Genetic Test Evaluation

understanding how genetic tests impact patient management

Oncotype DX Genomic Prostate Score (GPS) Assay (Genomic Health Inc.)

November 12, 2018

Screening and treatment for prostate cancer is controversial due to the potential for overdiagnosis and overtreatment, with possible harms that may affect quality of life. Many prostate cancers grow very slowly and affected men may die of other causes before prostate cancer becomes symptomatic. Despite available clinical risk stratification methods, there often remains uncertainty regarding the optimal management of individual patients with localized prostate cancer. Tumor tissue present in a needle biopsy specimen may not accurately represent the entire tumor, resulting in possible overestimation or underestimation of risk for disease progression. Desire for increased precision in diagnosis and management recommendations has led to a search for biomarkers that allow a more personalized approach to management and treatment. The Oncotype DX Genomic Prostate Score (GPS) assay is a tumor gene expression profile test developed to help make treatment decisions at the time of prostate cancer diagnosis. This report examines the published evidence regarding the Oncotype DX Genomic Prostate Score (GPS) assay.