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  • "Interchangeability" of PD-...
    Torlakovic, Emina; Lim, Hyun J; Adam, Julien; Barnes, Penny; Bigras, Gilbert; Chan, Anthony W H; 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

    Modern pathology, 01/2020, Volume: 33, Issue: 1
    Journal Article

    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.