QIAGEN N.V. (NASDAQ: QGEN; Frankfurt Prime Standard: QIA) today announced that its artus C. difficile QS-RGQ MDx Kit has been cleared by the U.S. Food and Drug Administration to qualitatively detect Clostridium difficile, a widespread healthcare-associated infection (HAI). In addition, the FDA has granted 510(k) regulatory clearance for the QIAsymphony RGQ MDx system, QIAGEN’s flagship automation platform that is transforming laboratory workflows and driving dissemination of molecular diagnostics. The U.S. milestone for QIAGEN’s global rollout of its sample-to-result automation platform, together with the FDA clearance of the first in a portfolio of tests for HAI infections, supports the expected growth in QIAsymphony placements globally to more than 1,250 by year-end 2014 and 1,500 by year-end 2015.
“Our QIAsymphony RGQ platform is revolutionizing laboratory workflows with flexible, efficient automation from sample to result – and the U.S. clearance affirms that we are well on track with our targets for this important growth driver,” said Peer M. Schatz, Chief Executive Officer. “QIAGEN is now positioned to rapidly expand the menu of standardized, regulator-approved diagnostic kits running on QIAsymphony. Our FDA cleared artus C. difficile QS-RGQ MDx Kit provides reliable detection of both the Toxin A and Toxin B of the infection. artus C. difficile QS-RGQ MDx Kit is the first test of our planned HAI portfolio in the United States. As we continue to deliver on a deep pipeline for infectious diseases and personalized healthcare diagnostics, the growing menu adds value for customers and patients by allowing consolidation of more tests on this platform.”