QIAGEN and AstraZeneca Collaborate to Develop Liquid Biopsy-Based Companion Diagnostic to Advance EGFR Mutation Profiling in Lung Cancer Patients

HILDEN, Germany and LONDON, July 28, 2014 /PRNewswire/ --

• Collaboration aims to create and commercialize companion diagnostic using genomic data from plasma samples to guide the use of IRESSA  for non-small cell lung cancer patients 
• New blood test will build on QIAGEN's FDA-approved therascreen  EGFR test and is planned to run on Rotor-Gene Q, member of the QIAsymphony family of automated instruments 
• Project enabled by AstraZeneca master framework agreement adds to QIAGEN's growing portfolio of liquid biopsy solutions, which  complement tissue-based testing solutions 

QIAGEN (NASDAQ: QGEN; Frankfurt, Prime Standard: QIA) today announced a collaboration agreement with AstraZeneca PLC (LSE, NYSE and OMX: AZN) for the co-development and commercialization of a liquid biopsy-based companion diagnostic to be paired with IRESSA, AstraZeneca's targeted therapy for non-small cell lung cancer (NSCLC). The project builds on a master framework agreement signed by both companies in 2013 and aims to develop and market a novel QIAGEN companion diagnostic that analyzes plasma samples to assess EGFR mutation status in NSCLC patients. The assay will be designed to guide the treatment of NSCLC patients with Astra Zeneca's oral monotherapy anti-cancer treatment when tumour tissue is not available. QIAGEN already offers the therascreen EGFR RGQ PCR Kit (therascreen EGFR test) as a tissue-based companion diagnostic for lung cancer patients, which was approved in the U.S. by the FDA in July 2013 and in China in May 2014.

The companies will collaborate to create a new companion diagnostic for IRESSA based on liquid biopsy samples from NSCLC patients, rather than requiring invasive surgical collection of tissue samples. Data from several studies, including the IFUM Study (IRESSA Follow-up Measure) presented at the "World Lung 2013" conference, provided evidence of the ability to assess the EGFR status of advanced lung cancer patients using blood / plasma samples. This breakthrough provides hope for patients for whom surgical biopsy is not an option by enabling them to have their EGFR mutation status assessed using a less invasive method.

Mondher Mahjoubi, Senior Vice President, Global Product Strategy for Oncology at AstraZeneca, said: "By combining AstraZeneca's expertise in lung cancer with QIAGEN's diagnostic capabilities, we have the potential to transform the way specific tumour types are identified and treated. The use of circulating tumour DNA testing will allow doctors to target the individual needs of each patient quickly and accurately."

"We are very pleased to collaborate with AstraZeneca in developing this new tool to improve life for lung cancer patients. This collaboration will further expand QIAGEN's rapidly growing portfolio of liquid biopsy solutions for personalized healthcare which paves a path for patient monitoring using blood tests for future QIAGEN therascreen companion diagnostics. We are changing the treatment landscape with highly reliable genomic tests based on blood samples or other body fluids, providing physicians and patients with additional options to determine treatments and monitor progress," said Peer M. Schatz, Chief Executive Officer of QIAGEN. "This new project with AstraZeneca under our master collaboration agreement, one of several such Pharma partnerships, adds to our expanding portfolio of reliable companion diagnostics which are creating valuable test content for the QIAsymphony family of automated instruments. As tests are developed, commercialization is accelerated through the established network of laboratories already using assays in QIAGEN's industry-leading portfolio of companion diagnostics."

IRESSA is an epidermal growth factor receptor-tyrosine kinase (EGFR-TK) inhibitor that acts to block signals for cancer cell growth and survival. Certain EGFR gene mutations occur in a significant number of lung cancers, and these mutation-positive tumours are particularly sensitive to IRESSA. QIAGEN and AstraZeneca plan to develop a test that detects 21 EGFR mutations to identify patients most likely to benefit from the therapy, adapting QIAGEN technologies from the FDA-approved therascreen^® EGFR RGQ PCR Kit. The new test kit is planned to run on QIAGEN's Rotor-Gene Q system, a member of the QIAsymphony family of automated instruments.

QIAGEN is at the forefront in developing and validating companion diagnostics to guide the selection of medicines in treating cancer and other diseases. In the United States, QIAGEN received FDA approvals in 2012 and 2014 for the therascreen^® KRAS RGQ PCR Kit in colorectal cancer and in 2013 for the therascreen EGFR test in NSCLC. Last month, QIAGEN announced a collaboration with Lilly to develop companion diagnostics for simultaneous analysis of DNA and RNA biomarkers in common cancers. Earlier this year, QIAGEN entered into a collaboration with Exosome Diagnostics to develop first-in-class, non-invasive diagnostics for key genetic biomarkers in lung and other cancers. QIAGEN's leading portfolio of liquid biopsy technologies also includes the QIAamp Circulating Nucleic Acid Kit, which is considered to be the gold standard sample technology for the processing of free circulating DNA and RNA, as well as the REPLI-g product line, which enables genomic analysis from single cells.

About QIAGEN 

QIAGEN N.V. is a Netherlands holding company publically traded on NASDAQ and Frankfurt Prime Standard. The Company is the leading global provider of Sample & Assay Technologies that are used to transform biological materials into valuable molecular insights. 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 more than 4,000 people in over 35 locations worldwide. Further information can be found at http://www.qiagen.com

About AstraZeneca 

AstraZeneca is a global, innovation-driven biopharmaceutical business that focuses on the discovery, development and commercialization of prescription medicines, primarily for the treatment of cardiovascular, metabolic, respiratory, inflammation, autoimmune, oncology, infection and neuroscience diseases. AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide. For more information please visit: http://www.astrazeneca.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).

Contacts:
Public Relations:
Dr. Thomas Theuringer
Director Public Relations
+49-2103-29-11826
+1-240-686-7425
Email: [email protected]

http://www.twitter.com/qiagen
pr.qiagen.com

Investor Relations:
John Gilardi
Vice President Corporate Communications and Investor Relations
+49-2103-29-11711
+1-240-686-2222
Email: [email protected]
ir.qiagen.com

SOURCE Qiagen