EANS-News: Epigenomics AG Certified for Diagnostic Product Development and Commercialization

ISO 13485 certification marks a milestone in Epigenomics' commercial
strategy

--------------------------------------------------------------------------------
Corporate news transmitted by euro adhoc. The issuer/originator is solely
responsible for the content of this announcement.
--------------------------------------------------------------------------------

companies/new product/Molecular Diagnostics

Press release, Berlin, Germany, and Seattle, WA, USA, June 30, 2009
(euro adhoc) - Epigenomics AG (Frankfurt Prime Standard: ECX), a
molecular diagnostics company focusing on the development and
commercialization of in vitro diagnostic products for cancer, has
received ISO 13485 certification for its quality management system.
The certification was granted for Epigenomics' headquarters in
Berlin, Germany, and its subsidiary Epigenomics, Inc. in Seattle, WA,
USA, for the design, development, manufacturing, and distribution of
in vitro diagnostic (IVD) products. The certificate demonstrates the
successful implementation and use of a quality management system that
conforms to the international quality management standard for medical
devices that also includes IVD products such as Epigenomics' tests
for colorectal, lung, and prostate cancer.

"We have implemented a quality management system that is a solid
foundation for future regulatory approval of our products on a global
basis," said Geert Nygaard, CEO of Epigenomics. "Over the last couple
of years we have transformed Epigenomics into a fully integrated
molecular diagnostics company. The ISO certification reflects our
strong commitment to quality and is an important corporate milestone
in the commercial strategy for our cancer tests."

ISO 13485 is an internationally recognized quality management
standard developed for medical devices by the International
Organization for Standardization (ISO), a world-wide federation of
national standards bodies. ISO 13485 specifies requirements for a
quality management system, which demonstrates the organization's
ability to provide medical devices and related services that
consistently meet customer and applicable regulatory requirements.
The implementation of an ISO 13485 compliant quality management
system demonstrates Epigenomics' commitment to develop safe and
effective diagnostic products.

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 in development aim at diagnosing
cancer at an early stage before symptoms occur and thereby may reduce
mortality from this dreaded disease.

Epigenomics' product pipeline contains a validated biomarker for the
early detection of colorectal cancer in blood plasma, and further
proprietary DNA methylation biomarkers at various stages of
development for prostate and lung cancer detection in urine, blood
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 multiple clinical
studies with in total more than 3,000 individuals tested. A large
prospective clinical study - PRESEPT - for evaluation of mSEPT9 in a
screening population is currently under way (www.presept.net).

For development and global commercialization of in vitro diagnostic
test products, Epigenomics pursues a non-exclusive partnering
strategy. Strategic diagnostics industry partners include Abbott
Molecular, Philips, Sysmex Corporation and Quest Diagnostics
Incorporated, 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 protected by more than 150
patent families 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.

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, Technologie All Share
Börsen: Frankfurt / regulated dealing/prime standard
Berlin / free trade
Hamburg / free trade
Stuttgart / free trade
Düsseldorf / free trade
München / free trade