EANS-News: Epigenomics AG Launches its Epi proColon Product in Europe - the First Ever In Vitro Diagnostic Blood Test for Colorectal Cancer Early Detection

Epi proColon is the first CE-marked test in accordance with European
IVD regulations for the early detection of colorectal cancer in a
simple blood draw

Epi proColon finds two thirds of cancers at
early, curable disease stages in final performance evaluation study

Epi proColon will now be made available to molecular diagnostics
laboratories, patients, and doctors in Europe

Epigenomics to
commercialize Epi proColon through direct marketing and sales in
Germany, Switzerland, Austria and via distributors in the rest of
Europe

Epigenomics commercial strategy evolves to a dual business
model combining direct commercialization and non-exclusive licensing
partnerships

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Company Information/New Products/Molecular diagnostics

Utl.: Epi proColon is the first CE-marked test in accordance with
European IVD regulations for the early detection of colorectal cancer
in a simple blood draw

Epi proColon finds two thirds of cancers at early, curable disease
stages in final performance evaluation study

Epi proColon will now be made available to molecular diagnostics
laboratories, patients, and doctors in Europe

Epigenomics to commercialize Epi proColon through direct marketing
and sales in Germany, Switzerland, Austria and via distributors in
the rest of Europe

Epigenomics commercial strategy evolves to a dual business model
combining direct commercialization and non-exclusive licensing
partnerships =

Press release, Berlin, Germany, and Seattle, WA, USA, October 06,
2009 (euro adhoc) - Epigenomics AG (Frankfurt Prime Standard: ECX), a
molecular diagnostics company focusing on the development and
commercialization of in vitro diagnostic (IVD) products for cancer,
today launched the world's first in vitro diagnostic blood test for
early detection of colorectal cancer. Epi proColon is an innovative
molecular diagnostic test that can detect tumor derived methylated
DNA of the Septin9 gene (mSEPT9) in blood plasma as a reliable
indicator, or biomarker, for colorectal cancer.

In a performance evaluation study, the final step of Epigenomics' IVD
product development, analyzing blood samples from about 260 patients
with colorectal cancer or without any evidence of colorectal cancer,
the Epi proColon test detected two thirds of the cancer cases in
early, still localized disease stages. When colorectal cancer is
still localized, i.e. has not spread to lymph nodes or distant
organs, about 90% of the patients can be cured from the disease (90%
5-year survival rate).

Preceding the performance evaluation study and the launch of Epi
proColon, Epigenomics had shown in seven clinical studies between
2005 and 2008 with a total of more than 3,000 subjects that mSEPT9 in
blood plasma is a strong biomarker for the presence of colorectal
cancer. In these studies mSEPT9 testing detected about 70% of the
cancers across all disease stages (i.e. early as well as later
stages) with about 90% specificity, results that were confirmed in
the most recent performance evaluation study for the Epi proColon
test.

Early detection of colorectal cancer in a simple blood draw has the
potential to overcome the most challenging hurdles in colorectal
screening - patient compliance.

Colorectal cancer screening in Germany is recommended by national
guidelines. Under this scheme annual screening with guaiac Fecal
Occult Blood Test (FOBT), a test that detects invisible blood in
stool, is recommended from the age of 50 years. From 55 years and
onwards an ambulant colonoscopy is recommended that should be
repeated after ten years. Individuals not willing to agree to a
colonoscopy are recommended to continue FOBT testing every other
year. Both, guaiac FOBT and colonoscopy are reimbursed by the public
healthcare scheme in Germany. Despite these recommendations the vast
majority of Germans over the age of 50 are not screened at all and as
a consequence colorectal cancer is mostly detected in symptomatic
later stages significantly lowering the patients' chances of
survival. Lack of convenience and reservations against invasive
methods are among the reasons most often cited for this lack of
compliance. Other European countries and the U.S. that have
comparable screening guidelines all face similar challenges.

A blood test for colorectal cancer early detection that can easily be
integrated into an annual health check-up and does not require
patient involvement is believed to be more acceptable to doctors and
patients and has the potential to greatly increase the effectiveness
of national screening programs by increasing overall screening
compliance. If tested positive in such an easy-to-use blood test,
patients would be referred to a gastroenterologist for colonoscopy to
confirm the diagnosis and initiate early treatment.

"The big issue in colorectal cancer screening remains that far too
few people make use of it. Stool tests and colonoscopy are still not
sufficiently accepted by patients?, explained Dr. Thomas Roesch,
Professor for Endoscopy at the University Medical Center
Hamburg-Eppendorf. "In this situation a simple blood test makes a lot
of sense as it is easy to use for the patients and quickly done. And
who wouldn't accept to undergo colonoscopy if the blood test already
indicated a high risk of having colorectal cancer?"

The Epi proColon blood test does not only have the chance to gain
better acceptance in the target group for colorectal cancer
screening. With a cancer detection rate of about 70% it also
significantly outperforms guaiac FOBTs, that are the currently most
widely used stool tests used for screening but only find 30-40% of
the cancer cases.

Epi proColon is the first CE-marked in vitro diagnostics product that
Epigenomics markets directly to molecular diagnostic laboratories in
Europe. Septin9 testing is currently being offered by selected
innovative early adopter laboratories including Viollier AG in
Switzerland and the German laboratories Krone, Limbach, MVZ Dr.
Stein, and MVZ Dr. Eberhard & Partner. These labs have established
and validated laboratory developed tests for the mSEPT9 biomarker.
With the availability of Epi proColon that has been fully validated
and CE-marked by Epigenomics as an aid in the detection of colorectal
cancer, Septin9 testing can now be implemented in a much broader
range of clinical laboratories with molecular diagnostics
capabilities across Europe. Epigenomics aims at serving the home
market in Germany, Austria and Switzerland through direct marketing
and sales, while initially commercializing through distributors in
other European markets.

"With the launch of Epi proColon we follow the request by our
customers to offer a CE-marked version of our Septin9 test that can
easily be implemented and takes away the burden of validation from
the laboratory ", explained Geert Nygaard, Chief Executive Officer of
Epigenomics. "It also marks a great leap forward in the execution of
our commercial strategy to become a leading molecular diagnostics
company. With Epi proColon we are the world's first company offering
a regulated IVD product for the early detection of colorectal cancer
using a simple blood draw. This test has the potential to be used for
population-wide colorectal cancer screening. With several hundred
million people world-wide being eligible for colorectal cancer
screening, our test has the potential to save many lives and at the
same time addresses one of the most attractive future markets in
molecular diagnostics."

To ensure the broadest possible availability of blood-based
colorectal cancer early detection, Epigenomics also pursues a
non-exclusive licensing strategy and is working with partners in the
diagnostics industry, including Abbott Molecular, Chicago, IL, U.S.A.
and Quest Diagnostics, Giralda Farms, NJ, U.S.A., that are expected
to start offering their Septin9 tests in Europe and the U.S.A.,
respectively, in the fourth quarter of 2009. Further partners include
ARUP Laboratories, Salt Lake City, UT, U.S.A., and Sysmex
Corporation, Kobe, Japan.

"With the decision for direct commercialization of Epi proColon in
addition to our partnering strategy, Epigenomics will take a much
more active role in building the colorectal cancer blood testing
market. We intend to leverage the know-how we have gathered in
colorectal cancer screening over the years as we developed the test
with some of the most influential opinion leaders in the field",
Nygaard explained Epigenomics' strategic move. "However, we continue
to be fully committed to our non-exclusive partnering strategy for
mSEPT9 and strongly believe in the synergies created by several
diagnostics players advocating colorectal cancer blood testing as an
alternative to current stool tests for screening and offering the
test on multiple diagnostic platforms. To this end we will continue
to support our current and future partners in their development and
commercialization efforts for colorectal cancer blood tests based on
mSEPT9 to the extent permitted and possible."

Epigenomics will introduce the Epi proColon test to German laboratory
physicians at the upcoming 6th Annual Conference German Society of
Clinical Chemistry and Laboratory Medicine (DGKL) in Leipzig,
Germany, on October 7-10, 2009 and to a broader European audience at
GASTRO 2009 in London, UK, on November 21-25, 2009.

Conference Call for Investors and Media

Epigenomics' management will host a conference call on the Epi
proColon launch and its strategy going forward at 4pm CET today,
Tuesday October 6, 2009. The dial-in numbers for the conference call
are:

Dial-in number (within Germany): +49 (0)69 247 501 891
Dial-in number (within the US): +1 212 444 0297

Participants are kindly requested to dial in 10 minutes prior to the
start of the call.

The presentation accompanying the conference call will be available
at 3 pm for download on the Epigenomics website:
http://www.epigenomics.com/en/down_loads/corporate_material/

A recording of the conference call will be provided on Epigenomics'
website subsequently:
http://www.epigenomics.com/en/down_loads/corporate_material/

Epigenomics at the DGKL and GASTRO Conferences

Epigenomics will be represented at the DGKL (German Society for
Clinical Chemistry and Laboratory Medicine) Conference 2009 in
Leipzig, Germany, from October 7th to 10th 2009, with a booth in the
Congress Center Leipzig, Hall 1, booth number 17+18.

A poster presentation reporting the first experiences with the
Septin9 test in daily laboratory routine will be presented by Dr.
Lothar Kruska, Head of Molecular biology laboratory at MVZ Dr. Stein,
Moenchengladbach, Germany, on October 8th 2009, from 3:30pm to 4:30
pm, at the Congress Center Leipzig, Hall 1, booth number 17+18.

Epigenomics will be represented at the GASTRO 2009 congress at ExCel
London, UK, One Western Gateway Royal Victoria Dock, from November
21st to 25th 2009, at the industry exhibition, booth number 90.

A poster presentation titled "Clinical Performance of a blood-based
test for detection of the Septin9 biomarker for colorectal cancer
screening" (Poster number P0964) will be presented during the poster
session "Colonic and Anorectal disorders II", by Dr. Gunter Weiss,
Vice President Product Development at Epigenomics AG, on Tuesday,
November 24th, 2009, from 9 am to 5 pm, at ExCel London, Hall S10.

About Epi proColon

The Epi proColon test is a CE-marked, in vitro diagnostic real-time
polymerase chain reaction (real-time PCR) test kit for the
qualitative detection of SEPT9 gene methylation (mSEPT9) in bisulfite
converted DNA isolated from human plasma samples. Presence of mSEPT9
is associated with, and may aid in, the detection of invasive
colorectal adenocarcinoma.

The mSEPT9 assay is based on detecting aberrant DNA methylation of
the v2 region of the Septin9 gene. Cytosine residues in the v2 region
become methylated in colorectal cancer tissue but not in normal colon
mucosa. This aberrant methylation can be detected by specific
amplification of DNA shed into the blood stream by tumor cells.
Detection of colorectal cancer DNA using the mSEPT9 biomarker has
been demonstrated in multiple case control studies with plasma
specimens from colorectal cancer patients and colonoscopy-verified
negative controls to be a strong indicator of the presence of
colorectal cancer.

For more information on Epi proColon test and its availability in
Europe visit {www.epiprocolon.com}[HYPERLINK:
http://www.epiprocolon.com] or contact Epigenomics directly by Email
({sales@products.epigenomics.com}[HYPERLINK:
mailto:sales@products.epigenomics.com]) or phone (+49 30 24345 111).

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 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}[HYPERLINK:
http://www.presept.net/]).

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
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Berlin / free trade
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