Epigenomics Successfully Completes Larger Clinical Study in Early Lung Cancer Detection

Panel with two biomarkers confirms solid performance in larger blood
plasma study

Berlin, Germany, and Seattle, WA, USA, June 18, 2008 - Epigenomics AG
(Frankfurt Prime Standard: ECX), a molecular diagnostics company
focusing on the development and commercialization of products for
cancer detection based on DNA methylation, today announced that it
successfully completed a larger clinical study in its lung cancer
program. The study was run in close collaboration with Prof. Dr.
Christian Witt and Dr. Bernd Schmidt at the Charité University
Hospital in Berlin, Germany.

The study on 256 patient samples confirmed that a two-biomarker panel
correctly identified two thirds of all lung cancers in blood plasma
(66% sensitivity) at a false positive rate of 12% (88% specificity).
Notably, about two thirds of the blood samples used in the study were
obtained from patients with early stage I and II cancer. Sensitivity
in stage II lung cancer patients reached 73%. Patients with early
stage cancer are significantly underdiagnosed in the current
diagnostic practice for lung cancer but could benefit most from early
therapeutic intervention.
These latest results independently confirm previous data from a much
smaller proof-of-concept study performed by Epigenomics in 2007 that
was weighted towards later stage disease reflecting the unfavorable
stage distribution found in the current diagnostic practice.
"Today, most patients having lung cancer present with symptoms or are
accidentally found, when many of them have locally advanced or
metastatic disease explaining their poor prognosis. In contrast,
patients diagnosed and treated at early stages can have encouraging
outcomes, with 5-year survival rates as high as 60% to 70%.
Identifying markers that are able to detect lung cancer using a
simple blood sample is an encouraging first step towards developing a
screening test for this deadly disease," says Prof. Dr. Christian
Witt, Head of the Department of Pneumology at the Charité, Berlin.
The biomarkers were identified within Epigenomics' proprietary
discovery program using its DMH (differential methylation
hybridization) technology and have been extensively validated on
tissue samples before being tested on blood plasma.
"With an aging population we expect to see more and more cancer
patients being diagnosed. Earlier this week the German government
introduced its National Cancer Plan. Similar public initiatives are
pursued in the U.S. and other countries. They all aim at reducing
cancer mortality and recognize that improved systematic population
wide screening is key. With our convenient screening tests for lung,
colorectal and prostate cancer in development we aim to contribute
significantly to these efforts and make a difference to the
individuals affected as well as improve the health economics of
cancer care", commented Geert Nygaard, Chief Executive Office of
Epigenomics.
Data from Epigenomics' lung cancer program will be presented at the
International Lung Cancer Conference, Liverpool, UK, July, 9 - 12,
2008 and the European Respiratory Society Annual Congress, Berlin,
Germany, October, 4 - 8, 2008.
About Lung Cancer
With about 386,300 new cases of lung cancer in Europe and more than
174,000 new cases in the US in 2006, lung cancer is one of the most
common cancers. As the leading cause of cancer death, it accounts for
one in every three cancer deaths in the United States..
Currently, screening guidelines do not recommend screening for lung
cancer. Diagnosis mostly relies on diagnostic imaging procedures such
as x-rays, Computed Tomography (CT) scans or Positron Emission
Tomography (PET) scans and invasive bronchoscopy confirmed by
histological analysis for definitive diagnosis. Lung cancer patients
usually are symptomatic or nodules are accidentally detected
resulting in the majority having advanced disease. The overall
five-year survival rate is 15% for all stages of lung cancer cases,
but 49% for cases detected when the disease is still localized.
The currently most promising approach to improve outcome of lung
cancer is to start treatment at an early stage. However, only 16% of
lung cancers are diagnosed at this early stage as symptoms occur late
and the majority of lung cancer cases are diagnosed in stages too
advanced for effective treatment. Non- or minimally invasive
screening tests for lung cancer with high sensitivity and specificity
that can be applied to large populations in a convenient, safe, and
cost-effective way are urgently needed.

About Epigenomics AG
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 body fluids.
Epigenomics' biomarker Septin 9 for the early detection of colorectal
cancer in a simple blood sample demonstrated continuously highest
performance in multiple clinical studies with in total more than
3,500 individuals tested.
For development and global commercialization as in vitro diagnostic
test kits, Epigenomics pursues a non-exclusive partnering strategy
with diagnostics industry companies. As a first strategic partner,
Abbott Molecular Inc. licensed the worldwide non-exclusive IVD rights
to Epigenomics' proprietary Septin 9 biomarker for colorectal cancer.
Epigenomics also aims at giving patients and doctors early access to
these biomarkers through reference laboratory testing services. As a
first reference laboratory partner, Quest Diagnostics Inc., the
leading provider of diagnostic testing, information and services,
obtained the license to commercialize a laboratory-developed test
(LDT) for Septin 9 in the U.S.
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.

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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.

Contact:

Epigenomics AG
Dr. Achim Plum
SVP Corporate Development
+49 30 24345 368 (phone)
achim.plum@epigenomics.com
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