• Uri Ladabaum, Ajitha Mannalithara, Robert E Schoen, Jason A Dominitz, and David Lieberman.
• Division of Gastroenterology and Hepatology and Department of Medicine, Stanford University School of Medicine, Stanford, California (U.L., A.M.).
• Ann. Intern. Med. 2024 Oct 29.

BackgroundCell-free DNA blood tests (cf-bDNA) and next-generation stool tests could change colorectal cancer (CRC) screening.ObjectiveTo estimate the clinical and economic impacts of novel CRC screening tests.DesignCost-effectiveness analysis using MOSAIC (Model of Screening and Surveillance for Colorectal Cancer).Data SourcesPublished data.Target PopulationAverage-risk persons.Time HorizonAges 45 to 100 years.PerspectiveHealth sector.InterventionNovel versus established CRC screening tests.Outcome MeasuresIncidence and mortality of CRC, quality-adjusted life-years (QALYs), costs.Results Of Base Case AnalysisFor colonoscopy every 10 years, annual fecal immunochemical test (FIT), and triennial next-generation multitarget stool DNA, FIT-RNA, cf-bDNA (Guardant Shield), or cf-bDNA (Freenome), the relative rates (RRs) and 95% uncertainty intervals (UIs) versus no screening for CRC incidence were 0.21 (0.19 to 0.22), 0.29 (0.27 to 0.31), 0.33 (0.32 to 0.36), 0.32 (0.30 to 0.34), 0.58 (0.55 to 0.61) and 0.58 (0.55 to 0.60), respectively; the RRs for CRC death were 0.19 (0.17 to 0.20), 0.25 (0.23 to 0.27), 0.28 (0.27 to 0.30), 0.28 (0.26 to 0.30), 0.44 (0.42 to 0.47), and 0.46 (0.44 to 0.49), respectively. The cf-bDNA test (Shield; list price $1495) cost $89 600 ($74 800 to $102 300) per QALY gained versus no screening; alternatives were less costly and more effective.Results Of Sensitivity AnalysisIncremental costs exceeded incremental benefits when novel test intervals were shortened to 2 or 1 years. The cf-bDNA test matched FIT's impact on CRC mortality at 1.35 (1.30 to 1.40)-fold FIT's uptake rate, assuming equal colonoscopy follow-up. If persons who accept colonoscopy or stool tests shifted to cf-bDNA, CRC deaths increased. This adverse effect was overcome if every 3 such substitutions were counterbalanced by cf-bDNA uptake by 2 or more persons refusing alternatives, assuming equal colonoscopy follow-up.LimitationLongitudinal test-specific participation patterns are unknown.ConclusionFirst-generation cf-bDNA tests may deliver net benefit or harm, depending on the balance between achieving screening in persons who decline alternatives versus substituting cf-bDNA for more effective alternatives.Primary Funding SourceThe Gorrindo Family Fund.

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