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EANS-News: Epigenomics AG: U.S. Development Partner Quest Diagnostics Completes Clinical Development of Septin9 Colorectal Cancer Blood Test

Geschrieben am 02-11-2009


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Company Information/Licensing Agreements/Molecular Diagnostics

Press release, Berlin, Germany, and Seattle, WA, USA, November 2,
2009 (euro adhoc) - The cancer molecular diagnostics company
Epigenomics AG (Frankfurt Prime Standard: ECX) today announced that
Quest Diagnostics Incorporated, Madison, NJ, U.S.A., the world's
leading provider of diagnostic testing, information and services,
successfully completed the clinical validation of its Septin9-based
laboratory-developed test for aiding the detection of colorectal
cancer. Under terms of a license agreement between the companies for
Epigenomics' proprietary DNA methylation biomarker Septin9,
Epigenomics will receive a milestone payment from Quest Diagnostics
upon reaching this milestone. The amount of the payment was not
disclosed.

"Validation of our Septin9 laboratory-developed test is an important
step forward in providing a test that physicians can use to help them
identify patients with colorectal cancer," said Jay G. Wohlgemuth,
M.D., Vice President of Science and Innovation, Quest Diagnostics.
"We intend to release the test in the U.S. later this year."

"Quest Diagnostics' successful development and validation of a
laboratory-developed blood test based on Septin9 is an important step
forward in making this innovative approach to colorectal cancer
detection broadly available," commented Geert Nygaard, Chief
Executive Officer of Epigenomics. "We are confident that this
patient-friendly option for colorectal cancer testing, once brought
to market in the U.S., will help reduce mortality from this disease
among Americans."

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 Epi proColon, a CE-marked IVD
blood test for the early detection of colorectal cancer based on the
validated biomarker mSEPT9, and further proprietary DNA methylation
biomarkers at various stages of development for colorectal, prostate
and lung cancer detection in blood, urine and bronchial lavage
specimens. Epigenomics' biomarker mSEPT9 for the early detection of
colorectal cancer in a simple blood sample has demonstrated
continuously highest performance in eight clinical case-control
studies with in total more than 3,300 individuals tested. A large
prospective clinical study - PRESEPT - to evaluate the performance
characteristics and the health economic benefit of colorectal cancer
screening with the mSEPT9 biomarker in a representative screening
population currently under way (www.presept.net).

Once completed, the PRESEPT Study will be one of the largest
commercially sponsored colorectal cancer screening clinical studies
ever conducted. The clinical performance and health economic analysis
results are expected to support future coverage of mSEPT9 testing by
public and private health insurers worldwide. Epigenomics' partners
developing IVD test kits for the mSEPT9 biomarker can co-fund and
access the PRESEPT sample collection to conduct clinical trials for
regulatory filings in the U.S.

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, Philips, 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.

Partners in the health care industry and the biomedical research
community can access Epigenomics' portfolio of proprietary DNA
methylation technologies and biomarkers through research products,
Biomarker Services, IVD Development Collaborations, and Licensing.
The company is headquartered in Berlin, Germany, and has a wholly
owned subsidiary in Seattle, WA, U.S.A. For more information, please
visit Epigenomics' website at {www.epigenomics.com}[HYPERLINK:
http://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.


Ende der Mitteilung 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, Technologie 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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