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

Test to aid in the diagnosis of lung cancer after positive CT
findings

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Berlin, Germany and Seattle, WA, U.S.A., (euro adhoc) - 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
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ots Originaltext: Epigenomics AG
Im Internet recherchierbar: http://www.presseportal.de

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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