FDA approves first-ever blood test to evaluate concussions

The Food and Drug Administration has authorized U.S. marketing of the first blood test with the ability to evaluate concussion, or mild traumatic brain injury (mTBI), in adults, the agency announced in a statement Wednesday.

The Banyan Brain Trauma Indicator—a test that works by measuring levels of the proteins UCH-L1 and GFAP in a patient’s blood—was reviewed and authorized for marketing within six months of submission, according to the statement. The Trauma Indicator analyzes levels of proteins released from the brain into the blood within 12 hours of a head injury, aiding in the diagnosis of mTBI or concussion.

The current standard for concussion diagnosis involves the 15-point Glasgow Coma Scale, as well as CT scans to detect brain damage, the FDA said, but most patients evaluated for mTBI don’t show any evidence of intracranial lesions post-CT.

“Availability of a blood test for concussion will help healthcare professional determine the need for a CT scan in patients suspected of having mTBI and help prevent unnecessary neuroimaging and associated radiation exposure to patients,” officials wrote.

TBI cases stack up into the millions on an annual basis, the U.S. Centers for Disease Control and Prevention reported in 2013, reaching 2.8 million cases of  TBI-related emergency department visits in that year alone. Of those instances, TBI contributed to the deaths of nearly 50,000 people, the CDC wrote.

The majority of TBI cases might be minor—roughly 75 percent are mTBIs—but the effects of a traumatic brain injury can range from impaired memory, thinking and sensation to compromised movement and emotional function.

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

Gottlieb, who called the Trauma Indicator part of a federal push to “ensure that each patient is getting the right imaging exam, at the right time, with the right radiation dose,” also said the new approach to concussion analysis will likely reduce the number of CT scans performed each year, cutting healthcare costs.

Before authorizing its release, the FDA evaluated data from a multi-center, prospective clinical study of nearly 2,000 individual blood samples from adults with suspected mTBI. Researchers compared mTBI blood results to results generated by a CT scan and quickly noted the Brain Trauma Indicator’s efficacy—it was able to predict the presence of intracranial lesions on a CT scan 97.5 percent of the time and the absence of intracranial lesions 99.6 percent of the time.

These findings led the FDA to deem the test a reliable predictor of the absence of intracranial lesions in possible mTBI patients, and officials said it could be a useful tool for ruling out the need for CT scanning in at least a third of patients.

Test results from the Trauma Indicator are generally available within three to four hours of the procedure.

The test was approved as part of the FDA’s Breakthrough Devices Program, which is a voluntary program for some medical devices that “demonstrate the potential to address unmet medical needs for life-threatening or irreversibly debilitating diseases or conditions that are subject to premarket approval applications.”

“Helping to deliver innovative testing technologies that minimize health impacts to patients while still providing accurate and reliable results to inform appropriate evaluation and treatment is an FDA priority,” Gottlieb said.

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After graduating from Indiana University-Bloomington with a bachelor’s in journalism, Anicka joined TriMed’s Chicago team in 2017 covering cardiology. Close to her heart is long-form journalism, Pilot G-2 pens, dark chocolate and her dog Harper Lee.

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