FDA Clears First Blood Test for Concussion Detection
The FDA granted marketing authorization to Banyan Biomarkers’ Brain Trauma Indicator — the first blood test for evaluating mild traumatic brain injuries, otherwise known as concussions,
The review and authorization, completed in less than six months, was expedited under the Breakthrough Devices Program in collaboration with the U.S. Defense Department.
The Banyan Brain Trauma Indicator measures neurologically released levels of proteins and it provides test results in no more than four hours to aid clinicians in determining whether to perform a CT scan in patients. The availability of the concussion blood test is expected to help reduce unnecessary brain CT scans and the association radiation exposure.
The FDA said the test has the potential to rule out the need for a CT scan in at least one-third patients who are suspected of having mild traumatic brain injuries.