TORONTO, Dec. 17 /CNW/ - GeneNews Limited (TSX: GEN), a company focused on developing simple blood-based molecular diagnostic tests for the early detection of diseases and personalized health management, today announced that it has started collecting patient samples for clinical validation studies of its lead product under development, ColonSentry(TM).
In June 2006, GeneNews presented training set results at the American Society of Clinical Oncology (ASCO) Annual Meeting which demonstrated that the expression profile of five genes in patients with colorectal cancer could be differentiated from controls. Blood RNA samples from an Asian population were profiled to identify differentially expressed genes. This analysis yielded a combination of five genes that achieved sensitivity of 90% and specificity of 79% in the training set.
Since June 2006, GeneNews has collected more than 10,000 patient blood samples through a network of clinical collaborations spanning more than 20 centers in the US and Canada. Included in the 10,000 samples are more than 500 blood samples from patients confirmed by pathology to have colorectal cancer and an additional 500 blood samples from patients with pre-cancerous polyps. These samples are being used by GeneNews to refine and optimize its ColonSentry biomarker panel.
GeneNews is now initiating patient sample accrual under GCP ("Guidelines for Good Clinical Practice") to create a bank of North American patient samples that would be eligible for inclusion in clinical validation studies of ColonSentry. These studies are expected to commence in 2008 as the Company advances its development efforts. The Company expects to initially offer ColonSentry as a reference laboratory-based test while it pursues regulatory approval for an IVD ("in-vitro diagnostic") version of the test.
About Colon Cancer and Screening
In the US, colon cancer is the second leading cause of cancer deaths for men and the third leading cause of cancer deaths for women. Colon cancer has a very poor prognosis if it is diagnosed after the cancer has spread outside the colon; however, if it is detected early it is usually curable. Current screening tests are generally invasive, expensive, inconvenient or not readily available. As a result, the vast majority of patients in the developed world are not adequately screened. It is estimated that there are approximately 80 million people in the US over the age of 50 who require regular screening and that only approximately 35% of this group complies with current screening guidelines. Outside the US, screening compliance is much lower.
GeneNews is focused on the application of functional genomics to enable early diagnosis and personalized therapeutic intervention based on disease-specific biomarkers. The Company has developed a novel approach, the Sentinel Principle(TM), to detect and stage virtually any disease or medical condition from a simple blood sample. GeneNews is currently applying the Sentinel Principle in major areas with unmet clinical needs such as cancer, arthritis, cardiovascular disease and neurological disorders. GeneNews' first product in development, ColonSentry, is a convenient and patient-friendly blood-based biomarker test that can detect colon cancer. For more information on GeneNews, visit www.genenews.com.
This press release contains forward-looking statements, which reflect the Company's current expectations regarding future events. The forward-looking statements involve risks and uncertainties. Actual events could differ materially from those projected herein. Investors should consult the Company's ongoing quarterly filings and annual reports for additional information on risks and uncertainties relating to these forward-looking statements. The reader is cautioned not to rely on these forward-looking statements. The Company disclaims any obligation to update these forward-looking statements.
SOURCE GeneNews Limited
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