Epigenomics DNA methylation test successfully detects colorectal cancer in blood
Epigenomics AG announced positive results of a series of large clinical studies, demonstrating that its molecular diagnostic test developed in collaboration with Roche Diagnostics was able to detect colorectal cancer from a standard, non-invasive blood draw. Epigenomics believes that this diagnostic, which works by interpreting changes in DNA methylation, has the potential to support large-scale, general population colorectal cancer screening since early detection of colorectal cancer significantly improves treatment outcome. The test targets asymptomatic men and women over the age of 50 who are recommended to take an early detection test for colorectal cancer on a regular basis.
Successfully meeting this milestone led to the full payment to Epigenomics of the milestone that had been agreed in the companies' collaboration agreement. Roche Diagnostics now has a worldwide exclusive license to this test and will commence to transfer the marker and technologies onto Roche Diagnostics' platforms in 2006.
At a set specificity of 95%, the lead marker demonstrated sensitivity values of 51%, 65% and 50%, respectively in three independent clinical studies, matching or surpassing the performance of today's best molecular screening tests. Importantly, early-stage cancers were identified with the same sensitivity as later stage cancers, proving the utility of this approach for general population screening. Results were obtained measuring only a single DNA methylation "anchor" marker. In addition, the test was able to detect colorectal cancers regardless of their location, addressing a critical medical need and shortfall of the existing fecal occult blood tests (FOBT), currently the most widely used screening test.
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