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

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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
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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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