EANS-News: Epigenomics AG submits the third module in its PMA filing with FDA for Epi proColon®

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New Products/Company Information/molecular diagnostics

Berlin, Germany, and Seattle, WA, U.S.A., June 12, 2012 (euro adhoc)
- Epigenomics AG (Frankfurt Prime Standard: ECX), the German-American
cancer molecular diagnostics company, announced today that it has
submitted the third module of its Premarket Approval (PMA)
application to the United States Food & Drug Administration (FDA) for
its blood-based colorectal cancer screening test Epi proColon®.

Module three describes the analytical performance of Epi proColon® in
terms of accuracy, precision and stability. Reproducibility and
validation of the analytical performance were assessed through
testing at three external laboratories. The first two modules of the
PMA are related to design control, manufacturing, quality management,
and software validation. The fourth and last module is planned for
submission in the second half of 2012 and will include the results of
a head-to-head comparative study with the goal of demonstrating
non-inferiority of Epi proColon® to fecal immunochemical testing
(FIT), which is currently underway and enrolling study subjects
according to plan. Furthermore, it will include 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®.

Under the FDA's modular PMA submission guidance, the complete
contents of a PMA is broken down into well-delineated modules, such
as non-clinical, clinical, and manufacturing, that together become a
complete application. The FDA reviews each module separately as it is
received, allowing companies to receive timely feedback during the
review process. The FDA guides that it will take 90 days to complete
its review of each module as stated in "Guidance for Industry and FDA
staff - Premarket Approval Application Modular Review" as posted on
FDA's homepage.

Geert Nygaard, Chief Executive Officer of Epigenomics commented: "The
submission of the third module concludes a significant part of our
PMA filing. We look forward to successfully finishing the ongoing
clinical trial and subsequently completing our PMA submission to FDA
by year end. Our team has been working expeditiously to finalize our
first US market application and we remain committed and focused on
introducing Epi proColon® as the first FDA approved blood-based test
for the early detection of colorectal cancer in the US. We firmly
believe that the test will help drive screening compliance and make a
difference in detecting cancers in patients who would otherwise avoid
being tested for colorectal cancer."

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