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Epigenomics Successfully Completes Larger Clinical Study in Early Lung Cancer Detection
Panel with two biomarkers confirms solid performance in larger blood plasma study
19 Jun 2008 -
Epigenomics AG announced that it successfully completed a larger clinical study in its lung cancer program. The study was run in close collaboration with Prof. Dr. Christian Witt and Dr. Bernd Schmidt at the Charité University Hospital in Berlin, Germany.
The study on 256 patient samples confirmed that a two-biomarker panel correctly identified two thirds of all lung cancers in blood plasma (66% sensitivity) at a false positive rate of 12% (88% specificity). Notably, about two thirds of the blood samples used in the study were obtained from patients with early stage I and II cancer. Sensitivity in stage II lung cancer patients reached 73%. Patients with early stage cancer are significantly underdiagnosed in the current diagnostic practice for lung cancer but could benefit most from early therapeutic intervention.
These latest results independently confirm previous data from a much smaller proof-of-concept study performed by Epigenomics in 2007 that was weighted towards later stage disease reflecting the unfavorable stage distribution found in the current diagnostic practice.
"Today, most patients having lung cancer present with symptoms or are accidentally found, when many of them have locally advanced or metastatic disease explaining their poor prognosis. In contrast, patients diagnosed and treated at early stages can have encouraging outcomes, with 5-year survival rates as high as 60% to 70%. Identifying markers that are able to detect lung cancer using a simple blood sample is an encouraging first step towards developing a screening test for this deadly disease," says Prof. Dr. Christian Witt, Head of the Department of Pneumology at the Charité, Berlin.
The biomarkers were identified within Epigenomics' proprietary discovery program using its DMH (differential methylation hybridization) technology and have been extensively validated on tissue samples before being tested on blood plasma.
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