OncoMethylome's Colorectal Cancer Screening Test Demonstrates High Performance in Clinical Trials

Liege (Belgium) -  September 19, 2007, 8:00am CET - OncoMethylome Sciences (Euronext Brussels: ONCOB, Euronext Amsterdam: ONCOA) published new data from its colorectal cancer program at the AACR conference on Molecular Diagnostics in Cancer Therapeutic Development. OncoMethylome showed that it has successfully identified methylation markers that, when combined in a test panel, are very accurate in detecting early-stage colorectal cancer via stool samples.
The new methylation markers are the result of OncoMethylome's own marker-discovery activities. The markers demonstrated strong performance in detecting early-stage cancer in stool samples collected from people with all stages of colorectal cancer. When combined in a test panel, the markers detected early-stage colorectal cancer with 86% sensitivity and 96% specificity. In other words, the test correctly detected 86% of early-stage colon cancers, and it correctly identified, as non-cancerous, 96% of controls consisting of stool collected from healthy, age-appropriate, people.
Colorectal cancer is the second most deadly cancer and often has no symptoms during its early onset. These characteristics highlight the need for screening age-appropriate, asymptomatic individuals for colorectal cancer. The colonoscopy procedure, which is a visual exam of the colon, is often used for this purpose; however, because it is invasive and costly, it is not adequately available and accepted. Therefore, the goal of OncoMethylome's colorectal cancer program is to develop non-invasive, user friendly tests that are appropriate for population screening. OncoMethylome's vision is that its stool-based test would eventually be used by asymptomatic people, to identify those who likely have cancer and should be further examined with a colonoscopy procedure.
The published data is based on stool collected from the first 147 participants in ongoing clinical trials that are designed to validate OncoMethylome's stool and blood based tests for colorectal cancer. In addition to the data published today, OncoMethylome intends to publish initial data on its blood-based colorectal cancer test before the end of 2007.
Dr. Adriaan de Bruïne, Professor of Pathology at the University Hospital of Maastricht, and collaborator in the study, commented: "Colorectal cancer can be successfully treated via the removal of pre-cancerous lesions and small tumors. It is challenging to find these abnormalities early in their development because due to their size they are almost always asymptomatic. This clinical trial showed that the test in development by OncoMethylome is able to detect these early abnormalities, even in stool. Therefore I see a large potential for the routine use of this accurate and non-invasive test by people over the age of 50 who are most prone to developing colorectal cancer and should be screened regularly."
 "We have demonstrated that our novel methylation markers are highly sensitive and specific in detecting colorectal cancer in stool. We will continue this ongoing clinical trial to further validate the performance of these markers, not only in stool, but also in blood samples. Developing patient-friendly, non-invasive, stool and blood tests for colorectal cancer is one of our highest priorities," said Herman Spolders, Chief Executive Officer of OncoMethylome. "We are discussing these new trial results with potential commercialization partners and are evaluating our options for commercialization."
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 Colorectal Cancer
Colorectal cancer mortality is a global problem. More than 900,000 new cases of colorectal cancer are diagnosed annually worldwide, and with 500,000 annual deaths, colorectal cancer is the second most deadly cancer. Colorectal cancer incidence increases with age, and the US Department of Health estimates that 50 to 60 percent of deaths from colorectal cancer could be prevented if everyone above the age of 50 were screened regularly. In Europe, there are 120 million people over the age of 50 who would benefit from regular screening for colorectal cancer. Using current screening methods, fewer than 40% of colorectal cancers are detected in early stages of development, when the cancer it is most treatable. The survival rate drops sharply if the cancer is detected in advanced stages of development; therefore, an urgent need exists for a sensitive and non-invasive screening test for this disease.
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 colorectal cancer, this technology identifies methylation of genes, or methylation markers, that have been shown to be associated with colorectal 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
or visit: www.oncomethylome.com


Press Release PDF Clinical Data PDF