EANS-News: Epigenomics AG Initiates Testing of Blood Plasma Samples from PRESEPT Study in Three Independent Clinical Laboratories

PRESEPT Study evaluates clinical performance and health economic
benefit of colorectal cancer screening with mSEPT9 blood test

Quest Diagnostics, ARUP Laboratories, and Charité -
Universitätsmedizin Berlin selected to test mSEPT9 biomarker in blood
plasma samples from PRESEPT Study subjects

Laboratories to use
recently launched Epi proColon CE Marked IVD test products for the
testing of the PRESEPT medical research study samples

Selection
of about 1,500 masked blood samples to be tested in several batches -
data analysis after last sample of last batch is tested

PRESEPT
enrollment now exceeds 6,400 subjects with more than three quarters
of targeted 50 colorectal cancer cases accrued

Laboratories to
start testing in October - completion expected late 2009 or early
2010

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Company Information/Research & Development/Molecular diagnostics

Utl.: PRESEPT Study evaluates clinical performance and health
economic benefit of colorectal cancer screening with mSEPT9 blood
test

Quest Diagnostics, ARUP Laboratories, and Charité -
Universitätsmedizin Berlin selected to test mSEPT9 biomarker in blood
plasma samples from PRESEPT Study subjects

Laboratories to use recently launched Epi proColon CE Marked IVD test
products for the testing of the PRESEPT medical research study
samples

Selection of about 1,500 masked blood samples to be tested in several
batches - data analysis after last sample of last batch is tested

PRESEPT enrollment now exceeds 6,400 subjects with more than three
quarters of targeted 50 colorectal cancer cases accrued

Laboratories to start testing in October - completion expected late
2009 or early 2010 =

Press release, Berlin, Germany, and Seattle, WA, USA, October 08,
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 early
cancer detection, today announced that it has initiated the testing
of the biomarker mSEPT9 in plasma samples collected in the PRESEPT
Study. Subject enrollment into the study at 32 clinical sites is
ongoing and progressing well.

PRESEPT is a prospective multi-center, multi-national clinical
research study to evaluate the performance characteristics and health
economic benefit of colorectal cancer screening using the mSEPT9
blood test in a representative asymptomatic screening eligible
population. Once completed, the PRESEPT Study will be the largest
commercially sponsored colorectal cancer screening studies ever
conducted.

Enrollment as of early October already exceeded 6,400 subjects among
which more than three quarters of the targeted 50 colorectal cancer
cases have been identified by colonoscopy. Epigenomics expects to
reach its original enrollment target of around 7,500 subjects during
Q4 of 2009 but will continue enrolling until the study population
comprises 50 colorectal cancer cases, a target expected to be reached
either in late 2009 or early 2010.

mSEPT9 testing will be performed by three independent high-profile
laboratories, namely Quest Diagnostics Incorporated headquartered in
Madison, NJ, U.S.A., ARUP Laboratories, Salt Lake City, UT, USA and
the Institute of Laboratory Medicine and Pathobiochemistry of Charite
- Universitätsmedizin Berlin, Germany. Each has passed a rigorous
quality audit as well as extensive training and qualification with
the mSEPT9 assay procedure before being selected for the study. The
laboratories will use the recently launched CE-marked Epi proColon
test kit to detect the mSEPT9 biomarker in the PRESEPT blood samples
for this research study. The contracted laboratories will measure the
mSEPT9 biomarker in a combined total of about 1,500 blood plasma
samples collected in the PRESEPT Study. Following a predefined
statistical analysis plan this subset of the about 7,500 PRESEPT
blood plasma samples will include all 50 CRC cases, several hundred
cases with polyps and a random selection of about 900-1000
colonoscopy-verified subjects with no evidence of disease as
controls. Following the processing of all samples, the results of
mSEPT9 testing will be compared to the findings by colonoscopy plus
the histopathology of the polyps and cancer cases by an independent
biostatistical group at the University of Minnesota.

The plasma samples to be tested are being selected by the Study
Principal Investigator and subject identity or clinical status are
masked to the testing laboratories. Thus, throughout mSEPT9 testing
neither Epigenomics nor its laboratory partners will know the
identity of the subjects corresponding to the samples or the
colonoscopy results of the respective subjects. The biostatistical
group will unmask the samples and compare the results of mSEPT9
testing with the findings in colonoscopy after all of the ~ 1,500
blood samples are analyzed for the mSEPT9 biomarker.

The blood plasma samples will be processed in several batches, the
first of which will be tested in the first half of October with
further batches scheduled for later in October, November, and
December. Testing of the last batch will commence once the 50th
cancer subject is identified. Each batch will contain randomized,
masked samples from cancer and polyp cases, and control subjects with
no evidence of disease. After unmasking and data analysis, the Study
Principal Investigator along with the PRESEPT Study independent
oversight group, the Clinical Study Steering Committee, will
accurately report the results of the PRESEPT Study according to the
highest standards of scientific and clinical research.

Epigenomics expects that preliminary results will be available either
late in 2009 or early 2010. The detailed results of the PRESEPT Study
will subsequently be submitted for publication in a top-tier
peer-reviewed journal and presented at major medical conferences in
the first half of 2010.

"With the start of blood plasma sample testing we have reached an
important milestone in the PRESEPT clinical study and have entered
the home stretch for completion", stated Cathy Lofton-Day, PhD,
Project Manager of PRESEPT at Epigenomics, Inc., Seattle. "We believe
that all three laboratories are excellent choices for testing the
samples and generating data for mSEPT9 biomarker performance in the
PRESEPT cohort", she added.

"Choosing to go with high-quality external clinical laboratories will
add significant credibility to the PRESEPT Study results and should
demonstrate the robustness of our assay in routine clinical
laboratory settings", Michael Wandell, PharmD, Study Director
PRESEPT, Epigenomics Inc., Seattle remarked. "We are using our Epi
proColon kit to measure the PRESEPT samples. This kit has recently
been CE marked and is commercially available to clinical laboratories
as an IVD test kit in Europe through Epigenomics' direct marketing
and sales organization."

Geert Nygaard, CEO of Epigenomics AG, further stated: "Demonstrating
the performance of our Epi proColon IVD blood test in this
prospective screening cohort will be of tremendous value to our
marketing efforts in Europe and in making the Septin9 blood test a
widely accepted additional option for colorectal cancer screening."

Further Information

For further information on PRESEPT, please visit HYPERLINK
"http://www.presept.net"www.presept.net or clinicaltrials.gov
(Identifier: NCT00855348).

More information on the partner laboratories can be found on their
respective web sites: Quest Diagnostics: HYPERLINK
"http://www.questdiagnostics.com"www.questdiagnostics.com ARUP
Laboratories: {www.aruplab.com}[HYPERLINK: http://www.aruplab.com]
ZLP, Charité - Universitätsmedizin Berlin: zlp.charite.de (German)

About Epi proColon

Epi proColon is a CE-marked, in vitro diagnostic real-time PCR test
kit for the qualitative detection of SEPT9 gene methylation (mSEPT9)
in cell-free 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 HYPERLINK
"http://www.epiprocolon.com"www.epiprocolon.com or contact
Epigenomics directly by Email (HYPERLINK "mailto:sales@products.epig
enomics.com"sales@products.epigenomics.com) or phone (+49 30 24345
111).

Epi proColon is not for sale in the United States of America.

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 eight clinical case-control
studies with in total more than 3,250 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 HYPERLINK
"http://www.epigenomics.com"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
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