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    DGAP-News  529  0 Kommentare Epigenomics AG: Epigenomics Provides Corporate Update


    DGAP-News: Epigenomics AG / Key word(s): Miscellaneous
    Epigenomics AG: Epigenomics Provides Corporate Update

    01.10.2014 / 14:00

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    Epigenomics Provides Corporate Update

    Berlin (Germany) and Germantown, MD (U.S.A.), October 1, 2014 - Epigenomics
    AG (Frankfurt Prime Standard: ECX, OTCQX: EPGNY), the German-American
    cancer molecular diagnostics company, today provides a corporate update on
    major developments.

    Epigenomics, in consultations with the U.S. Food and Drug Administration
    (FDA), has completed the design of the ADMIT (Adherence to Minimally
    Invasive Testing) study, which aims to demonstrate that Epi proColon(R)
    will increase participation in colorectal cancer (CRC) screening in
    patients being offered this convenient blood-based test as compared to
    those being offered a fecal immunochemical test (FIT). The study was
    requested as part of the FDA response letter on June 2, 2014 in relation to
    Epigenomics' PMA submission for the Company's CRC screening test. It will
    be conducted in average risk, screening eligible patients that have been
    historically non-compliant to CRC screening according to current
    guidelines. Once enrolled, patients will be randomized equally into two
    arms to be offered either the FIT stool test kit for home use or a blood
    draw for the Epi proColon(R) test. The rates of adherence between each arm
    will be measured and the primary objective of the study will be to show
    increased adherence for Epi proColon(R). The study's secondary endpoint is
    a measurement of compliance to colonoscopy in those patients with positive
    test results with Epi proColon(R) or FIT. For the identification of
    appropriate patients Epigenomics will be working with two major US health
    care systems, who actively manage CRC screening programs. Based on initial
    estimates, the Company expects the trial to be enrolled within a few months
    and costs for the study are projected to be less than EUR 1.0 million.

    In parallel, Epigenomics is working closely with its partner BioChain
    towards the approval of Epi proColon(R) in China, where CRC is a rapidly
    growing problem also. Epigenomics has supported the data generation and
    technical documentation efforts of BioChain throughout the approval
    process, which was initiated in April of this year. Additionally, clinical
    data generated in China have confirmed the performance of the Epi
    proColon(R) test in the Chinese population. These data were included in the
    formal submission to the China Food and Drug Administration (CFDA). Based
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    DGAP-News Epigenomics AG: Epigenomics Provides Corporate Update DGAP-News: Epigenomics AG / Key word(s): Miscellaneous Epigenomics AG: Epigenomics Provides Corporate Update 01.10.2014 / 14:00 --------------------------------------------------------------------- Epigenomics Provides Corporate Update Berlin …