In Brief: Cortecs
This article was originally published in The Gray Sheet
Executive Summary
Cortecs: Marketing partner Boehringer Mannheim files 510(k) with FDA for the firm's Helisal "one step" whole blood diagnostic kit for the detection of H. pylori bacterium antibodies in patients with ulcer symptoms. The on-site testing system provides results in five minutes "with accuracy comparable to laboratory-based serology tests," Cortecs says...