Data sharing and evaluation.

Abstract

Interinstitutional evaluations of molecular markers for the diagnosis and staging of cancer are highly dependent on strict standardization of assays to make clinical comparisons valid. New assays for cancer markers depend on discoveries of biochemical or cellular functions coupled with technologies suitable for making relevant measurements. Transfer of these technologies from the research laboratory to the diagnostic laboratory requires method validation that consists of specific information regarding assay principle, reagents, calibration, sensitivity, assay behavior, specimen requirements, clinical and method correlations, reference range, quality control, proficiency testing, critical steps, and guidelines for interpretation. Fulfillment of all the components of method validation will guarantee the fastest and most accurate implementation of new diagnostic assays in clinical studies and practice.