CD274 and urothelial carcinoma: With respect to analytical validity, remarks are included in the EPARs indicating that, at a certain point during assessment, discussion on the CDx had taken place: “The immuno-assays for quantification of durvalumab and soluble PD-L1 in human serum samples were adequately validated” (11), “The VENTANA PD-L1 (SP142) immunohistochemistry assay was not validated for intended use to measure PD-L1 expression on tumor cells in urothelial carcinoma.” (12), and “The validation report and addendums regarding peripheral blood specimens and inter-laboratory qualification were provided” (13).