EANS-News: Swiss Viollier AG First Laboratory in Europe to offer Epigenomics' Colorectal Cancer Blood Test

The Swiss private diagnostic laboratory will launch mSEPT9 blood
testing
service for colorectal cancer early detection on July 1,
2009

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new product/Molecular Diagnostics

Press release, Berlin, Germany, and Seattle, WA, USA, June 23, 2009 -
(euro adhoc) - 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 reports that its blood-based test for colorectal
cancer will be available for the first time to patients in Europe
starting from July 1, 2009. The test, which is able to detect
colorectal cancer in a simple blood draw, is based on Epigenomics'
patented biomarker mSEPT9 and is the first blood test ever for
colorectal cancer detection offered in Europe. As the first
laboratory network Swiss Viollier AG will offer the test to patients,
general practitioners and gastroenterologists. Viollier AG,
headquartered in the Basel area, is one of Switzerland's largest
private diagnostic laboratories and an innovative leader in
laboratory diagnostics.

"We are excited to be the first laboratory to work with the mSEPT9
test. This test is a true innovation in early cancer detection",
commented Edouard H. Viollier, MD, chairman, board of directors
Viollier AG. "Blood sampling is easy and convenient for both the
patient and the doctor and this test is performed in our professional
laboratory under highest quality standards that ensure reliable
results. We believe that this could be the future of non-invasive
colorectal cancer screening and key to increasing compliance to
screening programs."

With approximately 149,000 and 300,000 newly diagnosed individuals
each year in the U.S. and Europe, respectively, colorectal cancer is
the most frequent gastrointestinal tumor and second in cancer
mortality each year in the U.S. and Europe. With approximately 4,100
new cases every year Switzerland is the country with the highest
colorectal cancer incidence in Europe. In total 10.4% of all
cancer-related deaths in Switzerland are caused by colorectal cancer.

The majority of colorectal cancers are diagnosed in advanced stages,
limiting the chances for curative treatment. To improve prognosis for
this disease the cancer must be detected in early stages. More than
90% of all patients could be cured if the cancer was diagnosed at an
early, still localized stage.

Many countries including the U.S. and Germany introduced colonoscopy
- typically in ten year intervals - as a screening modality for
colorectal cancer. In Switzerland, although no national colorectal
cancer screening program was introduced yet, colonoscopy is
recommended from the age of 50 by private and public cancer
prevention initiatives. By these screening programs and initiatives,
the detection of colorectal cancer in early disease stages was
expected to improve considerably. However, only a minority of the
target population complies with screening recommendations, hence
limiting the success of these approaches. Time requirements,
invasiveness and fear of complications prevent most individuals from
undergoing this sensible screening procedure. Besides colonoscopy,
non-invasive tests for the detection of blood in stool samples (Fecal
Occult Blood Test - FOBT) are currently recommended as a screening
modality. However, they are not well accepted by patients because
they have to be performed by the patients themselves and certain
nutritional recommendations have to be followed. A blood-based test,
detecting early stages of colorectal cancer because of its
convenience for patients and doctors could encourage people, who
reject colonoscopy and stool tests, to participate in colorectal
cancer screening programs. An endoscopic examination would be
strongly recommended particularly to those patients with a positive
finding in the blood test.

"Compliance is the biggest hurdle in colorectal cancer screening.
Although there are procedures like colonoscopy and FOBT that have
been established as screening modalities for several years now, there
still is very little acceptance and poor compliance by the patients",
Prof. Peter Bauerfeind, of the Division of Gastroenterology &
Hepatology of the University Hospital Zurich, Switzerland, commented
the launch of the test. "A blood-based test fits into doctors' daily
routine and requires almost no patient involvement. Such a test for
colorectal cancer screening could find much better acceptance among
patients and drive compliance."

The mSEPT9 colorectal cancer blood test is designed to be as
convenient and patient friendly as possible. All it takes for the
patient is giving a blood sample in the doctor's office as part of
their regular check-up. The sample is shipped to a local or regional
diagnostic laboratory where it is tested for the mSEPT9 biomarker.
The test result is provided to the doctor who can discuss it with the
patient within a few days after the blood sample was taken. If the
test were positive, a colonoscopy would typically be performed to
confirm the test result and localize the tumor as a first step
towards cancer therapy.

Epigenomics has shown in a series of seven published case control
studies with over 3,000 patient-samples and controls, that the mSEPT9
assay reliably detects cell-free DNA derived from colorectal tumors
in blood samples and thereby indicates the presence of colorectal
cancer of all stages.

Epigenomics expects further diagnostic laboratories in Europe to
introduce mSEPT9 testing in due course. In addition, Epigenomics'
non-exclusively licenses the mSEPT9 biomarker and its technologies to
partners in the diagnostics industry for global commercialization of
in vitro diagnostic blood tests for colorectal cancer based on
mSEPT9. A first IVD test kit for mSEPT9 testing is expected to be
launched in Europe by the end of 2009. In the U.S., mSEPT9 testing is
expected to be offered initially by Quest Diagnostics, a leader in
diagnostic testing, information and services in the U.S. Quest
Diagnostics is currently in the process of establishing a
laboratory-developed test for mSEPT9 under license from Epigenomics.
FDA approved IVD products through Epigenomics' current and future IVD
partners will follow.

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 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 urine, blood
and bronchial lavage specimens. Epigenomics' biomarker mSEPT9 for the
early detection of colorectal cancer in a simple blood sample has
demonstrated continuously highest performance in multiple clinical
studies with in total more than 3,000 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
Incorporated, for diagnostics test products and services, 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.

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, 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
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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, Technologie All Share
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Berlin / free trade
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