Epigenomics AG / Key word(s): Miscellaneous 27.11.2013 16:30 Dissemination of an Ad hoc announcement according to § 15 WpHG, transmitted by DGAP - a company of EQS Group AG. The issuer is solely responsible for the content of this announcement. --------------------------------------------------------------------------- Berlin, Germany, November 27, 2013 - Epigenomics AG (ISIN: DE000A1K0516) announces that the Company was informed by the U.S. Food and Drug Administration (FDA) via the premarket approval (PMA) review process for Epi proColon(R) that the Meeting of the Molecular and Clinical Genetics Panel of the Medical Devices Advisory Committee has been tentatively scheduled for Tuesday, March 25th, 2014. Epigenomics expects the final date for the meeting will be announced publicly via a Federal Register notification. Epi proColon(R) is Epigenomics' blood-based screening test for colorectal cancer. The Company had completed filing a PMA submission in early 2013, which was subsequently accepted for review and granted priority review status by the FDA in February 2013. After the Company has completed all outstanding questions and information requests by the FDA, this represents an important step forward towards market introduction of Epi proColon(R) in the USA. - End of Ad hoc - 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/MedicalDe vices/MedicalDevicesAdvisoryCommittee/MolecularandClinicalGeneticsPanel/de Contact Epigenomics AG Antje Zeise CIRO Manager IR | PR Epigenomics AG Phone: +49 (0) 30 24345 386 ir@epigenomics.com www.epigenomics.com Epigenomics' legal disclaimers. 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. 27.11.2013 DGAP's Distribution Services include Regulatory Announcements, Financial/Corporate News and Press Releases. Media archive at www.dgap-medientreff.de and www.dgap.de --------------------------------------------------------------------------- Language: English Company: Epigenomics AG Kleine Präsidentenstraße 1 10178 Berlin Germany Phone: +49 30 24345-0 Fax: +49 30 24345-555 E-mail: ir@epigenomics.com Internet: www.epigenomics.com ISIN: DE000A1K0516 WKN: A1K051 Listed: Regulierter Markt in Frankfurt (Prime Standard); Freiverkehr in Berlin, Düsseldorf, München, Stuttgart End of Announcement DGAP News-Service ---------------------------------------------------------------------------
27. November 2013 - 0:00 (CEST)