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29 Apr 2014

Epigenomics Updates on Regulatory Status for Epi proColon in the USA

Epigenomics AG, the German–American cancer molecular diagnostics company, has provided an update on the status of its discussions with FDA regarding Epi proColon, the company’s blood-based colorectal cancer (CRC) screening test, following a recent meeting with the premarket approval (PMA) review team at the FDA.


The meeting focused on detailed discussions regarding submitted data, product labeling, design of the proposed post-approval study, as well as on topics raised at the recent Medical Devices Advisory Committee ('Advisory Committee”) meeting and progress was made in addressing open issues. The post-approval study proposed by Epigenomics is intended to investigate the test’s longitudinal performance in a programmatic setting to assess the long-term benefits of CRC screening using Epi proColon.


Dr Thomas Taapken, CEO/CFO of Epigenomics, commented: 'We look forward to continuing to diligently collaborate with FDA over the weeks to come on the topics discussed. Although FDA regulations do not allow Epigenomics to anticipate a decision or decision date, we remain confident that the data submitted supports our PMA application for Epi proColon.”


The company initially completed the PMA filing for Epi proColon for FDA approval in early 2013. As part of the PMA review process, an Advisory Committee was convened by FDA on 26 March 2014 to discuss and evaluate the effectiveness, safety and the benefit-risk profile of Epi proColon. Members of the Advisory Committee voted positively that the benefits of Epi proColon outweigh the risks of the test for use in patients who meet its application criteria.

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