"The present activity bolsters the FDA's Initiative to Reduce Unnecessary Radiation Exposure from Medical Imaging-a push to guarantee that every patient is getting the correct imaging exam, at the opportune time, with the correct radiation measurements", said FDA Commissioner Scott Gottlieb, M.D.
Levels of these blood proteins can help predict if a patient has probability of having intracranial lesions, which can help health care professionals determine how to manage their patients' conditions. Almost 2.8 million people visited USA emergency rooms in 2013 because of concussion or other traumatic brain injuries, according to the Centers for Disease Control and Prevention. The test could be used in emergency rooms across the U.S.by the end of the year. Accessibility of a blood test for blackout will enable wellbeing to mind experts decide the requirement for a CT check in patients associated with having mTBI and help forestall superfluous neuroimaging and related radiation presentation to patients. Its developers, Banyan Biometrics scientists, stated that their blood test can diagnose concussions within 12 hours after the injury occurred. Researchers compared mTBI blood results to results generated by a CT scan and quickly noted the Brain Trauma Indicator's efficacy-it was able to predict the presence of intracranial lesions on a CT scan 97.5 percent of the time and the absence of intracranial lesions 99.6 percent of the time. 14, 2018, approved a blood test that can detect concussions.
The test should save money and reduce a patient's exposure to radiation, according to the FDA. But Wednesday's green light by the Food and Drug Administration "is a big deal because then it opens the door and accelerates technology", said Michael McCrea, a brain injury expert at Medical College of Wisconsin.
The FDA's marketing authorization was supported by data from a multi-center, prospective clinical study involving 1,947 blood samples from adults with suspected mTBI/concussion. The FDA is particularly keen to get the test into the hands of the military, whose personnel suffer suspected concussion as a result of improvised explosives and other combat events.
San Diego-based Banyan has partnered with French firm bioMerieux SA to market the test to hospitals using bioMerieux's blood analyzing machines.
The FDA is allowing advertising of the Brain Trauma Indicator to Banyan Biomarkers, Inc.
Called the Brain Trauma Indicator, it measures two biomarkers that are released when the brain is injured.
It's also unknown how this test can determine subconcussive hits, "hits that don't cause symptoms but do cause a brain injury", he explained.