OncoMethylome Publishes Positive Clinical Trial Results for Urine-based Bladder Cancer Test

19-Sep-2007

OncoMethylome Sciences published interim data from its ongoing bladder cancer clinical trial. The trial results showed that the urine test that OncoMethylome is developing can successfully detect bladder cancer, especially when the cancer is in early stages of its development and most difficult to detect. In addition, the test´s performance was drastically superior to that of cytology, which is currently the most widely used urine test for bladder cancer.

OncoMethylome is developing a sensitive urine test for detecting early-stage bladder cancer and for early detection of cancer recurrence. Currently, bladder cancer is detected via microscopic analysis of urine (cytology), which detects approximately 38% of cancers, plus cystoscopy, which is a manual examination of the bladder with a scope inserted through a patient´s urethra. As cytology is not adequately sensitive, and the cystoscopy procedure is invasive and carries the risk of infection, OncoMethylome believes that an accurate and reproducible urine test would be of great value to urologists and patients.

The interim results from the ongoing clinical trial showed that OncoMethylome´s urine-based test detected early-stage bladder cancer with 88% sensitivity and 93% specificity. This means that the test detected 88% of early-stage cancers, and correctly identified as non-cancerous 93% of controls, even when those controls consisted of other abnormal bladder conditions. The molecular test in development is made up of 5 methylation makers, and is run on DNA isolated from urine. All of the methylation markers used in the test are the result of OncoMethylome´s proprietary marker discovery program, and were identified and developed by OncoMethylome.

The published data presented at the AACR conference on Molecular Diagnostics in Cancer Therapeutic Development represent interim findings from 218 participants in an ongoing clinical trial expected to enroll 400 people at its completion.

OncoMethylome´s bladder cancer clinical trial is conducted in conjunction with urology and pathology departments from University of Liege and Citadelle Hospital in Belgium, the Erasmus Medical Center in the Netherlands, and Cambridge University in the UK.

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