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

Geschrieben am 07-04-2010

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


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Corporate news transmitted by euro adhoc. The issuer/originator is solely
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Company Information/New Products/Molecular Diagnostics

Subtitle: 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


Berlin (euro adhoc) - Berlin, Germany, and Seattle, WA, USA, April 7, 2010 -
Epigenomics AG (Frankfurt Prime Standard: ECX), a cancer molecular diagnostics
company, today reports that synlab, one of the largest laboratory networks in
Europe, has started offering the blood-based Septin9 test Epi proColon for
colorectal cancer early detection through its 55 German sites. The test which is
able to detect colorectal cancer in a simple blood draw is based on Epigenomics'
patented Septin9 biomarker and is the first regulated molecular diagnostic blood
test ever for colorectal cancer early detection offered in Europe. The test was
introduced in October 2009 as a CE-marked in vitro diagnostic product in Europe.
Additional offering of Septin9 testing through the synlab network significantly
increases coverage in Germany as well as other countries making this innovative
test even more broadly available to doctors and patients in Europe.

Current colorectal cancer screening methods - including fecal occult blood tests
(FOBT) and colonoscopy- are perceived to be inconvenient and laborious and are
reluctantly and infrequently used by individuals aged 50 and older who should be
screened at regular intervals. This lack of compliance to screening
recommendations severely limits the effectiveness of national screening programs
as the majority of cancer cases are detected in advanced stages when symptoms
occur and the chances of survival are greatly diminished.

The Septin9 colorectal cancer blood test is designed to be as convenient and
patient friendly as possible: patients simply provide a blood sample in their
doctors' office, e.g. as part of a regular health check-up. The sample is then
shipped to a local, regional or national diagnostic laboratory where it is
tested for the Septin9 biomarker.

Dr. Wolfgang Schwabe, Head of Oncoscreen GmbH, Jena, the laboratory running the
Septin9 test within the synlab network, stated: "We are excited by the potential
of the Septin9 test to help doctors provide more convenient patient care. With
the Septin9 test we have broadened our portfolio of oncology services which
allows us to offer a more complete package of diagnostic services to doctors and
their patients."


The test is based on the detection of methylated Septin9 DNA 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 real-time PCR
assay is a reliable indicator of acute colorectal cancer.

Oncoscreen is the first laboratory to use a recently released version
of the Epi proColon real-time PCR assay to detect the Septin9
biomarker in blood plasma. This reagent kit has now been validated
for use with the Applied Biosystems 7500 Fast Real-Time PCR System of
Life Technologies Inc. as well as Roche's LightCycler® 480 instrument
on which the test was originally released in October 2009.
Availability on two standard real-time PCR instrument platforms found
in many clinical laboratories is expected to further facilitate
making Septin9 testing broadly available in Europe.

"The Septin9 assay is very robust and can easily be optimized for
different real-time PCR instruments, the standard technology platform
in molecular diagnostics", commented Dr. Uwe Staub, Senior Vice
President Product Development at Epigenomics. "This allows us as well
as our partners to make Septin9 testing available as broadly as
possible, an important prerequisite for a test that should eventually
be used in population wide colorectal cancer screening."

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
--------------------------------------------------------------------------------


ots Originaltext: Epigenomics AG
Im Internet recherchierbar: http://www.presseportal.de

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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