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EANS-News: Epigenomics' Licensee ARUP Reports Excellent Validation Results for Septin9 Colorectal Cancer Blood Test

Geschrieben am 20-10-2010

Presentation at ASCO - NCI - EORTC Molecular Markers Meeting


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

Subtitle: Presentation at ASCO - NCI - EORTC Molecular Markers
Meeting

Berlin and Seattle - October 20, 2010 (euro adhoc) - Epigenomics AG's
(Frankfurt Prime Standard: ECX) licensee, ARUP Laboratories,
yesterday presented results from a positive clinical validation study
for its Septin9 laboratory-developed test for the blood-based
detection of colorectal cancer.

In a poster presentation at the 2010 ASCO-NCI-EORTC* Annual Meeting
on Molecular Markers, in Hollywood, FL, USA, Karen A. Heichman, PhD,
Vice President of Oncology Technology Development & Licensing at
ARUP, reported that ARUP's Septin9 test found 90% of the cancer cases
at a specificity of 89% in the validation study.

ARUP's colorectal cancer blood test is based on Epigenomics'
proprietary Septin9 biomarker and DNA methylation technologies
non-exclusively licensed to ARUP in August 2009. ARUP made the test
available as a laboratory service in July 2010. The Septin9 test
detects methylated cell-free DNA of the Septin9 gene shed by the
tumor into the blood stream.

ARUP also reported supportive tissue data, which indicates that
methylation of Septin9 is an early event in the development of
colorectal cancer. The data demonstrated that the biomarker can be
found in malignant and premalignant lesions independent of location
in the colon, which is consistent with the equally good performance
of the blood test for proximal and distal cancers.

"ARUP's study represents an additional independent validation of the
Septin9 biomarker in plasma. It underscores the unique potential of
our proprietary Septin9 biomarker as an aid in the detection of
colorectal cancer when followed up with colonoscopy," commented Geert
Nygaard, Chief Executive Officer of the Berlin and Seattle based
cancer diagnostics company Epigenomics. "As a single biomarker test,
it compares very favorably in terms of clinical performance and
economics to competing molecular diagnostic approaches to stool and
blood testing."

ARUP Laboratories' Septin9 blood test, which is now available to
physicians and patients in the US, is not meant to replace
colonoscopy but primarily targets patients who cannot or will not
undergo the established screening methods.

The lack of compliance to conventional screening methods such as
colonoscopy and stool tests is considered to be the biggest hurdle to
effective colorectal cancer screening today. Screening experts
believe that a convenient blood test that can be integrated into a
regular check-up in the doctor's office may greatly enhance
compliance among the more than 80 million US citizens aged 50 years
and older for which current guidelines recommend regular colorectal
cancer screening.

*ASCC - NCI - EORTC: American Society of Clinical Oncology- National
Cancer Institute - European Organization for Research and Treatment
of Cancer

For more information, please contact:

Contact ARUP Laboratories

Kristofer Beldin
Tel (801) 583-2787, ext. 2451/(801) 946-2987 (cell)
kris.beldin@aruplab.com

Cyndee Holden
Tel (801) 583-2787, ext. 3318/(801) 386-6637 (cell)
cynthia.holden@aruplab.com

Contact Epigenomics AG

Dr. Achim Plum
Sen. VP Corporate Development
Epigenomics AG
Tel +49 (0) 30 24345 368
pr@epigenomics.com
www.epigenomics.com

Notes to Editor

About Epigenomics

Epigenomics AG 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 for
colorectal, lung, and prostate cancer aim at aiding in an earlier and
more accurate diagnosis of these diseases thereby potentially
increasing the patient's chances of survival.

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, USA. For more information, please visit Epigenomics'
website at www.epigenomics.com

About ARUP Laboratories

Founded in 1984, ARUP Laboratories is a leading national reference
laboratory and an enterprise of the University of Utah and its
Department of Pathology. ARUP offers more than 3,000 tests and test
combinations, ranging from routine screening tests to esoteric
molecular and genetic assays. ARUP serves clients across the United
States, including many of the nation's top university teaching
hospitals and children's hospitals, as well as multihospital groups,
major commercial laboratories, group purchasing organizations,
military and other government facilities, and major clinics. In
addition, ARUP is a worldwide leader in innovative laboratory
research and development, led by the efforts of the ARUP Institute
for Clinical and Experimental Pathology®. For more information,
please visit the website: www.aruplab.com

About the Septin9 Biomarker and Colorectal Cancer Blood Tests

The Septin9 biomarker is at the core of the world's first molecular
diagnostic blood tests for the detection of colorectal cancer
commercialized by Epigenomics (Epi proColon) and its Partner Abbott
Molecular (mS9) as IVD test kits in Europe and Asia/Pacific and its
licensees Quest Diagnostics (ColoVantage?) and ARUP laboratories
(Methylated Septin9 Test) as laboratory-developed tests in the US.
The tests all detect cell-free methylated DNA of the Septin9 gene
shed into the blood stream by colorectal.

In numerous studies, Epigenomics and its partners have demonstrated
that the detection of the Septin9 biomarker in blood plasma
correlates with the presence of colorectal cancer and thus can be
used as an aid in the detection of this common cancer. These studies
include the successfully completed PRESEPT Study, a prospective
evaluation of the Septin9 biomarker in a cohort of almost 8,000
individuals representative of a typical screening population.

Today, Septin9 is likely the most thoroughly tested and best studied
molecular diagnostic biomarker for colorectal cancer detection.

Lack of patient adherence to screening recommendations is the biggest
hurdle to an effective screening for colorectal cancer. Experts
believe that a blood test that is more convenient for the patients
than stool tests and colonoscopy could help to get more people
screened and thus be of medical and health economic benefit.

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 of America. The analytical and
clinical performance characteristics of any product based on this
technology which may be sold at some future time by Epigenomics in
the USA have not been established.


end of announcement euro adhoc
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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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