EANS-News: PRESEPT Study Results Sponsored by Epigenomics AG Presented at Digestive Disease Week

mSEPT9 biomarker successfully validated as the first biomarker in
blood capable of detecting previously unsuspected colorectal cancers
in prospective colorectal cancer screening study

Final data to be
submitted for publication in top-tier journal

The CE marked Epi
proColon assay, based on mSEPT9, provides attractive and convenient
alternative for colorectal cancer screening

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Company Information/Studies/ Molecular diagnostics

Subtitle: mSEPT9 biomarker successfully validated as the first
biomarker in blood capable of detecting previously unsuspected
colorectal cancers in prospective colorectal cancer screening study

Final data to be submitted for publication in top-tier journal

The CE marked Epi proColon assay, based on mSEPT9, provides
attractive and convenient alternative for colorectal cancer screening

Press release Berlin, Germany, and Seattle, WA, USA, May 05, 2010
(euro adhoc) - Epigenomics AG (Frankfurt Prime Standard: ECX), a
cancer molecular diagnostics company, announced today that the
PRESEPT Study results have been presented, in a Late-Breaking
Abstracts Session during this year's Digestive Disease Week (DDW) in
New Orleans. PRESEPT is a prospective multicenter multinational
clinical research study started in 2008 to evaluate the performance
characteristics and health economic benefit of colorectal cancer
screening using Epigenomics' mSEPT9 blood biomarker in a screening
population. Digestive Disease Week is the largest and most
prestigious conference for gastroenterologists worldwide.

The results were presented by Timothy R. Church, Ph.D., University of
Minnesota, Minneapolis, MN, U.S.A., Principal Investigator of the
PRESEPT Study on behalf of the PRESEPT Clinical Study Steering
Committee. The presentation summarized the results obtained from
testing three replicates for the presence of mSEPT9, which exhibited
a sensitivity of 66.7 % at a specificity of 88.4% in this cohort.

The final data of the PRESEPT Study will be submitted for publication
to a top-tier journal for peer review in due course.

Dr. Catherine Lofton-Day, Vice President Molecular Biology and
project manager of the PRESEPT Study at Epigenomics explained: "We
are very pleased with the results of our PRESEPT Study. The results
show that our mSEPT9 test meets the requirements for routine use in a
true screening population and could provide an attractive alternative
for patients not willing to accept current screening methods.
Furthermore the test could have the potential to resolve the problem
of poor patient compliance in CRC screening."

The PRESEPT Study is one of the largest commercially sponsored
colorectal cancer screening clinical studies ever conducted. Between
June 2008 and December 2009, in total 7,940 screening eligible
average risk subjects were enrolled into the PRESEPT Study at 32
clinical sites in the U.S. and Germany. This study population
contained 53 cases of previously unsuspected colorectal cancers that
were identified by screening colonoscopies performed on all study
participants. Over two-thirds of the 53 colorectal cancer cases
identified in the cohort were early stage disease (Stages I and II)
with a large proportion of the stage I colorectal cancer cases being
very early stage disease (histopathologically described as pT1).

Tim Church on behalf of the CSSC concluded that this prospective,
blinded study validates that a plasma-based marker can be used to
detect preclinical colorectal cancer in asymptomatic individuals.

A simple blood test for colorectal cancer screening that is available
for the large group of eligible patients, who are unwilling or unable
to use other available methods, has the potential to address the lack
of compliance with today's screening approaches. Based on the mSEPT9
marker performance data and the prevalence of colorectal cancer
observed in the PRESEPT Study cohort, a primary care physician
informing a patient of a mSEPT9 test result that is negative for
colorectal cancer can do so with the confidence of it being correct
99.7% of the time (Negative Predictive Value).

Geert Nygaard, CEO of Epigenomics AG, further stated: "Having
demonstrated the performance of our mSEPT9 biomarker in this
prospective screening cohort is of tremendous value to our efforts of
securing guideline inclusion and reimbursement in the major markets
and thereby making a convenient blood-based colorectal cancer
screening test available to the broader population."

2010 Digestive Week Presentation Details and other Activities

The presentation titled "Prospective clinical validation of an assay
for methylated SEPT9 DNA in human plasma as a colorectal cancer
screening tool in average risk men and women 50 years and older"
presented by Timothy R. Church, PhD. has been held at the Digestive
Disease Week 2010 (from May 1 - May 5, 2010), in New Orleans during
a Late-Breaking Abstracts Session on Tuesday, May 4, 2010.

Furthermore Dr. Catherine Lofton-Day Vice President Molecular Biology
and project manager of the PRESEPT Study at Epigenomics held a
presentation titled "Looking into alternatives: blood-based tests for
CRC screening" at the World Organization of Digestive Endoscopy
(OMED) Meeting.

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 mSEPT9, 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

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 outside of the
European Union, 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
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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
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