Ad hoc Releases 2016 Pursuant to § 15 WpHG (German Securities Trading Act)
Epigenomics AG appeals recent FDA request for additional information
Berlin, Germany, November 25, 2015 – Epigenomics AG, Berlin, Germany, (Frankfurt Prime Standard: ECX; ISIN: DE000A11QW50) the German-American cancer molecular diagnostics company, today announced that after discussions with FDA in relation to its premarket approval (PMA) application for the Company’s blood-based colorectal cancer (CRC) screening test Epi proColon®, it is appealing the agency’s decision on additional data requirements. Epigenomics is requesting a supervisory review of the recent decision to require additional clinical data to support PMA approval.
Epigenomics believes that an approval for the intended use of Epi proColon® is warranted based on the data that has been submitted to date. The Company has provided an extensive amount of data under its PMA application and received a favorable recommendation by the FDA Medical Device Advisory Committee in March 2014. Furthermore, in its appeal, Epigenomics has highlighted the difficulties to measure adherence in the intended use population under the existing regulatory framework along with a willingness to work with FDA to design an appropriate post-approval study.
FDA regulations provide several mechanisms to applicants for further review of the agency’s actions. A request for supervisory review is directed to the next organizational level above the level at which the decision was made. Based on respective guidelines and following discussions with FDA, Epigenomics believes the supervisory review will be completed in Q1 2016.
Any decision on the company’s appeal does not affect to the right of Epigenomics to amend its PMA application in the future.
– End of Ad hoc –
Contact Epigenomics AG
Peter Vogt, Investor & Public Relations
Phone +49 (0) 30 24345 386
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 which could cause the actual results, financial condition, performance or achievements of Epigenomics AG to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Epigenomics AG is providing this communication as of this date and does not undertake to update any forward-looking statements contained herein as a result of new information, future events or otherwise.
The information contained in this communication does not constitute nor imply an offer to sell or transfer any product, and no product based on this technology is currently available for sale by Epigenomics in the United States or Canada. The analytical and clinical performance characteristics of any Epigenomics product based on this technology which may be sold at some future time in the U.S. have not been established.