OncoMethylome Sciences: First Methylation Assay for Prostate Cancer Introduced by LabCorp

OncoMethylome's gene methylation technology used to advance the diagnosis of prostate cancer Liege (Belgium) - May 16, 2008, 14:30 CET - OncoMethylome Sciences (Euronext Brussels: ONCOB, Euronext Amsterdam: ONCOA) announced today that Laboratory Corporation of America® Holdings (LabCorp®) commercially launched an assay for prostate cancer including the detection of the methylation of the GST-Pi gene in tissue. This is the first DNA methylation test to become commercially and broadly available in the US for clinical use. When utilized in combination with conventional histopathology testing, an assay that detects the methylation status of key genes such as GST-Pi may provide for a more sensitive and accurate detection of prostate cancer than histology alone. The assay is anticipated to be useful for biopsies with suspicious histopathology, in cases where additional prognostic information is needed, and for patients who have elevated prostate specific antigen (PSA) values with biopsy findings that are repeatedly negative. Prostate cancer is the most common cancer in men with 230,000 cases diagnosed per year in the US, and it is the second leading cause of cancer-related deaths in the United States and the third in Europe. The diagnosis of prostate cancer is made by histopathology of prostate tissue removed during biopsy, a procedure done on close to a million men per year in the US. In the US, only one in four prostate biopsies is positive for prostate cancer but, due to the reportedly high false negative rate of biopsy results, repeat biopsies are commonly performed in men with elevated PSAs. Studies have shown that methylation of the GST-Pi gene occurs at a high frequency in prostate cancer samples. This is the first commercially available molecular diagnostic test that incorporates OncoMethylome's patented methylation technology. Following numerous published clinical studies demonstrating the value of the GST-Pi methylation marker in prostate cancer, OncoMethylome licensed the prostate cancer applications to Veridex LLC, a Johnson & Johnson company, who subsequently issued a sublicense to LabCorp. Under the terms of the Veridex sublicense agreement, OncoMethylome will receive royalties and milestone payments. LabCorp, an industry leader in oncology testing and the second largest clinical reference laboratory in the U.S., is headquartered in Burlington, North Carolina, USA. "The U.S. commercial launch of a methylation-based prostate cancer assay is an important milestone and turning point for OncoMethylome. As OncoMethylome has a pipeline of over ten novel diagnostic and personalized treatment tests, we hope this launch will be the first of many in the coming years. OncoMethylome plans to introduce this first prostate cancer test in Europe over the coming year." commented Herman Spolders, CEO of OncoMethylome. To download this press release as a PDF, click here: Press Release PDF 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, LabCorp, Schering-Plough Corp., GlaxoSmithKline Biologicals, Abbott, 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: Philip Devine Tel. +32-479-505-885 ir@oncomethylome.com www.oncomethylome.com