Epigenomics AG: Clinical Study Shows Lead Biomarker for Lung Cancer also works in Blood

08-27-2009: Epigenomics AG announced that it successfully completed a clinical feasibility study in lung cancer. This study has confirmed Epigenomics' proprietary lead biomarker mSHOX2 for lung cancer diagnosis when tested in blood samples.

In this study the amount of methylated DNA of the SHOX2 gene (mSHOX2) was successfully analyzed in blood plasma samples from 188 patients with confirmed lung cancer of all stages and 155 control patients consisting of individuals with benign lung disease, healthy subjects and smokers. The study, which has been conducted in cooperation with the Charité, Universitätsmedizin Berlin, has confirmed mSHOX2 as a promising lung cancer biomarker. The results demonstrate that the biomarker can reliably distinguish patients with lung cancer from patients with benign lung disease with high specificity when measured in routine blood plasma samples. In a population of patients undergoing diagnostic work-up for suspected lung cancer, of which typically about 40% actually have the cancer, an mSHOX2 test can predict the presence of the disease with 92% probability (positive predictive value).

Earlier studies had shown that mSHOX2 is a highly specific biomarker for lung cancer when measured in bronchial lavage samples that are routinely obtained by flushing the suspicious area of the lung during bronchoscopy. Based on these results, Epigenomics has decided to develop an in vitro diagnostic test for bronchial lavage. This mSHOX2 test is expected to be ready for launch in Europe as CE-marked product in the first half of 2010.

In this latest study, the mSHOX2 real-time PCR assay developed for the bronchial lavage specimen has been combined with the plasma DNA preparation workflow originally developed for Epigenomics' colorectal cancer blood test, underscoring the versatility and scalability of the Epigenomics product platform.