Table 2.

Summary of the associated scoring algorithms’ cutoffs and detection platforms for the approved companion diagnostic PD-L1 tests

Antibody (clone)	Scoring algorithms’ cutoff (tumor type)	Detection system/platform
Ventana PD-L1 SP142 Assay	≥5% IC (UC) ≥1% IC (TNBC) ≥50% TC or ≥10% IC (NSCLC)	OptiView Detection and Amplification Benchmark ULTRA
Dako PD-L1 IHC 28-8 pharmDx Assay	≥1% TC (NSCLC)	EnVision Flex-Autostainer Link 48
Dako PD-L1 IHC 22C3 pharmDx Assay	TPS ≥ 1% (NSCLC) CPS ≥ 10 (UC) CPS ≥ 1 (Gastric/GEJ carcinoma) CPS ≥ 1 (cervical carcinoma) CPS ≥ 10 (ESCC) CPS ≥ 1 (HNSCC) CPS ≥ 10 (TNBC)	EnVision Flex-Autostainer Link 48

UC: Urothelial carcinoma; TNBC: Triple-negative breast carcinoma; NSCLC: Non-small cell lung carcinoma; ESCC: Esophageal squamous cell carcinoma; HNSCC: Head and neck squamous cell carcinoma; GEJ: Gastroesophageal junction carcinoma; PD-L1: Programmed cell death ligand 1; IC: Immune cells; TC: Tumor cells.