- Biomarkers form basis of blood-based ColonSentry(TM) test -
TORONTO, April 14 /PRNewswire-FirstCall/ - GeneNews Limited (TSX: GEN), a company focused on developing blood-based biomarker tests for the early detection of diseases and personalized health management, today reported positive performance results from a large validation study of a six-gene biomarker panel for the assessment of a patient's current risk for colorectal cancer. This panel forms the basis of the Company's lead product, ColonSentry(TM), which is planned for launch in Canada in the third quarter of 2008 as a laboratory-developed test.
The validation study confirmed (p less than 0.05) that the panel was
able to stratify a population with average risk for colorectal cancer into
- Increased Probability: 18% of the population were defined as having a
3-fold increased probability of currently having colorectal cancer.
- Average Probability: 20% were defined as having an average probability
of currently having colorectal cancer.
- Decreased Probability: 62% were defined as having a 4-fold decreased
probability of currently having colorectal cancer.
"There is a need for a patient friendly test that can assess an individual's current risk for colorectal cancer, thereby enabling average risk patients to be stratified into more defined groups. This stratification would facilitate shared decision-making by physicians and their patients around screening options," commented Dr. Bernard Levin, an internationally recognized expert in colorectal cancer screening. "Although colorectal cancer can often be cured if detected early by screening, the majority of individuals do not comply willingly with screening recommendations because they find the screening methods such as stool tests or invasive endoscopic or radiologic procedures to be unpleasant or inconvenient. A blood test is more familiar and based on risk stratification could encourage more individuals to undergo screening. This could lead to earlier detection of colorectal cancer, thereby reducing suffering and death." Dr. Levin is the Chair of the Company's Colorectal Cancer Clinical Advisory Board.
Colorectal cancer is the second leading cause of cancer deaths in both men and women and the most common cause of cancer deaths in non-smokers. It is recommended that all individuals over the age of 50 undergo screening for colorectal cancer and pre-cancerous polyps on a regular basis. In the US, there are approximately 80 million people who are over the age of fifty.
The abstract, entitled "Stratification of colorectal cancer probability using six genes from whole blood" is being presented at the American Association for Cancer Research (AACR) Annual Meeting, in the Clinical Research 2 session, Poster Section 19, on Tuesday, April 15, 2008 at 8:00 AM. The abstract describes how RNA expression profiling of blood samples from a training set of 243 colorectal cancer and normal control patients was used to identify a combination of six biomarkers informative for stratifying the probability of having colorectal cancer in an average risk population. The performance of these six biomarkers was validated in a blind test set population of 337 colorectal cancer and control patients. The combined training/blind set had an average AUC (Area under the Curve) = 0.78% (95%CI: 0.73 to 0.84) and an average accuracy of 70.8% (95%CI: 65.3% to 76.2%).
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(TM) in major areas with unmet clinical needs such as cancer, arthritis, cardiovascular disease and neurological disorders. GeneNews' first product in development, ColonSentry(TM), is a convenient and patient-friendly blood-based test that can assess an individual's current risk for colorectal cancer. For more information on GeneNews, visit http://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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