Berlin, Germany, and Seattle, WA, U.S.A., May 6, 2011
Epigenomics AG (Frankfurt Prime Standard: ECX), the cancer molecular diagnosis company, today announced the signing of a supply agreement with Life Technologies Corporation, a global provider of innovative life science solutions. As the Original Equipment Manufacturer (OEM) Life Technologies will supply its Dynabeads® MyOne™ SILANE and buffers for Epigenomics’ Epi proColon® 2.0 – the company’s second-generation colorectal cancer blood test that is in development for the European and U.S. in vitro diagnostic (IVD) market.
Compared to the first generation test system, Epi proColon® 2.0 requires fewer components and handling steps, and can reach results within eight hours, making it easier to automate on a wide range of IVD automation solutions. A key feature of the new product is the use of Dynabeads® MyOne™ SILANE, which are monosized, magnetic beads that bind to nucleic acids (NAs, e.g. DNA) in biological samples. By applying a magnetic field, the Dynabeads®-NA complex can be separated and the NAs concentrated for diagnostic analysis such as the detection of methylated DNA of the SEPT9 gene, the biomarker that is targeted by Epi proColon® 2.0. Dynabeads®and associated reagents are manufactured in compliance with the quality management systems ISO 13485:2003 in Life Technologies’ facilities in Oslo, Norway.
All modifications to the assay incorporated into Epi proColon® 2.0 result in significantly improved clinical performance. In a feasibility study that included 97 colorectal cancer cases and 159 colonoscopy-confirmed controls, the detection of cancer cases was improved to a sensitivity of 91% at 87% specificity. In this study, the new assay identified 21 out of 27 Stage I cancer cases (78%) and 25 out of 25 Stage II cancer cases (100%). This is critically important since patients with Stage I and II of colorectal cancer have a combined five-year survival of about 90% and early clinical interventions can significantly improve survival. Stage III and Stage IV cancers were detected at sensitivities of 92% and 100%, respectively.
Dr. Uwe Staub, Senior Vice President Product Development at Epigenomics commented: “Securing access to Life Technologies’ magnetic beads and reagents for our second-generation Septin9 test has been very important for the development of Epi proColon® 2.0. By including these crucial components into our assay along with some other modifications, we were able to significantly improve clinical performance and shorten the overall time to result allowing for testing of higher volumes of samples.”
“Life Technologies prides itself in providing sophisticated technology for next-generation molecular diagnostics solutions that can have a major impact on human health and disease,” said Ole Dahlberg, Country Manager Life Technologies Norway. “The supply agreement between our two companies underscores the commitment to develop and launch new diagnostic applications.”
Epigenomics is currently transferring the manufacturing of its Epi proColon® 2.0 assay to its contract manufacturer NextPharma based in San Diego, CA, U.S.A. Epigenomics plans to conduct analytical and clinical validation studies in the second half of 2011. The company expects to submit a pre-market approval application (PMA) for Epi proColon® 2.0 to the FDA before year-end 2011.
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Epigenomics is a molecular diagnostics company developing and commercializing a pipeline of proprietary products for cancer. 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.
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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.