EANS-News: Epigenomics AG: Clinical Study Shows Lead Biomarker for Lung Cancer also works in Blood

Biomarker mSHOX2 could accelerate diagnostic work-up of patients with
suspected lung cancer

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Company Information/Molecular diagnostics/Products

Press release, Berlin, Germany, and Seattle, WA, USA, August 25, 2009
(euro adhoc) - Epigenomics AG (Frankfurt Prime Standard: ECX), a
molecular diagnostics company focusing on the development and
commercialization of in vitro diagnostic products for cancer, today
announced that it successfully completed a clinical feasibility study
in lung cancer. This study has confirmed Epigenomics' proprietary
lead biomarker mSHOX2 for lung cancer diagnosis when tested in blood
samples.

In this study the amount of methylated DNA of the SHOX2 gene (mSHOX2)
was successfully analyzed in blood plasma samples from 188 patients
with confirmed lung cancer of all stages and 155 control patients
consisting of individuals with benign lung disease, healthy subjects
and smokers. The study, which has been conducted in cooperation with
the Charité, Universitätsmedizin Berlin, has confirmed mSHOX2 as a
promising lung cancer biomarker. The results demonstrate that the
biomarker can reliably distinguish patients with lung cancer from
patients with benign lung disease with high specificity when measured
in routine blood plasma samples. In a population of patients
undergoing diagnostic work-up for suspected lung cancer, of which
typically about 40% actually have the cancer, an mSHOX2 test can
predict the presence of the disease with 92% probability (positive
predictive value).

"As an aid in diagnosis such a test could accelerate the diagnostic
workup of patients with suspected lung cancer and eventually save
costs. A positive mSHOX2 test result could support physicians in
their decision to opt for more aggressive and invasive procedures and
thereby avoid delays in establishing the final diagnosis and initiate
treatment sooner" says Dr. med. Bernd Schmidt, Epigenomics'
collaborator at the Charité Universitätsmedizin Berlin.

Earlier studies had shown that mSHOX2 is a highly specific biomarker
for lung cancer when measured in bronchial lavage samples that are
routinely obtained by flushing the suspicious area of the lung during
bronchoscopy. Based on these results, Epigenomics has decided to
develop an in vitro diagnostic test for bronchial lavage. This mSHOX2
test is expected to be ready for launch in Europe as CE-marked
product in the first half of 2010.

"With this study we have shown in a sizeable and clinically relevant
patient population the feasibility of detecting lung cancer with our
mSHOX2 assay in blood plasma. This may expand the potential use of
this tumor marker beyond patients undergoing bronchoscopy," explained
Dr. med. Volker Liebenberg, Vice President Product Development at
Epigenomics.

"Based on this successful clinical feasibility study we will further
evaluate product development opportunities using mSHOX2 in blood" Dr.
Uwe Staub, Senior Vice President Product Development at Epigenomics
added. "Our first priority in lung cancer product development,
however, remains to complete the clinical development and CE marking
of our mSHOX2 based bronchial lavage test to be launched in first
half of 2010."

In this latest study, the mSHOX2 real-time PCR assay developed for
the bronchial lavage specimen has been combined with the plasma DNA
preparation workflow originally developed for Epigenomics' colorectal
cancer blood test, underscoring the versatility and scalability of
the Epigenomics product platform.

About Lung Cancer

With about 386,300 new cases in Europe in 2006 and about 215,000 new
cases in the U.S. in 2008, lung cancer is the most common cancer in
men and women accounting for about 20 percent of all cancer deaths -
more than any other cancer.

Current guidelines do not recommend screening for lung cancer leading
to the majority of patients being diagnosed at advanced stages when
symptoms have occurred. The overall objective of this work-up is to
establish the diagnosis with the least invasive methods to minimize
the patient's risk. Individuals suspected to have lung carcinoma
typically undergo chest X-ray, or CT scanning followed by more
invasive procedures like bronchoscopy, i.e. the visual inspection of
the bronchial airways with an endoscope and biopsy by needle or
surgery. As of today tumor markers play only a very minor role in
this diagnostic process.

Epigenomics' lung cancer program aims at developing tests that
provide additional information in the diagnostic work-up of patients
with suspected lung cancer and thereby allow simplifying the
diagnostic process and minimize the risk of delays in establishing
the final diagnosis and initiating treatment.

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 in development aim at diagnosing
cancer at an early stage before symptoms occur and thereby may reduce
mortality from this dreaded disease.

Epigenomics' product pipeline contains a validated biomarker for the
early detection of colorectal cancer in blood plasma, and further
proprietary DNA methylation biomarkers at various stages of
development for prostate and lung cancer detection in urine, blood
and bronchial lavage specimens. Epigenomics' biomarker mSEPT9 for the
early detection of colorectal cancer in a simple blood sample has
demonstrated continuously highest performance in multiple clinical
studies with in total more than 3,500 individuals tested. A large
prospective clinical study - PRESEPT - for evaluation of mSEPT9 in a
screening population is currently under way (www.presept.net).

For development and global commercialization of in vitro diagnostic
test products, Epigenomics pursues a non-exclusive partnering
strategy. Strategic diagnostics industry partners include Abbott
Molecular, Philips, Sysmex Corporation and Quest Diagnostics
Incorporated, for diagnostics test products and services, and QIAGEN
N.V. for sample preparation solutions and research products.

Partners in the health care industry and the biomedical research
community can access Epigenomics' portfolio of proprietary DNA
methylation technologies and biomarkers protected by more than 150
patent families through research products, Biomarker Services, IVD
Development Collaborations, and Licensing. The company is
headquartered in Berlin, Germany, and has a wholly owned subsidiary
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.

end of announcement euro adhoc
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ots Originaltext: Epigenomics AG
Im Internet recherchierbar: http://www.presseportal.de

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, Technologie All Share
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Berlin / free trade
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