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ARTICLE | Clinical News

FDA approves Banyan's brain trauma blood test

February 16, 2018 7:38 PM UTC

FDA approved the Banyan Brain Trauma Indicator (BTI) from Banyan Biomarkers Inc. (Alachua, Fla.) as an in vitro diagnostic blood test to aid in the evaluation of adults with suspected mild traumatic brain injury (TBI). The approval, which came via FDA's de novo premarket review pathway, opens up a new regulatory classification under the 510(k) pathway for future devices of the same type, with Banyan BTI serving as a predicate device.

Banyan BTI measures two brain-specific protein biomarkers, ubiquitin carboxyl-terminal hydrolase L1 (UCHL1) and glial fibrillary acidic protein (GFAP), which appear in the blood after a brain injury. The diagnostic identifies patients with head trauma who can safely forgo a CT scan...