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Summary
Tests based on DNA sequencing methods are redefining diagnostic categories in oncology and providing a rational basis for the development and use of new cancer therapies, especially the many drugs targeted against mutant proteins that drive malignant growth (1). The medical and economic value of identifying specific genetic abnormalities in cancers has been established by the evidence-based use of targeted drugs and immunotherapies in cancer patients (see the figure for an example). For some cancer therapies, the U.S. Food and Drug Administration (FDA)–approved label calls for the use of a companion diagnostic test for the presence or absence of certain genetic changes before initiating treatment. Most recently, the FDA approved the use of the immunotherapeutic pembrolizumab for treatment of tumors that show a defect in DNA repair called microsatellite instability, irrespective of the tissue of origin; although an FDA-approved test for microsatellite instability is not yet available, many clinical laboratories are using assays for the relevant biomarkers (2).
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