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FDA Allows Marketing of Banyan Biomarkers Blood Test for Concussions

NEW YORK (360Dx) – The US Food and Drug Administration today said it has allowed for the first time the marketing of a blood test to evaluate mild traumatic brain injury, more commonly known as a concussion.

The test from Banyan Biomarkers called the Brain Trauma Indicator measures the levels of the proteins UCH-L1 and GFAP that are released into the blood from the brain within 12 hours of head injury. Levels of these proteins after a concussion can be used to predict which patients have intracranial lesions visible by CT scan and which don't, the FDA said in a statement.

Most patients suspected of having a head injury are examined using a neurological scale followed by CT scan, but a majority of patients evaluated for concussions don't have a detectable intracranial lesion after receiving a CT scan, the agency said. Being able to predict those patients with a low probability of intracranial lesions can help clinicians better manage them and decide whether a CT scan should be performed. Test results with Brain Trauma Indicator can be available in three to four hours, the FDA said.

"A blood-testing option for the evaluation of [mild traumatic brain injury]/concussion not only provides healthcare professionals with a new tool, but also sets the stage for a more modernized standard of care for testing of suspected cases," FDA Commissioner Scott Gottlieb said in a statement. "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 healthcare system the cost of often unnecessary neuroimaging tests."

"With extensive clinical research and scientific validation, Banyan [Brain Trauma Indicator] has shown that these two specific protein biomarkers ... can provide objective data to healthcare providers when evaluating patients with a traumatic brain injury," Banyan Biomarkers Chairman and CEO Henry Nordhoff said in a separate statement. "Receiving marketing authorization from the FDA for the first blood test for TBI is a significant milestone that will transform how brain injury is managed."

Citing statistics from the US Centers for Disease Control and Prevention, the FDA said that in 2013, there were about 2.8 million traumatic brain injury-related emergency department visits, hospitalizations, and deaths in the US. Of these cases, traumatic brain injuries contributed to the deaths of nearly 50,000 people. 

The Brain Trauma Indicator was reviewed under FDA's de novo premarket review pathway. 

While its test is the first blood-based concussion test approved by the FDA for marketing, other firms are developing blood-based concussion tests, including BioDirection, and Abbott. Also, in 2016 Banyan Biomarkers licensed two research-use-only assays to Quanterix for traumatic brain injury, and a year ago, BioMérieux signed a deal to commercialize Banyan Biomarkers' tests for diagnosing traumatic brain injuries.