Array
OncoFirm™ / Research / Evidence hub

Evidence hub · Updated 1 Oct 2026

Early Cancer Detection Evidence Hub: What Screening Trials, Blood Tests and Biomarkers Show in 2026

A dated, sourced reference to what is proven, what is promising and what is still unknown in early cancer detection. It covers screening trials by cancer, the 2026 results and regulatory decisions on multi-cancer blood tests, the real roles of protein biomarkers, and the frameworks for judging new tests. Every status line carries a date, because guidance changed faster in 2025–2026 than in any recent period.

By OncoFirm™ Scientific TeamFirst published 29 Aug 2026Updated 1 Oct 2026Sources trials, guidelines, regulators, linked

At a glance

Proven by randomized trials

Breast, cervical, colorectal, lung and (modestly) prostate screening

Multi-cancer blood tests

None FDA approved; FDA panel backed Galleri 23 Sep 2026, decision pending

Blood tests for colorectal cancer

Two FDA approved; second-line in ACS 2026 guideline

US Preventive Services Task Force

Not met since mid-2025; new members named 17 Sep 2026

OncoFirm™ status

Point-of-care protein assays in development; research use only

On this page

Status at a glance

Early detection in 2026, in three numbers

5cancers with randomized-trial evidence that screening reduces deaths
IRR 1.03NHS-Galleri primary endpoint: stage III–IV cancers not reduced; stage IV fell 14%
0multi-cancer early detection tests FDA approved as of 1 October 2026

Sources: trial publications and regulatory records in the references. Status is as of 1 October 2026 and is reviewed when a listed decision changes.

Definitions

Screening, early diagnosis and surveillance are different

  • Early diagnosis means recognizing symptoms quickly and getting people promptly to diagnosis and treatment. WHO calls it a priority in every health system, whatever its resources.
  • Screening means testing people without symptoms to find cancer or precancer. It is justified only where trials show benefit outweighs harm and a programme can deliver follow-up.
  • Surveillance means repeated testing of a defined high-risk group, such as ultrasound and AFP every six months in cirrhosis, or follow-up after cancer treatment.
  • Diagnosis confirms cancer, usually by pathology. A positive screening or blood test result is never a diagnosis on its own.

For the case for early detection, see why early detection matters; for access gaps worldwide, the global need for affordable diagnostics.

Reading the evidence

How to judge an early-detection claim

The evidence ladder for early cancer detection tests, October 2026Five rungs of evidence, from bottom to top: analytical validity, clinical validity, stage shift, mortality reduction in randomized trials, and net benefit at programme level. Point-of-care CEA and PSA assays, including OncoFirm research assays, are at the analytical validity rung. Blood-based colorectal tests and PATHFINDER 2 provide clinical validity. NHS-Galleri tested stage shift: its primary stage III to IV endpoint was not met, while stage IV diagnoses fell 14%. Mammography, low-dose CT, stool tests and colonoscopy, HPV testing and PSA have randomized mortality evidence. USPSTF A and B grades and national programmes represent net benefit.THE EVIDENCE LADDER · WHERE TESTS STAND, 1 OCT 20265Net benefit at scaleBenefits outweigh harms in a real programme?USPSTF A/B grades · UK NSC and EU programmes4Fewer cancer deaths (RCT)Randomized trial shows lower mortality?Mammography · low-dose CT · FIT/colonoscopy · HPV · PSA (modest)3Stage shiftFewer cancers found at a late stage?NHS-Galleri: stage III–IV not reduced (IRR 1.03); stage IV −14%2Clinical validitySeparates cancer from no cancer?Shield, SimpleScreen CRC · PATHFINDER 2 (PPV 60.3%)1Analytical validityMeasures the marker accurately?Point-of-care CEA/PSA assays, incl. OncoFirm™ (research use)Each rung needs the ones below it. Detecting cancer earlier (rung 3) does not by itself prove fewer deaths (rung 4).

Every early-detection test climbs the same ladder. Rung numbers loosely follow the five phases of biomarker development described by Pepe and colleagues, and the analytic-to-clinical steps of the CDC’s ACCE model.

  • Cancer-specific mortality in randomized trials is the reference endpoint. Survival time is not, because of the biases below.
  • Lead-time bias: diagnosis comes earlier but death does not, so survival looks longer.
  • Length bias: periodic screening preferentially finds slow-growing tumours.
  • Overdiagnosis: screening finds cancers that would never have caused symptoms or death.
  • Healthy-volunteer bias: people who choose screening are healthier to begin with.

Stage shift is the contested middle rung. A 2025 meta-analysis of 57 screening trials found that reductions in late-stage incidence correlated with reductions in mortality (correlation 0.69 overall; 0.91 for lung, 0.79 for breast, 0.58 for colorectal). A 2026 simulation by Sasieni, Brentnall and Duffy showed that a correlation of 0.41 can appear even when late stage has no causal effect on mortality, and argued that a surrogate needs causal reasoning, not meta-analysis alone. The UKCTOCS ovarian trial is the warning case: screening shifted cancers to earlier stages yet did not reduce deaths.

Programme criteria. Wilson and Jungner (WHO, 1968), Andermann's 2008 update and the UK National Screening Committee criteria ask whether a programme should exist at all. The USPSTF grades A to D and I rate net benefit; the IARC Handbooks rate evidence as sufficient, limited or inadequate.

Evidence by cancer

The five cancers with trial-proven screening

CancerUS recommendation (dated)Mortality evidence2024–2026 change
BreastUSPSTF B (Apr 2024): mammography every 2 years, ages 40–74; I for extra imaging in dense breastsAbout 20% relative reduction; roughly 1 death prevented per 235 women invited over 20 years, with about 3 overdiagnosed cases per death preventedMASAI RCT (Lancet, Feb 2026): AI-supported reading raised sensitivity from 73.8% to 80.5% at unchanged 98.5% specificity; FDA density notification required since Sep 2024
CervicalUSPSTF A (Aug 2018), ages 21–65; Dec 2024 draft adding HPV self-collection not finalizedEstablished for cytology and HPV testing; WHO 90-70-90 elimination targets for 2030ACS (Dec 2025): start at 25, primary HPV every 5 years, self-collection acceptable; first FDA-approved at-home collection device (May 2025)
ColorectalUSPSTF A 50–75, B 45–49 (May 2021); blood tests not includedStool tests and endoscopy reduce incidence and mortality; NordICC and COLONPREV show participation drives benefitACS (May 2026): ages 45–75, blood tests only for people who decline preferred tests; FDA approved SimpleScreen CRC (Jul 2026) after Shield (Jul 2024)
LungUSPSTF B (Mar 2021): annual low-dose CT, ages 50–80, ≥20 pack-years, quit ≤15 yearsNLST: 20% fewer lung cancer deaths; NELSON: 24% fewer in men at 10 yearsAustralia national programme from Jul 2025; only about 1 in 5 eligible US adults screened
ProstateUSPSTF C ages 55–69, D ≥70 (May 2018); update stalledERSPC at 23 years: 13% fewer prostate cancer deaths (RR 0.87); 456 men invited and 12 diagnosed per death preventedUK NSC (May 2026): screen only men with a BRCA2 variant, ages 45–61; MRI-first diagnostic pathways

No average-risk screening: ovarian (USPSTF D; UKCTOCS and PLCO showed no mortality benefit), skin (USPSTF I), gastric (national endoscopy programmes only in East Asia), esophageal (targeted evaluation for Barrett’s esophagus only) and liver, where surveillance with ultrasound ± AFP every six months is recommended only for people with cirrhosis or selected chronic hepatitis B.

US guideline status

Why every US recommendation here carries a date

The USPSTF has not met since mid-2025. In June 2025 the Supreme Court (Kennedy v. Braidwood) upheld no-cost coverage of USPSTF A/B services by placing the Task Force under the HHS Secretary's authority. Meetings were then cancelled or postponed; the Secretary dismissed the two vice chairs on 11 May 2026 and named eight new, mostly specialist members on 17 September 2026. No meeting date had been announced as of 1 October 2026. Existing grades remain in force.

In practice, professional societies are now moving ahead of the Task Force: the American Cancer Society updated cervical guidance in December 2025 and colorectal guidance in May 2026. Prostate screening and blood-based colorectal tests are the topics most likely to change when the reconstituted Task Force meets.

Blood tests and MCED

Blood-based screening: accurate enough to approve, not yet proven to save lives

Study or decisionDesignKey resultsWhat it means
NHS-Galleri (ASCO, Jun 2026)RCT, about 142,000 adults in England; 3 annual tests vs usual carePrimary stage III–IV endpoint not met (IRR 1.03, p=0.63); stage IV −14% (IRR 0.86); specificity 99.55%; PPV 52.0%; sensitivity 30.7% (54.7% for 12 deadly cancers)First randomized MCED evidence; mixed. No mortality data yet
PATHFINDER 2 (Nature Medicine, Sep 2026)Single-arm US cohort; 32,007 in performance analysisPPV 60.3%; specificity 99.64%; sensitivity 39.3%; origin correct 91.3%; 53% of detected cancers stage I–II; 0.6% had invasive proceduresAccuracy and safety, not outcomes
FDA advisory panel (23 Sep 2026)Galleri premarket approval application filed Jan 2026Safety 10–0; effectiveness 6–4; benefit-risk 7–2 (1 abstention)FDA decision pending; the vote is not binding
Medicare MCED law (3 Feb 2026)Public Law 119-75Allows Medicare coverage of FDA-approved or cleared MCED tests from 2028 at the earliest, with an age phase-inCoverage cannot start until a test is FDA authorized
NCI Vanguard StudyFeasibility study, up to 24,000 people; Shield MCD and Avantect MCDRecruitingGroundwork for a mortality-powered randomized trial
Colorectal blood testsShield (FDA, Jul 2024); SimpleScreen CRC (FDA, Jul 2026)Cancer sensitivity 81–83%; advanced precancerous lesions about 13–14%; specificity about 90%Second-line option for people who decline stool tests or colonoscopy

No professional society recommends MCED testing for routine screening. Expert reaction to NHS-Galleri was split: some called the stage IV signal promising, others warned against “moving the goal posts” after a missed primary endpoint. For how these tests work, see AI-driven biomarkers and early detection, cell-free DNA and liquid biopsy explained.

Protein biomarkers

CEA, PSA, AFP and CA-125: what they are for

MarkerGuideline-supported roleNot recommended forKey evidence
CEASurveillance after curative colorectal cancer surgery (with CT); monitoring metastatic diseaseScreening or diagnosisASCO: “not recommended as a screening test”; FACS trial: more curative surgery for recurrence, no clear survival gain
PSAEntry point to a shared-decision, risk-stratified prostate pathway (PSA density, secondary tests, MRI before biopsy)Unselected screening without shared decision-making; men 70+ (USPSTF D)ERSPC 23-year mortality benefit; PRECISION: MRI-first pathway avoided biopsy in about 28% of men
AFPLiver cancer surveillance with ultrasound every 6 months in cirrhosis (AASLD 2023)General population screeningGALAD score validated in studies; holds FDA Breakthrough designation, not marketing authorization
CA-125Monitoring treatment and recurrence of ovarian cancer; limited high-risk useAverage-risk ovarian screening (USPSTF D)UKCTOCS and PLCO: no reduction in ovarian cancer deaths; false positives led to surgery

Protein markers are inexpensive and well characterized, which is why multi-analyte research panels still include them. See the Cancer Biomarker Atlas 2026, what is biochemical diagnostics and research markers such as the Thomsen-Friedenreich antigen.

Harms and limits

What every screening test can cost

  • False positives and the cascade: recalls, imaging, biopsies and anxiety. Up to 8 in 10 positive PSA tests are false positives.
  • Overdiagnosis: treatment of cancers that would never have caused harm, most studied in breast, prostate, lung and thyroid.
  • False reassurance: a negative blood test can miss most early cancers; NHS-Galleri missed about two in three cancers arising during screening.
  • Procedural harm: colonoscopy perforation and bleeding, biopsy infection, radiation from CT.
  • Incidental findings: common with CT and whole-body imaging, often leading to further tests.
  • Inequity: uptake is lowest where risk is often highest; only about 1 in 5 eligible US adults gets lung screening.

Point of care and OncoFirm™

Where OncoFirm™ sits on the evidence ladder

Point-of-care quantitative immunoassays for CEA and PSA exist in several markets, but the published evidence is mostly small analytical-agreement studies, and none is known to be FDA cleared for point-of-care CEA or PSA use. OncoFirm™ is building its fluorescent lateral flow platform to meet the REASSURED benchmark for accessible diagnostics, using a small reader rather than a laboratory analyser, and to climb the evidence ladder one rung at a time.

Quantitative protein data

Fluorescent lateral flow assays designed to report CEA (1–100 ng/mL) and PSA (0.5–50 ng/mL), with planned traceability to WHO international standards. Platform

Rung 1 first

Method comparison, precision, limit of detection, hook-effect and interference studies against laboratory immunoassays before any clinical claim. How LFAs work

Guideline pathways, not screening

Intended uses mirror the laboratory assays: CEA monitoring and PSA risk stratification under clinical direction. Point-of-care oncology

Validation with partners

Clinical collaborations to generate independent evidence in the settings where tests would be used. Clinical collaborations

OncoFirm™ assays, reader and software are in development, have not been cleared or approved by the FDA or any other regulatory authority, are for research use only, are not for sale and make no screening or multi-cancer detection claims.

Decisions to watch

What will change this page next

DecisionStatus on 1 Oct 2026Why it matters
FDA decision on GalleriPending after 23 Sep 2026 panelWould be the first FDA-approved MCED test and the trigger for Medicare coverage
First meeting of the reconstituted USPSTFNo date announcedCervical self-collection draft; prostate and blood-based colorectal topics
NHS-Galleri mortality follow-upNot yet reportedThe endpoint that would settle whether stage IV reduction saves lives
UK ministerial decision on targeted prostate screeningAwaiting decision on UK NSC May 2026 recommendationFirst national PSA programme limited to BRCA2 carriers
Medicare MCED coverageLaw enacted; earliest start 2028Depends on FDA authorization of a test
NCI Vanguard StudyRecruitingFeasibility of a definitive randomized MCED trial

FAQ

Frequently asked questions

Which cancers have screening proven to reduce deaths?

Randomized trials show that screening reduces deaths from breast cancer (mammography), cervical cancer (HPV testing and cytology), colorectal cancer (stool tests and endoscopy), lung cancer in high-risk people (low-dose CT) and, more modestly, prostate cancer (PSA). No other cancer has an average-risk population screening programme recommended in the United States.

Is a multi-cancer early detection blood test FDA approved?

Not as of 1 October 2026. GRAIL filed the first premarket approval application for its Galleri test in January 2026, and on 23 September 2026 an FDA advisory panel voted 10–0 on safety, 6–4 on effectiveness and 7–2 with one abstention on benefit-risk. The FDA had not issued a decision at the time of writing.

What did the NHS-Galleri trial show?

In about 142,000 adults in England, adding three annual Galleri tests did not reduce stage III–IV cancers, the trial's primary endpoint (IRR 1.03). Stage IV diagnoses fell 14% as a secondary finding, specificity was 99.55% and positive predictive value 52%, but the test missed about two in three cancers that arose during screening. No mortality data are available yet.

Can CEA, PSA, AFP or CA-125 be used to screen for cancer?

Only PSA has a screening role, as the entry point to a shared-decision, risk-stratified prostate pathway that now includes MRI. AFP is used with ultrasound for liver cancer surveillance in people with cirrhosis. CEA is used to monitor colorectal cancer after treatment and is not recommended for screening. CA-125 screening did not reduce ovarian cancer deaths in large trials.

Why does finding cancer earlier not always save lives?

Earlier diagnosis can lengthen apparent survival without changing the date of death (lead-time bias), favour slow-growing tumours (length bias) and find cancers that would never have caused harm (overdiagnosis). In the UKCTOCS trial, ovarian screening shifted cancers to earlier stages yet did not reduce deaths. That is why cancer-specific mortality in randomized trials remains the reference standard.

Are blood tests for colorectal cancer screening recommended?

Two blood tests are FDA approved: Guardant Shield (2024) and Freenome SimpleScreen CRC (July 2026). The American Cancer Society's May 2026 guideline includes them only for people who decline or do not complete stool tests or colonoscopy, because they detect few advanced precancerous lesions. A positive result needs a follow-up colonoscopy.

Does OncoFirm™ offer a screening test?

No. OncoFirm™ is developing quantitative fluorescent lateral flow assays for protein biomarkers such as CEA and PSA, intended for point-of-care measurement within guideline-defined clinical pathways. They are in development, have not been cleared or approved by the FDA or any other regulatory authority, are for research use only and are not for sale.

Sources

References

  1. STAT. Kennedy names eight new members to the U.S. Preventive Services Task Force. September 17, 2026. www.statnews.com/2026/09/17/kennedy-names-eight-new-members-uspstf-task-force/
  2. Fierce Healthcare. Kennedy dismisses leaders of U.S. Preventive Services Task Force. May 2026. www.fiercehealthcare.com/regulatory/kennedy-dismisses-leaders-us-preventive-services-task-force
  3. U.S. Supreme Court. Kennedy v. Braidwood Management, Inc., No. 24-316. June 27, 2025. www.supremecourt.gov/opinions/24pdf/24-316_2c83.pdf
  4. USPSTF. Breast cancer: screening. Final recommendation, April 30, 2024. www.uspreventiveservicestaskforce.org/uspstf/recommendation/breast-cancer-screening
  5. Independent UK Panel on Breast Cancer Screening. The benefits and harms of breast cancer screening: an independent review. Lancet. 2012;380:1778–1786. doi.org/10.1016/S0140-6736(12)61611-0
  6. The ASCO Post. Randomized trial shows AI-supported mammography improves sensitivity and lowers interval cancer rate (MASAI). February 2026. ascopost.com/news/february-2026/randomized-trial-shows-ai-supported-mammography-improves-sensitivity-and-lowers-interval-cancer-rate/
  7. USPSTF. Cervical cancer: screening. Final recommendation, August 21, 2018; draft recommendation, December 2024. www.uspreventiveservicestaskforce.org/uspstf/recommendation/cervical-cancer-screening
  8. American Cancer Society. Updated cervical cancer screening guidelines. December 2025. pressroom.cancer.org/updated-cervical-cancer-screening-guidelines-2025
  9. World Health Organization. Global strategy to accelerate the elimination of cervical cancer as a public health problem. 2020. www.who.int/publications/i/item/9789240014107
  10. USPSTF. Colorectal cancer: screening. Final recommendation, May 18, 2021. www.uspreventiveservicestaskforce.org/uspstf/recommendation/colorectal-cancer-screening
  11. American Cancer Society. Colorectal cancer screening guideline update. May 27, 2026. pressroom.cancer.org/colorectal-cancer-screening-guideline-update-2026
  12. Chung DC, Gray DM, Singh H, et al. A cell-free DNA blood-based test for colorectal cancer screening (ECLIPSE). N Engl J Med. 2024;390:973–983. www.nejm.org/doi/full/10.1056/NEJMoa2304714
  13. The ASCO Post. FDA approves SimpleScreen CRC blood-based screening test for colorectal cancer. July 2026. ascopost.com/news/july-2026/fda-approves-simplescreen-crc-blood-based-screening-test-for-colorectal-cancer/
  14. Bretthauer M, Løberg M, Wieszczy P, et al. Effect of colonoscopy screening on risks of colorectal cancer and related death (NordICC). N Engl J Med. 2022;387:1547–1556. www.nejm.org/doi/full/10.1056/NEJMoa2208375
  15. Castells A, Quintero E, et al. Colonoscopy versus faecal immunochemical test for colorectal cancer screening (COLONPREV). Lancet. 2025. www.thelancet.com/journals/lancet/article/PIIS0140-6736(25)00145-X/fulltext
  16. USPSTF. Lung cancer: screening. Final recommendation, March 9, 2021. www.uspreventiveservicestaskforce.org/uspstf/recommendation/lung-cancer-screening
  17. National Lung Screening Trial Research Team. Reduced lung-cancer mortality with low-dose computed tomographic screening. N Engl J Med. 2011;365:395–409. www.nejm.org/doi/full/10.1056/NEJMoa1102873
  18. de Koning HJ, van der Aalst CM, et al. Reduced lung-cancer mortality with volume CT screening in a randomized trial (NELSON). N Engl J Med. 2020;382:503–513. www.nejm.org/doi/full/10.1056/NEJMoa1911793
  19. USPSTF. Prostate cancer: screening. Final recommendation, May 8, 2018. www.uspreventiveservicestaskforce.org/uspstf/recommendation/prostate-cancer-screening
  20. The ASCO Post. Extended ERSPC analysis demonstrates long-term mortality benefit of PSA screening. November 2025. ascopost.com/news/november-2025/extended-erspc-analysis-demonstrates-long-term-mortality-benefit-of-psa-screening-for-prostate-cancer/
  21. Cancer Research UK. UK NSC recommends prostate cancer screening for men with a BRCA2 gene change. May 28, 2026. news.cancerresearchuk.org/2026/05/28/uk-nsc-recommends-prostate-cancer-screening-for-men-with-a-brca2-gene-change-and-family-history-of-cancer/
  22. Menon U, Gentry-Maharaj A, Burnell M, et al. Ovarian cancer population screening and mortality after long-term follow-up in UKCTOCS. Lancet. 2021;397:2182–2193. www.thelancet.com/journals/lancet/article/PIIS0140-6736(21)00731-5/fulltext
  23. GRAIL. Full results from the NHS-Galleri trial presented at the 2026 ASCO Annual Meeting. News release, 2026. grail.com/press-releases/grail-reports-full-results-from-nhs-galleri-trial-demonstrating-substantial-reduction-in-stage-iv-cancer-diagnoses-at-2026-asco-annual-meeting/
  24. The ASCO Post. Annual Galleri screening reduced stage IV cancer diagnoses but missed primary endpoint in first randomized MCED trial. June 2026. ascopost.com/news/june-2026/annual-galleri-screening-reduced-stage-iv-cancer-diagnoses-but-missed-primary-endpoint-in-first-randomized-mced-trial/
  25. Science Media Centre. Expert reaction to full results of the NHS-Galleri trial. May 2026. www.sciencemediacentre.org/expert-reaction-to-press-release-from-grail-on-full-results-of-the-nhs-galleri-trial-being-presented-at-asco/
  26. Performance and safety of a multi-cancer early detection test: the PATHFINDER 2 study. Nature Medicine. September 2026. www.nature.com/articles/s41591-026-04618-w
  27. STAT. FDA advisory panel recommends approval of GRAIL's Galleri multi-cancer blood test. September 23, 2026. www.statnews.com/2026/09/23/fda-advisory-panel-recommends-approval-grail-galleri-multi-cancer-blood-test/
  28. Consolidated Appropriations Act, 2026, Public Law 119-75 (includes the Nancy Gardner Sewell Medicare Multi-Cancer Early Detection Screening Coverage Act). www.congress.gov/119/plaws/publ75/PLAW-119publ75.pdf
  29. National Cancer Institute, Division of Cancer Prevention. Cancer Screening Research Network: Vanguard Study. prevention.cancer.gov/research-areas/networks-consortia-programs/csrn/vanguard-study
  30. Locker GY, et al. ASCO 2006 update of recommendations for the use of tumor markers in gastrointestinal cancer. J Clin Oncol. 2006;24:5313–5327. ascopubs.org/doi/10.1200/JCO.2006.08.2644
  31. Primrose JN, et al. Effect of 3 to 5 years of scheduled CEA and CT follow-up on recurrence of colorectal cancer (FACS). JAMA. 2014;311:263–270. jamanetwork.com/journals/jama/fullarticle/1812958
  32. Kasivisvanathan V, et al. MRI-targeted or standard biopsy for prostate-cancer diagnosis (PRECISION). N Engl J Med. 2018;378:1767–1777. www.nejm.org/doi/full/10.1056/NEJMoa1801993
  33. Singal AG, et al. AASLD practice guidance on prevention, diagnosis, and treatment of hepatocellular carcinoma. Hepatology. 2023;78:1922–1965. journals.lww.com/hep/fulltext/2023/12000/aasld_practice_guidance_on_prevention,_diagnosis,.30.aspx
  34. Buys SS, et al. Effect of screening on ovarian cancer mortality: the PLCO randomized controlled trial. JAMA. 2011;305:2295–2303. jamanetwork.com/journals/jama/fullarticle/900476
  35. Late-stage outcomes as surrogates for mortality in cancer screening trials: a systematic review and meta-analysis. Cancer Epidemiol Biomarkers Prev. 2025;34(10):1694. aacrjournals.org/cebp/article/34/10/1694/765943/Late-Stage-Outcomes-as-Surrogates-for-Mortality-in
  36. Sasieni P, Brentnall A, Duffy S. Stage shift as a surrogate endpoint in cancer screening trials: a simulation study. eClinicalMedicine. 2026. www.sciencedirect.com/science/article/pii/S2589537026001094
  37. Pepe MS, et al. Phases of biomarker development for early detection of cancer. J Natl Cancer Inst. 2001;93:1054–1061. academic.oup.com/jnci/article/93/14/1054/2906417
  38. Wilson JMG, Jungner G. Principles and practice of screening for disease. World Health Organization; 1968. iris.who.int/handle/10665/37650
  39. UK National Screening Committee. Criteria for appraising the viability, effectiveness and appropriateness of a screening programme. www.gov.uk/government/publications/evidence-review-criteria-national-screening-programmes/criteria-for-appraising-the-viability-effectiveness-and-appropriateness-of-a-screening-programme
  40. USPSTF. Grade definitions. www.uspreventiveservicestaskforce.org/uspstf/about-uspstf/methods-and-processes/grade-definitions
  41. National Cancer Institute. Cancer screening overview (PDQ®), health professional version. www.cancer.gov/about-cancer/screening/hp-screening-overview-pdq
  42. World Health Organization. Guide to cancer early diagnosis. 2017. iris.who.int/handle/10665/254500
  43. Land KJ, Boeras DI, Chen XS, Ramsay AR, Peeling RW. REASSURED diagnostics to inform disease control strategies. Nature Microbiology. 2019;4:46–54. doi.org/10.1038/s41564-018-0295-3

About this hub. Compiled by the OncoFirm™ Scientific Team from randomized trials, guideline documents, regulatory records and peer-reviewed analyses, all linked above. Each status line is dated and reflects public information as of 1 October 2026; the page is reviewed when a decision in the watch list changes. Where sources disagreed on a detail, we used the more conservative wording. OncoFirm™ has no affiliation with the companies or tests named. This page is for education and is not medical advice; screening decisions should be made with a clinician. OncoFirm™ assays are in development, have not been cleared or approved by the FDA and are not available for sale.

Build the evidence with us

Clinicians, laboratories and research groups interested in validating quantitative point-of-care protein assays can reach the OncoFirm™ team. Collaboration inquiry · Investor inquiry

[email protected]+1 516.900.2606Port Washington, NY