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Qiagen Gets FDA 510(k) Clearance for MDx System, C. Diff Assay

NEW YORK (GenomeWeb) — Qiagen has received 510(k) clearance from the US Food and Drug Administration for its QIAsymphony RGQ MDx system and Artus C. difficile QS-RGQ MDx kit, the company said Monday after the close of the market.

QIAsymphony RGQ MDx is a modular system for performing entire laboratory workflows. It comprises the QIASymphony SP for sample preparation, QIAsymphony AS for assay setup, and Rotor-Gene Q MDx real-time PCR detection system, which received FDA clearance in 2012.

The Artus C. difficile kit, designed to aid in the diagnosis of Clostridium difficile infections by detecting Toxins A and B, will be the first test to run on the QIAsymphony RGQ MDx in the US. The test was developed and manufactured by IMDx under a multi-year development and license agreement inked between the companies in 2013.

The QIAsymphony RGQ MDx and Artus C. difficile kit have both previously received CE marking in Europe.

Additional hospital-acquired infection assay workflows developed by IMDx for the QIAsymphony RGQ MDx platform include the Artus VanR QS-RGQ MDx kit for the detection of vancomycin-resistant bacteria, available in Europe and expected to be submitted to the FDA this quarter; Artus MRSA QS-RGQ MDx kit for methicillin-resistant Staphylococcus aureus, expected to be launched in Europe this quarter and submitted to FDA in the third quarter.

IMDx said that it will continue to aid in expanding the Qiagen test menu through the companies' agreement. Additional tests in the pipeline for 2014 include an assay for detecting herpes simplex viruses 1 & 2 in male and female genital and oral lesions, and a test for detecting Group B Streptococcus from enriched cultures taken from pregnant women.