EANS-News: Epigenomics' Licensee ARUP Presents Clinical Data for Colorectal
Cancer Blood Test at AMP
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Corporate news transmitted by euro adhoc. The issuer/originator is solely
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New Products/Company Information/molecular diagnostics
Subtitle: Epigenomics to host a corporate workshop on advances in blood-based
colorectal cancer screening; ARUP Laboratories will present independent data for
its laboratory-developed Septin9 test
Grapevine, TX, U.S.A., November 16, 2011 (euro adhoc) - Epigenomics AG, the
German-American cancer molecular diagnostics company, announced today that its
licensing partner ARUP will be presenting recent study data for its
laboratory-developed Septin9 blood test for colorectal cancer (Septin9 LDT) at
the 2011 Annual Meeting of the Association for Molecular Pathology in Grapevine,
Texas. ARUP licensed the Septin9 biomarker from Epigenomics in 2009 and has been
marketing Septin9 LDT since July 2010. The data will be presented at a workshop
hosted by Epigenomics, entitled "Septin9 - A Plasma Marker for Colorectal
Cancer". Karen Heichman, Ph.D., Adjunct Assistant Professor of Pathology at the
University of Utah School of Medicine and VP Oncology Technology Development and
Licensing of ARUP Laboratories, Inc., Salt Lake City, UT, will present the ARUP
study data.
In the study, ARUP's Septin9 LDT detected 90% of the colorectal cancer cases at
a specificity of 88%. The detection rate for early, widely curable stage I and
II disease was at 87%. The test detected cancer cases irrespective of the
localization of the tumor in the colon. Using an alternative test interpretation
algorithm that favors specificity over sensitivity, the test detected 70% of the
cancer cases at 100% specificity, i.e. no false positive results. With these
study results, ARUP's Septin9 LDT shows an impressive performance gain over
earlier versions of Septin9 tests. Full results of the study will be published
in the BMC Medicine medical journal later this year.
Karen Heichman, Ph.D., commented:
"The study results for our independently developed Septin9 tests show a
significant improvement compared to historic data from earlier versions of the
test and are in line with performances of other second generation Septin9 tests.
With this performance and the convenience of a blood test, Septin9 tests can
provide viable alternatives for average risk individuals unwilling or unable to
undergo colonoscopy for colorectal cancer screening."
Geert Nygaard, Chief Executive Officer of Epigenomics, added:
"We are pleased to see that the performance of Septin9 tests independently
developed by our licensees like ARUP is comparable to previously released data
for our own second generation Septin9 test product, Epi proColon® 2.0, which we
recently launched in Europe. This underlines the value that blood-based Septin9
tests can bring to the detection of colorectal cancer."
Further contributions to Epigenomics' corporate workshop include an overview by
Brooks Cash, M.D., Bethesda, MD, of the colorectal cancer screening challenges
from the perspective of a practicing gastroenterologist; he will also share the
scope of this challenge in his everyday practice. Robert Day, M.D., President
and Director Emeritus of the Fred Hutchinson Cancer Research Center, Seattle,
WA, will give an account of the historical path that led to the identification
of Septin9 as a biomarker for colorectal cancer early detection and address why
new molecular screening tools are urgently needed. Nicolas Potter, Ph.D., Chief
Scientific Officer and Director of Molecular Diagnostics at Molecular Pathology
Laboratory Network, Inc., Maryville, TN, will describe the performance of an
investigational use (IUO) diagnostic test kit for Septin9 being evaluated in a
pivotal clinical trial sponsored by Epigenomics AG for FDA submission as well as
share his operational and analytical observations relating to methylated Septin9
analysis and performance in a molecular diagnostic laboratory.
- Ends -
Further Information
Epigenomics will host an AMP Annual Meeting 2011 Corporate Workshop entitled
"Septin9 - A Plasma Marker for Colorectal Cancer" today, Wednesday, November 16,
2011 at 4 pm at the Gaylord Texan Convention Center, Level 3, Room Texas 4. The
workshop will cover multiple perspectives of the challenges in colorectal cancer
screening and will include presentations by:
* Karen Heichman, Ph.D., Adjunct Assistant Professor of Pathology at the
University of Utah School of Medicine and VP Oncology Technology Development and
Licensing of ARUP Laboratories, Inc., Salt Lake City, UT,
* Brooks Cash, M.D., Gastroenterologist, Bethesda, MD,
* Robert Day, M.D., President and Director Emeritus of the Fred Hutchinson
Cancer Research Center, Seattle, WA, and
* Nicolas Potter, Ph.D., Chief Scientific Officer and Director of Molecular
Diagnostics at Molecular Pathology Laboratory Network, Inc., Maryville, TN.
Contact Epigenomics AG
Antje Zeise | CIRO
Manager IR/PR
Epigenomics AG
Tel +49 (0) 30 24345 386
pr@epigenomics.comwww.epigenomics.com
Media inquiries can also be directed at:
Dr. Robert Mayer
Account Manager
Tel +49 (0)89 5238 8030
robert.mayer@collegehill.com
About Epigenomics
Epigenomics 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:
Antje Zeise | CIRO
Manager IR/PR
Epigenomics AG
Tel: +49 30 24345 386
antje.zeise@epigenomics.com
end of announcement euro adhoc
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company: Epigenomics AG
Kleine Präsidentenstraße 1
D-10178 Berlin
phone: +49 30 24345-0
FAX: +49 30 24345-555
mail: ir@epigenomics.com
WWW: http://www.epigenomics.com
sector: Biotechnology
ISIN: DE000A1K0516
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language: English