FDA Approves First Blood Test to Evaluate Concussion


Test can aid in ruling out the need for CT scan

The United States Food and Drug Administration (FDA) has approved the first blood test intended to evaluate and test for mild traumatic brain injury (TBI), or concussion, in adults.

The test, known as the Banyan Brain Trauma Indicator, can help a physician determine whether there is a need for further testing via CT scan, helping a large portion of patients to avoid unnecessary exposure to radiation.

“These findings indicate that the test can reliably predict the absence of intracranial lesions,” read an FDA statement, “and that health care professionals can incorporate this tool into the standard of care for patients to rule out the need for a CT scan in at least one-third of patients who are suspected of having mTBI.”

A study of nearly 2,000 individual blood samples saw the Brain Trauma Indicator accurately predict the presence of intracranial lesions on CT scan 97.5 percent of the time, while correctly predicting the absence of said lesions 99.6 percent of the time.

Two different proteins—ubiquitin C-terminal hydrolase and glial fibrillary acidic protein—are released from the brain into the blood. The Brian Trauma Indicator measures the levels of these two proteins within 12 hours of the initial head injury.

SOURCE: U.S. Food and Drug Administration


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Rob Senior

Rob has 15 years of experience writing and editing for healthcare. He previously worked for ADVANCE from 2002 to 2012.

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