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

Press release Berlin and Seattle, July 21, 2010 (euro adhoc) -

  Corporate news transmitted by euro adhoc. The issuer/originator is solely
  responsible for the content of this announcement.
New Products/Molecular diagnostics/Partnerships
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

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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