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Epigenomics AG

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

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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