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Reference · First edition · 1 Oct 2026
OncoFirm™ Cancer Biomarker Atlas 2026: First Edition
The OncoFirm™ Cancer Atlas 2026 brings together educational insights on cancer biomarkers, tumor-associated antigens, emerging diagnostic technologies and evolving research approaches across eight major cancer types. It is designed as a reference for healthcare, research and industry readers, and it highlights the science behind earlier cancer detection, multi-biomarker analysis and next-generation diagnostics. Every chapter is sourced, dated and clear about what is proven and what is still research.
At a glance
Edition
First edition, published 1 October 2026
Theme chapters
Biomarkers, tumor-associated antigens, emerging technologies, multi-biomarker analysis
Cancer chapters
Breast, colorectal, lung, prostate, liver, ovarian, pancreatic, gastric
Standard
Every figure sourced; every guideline and regulatory status dated
OncoFirm™ status
Assays in development; research use only; not for sale
On this page
Key numbers
The Atlas in three numbers
20.6 Mnew cancer cases worldwide in 2024 (GLOBOCAN 2024)
13.7–98.2%range of five-year survival across the eight cancers covered (US, all stages)
12sourced chapters: four themes and eight cancer types
Sources: GLOBOCAN 2024 (Sung et al., 2026) and SEER Cancer Stat Facts. Full citations below.
Theme chapters
Start with the four cross-cutting themes
The seven biomarker categories, what each classic serum marker is and is not used for, standards and assay differences, and how biomarkers are validated. Read the chapter →
Antigen classes, the sugar structures TF, Tn and sialyl-Tn, what is established in diagnostics and what remains research. Read the chapter →
Liquid biopsy, multi-cancer tests, AI, proteomics and point-of-care testing, sorted by what is approved, marketed or still experimental. Read the chapter →
Why panels can beat single markers, which algorithms are cleared and for what, and how to tell a trustworthy panel from an overfitted one. Read the chapter →
Cancer chapters
Eight cancers, side by side
Five-year relative survival for all stages combined, with the share of cases found while still localized (SEER Cancer Stat Facts, diagnoses 2016–2022). Cancers that are usually found late have the lowest survival.
| Cancer chapter | New cases worldwide, 2024 | US 5-year survival | Found localized | Screening status, Oct 2026 |
|---|---|---|---|---|
| Prostate | 1,546,112 | 98.2% | 69% | PSA by shared decision, ages 55–69 (USPSTF C, 2018) |
| Breast | 2,434,087 | 91.9% | 64% | Mammography every 2 years, ages 40–74 (USPSTF B, 2024) |
| Colorectal | 2,041,007 | 65.4% | 34% | Stool tests or colonoscopy, ages 45–75 (USPSTF, 2021) |
| Ovarian | 330,731 | 52.0% | 22% | No screening recommended (USPSTF D, 2018) |
| Gastric | 980,286 | 39.8% | 32% | No US screening; national programmes in Korea and Japan |
| Lung | 2,637,005 | 29.5% | 24% | Low-dose CT for high-risk adults, ages 50–80 (USPSTF B, 2021) |
| Liver | 843,045 | 21.9% | 45% | Surveillance only in cirrhosis and high-risk hepatitis B |
| Pancreatic | 531,318 | 13.7% | 15% | No average-risk screening (USPSTF D, 2019); high-risk surveillance |
Each chapter covers burden, stage and survival, screening status, established biomarkers by clinical role, tumor-associated antigens, emerging approaches and open research questions.
Key findings
What the first edition shows
- Stage decides survival. Across all eight cancers, survival falls steeply from localized to distant disease. The share found early ranges from 69% for prostate cancer to 15% for pancreatic cancer.
- Biomarkers guide care more than they screen. No classic serum marker is recommended for general population screening. CEA is for monitoring, PSA starts a shared-decision pathway, and AFP supports surveillance in cirrhosis.
- Earlier stage is not the same as fewer deaths. Ovarian screening with CA-125 found cancers earlier but did not reduce deaths. Randomized trials with mortality endpoints remain the standard.
- No multi-cancer blood test is FDA approved as of 1 October 2026. The first randomized trial missed its primary endpoint; an FDA decision on one test is pending. See the early detection evidence hub.
- Cleared multi-marker algorithms are for triage, not screening. Each is indicated for a defined, higher-risk group.
- Sugar antigens such as TF remain research-stage. They are scientifically interesting and not yet validated for clinical use. See the TF antigen guide.
How to read the Atlas
Our editorial standards
- Sourced. Every number links to a peer-reviewed paper, guideline, registry or regulator. Where sources disagree, we say so or use the more conservative figure.
- Dated. Guideline and regulatory statements carry a date, because recommendations changed quickly in 2025 and 2026.
- Role-specific. For each biomarker we state what it is used for and what it is not used for.
- Honest about evidence. We separate approved tests from marketed laboratory tests and from research, and accuracy studies from outcome trials.
- Independent. No company named in the Atlas reviewed or sponsored it.
Not medical advice. The Atlas is an educational reference. Decisions about screening, testing and treatment should be made with a qualified clinician.
The five volumes
The full Atlas, volume by volume
Volume I · Foundations
Volume II · Biomarker atlas
Volume III · Cancer atlas
Volume IV · Technology
Planned for later editions: kidney, bladder, brain, melanoma, leukemia, lymphoma and multiple myeloma chapters, and individual biomarker monographs.
OncoFirm™ roadmap
Why a diagnostics developer publishes an Atlas
OncoFirm™ is developing quantitative point-of-care tests for protein biomarkers. Building them responsibly starts with knowing exactly what each biomarker can and cannot do, so we publish that evidence openly.
Quantitative protein assays
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
Guideline roles, not screening
Intended uses mirror established roles: CEA monitoring and PSA risk assessment under clinical direction. Point-of-care oncology
Research pipeline
AFP is a future pipeline candidate; TF antigen assay concepts and multi-marker panels are concept-stage research. One reader, one strip
Evidence with partners
Analytical validation first, then clinical studies with independent collaborators. 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 and are not for sale. Designed ranges and result times are development targets, not validated performance claims.
FAQ
Frequently asked questions
What is the OncoFirm™ Cancer Biomarker Atlas 2026?
It is a free educational reference from OncoFirm™ Diagnostics. The first edition has 12 chapters: four on cross-cutting themes (cancer biomarkers, tumor-associated antigens, emerging diagnostic technologies and multi-biomarker analysis) and eight on major cancer types. Each chapter is sourced, dated and written for healthcare, research and industry readers.
Which cancers does the first edition cover?
Breast, colorectal, lung, prostate, liver, ovarian, pancreatic and gastric cancer. Chapters on kidney, bladder, brain, melanoma and blood cancers are planned for later editions.
Can biomarkers be used to screen for cancer?
Rarely on their own. No classic serum tumor marker is recommended for screening the general population. PSA is used by shared decision between ages 55 and 69, and AFP is used with ultrasound for surveillance in people with cirrhosis. Most biomarkers guide care after diagnosis: choosing treatment, monitoring response and watching for recurrence.
Is any multi-cancer early detection blood test FDA approved?
Not as of 1 October 2026. An FDA advisory panel backed the Galleri test on 23 September 2026 and the decision is pending. The first randomized trial, NHS-Galleri, did not reduce late-stage diagnoses, its primary endpoint.
How current is the Atlas, and how is it updated?
Every chapter reflects public information as of 1 October 2026 and dates its regulatory and guideline statements. Chapters are reviewed when a major decision or trial result changes the picture, and corrections are welcome through the collaboration form.
Does the Atlas describe OncoFirm™ products?
Only as a development roadmap. OncoFirm™ fluorescent lateral flow 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 and are not for sale.
Sources
References
- Sung H, Filho AM, Laversanne M, et al. Global cancer statistics 2024: GLOBOCAN estimates of incidence and mortality worldwide for 34 cancers in 186 countries. CA Cancer J Clin. 2026. doi.org/10.3322/caac.70090
- National Cancer Institute. SEER Cancer Stat Facts (five-year relative survival by stage, diagnoses 2016–2022). seer.cancer.gov/statfacts/
- American Cancer Society. Cancer Facts & Figures 2026. www.cancer.org/research/cancer-facts-statistics/all-cancer-facts-figures/2026-cancer-facts-figures.html
- U.S. Preventive Services Task Force. A and B recommendations and published recommendation topics. www.uspreventiveservicestaskforce.org/uspstf/recommendation-topics
- FDA-NIH Biomarker Working Group. BEST (Biomarkers, EndpointS, and other Tools) Resource. www.ncbi.nlm.nih.gov/books/NBK326791/
- National Cancer Institute. Tumor markers: fact sheet. www.cancer.gov/about-cancer/diagnosis-staging/diagnosis/tumor-markers-fact-sheet
- U.S. Food and Drug Administration. List of cleared or approved companion diagnostic devices. www.fda.gov/medical-devices/in-vitro-diagnostics/list-cleared-or-approved-companion-diagnostic-devices-in-vitro-and-imaging-tools
- 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/
- 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/
- Menon U, 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
- 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
Each chapter lists its own full references.
About the Atlas. Written by the OncoFirm™ Scientific Team from peer-reviewed publications, clinical guidelines, cancer registries and regulatory records, reflecting public information as of 1 October 2026. It replaces the earlier outline of this page. It is for education and is not medical advice. OncoFirm™ has no affiliation with the companies or tests named. OncoFirm™ assays are in development, have not been cleared or approved by the FDA and are not available for sale.
Contribute to the next edition
Clinicians, laboratories, researchers and industry partners can send corrections, data or proposals for validation studies. Collaboration inquiry · Investor inquiry