EANS-News: Epigenomics AG reports EpiproColon® 2.0 finds 95% of cancers in clinical study

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Company Information/New Products/molecular diagnostics

Subtitle: Study provides clinical evidence for CE-marking in Europe
and paves way to US pivotal clinical trial for submission to FDA
before year-end

Berlin, Germany, and Seattle, WA, USA, September 19, 2011 (euro
adhoc) - Epigenomics AG (Frankfurt Prime Standard: ECX), the cancer
molecular diagnostics company, today reported positive results in a
clinical study for the Company's second generation blood-based test
for the early detection of colorectal cancer, Epi proColon® 2.0.

In the study, 98 patients with colorectal cancer and 149 patients
with no evidence of disease as verified by colonoscopy were tested
with the Epi proColon® 2.0 test. The test identified 95% of the
cancer cases (i.e. 95% sensitivity) at a specificity of 85%. Most
importantly, for stage I and II cancer where therapeutic
interventions have the greatest likelihood of curing the patient from
the disease, the combined sensitivity was 91%. These results
demonstrate a very significant improvement over the performance of
the first generation Epi proColon® test, currently marketed in
Europe. In the product validation study conducted with this product
in 2009, 67% of the cancer cases were detected at comparable
specificity.

The new study is the first of two studies by Epigenomics to
clinically validate the newly developed test. It provides the
clinical evidence required for CE-marking of Epi proColon® 2.0 for
launch in the European market later this year. Further, it paves the
way for the second validation study that is required for a submission
of the test to the U.S. Food and Drug Administration (FDA). This
pivotal clinical trial will be conducted at three external
laboratories, which will test a subset of blood samples from a
prospectively collected cohort of about 8,000 subjects. The study is
expected to be initiated and completed in time for a submission to
FDA before year-end 2011.

Geert Nygaard, Chief Executive Officer of Epigenomics commented:

"In this extremely positive study, Epi proColon® 2.0 has now
demonstrated a clinical performance that is unmatched by other
non-invasive tests for colorectal cancer early detection. With the
recent refocusing of the Company, we made a strong commitment to
bring our second generation colorectal cancer blood test to the
European and U.S. market and we have now delivered an important first
part of our promise. We will launch the new product in Europe in the
fourth quarter and we have already made preparations to start the
U.S. pivotal clinical trial in the coming weeks. We are confident
that we can keep our timeline of a submission to the FDA before year
end."

Epi proColon® 2.0 has a significantly enhanced performance over the
first generation Epi proColon® test and also features a number of
other improvements that should facilitate its use in the diagnostic
routine in different regulatory environments including the U.S. For
example, the test includes the use of cGMP manufactured reagents and
instrumentation, fewer reagents and simplified handling, and improved
automation capabilities along with the added feature that Epi
proColon® 2.0 results can be obtained within a typical laboratory
work shift of 8 hours compared to the two day workflow required by
the first test generation.

-Ends-

Contact Epigenomics AG

Dr. Achim Plum
Sen. VP Business & Strategy
Epigenomics AG
Tel +49 (0) 30 24345 368
pr@epigenomics.com
www.epigenomics.com

About Epigenomics

Epigenomics (www.epigenomics.com) is a molecular diagnostics company
developing and commercializing a pipeline of proprietary products for
cancer. The Company's products enable doctors to diagnose cancer
earlier and more accurately, leading to improved outcomes for
patients. Epigenomics' lead product, Epi proColon®, is a blood-based
test for the early detection of colorectal cancer, which is currently
marketed in Europe and is in development for the U.S.A. The Company's
technology and products have been validated through multiple
partnerships with leading global diagnostic companies including
Abbott, QIAGEN, Sysmex, and Quest Diagnostics. Epigenomics is an
international company with operations in Europe and the U.S.A.

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 or Canada. The analytical and
clinical performance characteristics of any Epigenomics product based
on this technology which may be sold at some future time in the U.S.
have not been established.

Further inquiry note:
Dr. Achim Plum
Sen. VP Business & Strategy
Epigenomics AG
Tel: +49 30 24345 368
achim.plum@epigenomics.com

end of announcement euro adhoc
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company: Epigenomics AG
Kleine Präsidentenstraße 1
D-10178 Berlin
phone: +49 30 24345-0
FAX: +49 30 24345-555
mail: ir@epigenomics.com
WWW: http://www.epigenomics.com
sector: Biotechnology
ISIN: DE000A1K0516
indexes: Prime All Share, Technology All Share
stockmarkets: regulated dealing/prime standard: Frankfurt, free trade: Berlin,
Hamburg, Stuttgart, Düsseldorf, München
language: English