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Epigenomics AG. (2/24/10). "Press Release: Epigenomics AG Introduces New Lung Cancer Test at German Cancer Congress. New IVD Test Expected to Be Launched in Q2 2010". Berlin & Seattle, WA.

Region Region Berlin
  Country Germany
Organisations Organisation Epigenomics AG (Frankfurt Prime Standard: ECX, OTCQX: EPGNY)
  Group Epigenomics (Group)
  Organisation 2 University Hospital Halle
  Group University of Halle (Martin-Luther Universität Halle-Wittenberg)
Products Product Epi proLung BL Reflex Assay
  Product 2 diagnostic test, lung cancer

– Test supports accurate diagnosis of lung cancer in suspicious cases
– Conference presentations on scientific evidence and clinical utility

Epigenomics AG (Frankfurt, Prime Standard: ECX), a cancer molecular diagnostics company, introduces its novel lung cancer test at the ongoing 29th German Cancer Congress in Berlin, Germany, this week. The Epi proLung BL Reflex Assay, the Company's second in vitro diagnostic product, is expected to be launched as a CE-marked diagnostic test kit in Europe in the second quarter of 2010.

The diagnostic test is being developed as an aid in diagnosis for lung cancer and may help pathologists to confirm the diagnosis of malignant lung disease when current diagnostic procedures fail to establish the presence of malignancy in patients with suspected lung cancer.

The test determines the DNA methylation status of the mSHOX2 gene in bronchial lavage material routinely obtained during the clinical workup of patients with suspected lung cancer, e.g. due to symptoms or accidental imaging findings. Increased DNA methylation of the SHOX2 gene indicates the presence of malignant lung disease.

In clinical care today, lung cancer is usually confirmed by analysis of tissue directly obtained from the tumor or by analyzing cellular material e.g. from rinsing the airways with saline solution during bronchial lavage. However, in routine care at the time of first bronchoscopy in approximately half of the suspected cancer cases, cytology and histology do not provide conclusive results. The need to confirm the diagnosis will likely lead to further time consuming and costly procedures bearing additional risks for the patient.

A molecular diagnostic test providing additional information to the physician and confirming the presence of lung cancer from bronchial lavage fluid could help to funnel patients with malignant lung disease into accelerated clinical staging and therapy, avoiding delay and potentially reducing costs.

Dr. Bernd Schmidt, Head of the Department of Pneumology at the University Hospital Halle, Germany, who collaborated with Epigenomics in the development of the test, will introduce the mSHOX2 biomarker and its clinical utility in an oral presentation at the German Cancer Congress today.
During the congress, Epigenomics will also host a press conference on Friday, February 26, 2010 on new epigenetic tests in different cancers.

The German Cancer Congress is organized by the German Cancer Society and is the most important oncological forum in German speaking countries.

Epigenomics at the 29th German Cancer Congress

Epigenomics will be represented at the 29th German Cancer Congress 2010 in Berlin, Germany, from February 24th to 27th 2010, with a booth at the ICC Berlin, Hall 17, booth number B15.

An oral presentation (lecture number: FV101) titled "Methylation of SHOX2 in bronchial lavage - a highly specific tumor marker for the lung carcinoma" will be presented within the Biomarker/ Molecular pathology session by Dr. Bernd Schmidt, Head of the Department of Pneumology, Clinic for Internal Medicine I, University Hospital Halle, Germany on February 24th, 2010, from 10.15 am to 11.45 am in hall 9 at the ICC Berlin.

A press conference titled "Innovative biomarkers for the diagnosis of lung- and colorectal cancer: Epigenetic tests open new ways in cancer diagnostics" will take place on Friday, February 26th, 2010, from 1:15 pm to 2:45 pm at the press center on the bridge, Room 43, Messedamm 22 at the ICC Berlin.

Interested journalists and media are kindly requested to contact Sandra Leinhoss, Manager Public Relations, Epigenomics AG, via Email: for participation details.

About Epi proLung

Epi proLung BL Reflex Assay is being developed as an in vitro diagnostic real-time PCR test kit for the analysis of SHOX2 gene methylation in bisulfite converted DNA isolated from human bronchial lavage fluid.Based on previous clinical research, it is believed that the presence of methylated SHOX2 DNA is associated with, and may aid in, the diagnosis of invasive carcinomas of the lung. The Epi proLung BL Reflex Assay will not be available for sale and cannot be put into service in Europe until Epigenomics declares that the product conforms to applicable EU directives and standards and can be CE-marked accordingly.

For more information on the Epi proLung BL Reflex Assay and its future availability in Europe please visit or contact Epigenomics directly by Email or phone +49 30 24345 111.

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 on the market and in development aim at diagnosing cancer at an early stage before symptoms occur and thereby may reduce mortality from this dreaded disease.

Epigenomics' product portfolio contains the CE-marked IVD test Epi proColon, the world's first regulatory cleared molecular diagnostic test for the detection of colorectal cancer in blood that is based on the biomarker Septin9, and further proprietary DNA methylation biomarkers and IVD products at various stages of development for colorectal, lung and prostate cancer. For development and global commercialization of IVD test products, Epigenomics pursues a dual business strategy in which direct commercialization of proprietary diagnostic test products is combined with non-exclusive licensing to diagnostic industry players with broad customer access. Strategic diagnostics industry partners include Abbott Molecular, Sysmex Corporation, Quest Diagnostics Incorporated, and ARUP Laboratories, Inc. for diagnostics test products and services, and QIAGEN N.V. for sample preparation solutions and research products. The company is headquartered in Berlin, Germany, and has a wholly owned subsidiary, Epigenomics Inc., in Seattle, WA, U.S.A. For more information, please visit Epigenomics' website at

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.

Record changed: 2017-04-02


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