ArticleJournal of clinical pathology2020
Analysis of real-world PD-L1 IHC 28-8 and 22C3 pharmDx assay utilisation, turnaround times and analytical concordance across multiple tumour types.
Article in Journal of clinical pathology, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 29 papers, 2 of them syntheses that pooled it.
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Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
29 citing papers in PubMed, 2 syntheses or guidelines pooled it, 51 citations in OpenAlex.
- Society for Immunotherapy of Cancer (SITC) clinical practice guideline on immunotherapy for the treatment of gynecologic cancer.Journal for immunotherapy of cancer · 2023Guideline
- Analytical Concordance of PD-L1 Assays Utilizing Antibodies From FDA-Approved Diagnostics in Advanced Cancers: A Systematic Literature Review.JCO precision oncology · 2021Pooled it
- Cabozantinib plus Nivolumab and Ipilimumab in Renal-Cell Carcinoma.The New England journal of medicine · 2023Trial
- Nivolumab plus Cabozantinib versus Sunitinib for Advanced Renal-Cell Carcinoma.The New England journal of medicine · 2021Trial
- Post‑translational modification‑governed immune states in cancer immunity: Biomarker implications for checkpoint competence, tumor visibility and immunotherapy resistance (Review).International journal of oncology · 2026Review
- Clinical Interchangeability of 22C3 and 28 - 8 PD-L1 assays for patient selection in esophageal squamous cell carcinoma.Virchows Archiv : an international journal of pathology · 2026Article
- QVT score, a radiomic biomarker of vascular complexity, enables prognostication and monitoring of NSCLC immunotherapy.Journal for immunotherapy of cancer · 2026Article
- The importance of specificity of drug treatment in head and neck cancer: current developments in personalized medicine to improve safety and tolerability.Expert review of clinical pharmacology · 2025Review
- Integrating COX-2, stromal PD-L1, and T-cell infiltration enhances prognostic stratification in colorectal cancer.BMC cancer · 2025Article
- [Histological diagnosis of squamous cell carcinomas of oral cavity and pharynx origin - prognostic and predictive factors].Magyar onkologia · 2025Review
- Augmented reality microscopy to bridge trust between AI and pathologists.NPJ precision oncology · 2025Article
- Assessing the genomic feature of Chinese patients with ampullary adenocarcinoma: potential therapeutic targets.BMC cancer · 2024Article
- Refining PD-1/PD-L1 assessment for biomarker-guided immunotherapy: A review.Biomolecules & biomedicine · 2024Review
- The impact of combined PD-L1 positive score on clinical response to nivolumab in patients with advanced esophageal squamous cell carcinoma.Esophagus : official journal of the Japan Esophageal Society · 2023Article
- Comparison of clinicopathological and genomic profiles in anal squamous cell carcinoma between Japanese and Caucasian cohorts.Scientific reports · 2023Article
- Expression of PD-L1 through evolution phase from pre-invasive to invasive lung adenocarcinoma.BMC pulmonary medicine · 2023Article
- Novel quantitative immunohistochemical analysis for evaluating PD-L1 expression with phosphor-integrated dots for predicting the efficacy of patients with cancer treated with immune checkpoint inhibitors.Frontiers in immunology · 2023Article
- PD-1T TILs as a Predictive Biomarker for Clinical Benefit to PD-1 Blockade in Patients with Advanced NSCLC.Clinical cancer research : an official journal of the American Association for Cancer Research · 2022Article
- Comparison of PD-L1 tumor cell expression with 22C3, 28-8, and SP142 IHC assays across multiple tumor types.Journal for immunotherapy of cancer · 2022Article
- Immuno-oncology trends: preclinical models, biomarkers, and clinical development.Journal for immunotherapy of cancer · 2022Review
Corrections and comments
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Authors and funding
7 authors at 2 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
aimsProgrammed death-1/programmed death ligand 1 (PD-1/PD-L1) inhibitor therapy is accompanied by companion or complementary PD-L1 testing in some tumour types. We investigated utilisation of the Dako PD-L1 IHC 28-8 and 22C3 pharmDx assays and the Ventana PD-L1 (SP142) assay and evaluated concordance between the 28-8 and 22C3 assays in a real-world cohort of patients tested at a single US national reference laboratory.
methodsNeoGenomics Laboratories performed PD-L1 testing on tumour samples between October 2015 and March 2018. PD-L1 test results were matched with patient characteristics using unique identifiers. Concordance between the 28-8 and 22C3 assays was evaluated in matched tumour samples. Data were evaluated across multiple tumour types and in subgroups of patients with lung cancer, melanoma, squamous cell carcinoma of the head and neck, and urothelial carcinoma.
results62 180 individual PD-L1 tests were conducted on samples from 55 652 patients. PD-L1 test volume increased ~10-fold over the period evaluated. Test failure rates were typically low, and test turnaround time (TAT) ranged between 2 and 4 days. Concordance between the 28-8 and 22C3 assays was strong in the overall population and across tumour type subgroups (Kendall's tau correlations of 0.94 and 0.92-0.98, respectively).
conclusionsTest failure rates for PD-L1 tests were low and TAT remained reasonable despite marked increases in test volume. Concordance was high between the 28-8 and 22C3 assays across a range of tumour types and biopsy locations. These findings add to the literature showing high concordance between the 28-8 and 22C3 assays.
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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.