Precision medicine and testing for tumor biomarkers—are all tests born equal?
Ce dossier présente deux articles, l'un évaluant la fiabilité et l'utilité, dans la prise en charge thérapeutique de patients atteints d'un cancer métastatique de la prostate, de deux tests commerciaux basés sur l'analyse de l'ADN libre à partir de biopsies liquides, l'autre comparant la performance, pour détecter des mutations des gènes BRAF, EGFR ou KRAS, de deux catégories de tests compagnons : ceux homologués par la "Food and Drug Administration" et ceux non homologués
Two semantic terms have been accepted as requisites for adoption of a tumor biomarker test into clinical care: analytical validity and clinical utility.1,2 Analytical validity entails preanalytic and analytic issues related to the test: is it accurate, reliable, and reproducible ? Clinical utility implies that high levels of evidence exist to support the claim that use of the tumor biomarker test produces better outcomes for the patient than if it were not available. One cannot have clinical utility without high analytical validity, but analytical validity alone is insufficient to introduce the test into routine practice.
JAMA Oncology , éditorial, 2016