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

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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               
[email protected]                     
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.

Further inquiry note:
Dr. Achim Plum
Sen. VP Corporate Development
Epigenomics AG
Tel: +49 30 24345 368
[email protected]
end of announcement euro adhoc
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company:     Epigenomics AG
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phone:       +49 30 24345-0
FAX:         +49 30 24345-555
mail:        [email protected]
WWW:         www.epigenomics.com
sector:      Biotechnology
ISIN:        DE000A0BVT96, DE000A0XFWF2
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