New Products In Brief
This article was originally published in The Gray Sheet
Executive Summary
Roche LightCycler MRSA Advanced Test: "Easy-to-use" molecular test for methicillin-resistant Staphylococcus aureus gains 510(k) clearance July 8, setting the stage for Roche to launch the product in the next few weeks, according to the company. The qualitative, in vitro diagnostic is designed to detect the presence of hard-to-treat Staphylococcal bacteria within two hours using nasal swab specimens. The test is performed on Roche's LightCycler 2.0 instrument. LightCycler is designed to help prevent and control MRSA infections in hospitals and other health care settings, and appears more sensitive than direct culture-based methods, according to the company. Roche gained CE-mark approval for overseas marketing in 2009