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Biotech / Medical : biotech firesales
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From: nigel bates11/5/2015 9:29:12 AM
   of 3661
 
Epigenomics 47%...

Berlin (Germany) and Germantown, MD (U.S.A.), November 4, 2015 – Epigenomics AG (Frankfurt Prime Standard: ECX, OTCQX: EPGNY), the German-American cancer molecular diagnostics company, 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....
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