EANS-News: Epigenomics AG Completes U.S. Clinical Validation Study for Colorectal Cancer Blood Test Epi proColon; Provides Update on U.S. Regulatory Plans

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Company Information/New Products/molecular diagnostics

Subtitle: Conference Call Scheduled for today, 9thDecember 2011 at 4
pm CET

Berlin, Germany, and Seattle, WA, U.S.A., December 9, 2011 (euro
adhoc) - Epigenomics AG (Frankfurt Prime Standard: ECX), the cancer
molecular diagnostic company, today reports the completion of the
clinical validation study for its second-generation colorectal cancer
blood test Epi proColon in the U.S. The study was designed to measure
the clinical performance of Epi proColon for the detection of
colorectal cancer in comparison to colonoscopy and is part of the
required data package to seek regulatory approval of the product in
the U.S. In the reported study, Epi proColon detected 68% of the
colorectal cancer cases (sensitivity) while correctly identifying 80%
of the patients free of disease (specificity). While the results of
the study represent the lower end of the expected performance data,
the findings of the study confirm the results obtained in a
previously conducted clinical study with the first generation of the
company's Epi proColon test in the same cohort of patients.

Study subjects tested were selected from a prospectively collected
cohort of 7.940 individuals, defined as being at average risk for
colorectal cancer by current screening guidelines and who underwent
colonoscopy for colorectal cancer screening. The tested study cohort
included 45 cancer cases. All plasma samples selected were blinded,
randomized, and tested with Epi proColon at three independent
laboratories in the U.S.

After consultation with the U.S. Food and Drug Administration (FDA),
the company confirmed that the clinical data would be assessed as
part of the regular Premarket Approval (PMA) review process. The
Company will begin the regulatory process with the FDA by submitting
the first module of its PMA this month. In addition to the clinical
validation study data, Epigenomics will also perform a head-to-head
comparative study for colorectal cancer detection through comparison
with fecal immunochemical testing (FIT) for the purpose of
demonstrating non-inferiority of Epi proColon to FIT. This study will
also become an integral part of the PMA submission to the FDA and is
anticipated to be completed in 2012.

Conference Call for Investors and Media

Epigenomics' management will host a conference call to discuss the
study results and to inform about the further process of the FDA
submission at 4 pm CET (10 am EST) today, December 9, 2011. The
dial-in numbers for the conference call are:

Dial-in number (within Germany): +49 69 247 501 899

Dial-in number (within U.K.): +44 203 147 4861

Dial-in number (within the US): +1 212 444 0297

Participants are kindly requested to dial in 10 minutes prior to the
start of the call.

A recording of the conference call will be provided on Epigenomics'
website subsequently:
http://www.epigenomics.com/en/news-investors.html

Contact Epigenomics AG

Antje Zeise
Manager IR | PR
Epigenomics AG
Tel +49 (0) 30 24345 368
ir@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 disclaimer

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:
Antje Zeise | CIRO
Manager IR/PR
Epigenomics AG
Tel: +49 30 24345 386
antje.zeise@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