Ad hoc Releases 2016 Pursuant to § 15 WpHG (German Securities Trading Act)
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Berlin, Germany, November 4, 2015 – Epigenomics AG, Berlin, Germany, (Frankfurt Prime Standard: ECX, ISIN: DE000A11QW50), announces 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®.
In its letter, the FDA provided guidance and recommendations on how to amend the PMA to make it approvable. The agency requested additional data demonstrating that the blood-based Epi proColon® test will increase compliance to CRC screening in the intended use population, i.e. in those patients with a history of noncompliance to recommended CRC screening programs.
The management of Epigenomics is taking immediate steps to address the FDA’s requests. This includes a meeting with the FDA in the near-term in order to discuss 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. Details of the study will be determined in dialogue with the FDA. As in the past, Epigenomics is committed to provide information about the regulatory way forward to its shareholders and to the public in a timely and comprehensive manner.
Together with its strategic commercialization partner Polymedco, Epigenomics will continue to diligently prepare for commercializing Epi proColon® in the United States.
In the previous ADMIT (Adherence to Minimally Invasive Testing) study, Epigenomics aimed to demonstrate that Epi proColon® will increase CRC participation in patients being offered this convenient blood-based test as compared to those being offered a fecal immunochemical test (FIT). While the adherence to Epi proColon® was nearly 100%, the participation rate to the FIT-test of 88% by far exceeded the levels seen in many studies. The FDA’s request for additional data suggests that the studied population in the ADMIT trial was not fully suitable for Epi proColon®.
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