EANS-News: Epigenomics AG Epigenomics AG submits the fourth module and
completes its PMA submission to the FDA for Epi proColon®
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Company Information/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 it has submitted the fourth and final
module of its Premarket Approval (PMA) to the United States Food & Drug
Administration (FDA) for its blood-based Epi proColon® test for the detection of
colorectal cancer in December 2012 as previously indicated, thereby completing
its submission to the FDA.
The fourth module of the PMA contained the clinical data generated with the
test, including the results of the recently reported head-to-head comparative
study of Epi proColon® to FIT, previously announced data from a clinical
validation study in a cohort of prospectively collected samples and other
clinical study results generated during the development of Epi proColon®.
Thomas Taapken, Chief Financial Officer and acting Chief Executive Officer of
Epigenomics commented: "The non-inferiority of Septin9 to FIT demonstrated by
the results of the head-to-head comparative study that were announced in
December 2012 was a very important milestone for us. We are very pleased that we
were able to complete the submission of the PMA to the FDA by year end 2012,
meeting our previously announced guidance. We continue to believe that our test
is as effective as other non-invasive tests currently used with the added
convenience of being a blood test, which will help drive screening compliance
and therefore save more lives."
- 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.
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