EANS-News: Epigenomics AG submits the third module in its PMA filing with FDA
for Epi proColon®
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New Products/Company Information/molecular diagnostics
Berlin, Germany, and Seattle, WA, U.S.A., June 12, 2012 (euro adhoc) -
Epigenomics AG (Frankfurt Prime Standard: ECX), the German-American cancer
molecular diagnostics company, announced today that it has submitted the third
module of its Premarket Approval (PMA) application to the United States Food &
Drug Administration (FDA) for its blood-based colorectal cancer screening test
Epi proColon®.
Module three describes the analytical performance of Epi proColon® in terms of
accuracy, precision and stability. Reproducibility and validation of the
analytical performance were assessed through testing at three external
laboratories. The first two modules of the PMA are related to design control,
manufacturing, quality management, and software validation. The fourth and last
module is planned for submission in the second half of 2012 and will include the
results of a head-to-head comparative study with the goal of demonstrating
non-inferiority of Epi proColon® to fecal immunochemical testing (FIT), which is
currently underway and enrolling study subjects according to plan. Furthermore,
it will include 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®.
Under the FDA's modular PMA submission guidance, the complete contents of a PMA
is broken down into well-delineated modules, such as non-clinical, clinical, and
manufacturing, that together become a complete application. The FDA reviews each
module separately as it is received, allowing companies to receive timely
feedback during the review process. The FDA guides that it will take 90 days to
complete its review of each module as stated in "Guidance for Industry and FDA
staff - Premarket Approval Application Modular Review" as posted on FDA's
homepage.
Geert Nygaard, Chief Executive Officer of Epigenomics commented: "The submission
of the third module concludes a significant part of our PMA filing. We look
forward to successfully finishing the ongoing clinical trial and subsequently
completing our PMA submission to FDA by year end. Our team has been working
expeditiously to finalize our first US market application and we remain
committed and focused on introducing Epi proColon® as the first FDA approved
blood-based test for the early detection of colorectal cancer in the US. We
firmly believe that the test will help drive screening compliance and make a
difference in detecting cancers in patients who would otherwise avoid being
tested for colorectal cancer."
- 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
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: free trade: Berlin, München, Hamburg, Düsseldorf, Stuttgart,
regulated dealing/prime standard: Frankfurt
language: English