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Epigenomics AG Demonstrates Feasibility of Convenient Blood Test for Lung Cancer Detection in Clinical Study

-- Positive clinical data from collaborative study with Charite

-- Potential to address a high unmet medical need as no IVD test for

lung cancer available thus far

-- Successful clinical proof-of-concept in third cancer screening test

development program

-- Further step towards building an early cancer detection franchise

with diagnostic industry partners

BERLIN and SEATTLE, June 27, 2007 (PRIME NEWSWIRE) -- Epigenomics AG (Frankfurt:ECX) (Prime Standard:ECX) takes a further step towards launching a convenient blood-based lung cancer screening test that could considerably improve the early detection of lung cancer, the most common cause of cancer-related death. The molecular diagnostics company today announced positive data resulting from a clinical study as part of its lung cancer screening test development program.

The program aims at developing a blood based test for the reliable and convenient early detection of lung cancer. In an initial study last year Epigenomics identified numerous candidate DNA methylation biomarkers that appear in lung tumors, but not in normal lung tissue. The objective of this most recent study, run in cooperation with the Department of Pneumology at the Charite in Berlin headed by Prof. Dr. Christian Witt, was to show that the most promising candidate biomarker identified previously can also be detected in blood plasma of lung cancer patients. This is an important prerequisite for developing a convenient blood based early detection test for this cancer. The study was carried out on a group of patients with either lung cancer or benign lung disease. The study came to the result that the most promising candidate biomarker detects patients with lung cancer, and differentiates them from individuals with positive computer tomography (CT) due to non-cancerous lung diseases. Based on this proprietary novel DNA methylation biomarker and the encouraging results, Epigenomics will continue the development of its lung cancer screening test. With these results in lung cancer, Epigenomics has achieved clinical proof-of-concept in the third major cancer indication, after successful clinical studies in colorectal cancer and prostate cancer screening programs.

In the clinical study, Epigenomics analyzed data for two DNA methylation biomarkers, a novel biomarker from Epigenomics' own discovery and a control biomarker, measured in 100 patients. The novel proprietary biomarker demonstrated a sensitivity of 69% at a specificity of 91% in discriminating non-small cell lung cancer (NSCLC) from controls with non-cancerous lung diseases in blood plasma. This means that no more than 9% false positive test results occurred and 69% of the non-small cell lung cancer patients were found through a simple blood test. The proprietary biomarker performed statistically significantly better than the control biomarker RASSF1A, one of the best described lung cancer DNA methylation biomarkers in the scientific literature, and will now be used as the central biomarker in Epigenomics' lung cancer screening test development program. The whole process from discovering novel lung cancer biomarkers to clinical proof-of-concept in blood took less than 12 months.

"Lung Cancer is responsible for 1.3 million deaths worldwide annually. Most patients are diagnosed when their disease is advanced, and nearly 90 percent die within two years, but catching lung cancer early could improve survival substantially. A convenient, blood based screening test such as the one being developed by Epigenomics with a high performance addresses an urgent unmet medical need, as the early and reliable detection of lung cancer offers better treatment options for patients," said Dr. Bernd Schmidt, responsible clinician for the project at Charite, Berlin.

"Currently no such test is available for the mass screening, especially for the high risk group of more than 90 million smokers in the major markets. We aim at developing such a test and have now made substantial progress to this end," said Christian Piepenbrock, Chief Operating Officer of Epigenomics. "In the next step, we will further improve the performance of the test based on our newly identified biomarker and potentially other complementary biomarkers."

"The clinical proof-of-concept for our lung cancer biomarker is an important step towards building an early cancer detection franchise together with diagnostic industry partners," said Geert W. Nygaard, Chief Executive Officer of Epigenomics. "The lung cancer test complements our colorectal and prostate cancer programs and increases our opportunities in our ongoing partnering discussions."

Epigenomics estimates the overall worldwide (U.S., Europe and Japan) peak sales potential for a lung cancer screening test when applied to the high risk target population of about 90 million smokers to reach EUR800 million for IVD companies, and if extended for use in the general population aged 45 or older, to reach more than EUR2 billion.

Over the next years Epigenomics will conduct further clinical studies to validate its lung cancer test in large patient cohorts, and in collaboration with diagnostics industry partners, aims to develop in vitro diagnostic (IVD) test kits that may be taken through clinical trials to support regulatory approvals.

About Lung Cancer Screening

With about 386,300 new cases of lung cancer in Europe and over 174,000 new cases in the U.S. in 2006, lung cancer is one of the most common cancers in men and women and accounts for about 20 percent of all cancer deaths, more than any other cancer.

Due to the lack of effective tests, screening guidelines currently do not recommend screening for lung cancer. Today, diagnosis mostly relies on diagnostic imaging procedures such as x-rays, Computed Tomography (CT) scans or Positron Emission Tomography (PET) scans followed in some cases by invasive bronchoscopy for definitive diagnosis. As these procedures are not suitable for screening, they are used once a patient reports symptoms that could be indicative of lung cancer. The five-year survival rate is 15% for all stages of lung cancer cases, but 49% for cases detected when the disease is still localized. Thus, 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 can potentially diagnose disease at an early stage and help guide physicians to select an appropriate therapy. Epigenomics' defined business strategy covers two complementary core business areas:

The company develops diagnostic screening tests for the early detection of cancer. Based on body fluid samples (e.g. blood and urine), these tests are aimed at finding cancer at an early stage before symptoms occur. Epigenomics' product pipeline contains a validated biomarker panel 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 aims at giving patients and doctors early access to these biomarkers through reference laboratory testing services. For development and global commercialization as in vitro diagnostic test kits, Epigenomics pursues a non-exclusive partnering strategy with diagnostics industry players.

As a second core business area, Epigenomics develops specialty diagnostics for individuals at high risk for cancer and cancer patients. These tests include surveillance applications of our colorectal cancer biomarkers and a tissue-based prognostic cancer molecular classification test for prostate cancer patients. Our tissue-based prostate cancer application is developed in strategic partnerships with Qiagen (pre-analytics) and Affymetrix (diagnostic device platform). The biomarkers for cancer specialty diagnostic applications will be made available through testing services in centralized reference laboratories. Epigenomics retains the flexibility to decide on further commercialization as in vitro diagnostic test kits in Europe.

Pharma, diagnostics and biotech partners can access Epigenomics' portfolio of proprietary DNA methylation technologies and biomarkers protected by more than 200 patent families through Biomarker Services, IVD Development Collaborations, and Licensing. The company is headquartered in Berlin, Germany, and has a wholly owned subsidiary in Seattle, WA, USA. For more information, please visit Epigenomics' website at www.epigenomics.com.


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