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Accurate PD-L1 Protocols for Non–Small Cell Lung Cancer can be Developed for Automated Staining Platforms With Clone 22C3

Røge, Rasmus MD*,†; Vyberg, Mogens MD*,†; Nielsen, Søren HT*

Applied Immunohistochemistry & Molecular Morphology: July 2017 - Volume 25 - Issue 6 - p 381–385
doi: 10.1097/PAI.0000000000000534
Technical Articles

Treatment using immunotherapy against PD-L1 or PD-1 has become one of the hottest topics in Pathology and Oncology. Correct selection of patients eligible for treatment requires optimal immunohistochemical staining protocols. Treatment with pembrolizumab requires diagnostic examination of the patient's tumour using the companion diagnostic Ready-To-Use pharmDx kit from Dako Agilent based on the mAb 22C3 clone on the Autostainer platform. However, not all diagnostic pathology labs have access to this staining platform. This purpose of this study was to develop and validate protocols for PD-L1 detection for all major staining platforms using the concentrated format of 22C3 that would give similar staining result (equal Tumour Proportion Scores) to the pharmDx kit.

*Institute of Pathology, Aalborg University Hospital

Department of Clinical Medicine, Aalborg University, Aalborg Denmark

The authors declare no conflict of interest.

Reprints: Rasmus Røge, MD, Institute of Pathology, Aalborg University Hospital, Ladegaardsgade 3, 9000 Aalborg, Denmark (e-mail:

Received March 30, 2017

Accepted April 5, 2017

Copyright 2017 Wolters Kluwer Health, Inc. All rights reserved.