Department of Laboratory Medicine, William Osler Health System, Brampton, ON L6R 3J7, Canada.
Division of Medical Oncology, William Osler Health System, Brampton, ON L6R 3J7, Canada.
Curr Oncol. 2022 Feb 23;29(3):1326-1334. doi: 10.3390/curroncol29030113.
: Biomarker data are critical to the delivery of precision cancer care. The average turnaround of next-generation sequencing (NGS) reports is over 2 weeks, and in-house availability is typically limited to academic centers. Lengthy turnaround times for biomarkers can adversely affect outcomes. Traditional workflows involve moving specimens through multiple facilities. This study evaluates the feasibility of rapid comprehensive NGS using the Genexus integrated sequencer and a novel streamlined workflow in a community setting. : A retrospective chart review was performed to assess the early experience and performance characteristics of a novel approach to biomarker testing at a large community center. This approach to NGS included an automated workflow utilizing the Genexus integrated sequencer, validated for clinical use. NGS testing was further integrated within a routine immunohistochemistry (IHC) service, utilizing histotechnologists to perform technical aspects of NGS, with results reported directly by anatomic pathologists. : Between October 2020 and October 2021, 578 solid tumor samples underwent genomic profiling. (IQR: 2-5). Four hundred eighty-one (83%) of the cases were resulted in fewer than 5 business days, and 66 (11%) of the cases were resulted simultaneously with diagnosis. Tumor types included lung cancer (310), melanoma (97), and colorectal carcinoma (68), among others. NGS testing detected key driver alterations at expected prevalence rates: lung (16%), (3%), (1%), melanoma (43%), colorectal / (67%), among others. : This is the first study demonstrating clinical implementation of rapid NGS. This supports the feasibility of automated comprehensive NGS performed and interpreted in parallel with diagnostic histopathology and immunohistochemistry. This novel approach to biomarker testing offers considerable advantages to clinical cancer care.
生物标志物数据对于提供精准癌症护理至关重要。下一代测序(NGS)报告的平均周转时间超过 2 周,内部可用性通常仅限于学术中心。生物标志物的长周转时间可能会对结果产生不利影响。传统的工作流程涉及将标本转移到多个设施。本研究评估了在社区环境中使用 Genexus 集成测序仪和新型简化工作流程进行快速综合 NGS 的可行性。
一项回顾性图表审查评估了在大型社区中心进行新型生物标志物检测方法的早期经验和性能特征。这种 NGS 方法包括利用经过临床验证的 Genexus 集成测序仪的自动化工作流程。NGS 测试进一步整合到常规免疫组织化学(IHC)服务中,利用组织技术人员执行 NGS 的技术方面,由解剖病理学家直接报告结果。
在 2020 年 10 月至 2021 年 10 月期间,578 个实体瘤样本进行了基因组分析。(IQR:2-5)。481 例(83%)的病例结果在不到 5 个工作日内得出,66 例(11%)的病例同时与诊断结果得出。肿瘤类型包括肺癌(310 例)、黑色素瘤(97 例)和结直肠癌(68 例)等。NGS 测试以预期的流行率检测到关键驱动因素改变:肺癌(16%)、黑色素瘤(3%)、结直肠癌(1%)、黑色素瘤(43%)、结直肠癌/(67%)等。
这是第一项展示快速 NGS 临床实施的研究。这支持了与诊断组织病理学和免疫组织化学平行进行自动化综合 NGS 的可行性。这种新型生物标志物检测方法为临床癌症护理提供了显著优势。