EANS-Adhoc: Ad hoc Announcement Pursuant to § 15 WpHG (German Securities Trading Act): Epigenomics AG Completes U.S. Clinical Validation Study for Colorectal Cancer Blood Test Epi proColon; Provides U

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ad-hoc disclosure pursuant to section 15 of the WpHG transmitted by euro
adhoc with the aim of a Europe-wide distribution. The issuer is solely
responsible for the content of this announcement.
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New Products/molecular diagnostics

09.12.2011

Berlin, Germany, December 9, 2011 - Epigenomics AG (ISIN:
DE000A1K0516) 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.

- End of Ad hoc -

Contact Epigenomics AG
Antje Zeise CIRO
Manager IR | PR
Epigenomics AG
Phone: +49 (0) 30 24345 386
ir@epigenomics.com
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.

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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issuer: 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