GeneNews Limited has announced that it has started collecting patient samples for clinical validation studies of its lead product under development, ColonSentry™.
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.