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.

Dubbed Epi proLung BL reflex assay, it demonstrated outstanding technical and clinical performance in an in vitro diagnostic (IVD) performance evaluation study. The study 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.

The study 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 shortly.

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 provides conclusive results at the time of a patient's first bronchoscopy.

The Epi proLung BL Reflex Assay was developed by Epigenomics Inc. (Berlin, Germany; and Seattle, WA, USA) 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.

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Epigenomics Inc.