Epigenomics AG

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