"Interchangeability" of PD-L1 immunohistochemistry assays: a meta-analysis of diagnostic accuracy.

"Interchangeability" of PD-L1 immunohistochemistry assays: a meta-analysis of diagnostic accuracy.

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 : an official journal of the united states and canadian academy of pathology, inc 2019
353
torlakovic2019interchangeabilitymodern

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.

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