NCI COMPASS

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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.