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

Liege (Belgium) - September 18, 2007, 8:00am CET - OncoMethylome Sciences (Euronext Brussels: ONCOB, Euronext Amsterdam: ONCOA) 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 today 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. "We are very proud that our test is successfully detecting early-stage bladder cancer in urine. Early detection of cancer and cancer recurrence is critical for effective treatment," stated Dr. Jim DiGuiseppi, Chief Technology Officer of OncoMethylome Sciences. "Based on these strong clinical trial results, we will move ahead with product development and will also evaluate our distribution and commercialization alternatives for this product." 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. To download this press release as a PDF, click here: Press Release PDF To download clinical data presented at the AACR Molecular Diagnostics in Cancer Therapeutic Development conference, click here: Clinical Data PDF About Bladder Cancer In the Western world, bladder cancer is the fourth most common cancer in men and the eight most common cancer in women. Five-year survival is excellent (>90%) in people whose cancer is diagnosed in the early stages, but it drops to 5% if the cancer is detected late. Because bladder cancer recurs in up to 70% of patients, frequent and ongoing testing is recommended for all people with a history of bladder cancer. Due to the benefits of early cancer detection and the frequent testing of bladder cancer survivors, a need exists for an accurate and non-invasive test for bladder cancer. About Methylation and Methylation Markers Methylation is a natural control mechanism that regulates gene expression in DNA. Abnormal methylation of certain genes, such as tumor suppressor genes, can silence gene expression and is associated with cancer development. Genes, whose methylation is linked to cancer, are called methylation markers. OncoMethylome owns proprietary technology that is highly sensitive and capable of detecting methylation markers, and thereby cancer, even in early stages of cancer development. In the case of bladder cancer, this technology identifies methylation of genes, or methylation markers, that have been shown to be associated with bladder cancer. About OncoMethylome Sciences OncoMethylome Sciences (Euronext Brussels: ONCOB; Euronext Amsterdam: ONCOA) is a molecular diagnostics company developing gene methylation tests to assist physicians in effectively detecting and treating cancer. Specifically, the company's tests are designed to help the physician (i) accurately detect cancer in early stages of cancer development, (ii) predict a patient's response to drug therapy, and (iii) predict the likelihood of cancer recurrence. OncoMethylome boasts a broad product development pipeline consisting of ten products and a solid partnering record. The company collaborates with leading international molecular oncology research centers, such as The Johns Hopkins University, and has a number of commercial and collaborative partnerships with Veridex LLC, a Johnson & Johnson company, Schering-Plough Corp., Millipore Corporation's BioScience Division, and EXACT Sciences Corp. OncoMethylome's products are based on methylation technology invented by Johns Hopkins University (USA). Established in January 2003, OncoMethylome has offices in Liege and Leuven (Belgium), in Durham, NC (USA), and in Amsterdam (the Netherlands). For more information please contact: Lucija Turcinov Tel. +32-479-801-902 Lucija.Turcinov@oncomethylome.com or visit: www.oncomethylome.com