EANS-News: Epigenomics announces initiation of PMA filing for Epi proColon,
provides update on regulatory timeline
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Company Information/New Products/molecular diagnostics
Berlin, Germany, and Seattle, WA, U.S.A., January 4, 2012 (euro adhoc) -
Epigenomics AG (Frankfurt Prime Standard: ECX), the German-American cancer
molecular diagnostics company, is pleased to announce that it has submitted the
first module of its premarket approval (PMA) submission to the US Food and Drug
Administration (FDA) on December 30, 2011.
On December 30, 2011 Epigenomics has initiated the process of gaining US
regulatory approval of its colorectal cancer (CRC) screening test Epi proColon®
by submitting the first module of its modular PMA approval submission to the
FDA. The first module of the submission includes all required documentation on
the manufacturing and quality controls section in relation to the product.
Further modules are scheduled to be submitted throughout the first and second
quarters of 2012 and the final module, including all clinical data is scheduled
for submission in the second half of 2012. Under the FDA´s modular PMA
submission protocol, in its guidance document "Guidance for Industry and FDA
staff - Premarket Approval Application Modular Review", the FDA provides for a
90 day review period by the agency for each individual module.
As previously announced, a head-to-head comparative study with the goal of
demonstrating non-inferiority of Epi proColon® to fecal immunochemical testing
(FIT) will be an integral part of the clinical module. The design of the
clinical study has been discussed with the FDA and upon finalizing of the study
protocol, it will be initiated in the coming months. The clinical module of the
PMA submission will encompass the results of the head-to-head comparative study,
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®.
Geert Nygaard, CEO of Epigenomics commented: "We are pleased that we have
initiated the regulatory process for our CRC screening test Epi proColon® with
the FDA. We intend to initiate the additional head-to-head study of our product
against FIT as soon as possible, which would be required to meet our ambitious
timeline for the completion of our submission in the second half of 2012."
- Ends -
Further Information
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
antje.zeise@epigenomics.com
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: regulated dealing/prime standard: Frankfurt, free trade: Berlin,
Hamburg, Stuttgart, Düsseldorf, München
language: English