EANS-News: Epigenomics AG Epigenomics receives notification of priority review
status and acceptance for filing by FDA of PMA application for Epi proColon®
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Corporate news transmitted by euro adhoc. The issuer/originator is solely
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Company Information/New Products/Molecular Diagnostics
Berlin, Germany, and Seattle, WA, U.S.A. (euro adhoc) - Epigenomics AG
(Frankfurt Prime Standard: ECX), the German-American cancer molecular
diagnostics company, announced today that the United States Food & Drug
Administration (FDA) accepted its Premarket Approval (PMA) application for Epi
proColon®. The agency concluded that all information needed for the substantive
review is included and has granted priority review status to the application.
Epi proColon® is Epigenomics' blood-based test for the detection of colorectal
cancer (CRC).
In December 2012, Epigenomics successfully completed its head-to-head
comparative study. Subsequently, the PMA submission was submitted to FDA by the
end of that year. The application is now under substantive review by the
agency.
Dr. Thomas Taapken, Chief Financial Officer and acting Chief Executive Officer
of Epigenomics, commented: "After the encouraging results from our final
clinical trial and the completion of our PMA submission late last year, we are
very pleased that the agency has filed the application and has granted the
priority review status to the application. We are now anticipating a productive
dialog with FDA. While we await the final decision from the regulators, we
continue to actively plan for commercialization. We look forward to potentially
being able to bring the advantages of this convenient blood-based testing
alternative for CRC to the benefit of patients in the US."
- Ends -
Contact Epigenomics AG
Antje Zeise
Manager IR | PR
Epigenomics AG
Tel +49 (0) 30 24345 368
ir@epigenomics.comwww.epigenomics.com
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 in development
for the U.S.A. The Company's technology and products have been validated
through multiple partnerships with leading global diagnostic companies
including Abbott, QIAGEN, Sysmex, and Quest Diagnostics. Epigenomics is an
international company with operations in Europe and the U.S.A.
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.[pic]
Further inquiry note:
Antje Zeise | CIRO
Manager IR/PR
Epigenomics AG
Tel: +49 30 24345 386
end of announcement euro adhoc
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company: Epigenomics AG
Kleine Präsidentenstraße 1
D-10178 Berlin
phone: +49 30 24345-0
FAX: +49 30 24345-555
mail: ir@epigenomics.com
WWW: http://www.epigenomics.com
sector: Biotechnology
ISIN: DE000A1K0516
indexes: Prime All Share, Technology All Share
stockmarkets: free trade: Berlin, München, Hamburg, Düsseldorf, Stuttgart,
regulated dealing/prime standard: Frankfurt
language: English