FDA clears first blood test for evaluating concussion

FDA
The diagnostic correctly predicted the presence of intracranial lesions 97.5% of the time. (Image: FDA)

The FDA has approved a blood test for use in the detection of concussion for the first time. Banyan Biomarkers picked up the approval after showing the test reliably rules out intracranial lesions.

Today, patients with suspected head injuries are assessed on a neurological scale before undergoing a CT scan. The scans show whether a patient has intracranial lesions that need treating. Most people are free from such lesions but scans are performed as precautionary measures. This exposes patients to radiation and drives up healthcare costs.

Banyan’s blood test is designed to cut the need for CT scans. The Brain Trauma Indicator analyzes the levels of UCH-L1 and GFAP, proteins that are elevated in patients with traumatic brain injuries. As the proteins arise from different pathways, researchers speculated analyzing both would yield tests with superior sensitivity and specificity than diagnostics that look at the biomarkers in isolation.

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Data generated by Banyan support that idea. Banyan applied its test to almost 2,000 blood samples taken from patients with suspected concussion and compared the results to CT scans. The diagnostic correctly predicted the presence of intracranial lesions 97.5% of the time. Importantly, it correctly ruled out the presence of intracranial lesions in 99.6% of cases. The FDA thinks the test will enable doctors to spare one-third of patients with suspected head injuries from undergoing CT scans.

RELATED: Banyan scores $26.3M DoD contract for TBI test

Sporting injuries dominate conversations about the need to prevent and detect concussion. But mild traumatic brain injuries affect a far wider demographic than that suggests. The FDA is particularly keen to get the test into the hands of the military, whose personnel suffer suspected concussion as a result of improvised explosives and other combat events.

“The FDA’s review team worked closely with the test developer and the U.S. Department of Defense to expedite a blood test for the evaluation of mTBI that can be used both in the continental U.S. as well as foreign U.S. laboratories that service the American military,” Jeffrey Shuren, M.D., director of the FDA’s Center for Devices and Radiological Health, said in a statement.

Shuren and his colleagues hustled the test through the review and authorization process in under six months. That turnaround was made possible by the practices the FDA established in its breakthrough devices program.