Qiagen products cleared by FDA

The US Food and Drug Administration (FDA) has cleared the Qiagen artus C. difficile QS-RGQ MDx Kit to qualitatively detect Clostridium difficile, a widespread healthcare-associated infection (HAI). The test was developed in partnership with IntelligentMDx (IMDx) and CE marked in December 2013.

“Our FDA-cleared artus C. difficile QS-RGQ MDx Kit provides reliable detection of both the Toxin A and Toxin B of the infection,” said Qiagen CEO Peer M Schatz. “artus C. difficile QS-RGQ MDx Kit is the first test of our planned HAI portfolio in the United States.”

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.

The FDA has additionally granted 510(k) regulatory clearance for the QIAsymphony RGQ MDx automation platform. The product is a modular system for handling entire laboratory workflows, consisting of the QIAsymphony SP for sample preparation, QIAsymphony AS for assay set-up and Qiagen’s real-time PCR detection platform Rotor-Gene Q MDx, which received FDA clearance in 2012.

“Our QIAsymphony RGQ platform is revolutionising laboratory workflows with flexible, efficient automation from sample to result - and the US clearance affirms that we are well on track with our targets for this important growth driver,” said Schatz. “Qiagen is now positioned to rapidly expand the menu of standardised, regulator-approved diagnostic kits running on QIAsymphony.”

Under a multiyear development and licence agreement with Qiagen, IMDx will continue to aid in expanding the company’s test menu through the design, development and manufacture of kits for use on the QIAsymphony RGQ MDx System. Additional tests in the 2014 pipeline include a test for the detection of herpes simplex viruses 1 and 2 in male and female genital and oral lesions and a test for the detection of Group B Streptococcus from enriched cultures taken from pregnant women