DGAP-News: Epigenomics AG: Epigenomics Updates on Regulatory Status for Epi proColon(R) in the U.S.A.

DGAP-News: Epigenomics AG: Epigenomics Updates on Regulatory Status for Epi 
proColon(R) in the U.S.A.

DGAP-News: Epigenomics AG / Key word(s): Miscellaneous
Epigenomics AG: Epigenomics Updates on Regulatory Status for Epi
proColon(R) in the U.S.A.

29.04.2014 / 09:00


Berlin (Germany), Germantown, MD (U.S.A.), April 29, 2014 - Epigenomics AG
(Frankfurt Prime Standard: ECX, OTCQX: EPGNY), the German-American cancer
molecular diagnostics company, today provides an update on the status of
its discussions with the Food and Drug Administration (FDA) regarding Epi
proColon(R), the Company's blood-based colorectal cancer (CRC) screening
test, following a recent meeting with the premarket approval (PMA) review
team at the FDA. The meeting focused on detailed discussions regarding
submitted data, product labeling, design of the proposed post-approval
study as well as on topics raised at the recent Medical Devices Advisory
Committee ("Advisory Committee") meeting and progress was made in
addressing open issues. The post-approval study proposed by Epigenomics is
intended to investigate the test's longitudinal performance in a
programmatic setting to assess the long-term benefits of CRC screening
using Epi proColon(R).

Dr. Thomas Taapken, CEO/CFO of Epigenomics, commented: "We look forward to
continuing to diligently collaborate with FDA over the weeks to come on the
topics discussed. While FDA regulations do not allow Epigenomics to
anticipate a decision or decision date, we remain confident that the data
submitted supports our PMA application for Epi proColon(R)."

The Company initially completed the PMA filing for Epi proColon(R) for FDA
approval in early 2013. As part of the PMA review process, an Advisory
Committee was convened by the FDA on March 26, 2014 to discuss and evaluate
the effectiveness, safety and the benefit-risk profile of Epi proColon(R).
Members of the Advisory Committee voted positively that the benefits of Epi
proColon(R) outweigh the risks of the test for use in patients who meet its
application criteria.

- Ends -

Contact Epigenomics AG

Antje Zeise, Manager IR | PR
Epigenomics AG 
Kleine Praesidentenstrasse 1
10178 Berlin
Tel +49 (0) 30 24345 386 

For U.S. press inquiries:

Epigenomics, Inc.
20271 Goldenrod Lane, Suite 2027
Germantown, Maryland 20876

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(R), is a blood-based test for the
early detection of colorectal cancer, which is currently marketed in Europe
and is under regulatory review by the FDA for the U.S.A. and the Chinese
Food and Drug Administration for China. Additionally, the company markets
its tissue assay for use in lung cancer diagnosis, Epi proLung(R), in
Europe. The Company's technology and products have been validated through
multiple partnerships with leading global diagnostic companies and testing
laboratories. 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.A. have not been established.

End of Corporate News


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Language:    English                                                
Company:     Epigenomics AG                                         
             Kleine Präsidentenstraße 1                             
             10178 Berlin                                           
Phone:       +49 30 24345-0                                         
Fax:         +49 30 24345-555                                       
E-mail:      ir@epigenomics.com                                     
Internet:    www.epigenomics.com                                    
ISIN:        DE000A1K0516                                           
WKN:         A1K051                                                 
Listed:      Regulierter Markt in Frankfurt (Prime Standard);       
             Freiverkehr in Berlin, Düsseldorf, München, Stuttgart  
End of News    DGAP News-Service  
265237 29.04.2014                                                      
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