Molecular diagnostics and cytopathology ideally are complementary medical services. When used together, they provide optimal benefit to patient care with the least risk of complications. However, many cytopathology laboratories are reluctant to bring in molecular tests, in part due to inexperience with regard to molecular test validation. This article is a brief review of the basic principles of molecular test validation as it applies to cytopathology samples. Regulatory constraints, practical considerations, and issues that are particular to cytopathology samples are discussed, along with a brief review of issues that pertain specifically to next-generation sequencing. This review should serve as a general guide to validating molecular tests in the cytopathology laboratory. Cancer Cytopathol 2017;125(6 suppl):465-9. © 2017 American Cancer Society.
Keywords: cytopathology; molecular diagnostics; next-generation sequencing; validation.
© 2017 American Cancer Society.