ChondroGene Reports on Blood-Based Colon Cancer Test Development

TORONTO -- ChondroGene Limited reported on the progress of its Colon Sentry™ blood-based colon cancer detection test. The Colon Sentry test is able to detect colon cancer and certain pre-cancerous colon pathologies from a simple blood sample. The test was developed using the company's proprietary Sentinel Principle™ technology, which is capable of readily identifying blood biomarkers for virtually any disease or medical condition.

Colon cancer was chosen as the target for the company's first commercial diagnostic application of the Sentinel Principle because of the critical clinical need and large market potential. Colon cancer is the second leading cause of cancer deaths and has a very poor prognosis if it is diagnosed after symptoms have begun to appear. If detected early, however, colon cancer is usually curable.

Additionally, detecting and removing pre-cancerous polyps prevents cancer from developing. It is recommended that everyone over the age of fifty be screened annually for colon cancer and pre-cancerous polyps. Unfortunately, current screening tests are inaccurate, invasive, expensive, inconvenient for patients or not readily available. As a result, the vast majority of patients in the developed world are not adequately screened.

To date, the company has collected over 2,500 blood samples in North America and Asia from patients who have undergone colonoscopic screening for colon cancer or who have been diagnosed with colon cancer. ChondroGene has used these samples to identify sets of biomarkers in blood that will form the basis of molecular diagnostic tests for the detection of colon cancer and pre-cancerous polyps.

In one study, ChondroGene identified a five-gene biomarker set for identifying patients with colon cancer that has a sensitivity of 90 percent and specificity of 79 percent. The company has also selected a biomarker set of seven genes in another study to identify patients with advanced adenomas and high risk polyps, the type of colon polyps at high risk for developing into colon cancer. The sensitivity and specificity of this seven-gene biomarker set for detecting patients with advanced adenomas and high risk polyps is 90 percent and 81 percent, respectively. The company is continuing to optimize these biomarker sets and is accruing additional blood samples from patients with colon cancer and advanced adenomas. The continued accruals will enable the company to further validate these initial biomarker sets with blinded studies prior to formal development of molecular diagnostic kits later this year.

"It is unfortunate that so few individuals over the age of fifty undergo adequate colon cancer screening, given that this cancer is lethal if detected late, yet usually curable if detected early," stated K. Wayne Marshall, MD, PhD, president and CEO of ChondroGene. "The lack of patient compliance with current screening approaches relates to a number of factors including the inconvenience to patients associated with dietary restrictions, handling of multiple stool samples, uncomfortable bowel preps and the discomfort and risks of an invasive endoscopic procedure. We believe that a simple, cost-effective, blood-based test for detecting colon cancer and advanced adenomas would enhance current colon cancer screening programs thereby saving lives and reducing overall healthcare costs associated with colon cancer."

About Colon Cancer
The American Cancer Society estimates that in 2004, there were 146,940 new cases of colorectal cancer diagnosed in the U.S. Of the total number of new cases of colorectal cancer, 40,570 of the new cases were diagnosed as rectal cancer (23,220 men and 17,350 women) and 106,370 were colon cancer (50,400 men and 55,970 women). The total population of colorectal cancer patients is over 1 million. Patients over age 50 are advised to have regular colorectal cancer screening. It is estimated that there are approximately 80 million people in the US over the age of 50, who require regular screening.

About ChondroGene
ChondroGene is focused on the application of functional genomics to enable early diagnosis and personalized therapeutic intervention based on disease-specific biomarkers.

Source: ChondroGene Limited

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