Concussion-Detecting Blood Test Received FDA Approval

Concussion-Detecting Blood Test Received FDA Approval

The U.S. Food and Drug Administration (FDA) approved a blood test for detecting symptoms of concussion with accuracy on February 19, 2018

Brain damage associated with concussion is severe health risk. More than 10 million people in India suffer from concussion annually. It can affect performance of athletes affecting their ranking. The disease is majorly diagnosed with lab imaging tests such as CT scan, which reveals the complexity of injury. Banyan Biomarkers Inc. have developed Brain Trauma Indicator, which can measure level of proteins called as UCH-L1 and GFAP. High level of these proteins indicate brain damage and results of the test are avaible within three-four hours.

Company is focused on providing innovative and efficient tool for screening of concussion along with avoiding radiation exposure to body due to imaging tests. As a part of the study, a total of 1947 blood samples were collected from individuals who were at risk of concussion. Brain Trauma Indicator efficiently detected presence of intracranial lesions on CT 97.5% accuracy and the absence of intracranial lesions with CT 99.6% accuracy.

“Today’s action supports the FDA’s Initiative to Reduce Unnecessary Radiation Exposure from Medical Imaging—an effort to ensure that each patient is getting the right imaging exam, at the right time, with the right radiation dose,” said FDA Commissioner Scott Gottlieb, M.D. “A blood-testing option for the evaluation of 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. In addition, availability of a blood test for mTBI/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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