- 07.04.2010, 10:02:09
- /
- OTE0004
EANS-News: Epigenomics AG: Laboratory Network synlab Now Offering Septin9 Testing
--------------------------------------------------------------------------------
Corporate news transmitted by euro adhoc. The issuer/originator is solely
responsible for the content of this announcement.
--------------------------------------------------------------------------------
Subtitle: European diagnostic laboratory network synlab has started offering
Septin9 blood testing through its 55 German sites
synlab to measure Septin9 using Epi proColon kit on Applied Biosystems 7500 Fast
Real-time PCR System; CE-marked kit now also validated for this instrument
Berlin (euro adhoc) - Berlin, Germany, and Seattle, WA, USA, April 7, 2010 -
Epigenomics AG (Frankfurt Prime Standard: ECX), a cancer molecular diagnostics
company, today reports that synlab, one of the largest laboratory networks in
Europe, has started offering the blood-based Septin9 test Epi proColon for
colorectal cancer early detection through its 55 German sites. The test which is
able to detect colorectal cancer in a simple blood draw is based on Epigenomics'
patented Septin9 biomarker and is the first regulated molecular diagnostic blood
test ever for colorectal cancer early detection offered in Europe. The test was
introduced in October 2009 as a CE-marked in vitro diagnostic product in Europe.
Additional offering of Septin9 testing through the synlab network significantly
increases coverage in Germany as well as other countries making this innovative
test even more broadly available to doctors and patients in Europe.
Current colorectal cancer screening methods - including fecal occult blood tests
(FOBT) and colonoscopy- are perceived to be inconvenient and laborious and are
reluctantly and infrequently used by individuals aged 50 and older who should be
screened at regular intervals. This lack of compliance to screening
recommendations severely limits the effectiveness of national screening programs
as the majority of cancer cases are detected in advanced stages when symptoms
occur and the chances of survival are greatly diminished.
The Septin9 colorectal cancer blood test is designed to be as convenient and
patient friendly as possible: patients simply provide a blood sample in their
doctors' office, e.g. as part of a regular health check-up. The sample is then
shipped to a local, regional or national diagnostic laboratory where it is
tested for the Septin9 biomarker.
Dr. Wolfgang Schwabe, Head of Oncoscreen GmbH, Jena, the laboratory running the
Septin9 test within the synlab network, stated: "We are excited by the potential
of the Septin9 test to help doctors provide more convenient patient care. With
the Septin9 test we have broadened our portfolio of oncology services which
allows us to offer a more complete package of diagnostic services to doctors and
their patients."
The test is based on the detection of methylated Septin9 DNA in blood. This
epigenetic modification of the Septin9 gene can be detected in the vast majority
of tumors in the colon and rectum. As tumors shed DNA into the bloodstream, the
detection of circulating methylated Septin9 DNA with the sensitive Epi proColon
real-time PCR assay is a reliable indicator of acute colorectal cancer.
Oncoscreen is the first laboratory to use a recently released version of the Epi
proColon real-time PCR assay to detect the Septin9 biomarker in blood plasma.
This reagent kit has now been validated for use with the Applied Biosystems 7500
Fast Real-Time PCR System of Life Technologies Inc. as well as Roche's
LightCycler® 480 instrument on which the test was originally released in October
2009. Availability on two standard real-time PCR instrument platforms found in
many clinical laboratories is expected to further facilitate making Septin9
testing broadly available in Europe.
"The Septin9 assay is very robust and can easily be optimized for different
real-time PCR instruments, the standard technology platform in molecular
diagnostics", commented Dr. Uwe Staub, Senior Vice President Product Development
at Epigenomics. "This allows us as well as our partners to make Septin9 testing
available as broadly as possible, an important prerequisite for a test that
should eventually be used in population wide colorectal cancer screening."
About Epigenomics
Epigenomics 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 aim at diagnosing cancer at an early
stage before symptoms occur and thereby may reduce mortality from this dreaded
disease.
Epigenomics' product portfolio contains the CE-marked IVD test Epi proColon, the
world's first regulatory cleared molecular diagnostic test for the detection of
colorectal cancer in blood that is based on the biomarker Septin9, and further
proprietary DNA methylation biomarkers and IVD products at various stages of
development for colorectal, lung and prostate cancer. 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, U.S.A. For more information, please visit Epigenomics'
website at www.epigenomics.com.
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 in the United States. The analytical and
clinical performance characteristics of any product based on this technology
which may be sold at some future time in the U.S. have not been established.
Further inquiry note:
Epigenomics AG
Dr. Achim Plum
Sen. VP Corporate Development
Tel: +49 30 24345 368
achim.plum@epigenomics.com
end of announcement euro adhoc
--------------------------------------------------------------------------------
issuer: Epigenomics AG
Kleine Präsidentenstraße 1
D-10178 Berlin
phone: +49 30 24345-0
FAX: +49 30 24345-555
mail: ir@epigenomics.com
WWW: www.epigenomics.com
sector: Biotechnology
ISIN: DE000A0BVT96, DE000A0XFWF2
indexes: Prime All Share, Technology All Share
stockmarkets: regulated dealing/prime standard: Frankfurt, free trade: Berlin,
Hamburg, Stuttgart, Düsseldorf, München
language: English
OTS-ORIGINALTEXT PRESSEAUSSENDUNG UNTER AUSSCHLIESSLICHER INHALTLICHER VERANTWORTUNG DES AUSSENDERS - WWW.OTS.AT | CNE