DGAP-News: Epigenomics AG: Epigenomics AG Announces FDA Advisory Committee Meeting to Review Epi proColon(R)
(firmenpresse) - DGAP-News: Epigenomics AG / Key word(s): Miscellaneous
Epigenomics AG: Epigenomics AG Announces FDA Advisory Committee
Meeting to Review Epi proColon(R)
27.11.2013 / 16:30
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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(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.
'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(R) to physicians and patients in North America', explained
Thomas Taapken, CEO/CFO of Epigenomics. 'We are looking forward to
discussing Epi proColon(R) in front of key opinion leaders in the US, who
play an important role in FDA review process.'
- Ends -
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
fault.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 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(at)epigenomics.com
www.epigenomics.com
For US press inquiries:
Epigenomics, Inc.
9700 Great Seneca Highway Rockville
Maryland 20850
pr(at)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.
End of Corporate News
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27.11.2013 Dissemination of a Corporate News, transmitted by DGAP - a
company of EQS Group AG.
The issuer is solely responsible for the content of this announcement.
DGAP's Distribution Services include Regulatory Announcements,
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Media archive at www.dgap-medientreff.de and www.dgap.de
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Language: English
Company: Epigenomics AG
Kleine Präsidentenstraße 1
10178 Berlin
Germany
Phone: +49 30 24345-0
Fax: +49 30 24345-555
E-mail: ir(at)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 News DGAP News-Service
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241997 27.11.2013
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Datum: 27.11.2013 - 16:30 Uhr
Sprache: Deutsch
News-ID 320828
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