Epigenomics AG: Epigenomics announces Date for the FDA Advisory Committee Meeting to Review Epi proColon and for the Publication of Preliminary Financial Results 2013

Berlin (Germany) and Germantown, MD (U.S.A.), February 06, 2014 – Epigenomics AG (Frankfurt Prime Standard: ECX, OTC: EPGNY), the German-American cancer molecular diagnostics company, today announced that the date for the FDA Advisory Committee meeting for Epigenomics’ blood-based colorectal cancer screening test Epi proColon(R) was published publicly via a Federal Register notification. The Meeting of the Molecular and Clinical Genetics Panel is scheduled for Wednesday, March 26th, 2014, from 8:00 am EST to 5:00 pm EST in the Hilton Washington DC North/Gaithersburg, Salons A, B, and C, 620 Perry Pkwy., Gaithersburg, MD 20877. Further information is available on the FDA website: http://www.fda.gov/AdvisoryCommittees/Calendar/ucm384559.htm.

The Company completed the PMA filing for this test in early 2013, which was subsequently accepted for review and granted priority review status by the FDA in February 2013.

Due to the upcoming Advisory Committee meeting, Epigenomics will announce preliminary figures for the financial year 2013 on February 26, 2014. The complete Annual Report for the financial year 2013, however, will be provided on the Company’s website as planned on March 28, 2014.

On March 28, 2014, Epigenomics AG will also host a conference for journalists, analysts and investors in Frankfurt/Main, Germany, in German language followed by a conference call in English language. The Management will present the detailed results for the financial year 2013 and give an update on the FDA Advisory Committee meeting. Details of both events will be made available prior to March 28, 2014, on Epigenomics’ website under www.epigenomics.com.

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About FDA’s Advisory Committee Meetings

The FDA uses 50 committees and panels to obtain independent expert advice on scientific, technical, and policy questions raised by the FDA as they consider regulatory decisions. The FDA is not bound by the committee’s recommendation, but it takes its advice into consideration when reviewing certain submissions. The Molecular and Clinical Genetics Panel of the Medical Devices Advisory Committee reviews and evaluates available data concerning the safety and effectiveness of marketed and investigational in vitro devices for use in clinical laboratory medicine including clinical and molecular genetics and makes appropriate recommendations to FDA. For more information also refer to:
http://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/MedicalDevices/MedicalDevicesAdvisoryCommittee/MolecularandClinicalGeneticsPanel/default.htm

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(R), 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. Additionally, the company markets its tissue assay for use in lung cancer diagnosis, Epi proLung(R), 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.

Contact Epigenomics AG

Antje Zeise, Manager IR | PR
Epigenomics AG
Kleine Praesidentenstrasse 1
10178 Berlin
Tel +49 (0) 30 24345 386
ir@epigenomics.com
www.epigenomics.com

For US press inquiries:

Epigenomics, Inc.
20271 Goldenrod Lane, Suite 2027
Germantown, Maryland 20876
pr@epigenomics.com

Epigenomics legal disclaimer

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. have not been established.