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EANS-News: Epigenomics AG
Epigenomics AG Moves Lung Cancer Test into Development after Successful Clinical Evaluation

Berlin, Germany and Seattle, WA, U.S.A., (euro adhoc) -

Test to aid in the diagnosis of lung cancer after positive CT 
findings
  ots.CorporateNews transmitted by euro adhoc. The issuer is responsible for
  the content of this announcement.
new product/companies/molecular diagnostics
March 18,
2009 - Epigenomics AG (Frankfurt, Prime Standard: ECX) a cancer 
molecular diagnostics company developing tests based on DNA 
methylation has initiated the development of an in vitro diagnostic 
test for lung cancer. The decision was made after a successful 
retrospective clinical evaluation of bronchial lavage specimen from 
several hundred patients with suspected lung cancer demonstrated the 
ability of company's lung cancer biomarkers to identify those with 
lung cancer.
Current guidelines do not recommend screening for lung cancer. 
Individuals suspected to have bronchial carcinoma based on symptoms 
or accidental findings typically undergo chest X-ray, or CT scanning 
and bronchoscopy, i.e. the visual inspection of the bronchial airways
with an endoscope, to establish the diagnosis. Often, the suspicious 
region in the lung cannot be assessed by endoscope directly and 
saline solution is injected (bronchial lavage) to recover cells for 
further cytological analysis by a pathologist. Unfortunately, the 
cytology report is frequently inconclusive and cannot confirm or 
exclude the presence of malignant disease. This poses an enormous 
challenge to the chest physician responsible for patient care as 
additional diagnostic procedures might be triggered including a 
second CT-scan after several months to check for growth of the 
nodules or an invasive needle or surgical lung biopsy. These 
additional diagnostic procedures result in either the loss of 
valuable time to treatment, or expose the patient to increased 
morbidity and mortality.
In the clinical evaluation conducted in collaboration with Prof. John
Field (University of Liverpool), principal investigator of the 
Liverpool Lung Cancer Project funded by the Roy Castle Lung Cancer 
Foundation (Liverpool, UK), and Prof. Dr. Christian Witt and Dr. 
Bernd Schmidt from the Charité - Universitätsmedizin Berlin 
(Germany), confirmed that Epigenomics' proprietary DNA methylation 
biomarkers reliably detected the majority of cancer cases from more 
than 400 patients with suspected lung cancer. Testing of previously 
collected bronchial lavage samples from patients suspected of having 
lung cancer, which were later found to have or not to have the 
disease, demonstrated virtually no false positive results even in 
cases with an inconclusive diagnosis by cytology.
"This clinical evaluation has confirmed the feasibility of utilizing 
Epigenomics' biomarkers as a diagnostic tool for lung cancer. In 
particular when the current diagnostic work-up of samples obtained 
during bronchoscopy shows an inconclusive result, a test based on 
these biomarkers could simplify and speed up the diagnostic process 
by identifying patients with malignant lung disease without requiring
additional invasive procedures. This assay may facilitate earlier 
diagnosis of lung cancer at a stage in which cure rates are higher", 
concluded Prof. John Field, who will present the study data at the 
upcoming 100th Annual Meeting of the American Association for Cancer 
Research in Denver, Colorado, U.S.A. on April 21, 2009.
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. About 200,000 bronchoscopies are 
performed in Germany alone every year, the vast majority of them for 
suspected lung cancer. Although most of these invasive procedures are
performed in specialized centers, bronchoscopy in combination with 
the investigation of tissues or cells by a pathologist in many cases 
does not yield conclusive results and warrants further diagnostic 
work-up of the patients.
Epigenomics expects to provide the diagnostic test to selected 
centers for investigational use in Europe already this year. The 
market launch of a CE-marked diagnostic test kit by Epigenomics is 
scheduled for the first half of 2010. In addition to direct 
commercialization, Epigenomics may work with commercial partners in 
certain market segments and regions.
"In vitro diagnostic tests for lung cancer could address a huge unmet
medical need in an area, that has seen very little innovation over 
the past few decades. With a reflex test following-up inconclusive 
bronchoscopies we can potentially bring great benefits to patients in
the near future. Our future product will address an attractive and 
highly centralized niche market where we have established 
collaborations with leading lung cancer experts. This gives us the 
opportunity to commercialize the product ourselves, at least in some 
regions, and capture a larger part of the value", explained Geert 
Nygaard, Chief Executive Officer of Epigenomics.
Conference Presentation Details
The poster with the Abstract No. LB-254 titled "SHOX2, a novel 
biomarker for the detection of lung cancer in bronchial fluid", by 
John K Field, Volker Liebenberg, Dimo Dietrich, Triantafillos 
Liloglou, Martin Walshaw, Olaide Raji, Thomas Schlegel, Christoph 
Kneip, Juergen Distler, Reimo Tetzner, Christian Witt, Michael 
Fleischhacker and Bernd Schmidt will be presented in the poster 
session "Late-Breaking Research: Clinical Research 2" in Hall B-F on 
April 21, 2009, 1:00 pm - 5:00 pm, at the 100th Annual Meeting of the
American Association for Cancer Research, April 18 - 22, 2009, 
Colorado Convention Center, Denver, Colorado, U.S.A..
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 earlier stage or more accurately 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 
repeatedly demonstrated excellent performance in multiple clinical 
studies with in total about 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 for 
diagnostics test products, 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.
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 organizations valued at more than £93 
million annually. Further information at: http://liv.ac.uk/
About The Roy Castle Lung Cancer Foundation
The Roy Castle Lung Cancer Foundation (Registered Charity England & 
Wales 1046854 - Scotland SC037596) is the only charity in the UK 
wholly dedicated to defeating lung cancer - the biggest cancer killer
in the world. Its approach benefits current and future lung cancer 
sufferers alike:
. The foundation funds research programs to detect lung cancer at a very
      early stage, which will save lives and is vital to the development of a
      future therapy.
    . The foundation offers patient support, advocacy and an information network
      providing information, guidance and support relevant to the needs of lung
      cancer patients and their families.
    . The foundation facilitates support groups across the UK that help
      sufferers to come to terms with the disease and provide patient advocacy
      services.
    . The foundation operates 'Quit Smoking' services for adults (Fag Ends).
    . KATS (Kids Against Tobacco Smoke) educational program for children which
      encourages young people never to start smoking.
    . ATYC (Anti Tobacco Youth Campaign) which gives young people a voice,
      knowledge and skills to campaign about smoking and other tobacco issues.
    . The Roy Castle Lung Cancer Foundation runs fundraising events and charity
      shops, both of which help to generate much needed voluntary donations
      (public and corporate), on which it relies to continue its fight to defeat
      lung cancer.
If you would like to know more about how you can support the Roy 
Castle Lung Cancer Foundation, please contact +44 (0)151 254 7200 or 
visit www.roycastle.org for further information.
Epigenomics' legal disclaimer. 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.
Products based on the biomarkers described are not available for sale
in the United States. The analytical and performance characteristics 
of any product to be eventually sold in the U.S. based on this 
technology have not been established.
end of announcement                               euro adhoc

Further inquiry note:

Dr. Achim Plum
Sen. VP Corporate Development
Epigenomics AG
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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