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.
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.
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