Development of FISH Molecular Diagnostics to support Clinical Trials at NCI

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The Chromosome Pathology Section (CPS) of the Laboratory of Pathology is a valuable resource at CCR, NCI to support active NCI clinical protocols. The section provides clinical diagnostic service for CCR investigators with Fluorescence In Situ Hybridization (FISH) CLIA/CAP testing in support of Surgical Pathology diagnostics and testing patients for NCI clinical protocol eligibility. More importantly, the laboratory represents a bench-to-bedside bridge that keeps pace with the latest discoveries in biomedical research, bringing new discoveries to clinical patient testing more rapidly than would be available from reference laboratories (the R&D component of the CPS). The Chromosome Pathology Section currently supports 16 clinical trials at the NCI. That includes requests from the entire community of CCR investigators: Neuro-Oncology Branch, Thoracic & GI Malignancies Branch, Vaccine Branch, Pediatric Oncology Branch, Experimental Transplantation and Immunology Branch, Surgery Branch, Urologic Oncology Branch, Office of the Director. The active test menu includes FISH assays for clinically significant chromosomal translocations and amplification events in solid tumors and hematologic malignancies. CPS actively participates in clinical and research collaborations with other investigators within the CCR and other NIH Institutes to advance basic and clinical research. The CPS promotes collaborations with other Investigators within the LP advancing clinical and basic research efforts of the LP programs. In addition to Molecular Cytogenetic testing, we have recently implemented an exciting new diagnostic clinical testing that uses Illumina platform for array-based genome-wide DNA methylation testing to to classify CNS tumors based on their unique genomic methylation profiles. This CPS group effort within the NCI COMPASS program has been a step forward for the goal to enhance the diagnostics precision in CNS and other tumor classification