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Epigenomics AG

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

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
Börsen: Frankfurt / regulated dealing/prime standard
Berlin / free trade
Hamburg / free trade
Stuttgart / free trade
Düsseldorf / free trade
München / free trade

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