EANS-News: Epigenomics AG Successfully Validates Lung Cancer Test in Clinical Trial

Epi proLung BL Reflex Assay demonstrates outstanding technical and
clinical performance in pivotal IVD performance evaluation study

Novel test introduced to leading pathologists and Oncologists

CE-marking and launch as IVD test expected within the next few weeks

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New Products/Molecular diagnostics

Subtitle: Epi proLung BL Reflex Assay demonstrates outstanding
technical and clinical performance in pivotal IVD performance
evaluation study

Novel test introduced to leading pathologists and Oncologists

CE-marking and launch as IVD test expected within the next few weeks

Press release, Berlin, Germany, and Seattle, WA, USA, June 23, 2010
(euro adhoc) - Epigenomics AG (Frankfurt Prime Standard: ECX), a
cancer molecular diagnostics company, successfully completed the
pivotal performance evaluation study for its Epi proLung BL Reflex
Assay, a lung cancer diagnostic test. The test determines the DNA
methylation status of the SHOX2 gene in bronchial lavage material
routinely obtained during the clinical workup of patients with
suspected lung cancer. Increased DNA methylation of the SHOX2 gene
indicates the presence of malignant lung disease. The study has
demonstrated that the analytical and clinical performance fulfills
the requirements for its intended use as an aid in the diagnosis of
lung cancer. This successful performance evaluation meets an
important clinical trial milestone as a regulatory prerequisite to
CE-marking of in vitro diagnostic products prior to market
introduction. The completion of the study now paves the way for the
European launch of the Epi proLung BL Reflex Assay which is expected
within the next few weeks.

In clinical care today, lung cancer is typically confirmed by the
analysis of tissue that is directly obtained from the tumor or by
analyzing cellular material e.g. from rinsing the airways with saline
solution during a bronchial lavage. However, in approximately half of
the suspected cancer cases neither cytology nor histology provide
conclusive results at the time of a patient's first bronchoscopy.
This frequently leads to further time consuming and costly procedures
bearing additional risks for patients. The Epi proLung BL Reflex
Assay test addresses this clear medical need by helping pathologists
to confirm the presence of malignant lung disease. "The Epi proLung
BL Reflex Assay may provide critical additional information to
pathologists when cytology is not unequivocal. This represents the
diagnostic value of the test", stated Prof. Manfred Dietel, Director
of the Institute of Pathology of Charité - University Medicine Berlin
at a recent Key Opinion Leader Meeting in Frankfurt am Main, Germany,
at which Epigenomics has introduced the novel test to pathologists
and oncologists.

The clinical performance of the test has been demonstrated in a case
control study with individuals that have undergone diagnostic
work-ups for suspected lung cancer within the University of Liverpool
Cancer Research Centre, Roy Castle Lung Cancer Research Program UK,
under Professor John K Field. Using the Epi proLung BL Reflex Assay,
the DNA methylation status of the SHOX2 gene was determined in
routinely obtained bronchial lavage of patients with confirmed
bronchial carcinoma and patients with no evidence of malignant lung
disease but other lung diseases at the time of bronchoscopy and a
minimum lung cancer free survival of 18 months. In this critical
patient group, the test correctly identified 81% of the lung cancer
cases with only 5% false positive results translating into a
specificity of 95%. This clinical performance evaluation study
confirms previous research studies showing that methylated SHOX2 DNA
is a highly specific biomarker for lung cancer in bronchial lavage.
Furthermore, the performance evaluation study has demonstrated that
the Epi proLung BL Reflex Assay is a technically robust and reliable
diagnostic tool. Simple handling, short time to results and
compatibility with standard molecular diagnostic laboratory equipment
are expected to facilitate introduction of this test into clinical
routine.

"We have shown in a number of clinical studies that the biomarker
mSHOX2 has utility in supporting physicians in detecting lung cancer
with certainty, thereby avoiding delays in establishing the final
diagnosis. This allows them to initiate treatment sooner, thus
improving the quality of life of the patient", stated Dr. Uwe Staub,
Senior Vice President Product Development at Epigenomics. "Based on
this successful pivotal clinical study showing impressive analytical
and clinical performance we have met a key milestone for the launch
of the Epi proLung BL Reflex Assay" added Dr. Staub. About Lung
Cancer

With about 386,300 new cases in Europe in 2006 and about 219,000 new
cases in the U.S. in 2009, lung cancer is the third (after Prostate
and Breast Cancer) 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 a situation in which the majority of patients are diagnosed at
advanced stages. The overall objective of the diagnostic work-up is
to establish the definitive 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. Until recently tumor markers have played only a
minor role in this diagnostic process.

About Epi proLung

Epi proLung BL Reflex Assay has been 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 is not yet launched and hence is not yet
available for sale and cannot be put into service in Europe or any
other market until applicable directives and standards are
demonstrated for product conformity or approval.

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

About the University of Liverpool

The University of Liverpool is a member of the Russell Group of
leading research-intensive institutions in the UK. It attracts
collaborative and contract research commissions from a wide range of
national and international organisations valued at more than £98
million annually. Visit www.liv.ac.uk

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 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, ARUP Laboratories, Inc.,
and Warnex Inc. for diagnostic 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 within or outside
of the European Union, 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
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