QIAGEN receives U.S. clearance for QIAsymphony RGQ MDx system and diagnostic workflow for C. difficile
- FDA clearance for QIAsymphony RGQ MDx, a complete sample-to-result automation platform, marks a milestone for one of QIAGEN’s major global growth drivers
- U.S. launch of artus C. difficile QS-RGQ MDx Kit will provide a reliable molecular test for a widespread healthcare-associated infection
- QIAGEN continues to advance pipeline with additional FDA submissions for HAI assay portfolio, including VanR and MRSA
- Assay development pipeline advancing well – record year of FDA submissions planned in 2014
GERMANTOWN, Maryland, and HILDEN, Germany, May 5, 2014 — QIAGEN N.V. (NASDAQ: QGEN; Frankfurt Prime Standard: QIA) today announced that its artus C. difficile QS-RGQ MDx Kit has been cleared by the U.S. Food and Drug Administration to qualitatively detect Clostridium difficile, a widespread healthcare-associated infection (HAI). In addition, the FDA has granted 510(k) regulatory clearance for the QIAsymphony RGQ MDx system, QIAGEN’s flagship automation platform that is transforming laboratory workflows and driving dissemination of molecular diagnostics. The U.S. milestone for QIAGEN’s global rollout of its sample-to-result automation platform, together with the FDA clearance of the first in a portfolio of tests for HAI infections, supports the expected growth in QIAsymphony placements globally to more than 1,250 by year-end 2014 and 1,500 by year-end 2015.
“Our QIAsymphony RGQ platform is revolutionizing laboratory workflows with flexible, efficient automation from sample to result – and the U.S. clearance affirms that we are well on track with our targets for this important growth driver,” said Peer M. Schatz, Chief Executive Officer. “QIAGEN is now positioned to rapidly expand the menu of standardized, regulator-approved diagnostic kits running on QIAsymphony. Our FDA cleared artus C. difficile QS-RGQ MDx Kit provides reliable detection of both the Toxin A and Toxin B of the infection. artus C. difficile QS-RGQ MDx Kit is the first test of our planned HAI portfolio in the United States. As we continue to deliver on a deep pipeline for infectious diseases and personalized healthcare diagnostics, the growing menu adds value for customers and patients by allowing consolidation of more tests on this platform.”
QIAsymphony RGQ MDx is a modular system for cost-effective handling of entire laboratory workflows. The three modules 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. The QIAsymphony family has the broadest test menu in its category in Europe and other markets. In the United States until now the system has been primarily used for laboratory-developed assays. The FDA clearance therefore marks an important milestone as a record number of assays is now positioned to be submitted for clearance or approval in the United States. With the launch of the artus C. difficile test, QIAGEN now offers four FDA-regulated diagnostics designed to run on the QIAsymphony family of automated platforms. In Europe, more than 20 CE-marked assays run on the system. Innovation continues to expand the content menu, with about 35 new tests in development.
The artus C. difficile kit, already available in Europe, will be the first U.S. launch among QIAGEN’s advanced diagnostics for healthcare-associated infections. Additional workflows for HAIs include the artus VanR QS-RGQ MDx Kit for detection of vancomycin-resistant bacteria, available in Europe and expected to be submitted in the second quarter 2014 to the FDA; the artus MRSA QS-RGQ MDx Kit for methicillin-resistant Staphylococcus aureus (MRSA), expected to be launched in Europe during the second quarter 2014 and to be submitted to the FDA in the third quarter 2014; and further additions under development. QIAGEN also is in advanced stages of developing test kits for diagnosis of group B streptococcus and herpes simplex virus (HSV1/2).
The artus C. difficile test was developed in partnership with IntelligentMDx under a multiyear agreement.
QIAGEN N.V., a Netherlands 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 December 31, 2013, QIAGEN employed approximately 4,000 people in more than 35 locations worldwide. Further information can be found at 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).