EANS-News: Epigenomics announces initiation of PMA filing for Epi proColon, provides update on regulatory timeline

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Company Information/New Products/molecular diagnostics

Berlin, Germany, and Seattle, WA, U.S.A., January 4, 2012 (euro
adhoc) - Epigenomics AG (Frankfurt Prime Standard: ECX), the
German-American cancer molecular diagnostics company, is pleased to
announce that it has submitted the first module of its premarket
approval (PMA) submission to the US Food and Drug Administration
(FDA) on December 30, 2011.

On December 30, 2011 Epigenomics has initiated the process of gaining
US regulatory approval of its colorectal cancer (CRC) screening test
Epi proColon® by submitting the first module of its modular PMA
approval submission to the FDA. The first module of the submission
includes all required documentation on the manufacturing and quality
controls section in relation to the product. Further modules are
scheduled to be submitted throughout the first and second quarters of
2012 and the final module, including all clinical data is scheduled
for submission in the second half of 2012. Under the FDA´s modular
PMA submission protocol, in its guidance document "Guidance for
Industry and FDA staff - Premarket Approval Application Modular
Review", the FDA provides for a 90 day review period by the agency
for each individual module.

As previously announced, a head-to-head comparative study with the
goal of demonstrating non-inferiority of Epi proColon® to fecal
immunochemical testing (FIT) will be an integral part of the clinical
module. The design of the clinical study has been discussed with the
FDA and upon finalizing of the study protocol, it will be initiated
in the coming months. The clinical module of the PMA submission will
encompass the results of the head-to-head comparative study,
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®.

Geert Nygaard, CEO of Epigenomics commented: "We are pleased that we
have initiated the regulatory process for our CRC screening test Epi
proColon® with the FDA. We intend to initiate the additional
head-to-head study of our product against FIT as soon as possible,
which would be required to meet our ambitious timeline for the
completion of our submission in the second half of 2012."

- Ends -

Further Information

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