Berlin, Germany, and U.S.A., November 27, 2013 - Epigenomics AG (Frankfurt Prime Standard: ECX, OTC: EPGNY), the German-American cancer molecular diagnostics company, today announced that the Company was informed by the U.S. Food and Drug Administration (FDA) via the premarket approval (PMA) review process for Epi proColon® 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® 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.
“We are extremely pleased to announce that the FDA Advisory Committee meeting for our blood based colorectal cancer screening test has now been scheduled. After having completed all outstanding questions and information requests by the FDA, this represents an important step forward in bringing Epi proColon® to physicians and patients in North America”, explained Thomas Taapken, CEO/CFO of Epigenomics. “We are looking forward to discussing Epi proColon® in front of key opinion leaders in the US, who play an important role in FDA review process.”
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®, is a blood-based test for the early detection of colorectal cancer, which is currently marketed in Europe and is under regulatory review for the U.S.A. The Company’s technology and products have been evaluated 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.
9700 Great Seneca Highway Rockville
Maryland 20850
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.
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