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Indirect Clinical Validation of a Programmed Death-Ligand 1 Laboratory-Developed Test for Gastric/Gastroesophageal Junction Adenocarcinoma with 22C3 Antibody Concentrate
DC Field | Value | Language |
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dc.contributor.author | Kim, Ji Min | - |
dc.contributor.author | Kim, Binnari | - |
dc.contributor.author | Kim, Eunji | - |
dc.contributor.author | Jang, Minsun | - |
dc.contributor.author | Cho, Jun Hun | - |
dc.contributor.author | Lee, Hye Seung | - |
dc.contributor.author | Kwak, Yoonjin | - |
dc.contributor.author | Huang, Lingkang | - |
dc.contributor.author | Krishnan, Radha | - |
dc.contributor.author | Bai, Sally Y. | - |
dc.contributor.author | Mounawar, Mounia | - |
dc.contributor.author | Kim, Kyoung-Mee | - |
dc.date.accessioned | 2023-01-09T00:24:57Z | - |
dc.date.available | 2023-01-09T00:24:57Z | - |
dc.date.created | 2022-11-08 | - |
dc.date.issued | 2022-11 | - |
dc.identifier.citation | Molecular Diagnosis and Therapy, Vol.26 No.6, pp.679-688 | - |
dc.identifier.issn | 1177-1062 | - |
dc.identifier.uri | https://hdl.handle.net/10371/188896 | - |
dc.description.abstract | Background The PD-L1 IHC 22C3 pharmDx used on the Dako Autostainer Link 48 (ASL48) staining platform is an established method for assessing programmed death-ligand 1 (PD-L1) expression in tumor tissue and determining patient eligibility for pembrolizumab treatment; however, the availability of this platform is limited in Europe and Asia. Objectives The aims of this study were to develop and optimize protocols for the PD-L1 22C3 antibody concentrate with multiple immunohistochemistry staining platforms and to validate these protocols using PD-L1 combined positive score (CPS) with a cut-off of >= 1 in gastric or gastroesophageal junction adenocarcinoma. Design The 22C3 antibody concentrate was tested and optimized protocols were developed for use with three staining platforms: Dako ASL48, Ventana BenchMark ULTRA, and Leica BOND-MAX. Tumor specimens (N = 120) from patients with gastric or gastroesophageal junction adenocarcinoma were used for the validation study; these specimens were evaluated independently by three pathologists for PD-L1 CPS as a continuous variable and using a cut-off of >= 1. PD-L1 IHC 22C3 pharmDx used on the Dako ASL48 platform served as the reference or gold standard. Results The intraclass correlation coefficient of CPS as a continuous variable between the gold standard and each staining platform assessed was 0.910-0.989. When CPS was dichotomized based on a cut-off of >= 1, depending on the pathologist and the platform used, positive percentage agreement was 81-99% and negative percentage agreement was 90-100%. Interobserver agreement using the gold standard showed substantial agreement (kappa = 0.779). Conclusion The PD-L1 22C3 antibody concentrate can potentially be used with the laboratory-developed test on three commercially available immunohistochemistry staining platforms to determine PD-L1 expression in tumor samples from patients with gastric or gastroesophageal junction adenocarcinoma. | - |
dc.language | 영어 | - |
dc.publisher | Adis International Ltd. | - |
dc.title | Indirect Clinical Validation of a Programmed Death-Ligand 1 Laboratory-Developed Test for Gastric/Gastroesophageal Junction Adenocarcinoma with 22C3 Antibody Concentrate | - |
dc.type | Article | - |
dc.identifier.doi | 10.1007/s40291-022-00605-2 | - |
dc.citation.journaltitle | Molecular Diagnosis and Therapy | - |
dc.identifier.wosid | 000859530300001 | - |
dc.identifier.scopusid | 2-s2.0-85138336983 | - |
dc.citation.endpage | 688 | - |
dc.citation.number | 6 | - |
dc.citation.startpage | 679 | - |
dc.citation.volume | 26 | - |
dc.description.isOpenAccess | N | - |
dc.contributor.affiliatedAuthor | Lee, Hye Seung | - |
dc.contributor.affiliatedAuthor | Kwak, Yoonjin | - |
dc.type.docType | Article | - |
dc.description.journalClass | 1 | - |
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