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Epigenomics AG

EANS-News: Epigenomics Initiates Clinical Market Observation Study for Colorectal Cancer Blood Test

Berlin and Seattle, November 23, 2010 (euro adhoc) -

  Corporate news transmitted by euro adhoc. The issuer/originator is solely
  responsible for the content of this announcement.
Company Information/Molecular diagnostics
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a chemical stool test, which is outdated in performance and lacks convenience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."
-Ends-
Contact Epigenomics AG
Dr. Achim Plum
Sen. VP Corporate Development
Epigenomics AG
Tel +49 (0) 30 24345 0 
pr@epigenomics.com
www.epigenomics.com
About Epigenomics
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
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.
end of announcement                               euro adhoc

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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