Division of Thoracic Oncology, Shizuoka Cancer Center, Shizuoka, Japan.
Respiratory Medicine and Infectious Diseases, Oita University Faculty of Medicine, Oita, Japan.
Thorac Cancer. 2024 Jul;15(21):1665-1672. doi: 10.1111/1759-7714.15382. Epub 2024 Jun 19.
The AmoyDx Pan lung cancer PCR panel (AmoyDx PLC panel) has been approved as a companion diagnostic tool for multiple anticancer agents in patients with non-small cell lung cancer (NSCLC). However, the suitability of cytology specimens as samples for the AmoyDx PLC panel remains unclear. We evaluated the performance of frozen cell pellets from cytology specimens (FCPs) in the Amoy 9-in-1 assay, a preapproval assay of the AmoyDx PLC panel.
We retrospectively collected data of NSCLC patients enrolled in LC-SCRUM-Asia from the Shizuoka Cancer Center between September 2019 and May 2021.
A total of 49 cases submitted FCPs for evaluation of oncogenic driver alterations and were assessed using Amoy 9-in-1 and next-generation sequencing (NGS) assays. The success rates of DNA and RNA analyses using the Amoy 9-in-1 were both 100%, compared with 86% and 45%, respectively, using NGS assays. Oncogenic driver alterations were detected in 27 (55%) and 23 (47%) patients using Amoy 9-in-1 and NGS, respectively. No inconsistent results were observed among 19 cases in which both assays showed successful detection. In the remaining 30 cases, 10 had inconsistent results: nine oncogenic driver alterations (3 MET, 2 ALK, 2 ROS1, and 2 KRAS) were detectable only in Amoy 9-in-1, and one epidermal growth factor receptor (EGFR) mutation was detectable only in NGS.
FCPs can be successfully used in the AmoyDx PLC panel, with higher success rate compared with the NGS assay. The AmoyDx PLC panel may be an option in cases when insufficient tissue sample is available for the NGS assay.
AmoyDx Pan 肺癌 PCR 检测试剂盒（AmoyDx PLC 检测试剂盒）已被批准作为多种非小细胞肺癌（NSCLC）抗癌药物的伴随诊断工具。然而，细胞学标本作为 AmoyDx PLC 检测试剂盒样本的适用性尚不清楚。我们评估了 Amoy 9-in-1 检测（AmoyDx PLC 检测试剂盒的预批准检测）中细胞学标本的冻存细胞沉淀（FCP）的性能。
我们回顾性收集了 2019 年 9 月至 2021 年 5 月期间在静冈癌症中心参加 LC-SCRUM-Asia 研究的 NSCLC 患者的数据。
共有 49 例患者提交了 FCPs 进行致癌驱动基因改变的评估，并使用 Amoy 9-in-1 和下一代测序（NGS）检测进行评估。Amoy 9-in-1 进行 DNA 和 RNA 分析的成功率均为 100%，而 NGS 检测分别为 86%和 45%。使用 Amoy 9-in-1 和 NGS 分别在 27（55%）和 23（47%）例患者中检测到致癌驱动基因改变。在两种检测方法均成功检测的 19 例患者中，未观察到不一致的结果。在其余 30 例患者中，有 10 例存在不一致的结果：9 例致癌驱动基因改变（3 例 MET、2 例 ALK、2 例 ROS1 和 2 例 KRAS）仅在 Amoy 9-in-1 中可检测到，1 例表皮生长因子受体（EGFR）突变仅在 NGS 中可检测到。
FCPs 可成功用于 AmoyDx PLC 检测试剂盒，其成功率高于 NGS 检测。当 NGS 检测的组织样本不足时，AmoyDx PLC 检测试剂盒可能是一种选择。
