QIAGEN achieves 1,250 cumulative QIAsymphony system placements, expands artus U.S. test menu

Jan. 12, 2015

QIAGEN has announced that it exceeded its goal for 250 new placements of the QIAsymphony modular automation solution in 2014, bringing the total number of cumulative placements to more than 1,250 at year’s end. For 2015, QIAGEN reaffirmed its goal to exceed 1,500 cumulative total placements worldwide, making it one of the most widely placed medium-throughput systems for molecular testing.

QIAGEN also announced its fifth U.S. regulatory decision during 2014, with the Food and Drug Administration having cleared in late December its artus HSV-1/2 QS-RGQ MDx Kit to diagnose herpes simplex virus type 1 and type 2 (HSV-1 and HSV-2) infections. The artus HSV-1/2 test was cleared by the FDA to run on the QIAsymphony RGQ MDx system.

Other positive U.S. regulatory decisions achieved during 2014 involved the 510(k) clearance of the QIAsymphony RGQ MDx workflow with the artus test for detection of the potentially fatal infection with C. Difficile and two pre-marketing approvals for tests using the Rotor-Gene Q MDx: an assay for cytomegalovirus (CMV), and a therascreen KRAS companion diagnostic paired with Vectibix, a leading targeted therapy for treatment of certain types of metastatic colorectal cancer. In addition, three tests received a CE-IVD mark in Europe during 2014 for use on the full QIAsymphony system: artus tests for the detection of vancomycin-resistant bacteria, methicillin-resistant Staphylococcus aureus, and Group B streptococcal infection.

The artus HSV-1/2 QS-RGQ MDx Kit is a ready-to-use system for detection of HSV-1 and HSV-2 DNA using polymerase chain reaction on the Rotor-Gene Q MDx, with sample processing and assay setup through the QIAsymphony SP and QIAsymphony AS modules. QIAsymphony is a modular system that integrates a molecular laboratory's workflow from initial biological sample processing to final insights. The three modules in QIAsymphony RGQ MDx are QIAsymphony SP for sample preparation, QIAsymphony AS for assay setup, and QIAGEN's real-time PCR detection platform Rotor-Gene Q MDx.

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