Journal Article

“Interchangeability” of PD-L1 immunohistochemistry assays: a meta-analysis of diagnostic accuracy

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

2020

Overview

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.

• Publisher: Nature Publishing Group US,Elsevier Limited
• Subject: 13/51 / 631/1647/664/1257 / 631/67/1612/1350 / 692/53/2423 / Accuracy / B7-H1 Antigen - analysis / FDA approval / Food / Humans / Immunohistochemistry / Immunohistochemistry - methods / Immunohistochemistry - standards / Immunotherapy / Laboratory Medicine / Medical diagnosis / Medicine / Medicine & Public Health / Meta-analysis / Pathology / PD-L1 protein / Review / Review Article / Reviews / Testing laboratories