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Epigenomics AG

EANS-News: Epigenomics AG Receives Allowance of Key Patent in the U.S.

Patent covers detection of colorectal cancer with Septin9 Biomarker
  Corporate news transmitted by euro adhoc. The issuer/originator is solely
  responsible for the content of this announcement.
Patents, Copyright & Trademarks/Molecular diagnostics
Subtitle: Patent covers detection of colorectal cancer with Septin9 
Biomarker
Press release, Berlin, Germany, and Seattle, WA, USA, April 27, 2010 
(euro adhoc) - Epigenomics AG (Frankfurt Prime Standard: ECX), a 
cancer molecular diagnostics company, today announced that it has 
received a "Notice of Allowance" notification stating that the United
States Patent and Trademark Office intends to grant a patent for 
Epigenomics' Septin9 DNA methylation biomarker (mSEPT9). The company 
received the grant of the corresponding patent in Europe in 2008. The
application for which Epigenomics received the Notice of Allowance 
covers a method for the detection or classification of colorectal 
cancer by means of the DNA methylation status of the Septin9 gene.
Septin9 is at the core of the Epi proColon product, Epigenomics' in 
vitro diagnostic blood test for early detection of colorectal cancer.
The test is based on the detection of methylated Septin9 DNA (mSEPT9)
in blood. This epigenetic modification of the Septin9 gene can be 
detected in the vast majority of tumors in the colon and rectum. As 
tumors shed DNA into the bloodstream, the detection of circulating 
methylated Septin9 DNA with the sensitive Epi proColon assay is a 
reliable indicator of acute colorectal cancer. In October 2009 Epi 
proColon has been introduced as a CE-marked in vitro diagnostic 
product in Europe.
Following the receipt of the patent allowance Geert Nygaard, CEO of 
Epigenomics, commented: "Receiving the grant of the Septin9 patent in
the U.S. significantly strengthens our intellectual property 
portfolio. We now have patents covering the Septin9 biomarker in our 
colorectal cancer screening business in Europe as well as the U.S. 
This strong patent position for diagnostic content is at the heart of
our business model and we leverage this asset in our deals with 
diagnostic industry partners such as Abbott, Sysmex, Quest and ARUP 
as well as direct commercialization in certain market segments."
Dr. Andrew Sledziewski, Senior Vice President of Research at 
Epigenomics added: "The Septin9 patent is one of multiple biomarker 
patent applications we have filed over the past several years 
covering novel DNA methylation biomarkers in many cancer indications.
The current Notice of Allowance further validates the innovative 
nature of our Septin9 colorectal cancer blood test and underscores 
our company's leadership in molecular diagnostics based on DNA 
methylation."
About Epi pro Colon
Epi proColon is Epigenomics' CE-marked, in vitro diagnostic real-time
PCR test kit for the qualitative detection of Septin9 gene 
methylation in cell-free bisulfite converted DNA isolated from human 
plasma samples. Presence of methylated Septin9 DNA is associated 
with, and may aid in the detection of, invasive colorectal 
adenocarcinoma.
For more information on the Epi proColon test and its availability 
and distribution options in Europe please visit www.epiprocolon.com 
or contact Epigenomics directly by Email  
sales@products.epigenomics.com or phone +49 30 24345 111.
Epi proColon is not for sale in the United States of America. The 
analytical and clinical performance characteristics of the product 
have not been evaluated by the US Food and Drug Administration. The 
product is CE-marked in compliance with the European IVD Directive 
98/79/EC.
About Epigenomics
Epigenomics is a molecular diagnostics company with a focus on the 
development of novel products for cancer. Using DNA methylation 
biomarkers, Epigenomics' tests on the market and in development aim 
at diagnosing cancer at an early stage before symptoms occur and 
thereby may reduce mortality from this dreaded disease.
Epigenomics' product portfolio contains the CE-marked IVD test Epi 
proColon, the world's first regulatory cleared molecular diagnostic 
test for the detection of colorectal cancer in blood that is based on
the biomarker Septin9, and further proprietary DNA methylation 
biomarkers and IVD products at various stages of development for 
colorectal, lung and prostate cancer. For development and global 
commercialization of IVD test products, Epigenomics pursues a dual 
business strategy in which direct commercialization of proprietary 
diagnostic test products is combined with non-exclusive licensing to 
diagnostic industry players with broad customer access. Strategic 
diagnostics industry partners include Abbott Molecular, Sysmex 
Corporation, Quest Diagnostics Incorporated, and ARUP Laboratories, 
Inc. for diagnostics test products and services, and QIAGEN N.V. for 
sample preparation solutions and research products. The company is 
headquartered in Berlin, Germany, and has a wholly owned subsidiary, 
Epigenomics Inc., in Seattle, WA, U.S.A. For more information, please
visit Epigenomics' website at www.epigenomics.com
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 in the 
United States. The analytical and clinical performance 
characteristics of any product based on this technology which may be 
sold at some future time in the U.S. have not been established.
end of announcement                               euro adhoc

Further inquiry note:

Epigenomics AG
Dr. Achim Plum
Sen. VP Corporate Development
Tel: +49 30 24345 368
achim.plum@epigenomics.com

Branche: Biotechnology
ISIN: DE000A0BVT96
WKN: A0BVT9
Index: Prime All Share, Technology All Share
Börsen: Frankfurt / regulated dealing/prime standard
Berlin / free trade
Hamburg / free trade
Stuttgart / free trade
Düsseldorf / free trade
München / free trade

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  • 19.04.2010 – 15:02

    EANS-News: Epigenomics AG sponsored Felix Burda Award 2010

    Company for the first time supported prestigious award for achievement in colorectal cancer screening Epigenomics' Septin9 blood test for colorectal cancer early detection available in Germany since October 2009 Research study aimed at enhancing blood test to detect precursor lesions nominated for the award Corporate news transmitted by euro adhoc. The issuer/originator is solely responsible for the content ...

  • 07.04.2010 – 10:02

    EANS-News: Epigenomics AG: Laboratory Network synlab Now Offering Septin9 Testing

    European diagnostic laboratory network synlab has started offering Septin9 blood testing through its 55 German sites synlab to measure Septin9 using Epi proColon kit on Applied Biosystems 7500 Fast Real-time PCR System; CE-marked kit now also validated for this instrument Corporate news transmitted by euro adhoc. The issuer/originator is solely responsible ...