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Epigenomics AG Receives Allowance for Key Patent in Europe

Patent covers biomarker Septin 9 for colorectal cancer screening and
diagnosis

Berlin, Germany, and Seattle, WA, USA, July 29, 2008 - Epigenomics AG
(Frankfurt Prime Standard: ECX), a molecular diagnostics company
focusing on the development and commercialization of products for
cancer detection based on DNA methylation, today announced that it
received a Rule 71(3) notification stating that the European Patent
Office intends to grant a patent for Epigenomics' Septin 9 biomarker.
This notification is equivalent to a "Notice of Allowance" by the
United States Patent and Trademark Office. Patent application EP
1721992, titled "Methods and nucleic acids for analyses of cellular
proliferative disorders.", claims very broadly methods, substances
and kits for the methylation analysis of Epigenomics' Septin 9
biomarker. The patent application is also pending in the USA, Japan
and 15 other countries outside of Europe.
Following the receipt of the patent allowance Geert Nygaard,
Epigenomics' Chief Executive Officer, commented: "This allowance
marks a major milestone in our commercial strategy and company
development. The patent adds a strong layer of protection to our
colorectal cancer screening product and entitles us to significant
royalties in years to come from our diagnostics partnerships for this
biomarker."
"Our patent protection is now not only covering our preanalytics and
sensitive detection technologies such as Heavy Methyl (HM) and
MethyLight proprietary, but also the core of the product, the Septin
9 biomarker, for the detection of colorectal cancer in blood", adds
Dr. Kurt Berlin, Epigenomics' Chief Scientific Officer. "This is one
of several dozen biomarker patent applications covering hundreds of
proprietary DNA methylation biomarkers in many cancer indications.
This patent portfolio underscores our leading position in molecular
diagnostics based on DNA methylation."

About Colorectal Cancer Screening

Colorectal cancer is the second leading cause of cancer related death
in the U.S. with an estimated direct medical treatment cost of $8.3
billion in 2007. With a cure rate over 90% if diagnosed in early
stages in the United States, there is now general agreement that
average-risk adults aged 50 and older should be screened for
colorectal cancer. If detected early, individual treatment costs for
colon cancer are estimated at $30,000 per patient, whereas treatment
for a patient who has developed late stage disease is estimated at
$120,000. However, less than 50% of the screening population has had
a recent test. Given today's treatment options for colorectal cancer,
patient outcomes could potentially be greatly improved if more
cancers were detected in early stages.

However, from public health as well as health economics perspectives,
the poor adoption of current screening options limits the
effectiveness of colorectal cancer screening initiatives; Current
colorectal cancer screening guidelines include FOBT, sigmoidoscopy
(alone or with FOBT), or colonoscopy. Non-invasive screening is
conducted using FOBT, which while inexpensive, exhibits a low
compliance rate (around 14% in the US) due to its use restrictions,
perceived inconvenience and lack of consumer acceptance. The gold
standard procedure for colorectal cancer detection is colonoscopy; it
exhibits excellent performance characteristics, but has a limited
utility as a first line screen due to its high cost, healthcare
delivery resource limitations, and inadequate patient acceptance. It
is believed a noninvasive, first-line screening assay capable of
detecting individuals with colorectal disease, confirmed by
colonoscopy, would have greater utility for population screening.

About the Septin 9 Biomarker

The Septin 9 gene encodes a protein involved in cell division and is
thought to play a role in the onset of cancer. Epigenomics has
demonstrated in multiple clinical case control studies with over
3,500 samples from colorectal cancer patients, healthy controls, and
patients with non-cancerous colon diseases that methylated DNA of the
Septin 9 gene shed by tumors into the blood stream can serve as a
biomarker for the sensitive and specific detection of colorectal
cancer. As a first strategic partner, Abbott Molecular, Inc. licensed
the worldwide non-exclusive IVD rights to Epigenomics' proprietary
Septin 9 biomarker for colorectal cancer. In addition, Quest
Diagnostics Inc., the leading provider of diagnostic testing,
information and services, obtained the license to commercialize a
laboratory-developed test (LDT) for Septin 9 in the U.S.

About Epigenomics AG

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 body fluids.
Epigenomics' biomarker Septin 9 for the early detection of colorectal
cancer in a simple blood sample demonstrated continuously highest
performance in multiple clinical studies with in total more than
3,500 individuals tested.

For development and global commercialization as in vitro diagnostic
test kits, Epigenomics pursues a non-exclusive partnering strategy
with diagnostics industry companies. As a first strategic partner,
Abbott Molecular Inc. licensed the worldwide non-exclusive IVD rights
to Epigenomics' proprietary Septin 9 biomarker for colorectal cancer.
Epigenomics also aims at giving patients and doctors early access to
these biomarkers through reference laboratory testing services. As a
first reference laboratory partner, Quest Diagnostics Inc., the
leading provider of diagnostic testing, information and services,
obtained the license to commercialize a laboratory-developed test
(LDT) for Septin 9 in the U.S.

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.

###

Disclaimer
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.
Contact:

Epigenomics AG
Dr. Achim Plum
SVP Corporate Development
+49 30 24 345 368
achim.plum@epigenomics.com
Copyright © Hugin AS 2008. All rights reserved.



 
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