Table 6 Data on intra-block and intra-case concordance in PD-L1 classification, from publicly available FDA documentsa
Assay | TC PD-L1 staining % OPA (% cut-off) | IC PD-L1 staining % OPA (% cut-off) | TC or IC PD-L1 staining % OPA (% cut-off) | n |
|---|---|---|---|---|
Intra-block concordance in PD-L1 classification | ||||
 Dako 22C3 | ||||
  NSCLC [24] | 100% (≥50%) | – | – | 20 |
  Dako 28–8 [25] | – | – | – |  |
 VENTANA SP142 | ||||
  NSCLC [26] | – | – | 96% (≥50% TC or ≥ 10% IC) | 24 |
  UC [27] | – | 100% (≥5%) | – | 8 |
Intra-case concordance in PD-L1 classification | ||||
 Dako 22C3 | ||||
  NSCLC [24] | 100% (≥50%) | – | – | 20 |
 Dako 28–8 | ||||
  NSCLC [25] | 94% (≥1%; ≥5%; ≥10%) | – | – | 16 |
 VENTANA SP142 | ||||
  NSCLC [26] | – | – | 81% (≥50% TC or ≥ 10% IC) | 27 |
  UC [27] | – | 91% (≥5%) | – | 22 |