EANS-News: Epigenomics AG: Licensee ARUP Launches Septin9 Colorectal Cancer Blood Test in the United States

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New Products/Molecular diagnostics/Partnerships

Press release Berlin and Seattle, July 21, 2010 (euro adhoc) -
Epigenomics AG (Frankfurt Prime Standard: ECX) announced that its
licensee ARUP Laboratories, Salt Lake City, UT, U.S.A., has launched
a laboratory-developed test for the blood-based detection of
colorectal cancer yesterday. The test is based on Epigenomics'
proprietary Septin9 biomarker and DNA methylation technologies
non-exclusively licensed to ARUP in August 2009.

The launch of ARUP's Septin9 test marks another important milestone
in Epigenomics' dual business strategy of direct commercialization
and non-exclusive licensing and partnering of its proprietary
biomarkers and technologies for cancer molecular diagnostics.
Multiple in vitro diagnostic and laboratory-developed blood tests for
the early detection of colorectal cancer based on the Septin9
biomarker have been made available since October 2009 in Europe,
Asia/Pacific and the U.S. by Epigenomics and its partners Abbott
Molecular, Quest Diagnostics, and ARUP Laboratories. Furthermore,
Canadian Warnex Laboratories is working on a laboratory-developed
test for Septin9 that is expected to be launched later this year.

According to ARUP the independently developed and validated Septin9
test identifies nine out of ten people with previously undetected
colorectal cancer, including those with early stage disease.

"The test performance demonstrated by ARUP in the clinical validation
of their laboratory-developed test for the Septin9 biomarker
underscores the full potential this biomarker has," commented Geert
Nygaard, Chief Executive Officer of Epigenomics. "As a single
biomarker test it compares very favorably in terms of its clinical
performance and economics to competing approaches that often require
a handful of biomarkers be tested in stool to more than two hundred
biomarkers for blood testing on an array and complex algorithms to
get to similar performance levels in sensitivity and specificity," he
continued.

ARUP Laboratories' Septin9 blood test, which is now available to
physicians and patients in the U.S., is not meant to replace
colonoscopy but primarily aims at 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.

Prior to and accompanying its introduction into the clinical
diagnostics market, the Septin9 biomarker has been evaluated
extensively in numerous carefully designed case control studies and a
prospective clinical cohort study, of almost 8,000 subjects - PRESEPT
- demonstrating its applicability to population-based colorectal
cancer screening. Today, Septin9 is likely the most thoroughly and
widely tested molecular diagnostic biomarker for colorectal cancer
meeting the most stringent requirements of clinical validation.

"The level of clinical validation required to meet regulatory
standards as well as the expectations of the medical community to
achieve widespread adoption of new diagnostic tests have been
steadily increasing over the last couple of years," Nygaard
explained. "While we see many research studies with new biomarker
combinations for blood based colorectal cancer screening being
published, none have so far met the high standards we have set with
the systematic clinical validation of Septin9."

Founded in 1984, ARUP Laboratories is a 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. Clients across the United States include university
teaching hospitals, multihospital groups, major commercial
laboratories, military and other government facilities, as well as
major clinics.

More Information

For more information, please see the press release issued by ARUP
Laboratories http://www.aruplab.com/AboutARUP/PressRoom/index.jsp or
visit ARUP Consult®,
http://www.arupconsult.com/Topics/ColorectalCancer.html

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 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, Epi proLung, a CE-marked test kit to aid in
the diagnosis of lung cancer, 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, ARUP Laboratories, and
Warnex Inc. for diagnostic 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 by
Epigenomics in the United States. The analytical and clinical
performance characteristics of any product based on this technology
which may be sold by Epigenomics at some future time in the U.S. 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
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