Banyan Biomarkers, Inc., a pioneer in developing biomarkers for traumatic brain injury (TBI), today announced the publication of the results for the ALERT-TBI study, an international, multicenter clinical trial utilizing the Banyan Brain Trauma Indicator® (Banyan BTI™). The Banyan BTI is a diagnostic blood test used to rule out the need for a head CT scan in patients 18 years of age and older with a suspected TBI. The results, published in The Lancet Neurology, support the clinical role of the biomarker test for ruling out the need for a head CT scan among emergency department TBI patients who would normally receive a head CT scan.
The ALERT-TBI study enrolled patients at 22 independent clinical sites in the United States and Europe and compared the Banyan BTI test’s results to head CT scans of patients presenting to emergency departments with suspected head injury. Analysis of 1,959 patients presenting with an initial Glasgow Coma Scale of 9-15 from the study showed that the Banyan BTI achieved high sensitivity (97.6%) and high negative predictive value (NPV) (99.6%) for ruling out the need for a head CT scan in these patients.
Banyan BTI identifies two brain-specific protein biomarkers Ubiquitin Carboxy-terminal Hydrolase-L1 (UCH-L1) and Glial Fibrillary Acidic Protein (GFAP) that are detected in the blood soon after a brain injury. In February, the U.S. Food and Drug Administration (FDA) granted marketing authorization to Banyan Biomarkers for the commercialization of Banyan BTI to aid in the evaluation of patients with a suspected mild TBI or concussion. There is another biomarker, S100B, that has limited adoption in Europe but is not approved for use in the United States.
“This blood test meets an important public health need to reduce the number of unnecessary CT scans particularly among those with mild TBI—also called concussion—who make up over 85% of all TBIs. In emergency medicine, CT scans are often used in evaluating these patients, even though fewer than 10 percent of scans reveal an abnormality,” said Jeff Bazarian, MD, MPH, principal investigator of the study, one of the lead authors on the publication, and professor of Emergency Medicine and Neurology at The University of Rochester School of Medicine. “This extensive clinical study shows that these two blood-based brain biomarkers can predict the absence of intracranial injury and reduce unnecessary head CT scanning, thereby reducing radiation exposure and healthcare costs while improving patient care and emergency department efficiency.”
“This large, prospective, multicenter trial validated the ability of the Banyan BTI to rule out the need for head CT scan in patients with a suspected TBI within 12 hours after injury. The FDA reviewed and authorized for marketing the test in fewer than six months as part of its Breakthrough Devices Program,” said Henry L. Nordhoff, Chairman and CEO of Banyan Biomarkers. “We are working closely with our commercial partners to make the test available in hospitals and emergency departments.”
The company is also engaged in additional TBI studies to evaluate the biomarkers in sports concussions, in adolescents, and for monitoring recovery from brain injury.
The clinical study was supported by the U.S. Army Medical Research and Materiel Command under Contract No. W81XWH-10-C-0251. Any views, opinions, conclusions, and/or findings contained in this press release are those of Banyan Biomarkers, Inc. and should not be construed as an official Department of the Army position, policy, or decision, unless so designated by other documentation.