HILDEN, Germany, and GERMANTOWN, Maryland, January 8, 2015 – QIAGEN N.V. (NASDAQ: QGEN; Frankfurt Prime Standard: QIA) today 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.
About QIAGEN
QIAGEN N.V., a Netherlands-based holding company, is the leading global provider of Sample & Assay Technologies that are used to transform biological materials into valuable molecular information. Sample technologies are used to isolate and process DNA, RNA and proteins from biological samples such as blood or tissue. Assay technologies are then used to make these isolated biomolecules visible and ready for interpretation. QIAGEN markets more than 500 products around the world, selling both consumable kits and automation systems to customers through four customer classes: Molecular Diagnostics (human healthcare), Applied Testing (forensics, veterinary testing and food safety), Pharma (pharmaceutical and biotechnology companies) and Academia (life sciences research). As of September 30, 2014, QIAGEN employed approximately 4,200 people in over 35 locations worldwide. Further information can be found at http://www.qiagen.com.
Certain of the statements contained in this news release may be considered forward-looking statements within the meaning of Section 27A of the U.S. Securities Act of 1933, as amended, and Section 21E of the U.S. Securities Exchange Act of 1934, as amended. To the extent that any of the statements contained herein relating to QIAGEN’s products, markets, strategy or operating results, including without limitation its expected operating results, are forward-looking, such statements are based on current expectations and assumptions that involve a number of uncertainties and risks. Such uncertainties and risks include, but are not limited to, risks associated with management of growth and international operations (including the effects of currency fluctuations, regulatory processes and dependence on logistics), variability of operating results and allocations between customer classes, the commercial development of markets for our products in applied testing, personalized healthcare, clinical research, proteomics, women’s health/HPV testing and nucleic acid-based molecular diagnostics; changing relationships with customers, suppliers and strategic partners; competition; rapid or unexpected changes in technologies; fluctuations in demand for QIAGEN’s products (including fluctuations due to general economic conditions, the level and timing of customers’ funding, budgets and other factors); our ability to obtain regulatory approval of our products; difficulties in successfully adapting QIAGEN’s products to integrated solutions and producing such products; the ability of QIAGEN to identify and develop new products and to differentiate and protect our products from competitors’ products; market acceptance of QIAGEN’s new products, the consummation of acquisitions, and the integration of acquired technologies and businesses. For further information, please refer to the discussions in reports that QIAGEN has filed with, or furnished to, the U.S. Securities and Exchange Commission (SEC).
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