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EANS-News: Epigenomics AG reports progress in clinical development of its colorectal cancer blood test during Digestive Disease Week

mSEPT9 biomarker facilitates innovative blood test for colorectal 
cancer
mSEPT9 data published in Clinical Chemistry
PRESEPT 
Study for colorectal cancer screening with mSEPT9 well on track
  Corporate news transmitted by euro adhoc. The issuer/originator is solely
  responsible for the content of this announcement.
new product/research/Molecular diagnostics
Press release, Berlin, Germany, and Seattle, WA, USA, June 2, 2009 
(euro adhoc) - Epigenomics AG (Frankfurt Prime Standard: ECX), a 
molecular diagnostics company focusing on the development and 
commercialization of products for cancer detection based on DNA 
methylation, today reports on the status and progress in the clinical
development of its blood test for colorectal cancer in a poster 
presentation during this year's Digestive Disease Week (DDW) in 
Chicago. The test, which is able to detect colorectal cancer in a 
simple blood draw, is based on Epigenomics' patented mSEPT9 
biomarker. The Digestive Disease Week is the largest and most 
prestigious conference for gastroenterologists worldwide.
Dr. Catherine Lofton-Day, Vice President Molecular Biology and 
project manager of the PRESEPT Study at Epigenomics, will present an 
overview on Epigenomics' discovery and clinical validation work for 
the mSEPT9 biomarker. In particular she will focus on the results of 
two case-control studies with several hundred patients finished in 
2008 to demonstrate the performance of the mSEPT9 biomarker in 
detecting colorectal cancer in blood samples. The study results were 
recently published in a peer-reviewed publication in Clinical 
Chemistry titled "Circulating Methylated Septin 9 DNA in Plasma is a 
Biomarker for Colorectal Cancer".
"The two case control studies now published are the latest in a 
series of seven published studies with over 3,000 cancer patients and
controls in which we demonstrated the underlying principle of the 
test that our mSEPT9 assay reliably detects DNA derived from 
colorectal tumors in blood samples, thereby indicating the presence 
of colorectal cancer of all stages", explained Dr. Lofton-Day.
Furthermore Dr. Lofton-Day will focus on the progress of the PRESEPT 
Study that is sponsored by Epigenomics. PRESEPT is a multi-center, 
multinational clinical study to prospectively evaluate the clinical 
utility of the mSEPT9 testing for population-wide colorectal cancer 
screening. The study includes individuals at average to increased 
risk for colorectal cancer who have been scheduled for a screening 
colonoscopy in the U.S. The study population of about 7,500 
individuals is expected to harbor about 50 cases with undetected 
colorectal cancer. The results of the mSEPT9 blood testing, which 
will be performed in independent laboratories, will be compared to 
the results of colonoscopy - the gold standard in colorectal cancer 
diagnosis - to demonstrate the performance of this innovative test in
colorectal cancer screening. The performance characteristics 
determined in the PRESEPT Study will also provide input for a health 
economic evaluation of mSEPT9 blood testing for population-wide 
colorectal cancer screening. It is one of the first studies ever to 
evaluate the performance of a non-invasive test using a standard 
blood draw to indicate the presence of colorectal cancer in a cohort 
representing the colorectal cancer screening population.
"To this date we have made great progress in our PRESEPT Study and we
are confident the original schedule will be kept with first results 
presented by the end of this year", explained Dr. Lofton-Day. 
According to Dr. Lofton-Day approximately 4,400 individuals have been
enrolled into the study and more than half of the 50 expected cases 
with previously undetected colorectal cancers have been identified.
It is anticipated that a positive outcome of the PRESEPT Study would 
promote rapid acceptance among primary care physicians and 
gastroenterologists of this novel diagnostic method as an aid in 
detecting early stage colorectal cancer. Epigenomics and its partners
intend to launch both an in vitro diagnostic mSEPT9-based blood test 
in Europe, and laboratory developed test (LDT) in the U.S. still in 
2009.
2009 Digestive Disease Week Presentation Details
The poster titled "Circulating Methylated Septin 9 DNA in Plasma is a
Biomarker for colorectal cancer" by Theo de Vos, Reimo Tetzner, 
Fabian Model, Gunter Weiss, Matthias Schuster, Juergen Distler, 
Robert Grützmann, Christian Pilarsky, Jens K. Habermann, Phillip 
Fleshner, Benton M. Oubre, Robert W. Day, Andrew Sledziewski, Michael
Wandell, and Catherine Lofton-Day will be presented at the Digestive 
Disease Week 2009 in Chicago, on June 2, 2009, 8 am - 5 pm at 
McCormick Place, South Hall, by Dr. Catherine Lofton-Day, Vice 
President Molecular Biology and Project Manager PRESEPT at 
Epigenomics.
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 in development aim at diagnosing 
cancer at an early stage before symptoms occur and thereby may reduce
mortality from this dreaded disease.
Epigenomics' product pipeline contains a validated biomarker for the 
early detection of colorectal cancer in blood plasma, and further 
proprietary DNA methylation biomarkers at various stages of 
development for prostate and lung cancer detection in urine, blood 
and bronchial lavage specimens. Epigenomics' biomarker mSEPT9 for the
early detection of colorectal cancer in a simple blood sample has 
demonstrated continuously highest performance in multiple clinical 
studies with in total more than 3,000 individuals tested. A large 
prospective clinical study - PRESEPT - for evaluation of mSEPT9 in a 
screening population is currently under way (www.presept.net).
For development and global commercialization of in vitro diagnostic 
test products, Epigenomics pursues a non-exclusive partnering 
strategy. Strategic diagnostics industry partners include Abbott 
Molecular, Philips, Sysmex Corporation and Quest Diagnostics 
Incorporated for diagnostics test products and services, and QIAGEN 
N.V. for sample preparation solutions and research products.
Partners in the health care industry and the biomedical research 
community can access Epigenomics' portfolio of proprietary DNA 
methylation technologies and biomarkers protected by more than 150 
patent families through research products, Biomarker Services, IVD 
Development Collaborations, and Licensing. The company is 
headquartered in Berlin, Germany, and has a wholly owned subsidiary 
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, 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, Technologie All Share
Börsen: Frankfurt / regulated dealing/prime standard
Berlin / free trade
Hamburg / free trade
Stuttgart / free trade
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München / free trade

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