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EANS-News: Epigenomics AG Successfully Validates Lung Cancer Test in Clinical Trial
Epi proLung BL Reflex Assay demonstrates outstanding technical and clinical performance in pivotal IVD performance evaluation study Novel test introduced to leading pathologists and Oncologists CE-marking and launch as IVD test expected within the next few weeks
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New Products/Molecular diagnostics
Subtitle: Epi proLung BL Reflex Assay demonstrates outstanding technical and clinical performance in pivotal IVD performance evaluation study
Novel test introduced to leading pathologists and Oncologists
CE-marking and launch as IVD test expected within the next few weeks
Press release, Berlin, Germany, and Seattle, WA, USA, June 23, 2010 (euro adhoc) - Epigenomics AG (Frankfurt Prime Standard: ECX), a cancer molecular diagnostics company, successfully completed the pivotal performance evaluation study for its Epi proLung BL Reflex Assay, a lung cancer diagnostic test. The test determines the DNA methylation status of the SHOX2 gene in bronchial lavage material routinely obtained during the clinical workup of patients with suspected lung cancer. Increased DNA methylation of the SHOX2 gene indicates the presence of malignant lung disease. The study has demonstrated that the analytical and clinical performance fulfills the requirements for its intended use as an aid in the diagnosis of lung cancer. This successful performance evaluation meets an important clinical trial milestone as a regulatory prerequisite to CE-marking of in vitro diagnostic products prior to market introduction. The completion of the study now paves the way for the European launch of the Epi proLung BL Reflex Assay which is expected within the next few weeks.
In clinical care today, lung cancer is typically confirmed by the analysis of tissue that is directly obtained from the tumor or by analyzing cellular material e.g. from rinsing the airways with saline solution during a bronchial lavage. However, in approximately half of the suspected cancer cases neither cytology nor histology provide conclusive results at the time of a patient's first bronchoscopy. This frequently leads to further time consuming and costly procedures bearing additional risks for patients. The Epi proLung BL Reflex Assay test addresses this clear medical need by helping pathologists to confirm the presence of malignant lung disease. "The Epi proLung BL Reflex Assay may provide critical additional information to pathologists when cytology is not unequivocal. This represents the diagnostic value of the test", stated Prof. Manfred Dietel, Director of the Institute of Pathology of Charité - University Medicine Berlin at a recent Key Opinion Leader Meeting in Frankfurt am Main, Germany, at which Epigenomics has introduced the novel test to pathologists and oncologists.
The clinical performance of the test has been demonstrated in a case control study with individuals that have undergone diagnostic work-ups for suspected lung cancer within the University of Liverpool Cancer Research Centre, Roy Castle Lung Cancer Research Program UK, under Professor John K Field. Using the Epi proLung BL Reflex Assay, the DNA methylation status of the SHOX2 gene was determined in routinely obtained bronchial lavage of patients with confirmed bronchial carcinoma and patients with no evidence of malignant lung disease but other lung diseases at the time of bronchoscopy and a minimum lung cancer free survival of 18 months. In this critical patient group, the test correctly identified 81% of the lung cancer cases with only 5% false positive results translating into a specificity of 95%. This clinical performance evaluation study confirms previous research studies showing that methylated SHOX2 DNA is a highly specific biomarker for lung cancer in bronchial lavage. Furthermore, the performance evaluation study has demonstrated that the Epi proLung BL Reflex Assay is a technically robust and reliable diagnostic tool. Simple handling, short time to results and compatibility with standard molecular diagnostic laboratory equipment are expected to facilitate introduction of this test into clinical routine.
"We have shown in a number of clinical studies that the biomarker mSHOX2 has utility in supporting physicians in detecting lung cancer with certainty, thereby avoiding delays in establishing the final diagnosis. This allows them to initiate treatment sooner, thus improving the quality of life of the patient", stated Dr. Uwe Staub, Senior Vice President Product Development at Epigenomics. "Based on this successful pivotal clinical study showing impressive analytical and clinical performance we have met a key milestone for the launch of the Epi proLung BL Reflex Assay" added Dr. Staub. About Lung Cancer
With about 386,300 new cases in Europe in 2006 and about 219,000 new cases in the U.S. in 2009, lung cancer is the third (after Prostate and Breast Cancer) 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 a situation in which the majority of patients are diagnosed at advanced stages. The overall objective of the diagnostic work-up is to establish the definitive 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. Until recently tumor markers have played only a minor role in this diagnostic process.
About Epi proLung
Epi proLung BL Reflex Assay has been 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 is not yet launched and hence is not yet available for sale and cannot be put into service in Europe or any other market until applicable directives and standards are demonstrated for product conformity or approval.
For more information on the Epi proLung BL Reflex Assay and its future availability in Europe please visit www.epiprolung.com or contact Epigenomics directly by Email email@example.com or phone +49 30 24345 111.
About the University of Liverpool
The University of Liverpool is a member of the Russell Group of leading research-intensive institutions in the UK. It attracts collaborative and contract research commissions from a wide range of national and international organisations valued at more than £98 million annually. Visit www.liv.ac.uk
Epigenomics is a molecular diagnostics company with a focus on the development of novel products for cancer. Using DNA methylation biomarkers, Epigenomics' tests 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, ARUP Laboratories, Inc., and Warnex Inc. for diagnostic 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 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 within or outside of the European Union, 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.
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Further inquiry note:
Dr. Achim Plum
Sen. VP Corporate Development
Tel: +49 30 24345 368
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