QIAGEN Exceeds 2014 Goal to Achieve 1,250 Cumulative QIAsymphony System Placements and Expands <i>artus</i> U.S. Test Menu

QIAGEN N.V. announced that it had 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-end.

QIAGEN also announced its fifth U.S. regulatory decision during 2014 with the U.S. 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, further expanding the menu of diagnostic kits running on the QIAsymphony family of instruments. 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 (c.diff), and two pre-marketing approvals (PMA) 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, a total of 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 (VanR), methicillin-resistant Staphylococcus aureus (MRSA) and Group B streptococcal infection (GBS) – expanding the CE-IVD menu on the full QIAsymphony system to 13 assays.

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.

“Our QIAsymphony automation solution is revolutionizing molecular testing workflows with flexible, efficient processing from sample to insight – and our rapidly expanding menu of standardized, regulator-approved diagnostic kits is adding value by allowing consolidation of more tests on the QIAsymphony,” said Peer M. Schatz, Chief Executive Officer. “We have set a goal for another 250 system placements in 2015 and look forward to further expanding the test menu in the U.S., Europe and other markets through new submissions during the year.”

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 (PCR) on the Rotor-Gene Q MDx, with sample processing and assay setup through the QIAsymphony SP and QIAsymphony AS modules. Both types of herpes simplex virus are widespread and can cause serious infections: HSV-1 often manifests in oral infections, while HSV-2 is most often associated with genital infections. However, both types can infect both mouth and genitals.

QIAsymphony is an innovative, easy-to-use modular system that integrates a molecular laboratory's workflow from initial biological sample processing to final insights. The system is QIAGEN’s flagship solution for cost-effective handling of entire laboratory workflows. 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, which received FDA clearance in 2012.