Qiagen submits C. difficile assay to FDA

Sample and assay technologies company Qiagen plans to roll out a portfolio of assays for the QIAsymphony platform to aid in the diagnosis of healthcare-associated infections (HAIs). A modular system that covers entire laboratory workflows, the platform comprises QIAsymphony SP for sample preparation, the QIAsymphony AS for assay set-up and the real-time PCR detection platform Rotor-Gene Q MDx.

The company’s first new test, the artus C. difficile QS-RGQ MDx Kit, has been submitted to the US Food and Drug Administration (FDA). The company had already launched a C. difficile test in Europe after receiving CE-marking in December. Qiagen also submitted the automation platform QIAsymphony RGQ MDx to the FDA.

“The US submission of the QIAsymphony RGQ MDx system is a pivotal step in expanding global adoption of the QIAsymphony platform to revolutionise laboratory workflows,” said Qiagen CEO Peer M Schatz. “As novel new content continues to emerge from our pipeline, users will be able to consolidate the broadest range of molecular tests available on a single instrument platform.”

The C. difficile tests will aid in the diagnosis of Clostridium difficile infection, the most prevalent HAI in the United States. C. difficile often infects patients in hospitals or nursing facilities, causing symptoms ranging from diarrhoea to life-threatening inflammation of the colon.

Qiagen’s ready-to-use molecular assay delivers sensitive and specific detection of both toxin A and toxin B of C. difficile. The assay was developed in partnership with IntelligentMDx under a multiyear agreement.