EANS-News: Epigenomics AG: New Clinical Data for Septin9 Colorectal Cancer Blood Test Presented at UEGW

Independent validation of laboratory test used in PRESEPT Study shows
that the test finds 86% of the cancers

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Company Information/Molecular diagnostics

Subtitle: Independent validation of laboratory test used in PRESEPT
Study shows that the test finds 86% of the cancers

BERLIN and SEATTLE - October 27, 2010 (euro adhoc) - Epigenomics AG,
the cancer diagnostics company, announced that new data obtained in a
clinical study with the Company´s proprietary Septin9 biomarker for
the blood-based detection of colorectal cancer were presented
yesterday at the 18th United European Gastroenterology Week (UEGW) in
Barcelona, Spain.

The new data were presented by Dr. Juergen Beck, MD, who recently
joined Epigenomics as Senior Vice President Medical Affairs, and
validate findings in the successfully completed prospective PRESEPT
Study, also presented at the conference.

In the PRESEPT Study, Epigenomics´ proprietary Septin9 blood test
detected 67% of the colorectal cancer cases at a specificity of 88%
when compared to colonoscopy, the gold standard in colorectal cancer
detection. PRESEPT is a prospective evaluation of the Septin9
biomarker in a study cohort representative of the screening
population for colorectal cancer. Almost 8,000 individuals undergoing
colonoscopy for routine colorectal cancer screening were enrolled at
32 clinical sites in the US and Germany over a period of about 18
months in this benchmark study. The study was sponsored by
Epigenomics, the discoverer of the Septin9 biomarker. It is the
largest privately sponsored study in colorectal cancer screening ever
conducted.

In his poster presentation, Dr. Beck further presented data obtained
in a smaller case-control study following the large PRESEPT Screening
Study to independently validate the diagnostics assay that had been
used in the PRESEPT Study. Investigators in an independent
third-party laboratory analyzed cancer cases and colonoscopy-negative
controls following the PRESEPT testing protocol. Within this study,
the data of which have not been presented before, a sensitivity of
86% and a specificity of 93% were observed.

"The prospective PRESEPT Study has established that a plasma-based
marker can be used to detect colorectal cancer in asymptomatic
individuals", concluded Prof. Dr. Thomas Roesch, Medical Director of
the Department of Interdisciplinary Endoscopy at the University
Hospital Hamburg-Eppendorf and Study Director of PRESEPT in Germany.
"Further investigations will look into acceptance and uptake to
determine whether the Septin9 test will help to get more people
screened for colorectal cancer as well as cost-benefit aspects."

Prof. Roesch was chairing a round table of international colorectal
cancer screening experts to review and discuss the results of the
PRESEPT Study. The round table was jointly organized by Epigenomics
and its commercialization partner Abbott Molecular and took place in
Barcelona concurrent with the UEWG. Both companies offer CE-marked in
vitro diagnostic (IVD) test for the detection of the Epigenomics´
proprietary Septin9 biomarker in blood plasma as an aid in the
detection of colorectal cancer in Europe and Asia/Pacific.
Epigenomics and Abbott Molecular are also working on making Septin9
assays available as FDA-cleared IVD test kits for the US market.

"The PRESEPT Study and the independent validation of the assay system
used demonstrates the clinical utility of Septin9 testing as an aid
in the detection of colorectal cancer when followed up with
colonoscopy and underscores once again the unique potential of our
proprietary Septin9 biomarker," commented Geert Nygaard, Chief
Executive Officer of Epigenomics. "As a single biomarker test, the
Septin9 test compares very favorably in terms of clinical performance
and simplicity of handling and interpretation to emerging competing
molecular diagnostic approaches to stool and blood testing for
colorectal cancer."

- Ends-

Contact Epigenomics AG:

Dr. Achim Plum

Sen. VP Corporate Development
Epigenomics AG
Tel +49 (0) 30 24345 368
pr@epigenomics.com
www.epigenomics.com

Notes to Editors

About Epigenomics

Epigenomics AG 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 for
colorectal, lung, and prostate cancer aim at aiding in an earlier and
more accurate diagnosis of these diseases, thereby potentially
increasing the patient´s chances of survival.

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, USA. For more
information, please visit Epigenomics´ website at
www.epigenomics.com.

About the Septin9 Biomarker and Colorectal Cancer Blood Tests

The Septin9 biomarker is at the core of the world´s first molecular
diagnostic blood tests for the detection of colorectal cancer
commercialized by Epigenomics (Epi proColon) and its Partner Abbott
Molecular (mS9) as IVD test kits in Europe and Asia/Pacific and its
licensees Quest Diagnostics (ColoVantage?) and ARUP Laboratories
(Methylated Septin9 Test) as laboratory- developed tests in the US.
The tests all detect cell-free methylated DNA of the Septin9 gene
shed into the blood stream by colorectal tumors.

In numerous studies, Epigenomics and its partners have demonstrated
that the detection of the Septin9 biomarker in blood plasma
correlates with the presence of colorectal cancer and thus can be
used as an aid in the detection of this common cancer. These studies
include the successfully completed PRESEPT Study, a prospective
evaluation of the Septin9 biomarker in a cohort of almost 8,000
individuals representative of a typical screening population.

Today, Septin9 is likely the most thoroughly tested and best studied
molecular diagnostic biomarker for colorectal cancer detection.

Lack of patient adherence to screening recommendations is the biggest
hurdle to an effective screening for colorectal cancer. Experts
believe that a blood test that is more convenient for the patients
than stool tests and colonoscopy could help to get more people
screened and thus be of medical and health economic benefit.

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 by
Epigenomics in the United States of America. The analytical and
clinical performance characteristics of any product based on this
technology which may be sold at some future time in the USA 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, Technology All Share
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Berlin / free trade
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