EANS-News: Epigenomics AG Launches Diagnostic Lung Cancer Test in Europe

The Epi proLung BL Reflex Assay complements conventional diagnostic
methods

Test may identify cancers otherwise missed

Epigenomics' second molecular diagnostic product launched in Europe

Commercial potential from direct sales as well as licensing and
partnering going forward

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

New Products/Molecular diagnostics

Subtitle: The Epi proLung BL Reflex Assay complements conventional
diagnostic methods

Test may identify cancers otherwise missed

Epigenomics' second molecular diagnostic product launched in Europe

Commercial potential from direct sales as well as licensing and
partnering going forward

Press release, Berlin, Germany, and Seattle, WA, USA, July 07, 2010
(euro adhoc) - Epigenomics AG (Frankfurt Prime Standard: ECX), a
cancer molecular diagnostics company, has launched the Epi proLung BL
Reflex Assay, its second CE-marked in vitro diagnostic (IVD) product,
in Europe today. The novel molecular diagnostic test can help
pathologists and clinicians to establish the presence of malignancy
with more certainty in patients with suspected lung cancer when
conventional diagnostic procedures fail or deliver inconclusive
results.

"Epi proLung is the second IVD product we have introduced into the
European market, only nine months after we began offering Epi
proColon, the blood test for colorectal cancer early detection, in
October 2009," commented Geert Nygaard, Chief Executive Officer of
Epigenomics AG. "Over the last two years we have established an
efficient product development organization fully compliant with all
applicable laws and regulations. This organization now has shown once
more that starting with a clinical question it can systematically
develop and launch innovative molecular diagnostic tests that address
important challenges in the early detection and diagnosis of cancer."

The Epi proLung BL Reflex Assay detects methylated DNA of the SHOX2
gene in bronchial lavage. This sample material is 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 clinical utility of the novel test has recently been demonstrated
in a performance evaluation study, the final step of Epigenomics' IVD
product development, with individuals that have undergone diagnostic
work-up for suspected lung cancer within the Roy Castle Lung Cancer
Foundation's Research Program at The University of Liverpool Cancer
Research Centre directed by Professor John K Field. The study
confirmed previous research studies showing that methylated SHOX2 DNA
is a sensitive and highly specific biomarker for the detection of
lung cancer in bronchial lavage specimen.

"In the recent performance evaluation study, it was particularly
interesting to see that the test identified a large proportion of
cancers that were originally missed at the time of the first
bronchoscopy," stated Prof. John K Field, who closely worked with
Epigenomics in the clinical evaluation of the SHOX2 biomarker. "This
shows that the test has the potential to complement conventional
approaches used to establish the presence of malignant lung disease,"
he continued.

Dr. Bernd Schmidt, Head of the Department of Pneumology at the
University Hospital Halle, Germany, who advised Epigenomics on the
medical need and clinical use of the test in Germany throughout the
research and development phases remarked: "The test will help
pathologists and clinicians to extract more relevant information from
bronchial aspirates, samples we obtain anyway in those cases where we
cannot reach the suspicious area of the lung with the endoscope. This
may allow physicians to establish a diagnosis with more certainty in
the many inconclusive cases - at no additional risk or discomfort for
the patient."

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 one of the most common
cancers in men and women and is the cancer with the highest mortality
rate worldwide. The overall objective of a diagnostic work-up, when
cancer is suspected, is to establish the definitive diagnosis with
the least invasive methods and thereby minimize the patient's risk.
Individuals suspected of having lung cancer 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. The diagnosis is typically confirmed by an
analysis of tissue directly obtained from the tumor by a biopsy
obtained during bronchoscopy or by analyzing cellular material e.g.
from rinsing the airways with saline solution during what is called a
bronchial lavage. However, in routine care for approximately half of
the suspected cancer cases, cytology and histology do not provide
conclusive results at the time of first bronchoscopy. The need to
confirm the diagnosis often leads to further time consuming and
costly procedures bearing additional risks for the patient.

The Epi proLung BL Reflex Assay has been developed as an aid in the
diagnosis of lung cancer providing additional information to confirm
the presence of malignant lung disease using routinely obtained
bronchial lavage fluid. The test provides the opportunity to diagnose
more patients with a much higher degree of certainty at the time of
first bronchoscopy. Patients with positive test results may then be
funneled into accelerated clinical staging and therapy, avoiding
delays and potentially reducing costs.

In Germany, about 172,000 bronchoscopies are performed for suspected
lung cancer every year. For the introduction of the novel test,
Epigenomics will work with a selected number of pathology institutes
at university hospitals with a focus on lung cancer in Germany and
Switzerland. These reference centers will include Charité -
University Medicine Berlin and University Hospital Zurich. Leading
pathologists and clinicians at these reference centers will provide
scientific and medical oversight in the launch phase. Following the
successful introduction into these home markets, Epigenomics intends
to address further European markets through direct marketing and
sales as well as distributors. In line with its dual
commercialization strategy, the company is also looking at licensing
the biomarker to other in vitro diagnostic industry players.

"At a stage where the assay is fully validated and mature, we have maintained
full commercial control over this product and the biomarker which allows us to
leverage its commercial potential in the best possible way by direct product
sales as well as distribution and licensing partnerships at the optimal time in
the product life cycle", Geert Nygaard explained.

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 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.

For more information on the Epi proLung BL Reflex Assay and its 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 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.

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, Epi proLung, a CE-marked test kit to aid in
the diagnosis of lung cancer, 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 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
--------------------------------------------------------------------------------

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
Index: Prime All Share, Technology All Share
Börsen: Frankfurt / regulated dealing/prime standard
Berlin / free trade
Hamburg / free trade
Stuttgart / free trade
Düsseldorf / free trade
München / free trade