How was the gene panel for the Oncotype DX Colon Cancer Assay developed and validated?
The identification of the gene panel for the Oncotype DX Colon Cancer Assay started with an extensive analysis of the human genome. Following the identification of a large set of genes associated with colon cancer, four developmental studies explored the expression of 761 genes in patient tumor samples that were obtained at the time of initial diagnosis of colon cancer. The results of these studies were analyzed and used to develop a 12-gene assay that incorporated the genes which consistently correlated with recurrence-free survival. This assay was then validated, using prospectively-defined endpoints, in an independent clinical study of 1,436 patients from the landmark QUASAR Study.