QIAGEN and Lilly collaborate to co-develop companion diagnostics for simultaneous analysis of DNA and RNA biomarkers in common cancers
Fourth oncology project with Lilly expands QIAGEN’s Personalized Healthcare pipeline
Development of modular assay panels focuses on multiple biomarkers targeting cellular pathways associated with innovative cancer therapies under development by Lilly
Project to include assays for QIAGEN’s new multi-modal, multi-analyte Modaplex platform
HILDEN, Germany, and GERMANTOWN, Maryland, May 30, 2014 — QIAGEN N.V. (NASDAQ: QGEN; Frankfurt Prime Standard: QIA) today announced a collaboration with Eli Lilly and Company (NYSE: LLY) to co-develop universal and modular assay panels for the simultaneous analysis of DNA and RNA biomarkers targeting multiple cellular pathways involved in common cancer types. The agreement includes the development of tests that will be based on QIAGEN’s multi-modal, multi-analyte Modaplex analysis platform, which can process multiple sample types and biomarkers in a single test.
“We are excited to add a new stage to our successful collaboration with Lilly, this time co-developing a broad panel of molecular assays covering a range of biomarkers with diverse nucleic acid analytes and modalities to guide the use of tailored therapies. We believe our technology can enhance Lilly’s development of innovative therapies for the benefit of cancer patients,” said Peer M. Schatz, Chief Executive Officer of QIAGEN. “In addition to a broad portfolio of PCR-based assays targeting more than 25 biomarkers, QIAGEN’s Personalized Healthcare offering has expanded to include universal solutions using next-generation sequencing (NGS) and now also a unique and proprietary multi-modal, multi-analyte testing technology. Our collaborations with Lilly are among more than 20 co-development and co-commercialization projects underway with leading pharmaceutical and biotechnology companies.”
Richard B. Gaynor, M.D., Senior Vice President, Oncology-Clinical Product Development and Medical Affairs, of Lilly, said: “Certain applications in biomarker development for tailoring oncology therapeutics require the combined analysis of DNA and RNA, and this collaboration provides a multi-modal, multi-analyte solution that can process multiple sample types and biomarkers in a single test. We are pleased to work with QIAGEN on this novel platform to support our development programs.”
The new collaboration is the fourth project in the two companies’ long-standing partnership. QIAGEN’s therascreen® KRAS RGQ PCR Kit has been widely adopted by laboratories since its 2012 approval by the U.S. Food and Drug Administration (FDA) as a companion diagnostic to detect KRAS gene mutations in metastatic colorectal cancer patients. The test indicates which patients would benefit from a tailored oncology therapy marketed by Lilly and Bristol-Myers Squibb. In 2011, QIAGEN and Lilly partnered to develop a companion diagnostic that evaluates a gene mutation which plays a role in some blood cancers. In 2013, QIAGEN announced a third project, building on a master collaboration agreement, to create a companion diagnostic to guide use of an undisclosed Lilly oncology compound.
QIAGEN offers companion diagnostic programs spanning a range of molecular testing platforms, including real-time PCR assays for use on QIAGEN’s QIAsymphony family and next-generation sequencing (NGS) panels. QIAGEN also offers a novel, multi-modal, multi-analyte platform which was added from PrimeraDx, a privately held Boston-area company. The proprietary technology covers a unique molecular testing approach, enabling laboratories to process multiple samples in a fast, cost-efficient run. The technology allows the analysis of dozens of DNA and RNA biomarkers as well as their copy numbers, expression levels and mutations in one assay and at the same time. This is a key need in particular in companion diagnostics which is not offered by any other platform and therefore represents an attractive addition to QIAGEN’s molecular testing platform options as well as to QIAGEN’s proven assay development capabilities. The platform has been cleared by the FDA in December 2013. The employees of PrimeraDx have joined 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 March 31, 2014, QIAGEN employed approximately 4,000 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, new product developments, new product launches, regulatory submissions, and financing plans 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).