Ki-67 Remains Solely a Prognostic Biomarker in Localized Prostate Cancer

The pursuit of personalized medicine has led to a surge in the development and approval of molecular diagnostic tests, with now >40 approved in the United States. These tests can generally be classified into 3 categories of biomarkers: diagnostic, prognostic, and predictive. Diagnostic biomarkers include those that assess an analyte (eg, DNA, RNA, or protein) that defines a diagnostic entity. For example, the ResponseDx Tissue of Origin test is a gene expression classifier that is used to identify the primary tumor type for tumors of unknown primary (1).

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