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OncoMethylome's Novel Test for Bladder Cancer Demonstrates Excellent Performance in Clinical Trial

02 Jun 2008 - OncoMethylome Sciences released additional data today from an ongoing clinical verification trial of their bladder cancer test. The new data confirms the ability of this non-invasive urine-based test to accurately detect early-stage bladder cancer. The test procedure was successfully simplified without compromising performance. Multi-center trial shows that the test is highly reproducible.
 
The new findings from an additional 197 patients are statistically consistent with initial interim data and show an improvement in the performance of the test to 91% sensitivity and 93% specificity, meaning that the test correctly identified 91% of bladder cancer cases and 93% of patients who were negative for bladder cancer. Only patients with early-stage bladder cancer were included in this part of the clinical trial, demonstrating that the test indeed detects cancer in early stages, when the cancer is most treatable. Furthermore, as a result of the trial, the test was simplified by reducing the number of methylation markers from five to three, without compromising the test's performance.
 
Dr. Jim DiGuiseppi, CTO of OncoMethylome commented on the new findings which were presented at the Cancer Epigenetics conference in Boston, USA. "The non-invasive molecular diagnostic test of OncoMethylome Sciences continues to demonstrate excellent performance. We are very excited that this test is showing even better results now, than the already excellent interim results we released last year. We are now in the process of organizing larger validation trials and will be starting discussions with potential commercial partners."