EANS-News: Epigenomics AG reports EpiproColon® 2.0 finds 95% of cancers in
clinical study
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Company Information/New Products/molecular diagnostics
Subtitle: Study provides clinical evidence for CE-marking in Europe and paves
way to US pivotal clinical trial for submission to FDA before year-end
Berlin, Germany, and Seattle, WA, USA, September 19, 2011 (euro adhoc) -
Epigenomics AG (Frankfurt Prime Standard: ECX), the cancer molecular diagnostics
company, today reported positive results in a clinical study for the Company's
second generation blood-based test for the early detection of colorectal cancer,
Epi proColon® 2.0.
In the study, 98 patients with colorectal cancer and 149 patients with no
evidence of disease as verified by colonoscopy were tested with the Epi
proColon® 2.0 test. The test identified 95% of the cancer cases (i.e. 95%
sensitivity) at a specificity of 85%. Most importantly, for stage I and II
cancer where therapeutic interventions have the greatest likelihood of curing
the patient from the disease, the combined sensitivity was 91%. These results
demonstrate a very significant improvement over the performance of the first
generation Epi proColon® test, currently marketed in Europe. In the product
validation study conducted with this product in 2009, 67% of the cancer cases
were detected at comparable specificity.
The new study is the first of two studies by Epigenomics to clinically validate
the newly developed test. It provides the clinical evidence required for
CE-marking of Epi proColon® 2.0 for launch in the European market later this
year. Further, it paves the way for the second validation study that is required
for a submission of the test to the U.S. Food and Drug Administration (FDA).
This pivotal clinical trial will be conducted at three external laboratories,
which will test a subset of blood samples from a prospectively collected cohort
of about 8,000 subjects. The study is expected to be initiated and completed in
time for a submission to FDA before year-end 2011.
Geert Nygaard, Chief Executive Officer of Epigenomics commented:
"In this extremely positive study, Epi proColon® 2.0 has now demonstrated a
clinical performance that is unmatched by other non-invasive tests for
colorectal cancer early detection. With the recent refocusing of the Company, we
made a strong commitment to bring our second generation colorectal cancer blood
test to the European and U.S. market and we have now delivered an important
first part of our promise. We will launch the new product in Europe in the
fourth quarter and we have already made preparations to start the U.S. pivotal
clinical trial in the coming weeks. We are confident that we can keep our
timeline of a submission to the FDA before year end."
Epi proColon® 2.0 has a significantly enhanced performance over the first
generation Epi proColon® test and also features a number of other improvements
that should facilitate its use in the diagnostic routine in different regulatory
environments including the U.S. For example, the test includes the use of cGMP
manufactured reagents and instrumentation, fewer reagents and simplified
handling, and improved automation capabilities along with the added feature that
Epi proColon® 2.0 results can be obtained within a typical laboratory work shift
of 8 hours compared to the two day workflow required by the first test
generation.
-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