Table 1 Comparison of PD-L1 assays

VENTANA PD-L1 (SP263) Assay [5, 6]

FDA and CE-IVD approved for UC and CE-IVD approved for NSCLC

NSCLC

UC

Durvalumab: TC ≥ 1% post chemoradiation therapy

Pembrolizumab: TC ≥ 50% in first line; TC ≥ 1% in second line

Nivolumab: TC ≥ 1%,≥5%, and≥10% in second line

Durvalumab: TC ≥ 25%; or ICP > 1% and IC ≥ 25%; or ICP = 1% and IC = 100% in second line

VENTANA PD-L1 (SP142) Assay [7, 8]

FDA and CE-IVD approved

NSCLC

UC

Atezolizumab: TC ≥ 50% or IC ≥ 10%

Atezolizumab: IC ≥ 5%

Dako PD-L1 IHC 28-8 pharmDx [9, 10]

FDA and CE-IVD approved

NSCLC

UC

HNSCC

Melanoma

Nivolumab: TPS ≥ 1%, ≥5%, ≥10%

Nivolumab: TPS ≥ 1%

Nivolumab: TPS ≥ 1%

Nivolumab: TPS ≥ 1%

Dako PD-L1 IHC 22C3 pharmDx [11, 12]

FDA approved for NSCLC, gastric adenocarcinoma, UC, and cervical cancer

CE-IVD approved for melanoma, NSCLC, and UC

NSCLC

UC

Gastric adenocarcinoma

Cervical carcinoma

Pembrolizumab: TPS ≥ 1% or TPS ≥ 50%

Pembrolizumab: CPS ≥ 10

Pembrolizumab: CPS ≥ 1

Pembrolizumab: CPS ≥ 1