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Which test

Multiple PD-L1 IHC diagnostic tests are approved or in development with individual PD-1/PD-L1 therapies

  • It is vital to be able to compare the analytical performance of PD-L1 diagnostic assays to allow appropriate interpretation of their predictive value with respect to clinical outcomes1
  • A number of initiatives have been completed, or are ongoing to understand concordance/compatibility between PD-L1 tests via independent review1–5

Blueprint initiative: a cross-industry initiative to determine the analytic similarities across PD-L1 diagnostic assays in development, with an initial focus on NSCLC2

GoalTo help the clinical and testing community understand the comparative analytical performance of each PD-L1 assay that is under development and exists as an IUO grade assay (28-8, 22C3, SP263, SP142)

MembersAstraZeneca, Bristol-Myers Squibb, Merck, Roche, Dako, Ventana

Phase 1Feasibility phase, N=39 samples, stained and read by the diagnostic manufacturers’ pathologists

Phase 2Planned

  • Recent data from compatibility studies in NSCLC2,3 and HNSCC1 tumour samples suggest that Dako 22C3, Dako 28-8 and Ventana SP263 could potentially be used interchangeably to determine PD-L1 expression levels in tumour cells and immune cells
  • Assay compatibility studies in urothelial bladder cancer are ongoing

IHC, immunohistochemistry; IUO, investigational use only; NSCLC, non-small cell lung cancer; HNSCC, head and neck squamous cell carcinoma; PD-1, programmed cell death-1; PD-L1, programmed cell death ligand-1


  1. Ratcliffe MJ, et al. Poster presented at ESMO 2016 (955PD)
  2. Hirsch FR, et al. J Thorac Oncol 2017;12:208-22
  3. Ratcliffe, MJ, et al. Clin Cancer Res 2017; doi: 10.1158/1078-0432.CCR-16-2375
  4. Scheel A, et al. Mod Pathol 2016;29:1165–72
  5. Rimm DL, et al. Oral presentation at IASLC 2016