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FDA Clears First Blood Test to Aid Concussion Evaluations

Posted 14 February 2018 | By Zachary Brennan 

FDA Clears First Blood Test to Aid Concussion Evaluations

The US Food and Drug Administration (FDA) on Wednesday signed off on the first blood test to help evaluate concussions in adults.

Banyan Biomarkers, Inc.’s Brain Trauma Indicator, authorized under the FDA’s de novo premarket review pathway in fewer than six months thanks to the agency’s breakthrough devices program, works by measuring levels of certain proteins released from the brain into blood and measured within 12 hours of head injury.

“Levels of these blood proteins after mTBI [mild traumatic brain injury]/concussion can help predict which patients may have intracranial lesions visible by CT scan and which won’t,” FDA said. “Being able to predict if patients have a low probability of intracranial lesions can help health care professionals in their management of patients and the decision to perform a CT scan. Test results can be available within 3 to 4 hours.”

According to the US Centers for Disease Control and Prevention, in 2013 there were approximately 2.8 million TBI-related emergency department visits, hospitalizations and deaths in the US.

Jeffrey Shuren, director of FDA’s Center for Devices and Radiological Health, said in a statement: “The FDA’s review team worked closely with the test developer and the US 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 US laboratories that service the American military.”

The approval was based on data from a multi-center, prospective clinical study of 1,947 individual blood samples from adults with suspected mTBI/concussion and reviewed the product’s performance by comparing mTBI/concussion blood tests results with CT scan results. The Brain Trauma Indicator was able to predict the presence of intracranial lesions on a CT scan 97.5% of the time and those who did not have intracranial lesions on a CT scan 99.6% of the time, according to FDA. 

Categories: Regulatory News

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