Banyan Biomarkers has secured marketing approval from the US Food and Drug Administration (FDA) for the first in vitro diagnostic blood test for traumatic brain injury (TBI).
The regulator granted de novo status to the Banyan BTI (brain trauma indicator), which is a diagnostic blood test to help assess patients with suspected TBI or concussion.
The new blood test can identify two brain-specific protein biomarkers such as Ubiquitin Carboxy-terminal Hydrolase-L1 (UCH-L1) and Glial Fibrilliary Acidic Protein (GFAP), which quickly appear in the blood after a brain injury.
The test will offer objective information to evaluate patients with suspected mild TBI, helping to identify patients with head trauma.
It enables patients to avoid undergoing CT scan and prevent unnecessary radiation to the brain.
The approval was based on a prospective multi-center pivotal study, ALERT-TBI, which recruited 2,011 patients at 24 independent clinical sites in the US and European Union.
According to the company, the study demonstrated that Banyan BTI achieved high sensitivity and high negative predictive value (NPV) for eliminating the need for a head CT and offered objective data for healthcare providers to assess patients with suspected TBI.
Banyan Biomarkers chairman and CEO Henry Nordhoff said: “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.
“We are honored to have as our partner, the U.S. 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.”
Image: Banyan Biomarkers’ in vitro diagnostic blood test will help assess patients with suspected traumatic brain injury. Photo: courtesy of sakhorn38 / FreeDigitalPhotos.net.