EANS-News: Epigenomics Provides Update on Progress with US Product Development for Epi proColon

- Strong feasibility study data for improved product concept with 91%
sensitivity and 87% specificity
- FDA sets February date for Pre-IDE meeting

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New Products/Molecular diagnostics

Subtitle: - Strong feasibility study data for improved product concept with 91%
sensitivity and 87% specificity
- FDA sets February date for Pre-IDE meeting

Berlin, Germany, and Seattle, WA, USA, January 13, 2011 (euro adhoc) -
Epigenomics AG (Frankfurt Prime Standard: ECX), the cancer molecular diagnostic
company, today announced that it has concluded the feasibility phase in the
development of an improved product concept for Epi proColon, the Company´s DNA
methylation-based blood test for assistance in the detection of individuals with
colorectal cancer. This improved product concept is being developed for the US
market and as a second generation product for the European and other markets. At
the same time, the FDA has set a date in February for a Pre-IDE meeting to
discuss with Epigenomics the product concept, its intended use and the clinical
data required to support an application for marketing of the product in the US.

Epi proColon is currently marketed in Europe and a number of other countries

outside the USA and its utility in the early detection of colorectal
cancer in a blood draw is extensively supported by numerous clinical
studies. While the new assay measures the same epigenetic information
in the Septin9 gene, design changes have been implemented that are
based on the findings in the more recent studies performed by
Epigenomics and its partners as well as feedback from current
customers in Europe and market surveys in the US. The new device will
use reagents manufactured under the cGMP standard and a real-time PCR
platform that has previously been cleared by the FDA for use with
diagnostic assays. Performing the assay will require fewer components
and handling steps and results can be obtained within a typical
laboratory work shift of 8 hours. Further, the new assay will have
improved automation capabilities.

In a feasibility study that included 97 colorectal cancer patients
and 159 colonoscopy-confirmed controls in the improved assay had a
sensitivity for cancer of 91% at 87% specificity. In this study, the
test was able to identify 22 out of 27 Stage I cancer cases (78%) and
25 out of 25 Stage II cancer cases (100%). This is particularly
important as patients with Stage I and II of colorectal cancer have a
combined five year survival of about 90% and early clinical
interventions are effective in improving survival.

Dr. Uwe Staub, Senior Vice President Product Development at
Epigenomics said: "The excellent results of this feasibility study
are a direct reflection of the improvements we have made to the test.
Following our upcoming dialogue with the FDA, we hope to be able to
finalize our clinical validation plan for the intended use of the
improved test and later this year run the pivotal study using the
samples already collected as part of the prospectively enrolled
PRESEPT cohort. It should be noted that the higher proportion of pT1
subgroup of Stage I cases may mean that the sensitivity in a
prospective evaluation would not be as high as we have just seen in
the feasibility study."

Geert Nygaard, Chief Executive Officer of Epigenomics added: "We are
delighted to have this confirmation that the improvements and
adaptations we made to the assay should result in a product that
meets USFDA as well as European regulatory and market requirements
but also shows potentially improved clinical performance. We are
looking forward to our upcoming discussions with the FDA, which
commence shortly. Once those discussions conclude in the period
following our face-to-face meeting we will be in the position to
provide more detail on the next steps towards launching our Epi
proColon test in the US."

The Company also intends to make the improved next generation Epi
proColon product available in Europe and other markets once it has
been adapted to the LightCycler 480 as well as the AB7500 instruments
currently used in these markets. The second generation product is
likely to reach these markets by during the second half of 2011.

-Ends-

Contact Epigenomics AG
Dr. Achim Plum
Sen. VP Corporate Development
Epigenomics AG
Tel +49 (0) 30 24345 368
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.

About Epi proColon

Epi proColon, developed by Epigenomics, is a test for the detection
of methylated DNA of the Septin9 gene in blood plasma. Detection of
this Septin9 biomarker in blood plasma 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.

Lack of patient adherence to screening recommendations is the biggest
hurdle to an effective screening for colorectal cancer. Experts
believe that a blood test that is more convenient for the patients
than stool tests and colonoscopy could help to get more people
screened and thus be of medical and health economic benefit.

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 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.

end of announcement euro adhoc
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ots Originaltext: Epigenomics AG
Im Internet recherchierbar: http://www.presseportal.de

Further inquiry note:

Dr. Achim Plum
Sen. VP Corporate Development
Epigenomics AG
Tel: +49 30 24345 368
achim.plum@epigenomics.com

Branche: Biotechnology
ISIN: DE000A0BVT96
WKN: A0BVT9
Index: Prime All Share, Technology All Share
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