QIAGEN, Epigenomics enter option agreement to commercialize colorectal cancer blood test

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.