EANS-News: Epigenomics AG / Epigenomics AG submits the fourth module and completes its PMA submission to the FDA for Epi proColon®

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Company Information/molecular diagnostics

Berlin, Germany, and Seattle, WA, U.S.A. (euro adhoc) - Epigenomics
AG (Frankfurt Prime Standard: ECX), the German-American cancer
molecular diagnostics company, announced today that it has submitted
the fourth and final module of its Premarket Approval (PMA) to the
United States Food & Drug Administration (FDA) for its blood-based
Epi proColon® test for the detection of colorectal cancer in December
2012 as previously indicated, thereby completing its submission to
the FDA.

The fourth module of the PMA contained the clinical data generated
with the test, including the results of the recently reported
head-to-head comparative study of Epi proColon® to FIT, previously
announced data from a clinical validation study in a cohort of
prospectively collected samples and other clinical study results
generated during the development of Epi proColon®.

Thomas Taapken, Chief Financial Officer and acting Chief Executive
Officer of Epigenomics commented: "The non-inferiority of Septin9 to
FIT demonstrated by the results of the head-to-head comparative study
that were announced in December 2012 was a very important milestone
for us. We are very pleased that we were able to complete the
submission of the PMA to the FDA by year end 2012, meeting our
previously announced guidance. We continue to believe that our test
is as effective as other non-invasive tests currently used with the
added convenience of being a blood test, which will help drive
screening compliance and therefore save more lives."

- Ends -

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

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: free trade: Berlin, München, Hamburg, Düsseldorf, Stuttgart,
regulated dealing/prime standard: Frankfurt
language: English