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

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
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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