FDA approves Banyan BTI (Brain Trauma Indicator) diagnostic to detect brain trauma injury.- Banyan Biomarkers Inc.
Banyan Biomarkers, Inc., a pioneer in developing biomarkers for traumatic brain injury (TBI),announced that the FDA has granted the De Novo request for the commercialization of Banyan BTI (Brain Trauma Indicator), an in vitro diagnostic blood test to aid in the evaluation of patients with suspected TBI, also known as concussion.
The FDA, in keeping with its commitment to address urgent medical concern of brain injuries, reviewed the test under the Breakthrough Devices Program, which is intended to facilitate the development and expedite the review of innovative breakthrough technologies. Banyan BTI identifies two brain-specific protein biomarkers (Ubiquitin Carboxy-terminal Hydrolase-L1 or UCH-L1 and Glial Fibrilliary Acidic Protein or GFAP) that rapidly appear in the blood after a brain injury, providing objective information to assess patients with suspected mild TBI. The goal of the study was to identify patients with head trauma who could safely forego the need for a CT scan thereby avoiding unnecessary radiation to the brain and reduce costs of care.
Comment: This is the first blood test for TBI. Currently, the CT scan is routinely used to assist physicians in the evaluation of TBI. However, the use of CT scans is highly variable especially in the face of significant trauma with minimal symptoms. Lacking an approved biomarker to guide decision making, the default for physicians was to obtain a CT scan. More than 90 percent of patients presenting to the emergency department with mild TBI or concussion, have a negative CT scan