FDA: First Blood Test for Concussion Diagnosis Approved

The US Food and Drug Administration has approved the first blood test to assess concussion, or mild traumatic brain injury (mTBI), in adults.

In recent years, most patients with a suspected head injury have been evaluated with the 15-point Glasgow Coma Scale and a subsequent CT scan for intracranial lesions. However, most patients with suspected mTBI do not have detectable intracranial lesions following a CT scan.

According to the FDA, the new Banyan Brain Trauma Indicator will not only help health care professionals determine the need for a computed tomography (CT) scan in patients with suspected mTBI, but it will also help prevent unnecessary neuroimaging and associated radiation exposure.

“A blood-testing option for the evaluation of mTBI/concussion not only provides health care professionals with a new tool, but also sets the stage for a more modernized standard of care for testing of suspected cases,” said FDA Commissioner Scott Gottlieb, MD, in a press release.

—Christina Vogt

Reference:

FDA authorizes marketing of first blood test to aid in the evaluation of concussion in adults [press release]. US Food and Drug Administration. February 14, 2018. https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm596531.htm. Accessed on February 15, 2018.