Epigenomics AG Receives Notification of Priority Review Status and Acceptance for Filing by FDA of PMA Application for Epi proColon®

Published: Feb 21, 2013

Berlin, Germany, and Seattle, WA, U.S.A., February 21, 2013 - Epigenomics AG (Frankfurt Prime Standard: ECX), the German-American cancer molecular diagnostics company, announced today that the United States Food & Drug Administration (FDA) accepted its Premarket Approval (PMA) application for Epi proColon®. The agency concluded that all information needed for the substantive review is included and has granted priority review status to the application. Epi proColon® is Epigenomics’ blood-based test for the detection of colorectal cancer (CRC).

In December 2012, Epigenomics successfully completed its head-to-head comparative study. Subsequently, the PMA submission was submitted to FDA by the end of that year. The application is now under substantive review by the agency.

Dr. Thomas Taapken, Chief Financial Officer and acting Chief Executive Officer of Epigenomics, commented: “After the encouraging results from our final clinical trial and the completion of our PMA submission late last year, we are very pleased that the agency has filed the application and has granted the priority review status to the application. We are now anticipating a productive dialog with FDA. While we await the final decision from the regulators, we continue to actively plan for commercialization. We look forward to potentially being able to bring the advantages of this convenient blood-based testing alternative for CRC to the benefit of patients in the US.”

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Antje Zeise

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Epigenomics AG

Tel +49 (0) 30 24345 368



About Epigenomics

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 in development for the U.S.A. The Company’s technology and products have been validated through multiple partnerships with leading global diagnostic companies including Abbott, QIAGEN, Sysmex, and Quest Diagnostics. Epigenomics is an international company with operations in Europe and the U.S.A.

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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. have not been established.

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