Food and Drug Administration Permits Marketing of First Blood Test to Evaluate Concussion


As part of the breakthrough devices program, the Food and Drug Administration (FDA) permitted marketing of the brain trauma indicator (Banyan Biomarkers, Inc; San Diego, California), the first blood test for a biomarker of mild traumatic brain injury (mTBI), or concussion, in adult patients. The breakthrough devices program paved the way for review and approval by the FDA in fewer than 6 months. This is a regulatory pathway for some low- to moderate-risk devices that are novel and for which there is no prior legally marketed device.

The brain-trauma indicator measures levels of the proteins ubiquitin carboxy-terminal hydrolase L1(UCHL1) and glial fibrillary acidic protein (GFAP), which when found within 12 hours of injury can help predict whether or not a patient is likely to have an intracranial injury on CT or MRI. Results from the brain-trauma indicator are available 3-4 hours after a patient’s blood is drawn.

In a multicenter prospective study of 1,947 blood samples, a positive measurement for UCHL1 and GFAP correlated with the presence of an intracranial lesion on CT in 97.5% of patients with such lesions. A negative result correlated with the absence of such lesions in 99.6% of patients who did not have lesions. These findings suggest this test may predict the absence of intracranial lesions and could be used to rule out the need for a CT scan in some cases.

The Centers for Disease Control and Prevention estimates that there were 2.8 million emergency department visits in related to TBI (from mild to severe), and it has been suggested that as much as 75% of those visits are for mTBI. Currently, patients with suspected traumatic brain injury are evaluated with rating scales such as the Glasgow Coma Score or the Mayo Concussion Scale combined with brain imaging studies. A majority of patients evaluated for mTBI have negative imaging results. Availability of a blood test for concussion could reduce the use of CT and associated radiation exposure for patients with suspected mTBI.

"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. Today's action supports the FDA 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," said FDA Commissioner Dr. Scott Gottlieb

"A blood test to aid in concussion evaluation is an important tool for the American public and for our service members abroad who need access to quick and accurate tests," said Jeffrey Shuren, M.D., director of the FDA's Center for Devices and Radiological Health. "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."


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