From: Alice Jacobs Nesselrodt To: Alice Jacobs Nesselrodt Subject: IMDx achieves 4th FDA clearance--QIAGEN anus C difficile QS-RGQ MDx--a test for a serious healthcare-associated infection Date: Thu, 08 May 2014 16:18:52 +0000 Attachments: IMDx release_05MAY2014.pdf I hope you all is well with you. Spring has finally arrived in Boston and we have exciting news (see below) to share as IMDx achieves its first FDA clearance for QIAGEN — the QIAGEN artus C. difficile QS-RGQ MDx Kit. This is the fourth FDA clearance in less than a year for IMDx (3 FDA clearances were obtained for Abbott kits). In April, the FDA cleared the QIAGEN artus C. difficile QS-RGQ MDx Kit, developed and manufactured by IMDx, for use on the QIAGEN QlAsymphony RGQ MDx System. In addition, IMDx and QIAGEN continue to expand the pipeline for QlAsymphony SP/AS and Rotor- Gene Q Instruments. My best, Alice FDA Clears QIAGEN's artus C. difficile QS-RGQ MDx Kit, developed in partnership with IMDx; IMDx and QIAGEN Continue to Expand Pipeline for QlAsymphony SP/AS and Rotor-Gene Q Instruments Waltham, MA — In April 2014, the FDA cleared the QIAGEN artus C. difficile QS-RGQ MDx Kit, developed and manufactured IMDx, for use on the QIAGEN QlAsymphony RGQ MDx System, for use in the United States. The artus C. difficile QS-RGQ MDx Kit, which is used as an aid in diagnosis of Clostridium difficile (C. difficile) infection, was CE- marked in December 2013. The QlAsymphony RGQ MDx System was simultaneously cleared by the FDA, and provides an integrated automated sample preparation and assay setup for a full sample to result workflow solution. The artus VanR QS-RGQ Kit, another product in the healthcare-acquired infection test menu designed, developed and manufactured by IMDx for use on the QIAGEN QlAsymphony RGQ MDx System, was CE-marked in March 2014. The artus VanR QS-RGQ Kit is intended as an aid to identify, prevent, and control vancomycin-resistant colonization in patients at risk for vanc