“Interchangeability” of PD-L1 immunohistochemistry assays: a meta-analysis of diagnostic accuracy Academic Article uri icon

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abstract

  • Different clones, protocol conditions, instruments, and scoring/readout methods may pose challenges in introducing different PD-L1 assays for immunotherapy. The diagnostic accuracy of using different PD-L1 assays interchangeably for various purposes is unknown. The primary objective of this meta-analysis was to address PD-L1 assay interchangeability based on assay diagnostic accuracy for established clinical uses/purposes. A systematic search of the MEDLINE database using PubMed platform was conducted using "PD-L1" as a search term for 01/01/2015 to 31/08/2018, with limitations "English" and "human". 2,515 abstracts were reviewed to select for original contributions only. 57 studies on comparison of two or more PD-L1 assays were fully reviewed. 22 publications were selected for meta-analysis. Additional data were requested from authors of 20/22 studies in order to enable the meta-analysis. Modified GRADE and QUADAS-2 criteria were used for grading published evidence and designing data abstraction templates for extraction by reviewers. PRISMA was used to guide reporting of systematic review and meta-analysis and STARD 2015 for reporting diagnostic accuracy study. CLSI EP12-A2 was used to guide test comparisons. Data were pooled using random-effects model. The main outcome measure was diagnostic accuracy of various PD-L1 assays. The 22 included studies provided 376 2×2 contingency tables for analyses. Results of our study suggest that, when the testing laboratory is not able to use an Food and Drug Administration-approved companion diagnostic(s) for PD-L1 assessment for its specific clinical purpose(s), it is better to develop a properly validated laboratory developed test for the same purpose(s) as the original PD-L1 Food and Drug Administration-approved immunohistochemistry companion diagnostic, than to replace the original PD-L1 Food and Drug Administration-approved immunohistochemistry companion diagnostic with a another PD-L1 Food and Drug Administration-approved companion diagnostic that was developed for a different purpose.

authors

  • Torlakovic, Emina
  • Lim, Hyun J
  • Adam, Julien
  • Barnes, Penny
  • Bigras, Gilbert
  • Chan, Anthony WH
  • Cheung, Carol C
  • Chung, Jin-Haeng
  • Couture, Christian
  • Fiset, Pierre O
  • Fujimoto, Daichi
  • Han, Gang
  • Hirsch, Fred R
  • Ilie, Marius
  • Ionescu, Diana
  • Li, Chao
  • Munari, Enrico
  • Okuda, Katsuhiro
  • Ratcliffe, Marianne J
  • Rimm, David L
  • Ross, Catherine
  • Røge, Rasmus
  • Scheel, Andreas H
  • Soo, Ross A
  • Swanson, Paul E
  • Tretiakova, Maria
  • To, Ka F
  • Vainer, Gilad W
  • Wang, Hangjun
  • Xu, Zhaolin
  • Zielinski, Dirk
  • Tsao, Ming-Sound

publication date

  • January 2020