GeneNews Limited has announced the publication of a paper entitled "Novel Blood-Based, Five-Gene Biomarker Set for the Detection of Colorectal Cancer", which appears in the January 15, 2008 issue of Clinical Cancer Research.
The paper reports that blinded clinical data from 92 patient samples has validated training set data initially presented at the 2006 ASCO Annual Meeting, further demonstrating that a five-gene biomarker panel effectively stratifies patients into defined risk groups for colon cancer (low, intermediate, high), providing actionable clinical data for use by patients and physicians to facilitate decisions around further colorectal (CRC) screening options.
"This publication is further validation of our proprietary approach to detecting colon cancer by monitoring the gene expression patterns of unique biomarker sets in blood," said C.C. Liew, PhD, Chief Scientist of GeneNews.
"Since this study, we have advanced our technology and worked with an expanded patient population to identify additional markers specific to colon cancer and to refine our algorithms for choosing optimal marker combinations. These results give us confidence that the enhanced panel we are completing for validation trials and commercialization will yield clinically-robust results."
In addition, GeneNews has completed collection of a further 10,000 patient blood samples through a network of clinical collaborations spanning more than 20 leading centers in the US and Canada.
More than 500 samples from patients with colorectal cancer and an additional 500 samples from patients with pre-cancerous polyps are included in the 10,000 patient blood samples which are currently being used by GeneNews to optimize and refine its ColonSentry™ biomarker panel.
The Company also recently announced that it has initiated accrual of a new cohort of patient samples for clinical validation studies of ColonSentry to be performed in 2008. GeneNews anticipates initially offering ColonSentry as a reference laboratory-based test while it pursues regulatory approval for an In Vitro Diagnostic (IVD) version.
"There is a critical need for a patient-friendly front-line test to assess an individual's risk for colorectal cancer before proceeding to the more invasive screening and diagnostic tools currently available. As a blood-based test, ColonSentry is well-positioned to meet this critical need and encourage patient compliance with colorectal cancer screening programs," said Dr. K. Wayne Marshall, MD, PhD, President and CEO of GeneNews.