QIAGEN signs ninth master collaboration agreement for companion diagnostics

  • Master collaboration agreement is a framework for developing and commercializing QIAGEN companion diagnostics, paired with new or existing products
  • New agreement provides options across therapeutic areas
  • Collaboration adds to QIAGEN’s more than 20 projects with pharma companies for development of blood- or tissue-based biomarker tests to guide treatments
  • Hilden, Germany, and Manchester, England, November 11, 2014 — QIAGEN N.V. (NASDAQ: QGEN; Frankfurt Prime Standard: QIA) today announced it has entered into a master collaboration agreement with the Swiss pharmaceutical company Novartis AG to enable the development and commercialization of companion diagnostics to be paired with existing Novartis pharmaceutical products as well as compounds in its development pipeline.

    The non-exclusive agreement with Novartis creates a framework for collaborations that would include developing QIAGEN companion diagnostics to guide treatment decisions for Novartis pharmaceutical products. The scope of the collaboration can cover all QIAGEN platforms, indications or biomarkers. Financial terms of the agreement were not disclosed.

    The collaboration with Novartis is the ninth master framework agreement reached by QIAGEN for the development of companion diagnostics, underscoring its position as the preferred partner to pharma companies.

    “We are very pleased to be working with Novartis in the development and commercialization of companion diagnostics to support their innovative pharmaceutical products. Healthcare providers are increasingly benefitting from personalized treatment strategies based on genomic insights, to select the right drug for the right patient at the right time and in the right dose," said Peer M. Schatz, Chief Executive Officer of QIAGEN N.V. “This broad agreement gives Novartis and QIAGEN the flexibility to pursue co-development projects. We are committed working with our partners like Novartis to make improvements in life possible.”

    QIAGEN is pursuing more than 20 collaborative projects with Pharma and biotech companies to develop, validate and market companion diagnostics designed to guide the treatment of cancers and other diseases. Around the world, QIAGEN already markets companion diagnostics based on molecular biomarkers, and the company has a growing portfolio of novel targets in development.

    The companion diagnostic programs span a range of platforms for molecular testing. A number of the diagnostics are real-time PCR assays for analysis on QIAGEN’s Rotor-Gene Q, a component of the QIAsymphony family of automated instruments. For example, QIAGEN received FDA approvals in 2012 and 2014 for its therascreen® KRAS RGQ PCR Kit in colorectal cancer and in 2013 for the therascreen® EGFR test in NSCLC – both running on Rotor-Gene Q. In addition, QIAGEN is a leader in developing universal solutions for NGS platforms which include a broad number of gene panels that cover an extensive range of cancer-related genes and gene regions. A recent addition to the portfolio of QIAGEN platforms for companion diagnostics is the multi-modal, multi-analyte Modaplex system, which enables laboratories to analyze multiple sample types simultaneously for dozens of DNA and RNA biomarkers.

    QIAGEN also is pioneering companion diagnostics based on blood or other fluid samples for medical situations that make surgical biopsies difficult. QIAGEN has collaborations to develop first-in-class, non-invasive tests for genetic biomarkers using liquid biopsies, which use blood or other fluid samples rather than tissue samples. QIAGEN’s liquid biopsy technologies include industry-leading kits for processing free-circulating DNA and RNA, genomic material from single cells, or exosomes circulating in the body.

    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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