Epigenomics AG

EANS-News: Epigenomics AG: Clinical Study Shows Lead Biomarker for Lung Cancer also works in Blood

Biomarker mSHOX2 could accelerate diagnostic work-up of patients with suspected lung cancer

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Company Information/Molecular diagnostics/Products

Press release, Berlin, Germany, and Seattle, WA, USA, August 25, 2009 (euro adhoc) - Epigenomics AG (Frankfurt Prime Standard: ECX), a molecular diagnostics company focusing on the development and commercialization of in vitro diagnostic products for cancer, today announced that it successfully completed a clinical feasibility study in lung cancer. This study has confirmed Epigenomics' proprietary lead biomarker mSHOX2 for lung cancer diagnosis when tested in blood samples.

In this study the amount of methylated DNA of the SHOX2 gene (mSHOX2) was successfully analyzed in blood plasma samples from 188 patients with confirmed lung cancer of all stages and 155 control patients consisting of individuals with benign lung disease, healthy subjects and smokers. The study, which has been conducted in cooperation with the Charité, Universitätsmedizin Berlin, has confirmed mSHOX2 as a promising lung cancer biomarker. The results demonstrate that the biomarker can reliably distinguish patients with lung cancer from patients with benign lung disease with high specificity when measured in routine blood plasma samples. In a population of patients undergoing diagnostic work-up for suspected lung cancer, of which typically about 40% actually have the cancer, an mSHOX2 test can predict the presence of the disease with 92% probability (positive predictive value).

"As an aid in diagnosis such a test could accelerate the diagnostic workup of patients with suspected lung cancer and eventually save costs. A positive mSHOX2 test result could support physicians in their decision to opt for more aggressive and invasive procedures and thereby avoid delays in establishing the final diagnosis and initiate treatment sooner" says Dr. med. Bernd Schmidt, Epigenomics' collaborator at the Charité Universitätsmedizin Berlin.

Earlier studies had shown that mSHOX2 is a highly specific biomarker for lung cancer when measured in bronchial lavage samples that are routinely obtained by flushing the suspicious area of the lung during bronchoscopy. Based on these results, Epigenomics has decided to develop an in vitro diagnostic test for bronchial lavage. This mSHOX2 test is expected to be ready for launch in Europe as CE-marked product in the first half of 2010.

"With this study we have shown in a sizeable and clinically relevant patient population the feasibility of detecting lung cancer with our mSHOX2 assay in blood plasma. This may expand the potential use of this tumor marker beyond patients undergoing bronchoscopy," explained Dr. med. Volker Liebenberg, Vice President Product Development at Epigenomics.

"Based on this successful clinical feasibility study we will further evaluate product development opportunities using mSHOX2 in blood" Dr. Uwe Staub, Senior Vice President Product Development at Epigenomics added. "Our first priority in lung cancer product development, however, remains to complete the clinical development and CE marking of our mSHOX2 based bronchial lavage test to be launched in first half of 2010."

In this latest study, the mSHOX2 real-time PCR assay developed for the bronchial lavage specimen has been combined with the plasma DNA preparation workflow originally developed for Epigenomics' colorectal cancer blood test, underscoring the versatility and scalability of the Epigenomics product platform.

About Lung Cancer

With about 386,300 new cases in Europe in 2006 and about 215,000 new cases in the U.S. in 2008, lung cancer is the most common cancer in men and women accounting for about 20 percent of all cancer deaths - more than any other cancer.

Current guidelines do not recommend screening for lung cancer leading to the majority of patients being diagnosed at advanced stages when symptoms have occurred. The overall objective of this work-up is to establish the diagnosis with the least invasive methods to minimize the patient's risk. Individuals suspected to have lung carcinoma 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 and biopsy by needle or surgery. As of today tumor markers play only a very minor role in this diagnostic process.

Epigenomics' lung cancer program aims at developing tests that provide additional information in the diagnostic work-up of patients with suspected lung cancer and thereby allow simplifying the diagnostic process and minimize the risk of delays in establishing the final diagnosis and initiating treatment.

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 3,500 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

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