The Defense and Veterans Brain Injury Center https://dubic.dcoe.mil reports that over 375,000 service members have been diagnosed with TBI since 2000. Approximately 82 percent of those TBI cases are classified as mild TBI or a concussion.
As announced by the U.S. Army Medical Materiel Development Activity (USAMMDA) https://www.usammda.army.mil, FDA has granted the De Novo request for the commercialization of Banyan BTI™. Biomarkers, Inc. https://www.banyanbio.com plans to market their BTI™ brain trauma indicator assay.
According to Army Lt. Col Kara Schmid, Project Manager for the Neurotrauma and Psychological Health Project Management Office at USAMMDA, “Getting approval of this assay is a monumental success for the TBI community. “
She reports, “There are blood tests for many diseases on the market, but this is the first blood test dedicated to TBI. For the first time, medical personnel won’t have to rely only on a description of the incident and symptoms, but will have access to an objective marker of injury to the brain—all from a simple blood test. ”Schmid adds, “This test will open the doors to what blood based biomarkers can do to evaluate mild TBI. This test holds promise to change the practice of medicine for brain injuries”.
FDA’s approval was supported by a multi-center study called ALERT-TBI 2,011 which included patients enrolled at 24 independent clinical sites in the U.S and European Union. The study compared the test results to CT scans of the head on patients coming to emergency departments with suspected head injuries.
The study showed that Banyan BTI achieved high sensitivity and high negative predictive value for ruling out the need for a head CT scan when unnecessary. Banyan BTI is able to identify two brain specific protein biomarkers that rapidly appear in the blood after a brain injury providing objective information so can be assess whether a patient has a suspected mild TBI.
The research on the Banyan BTI started as an idea between scientists at the University of Florida www.ufl.edu and the Walter Reed Army Institute of Research https://www.wrair.army.mil and was funded by the Army and the Defense Health Program https://health.mil. The development of Banyan BTI was supported by the U.S. Army Medical Research and Materiel Commend under Contract no. W81XWH-10-C-0251.