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EANS-News: Epigenomics AG: Blood Test for Colorectal Cancer Now Available Nationwide in Germany and Switzerland

Geschrieben am 23-02-2010

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


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Corporate news transmitted by euro adhoc. The issuer/originator is solely
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New Products/Molecular diagnostics/ Congress

Subtitle: 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

Press release, Berlin, Germany, and Seattle, WA, U.S.A., February 23,
2010 (euro adhoc) - 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: sandra.leinhoss@epigenomics.com 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
{www.epiprocolon.com}[HYPERLINK: http://www.epiprocolon.com] or
contact Epigenomics directly by Email
{sales@products.epigenomics.com}[HYPERLINK:
mailto:sales@products.epigenomics.com] 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 {www.epigenomics.com}[HYPERLINK:
http://www.epigenomics.com/].

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.


end of announcement euro adhoc
--------------------------------------------------------------------------------


ots Originaltext: Epigenomics AG
Im Internet recherchierbar: http://www.presseportal.de

Further inquiry note:

Epigenomics AG

Dr. Achim Plum

Sen. VP Corporate Development

Tel: +49 30 24345 368

achim.plum@epigenomics.com

Branche: Biotechnology
ISIN: DE000A0BVT96
WKN: A0BVT9
Index: Prime All Share, Technology All Share
Börsen: Frankfurt / regulated dealing/prime standard
Berlin / free trade
Hamburg / free trade
Stuttgart / free trade
Düsseldorf / free trade
München / free trade


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