July 2014—Qiagen’s artus C. difficile QS-RGQ MDx Kit received FDA clearance, and its QIAsymphony RGQ MDx system was granted 510(k) regulatory clearance by the FDA. In addition, the artus VanR QS-RGQ MDx Kit for detection of vancomycin-resistant bacteria, available in Europe, is expected to be submitted to the FDA this year. The artus MRSA QS-RGQ MDx Kit for methicillin-resistant Staphylococcus aureus is expected to be launched in Europe this year and submitted to the FDA in the third quarter of 2014. Test kits for diagnosis of group B streptococcus and herpes simplex virus (HSV 1/2) are in the advanced stages of development.
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