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Supported assays typically involve molecular or cellular biomarkers and are analytically validated in the first phase and then clinically validated using well-annotated human biospecimens from existing studies or trials to demonstrate association with relevant clinical endpoints. These assays may test for predictive biomarkers (associated with treatment response or resistance) or prognostic biomarkers (associated with natural disease progression and patient outcomes), as long as they provide clinically useful information. Funding support through these programs has led to commercial partnerships and subsequent larger-scale clinical trials resulting in approved in vitro diagnostics. These programs have also developed laboratory-developed tests to serve patients with rare forms of cancer, to screen and enroll clinical trial participants for early stage drug testing (eg, identifying individuals whose tumors carry rare mutations that match a new drug\u2019s target), and to accelerate the clinical adoption of innovative technologies for detection and diagnosis. This commentary is organized as a perspective followed by historical examples of successful projects and concluding remarks on the requirements for rigorous diagnostics development.<\/jats:p>","DOI":"10.1093\/jnci\/djag386","type":"journal-article","created":{"date-parts":[[2026,10,9]],"date-time":"2026-10-09T11:52:25Z","timestamp":1791546745000},"source":"Crossref","is-referenced-by-count":0,"title":["National Cancer Institute\u2019s Clinical Assay Development Program: supporting translation of biomarkers for cancer diagnosis"],"prefix":"10.1093","author":[{"ORCID":"https:\/\/orcid.org\/0009-0008-8584-032X","authenticated-orcid":false,"given":"Sumana M","family":"Dey","sequence":"first","affiliation":[{"name":"Division of Cancer Treatment and Diagnosis, National Cancer Institute, National Institutes of Health , Rockville, MD,","place":["United 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