e t a l . P D - L 1 immunohistochemistry assays for lung cancer: results from phase 1 of the blueprint PD-L1 IHC assay comparison project. J Thorac Oncol, 2017, 12(2): 208-222. doi: 10.1016/j.jtho.2016.11.2...
安捷伦公司为帕博利珠单抗量身定制的 PD-L1 伴随诊断PD-L1 IHC 22C3 pharmDx 率先获批,因此TPS被推广认可。然而后期进入 PD-L1 检测的其他试剂和平台为了防止知识产权纠纷选用 TC 作为指标名称,比如 FDA 批准VENTANAPD-L1(SP142) assay用于阿替利珠单抗伴随/补充诊断,获批的阈值为TC ≥ 50% 或 IC ≥ 10%。
其中,IASLC PD-L1 IHC Blueprint (BP)一期和二期研究证实PD-L1(SP263)和PD-L1(22C3)、PD-L1(28-8)检测体系在评估肿瘤细胞(Tumor Cell, TC)染色性能方面整体一致性很高[27][28]。另外一项AstraZeneca一致性评价研究中,在多种临床诊治决策PD-L1...
[6] Hirsch FR, McElhinny A, Stanforth D, et al. PD-L1 Immunohistochemistry Assays for Lung Cancer: Results from Phase 1 of the Blueprint PD-L1 IHC Assay Comparison Project. J Thorac Oncol. 2017;12(2):208-222. doi:10.1016/j.jtho.2016.11.2228 [7] Tsao MS, Kerr KM, Kockx M, et...
9 H i r s c h F R , Mc e l h i n n y A , S t a n f o r t h D, e t a l . P D - L 1 immunohistochemistry assays for lung cancer: results from phase 1 of the blueprint PD-L1 IHC assay comparison project. J Thorac Oncol, 2017, 12(2): 208-222. doi: 10.1016...
(ateolizumab)伴随诊断免疫组化检测试剂为VENTANA PD-L1 (SP142) Assay,应用兔单抗SP142和OptiView DAB IHC检测试剂盒,在VENTANA BenchMark ULTRA染色平台对尿路上皮癌的石蜡切片进行PD-L1表达的分析。PD-L1表达状况定义为任何强度PD-L1+的浸润免疫细胞(IC)所占据的肿瘤细胞面积的百分比,肿瘤细胞上的PD-L1表达不...
抗PD-L1抗体检测试剂(免疫组织化学法)属于PD-L1 IHC检测,英文名称:VENTANA PD-L1 (SP263) Assay,文献或会议报道中常简称PD-L1 (SP263) 或SP263,临床中主要用于免疫治疗最具代表的PD-1/PD-L1免疫检查点抑制剂相关适应症治疗决策时疗效预测,是现阶段临床实践中经试验验证、法规审批的疗效预测标志物之一[2][4...
PD-1/PD-L1信号通路能诱导与维持外周T细胞的耐受,是肿瘤免疫逃避的关键分子机制,导致肿瘤发生发展。PD-L1检测方法包括免疫组织化学技术(immunohistochemistry, IHC)、酶联免疫吸附测定(enzyme-linked immunosorbent assay, ELISA)、定量免疫荧光(immunofluorescence, IF)和流式细胞术(flow cytometry, FC)等多种,其中IHC以...
We agree with the authors in that the development of unique PD-L1 IHC assay for each available anti-PD-L1/anti PD-1 agent has made it very complex for laboratories to be able to implement and offer these tests. This article is protected by copyright. All rights reserved....
下面的讨论描述了这些测定之一[VENTANA PD-L1 (SP263) Assay]的开发;该测定被FDA批准作为PD-L1靶向药杜伐单抗用于治疗局部晚期或转移性UCC患者的补充诊断。 开发PD-L1作为癌症生物标志物的测定的主要挑战来自于这样一个事实,即PD-L1的表达不仅可以在肿瘤细胞中出现,也可以在TAICs中出现。