Breast Cancer Expression Signature in Localized Prostate Cancer

Biomarkers are developed for specific contexts of use following a defined paradigm that requires an analytically-valid assay and a sequence of clinical studies whose objective is to prove clinical utility: that patient outcomes are improved through the use of the biomarker test relative to nonuse. In this issue, Zhao et al follow this paradigm by applying a US Food and Drug Administration-cleared and Conformité Européene-marked gene–expression-based classifier derived from breast cancer, called PAM50, to potential use as a predictive biomarker in localized prostate cancer.

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