FDA permits marketing of new blood test for concussions

Editor's Note

The Food & Drug Administration (FDA) on February 14 authorized marketing of the first blood test to help evaluate concussions in adults and reduce the need for CT scans.

The Banyan Brain Trauma Indicator works by measuring levels of proteins (ie, UCH-L1 and GFAP) that are released from the brain into the patient’s blood within 12 hours of a head injury.

In studies, the Brain Trauma Indicator was able to predict the presence of intracranial lesions 97.5% of the time and those who did not have intracranial lesions 99.6% of the time.

The U.S. Food and Drug Administration today permitted marketing of the first blood test to evaluate mild traumatic brain injury (mTBI), commonly referred to as concussion, in adults. The FDA reviewed and authorized for marketing the Banyan Brain Trauma Indicator in fewer than 6 months as part of its Breakthrough Devices Program.

Read More >>