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Epigenomics AG. (11/23/10). "Press Release: Epigenomics Initiates Clinical Market Observation Study for Colorectal Cancer Blood Test". Berlin & Seattle, WA.
Epigenomics AG, the cancer diagnostics company, today announced that they have initiated an observational clinical study for the Epi proColon test to examine adoption patterns in the marketplace.
Epi proColon is the world's first CE-marked molecular diagnostic test for the early detection of colorectal cancer in blood. This diagnostic laboratory test was first launched in October 2009 in Europe and is currently being marketed by Epigenomics to privately insured individuals and self-payors in Germany, Austria and Switzerland and through distributors in other markets.
With the clinical performance of the test's underlying biomarker, Septin9, well established in numerous case control studies and a large prospective screening study, the current study focuses on behavioral and demographic aspects of current users of the test. The observational study is expected to include approximately 300 primary care physicians, enrolling up to 3,000 patients taking the Epi proColon test in Germany and Switzerland. The study, which has recently already been cleared by the Berlin Ethics Board, is expected to be fully enrolled in 2011.
"While the preparedness to pay out of pocket among patients in Switzerland is very high, Germans still tend to rely mostly on the public health care system", explained Dr. Juergen Beck, Senior Vice President Medical Affairs at Epigenomics. "The only non-invasive alternative to colonoscopy for colorectal cancer screening that is currently reimbursed under the German public scheme is a chemical stool test, which is outdated in performance and lacks convenience and patient-friendliness. With this new study, we expect to learn more about those individuals that opt to use our convenient blood test. We expect the results of this study to help with both fine-tuning the positioning of the test in the self-payor market segment and in seeking general reimbursement under the public health care scheme."
Contact Epigenomics AG
Dr. Achim Plum
Sen. VP Corporate Development
Tel +49 (0) 30 24345 0
Epigenomics AG is a molecular diagnostics company with a focus on the development of novel products for cancer. Using DNA methylation biomarkers, Epigenomics' tests on the market and in development for colorectal, lung, and prostate cancer aim at aiding in an earlier and more accurate diagnosis of these diseases thereby potentially increasing the patient's chances of survival.
For development and global commercialization of IVD test products, Epigenomics pursues a dual business strategy in which direct commercialization of proprietary diagnostic test products is combined with non-exclusive licensing to diagnostic industry players with broad customer access. Strategic diagnostics industry partners include Abbott Molecular, Sysmex Corporation, Quest Diagnostics Incorporated, ARUP Laboratories, Inc., and Warnex Laboratories, Inc. for diagnostics test products and services, and QIAGEN N.V. for sample preparation solutions and research products.
The company is headquartered in Berlin, Germany, and has a wholly owned subsidiary, Epigenomics Inc., in Seattle, WA, USA. For more information, please visit Epigenomics' website at www.epigenomics.com.
Notes for editors:
Epi proColon, developed by Epigenomics, is a CE-marked test kit for the detection of methylated DNA of the Septin9 gene in blood plasma. This Septin9 biomarker has been shown in numerous clinical studies to be closely associated with the presence of colorectal cancer and may aid in the detection of this common cancer. Septin9 is one of the best and most systematically validated biomarkers for the early detection of colorectal cancer today. In particular, the recent PRESEPT Study was a successful prospective evaluation of Epi proColon detection of methylated Septin9 in a cohort of about 8,000 individuals representative of a typical screening population.
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 of America. The analytical and clinical performance characteristics of any product based on this technology which may be sold at some future time in the USA have not been established.
Record changed: 2016-06-15
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