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Qiagen Gets CE Mark for GBS Assay Developed Under IMDx Partnership


NEW YORK (GenomeWeb) — IntelligentMDx (IMDx) said today that the artus GBS QS-RGQ kit, developed in partnership with Qiagen, has received CE marking for use with Qiagen's QIAsymphony SP/AS and Rotor-Gene Q instruments.

In addition, IMDx said that it has begun working to broaden the claims of other CE-marked tests previously developed as part of its partnership with Qiagen.

Group B Streptococcus infections can be life-threatening in newborns, making screening of pregnant women important in order to initiate treatment and prevent transmission. Using the automated workflow of the QIAsymphony SP/AS and RGQ real-time PCR instruments, the artus GBS QS-RGQ kit enables simultaneous screening of large numbers of at-risk women by providing results for up to 70 samples in one work shift, IMDx said.

This is the third CE-marked molecular diagnostic assay to be designed, developed, and manufactured under a multi-year development and license agreement inked by IMDx and Qiagen in early 2013.

IMDx, based in Waltham, Mass., uses a bioinformatics process to predict success or failure of molecular diagnostic tests by simulating real-life conditions such as contamination or genetic mutations, which can impact a test's clinical performance. Qiagen tapped into the company's assay-development expertise to help it rapidly expand the menu for its QIAsymphony RGQ platform.

Other CE-marked tests developed by the partners thus far include the artus C. difficile and VanR QS-RGQ kits for detecting Clostridium difficile and vancomycin-resistant bacteria, respectively.

IMDx said today that it has initiated work to broaden the claims of these kits, validating them for use with eNAT tubes as well as re-use of reagents in order to facilitate runs of smaller batches in an attempt to target lower-volume laboratories in the EU.

In addition, IMDx said that it has initiated development of a fourth test intended for use in the EU on Qiagen's platforms. This assay will detect an undisclosed pathogen in whole blood and plasma, and will be intended for monitoring of transplant patients, IMDx said.

This week Qiagen also received US Food and Drug Administration approval for the artus CMV RGQ MDx kit for human cytomegalovirus. Despite sharing the artus brand name, this kit was not developed in partnership with IMDx, and IMDx spokesperson said.