GRAIL, Menlo Park, California, USA.
Natera, Austin, Texas, USA.
Clin Transl Sci. 2024 Sep;17(9):e70016. doi: 10.1111/cts.70016.
In the United States, 2.0 million new cancer cases and around 600,000 cancer deaths are estimated to occur in 2024. Early detection gives cancer patients the best chance for treatment success. Currently, cancer screening in the general population is recommended for a limited set of cancers; as a result, most cancer types are not regularly screened. Thus, in recent years, we have seen a wave of novel, non-invasive, single- and multi-cancer detection tests (SCD and MCD), promising detection of cancer signals prior to the onset of symptoms and/or clinical diagnosis. To accelerate the development, access, and adoption of these tests, the Blood Profiling Atlas in Cancer (BLOODPAC) Consortium, a collaborative infrastructure for developing standards and best practices, established the Early Detection & Screening (ED&S) Working Group. The early detection space is in need of consensus around definitions for SCD and MCD tests that harmonize terminology across diverse stakeholders, thereby reducing communication barriers and ultimately advancing the discipline. To this end, the ED&S Working Group compiled a lexicon of terms, chosen based on perceived importance, frequency of use, lack of clarity, and unique challenges in the context of SCD and MCD tests. This lexicon was submitted to the FDA for their feedback, which was incorporated. In this work, we present the first installment of the lexicon, consisting of 14 primary terms, that will be part of an online dictionary and provide a foundation for future projects of BLOODPAC's ED&S Working Group.
在美国，预计 2024 年将有 200 万例新癌症病例和约 60 万例癌症死亡。早期发现为癌症患者提供了治疗成功的最佳机会。目前，一般人群中的癌症筛查仅推荐用于有限数量的癌症；因此，大多数癌症类型并未定期进行筛查。因此，近年来，我们看到了一波新型的、非侵入性的单癌和多癌检测测试（SCD 和 MCD），这些测试有望在症状出现和/或临床诊断之前检测到癌症信号。为了加速这些测试的开发、获取和采用，血液图谱癌症联盟（BLOODPAC）合作组织建立了早期检测和筛查（ED&S）工作组，这是一个开发标准和最佳实践的协作基础设施。SCD 和 MCD 测试的定义需要在早期检测领域达成共识，这些定义要协调不同利益相关者之间的术语，从而减少沟通障碍，最终推动该学科的发展。为此，ED&S 工作组根据感知重要性、使用频率、缺乏清晰度以及 SCD 和 MCD 测试背景下的独特挑战，编制了术语词汇表。该词汇表已提交给 FDA 征求意见，意见已被采纳。在这项工作中，我们提出了词汇表的第一部分，共包含 14 个主要术语，这些术语将成为在线词典的一部分，并为 BLOODPAC 的 ED&S 工作组的未来项目提供基础。
