Epigenomics AG Successfully Validates Lung Cancer Test in Clinical Trial

06-24-2010: Epigenomics AG 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.