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    DGAP-News  1252  0 Kommentare Epigenomics AG Provides Update on Regulatory Status and Information on Additional Clinical Study for Epi proColon(R) in the U.S. - Seite 2


    setting. The Company remains committed to study the performance of its
    blood-based test in a programmatic setting after potential approval in the
    context of a post-marketing study as previously proposed in its PMA
    application. Based on initial estimates, Epigenomics expects additional
    costs for the study to be in the range of less than EUR 1.0 million.

    Dr. Thomas Taapken, CEO/CFO of Epigenomics, commented: "After a productive
    dialogue with the FDA, we now have a better understanding of the issues and
    background of the agency's assessment. We are confident that we can
    complete the requested clinical study within a reasonable period of time.
    Although Epigenomics is currently able to fund these additional activities,
    we are constantly evaluating various options to maintain the Company's
    financial flexibility and to allow for the preparation of commercialization
    in the U.S. in order to rapidly enter the market post approval."

    The discussed clinical study was requested as part of the FDA response
    letter in relation to Epigenomics' PMA application for the Company's
    blood-based colorectal cancer screening test Epi proColon(R) the Company
    received at the beginning of June 2014.

    - End -

    Contact Epigenomics AG

    Antje Zeise, Manager IR | PR
    Epigenomics AG
    Kleine Praesidentenstrasse 1
    10178 Berlin
    Tel +49 (0) 30 24345 386
    ir@epigenomics.com
    www.epigenomics.com

    For U.S. press inquiries:
    Epigenomics, Inc.
    20271 Goldenrod Lane, Suite 2027
    Germantown, Maryland 20876
    pr@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(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
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