Kramer Astrid, Schuuring Ed, Vessies Daan C L, van der Leest Paul, Geerlings Maartje J, Rozendal Pim, Lanfermeijer Mirthe, Linders Theodora C, van Kempen Léon C, Fijneman Remond J A, Ligtenberg Marjolijn J L, Meijer Gerrit A, van den Broek Daan, Retèl Valesca P, Coupé Veerle M H
Department of Epidemiology and Data Science, Amsterdam University Medical Centers, Amsterdam, the Netherlands.
Department of Pathology and Medical Biology, University of Groningen, University Medical Center Groningen, Groningen, the Netherlands.
J Mol Diagn. 2023 Jan;25(1):36-45. doi: 10.1016/j.jmoldx.2022.10.004. Epub 2022 Nov 17.
Circulating tumor DNA (ctDNA) is a promising new biomarker with multiple potential applications in cancer care. Estimating total cost of ctDNA testing is necessary for reimbursement and implementation, but challenging because of variations in workflow. We aimed to develop a micro-costing framework for consistent cost calculation of ctDNA testing. First, the foundation of the framework was built, based on the complete step-wise diagnostic workflow of ctDNA testing. Second, the costing method was set up, including costs for personnel, materials, equipment, overhead, and failures. Third, the framework was evaluated by experts and applied to six case studies, including PCR-, mass spectrometry-, and next-generation sequencing-based platforms, from three Dutch hospitals. The developed ctDNA micro-costing framework includes the diagnostic workflow from blood sample collection to diagnostic test result. The framework was developed from a Dutch perspective and takes testing volume into account. An open access tool is provided to allow for laboratory-specific calculations to explore the total costs of ctDNA testing specific workflow parameters matching the setting of interest. It also allows to straightforwardly assess the impact of alternative prices or assumptions on the cost per sample by simply varying the input parameters. The case studies showed a wide range of costs, from €168 to €7638 ($199 to $9124) per sample, and generated information. These costs are sensitive to the (coverage of) platform, setting, and testing volume.
循环肿瘤DNA（ctDNA）是一种很有前景的新型生物标志物，在癌症治疗中有多种潜在应用。估算ctDNA检测的总成本对于报销和实施来说很有必要，但由于工作流程的差异，这具有挑战性。我们旨在开发一个微观成本核算框架，以便对ctDNA检测进行一致的成本计算。首先，基于ctDNA检测完整的逐步诊断工作流程构建了该框架的基础。其次，建立了成本核算方法，包括人员、材料、设备、间接费用和失败成本。第三，由专家对该框架进行评估，并将其应用于来自荷兰三家医院的六个案例研究，包括基于聚合酶链反应（PCR）、质谱和下一代测序的平台。所开发的ctDNA微观成本核算框架涵盖了从血样采集到诊断测试结果的诊断工作流程。该框架是从荷兰的角度开发的，并考虑了检测量。提供了一个开放获取工具，以允许进行特定实验室的计算，从而探索与感兴趣的设置相匹配的ctDNA检测特定工作流程参数的总成本。它还允许通过简单改变输入参数，直接评估替代价格或假设对每个样本成本的影响。案例研究显示每个样本的成本范围很广，从168欧元到7638欧元（199美元到9124美元），并生成了相关信息。这些成本对平台（的覆盖范围）、设置和检测量很敏感。
