QIAGEN seeks U.S. regulatory clearance for full QIAsymphony RGQ MDx workflow and announces submission of first assay of its HAI portfolio
- Diagnostic workflow for C. difficile is launched in Europe and submitted in the U.S. for 510(k) clearance as the first of several new kits in QIAGEN’s pipeline for healthcare-associated infections (HAI)
- QIAGEN submits automation system QIAsymphony RGQ MDx to FDA for regulatory clearance, reiterates goals of 1,250 cumulative placements by year-end 2014 and 1,500 by end of 2015
GERMANTOWN, Maryland, and HILDEN, Germany, January 29, 2014 — QIAGEN N.V. (NASDAQ: QGEN; Frankfurt Prime Standard: QIA) today announced plans to roll out a portfolio of assays for the QIAsymphony platform to aid in the diagnosis of healthcare-associated infections. The first new test the artus C. difficile QS-RGQ MDx Kit has been submitted to the U.S. Food and Drug Administration (FDA). QIAGEN already launched a C. difficile test in Europe after receiving CE-marking in December.
Along with the C. difficile test, QIAGEN also submitted the automation platform QIAsymphony RGQ MDx to the FDA. QIAsymphony is a modular system that covers entire laboratory workflows from sample to results. It is composed of QIAsymphony SP for sample preparation, the QIAsymphony AS for assay setup, and QIAGEN's real-time PCR detection platform Rotor-Gene Q MDx, which received FDA clearance in 2012. While the QIAsymphony platform has the broadest menu in its category in Europe and other markets, the system is currently primarily used for laboratory developed assays in the United States.
“QIAGEN’s highly reliable diagnostics running on the QIAsymphony platform allow customers to experience excellent assay performance, quicker results to benefit patients, and improved laboratory efficiency. The expanding content menu adds value to QIAsymphony, which has become the system of choice in medium-throughput molecular testing,” said Peer M. Schatz, Chief Executive Officer.
“The U.S. submission of the QIAsymphony RGQ MDx system is a pivotal step in expanding global adoption of the QIAsymphony platform to revolutionize laboratory workflows. As novel new content continues to emerge from our pipeline, users will be able to consolidate the broadest range of molecular tests available on a single instrument platform,” Mr. Schatz said. “The QIAsymphony platform is positioned for long term, strong growth for QIAGEN. In 2013 we exceeded our target of 1,000 placements and we now target more than 1,250 placements by the end of 2014 and 1,500 by the end of 2015. The strong increase in placements coupled with the expanding menu creates an exciting future for this franchise.”
Healthcare-associated infections - addressing an urgent need
Healthcare-associated infections (also called HAIs) affect an estimated 5.8 million hospitalized patients a year in Europe and the United States, leading to more than 100,000 deaths, according to the World Health Organization. These pathogens also impose an economic burden with direct costs estimated at 7 billion euros in Europe and $6.5 billion in the U.S. due to extra days of hospitalization, according to the World Health Organization. Figures are less precise in less developed regions of the world, but HAIs pose a global challenge in healthcare.
The C. difficile tests launched in Europe and under review in the U.S. will aid in the diagnosis of Clostridium difficile infection, the most prevalent HAI in the United States. C. difficile often infects patients in hospitals or nursing facilities, causing symptoms ranging from diarrhea to life-threatening inflammation of the colon. QIAGEN’s ready-to-use molecular assay delivers sensitive and specific detection of both toxin A and toxin B of C. difficile. This assay for the QIAsymphony system was developed in partnership with IntelligentMDx, based in Waltham, Massachusetts, under a multiyear agreement.
QIAGEN aims to market the broadest test portfolio for healthcare associated infections in Europe, North America and rest of the world. The VanR and MRSA/SA tests are in advanced stage of development and will be submitted for clearance this year, followed by further additions to QIAGEN’s HAI panel as well as other panels.
QIAsymphony content menu expanding
QIAGEN’s portfolio now includes more than 20 CE-marked assays in Europe along with one FDA-cleared and two FDA-approved diagnostic assays in the United States designed to run on the Rotor-Gene Q MDx platform, which is part of the QIAsymphony family. About 35 new tests are currently in development for a variety of biomarkers.
In Personalized Healthcare, the QIAsymphony content menu continues to add companion diagnostics in cancer and other diseases. In January, the CE-marked therascreen IDH1/2 RGQ Kit was launched in Europe, enabling physicians to better diagnose and assess the prognosis of patients with gliomas (tumors of the brain and spinal cord). QIAGEN has partnered with more than 15 leading pharmaceutical and biotechnology companies to co-develop additional companion diagnostics.
In Profiling of infectious diseases, the RespiFinder RG Panel, a multiplex PCR assay for the simultaneous detection and differentiation of 21 respiratory pathogens, also was recently launched in Europe. It is the first highly multiplexed pathogen assay designed to run on the Rotor-Gene Q.
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 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).