Berlin (Germany) and Germantown, MD (U.S.A.) – Epigenomics AG (ISIN: DE000A1K0516, OTCQX: EPGNY) today announced 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 determined that while the studies performed so far have established the clinical performance characteristics of the test, the PMA application does not yet contain sufficient evidence to warrant an approval for Epi proColon®. However, the FDA provided helpful guidance on how to amend the PMA to make it approvable. The main item stressed in their response letter revolves around the need for 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 who today do not undergo CRC screening by guideline recommended methods such as colonoscopy or FIT. Since Epigenomics’ originally conducted clinical studies were performed in patients who had agreed to a routine screening colonoscopy, the FDA is requesting Epigenomics to demonstrate whether patients in the targeted population can be turned compliant to CRC screening by Epi proColon®.
Epigenomics has scheduled a meeting with the FDA at the end of June in order to discuss next steps and 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 to address FDA’s outstanding requests. Details around this study will be determined in dialog with the FDA.
Formally, a “Not Approvable Letter” is issued when the FDA determines that a PMA submission lacks significant information for approval at the time of review. FDA will identify what is necessary to make the PMA approvable. Epigenomics has 180 days to respond and amend the PMA, or request an extension of time with an estimate when the requested information will be submitted.
Epi proColon® is approved for marketing in Europe since 2012. The Septin9 marker has been incorporated into laboratory developed tests (LDTs) in the United States. In addition, Epigenomics’ strategic partner BioChain has officially submitted an application to the China Food and Drug Administration (CFDA) in April for the approval of Epi proColon® in the Chinese market. Both companies expect commercialization of the test in China to start in 2015. The FDA decision will have no impact on the commercialization of Septin9 assays by LDT partners and on the existing commercial arrangements for Epi proColon® in other regions.
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