Alle Storys
Folgen
Keine Story von Epigenomics AG mehr verpassen.

Epigenomics AG

EANS-News: Epigenomics' Licensee ARUP Reports Excellent Validation Results for Septin9 Colorectal Cancer Blood Test

Berlin and Seattle - October 20, 2010 (euro adhoc) -

Presentation at ASCO - NCI - EORTC Molecular Markers Meeting
  Corporate news transmitted by euro adhoc. The issuer/originator is solely
  responsible for the content of this announcement.
Company Information/Molecular diagnostics
Subtitle: Presentation at ASCO - NCI - EORTC Molecular Markers 
Meeting
Epigenomics AG's
(Frankfurt Prime Standard: ECX) licensee, ARUP Laboratories, 
yesterday presented results from a positive clinical validation study
for its Septin9 laboratory-developed test for the blood-based 
detection of colorectal cancer.
In a poster presentation at the 2010 ASCO-NCI-EORTC* Annual Meeting 
on Molecular Markers, in Hollywood, FL, USA, Karen A. Heichman, PhD, 
Vice President of Oncology Technology Development & Licensing at 
ARUP, reported that ARUP's Septin9 test found 90% of the cancer cases
at a specificity of 89% in the validation study.
ARUP's colorectal cancer blood test is based on Epigenomics' 
proprietary Septin9 biomarker and DNA methylation technologies 
non-exclusively licensed to ARUP in August 2009. ARUP made the test 
available as a laboratory service in July 2010. The Septin9 test 
detects methylated cell-free DNA of the Septin9 gene shed by the 
tumor into the blood stream.
ARUP also reported supportive tissue data, which indicates that 
methylation of Septin9 is an early event in the development of 
colorectal cancer. The data demonstrated that the biomarker can be 
found in malignant and premalignant lesions independent of location 
in the colon, which is consistent with the equally good performance 
of the blood test for proximal and distal cancers.
"ARUP's study represents an additional independent validation of the 
Septin9 biomarker in plasma. It underscores the unique potential of 
our proprietary Septin9 biomarker as an aid in the detection of 
colorectal cancer when followed up with colonoscopy," commented Geert
Nygaard, Chief Executive Officer of the Berlin and Seattle based 
cancer diagnostics company Epigenomics. "As a single biomarker test, 
it compares very favorably in terms of clinical performance and 
economics to competing molecular diagnostic approaches to stool and 
blood testing."
ARUP Laboratories' Septin9 blood test, which is now available to 
physicians and patients in the US, is not meant to replace 
colonoscopy but primarily targets patients who cannot or will not 
undergo the established screening methods.
The lack of compliance to conventional screening methods such as 
colonoscopy and stool tests is considered to be the biggest hurdle to
effective colorectal cancer screening today. Screening experts 
believe that a convenient blood test that can be integrated into a 
regular check-up in the doctor's office may greatly enhance 
compliance among the more than 80 million US citizens aged 50 years 
and older for which current guidelines recommend regular colorectal 
cancer screening.
*ASCC - NCI - EORTC: American Society of Clinical Oncology- National 
Cancer Institute - European Organization for Research and Treatment 
of Cancer
For more information, please contact:
Contact ARUP Laboratories
Kristofer Beldin
Tel (801) 583-2787, ext. 2451/(801) 946-2987 (cell) 
kris.beldin@aruplab.com
Cyndee Holden
Tel (801) 583-2787, ext. 3318/(801) 386-6637 (cell) 
cynthia.holden@aruplab.com
Contact Epigenomics AG
Dr. Achim Plum
Sen. VP Corporate Development
Epigenomics AG
Tel +49 (0) 30 24345 368 
pr@epigenomics.com
www.epigenomics.com
Notes to Editor
About Epigenomics
Epigenomics AG is a molecular diagnostics company with a focus on the
development of novel products for cancer. Using DNA methylation 
biomarkers, Epigenomics' tests on the market and in development for 
colorectal, lung, and prostate cancer aim at aiding in an earlier and
more accurate diagnosis of these diseases thereby potentially 
increasing the patient's chances of survival.
For development and global commercialization of IVD test products, 
Epigenomics pursues a dual business strategy in which direct 
commercialization of proprietary diagnostic test products is combined
with non-exclusive licensing to diagnostic industry players with 
broad customer access. Strategic diagnostics industry partners 
include Abbott Molecular, Sysmex Corporation, Quest Diagnostics 
Incorporated, and ARUP Laboratories, Inc. for diagnostics test 
products and services, and QIAGEN N.V. for sample preparation 
solutions and research products. The company is headquartered in 
Berlin, Germany, and has a wholly owned subsidiary, Epigenomics Inc.,
in Seattle, WA, USA. For more information, please visit Epigenomics' 
website at www.epigenomics.com
About ARUP Laboratories
Founded in 1984, ARUP Laboratories is a leading national reference 
laboratory and an enterprise of the University of Utah and its 
Department of Pathology. ARUP offers more than 3,000 tests and test 
combinations, ranging from routine screening tests to esoteric 
molecular and genetic assays. ARUP serves clients across the United 
States, including many of the nation's top university teaching 
hospitals and children's hospitals, as well as multihospital groups, 
major commercial laboratories, group purchasing organizations, 
military and other government facilities, and major clinics. In 
addition, ARUP is a worldwide leader in innovative laboratory 
research and development, led by the efforts of the ARUP Institute 
for Clinical and Experimental Pathology®. For more information, 
please visit the website: www.aruplab.com
About the Septin9 Biomarker and Colorectal Cancer Blood Tests
The Septin9 biomarker is at the core of the world's first molecular 
diagnostic blood tests for the detection of colorectal cancer 
commercialized by Epigenomics (Epi proColon) and its Partner Abbott 
Molecular (mS9) as IVD test kits in Europe and Asia/Pacific and its 
licensees Quest Diagnostics (ColoVantage?) and ARUP laboratories 
(Methylated Septin9 Test) as laboratory-developed tests in the US. 
The tests all detect cell-free methylated DNA of the Septin9 gene 
shed into the blood stream by colorectal.
In numerous studies, Epigenomics and its partners have demonstrated 
that the detection of the Septin9 biomarker in blood plasma 
correlates with the presence of colorectal cancer and thus can be 
used as an aid in the detection of this common cancer. These studies 
include the successfully completed PRESEPT Study, a prospective 
evaluation of the Septin9 biomarker in a cohort of almost 8,000 
individuals representative of a typical screening population.
Today, Septin9 is likely the most thoroughly tested and best studied 
molecular diagnostic biomarker for colorectal cancer detection.
Lack of patient adherence to screening recommendations is the biggest
hurdle to an effective screening for colorectal cancer. Experts 
believe that a blood test that is more convenient for the patients 
than stool tests and colonoscopy could help to get more people 
screened and thus be of medical and health economic benefit.
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 of America. The analytical and 
clinical performance characteristics of any product based on this 
technology which may be sold at some future time by Epigenomics in 
the USA have not been established.
end of announcement                               euro adhoc

Further inquiry note:

Epigenomics AG
Dr. Achim Plum
Sen. VP Corporate Development
Tel: +49 30 24345 368
achim.plum@epigenomics.com

Branche: Biotechnology
ISIN: DE000A0BVT96
WKN: A0BVT9
Index: Prime All Share, Technology All Share
Börsen: Frankfurt / regulated dealing/prime standard
Berlin / free trade
Hamburg / free trade
Stuttgart / free trade
Düsseldorf / free trade
München / free trade

Weitere Storys: Epigenomics AG
Weitere Storys: Epigenomics AG