FDA Marks Brain Injury Month With Newly Approved Concussion Blood Test, Advice For Consumers

As part of Brain Injury Month, federal health regulators are making an effort to raise awareness among consumers about the risks associated with traumatic brain injuries, and also highlighting a recently approved blood test that is designed to help identify mild concussions, which may play a vital role in making sure proper treatment is received. 

On March 20, the FDA issued an update on its current actions and research into traumatic brain injuries. The update includes information on the Banyan Brain Trauma Indicator, which as approved for marketing last month.

Traumatic brain injuries (TBIs) involve trauma to the head that disrupt the brain’s normal function. Mild TBIs are often referred to as concussions. Symptoms can include headaches, confusion, blurred vision, behavioral changes, vomiting or nausea, slurred speech, weakness in the limbs, and cognitive problems.

The U.S. Centers for Disease Control and Prevention estimates that about 2.8 million TBI’s occurred in 2013, resulting in emergency room visits, hospitalizations, and deaths.

Head injuries are traditionally hard to diagnose, yet proper treatment and diagnosis can be extremely important in preventing or minimizing long-term impacts. There is not even a universally accepted standard for a traumatic brain injury diagnosis, the FDA notes.

On February 14, the FDA approved the Banyan Brain Trauma Indicator, which measures levels of proteins known as UCH-L1 and GFAP, that the brain releases into the blood. These levels are different within 12 hours after a concussion.

The FDA approved the device in less than six months as part of its controversial Breakthrough Devices Program.

“We’re excited about today’s advances in research and development,” Dr. Christian Shenouda, a medical device reviewer in the FDA’s Division of Neurological and Physical Medicine Devices, said in the update. “We hope these advances will lead to further patient access to additional diagnostics and treatments.”

The FDA also indicated that it is continuing to research concussion diagnostic measures, looking at biomarkers and physical indicators in both human and animal studies that are currently ongoing.

The agency advises anyone displaying signs of a moderate of severe head injury to seek immediate medical attention.