Within each cancer subgroup in the Phase III stage, where disease status confirmation is available, the sensitivity (true positive outcomes/true positive outcomes + false negative outcomes) and positive predictive value (true positive outcomes/true positive outcomes + false positive outcomes) will be calculated on a per patient basis. The general criteria for assessment of comparability is that the study group sensitivity percent and positive predictive value percent values have a difference of not less than 15 percent from the appropriately matched literature values. For subgroups with significant patient numbers statistical analysis of comparability will be undertaken.