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

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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
[email protected] 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.

Further inquiry note:
Epigenomics AG
Dr. Achim Plum
Sen. VP Corporate Development
Tel: +49 30 24345 368
[email protected]
end of announcement euro adhoc
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issuer: Epigenomics AG
Kleine Präsidentenstraße 1
D-10178 Berlin
phone: +49 30 24345-0
FAX: +49 30 24345-555
mail: [email protected]
WWW: www.epigenomics.com
sector: Biotechnology
ISIN: DE000A0BVT96, DE000A0XFWF2
indexes: Prime All Share, Technology All Share
stockmarkets: regulated dealing/prime standard: Frankfurt, free trade: Berlin,
Hamburg, Stuttgart, Düsseldorf, München
language: English

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