Banyan BTI (Brain Trauma Indicator), reportedly the first blood test to aid in the evaluation of patients with suspected TBI, has received De Novo marketing approval from the US Food and Drug Administration (FDA).
Lacking an approved biomarker to guide decision-making, physicians use the CT scan to aid in their evaluation of TBI in patients. However, it is estimated that more than 90% of patients who present to the emergency department with mild TBI or concussion have a negative CT scan.
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, and can therefore identify patients with head trauma who could safely forego the need for a CT scan, according to a media release from the test’s developer, Banyan Biomarkers Inc.
“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,” says Henry L. Nordhoff, chairman and CEO of Banyan Biomarkers. “We are honored to have as our partner, the US Department of Defense and the US Army Medical Research and Materiel Command, for supporting the research and development of a diagnostic test that now provides objective quantifiable information to physicians, to eliminate unnecessary CT scans, and guide patient care.”
Lt Col Kara Schmid, project manager for the Neurotrauma and Psychological Health Project Management Office for the US Army Medical Materiel Development Activity, adds in the release that, “Obtaining FDA authorization for the first objective blood-based biomarkers of mild TBI is a huge success for the TBI community. This assay will provide a remarkable capability for the way we evaluate and care for our service members with TBI.”
The FDA reviewed the test under the Breakthrough Devices Program, which is intended to facilitate the development and expedite the review of innovative breakthrough technologies. The FDA granting of the De Novo request for Banyan BTI also creates a classification regulation for devices of this type and permits this diagnostic test to serve as a predicate device, per the release.
[Source(s): Banyan Biomarkers Inc, Business Wire]