EANS-News: Epigenomics AG: Screening More People for Colorectal Cancer with Septin9 Blood Tests Could Provide Medical Benefit and Be Cost-Effective

Health economic analysis in favor of Septin9 testing presented by
renowned Stanford University researcher at Digestive Disease Week
2011

Patient behavior study underway to demonstrate compliance
benefit

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Company Information/molecular diagnostics

Subtitle: Health economic analysis in favor of Septin9 testing
presented by renowned Stanford University researcher at Digestive
Disease Week 2011

Patient behavior study underway to demonstrate compliance benefit

Berlin, Germany, and Seattle, WA, USA, May 9, 2011 (euro adhoc) -
Epigenomics AG (Frankfurt Prime Standard: ECX), the cancer molecular
diagnostics company, reports that Dr. Uri Ladabaum, Associate
Professor in the Department of Gastroenterology and Hepatology at the
School of Medicine of Stanford University (Redwood City, CA, U.S.A.),
has presented the results of a health economic analysis of potential
future colorectal cancer screening with Septin9 blood tests at the
ongoing Digestive Disease Week 2011 (Ref. 1). Septin9 tests detect
cell-free DNA derived from tumors in the colon and rectum in the
blood stream by means of a DNA methylation pattern in the SEPT9 gene
that is specific for colorectal cancer. The biomarker and detection
technologies used in Septin9 testing are proprietary to Epigenomics.

Using a validated Markov model for colorectal cancer screening
reflecting U.S. colorectal cancer epidemiology and health care cost
structure, Dr. Ladabaum and coworkers compared Septin9 testing to
current standard methods of colorectal cancer screening, i.e. fecal
occult blood testing (FOBT), fecal immunochemical testing (FIT),
sigmoidoscopy and colonoscopy.

Their analysis is based on clinical performance data for Septin9
testing from a prospective trial with over 7,900 average-risk
screening guideline-eligible subjects, previously reported at
Digestive Disease Week in 2010. In this study, a first generation
Septin9 test detected up to 67% of the cancer cases at 88%
specificity (Ref. 2).

The analysis demonstrates that at the population level, Septin9
testing yielded the greatest incremental benefit at acceptable costs
when it increases the fraction of the population screened. The group
concluded that screening for colorectal cancer using Septin9 tests is
a medically beneficial and health economically cost-effective
strategy when it addresses the currently unscreened population in the
U.S.

Patient behavior studies to understand screening barriers in
unscreened individuals and the potential impact of a blood test as an
alternative option for screening are ongoing at the University of
Utah and the Huntsman Cancer Institute in collaboration with ARUP
Laboratories, Salt Lake City, UT, U.S.A. First results from focus
groups, recently presented by Jennifer Taber, M.S., of the Department
of Psychology at the University of Utah at the 2011 Annual Meeting of
the American Society of Preventive Oncology, indicated that the
majority of the currently unscreened patients would take a Septin9
test for screening. No significant differences with regard to gender,
religion, marital status, health care coverage or ethnicity were
observed. Going forward, a quantitative survey and a prospective
longitudinal clinical study are planned to further investigate the
impact of blood tests on patient acceptance of colorectal cancer
screening and their potential to increase overall screening
compliance (Ref. 3).

Jennifer Taber remarked: "The initial results suggest that community
members are interested in Septin9 testing in part because of its high
accuracy and the convenient and noninvasive aspects of the procedure.
Going forward, we hope to learn whether blood-based tests will
increase colorectal cancer screening rates by reducing the currently
existing barriers."

Dr. Philip Schoenfeld, M.D., M.Sc., M.Sc., Associate Professor of
Medicine, Division of Gastroenterology at the University of Michigan
School of Medicine and member of Epigenomics´ Medical Advisory Board
commented on the two studies: "The cost effectiveness and patient
behavior studies are important additions to the clinical utility
study completed last year for Septin9. These are essential steps to
support physician and payer acceptance of Septin9 testing, and its
potential to improve patient access to colorectal cancer screening
approaches with clear clinical benefit."

Under licenses by Epigenomics, Septin9 testing is currently offered
in the U.S. by Quest Diagnostics (ColoVantage?) and ARUP Laboratories
(Methylated Septin9 Test) based on laboratory-developed tests aiding
in the detection of colorectal cancer. Epigenomics and its partner
Abbott already market their respective first generation CE-marked
Septin9 tests in Europe, the Middle East, Asia/Pacific and further
markets. Epigenomics is in the process of developing a second
generation Septin9 assay as a colorectal cancer screening test for
the U.S. and European market. Epigenomics expects to submit this
enhanced Septin9 test branded Epi proColon® 2.0 to the FDA for
regulatory review and pre-market approval as a colorectal cancer
screening test before year-end 2011.

Dr. Juergen Beck, M.D., Epigenomics´ Senior Vice President of Medical
Affairs commented: "Dr. Ladabaum and his colleagues have undertaken a
thorough and stringent analysis. The results of the study confirm our
own expectations on the medical benefit and cost-effectiveness of
Septin9 testing and are in line with a future positioning as an
additional screening option for those people currently reluctant to
undergo screening by available conventional methods. Our emphasis in
clinical research now lies on demonstrating the required compliance
benefit of Septin9 blood tests and we are looking forward to further
results of the ongoing study at the University of Utah and the
Huntsman Cancer Institute."

-Ends-

About Colorectal Cancer

For 2011 the American Cancer Society expects an estimated 140,000 new
cases of colorectal cancer to be diagnosed in the United States and
almost 50,000 U.S. citizens to die from the disease. The 5-year
survival rate is over 90% if the disease is treated in early stages
but diminishes to about 12% once the cancer has affected other
organs. Today, the majority of cancers are still found in advanced
stages due to insufficient patient compliance to screening
recommendations that leaves 47% of the population unscreened.
Increasing compliance to regular cancer screening in the population
aged 50 years and older is considered key to decreasing mortality
from this disease. (Ref. 4)

References

Ref. 1: Ladabaum, Uri; Allen, John I.; Wandell, Michael; Ramsey,
Scott: Screening for Colorectal Cancer with a Blood Test: Projected
Effectiveness and Cost-Effectiveness of a Novel Plasma Methylated
Septin-9 DNA (mSEPT9) Assay. Oral presentation at Digestive Disease
Week 2011, May 7-10 2011, Chicago, IL, U.S.A. (Abstract #220)

Ref. 2: Church et al.: Methylated SEPT9 Gene in Plasma as a Marker
for Detection of Occult Colorectal Cancer in a Screening Population.
Oral presentation at Digestive Disease Week 2010, May 1-5, 2010, New
Orleans, LA, U.S.A. (Abstract #711d)

Ref. 3: Taber, Jennifer M.; Aspinwall, Lisa G.; Heichman, Karen;
Kinney, Anita Y.: Blood-based colorectal cancer screening: Eliciting
attitudes and determining predictors of interest in a multiethnic
sample. Poster presentation at the 35th Annual Meeting of the
American Society of Preventive Oncology, March 4-8, 2011, Las Vegas,
NV, U.S.A.

Ref. 4: American Cancer Society. Colorectal Cancer Facts & Figures
2011-2013. Atlanta: American Cancer Society, 2011.

Contact Epigenomics AG
Dr. Achim Plum
Sen. VP Corporate Development
Epigenomics AG
Tel +49 (0) 30 24345 368
pr@epigenomics.com
www.epigenomics.com

About Epigenomics

Epigenomics (www.epigenomics.com) is a molecular diagnostics company developing

and commercializing a pipeline of proprietary products for cancer.
The Company´s products enable doctors to diagnose cancer earlier and
more accurately, leading to improved outcomes for patients.
Epigenomics´ lead product, Epi proColon®, is a blood-based test for
the early detection of colorectal cancer, which is currently marketed
in Europe and is in development for the U.S.A. The Company´s
technology and products have been validated through multiple
partnerships with leading global diagnostic companies including
Abbott, QIAGEN, Sysmex, and Quest Diagnostics. Epigenomics is an
international company with operations in Europe and the U.S.A.

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 by
Epigenomics in the United States or Canada. The analytical and
clinical performance characteristics of any Epigenomics 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
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ots Originaltext: Epigenomics AG
Im Internet recherchierbar: http://www.presseportal.de

Further inquiry note:

Dr. Achim Plum
Sen. VP Corporate Development
Epigenomics AG
Tel: +49 30 24345 368
achim.plum@epigenomics.com

Branche: Biotechnology
ISIN: DE000A0BVT96
WKN: A0BVT9
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