NCI COMPASS

分子诊断科是目前唯一的CLIA和美国病理学院批准的临床实验室，在NCI认证下对来自NIH患者的病理材料进行分子肿瘤学检测。新建立的COMPASS项目旨在扩大下一代测序以支持CCR的临床和研究。在2020财年，在实验室继续使用Ion Torrent NGS系统运行原发性脑肿瘤小组（PBTP）和Oncomine综合分析v3 （OCAv3）的同时，我们已经完全建立了使用Illumina NGS系统的干湿实验室的新基础设施。2019年10月，该实验室推出了TruSight肿瘤500基因面板（TSO500: 523个基因的DNA突变、TMB、MSI和RNA融合检测）作为临床测试。该实验室与其他两个小型NGS小组（PBTP和OCAv3）一起，于2019年7月至2020年6月进行了1055例NGS病例，并发表了综合分子报告。这些结果为NCI的50个临床方案和NIDDK的1个方案提供了精确病理诊断和精确肿瘤学支持，包括CCR罕见肿瘤、肝脏和前列腺癌登月项目。我们还在COMPASS项目中验证了OCAv3和TSO500用于NCI-MATCH，并获得了NCI-MTACH团队的批准，用于筛查来自CCR校内诊所的患者。COMPASS计划通过举办每周一次的NGS技术评审会议、每周一次的分子病理学/神经肿瘤学会议和每周一次的分子病理学/儿科肿瘤学会议，为病理学和肿瘤学团队，特别是下一代病理学家和内科科学家提供了培训或继续教育的绝佳机会，讨论分子发现、治疗和超越弓根患者或突变。我们还完成了全外显子组DNA测序（WES）在临床应用中的评估和验证。很快在2021财年，临床WES检测将提供给CCR临床社区。

The Molecular Diagnostics Section is currently the only CLIA and College of American Pathology approved clinical laboratory within the NCI certified for performing molecular oncology testing on pathology materials from NIH patients. The newly established COMPASS program is to expand next-generation sequencing to support clinical and research in CCR. In FY20, while the laboratory is continuing to utilize Ion Torrent NGS system to run the Primary Brain Tumor panel (PBTP) and Oncomine Comprehensive Assay v3 (OCAv3), we have completely setup the new infrastructure of wet and dry laboratories with Illumina NGS system. In October 2019, the lab has launched the TruSight Oncology 500 Gene Panel (TSO500: DNA mutations for 523 genes, TMB, MSI, and RNA fusion detections) as a clinical test. Together with other two small NGS panels (PBTP and OCAv3), the lab performed 1055 NGS cases from July 2019 to June 2020 and issued the comprehensive molecular reports. These results have provided support of precision pathological diagnosis and precision oncology for 50 clinical protocols from NCI and 1 protocol from NIDDK including CCR Rare Tumor, Liver and Prostate Cancer Moonshot projects. We also validated both OCAv3 and TSO500 for NCI-MATCH in COMPASS program and received the approval from NCI-MTACH team to use screen patients from CCR intramural clinics. The COMPASS program provided the great opportunities of training or continuing education for both pathology and oncology teams especially next generation of pathologists and physician scientists by running weekly NGS technical review conference, weekly molecular pathology/neuro-oncology conference, and weekly molecular pathology/pediatric oncology conference to discuss molecular finding, treatment, and beyond pedicular patient or mutation. We have also completed evaluation and validation of whole exome DNA sequencing (WES) in clinical use. Soon in FY21, clinical WES testing will be available to CCR clinical communities.