DGAP-News Epigenomics AG: Clinical study conducted in the Czech Republic confirms blood-based Septin9 test to be an attractive alternative for CRC screening programs
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| 05.03.2014, 09:00 | 123 Aufrufe | 0 | druckversion
DGAP-News: Epigenomics AG / Key word(s): Study
Epigenomics AG: Clinical study conducted in the Czech Republic
confirms blood-based Septin9 test to be an attractive alternative for
CRC screening programs
05.03.2014 / 09:00
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Epigenomics AG: Clinical study conducted in the Czech Republic confirms
blood-based Septin9 test to be an attractive alternative for CRC screening
programs
- Study conducted using Epigenomics' Epi proColon(R) 2.0 CE
- Results in line with the results achieved in the CE marking study
reported in 2011
- Patient convenience might help to increase early colorectal cancer
(CRC) detection especially with non-compliant individuals
Berlin (Germany) and Germantown, MD (U.S.A.), March 5, 2014 - Epigenomics
AG (Frankfurt Prime Standard: ECX), the German-American cancer molecular
diagnostics company, today announced findings from a study executed in
different centers in Prague, Pilsen, and Brno. According to the study
published in "Vnitr Lék", a leading Czech journal for internal medicine, in
late 2013 blood-based Septin9 testing could be an attractive screening
alternative to established methods for a population that would otherwise be
non-compliant to colorectal cancer screening. The study was conducted by MU
Dr. Zdenek BeneÅ , CSc., Head, Medical department of Thomayer Hospital,
Prague.
The case control study comprised 57 patients; 33 asymptomatic individuals
with negative colonoscopies, and 24 patients with proven adenomas. In this
study, Epi proColon(R) 2.0 CE showed a sensitivity of 92% and a specificity
of 97%. These results are in line with the results achieved in the CE
marking study reported in 2011, which followed the same principle of data
interpretation (80% sensitivity and 99% specificity).
According to the authors of the publication, Septin9 testing can be seen as
an attractive alternative to existing CRC screening methods in areas where
sufficient compliance to CRC screening programs is currently not achieved.
Established screening methods, including fecal occult blood testing (FOBT),
fecal immunochemical testing (FIT), flexible sigmoidoscopy and colonoscopy
are effective and cost-efficient, however, have not reached the effect
required based on low patient participation. The benefits of blood-based
Septin9 testing over current standard procedures can be seen in the higher
convenience for patients given that the test just requires simple blood
draw, the non-invasive nature of the test which can be part of routine
physician visits and its ability to detect carcinoma independent of its
location.
"CRC has a very good prognosis if detected in early stages. Regular
screening and early detection of cancers therefore is highly desirable, but
screening programs in many countries have very low compliance rates,"
commented Dr. Thomas Taapken, CEO/CFO of Epigenomics. "Screening programs
based on a convenient blood test have the potential to significantly
improve uptake and adherence and ultimately reduce CRC incidence and
mortality as well as resulting healthcare cost."
According to the study, the Czech Republic belongs to the European
countries with the highest incidences of colorectal cancer. 94.4 new cases
per year are diagnosed in men and 46 in women per 100,000 inhabitants. In
the Czech Republic the compliance with a nationwide two-phase screening
program based on the detection of occult blood in stool (FOBT) in the
asymptomatic population above 50 years was only 22.7% in 2010. Therefore,
alternative solutions to improve CRC detection are currently evaluated in
the Czech Republic.
- Ends -
Contact Epigenomics AG
Antje Zeise, Manager IR | PR
Epigenomics AG
Kleine Praesidentenstrasse 1
10178 Berlin
Tel. +49 (0) 30 24345 368
ir@epigenomics.com
www.epigenomics.com
For US press inquiries:
Epigenomics, Inc.
20271 Goldenrod Lane, Suite 2027
Germantown, Maryland 20876
pr@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(R), is a blood-based test for the
early detection of colorectal cancer, which is currently marketed in Europe
and is under regulatory review by the FDA for the U.S.A. Additionally, the
company markets its tissue assay for use in lung cancer diagnosis, Epi
proLung(R), in Europe. The Company's technology and products have been
validated through multiple partnerships with leading global diagnostic
companies and testing laboratories. Epigenomics is an international company
with operations in Europe and the U.S.A.
Epigenomics legal disclaimer
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 Corporate News
