The findings indicate that the test can reliably predict the absence of intracranial lesions.
Today, the US Food and Drug Administration (FDA) permitted marketing of the first blood test evaluating mild traumatic brain injury (mTBI), or concussion, in adults.
The FDA reviewed and authorized marketing for the Banyan Brain Trauma Indicator in fewer than 6 months.
“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,” Scott Gottlieb, MD, FDA Commissioner, said in a statement. “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.”
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.
The device was able to predict the presence of intracranial lesions on a CT scan 97.5% of the time, and those without lesions on a CT scan 99.6% of the time.
The findings indicate that the test can reliably predict the absence of intracranial lesions. Health care professionals now have the opportunity to incorporate the tool into the standard of care for patients in order to rule out the need for a CT scan in at least one-third of those suspected to have mTBI.
The availability of a blood test for concussion will help health care professionals to determine the need for a CT scan in patients suspected of having mTBI, preventing unnecessary neuroimaging and associated radiation exposure.
“In addition, availability of a blood test for mTBI/concussion will likely reduce the CT scans performed on patients with concussion each year, potentially saving our health care system the cost of often unnecessary neuroimaging test,” Gottlieb added.
The Brain Trauma Indicator, reviewed under the FDA’s De Novo premarket review pathway, measures levels of proteins known as UCH-L1 and GFAP, that are released from brain into the blood within 12 hours of a head injury.
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. The opportunity to predict if patients have a low probability of intracranial lesions can help professionals in the management of patients.
Test results can be available within 3—4 hours.
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