Performance Analysis of Leica Biosystems Monoclonal Antibody Programmed Cell Death Ligand 1 Clone 73-10 on Breast, Colorectal, and Hepatocellular Carcinomas.

IF 1.3 4区 医学 Q3 ANATOMY & MORPHOLOGY
Konstantin Shilo, Tiansheng Shen, Scott Hammond, Anil V Parwani, Zaibo Li, Shubham Dayal, Joseph Chiweshe, Fangru Lian
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引用次数: 0

Abstract

Programmed cell death receptor 1/Programmed cell death ligand 1 (PD-L1) checkpoint pathway is responsible for the control of immune cell responses. Immunotherapy using checkpoint inhibitors, such as anti-PD-L1 therapy, aids disease management and potentiates clinical outcomes. This study aimed to analyze the performance of the Leica Biosystems (LBS) USA FDA class I in vitro diagnostic monoclonal antibody (clone 73-10) to detect PD-L1 expression in breast, colorectal, and hepatocellular carcinomas compared with the class III FDA-approved PD-L1 detecting antibodies [SP263 (Ventana), 22C3 (Dako), and 28-8 (Dako)] using 208 unique tissue microarray-based cases for each tumor type. The interassay concordances between LBS 73-10 clone and other PD-L1 antibodies ranged from 0.59 to 0.95 Cohen kappa coefficient (K) and from 0.66 to 0.90 (K) for cutoff values of 1% and 50% tumor proportion score (TPS), respectively. The 73-10 clones showed inter-pathologist agreements ranging from 0.53 to 1.0 (K) and 0.34 to 0.94 (K) for cutoff values of 1% and 50% TPS, respectively. For the immune cell proportion score (IPS) using a cutoff of 1%, the Kappa coefficient of interassay concordances and inter-pathologist agreements ranged from 0.34 to 0.94. The 73-10 clone assay's sensitivity ranged from 78.3% to 100% (TPS ≥1%), 100% (TPS ≥50%), and 77.4% to 93.5% (IPS ≥1%), while its specificity was 97.9% to 100% (TPS ≥1%), 99.5% to 99.8% (TPS ≥50%), and 97.9% to 100% (IPS ≥1%). This exploratory evaluation of LBS 73-10 monoclonal antibody on a large set of breast, colorectal, and hepatocellular carcinomas showed the assay's technical performance is comparable to the FDA-approved companion/complementary diagnostics PD-L1 detection assays.

Leica Biosystems 单克隆抗体程序性细胞死亡配体 1 克隆 73-10 在乳腺癌、结直肠癌和肝细胞癌上的性能分析。
程序性细胞死亡受体1/程序性细胞死亡配体1(PD-L1)检查点通路负责控制免疫细胞反应。使用检查点抑制剂(如抗PD-L1疗法)的免疫疗法有助于疾病管理和提高临床疗效。本研究旨在分析徕卡生物系统公司(LBS)的美国 FDA I 类体外诊断单克隆抗体(克隆 73-10)与 FDA 批准的 III 类 PD-L1 检测抗体[SP263(Ventana)、22C3(Dako)和 28-8(Dako)]在检测乳腺癌、结直肠癌和肝细胞癌中的 PD-L1 表达方面的性能比较。LBS 73-10 克隆与其他 PD-L1 抗体的测定间一致性为 0.59 至 0.95 Cohen kappa coefficient (K),截断值为 1%和 50%的肿瘤比例评分(TPS)分别为 0.66 至 0.90 (K)。73-10克隆的病理学家之间的一致性在1%和50% TPS的临界值上分别为0.53至1.0(K)和0.34至0.94(K)。免疫细胞比例评分(IPS)的临界值为 1%,测定间一致性和病理学家间一致性的 Kappa 系数范围为 0.34 至 0.94。73-10 克隆测定的灵敏度为 78.3%至 100%(TPS ≥1%)、100%(TPS ≥50%)和 77.4%至 93.5%(IPS ≥1%),特异性为 97.9%至 100%(TPS ≥1%)、99.5%至 99.8%(TPS ≥50%)和 97.9%至 100%(IPS ≥1%)。LBS 73-10单克隆抗体对大量乳腺癌、结直肠癌和肝细胞癌的探索性评估表明,该检测方法的技术性能与FDA批准的辅助/补充诊断PD-L1检测方法相当。
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来源期刊
Applied Immunohistochemistry & Molecular Morphology
Applied Immunohistochemistry & Molecular Morphology ANATOMY & MORPHOLOGY-MEDICAL LABORATORY TECHNOLOGY
CiteScore
3.20
自引率
0.00%
发文量
153
期刊介绍: ​Applied Immunohistochemistry & Molecular Morphology covers newly developed identification and detection technologies, and their applications in research and diagnosis for the applied immunohistochemist & molecular Morphologist. Official Journal of the International Society for Immunohistochemisty and Molecular Morphology​.
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