No abstract

Using a primary gene amplification-based assay to guide AT therapy for HER2-positive breast cancer probably results in lower US medical costs, increased life-years and increased quality of life compared with confirmation of IHC 2+ with a gene amplification-based assay. We recommend the ASCO/CAP guidelines reflect 98% or greater concordance relative to a reference assay. Additional research regarding therapy response is required to further differentiate between gene amplification-based assays.

No abstract

While obtaining accurate data on therapy cost and benefits, test performance remains a key challenge in these analyses, the model presents key trade-offs and priorities for research to obtain more accurate clinical and economic information.

Studies that use the number of individuals treated for a medical condition to investigate its prevalence understate true prevalence and obscure prevalence trends. For example, treated diabetes prevalence was less than half of true prevalence in 1999-2000. Over the ensuing twelve years, the rate of increase in treated prevalence was more than 50 percent higher than that of true prevalence.