{"entity":{"id":"idea-prev-interval-cancer-audit-blood-tests","kind":"idea","name":"Mandatory interval-cancer audit for every blood-based screening test","aka":[],"tldr":"When a screening test misses a cancer, we should know. Linking every negative result to the cancer registry and publishing what was missed, by stage, should be a condition of use.","summary":"Cervical and breast programmes audit interval cancers routinely; commercial blood tests do not. Propose that authorisation or reimbursement for MCED and single-cancer blood tests requires registry linkage of all negatives, with annual publication of stage-specific sensitivity, interval cancer rates, and test-negative cancers by subtype.","asOf":"2026-09-08","links":[{"label":"Bottleneck evidence (The hardest cancers are found late): Crosby et al., Early detection of cancer (Science 2022)","url":"https://doi.org/10.1126/science.aay9040"}],"tags":[],"related":["seer"],"cancers":[],"sections":["early-detection"],"technologies":["liquid-biopsy","mced"],"targets":[],"drugs":["shield","galleri"],"companies":[],"institutions":[],"pathways":[],"terms":["real-world-evidence"],"trials":[],"people":[],"bottlenecks":["b-early-detection","b-biomarker-validation","b-real-world-evidence"],"keyPapers":["paper-crosby-science"],"journals":[],"dependsOn":[],"notes":[],"hypothesis":"Registry-linked audit will reveal real-world stage I sensitivity materially below case-control estimates for at least some cancers, and will change which tests payers cover.","rationale":"Case-control designs overstate sensitivity through spectrum bias; only prospective negatives tell the truth. The audit is cheap where registries exist.","test":"Pilot with one approved test (e.g. Shield for colorectal cancer) in a state with a complete registry; publish the two-year interval cancer rate.","maturity":"speculative","actor":"regulator","cost":"small","horizonYears":2},"route":"/ideas/idea-prev-interval-cancer-audit-blood-tests/","neighbours":{"collection":[{"id":"seer","kind":"collection","name":"SEER (Surveillance, Epidemiology, and End Results)","route":"/collections/seer/"}],"section":[{"id":"early-detection","kind":"section","name":"Early Detection & Screening","route":"/fronts/early-detection/"}],"technology":[{"id":"liquid-biopsy","kind":"technology","name":"Liquid biopsy (ctDNA)","route":"/technologies/liquid-biopsy/"},{"id":"mced","kind":"technology","name":"Multi-cancer early detection (MCED)","route":"/technologies/mced/"}],"drug":[{"id":"galleri","kind":"drug","name":"Galleri","route":"/drugs/galleri/"},{"id":"shield","kind":"drug","name":"Shield","route":"/drugs/shield/"}],"term":[{"id":"real-world-evidence","kind":"term","name":"Real-world evidence","route":"/terms/real-world-evidence/"}],"bottleneck":[{"id":"b-biomarker-validation","kind":"bottleneck","name":"Biomarkers are not validated or standardised","route":"/bottlenecks/b-biomarker-validation/"},{"id":"b-early-detection","kind":"bottleneck","name":"The hardest cancers are found late","route":"/bottlenecks/b-early-detection/"},{"id":"b-real-world-evidence","kind":"bottleneck","name":"Weak real-world evidence and registries","route":"/bottlenecks/b-real-world-evidence/"}],"paper":[{"id":"paper-crosby-science","kind":"paper","name":"Early detection of cancer","route":"/key-papers/paper-crosby-science/"}]}}