Berlin (Germany) and Germantown, MD (U.S.A.), November 26, 2015 – Epigenomics AG (Frankfurt Prime Standard: ECX, OTCQX: EPGNY), 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.
“We are convinced that our appeal is well substantiated and in the best interest of patients, healthcare professionals and our shareholders,” said Dr. Thomas Taapken, CEO of Epigenomics. “While it is proven that screening and early detection of colorectal cancer can save lives, still one out of three eligible U.S. citizens does not undergo colorectal cancer screening. Epi proColon® will allow those patients to make a health care choice that may benefit early detection and treatment of colorectal cancer. We are committed to continuing to work closely and collaboratively with FDA reviewers and supervisory staff through the process.”
Epigenomics is a molecular diagnostics company focused on blood-based detection of cancers using its proprietary DNA methylation biomarker technology. The Company develops and commercializes diagnostic products across multiple cancer indications with high medical need. Epigenomics’ lead product, Epi proColon®, is a blood-based screening test for the early detection of colorectal cancer. Epi proColon® is currently marketed in Europe and China. For more information, visit www.epigenomics.com.
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