The NCI’s Surveillance Research Program, which oversees the SEER registries, is currently investigating the feasibility of a Virtual Tissue Repository (VTR) to establish an infrastructure for acquisition of deidentified clinical data, tissue resources, and whole slide images for cancer research at the population level. The Surveillance, Epidemiology, and End Results (SEER) cancer registry system, sponsored by the National Cancer Institute (NCI), is a unique data resource that routinely collects data on all incident cancer cases, including long-term follow-up information. 2– 4 One alternative source of tissue from cancer patients is archival formalin-fixed, paraffin-embedded (FFPE) tissue, routinely collected in clinical practice for diagnostic purposes. Additionally, such investigator-initiated and pharmaceutical company–sponsored studies are not necessarily representative of the US population. 1 Not only is the procedure for acquiring fresh tumor specimens costly and not always feasible, but researchers collecting such tissue specimens do not always have access to clinical records and long-term follow-up information. With the rise of personalized medicine for cancer treatment, there is an increasing demand to profile molecular features of tumors. 2903 - Public Law 100-578, 100th Congress (31 October 1988).Surveillance Research Program, Division of Cancer Control and Population Sciences (Yuan, Van Dyke, Petkov, Hussey, Penberthy), and the Cancer Diagnosis Program, Division of Cancer Treatment and Diagnosis (Moravec), National Cancer Institute, National Institutes of Health, Rockville, Maryland the HIV/AIDS Program, National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, Maryland (Altekruse) the Cancer Registry of Greater California, Department of Public Health, Sacramento (Sandoval, Cress) the Connecticut Tumor Registry, State Department of Public Health, Hartford (Mueller) the Hawaii Tumor Registry, University of Hawaii Cancer Center, Honolulu (Mogi, Hernandez) the Iowa Cancer Registry, The University of Iowa, Iowa City (Selk, Lynch) the Kentucky Cancer Registry, University of Kentucky, Markey Cancer Center, Lexington (Tucker) the Louisiana Tumor Registry, Louisiana State University School of Public Health, New Orleans (Lynch, Lefante, Wu) and the Utah Cancer Registry (Sweeney, Doherty) and Huntsman Cancer Institute (Doherty), University of Utah, Salt Lake City. Clinical Laboratory Improvement Amendments (CLIA): CLIA Law and Regulations (accessed 7 September 2022). Functional Statement (accessed 7 September 2022). US Center for Clinical Standards and Quality, CMS. US Clinical Laboratory Improvement Advisory Committee (CLIAC) (accessed 7 September 2022). Strategic Plan (accessed 7 September 2022). US Centers for Medicare & Medicaid Services (CMS). Fiscal Year 2023: Budget in Brief (accessed 7 September 2022). Clinical Laboratory Improvement Amendments (CLIA) Laboratory Guidance During COVID-19 Public Health Emergency (March 26, 2020) (accessed 7 September 2022).įurness, P. US Department of Health & Human Services (HHS), Center for Clinical Standards and Quality/Survey & Certification Group Ref: QSO-20-21-CLIA. Ensuring remote diagnostics for pathologists: an open letter to the US Congress
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