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EANS-News: Epigenomics AG Introduces New Lung Cancer Test at German Cancer Congress

Geschrieben am 24-02-2010

New IVD test expected to be launched in Q2 2010



Test supports accurate diagnosis of lung cancer in suspicious cases



Conference presentations on scientific evidence and clinical utility


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Corporate news transmitted by euro adhoc. The issuer/originator is solely
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New Products/Molecular diagnostics/ Congress

Subtitle: New IVD test expected to be launched in Q2 2010

Test supports accurate diagnosis of lung cancer in suspicious cases

Conference presentations on scientific evidence and clinical utility

Press release, Berlin, Germany, and Seattle, WA, U.S.A., February 24,
2010 (euro adhoc) - Epigenomics AG (Frankfurt, Prime Standard: ECX),
a cancer molecular diagnostics company, introduces its novel lung
cancer test at the ongoing 29th German Cancer Congress in Berlin,
Germany, this week. The Epi proLung BL Reflex Assay, the Company's
second in vitro diagnostic product, is expected to be launched as a
CE-marked diagnostic test kit in Europe in the second quarter of
2010.

The diagnostic test is being developed as an aid in diagnosis for
lung cancer and may help pathologists to confirm the diagnosis of
malignant lung disease when current diagnostic procedures fail to
establish the presence of malignancy in patients with suspected lung
cancer. The test determines the DNA methylation status of the mSHOX2
gene in bronchial lavage material routinely obtained during the
clinical workup of patients with suspected lung cancer, e.g. due to
symptoms or accidental imaging findings. Increased DNA methylation of
the SHOX2 gene indicates the presence of malignant lung disease.

In clinical care today, lung cancer is usually confirmed by analysis
of tissue directly obtained from the tumor or by analyzing cellular
material e.g. from rinsing the airways with saline solution during
bronchial lavage. However, in routine care at the time of first
bronchoscopy in approximately half of the suspected cancer cases,
cytology and histology do not provide conclusive results. The need to
confirm the diagnosis will likely lead to further time consuming and
costly procedures bearing additional risks for the patient.

A molecular diagnostic test providing additional information to the
physician and confirming the presence of lung cancer from bronchial
lavage fluid could help to funnel patients with malignant lung
disease into accelerated clinical staging and therapy, avoiding delay
and potentially reducing costs.

Dr. Bernd Schmidt, Head of the Department of Pneumology at the
University Hospital Halle, Germany, who collaborated with Epigenomics
in the development of the test, will introduce the mSHOX2 biomarker
and its clinical utility in an oral presentation at the German Cancer
Congress today. During the congress, Epigenomics will also host a
press conference on Friday, February 26, 2010 on new epigenetic tests
in different cancers.

The German Cancer Congress is organized by the German Cancer Society
and is the most important oncological forum in German speaking
countries.

Epigenomics at the 29th German Cancer Congress

Epigenomics will be represented at the 29th German Cancer Congress
2010 in Berlin, Germany, from February 24th to 27th 2010, with a
booth at the ICC Berlin, Hall 17, booth number B15.

An oral presentation (lecture number: FV101) titled "Methylation of
SHOX2 in bronchial lavage - a highly specific tumor marker for the
lung carcinoma" will be presented within the Biomarker/ Molecular
pathology session by Dr. Bernd Schmidt, Head of the Department of
Pneumology, Clinic for Internal Medicine I, University Hospital
Halle, Germany on February 24th, 2010, from 10.15 am to 11.45 am in
hall 9 at the ICC Berlin.

A press conference titled "Innovative biomarkers for the diagnosis of
lung- and colorectal cancer: Epigenetic tests open new ways in cancer
diagnostics" will take place on Friday, February 26th, 2010, from
1:15 pm to 2:45 pm at the press center on the bridge, Room 43,
Messedamm 22 at the ICC Berlin.

Interested journalists and media are kindly requested to contact
Sandra Leinhoss, Manager Public Relations, Epigenomics AG, via Email:
sandra.leinhoss@epigenomics.com for participation details.

About Epi proLung

Epi proLung BL Reflex Assay is being developed as an in vitro
diagnostic real-time PCR test kit for the analysis of SHOX2 gene
methylation in bisulfite converted DNA isolated from human bronchial
lavage fluid.Based on previous clinical research, it is believed that
the presence of methylated SHOX2 DNA is associated with, and may aid
in, the diagnosis of invasive carcinomas of the lung. The Epi proLung
BL Reflex Assay will not be available for sale and cannot be put into
service in Europe until Epigenomics declares that the product
conforms to applicable EU directives and standards and can be
CE-marked accordingly.

For more information on the Epi proLung BL Reflex Assay and its
future availability in Europe please visit www.epigenomics.com or
contact Epigenomics directly by Email contact@epigenomics.com or
phone +49 30 24345 111.

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}[HYPERLINK:
http://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
--------------------------------------------------------------------------------


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, Technology All Share
Börsen: Frankfurt / regulated dealing/prime standard
Berlin / free trade
Hamburg / free trade
Stuttgart / free trade
Düsseldorf / free trade
München / free trade


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