QIAGEN has announced that its artus C. difficile QS-RGQ MDx Kit has been cleared by the US Food and Drug Administration (FDA) 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 US 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.
QIAGEN CEO Peer M Schatz noted that the company’s QIAsymphony RGQ platform is revolutionizing laboratory workflows with flexible, efficient automation from sample to result – and the US clearance affirms that the company is well on track with its targets for this important growth driver.
"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," Schatz added.
QIAsymphony RGQ MDx is a modular system for cost-effective handling of entire laboratory workflows. The three modules are QIAsymphony SP for sample preparation, QIAsymphony AS for assay setup, and QIAGEN’s real-time PCR detection platform Rotor-Gene Q MDx, which received FDA clearance in 2012.
The QIAsymphony family has the broadest test menu in its category in Europe and other markets. In the United States until now the system has been primarily used for laboratory-developed assays. The FDA clearance therefore marks an important milestone as a record number of assays is now positioned to be submitted for clearance or approval in the United States.
With the launch of the artus C. difficile test, QIAGEN now offers four FDA-regulated diagnostics designed to run on the QIAsymphony family of automated platforms. In Europe, more than 20 CE-marked assays run on the system. Innovation continues to expand the content menu, with about 35 new tests in development.
The artus C. difficile kit, already available in Europe, will be the first US launch among QIAGEN’s advanced diagnostics for healthcare-associated infections.
Additional workflows for HAIs include the artus VanR QS-RGQ MDx Kit for detection of vancomycin-resistant bacteria, available in Europe and expected to be submitted in the second quarter 2014 to the FDA; the artus MRSA QS-RGQ MDx Kit for methicillin-resistant Staphylococcus aureus (MRSA), expected to be launched in Europe during the second quarter 2014 and to be submitted to the FDA in the third quarter 2014; and further additions under development.
QIAGEN also is in advanced stages of developing test kits for diagnosis of group B streptococcus and herpes simplex virus (HSV1/2).
The artus C. difficile test was developed in partnership with IntelligentMDx under a multiyear agreement.