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.
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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
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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@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
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27. November 2013 - 0:00 (CEST)