EANS-News: Epigenomics announces the European launch of Epi proColon® 2.0 CE
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Corporate news transmitted by euro adhoc. The issuer/originator is solely
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New Products/Company Information/molecular diagnostics
Subtitle: Presentation of the powerful second generation blood test for
colorectal cancer screening during UEGW in Stockholm
Berlin, Germany, and Stockholm, Sweden, October 25, 2011 (euro adhoc) -
Epigenomics AG (Frankfurt Prime Standard: ECX), the cancer molecular diagnostics
company, today announced the upcoming launch of Epi proColon® 2.0 CE in Europe
during the United European Gastroenterology Week (UEGW) in Stockholm, Sweden.
Epi proColon® 2.0 CE is the Company's second generation blood-based test for the
early detection of colorectal cancer. The rollout of the new test is expected to
start in the near future in Europe and other selected regions through
Epigenomics and its network of distributors.
The announcement of the launch follows a thorough clinical validation in which
the convenient blood test, optimized for maximum specificity for colorectal
cancer, demonstrated an accuracy of detecting colorectal cancer that is
unmatched by any other non-invasive method of colorectal cancer detection. In
particular, the positive predictive value (PPV) of the test - a commonly used
measure for the likelihood of actually having cancer when a test is positive -
was found to be 45% in a large study evaluating its performance when compared to
the PPV of only 10% reported for the most widely used stool tests for colorectal
cancer (CRC) screening. To specifically meet market requirements in many
European countries, the new product minimizes the number of false positive
results while maintaining excellent sensitivity in CRC detection. Thus, Epi
proColon 2.0 CE detects more than 80% of all colorectal cancers at 99%
specificity. With this high level of performance, the new test provides a
reliable and convenient alternative to conventional methods of colorectal cancer
screening such as stool tests.
Geert Nygaard, Chief Executive Officer of Epigenomics commented: "The
combination of both high sensitivity and an almost perfect specificity in a
single convenient and patient-friendly blood test is what sets Epi proColon® 2.0
CE apart from currently available in vitro diagnostic tests for colorectal
cancer early detection. This test provides a compelling alternative for
non-invasive colorectal cancer screening and has an unmatched potential to find
acceptance among patients, doctors, and payers."
Epi proColon® 2.0 CE not only has a significantly enhanced performance over the
first generation Epi proColon® test, but it also features a number of other
improvements that should facilitate its use for the diagnostic routine,
including fewer reagents and handling steps and a shorter time to results. The
test is optimized for the commonly used Roche LightCycler® 480 and the Applied
Biosystems® 7500 Fast real-time PCR systems.
The new Epi proColon® 2.0 CE test can also be optimized for high sensitivity to
colorectal cancer. The Company previously announced data from clinical
validation of the blood test using an algorithm optimized for high sensitivity,
in which the test demonstrated a sensitivity of 95% and a specificity of 85%.
Epigenomics will hold a press briefing at the UEGW, today, Tuesday, October 25,
2011 at 10:35 am CET at booth A13:34 in Hall A, Stockholmsmässan, Mässvägen 1,
Älvsjö, 125 80 Stockholm, Sweden. The briefing will include the following
presentations:
* Dr. Gunter Weiss, Epigenomics' Vice President Product Development will give an
overview on the development and technical improvements of Epi proColon® 2.0 CE.
* Dr. med. Juergen Beck,Senior Vice President Medical Affairs will point out the
clinical advantages of the new Epi proColon® 2.0 CE.
* An open discussion afterwards allows enough time for the plenum to ask
questions.
Interested parties not present at UEGW can follow the presentations and
contribute to the discussion in an audio webcast. The dial-in details for the
audio webcast will be available on Epigenomics' website at
http://www.epigenomics.com/en/news-investors.html.
-Ends-
Contact Epigenomics AG
Dr. Achim Plum
Sen. VP Business & Strategy
Epigenomics AG
Tel +49 (0) 30 24345 368
pr@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 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.
Further inquiry note:
Dr. Achim Plum
Sen. VP Business & Strategy
Epigenomics AG
Tel: +49 30 24345 368
achim.plum@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