Epigenomics and QIAGEN Sign Collaboration Agreement in Colorectal Cancer Blood Testing

Epigenomics AG (FWB:ECX), the cancer molecular diagnostics company, and QIAGEN (NASDAQ: QGEN; Frankfurt, Prime Standard: QIA) today announced that the companies have entered into an option agreement allowing QIAGEN to develop and, should QIAGEN exercise the option, commercialize a colorectal cancer blood test based on Epigenomics’ proprietary biomarker mSEPT9 and certain DNA methylation analysis technologies.

Under the terms of the agreement, QIAGEN receives an option to a worldwide non-exclusive commercial license to Epigenomics’ proprietary mSEPT9 biomarker and DNA methylation technologies for the detection of colorectal cancer in blood. The option can be exercised by QIAGEN within the next two years. Furthermore, Epigenomics has granted QIAGEN a research license to the mSEPT9 biomarker and the technologies. Under this license, QIAGEN is currently developing a novel sample preparation technology that meets the requirements for the future broad implementation of methylation-based molecular diagnostics, such as Septin9-targeted blood testing for the detection of colorectal cancer, on QIAGEN’s modular molecular testing platform QIAsymphony. Epigenomics will support QIAGEN in the R&D phase through know-how transfer and the collection of clinical specimens as required.

Geert Nygaard, CEO of Epigenomics, commented: "With a clear focus on cancer molecular diagnostics and proven excellence in its fully integrated sample preparation and assay technology platforms for molecular testing, QIAGEN is an ideal further partner to give laboratories and thereby physicians and patients broad access to colorectal cancer blood testing as a convenient addition to currently available methods for early detection. This new agreement significantly expands our existing long-lasting and successful partnership with QIAGEN, and we are looking forward to moving this project to the next stage.”

Under the terms of the option agreement, Epigenomics will receive an upfront payment from QIAGEN and will be reimbursed for any R&D support and clinical specimens provided during the R&D phase. Upon QIAGEN exercising the option Epigenomics would receive a further license payment. Once QIAGEN commercializes a colorectal cancer blood test based on Epigenomics’ biomarkers and technology, Epigenomics would be entitled to royalties on QIAGEN’s net sales as well as certain commercial milestones upon reaching specific revenue targets.

"This agreement adds to our content pipeline and further broadens the menu of assays optimized for superior performance on our novel modular QIAsymphony and QIAensemble platforms”, says Ulrich Schriek, Vice President Global Business Development at QIAGEN. ”QIAGEN has several ongoing programs which target to expand our "Prevention” assay portfolio which currently includes infectious disease assays as well as HPV screening for the early detection of cervical cancer risks. Prevention assays are key contributors to early detection of disease and to significant reduction of disease burden.”

By signing this agreement with QIAGEN, Epigenomics continues to implement its dual business strategy of direct global commercialization of its colorectal cancer blood test, under its own brand name Epi proColon, and non-exclusive licensing of its proprietary mSEPT9 biomarker and DNA methylation technologies to leading companies in the diagnostic industry. Epigenomics employs this strategy to maximize access to colorectal cancer blood testing on a range of diagnostic instrument platforms and accelerate adoption of this innovative and patient-friendly approach to the early detection of colorectal cancer. Today, Septin9 blood testing for colorectal cancer is available in Europe, the Middle East, Asia/Pacific and the U.S.A. based on CE-marked diagnostic products and laboratory-developed tests by Epigenomics and its licensing partners.

Notes to the Editor

About the Septin9 Biomarker and Colorectal Cancer Blood Tests

The mSEPT9 biomarker is at the core of the world’s first molecular diagnostic blood tests for the detection of colorectal cancer commercialized by Epigenomics (Epi proColon) and its partner Abbott Molecular (mS9) as IVD test kits in Europe and Asia/Pacific and its licensees Quest Diagnostics (ColoVantage™), ARUP Laboratories (Methylated Septin9 Test), and Warnex Laboratories (Septin9 Test) as laboratory-developed tests in the US and Canada, respectively. The tests all detect cell-free methylated DNA of the SEPT9 gene, which is indicative of the presence of colorectal cancer.

In numerous studies, Epigenomics and its partners have demonstrated that the detection of the mSEPT9 biomarker in blood plasma correlates with the presence of colorectal cancer and thus can be used as an aid in the detection of this common cancer. These studies include the successfully completed PRESEPT Study, a prospective evaluation of the Septin9 biomarker in a cohort of almost 8,000 individuals representative of a typical screening population.

Today, mSEPT9 is likely the most thoroughly tested and best studied molecular diagnostic biomarker for colorectal cancer detection.

Lack of patient adherence to screening recommendations is the biggest hurdle to an effective screening for colorectal cancer. Experts believe that a blood test that is more convenient for the patients than stool tests and colonoscopy could encourage more people to be screened and thus be of medical and health economic benefit.

About Epigenomics

Epigenomics (www.epigenomics.com) is a cancer molecular diagnostics company developing and commercializing a pipeline of proprietary products. The Company’s products enable doctors to diagnose cancer earlier and more accurately, leading to improved outcomes for patients. Epigenomics’ lead product, Epi proColon, is a blood-based test for the early detection of colorectal cancer, which is currently marketed in Europe and is in development for the U.S.A. The Company’s technology and products have been validated through multiple partnerships with leading global diagnostic companies including Abbott, QIAGEN, Sysmex, and Quest Diagnostics. Epigenomics is an international company with operations in Europe and the U.S.A.

Epigenomics’ legal disclaimers. This communication expressly or implicitly contains certain forward-looking statements concerning Epigenomics AG and its business. Such statements involve certain known and unknown risks, uncertainties and other factors which could cause the actual results, financial condition, performance or achievements of Epigenomics AG to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Epigenomics AG is providing this communication as of this date and does not undertake to update any forward-looking statements contained herein as a result of new information, future events or otherwise.

The information contained in this communication does not constitute nor imply an offer to sell or transfer any product, and no product based on this technology is currently available for sale by Epigenomics in the United States or Canada. The analytical and clinical performance characteristics of any Epigenomics product based on this technology which may be sold at some future time in the U.S. have not been established.

About QIAGEN

QIAGEN N.V., a Netherlands holding company, is the leading global provider of sample and assay technologies. Sample technologies are used to isolate and process DNA, RNA and proteins from biological samples such as blood or tissue. Assay technologies are used to make such isolated bio-molecules visible. QIAGEN has developed and markets more than 500 sample and assay products as well as automated solutions for such consumables. The company provides its products to molecular diagnostics laboratories, academic researchers, pharmaceutical and biotechnology companies, and applied testing customers for purposes such as forensics, animal or food testing and pharmaceutical process control. QIAGEN's assay technologies include one of the broadest panels of molecular diagnostic tests available worldwide. This panel includes the digene HPV Test, which is regarded as a "gold standard" in testing for high-risk types of human papillomavirus (HPV), the primary cause of cervical cancer, as well as a broad suite of solutions for infectious disease testing and companion diagnostics. QIAGEN employs nearly 3,600 people in over 35 locations worldwide. Further information about QIAGEN can be found at www.qiagen.com.

QIAGEN’s legal disclaimer. 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, and to expected growth of QIAGEN's business in India in particular, are forward-looking, such statements are based on current expectations 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 and risks of dependency on logistics), variability of operating results, the commercial development of the applied testing markets, clinical research markets and proteomics markets, nucleic acid-based molecular diagnostics market, and genetic vaccination and gene therapy markets, competition, rapid or unexpected changes in technologies, fluctuations in demand for QIAGEN's products (including fluctuations due to the level and timing of customers' funding, budgets, and other factors), our ability to obtain regulatory approval of our infectious disease panels, 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 its products from competitors' products, market acceptance of QIAGEN's new products and the integration of acquired technologies and businesses. For further information, refer to the discussions in reports that QIAGEN has filed with, or furnished to, the U.S. Securities and Exchange Commission (SEC).