FDA approves Banyan Biomarkers' blood test to help evaluate traumatic brain injury in adults

The FDA announced Wednesday the De Novo approval of Banyan Biomarkers' Banyan Brain Trauma Indicator (BTI), which the regulator said is the first blood test to help evaluate mild traumatic brain injury (mTBI) in adults. Scott Gottlieb, FDA commissioner, remarked that "a blood-testing option for the evaluation of mTBI/concussion not only provides healthcare professionals with a new tool, but also sets the stage for a more modernised standard of care for testing of suspected cases." He added that the "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." 

According to the FDA, the approval was based on data from a study, which included 1947 blood samples from adults with suspected mTBI.  The results showed that Banyan BTI achieved high sensitivity and high negative predictive value for ruling out the need for a CT scan. Specifically, study data indicated that Banyan BTI could predict the presence of intracranial lesions on a CT scan 97.5 percent of the time and in participants who did not have intracranial lesions on a CT scan 99.6 percent of the time. 

The FDA said that the results suggest that Banyan BTI "can reliably predict the absence of intracranial lesions" adding that the test should be incorporated "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." 

According to the agency, Banyan BTI, which provides results within three hours to four hours, identifies two brain-specific protein biomarkers, ubiquitin carboxy-terminal hydrolase-L1 (UCH-L1) and glial fibrilliary acidic protein (GFAP), which rapidly appear in the blood after a brain injury.  

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