Health Care

FDA approves first blood test for concussion

FDA approves first blood test for concussion

Blood test detects concussions related brain damage more quickly. But the remainder may have bruising, bleeding or swelling in the brain, and need a CT scan to locate, monitor and possibly treat the injury. 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.

The blood test's approval "supports the FDA's Initiative to Reduce Unnecessary Radiation Exposure from Medical Imaging - an effort to ensure that each patient is getting the right imaging exam, at the right time, with the right radiation dose", Dr. Scott Gottlieb, the FDA commissioner, said in the news release. Results from the Brain Trauma Indicator (Banyan Biomarkers, Inc.) are available within 3 to 4 hours, according to the FDA.

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. Using the test could rule out the need for CT scans in at least one-third of suspected concussion patients, the FDA says.

The new test measures blood for proteins that are released from the brain within 12 hours of the head injury, according to the FDA. That means going forward, the Banyan test will be the basis upon which the FDA reviews new blood tests for brain injury developed by Banyan or other companies. It's created to help doctors quickly determine which patients with suspected concussions may have brain bleeding or other brain injury.

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Traumatic brain injuries contributed to about 2.8 million emergency room visits and almost 50,000 deaths in 2013, according to data from the Centers for Disease Control and Prevention.

Currently, it's routine to order a CT scan for all patients with suspected closed head injuries, the FDA noted, but most scans do not show detectable lesions. A recent clinical study demonstrated the blood test was 97.5 percent effective in predicting patients with intracranial lesions and even more importantly, was 99.6 percent effective in predicting patients that did not have intracranial lesions.

The test doesn't detect concussions and the approval won't immediately change how patients with suspected concussions or other brain trauma are treated.

"I think there will be some off-label usage" in children with TBI, said Nordhoff, referring to physicians' legal use of products in different ways or on different populations than those for which the products have been approved by the FDA.


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