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From mammograms and colonoscopies to a single blood draw that might screen for dozens of cancers, with the FDA's first decision imminent.
Starting from organ-specific screening proven over decades, the Pap smear, mammography, colonoscopy and FIT, PSA and low-dose CT after NLST, this roadmap follows the cfDNA and methylation science behind the CCGA study, Galleri, Cologuard and Epi proColon. The current step covers pivotal trials and first approvals, with NHS-Galleri, PATHFINDER 2, Shield as the first FDA-approved blood test for colorectal screening and GRAIL's PMA filing, leading to FDA and NHS decisions and Medicare coverage. The speculative end is annual multi-analyte blood screening with tissue-of-origin-directed imaging. The route links mammography, MCED, liquid biopsy, methylation profiling, AI in radiology and whole-body MRI, and is pointed to by pancreatic and cervical cancer and the late-detection bottleneck.
Pap smear (1943), mammography (1970s-80s RCTs), colonoscopy/FIT, PSA (contested), low-dose CT for lung (NLST 2011). Each reduces mortality in its cancer; together they cover under half of cancer deaths.
CCGA study (GRAIL) shows methylation classifiers detect >50 cancers with ~0.5% false positives and predict tissue of origin; Galleri launched as an LDT (2021); Cologuard and Epi proColon establish stool and blood DNA screening.
NHS-Galleri randomises 140,000; PATHFINDER 2 enrols 35,000; Shield becomes the first FDA-approved blood test for CRC screening (2024) and Medicare covers it; Exact launches Cancerguard as an LDT (2025); GRAIL files PMA (Jan 2026), advisory committee 23 Sep 2026. AI mammography reading validated at scale (MASAI).
Numbers are from the trial as recorded here; see the source links in the table below. This is orientation, not medical advice: ask your team how closely the trial population matches you.
Numbers are from the trial as recorded here; see the source links in the table below. This is orientation, not medical advice: ask your team how closely the trial population matches you.
FDA decision on Galleri; NHS decision on rollout; Medicare MCED coverage legislation; integration with risk-based screening (Mirai, polygenic scores); management pathways for positive signals with no imaging correlate; cost-effectiveness and overdiagnosis debates.
Annual multi-analyte blood screening for adults over 50 with tissue-of-origin-directed imaging; MCED-detected pancreatic and ovarian cancers at resectable stages; risk-adapted intervals from AI; proteomic and fragmentomic layers improving stage I sensitivity.
Every era's records, trial outcomes and papers, and every watch item, as JSON.
Probability ranges are named estimates that the claim is borne out on roughly a five-year horizon. They are meant to be argued with: propose a revision with your name and reasoning via a pull request to src/data/confidence.ts.
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NHS-Galleri is the trial that will decide whether a blood test for many cancers at once should be offered by a health system. Its endpoint is a reduction in late-stage cancer rather than deaths, so even a positive result leaves the mortality question to be settled by longer follow-up.
Fixes the window in which a blood test could plausibly work and shows why CA 19-9 alone is not enough: half of early cases are missed even at diagnosis, and Lewis-negative patients are missed entirely.
The document that defines who is offered a scan in the United States, and therefore the document any argument about the screening eligibility gap has to engage with. Eligibility is still defined by pack-years and years since quitting rather than by an individual risk estimate.
A negative screening trial that saved a generation from a useless test, and the reason low-dose computed tomography had to be proved separately rather than assumed to work because it saw more.
The evidence that prostate-specific antigen screening works, stated together with the price. It is the reason screening programmes are debated rather than simply adopted, and the reason every subsequent proposal, from magnetic resonance imaging first to risk-model invitation, is judged on whether it keeps the mortality benefit while reducing the 48.
The trial that made prostate screening contested in the United States, and the reason the 2012 task force recommended against it. Its main lesson is methodological: a screening trial whose control group screens itself cannot measure the effect of screening.
The paper that made opportunistic prostate-specific antigen testing routine, and the source of the threshold still printed on laboratory reports. Everything in the overdiagnosis literature is, in effect, an audit of what this recommendation did when it was applied to whole populations.
Shares Screening by chest radiograph and lung cancer mortality: the Prostate, Lung, Colorectal, and Ovarian (PLCO) randomized trial, Decide who is screened for lung cancer by individual risk, not by pack-years, Screening for Lung Cancer: US Preventive Services Task Force Recommendation Statement, Positive predictive value (PPV).
Shares PATHFINDER 2, Whole-body MRI, Galleri, NHS-Galleri.
Shares NHS-Galleri: design of the largest randomised trial of a multi-cancer blood test, Galleri, NHS-Galleri, Positive predictive value (PPV).
Shares NHS-Galleri: design of the largest randomised trial of a multi-cancer blood test, PATHFINDER 2, Galleri, NHS-Galleri.
Shares PATHFINDER 2, Galleri, NHS-Galleri, Positive predictive value (PPV).
Shares PATHFINDER 2, Galleri, NHS-Galleri, Positive predictive value (PPV).
Shares Exact Sciences (Abbott), Shield, Galleri, Positive predictive value (PPV).
Shares PATHFINDER 2, Galleri, NHS-Galleri, Multi-cancer early detection (MCED).