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Epigenomics AG. (2/23/10). "Press Release: Epigenomics AG. Blood Test for Colorectal Cancer Now Available Nationwide in Germany and Switzerland". Berlin & Seattle, WA.

Region Region Germany
Organisations Organisation Epigenomics AG (Frankfurt Prime Standard: ECX, OTCQX: EPGNY)
  Group Epigenomics (Group)
  Organisation 2 Universitätsklinikum Hamburg-Eppendorf (UKE)
  Group University of Hamburg
Products Product Epi proColon® blood test
  Product 2 cancer test, early detection

Colorectal cancer test Epi proColon now available nationwide in Germany and Switzerland four months after product launch

Epigenomics to present recent clinical data at 29th German Cancer Congress (Deutscher Krebskongress) in Berlin, Germany

Only four months after launch, Epigenomics AG (Frankfurt, Prime Standard: ECX), a cancer molecular diagnostics company, today reported that its blood based Septin9 test for colorectal cancer Epi proColon is now available nationwide in Germany and Switzerland. The test which is able to detect colorectal cancer in a simple blood draw is based on Epigenomics' patented biomarker mSEPT9 and is the first blood test ever for colorectal cancer early detection offered in Europe. The test was introduced in October 2009 as a CE-marked in vitro diagnostic product in Europe. As of today, the test is offered by 16 laboratories in Germany and Switzerland making it available to doctors and patients across both countries.

Current colorectal cancer screening methods - including fecal occult blood tests (FOBT) and colonoscopy - are perceived to be inconvenient and laborious and are reluctantly and infrequently used by individuals aged 50 and older who should be screened at regular intervals. This lack of compliance to screening recommendations severely limits the effectiveness of national screening programs as the majority of cancers are detected in advanced stages when symptoms occur and the chances of survival are greatly diminished.
As one of the laboratory networks operating nationwide, Berlin-based MDI - Medizinisches Diagnostisches Institut -started offering the Septin9 test across Germany in February 2010. "The Septin9 test for the early detection of colorectal cancer provides an attractive alternative to current stool-based tests to our clients", commented Dr. Heinz-Detlef Gremmels, Head of the MDI laboratory. "We are confident that many patients will prefer this new approach in cancer screening. With the introduction of the sensitive Septin9 test colorectal cancer cases can be detected earlier and the current high mortality rate from colorectal cancer could be reduced significantly."

The test is based on the detection of methylated Septin9 DNA (mSEPT9) in blood. This epigenetic modification of the Septin9 gene can be detected in the vast majority of tumors in the colon and rectum. As tumors shed DNA into the bloodstream, the detection of circulating methylated Septin9 DNA with the sensitive Epi proColon assay is a reliable indicator of acute colorectal cancer.

The Septin9 colorectal cancer blood test is designed to be as convenient and patient friendly as possible: patients simply provide a blood sample in the doctor's office, e.g. as part of a regular health check-up. The sample is shipped to a local, regional or national diagnostic laboratory where it is tested for the mSEPT9 biomarker. Recent clinical data from a case control study evaluating the performance of the CE-marked Epi proColon in colorectal cancer detection will be presented in a poster presentation by Epigenomics at the German Cancer Congress tomorrow. During the Congress Epigenomics will also host a press conference on Friday, February 26, 2010 on new epigenetic tests in different cancers including a presentation by Prof. Dr. Thomas Rösch, University Hospital Hamburg-Eppendorf titled "The Medical Need of the Septin9 Test Epi proColon for Colorectal Cancer Early Detection".

The German Cancer Congress is organized by the German Cancer Society (Deutsche Krebsgesellschaft e.V.) and is the most important oncology forum in German speaking countries.

Epigenomics at the 29th German Cancer Congress

Epigenomics will be represented at the 29th German Cancer Conference Congress 2010 (Deutscher Krebskongress - DKK) in Berlin, Germany, from February 24th to 27th 2010, with a booth at the ICC Berlin, Hall 17, booth number B15.
A poster presentation (poster number: PO039) titled "The tumor marker mSEPT9 for colorectal cancer early detection: Introduction of current clinical data" will be presented within the Biomarker Session by Dr. Philipp Schatz, Epigenomics AG, Berlin, Germany, on February 24th, 2010, from 1.15 pm to 2.45 pm, in Hall Koch at the ICC Berlin.

A press conference titled "Innovative biomarkers for the diagnosis of lung- and colorectal cancer: Epigenetic tests open new ways in cancer diagnostics" will take place on Friday, February 26th, 2010, from 1:15 pm to 2:45 pm at the press center on the bridge, Room 43, Messedamm 22 at the ICC Berlin. Presentations will be held by Prof. Dr. Thomas Rösch, University Hospital Hamburg-Eppendorf, Dr. Thomas Mairinger, Helios Hospital Emil von Behring, Berlin-Zehlendorf and Dr. Achim Plum, Epigenomics AG, Berlin.

Interested Journalists and Media are kindly requested to contact Sandra Leinhoss via Email: for participation details.

About Epi proColon

Epi proColon is Epigenomics' CE-marked, in vitro diagnostic real-time PCR test kit for the qualitative detection of Septin9 gene methylation in cell-free bisulfite converted DNA isolated from human plasma samples. Presence of methylated Septin9 DNA is associated with, and may aid in, the detection of invasive colorectal adenocarcinoma.

For more information on the Epi proColon test and its availability and distribution options in Europe please visit or contact Epigenomics directly by Email or phone +49 30 24345 111.

Epi proColon is not for sale in the United States of America. The analytical and clinical performance characteristics of the product have not been evaluated by the US Food and Drug Administration. The product is CE-marked in compliance with the European IVD Directive 98/79/EC.

About Colorectal Cancer

Colorectal cancer (or colorectal carcinoma) refers to a malignant growth of the colorectal mucosa. Colorectal cancer develops usually in several phases and over many years, beginning with abnormal cell proliferation inside the colon that over the time forms adenomas that, depending on their shape are often referred to as polyps or flat lesions. These benign precursors can become tumors which are initially localized (stage I or II), but over the course of the disease spread into lymph nodes (stage III) and finally metastasize to distant organs such as the liver, bones or lung (stage IV). The development from a small polyp or a flat lesion to a cancer takes an average of 5 to 10 years.

With approximately 72,000 newly diagnosed individuals each year in Germany, colorectal cancer is the second most frequent gastrointestinal tumor among women and men and about 29,000 individuals die from the disease every year. With approximately 4,100 new cases every year Switzerland is the country with the highest colorectal cancer incidence in Europe. In total 10.4% of all cancer-related deaths in Switzerland are caused by colorectal cancer. The five-year survival rate for patients is about 90% if the cancer is diagnosed at an early stage while it is still localized but drops to below 10% in stage IV. As a consequence, the early diagnosis of colorectal cancer is of the highest importance to a successful therapy.

About Epigenomics

Epigenomics 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 aim at diagnosing cancer at an early stage before symptoms occur and thereby may reduce mortality from this dreaded disease.

Epigenomics' product portfolio contains the CE-marked IVD test Epi proColon, the world's first regulatory cleared molecular diagnostic test for the detection of colorectal cancer in blood that is based on the biomarker Septin9, and further proprietary DNA methylation biomarkers and IVD products at various stages of development for colorectal, lung and prostate cancer. 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, and ARUP 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, U.S.A. For more information, please visit Epigenomics' website at

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 in the United States. The analytical and clinical performance characteristics of any product based on this technology which may be sold at some future time in the U.S. have not been established.

Record changed: 2017-04-02


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