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首页> 外文期刊>Clinical Chemistry: Journal of the American Association for Clinical Chemists >Generic Protocols for the Analytical Validation of Next-Generation Sequencing-Based ctDNA Assays: A Joint Consensus Recommendation of the BloodPAC's Analytical Variables Working Group
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Generic Protocols for the Analytical Validation of Next-Generation Sequencing-Based ctDNA Assays: A Joint Consensus Recommendation of the BloodPAC's Analytical Variables Working Group

机译：基于下一代测序的CTDNA分析的分析验证的通用协议：Bloodpac分析变量工作组的联合共识建议

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摘要

Liquid biopsy, particularly the analysis of circulating tumor DNA (ctDNA), has demonstrated considerable promise for numerous clinical intended uses. Successful validation and commercialization of novel ctDNA tests have the potential to improve the outcomes of patients with cancer. The goal of the Blood Profiling Atlas Consortium (BloodPAC) is to accelerate the development and validation of liquid biopsy assays that will be introduced into the clinic. To accomplish this goal, the BloodPAC conducts research in the following areas: Data Collection and Analysis within the BloodPAC Data Commons; Preanalytical Variables; Analytical Variables; Patient Context Variables; and Reimbursement. In this document, the BloodPAC's Analytical Variables Working Group (AV WG) attempts to define a set of generic analytical validation protocols tailored for ctDNA-based Next-Generation Sequencing (NGS) assays. Analytical validation of ctDNA assays poses several unique challenges that primarily arise from the fact that very few tumor-derived DNA molecules may be present in circulation relative to the amount of nontumor-derived cell-free DNA (cfDNA). These challenges include the exquisite level of sensitivity and specificity needed to detect ctDNA, the potential for false negatives in detecting these rare molecules, and the increased reliance on contrived samples to attain sufficient ctDNA for analytical validation. By addressing these unique challenges, the BloodPAC hopes to expedite sponsors' presubmission discussions with the Food and Drug Administration (FDA) with the protocols presented herein. By sharing best practices with the broader community, this work may also save the time and capacity of FDA reviewers through increased efficiency.
机译：液体活检，特别是对循环肿瘤DNA（CTDNA）的分析，对许多临床预期用途表现出相当大的许可。新型CTDNA测试的成功验证和商业化有可能改善癌症患者的结果。血液分析图案化联盟（Bloodpac）的目标是加速将引入诊所的液检和验证的液检和验证。为了实现这一目标，Bloodpac在以下领域进行了研究：Bloodpac数据公共区域内的数据收集和分析; preanalytical变量;分析变量;患者上下文变量;和报销。在本文档中，BloodPac的分析变量工作组（AV WG）试图定义为基于CTDNA的下一代测序（NGS）测定而定制的一组通用分析验证协议。 CTDNA测定的分析验证造成了若干独特的挑战，主要是由于肿瘤衍生的DNA分子可能存在于相对于不源性细胞的无细胞DNA（CFDNA）的量存在循环中的事实。这些挑战包括检测CTDNA所需的精致性敏感性和特异性，检测这些稀有分子的假阴性的可能性，以及增加对学历样本的依赖以获得足够的CTDNA进行分析验证。通过解决这些独特的挑战，BloodPAC希望通过本文提出的方案加快与食品和药物管理局（FDA）的提案国的预订讨论。通过与更广泛的社区分享最佳实践，这项工作也可能通过提高效率来节省FDA审稿人的时间和能力。

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