EANS-News: Epigenomics' Licensee ARUP Presents Clinical Data for Colorectal
Cancer Blood Test at AMP
Geschrieben am 16-11-2011 |
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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.com
www.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
indexes: Prime All Share, Technology All Share
stockmarkets: regulated dealing/prime standard: Frankfurt, free trade: Berlin,
Hamburg, Stuttgart, Düsseldorf, München
language: English
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