Companion diagnostic requirements for spatial biology using multiplex immunofluorescence and multispectral imaging.
Companion diagnostic requirements for spatial biology using multiplex immunofluorescence and multispectral imaging.
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DOI：
10.3389/fmolb.2023.1051491
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发表时间：
2023
影响因子：
5
通讯作者：
中科院分区：
文献类型：
--
作者：
免疫组织化学长期以来一直被认为是了解治疗相关蛋白质表达模式以鉴定预后和预测生物标志物的金标准。肿瘤靶向治疗的患者选择成功地依赖于标准的显微镜为基础的方法，如单标记明视野显色免疫组化。尽管这些结果很有希望，但除了少数例外，对一种蛋白质的分析不再提供足够的信息来得出关于治疗反应概率的有效结论。更多方面的科学查询推动了高通量和高阶技术的发展，以询问肿瘤微环境中生物标志物表达模式和细胞表型之间的空间相互作用。这种多参数数据分析在历史上一直保留给缺乏免疫组织化学提供的空间背景的技术。在过去的十年中，多重荧光免疫组织化学的技术发展和改进图像数据分析平台的发现突出了某些生物标志物之间的空间关系在理解患者对免疫检查点抑制剂（通常）反应的可能性方面的重要性。与此同时，个性化医疗也促使临床试验设计及其实施发生了变化，从而使药物开发和癌症治疗更加有效、精确和经济。免疫肿瘤学中的精准医学正受到数据驱动方法的指导，以深入了解肿瘤及其与免疫系统的动态相互作用。考虑到涉及一种以上免疫检查点药物和/或将其与常规癌症治疗结合使用的试验数量的快速增长，这一点尤其必要。由于多重方法（如免疫荧光）突破了免疫组织化学的界限，因此了解该技术的基础以及如何将其用作受监管的检测以确定单药和联合治疗的反应前景变得至关重要。为此，这项工作将侧重于：1）开发临床多重免疫荧光检测的科学、临床和经济要求; 2）Akoya Phenoptics工作流程支持预测性检测的属性，包括设计原则、验证和确认需求; 3）监管、安全和质量考虑因素; 4）通过实验室开发的测试和规范的体外诊断装置应用多重免疫组织化学。
Immunohistochemistry has long been held as the gold standard for understanding the expression patterns of therapeutically relevant proteins to identify prognostic and predictive biomarkers. Patient selection for targeted therapy in oncology has successfully relied upon standard microscopy-based methodologies, such as single-marker brightfield chromogenic immunohistochemistry. As promising as these results are, the analysis of one protein, with few exceptions, no longer provides enough information to draw effective conclusions about the probability of treatment response. More multifaceted scientific queries have driven the development of high-throughput and high-order technologies to interrogate biomarker expression patterns and spatial interactions between cell phenotypes in the tumor microenvironment. Such multi-parameter data analysis has been historically reserved for technologies that lack the spatial context that is provided by immunohistochemistry. Over the past decade, technical developments in multiplex fluorescence immunohistochemistry and discoveries made with improving image data analysis platforms have highlighted the importance of spatial relationships between certain biomarkers in understanding a patient’s likelihood to respond to, typically, immune checkpoint inhibitors. At the same time, personalized medicine has instigated changes in both clinical trial design and its conduct in a push to make drug development and cancer treatment more efficient, precise, and economical. Precision medicine in immuno-oncology is being steered by data-driven approaches to gain insight into the tumor and its dynamic interaction with the immune system. This is particularly necessary given the rapid growth in the number of trials involving more than one immune checkpoint drug, and/or using those in combination with conventional cancer treatments. As multiplex methods, like immunofluorescence, push the boundaries of immunohistochemistry, it becomes critical to understand the foundation of this technology and how it can be deployed for use as a regulated test to identify the prospect of response from mono- and combination therapies. To that end, this work will focus on: 1) the scientific, clinical, and economic requirements for developing clinical multiplex immunofluorescence assays; 2) the attributes of the Akoya Phenoptics workflow to support predictive tests, including design principles, verification, and validation needs; 3) regulatory, safety and quality considerations; 4) application of multiplex immunohistochemistry through lab-developed-tests and regulated in vitro diagnostic devices.
以技术为基础，循证驱动和以患者为中心的：将软件作为医疗设备进行调节的前进之路。
影响因子：
3.2
作者：
Carolan JE;McGonigle J;Dennis A;Lorgelly P;Banerjee A
通讯作者：
Banerjee A
图像肿瘤的新技术。
影响因子：
--
作者：
McNamara G;Lucas J;Beeler JF;Basavanhally A;Lee G;Hedvat CV;Baxi VA;Locke D;Borowsky A;Levenson R
通讯作者：
Levenson R