Epigenomics appeals recent FDA request for additional information

Company believes that an approval for the intended use of Epi proColon is warranted based on the data that has been submitted to date.

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 US citizens does not undergo colorectal cancer screening. Epi proColon(R) will allow those patients to make a healthcare 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."