Tumor Indication* Intended Use PD-L1 Expression Clinical Cut off
nsNSCLC PD-L1 expression as detected by PD-L1 IHC 28-8 pharmDx in non-squamous NSCLC and SCCHN may be associated with enhanced survival from OPDIVO® (nivolumab). ≥1%, ≥5%, ≥10%
SCCHN ≥1%
UC PD-L1 expression as detected by PD-L1 IHC 28-8 pharmDx in UC may be associated with enhanced response rate from OPDIVO®. ≥1%
Melanoma Positive PD-L1 status as determined by PD-L1 IHC 28-8 pharmDx in melanoma is correlated with the magnitude of the treatment effect on progression-free survival from OPDIVO®. ≥1%

*For details on staining interpretation, refer to section 13 of the product insert and indication specific PD-L1 IHC 28-8 pharmDx Interpretation Manuals.