The Brian Trauma Indicator measures the levels of these two proteins within 12 hours of the initial head injury. 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.
FDA Commissioner Dr. Scott Gottlieb said the test fits with the agency's goals for delivering new technologies to patients and reducing unnecessary radiation exposure. The agency said a blood test could help avoid unnecessary computed tomography scans of the head, because most patients evaluated for concussion do not have detectable intracranial lesions. The company is also studying how its tests could be used to assess other brain conditions.
When compared with a CT scan, the blood test was 97.5 percent as effective in detecting concussion and 99.6 percent effective in ruling out concussion.
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While the blood test can not now detect concussions conclusively, it does allow doctors to scan brain cells for proteins that indicate brain bleeding and other neurological injuries after a blow to the head, the Associated Press reported. The test could be used in emergency rooms across the U.S.by the end of the year. The FDA, in keeping with its commitment to address urgent medical concern of brain injuries, reviewed the test under the Breakthrough Devices Program, which is meant to facilitate the development and expedite the review of innovative breakthrough technologies. Currently, most patients with suspected traumatic brain injury are evaluated using a neurological exam, followed by a CT scan. The Centers for Disease Control and Prevention has estimated that in 2013, there were roughly 2.8 million emergency department visits, hospitalizations and deaths in the US related to traumatic brain injury, or TBI.
"Over 90 per cent of CT scans (for concussion) are negative". Banyan Biomarkers picked up the approval after showing the test reliably rules out intracranial lesions. The proteins involved are UCH-L1 and GFAP, which can be detected in elevated levels within 15 to 20 minutes of injury.
Thus, Banyan Biometrics was hired to develop such a blood test and all the expenses with the development and clinical trials were supported by the US Army Medical Research and Materiel Command. "A blood test to aid in concussion evaluation is an important tool for the American public and for our service members overseas, who need access to quick and accurate tests", said Jeffrey Shuren, director of FDA's medical device division. But mild traumatic brain injuries affect a far wider demographic than that suggests.