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    DGAP-News  6198  0 Kommentare Epigenomics AG: FDA Issues Response Letter for Epigenomics' Colorectal Cancer Screening Blood Test Epi proColon(R) Requesting Further Data Pre-Approval


    DGAP-News: Epigenomics AG / Key word(s): Miscellaneous
    Epigenomics AG: FDA Issues Response Letter for Epigenomics' Colorectal
    Cancer Screening Blood Test Epi proColon(R) Requesting Further Data
    Pre-Approval

    02.06.2014 / 21:30

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    - Meeting to discuss next steps with FDA scheduled in June

    - FDA decision has no impact on commercialization of Septin9-based tests
    by LDT partners or existing commercial arrangements for Epi proColon(R)
    in other regions

    - Company remains committed to offer highly efficient and convenient
    alternative for CRC screening

    Berlin (Germany) and Germantown, MD (U.S.A.), June 2, 2014 - Epigenomics AG
    (Frankfurt Prime Standard: ECX, OTCQX: EPGNY), the German-American cancer
    molecular diagnostics company, today announced that it has received a
    response letter from the U.S. Food and Drug Administration (FDA) in
    relation to its premarket approval (PMA) application for the Company's
    blood-based colorectal cancer (CRC) screening test Epi proColon(R).

    In its letter, the FDA determined that while the studies performed so far
    have established the clinical performance characteristics of the test, the
    PMA application does not yet contain sufficient evidence to warrant an
    approval for Epi proColon(R). However, the FDA provided helpful guidance on
    how to amend the PMA to make it approvable. The main item stressed in their
    response letter revolves around the need for additional data demonstrating
    that the blood-based Epi proColon(R) test will increase compliance to CRC
    screening in the intended use population, i.e. in those patients who today
    do not undergo CRC screening by guideline recommended methods such as
    colonoscopy or FIT. Since Epigenomics' originally conducted clinical
    studies were performed in patients who had agreed to a routine screening
    colonoscopy, the FDA is requesting Epigenomics to demonstrate whether
    patients in the targeted population can be turned compliant to CRC
    screening by Epi proColon(R).

    Epigenomics has scheduled a meeting with the FDA at the end of June in
    order to discuss next steps and how to best address the outstanding
    questions. It is expected that an additional study to demonstrate increased
    compliance and adherence of patients to blood-based CRC testing will be
    needed to address FDA's outstanding requests. Details around this study
    will be determined in dialog with the FDA.

    "We were surprised with FDA's assessment of our PMA submission. While this
    is not what we expected, we remain fully committed to offering people who
    are unwilling or unable to undergo recommended CRC screening a highly
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    DGAP-News Epigenomics AG: FDA Issues Response Letter for Epigenomics' Colorectal Cancer Screening Blood Test Epi proColon(R) Requesting Further Data Pre-Approval DGAP-News: Epigenomics AG / Key word(s): Miscellaneous Epigenomics AG: FDA Issues Response Letter for Epigenomics' Colorectal Cancer Screening Blood Test Epi proColon(R) Requesting Further Data Pre-Approval 02.06.2014 / 21:30 …