EANS-News: Epigenomics announces the European launch of Epi proColon® 2.0 CE
Geschrieben am 25-10-2011 |
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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.com
www.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
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