FDA Authorizes Marketing of First Blood Test Aiding in Evaluation of Concussion


The Brain Trauma Indicator measures levels of specific proteins that are released from the brain into the bloodstream within 12 hours of a head injury. Test results can be available within 3 to 4 hours.

The Food and Drug Administration approved a blood test Wednesday that it says can help diagnose concussions more quickly, without the need for X-rays. The company is also studying how its tests could be used to assess other brain conditions.

Levels of the blood proteins after mTBI can help predict patients that could have intracranial lesions visible by CT scan and those that won't. These findings indicate that the test can reliably predict the absence of intracranial lesions.

Due to the frequent brain injuries suffered by the U.S. soldiers in Iraq and Afghanistan, the army representatives declared that the production of blood tests to accurately depict brain trauma within hours are a necessity in conflict zones.

With Department of Defense funding, Banyan's research shows its Brain Trauma Indicator can accurately pick up brain trauma later found on CT scans.

It was a quick approval for the test.

Almost 2.8 million people visited US emergency rooms in 2013 because of concussion or other traumatic brain injuries, according to the Centers for Disease Control and Prevention. As a part of the Breakthrough Devices Program conducted by the FDA, the government health organization has authorized and reviewed for the marketing of Banyan Brain Trauma Indicator for less than 6 months. Conventional concussion evaluation used to involve a CT scanning of head for detecting damage in any of the brain tissues.

"But in 99 percent of concussions you do not need a CT scan because they're not clinically important, meaning there's not an immediate need for surgery", said Alberts. Of these cases, concussion-related head injuries contributed to the deaths of almost 50,000 patients. Of these, almost 50,000 people died.

"A blood-testing option for the evaluation of mild TBI/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 Dr. Scott Gottlieb. Avoiding scans when possible will cut unnecessary radiation exposure as well as the cost of the scans, the FDA said in a statement.

The decision was based on data from a prospective clinical study of 1947 individual blood samples from adults with suspected mTBI and reviewed the product's performance by comparing mTBI blood test results with CT scan results.