WALTHAM, Mass., Jan. 29, 2014 /PRNewswire/ -- IMDx announced today that the artus C. difficile QS-RGQ Kit has received CE-marking for use with QIAsymphony SP/AS and Rotor-Gene Q instruments. This is the first of a series of assays designed, developed, and manufactured by IMDx for QIAGEN under a multi-year development and license agreement. Concurrently in December 2013, a Premarket Notification 510(k) submission for the test was submitted to FDA for review.
Clostridium difficile (C. difficile) is the most common cause of hospital-associated diarrhea. If not treated properly, infection with C. difficile can lead to more severe complications including pseudomembranous colitis and toxic megacolon.
The artus C. difficile QS-RGQ Kit detects the presence of toxigenic C. difficile in human liquid or soft stool from patients suspected of having C. difficile-associated disease. The test is intended to be used directly on patient samples to aid in diagnosis of C. difficile infection.
"CE-marking of the artus C. difficile QS-RGQ Kit is the first step toward our mission of making new tests available globally to customers using QIAsymphony SP/AS and Rotor-Gene Q instruments," says Dr. Alice Nesselrodt, Chairman & CEO of IMDx. "We are looking forward to continuing our partnership with QIAGEN in 2014 with the CE-marking and 510(k) submissions of other products currently in our development pipeline."
Based in Waltham, MA, IMDx (www.IntelligentMDx.com) designs, develops and manufactures platform-agnostic, regulatory-cleared molecular diagnostic tests that enable partners to more rapidly and efficiently expand test menus. Beyond growing its portfolio of assays for infectious disease, IMDx is pursuing new targets in companion diagnostics, oncology and human genetics, as well as next generation instrument systems. IMDx facilities are ISO 13485:2003 certified and all products are developed and manufactured within a regulatory compliant (FDA QSR, CE-IVDD and cGMP) environment.