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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
  Corporate news transmitted by euro adhoc. The issuer/originator is solely
  responsible for the content of this announcement.
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

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
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München / free trade

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