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Berlin (Germany), Germantown, MD (U.S.A.) – Epigenomics AG (Frankfurt Prime Standard: ECX, OTCQX: EPGNY), the German-American cancer molecular diagnostics company, today provides an update on the status of its discussions with the Food and Drug Administration (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. While 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 the FDA on March 26, 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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Epigenomics (www.epigenomics.com) is a molecular diagnostics company developing and commercializing a pipeline of proprietary products for cancer. The Company’s products enable doctors to diagnose cancer earlier and more accurately, leading to improved outcomes for patients. Epigenomics’ lead product, Epi proColon®, is a blood-based test for the early detection of colorectal cancer, which is currently marketed in Europe and is under regulatory review by the FDA for the U.S.A. and the Chinese Food and Drug Administration for China. Additionally, the company markets its tissue assay for use in lung cancer diagnosis, Epi proLung®, in Europe. The Company’s technology and products have been validated through multiple partnerships with leading global diagnostic companies and testing laboratories. Epigenomics is an international company with operations in Europe and the U.S.A.
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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.A. have not been established.