EANS-News: Epigenomics AG Presents Colorectal Cancer Blood Test at ESMO Conference

mSEPT9 biomarker facilitates innovative blood test for colorectal
cancer

PRESEPT Study for colorectal cancer screening with mSEPT9
well on track

First European diagnostic laboratory to offer mSEPT9
testing on 1st July

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new product/research/Molecular Diagnostics

Press release, Berlin, Germany, and Seattle, WA, USA, June 25, 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, will report on the development status and performance of
its blood-based test for colorectal cancer in a poster presentation
during this year's European Society for Medical Oncology (ESMO)
Conference: 11th World Congress on Gastrointestinal Cancer, in
Barcelona, Spain. The European Society for Medical Oncology (ESMO) is
the leading European non-profit, professional organization for
medical oncology with a focus on promoting multidisciplinary cancer
treatment around the world.

Epigenomics' test, which is able to detect colorectal cancer in a
simple blood draw, is based on the patented biomarker mSEPT9. The
biomarker, which has previously been successfully tested in several
case-control studies with more then 3,000 participants in total, is
currently being evaluated for its utility in population wide
colorectal cancer screening in the ongoing prospective PRESEPT Study.

In her presentation, Dr. Catherine Lofton-Day, Vice President
Molecular Biology and project manager of the PRESEPT Study at
Epigenomics, will give an overview on the extensive validation work
for the mSEPT9 biomarker. In particular she will be focusing on
results from two clinical case control studies with several hundred
patients successfully completed in 2008 that demonstrate the
performance of the mSEPT9 biomarker in detecting colorectal cancer in
blood samples. The study results have recently been published in a
peer-reviewed publication in Clinical Chemistry titled "Circulating
Methylated Septin 9 DNA in Plasma is a Biomarker for Colorectal
Cancer" (1).

"These 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 be focusing 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 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. 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 utility 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 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 more than 4,600 individuals have been
enrolled into the study and two thirds 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 of this novel diagnostic method among
primary care physicians and gastroenterologists 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. in 2009.
From July 1st 2009 onwards the European laboratory network,
Switzerland based Viollier AG, will be the first clinical laboratory
to begin offering mSEPT9-testing to patients, primary care physicians
and gastroenterologists in Europe.

2009 ESMO Conference: 11th World Congress on Gastrointestinal Cancer
Presentation Details

The poster, titled "Clinical Studies verify performance of the
Blood-based Septin 9 DNA Methylation Assay for the Detection of
Colorectal Cancer" by, Catherine Lofton-Day, Theo de Vos, Matthias
Schuster, Andrew Sledziewski, Michael Wandell and Thomas Rösch will
be presented at the ESMO Conference: 11th World Congress on
Gastrointestinal Cancer in Barcelona, Spain on Friday, June 26, 2009,
6.15 pm - 6.45 pm at the CCIB, Exhibit Hall, by Dr. Catherine Lofton-
Day, Vice President Molecular Biology and Project Manager of PRESEPT
at Epigenomics.

(1) Article published online in April 2009: www.clinicalchemistry.org
A printed version will be published in Clinical Chemistry, on July
1st, 2009, Issue: 55 (7), p. 1337. Author: De Vos, T. et al; Title:
"Circulating Methylated Septin 9 DNA in Plasma is a Biomarker for
Colorectal Cancer".

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
Index: Prime All Share, Technologie All Share
Börsen: Frankfurt / regulated dealing/prime standard
Berlin / free trade
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