EANS-News: Epigenomics AG / Epigenomics receives notification of priority review status and acceptance for filing by FDA of PMA application for Epi proColon®

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Company Information/New Products/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 the United States
Food & Drug Administration (FDA) accepted its Premarket Approval
(PMA) application for Epi proColon®. The agency concluded that all
information needed for the substantive review is included and has
granted priority review status to the application. Epi proColon® is
Epigenomics' blood-based test for the detection of colorectal cancer
(CRC).

In December 2012, Epigenomics successfully completed its head-to-head
comparative study. Subsequently, the PMA submission was submitted to
FDA by the end of that year. The application is now under substantive
review by the agency.

Dr. Thomas Taapken, Chief Financial Officer and acting Chief
Executive Officer of Epigenomics, commented: "After the encouraging
results from our final clinical trial and the completion of our PMA
submission late last year, we are very pleased that the agency has
filed the application and has granted the priority review status to
the application. We are now anticipating a productive dialog with
FDA. While we await the final decision from the regulators, we
continue to actively plan for commercialization. We look forward to
potentially being able to bring the advantages of this convenient
blood-based testing alternative for CRC to the benefit of patients in
the US."

- 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.[pic]

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