Department of Diagnostic Pathology, National Cancer Center, Tokyo, Japan.
Department of Laboratory Medicine, National Cancer Center Hospital, Tokyo, Japan.
Pathol Int. 2020 Dec;70(12):921-931. doi: 10.1111/pin.13023. Epub 2020 Sep 21.
The year 2019 was considered to be the first year of cancer genome medicine in Japan, with three gene-panel tests using next-generation sequencing (NGS) techniques being introduced into clinical practice. Among the three tests, the Oncomine CDx Target test was approved under the category of regular molecular testing for lung cancer, which meant that this test could be used to select patients for molecularly targeted drugs. Conversely, the other two tests, NCC OncoPanel and FoundationOne CDx, were assigned to be used under the National Cancer Genome Medicine Network, and implementation was restricted to patients for whom standard treatment was completed or expected to be completed. These NGS tests can detect a series of genetic alterations in individual tumors, which further promotes the development of therapeutic agents and elucidates molecular pathways. The NGS tests require appropriate tissue size and tumor cell content, which can be accessed only by pathologists. In this report, we review the current reimbursement schema in our national healthcare policy and the requirements of the specimens for NGS testing based on the recently published 'Guidance of Gene-panel Testing Using Next-Generation Sequencers for Lung Cancer', by the Japanese Society of Lung Cancer.
2019 年被认为是日本癌症基因组医学的元年，三种基于下一代测序（NGS）技术的基因panel 检测被引入临床实践。在这三种检测中，Oncomine CDx Target 检测被批准作为肺癌常规分子检测类别，这意味着该检测可用于选择接受分子靶向药物治疗的患者。相反，其他两项检测，NCC OncoPanel 和 FoundationOne CDx，则被指定用于国家癌症基因组医学网络，并且仅在标准治疗已完成或预计完成的患者中实施。这些 NGS 检测可以检测个体肿瘤中的一系列遗传改变，这进一步促进了治疗药物的发展并阐明了分子途径。NGS 检测需要适当的组织大小和肿瘤细胞含量，这只能由病理学家获得。在本报告中，我们根据日本肺癌学会最近发布的“使用下一代测序仪进行肺癌基因panel 检测的指南”，回顾了我们国家医疗保健政策中的现行报销方案和 NGS 检测标本的要求。
