FDA Oks First Blood Based Concussion Detection Test

A new blood-based test could help change the way TBI’s such as concussions are detected in patients. FDA recently granted a De Novo request to Banyan Biomarkers to market the Banyan Brain Trauma Indicator (BTI). “The goal standard right now is the CT scan and it’s better than anything else out there,” Henry Nordhoff, chairman and CEO of Banyan Biomarkers, told MD+DI. “But the problem with CT is the cost; the time it takes; and the amount of ionizing radiation that’s delivered to the brain. It’s particularly dangerous when it’s a developing brain. You’re getting about 100 times the ionizing radiation in a brain scan that you’re getting in a chest X-ray.” The San Diego-based company’s test 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. Network with your colleagues in medtech at ADM Cleveland, March 7–8, 2018.  “The test is totally objective and semi-quantitative,” Nordhoff said. “We haven’t set a price yet, but it’s [probably] going to be about $150 per test.” The Banyan BTI takes about four hours, but as the company works on automating the assay, that time could be reduced to about an hour. FDA signed off on the Banyan BTI because of  strong results from the ALERT-TBI study, which enrolled 2,011 patients at 24 independent clinical sites in the U.S. and Europe. The study compared the te...
Source: MDDI - Category: Medical Devices Authors: Tags: Medical Device Business Source Type: news