US-based IntelligentMDx (IMDx) has obtained CE Mark approval for its artus C. difficile QS-RGQ kit 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.
In December 2013, the company has filed a 510(k) premarket notification with the US Food and Drug Administration (FDA) for the test.
IMDx’s artus C. difficile QS-RGQ kit detects the presence of Clostridium difficile (C. difficile), the most common cause of hospital-associated diarrhea. The kit detects 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 help in diagnosis of C. difficile infection.
IMDx chairman and CEO Dr Alice Nesselrodt noted CE-marking of the artus C. difficile QS-RGQ kit is the first step toward the company’s mission of making new tests available globally to customers using QIAsymphony SP/AS and Rotor-Gene Q instruments.
"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," Dr Nesselrodt added.