DevicePMAs@therightstef:P150013_S001 JSONTXT 11 Projects

Approval for PD-L1 IHC 22C3 pharmDx is a qualitative immunohistochemical assay using Monoclonal Mouse Anti-PD-L1, Clone 22C3 intended for use in the detection of PD-L1 protein in formalin-fixed, paraffin-embedded (FFPE) non-small cell lung cancer (NSCLC) tissue using EnVision FLEX visualization system on Autostainer Link 48. PD-L1 protein expression is determined by using Tumor Proportion Score (TPS), which is the percentage of viable tumor cells showing partial or complete membrane staining at any intensity. The specimen should be considered to have PD-L1 expression if TPS greater than or equal to 1% and high PD-L1 expression if TPS is greater than or equal to 50%. PD-L1 IHC 22C3 pharmDx is indicated as an aid in identifying NSCLC patients for treatment with KEYTRUDA (pembrolizumab). See the KEYTRUDA product label for expression cutoff values guiding therapy in specific clinical circumstances. This device is for in vitro diagnostic use.