EANS-News: Epigenomics AG: PRESEPT Study Subject Enrollment Successfully Completed

7,852 subjects prospectively enrolled including more than 50 cancer
cases

Blood samples selected for testing by independent
biostatistics group

Septin9 testing in three independent
laboratories on track; majority of samples tested

Completion of
PRESEPT Study and reporting of top-line results expected for early
2010

--------------------------------------------------------------------------------
Corporate news transmitted by euro adhoc. The issuer/originator is solely
responsible for the content of this announcement.
--------------------------------------------------------------------------------

Company Information/Molecular diagnostics/Products

Subtitle: 7,852 subjects prospectively enrolled including more than
50 cancer cases

Blood samples selected for testing by independent biostatistics group

Septin9 testing in three independent laboratories on track; majority
of samples tested

Completion of PRESEPT Study and reporting of top-line results
expected for early 2010

Press release, Berlin, Germany, and Seattle, WA, U.S.A., December 17,
2009 (euro adhoc) - Epigenomics AG (Frankfurt Prime Standard: ECX), a
cancer molecular diagnostics company and sponsor of the PRESEPT Study
reports that the enrollment of subjects was successfully completed.
By December 16, total prospective enrollment has reached 7,852 study
subjects at 32 clinical sites in the U.S.A. and Germany. In this
representative screening population a total of 52 potential invasive
colorectal adenocarcinoma cases have been identified by colonoscopy
until that day exceeding the originally targeted number of 50 cases.
To date 49 have been confirmed by pathological examination of tissue
obtained by biopsy or surgical resection. Epigenomics expects the
remaining colorectal cancer cases to be confirmed following scheduled
surgeries during December 2009.

PRESEPT is a prospective multi-center clinical research study started
in 2008 to evaluate the performance characteristics and health
economic benefit of colorectal cancer screening using Epigenomics'
Septin9 blood test in an asymptomatic screening population. Once
completed, the PRESEPT Study will likely be the largest privately
sponsored colorectal cancer screening studies ever conducted. The
PRESEPT screening study follows the successful clinical validation of
the Septin9 biomarker as an aid in the diagnosis of colorectal cancer
in eight case control studies with in total more than 3,300
colorectal cancer patients and controls conducted by Epigenomics
between 2005 and 2009.

With PRESEPT, Septin9 blood testing will be benchmarked against
colonoscopy, the gold standard in colorectal cancer diagnosis, to
determine the sensitivity and specificity of the Septin9 test for
colorectal cancer and different classes of precancerous polyps
(adenomas) when applied in its intended use population. Following a
predefined statistical analysis plan a subset of about 1,500 of the
PRESEPT blood plasma samples were independently selected and are
being tested for Septin9. This subset includes blood samples from all
confirmed invasive colorectal carcinoma cases, 55 cases with
carcinomas in situ, a subset of cases with other advanced adenomas,
approximately two hundred randomly selected cases with polyps less
than 10 mm and a random selection of about one thousand
colonoscopy-verified subjects with no apparent colon disease. The
plasma samples to be tested were selected by an independent
biostatistics team at the University of Minnesota and subject code
and clinical status are masked to the testing laboratories. Following
the Septin9 testing of the plasma samples, the test results are sent
by the testing laboratories directly to the biostatistics team at the
University of Minnesota, where the sample identities will be unmasked
and the Septin9 testing data compared to the colonoscopy results and
the histopathological findings.

The PRESEPT blood samples are tested in three independent
high-profile laboratories, namely Quest Diagnostics Incorporated
headquartered in Madison, NJ, U.S.A., ARUP Laboratories, Salt Lake
City, UT, U.S.A. and the Institute of Laboratory Medicine and
Pathobiochemistry of Charité - Universitätsmedizin Berlin, Germany.
The laboratories use Epigenomics' recently launched CE-marked Epi
proColon test kit to detect the Septin9 biomarker. Testing has been
ongoing since October 2009 and is in the final stages of completion.
After unmasking of the sample identities and data analysis, the Study
Principal Investigator, Dr. Timothy Church, University of Minnesota,
along with the independent PRESEPT Clinical Study Steering Committee,
chaired by Prof. David Ransohoff, University of North Carolina, will
report the results of the PRESEPT Study according to all applicable
standards of scientific and clinical research.

Epigenomics expects to provide initial results in early 2010
demonstrating whether Septin9 testing using the Epi proColon assay
meets the requirements put forth in current US colorectal cancer
screening guidelines in detecting "the majority of prevalent or
incident cancers at the time of testing". The detailed data analysis
will subsequently be submitted to a top-tier journal for peer review
and will be presented at major medical conferences beginning in the
first half of 2010.

"With the last subject enrolled we took an amazing step forward on
our way to finishing the PRESEPT Study," stated Cathy Lofton-Day,
PhD, Project Manager of PRESEPT at Epigenomics, Inc., Seattle. "A
focused effort by our study management staff and devotion to the
PRESEPT Study by our many clinical sites allowed us to reach our
targeted enrollment numbers and maintain our timeline", she added.

"We would not have been able to get this far in completing a
prospective study of this magnitude and medical importance without
the support of our Medical Advisory Board and the PRESEPT Clinical
Study Steering Committee", Michael Wandell, PharmD, PRESEPT Study
Director, Epigenomics Inc., Seattle remarked. "We benefited
enormously from their guidance and confidence in our design and
execution of the study."

More Information on the PRESEPT Study

For more information on the PRESEPT Study, please visit
{www.presept.net}[HYPERLINK: http://www.presept.net] and
{www.clinicaltrials.gov}[HYPERLINK: http://www.clinicaltrials.gov]
(Identifier: NCT00855348).

About the Septin9 test

The Septin9 test was specifically developed for the convenient detection of
invasive colorectal carcinomas of all stages and all locations using a blood
sample obtained by a routine blood draw. The test concept is based on detecting
aberrant DNA methylation of a specific region of the Septin9 gene. Specific
Cytosine residues of the DNA in this region become methylated in colorectal
cancer tissue but not in normal colon mucosa. This aberrant methylation can be
detected by specific amplification of DNA shed into the blood stream by tumor
cells. Detection of colorectal cancer DNA in blood samples by testing for
methylated Septin9 DNA has been demonstrated in multiple case control studies
with more than 3,300 colorectal cancer patients and controls to be a strong
indicator (biomarker) for the presence of colorectal cancer. To make Septin9
testing broadly available to doctors and patients, Epigenomics pursues a dual
strategy of direct commercialization of the Septin9 test and non-exclusive
licensing of the Septin9 biomarker to IVD industry players with broad market
access. Licensees include Abbott Molecular, Sysmex Corporation, Quest
Diagnostics Incorporated, and ARUP Laboratories, Inc.

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 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.

In the U.S. approximately 147,000 people are estimated to be
diagnosed with colorectal cancer in 2009. In Europe, including
Germany, 413,000 cases were diagnosed in 2006. 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.
Accordingly, effective population-wide screening aiming at catching
the cancer in early, still asymptomatic stages is considered key in
lowering the mortality from this disease.

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, Philips,
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 disclaimer. 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.

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