma".
The United States Food and Drug Administration approved blood test to detect concussions in people and more quickly identify those with possible brain injuries. And it's just the latest example of technology striving to revolutionize how we diagnose diseases and injuries by making tests less invasive (and health care less costly). Conventional concussion evaluation used to involve a CT scanning of head for detecting damage in any of the brain tissues. A sizeable number do not, as the FDA points out. The Brain Trauma Indicator could could also be used at sports games and in the military, the agency said. The test, called the Brain Trauma Indicator, was approved in fewer than 6 months as part of the FDA's breakthrough devices program. "In addition, availability of a blood test for TBI/concussion will likely reduce the CT scans performed on patients with concussion each year, potentially saving our health care system the cost of often unnecessary neuroimaging tests".
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The move means Banyan Biomarkers can commercialize its test, giving the San Diego-based company an edge in the biotech industry's race to find a way to diagnose concussions.
FDA Commissioner Scott Gottlieb, MD, stated, "A blood-testing option for the evaluation of mTBI/concussion not only provides healthcare professionals with a new tool, but also sets the stage for a more modernized standard of care for testing of suspected cases".
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As the company brings on two companies to produce a smaller, faster blood-testing instrument, Nordhoff predicted that within two years, the assay will be available for rapid use in ambulances, emergency departments and in athletic training rooms. 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. The manufacturer Banyan Biomarkers said that the test can be taken within 12 hours of injury. Rather, it's an indicator of the likelihood that a CT scan will show intracranial lesions, and hence may be valuable in deciding whether CT scans are indicated. The proteins involved are UCH-L1 and GFAP, which can be detected in elevated levels within 15 to 20 minutes of injury.
"That's what we'd like to have for the brain", he said. The results showed that the blood test matched CT results for detecting intracranial lesions in more than 97% of cases - and found the absence of lesions in 99% of cases.
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