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Cancer Atlas 2026 · Pancreatic cancer

Pancreatic Cancer Biomarkers and Early Detection in 2026: CA 19-9, KRAS and High-Risk Surveillance

Pancreatic cancer is the 11th most common cancer worldwide but the 6th leading cause of cancer death. No screening test is recommended for people at average risk, and the one widely used blood marker, CA 19-9, is a monitoring tool with known blind spots. This article covers surveillance for high-risk groups, the biomarkers that guide care, and what new blood tests and AI have shown as of 1 October 2026.

By OncoFirm™ Scientific TeamPublished 1 Oct 2026Updated 1 Oct 2026Sources peer-reviewed, guidelines, regulators, linked

At a glance

Burden

531,318 new cases and 490,786 deaths worldwide in 2024. US, 2026: 67,530 new cases and 52,740 deaths.

Stage

US five-year relative survival: 43.6% localized, 3.4% distant. Only 15% of cases are localized at diagnosis (SEER, 2016–2022).

Screening

None for average-risk adults (USPSTF 2019, Grade D). Imaging surveillance is for people at high inherited or familial risk.

Key biomarkers

CA 19-9 for monitoring, not screening. Germline BRCA1/2 and PALB2, KRAS mutations and rare NRG1 fusions inform treatment.

OncoFirm™ status

Assays in development; research use only; not cleared or approved by the FDA or any other regulatory authority; not for sale. No pancreatic cancer claims.

On this page

Key numbers

Pancreatic cancer in three numbers

490,786deaths worldwide in 2024, against 531,318 new cases
15%of US cases are localized at diagnosis
3.4%US five-year relative survival when diagnosed at distant stage

Sources: GLOBOCAN 2024 (Sung et al., 2026) and SEER Cancer Stat Facts: Pancreatic Cancer (diagnoses 2016–2022), accessed 1 October 2026.

Burden

An uncommon cancer with a very high death rate

GLOBOCAN 2024, the global estimate published in 2026, counts 531,318 new cases of pancreatic cancer in 2024 (2.6% of all cancers, rank 11) and 490,786 deaths (5.0% of all cancer deaths, rank 6). Deaths equal about 92% of new cases.

In the United States, the American Cancer Society (ACS) estimates 67,530 new cases and 52,740 deaths in 2026. Incidence has risen by about 1% a year since the late 1990s. The GLOBOCAN report cites five-year survival of 13% in the US, 8% in the UK and 14% in Australia.

Most of this article concerns pancreatic ductal adenocarcinoma (PDAC), the main form of the disease. This page is part of the OncoFirm™ Cancer Atlas 2026; for the basic terms, see Cancer biomarkers explained.

Why stage matters

Only 15% of US cases are found while still localized

Pancreatic cancer: five-year relative survival by stage at diagnosisBar chart of five-year relative survival for Pancreatic cancer by stage at diagnosis in the United States, 2016–2022: Localized 43.6% survival, 15% of cases; Regional 17.0% survival, 28% of cases; Distant 3.4% survival, 51% of cases. All stages combined: 13.7%. Source: SEER Cancer Stat Facts.PANCREATIC CANCER · FIVE-YEAR RELATIVE SURVIVAL BY STAGE (US, 2016–2022)0%25%50%75%100%Localized15% of cases43.6%Regional28% of cases17.0%Distant51% of cases3.4%All stages combined: 13.7% · SEER Cancer Stat Facts

Five-year relative survival for pancreatic cancer by stage at diagnosis, United States, 2016–2022. The SEER pancreas category covers all pancreatic cancers, including neuroendocrine tumors, which have better survival. Unstaged cases (5%, 12.5% survival) are not shown. Source: SEER Cancer Stat Facts: Pancreatic Cancer, accessed 1 October 2026.

SEER, the US National Cancer Institute registry program, uses three summary stages: localized (confined to the pancreas), regional (spread to nearby lymph nodes or tissues) and distant (spread to other parts of the body). For diagnoses from 2016 to 2022, five-year relative survival (survival compared with similar people in the general population) was 43.6% at localized stage, 17.0% at regional stage and 3.4% at distant stage. Only 15% of cases were localized, 28% were regional and 51% were distant. Across all stages, survival was 13.7%.

Two points stand out. First, the SEER pancreas category includes neuroendocrine tumors, which have much better survival (72% at five years in ACS data), so figures for PDAC alone are lower. Second, even localized disease has five-year survival below 50%. Useful early detection probably has to find very small stage I cancers or high-grade precursor lesions (growths that can turn into cancer).

Read this chart with care. Survival by stage is not the gain a test would deliver. Lead-time bias (diagnosis moves earlier, death does not) and length bias (testing finds slower-growing cancers) inflate survival by stage. See Why early detection matters and the Early detection evidence hub.

Screening

No average-risk screening; surveillance for high-risk groups

On 6 August 2019 the USPSTF recommended against screening for pancreatic cancer in adults without symptoms (Grade D). The statement does not apply to people at high risk from inherited syndromes (such as Peutz-Jeghers syndrome or hereditary pancreatitis) or familial pancreatic cancer. ACS says high-risk individuals may benefit from annual surveillance.

Why not test everyone? The disease is rare, so false positives outnumber true positives. A worked example: if 1 in 100 people tested has cancer, a test with 85% sensitivity and 95% specificity gives a positive result that is correct only about 15% of the time. In the general population the share is far lower.
  • High-risk surveillance: specialist centers follow people with a strong family history or certain inherited gene variants, using MRI and endoscopic ultrasound (an ultrasound probe passed down the throat to view the pancreas).
  • What it has shown: a 2024 study compared 26 high-risk people whose PDAC was found under surveillance in the CAPS program with 1,504 matched SEER controls. Stage I at diagnosis was 38.5% versus 10.3%, and five-year survival was 50% versus 9%. With 26 cases, and lead-time and length bias, this supports surveillance in defined high-risk groups, not population screening.
  • Cohorts under study: the PRECEDE consortium follows 1,759 people in its highest-risk group across North American and European centers.
  • New-onset diabetes: this is the main candidate for a second higher-risk group. A randomized trial, the Early Detection Initiative, is testing algorithm-based screening in it. No results were found in the sources reviewed.

Biomarkers

Established biomarkers: CA 19-9 and the genes that guide treatment

BiomarkerTypeUsed forNot used for
CA 19-9Serum glycan antigenMonitoring treatment and prognosis in diagnosed cancerScreening; stand-alone diagnosis
Germline BRCA1/2, PALB2Inherited gene variantsFamily risk; treatment planning (olaparib maintenance was tested in BRCA carriers)Population screening
KRAS mutationsTumor driver alterationFound in more than 90% of patients; target of a RAS inhibitor approved in 2026Early detection
NRG1 fusions (rare)Tumor driver alterationZenocutuzumab (accelerated approval, December 2024)Screening

CA 19-9 has four limits that every reader should know.

  • It works best in people with symptoms. There, sensitivity is 79 to 81% and specificity is 82 to 90%. The US National Cancer Institute lists its use as checking whether treatment is working.
  • It fails as a screen. In people without symptoms, its positive predictive value is only 0.5 to 0.9%.
  • Some people cannot make it. About 5 to 10% of people are Lewis antigen-negative, a blood group trait, and do not produce CA 19-9, so a normal result does not rule out cancer. A second review puts the share at about 6% of Caucasian and 22% of non-Caucasian populations.
  • Benign disease raises it. Pancreatitis and bile duct obstruction can raise CA 19-9. False positives occur in 10 to 60% of patients with obstructive jaundice. The usual cut-off is 37 U/mL.

KRAS-targeted therapy arrived in 2026. On 26 August 2026 the FDA approved daraxonrasib, which blocks active RAS proteins, for adults with metastatic pancreatic adenocarcinoma who have had prior systemic therapy or cannot have multi-agent therapy, according to trade and cancer center reports. In the phase 3 RASolute 302 trial of 500 patients, median overall survival was 13.2 months with daraxonrasib and 6.7 months with chemotherapy (hazard ratio 0.40). This is a treatment advance. It does not change how the cancer is found.

Antigens and glycans

CA 19-9 is a glycan antigen; other glycans remain research

A tumor-associated antigen is a non-mutated molecule that tumors make in abnormal amounts or altered forms (see Tumor-associated antigens). CA 19-9 is one: a sugar structure (glycan) called sialyl-Lewis a. It is the only glycan antigen in clinical use for pancreatic cancer.

  • Truncated O-glycans: the short sugar chains Tn and sialyl-Tn appear when the enzymes that extend these chains are disrupted. Laboratory studies link them to invasion and spread.
  • Mucins: high expression of the mucins MUC4, MUC16 and MUC20 correlates with poor survival.
  • Research stage: sialyl-Lewis x has been reported in some cancers that do not make CA 19-9. Thomsen-Friedenreich (TF) antigen and mucin glycoforms are also studied (TF is commonly detected with the lectin peanut agglutinin). None is a validated diagnostic for pancreatic cancer.

Emerging

Emerging approaches in 2025 and 2026

Several blood tests reported strong results in 2025 and 2026. Most add new markers to CA 19-9, an example of multi-biomarker analysis.

TestMeasuresReported resultEvidence
PAC-MANN (2025)Protease activityWith CA 19-9, 85% detection of stage I350 samples; further trials planned
Four-protein panel (January 2026)ANPEP, PIGR, THBS2 and CA 19-987.5% of stage I and II cancers identifiedRetrospective banked samples
PANXEON (September 2026)10 microRNAs and CA 19-986.8% sensitivity for stage I and II1,785 people, four countries
PancreaSure (June 2026)Not stated in the source83.3% sensitivity for stage I and II at 91.6% specificityCompany-reported
None of these is FDA approved, and none has prospective screening evidence. The studies are retrospective or case-control (known cancers compared with controls), a design that tends to overstate accuracy. PANXEON shows why the control group matters: its false-positive rate was 3.2% in low-risk controls but 15.6% in high-risk controls, the people who would be tested in practice.
  • AI on routine CT: the REDMOD model (Gut, April 2026) was tested on CT scans taken before diagnosis and first read as normal. It flagged 73.0% of the later cancers, a median of 475 days before diagnosis, with 81.1% specificity. The study is retrospective, and that specificity would mean many false alarms in unselected patients.
  • Multi-cancer early detection (MCED): no MCED blood test is FDA approved as of 1 October 2026. Pancreatic cancer was one of 12 prespecified cancers in the randomized NHS-Galleri trial, which missed its primary endpoint. No pancreas-specific results were released. An FDA advisory panel backed the Galleri test on 23 September 2026; the FDA decision is pending.

See also Emerging cancer diagnostic technologies and the guides to liquid biopsy and AI and multi-biomarker blood tests.

Open questions

Open research questions

  1. Who should be tested? Which group (familial risk, new-onset diabetes, pancreatic cysts) has enough cancer for a positive result to be useful?
  2. Do blood tests hold up prospectively in people with pancreatitis, cysts, diabetes or bile duct obstruction?
  3. Can tests find stage I cancers and high-grade precursors, not just disease that already causes symptoms?
  4. How should CA 19-9 non-producers be covered? Other glycans or non-glycan markers are candidates.
  5. Does surveillance reduce deaths once lead-time and length bias are accounted for, and what are the harms of surgery?

OncoFirm™ roadmap

How pancreatic cancer relates to the OncoFirm™ roadmap

OncoFirm™ makes no pancreatic cancer claims. This page is in the Atlas because CA 19-9 shows clearly what a serum antigen can and cannot do, a lesson that applies to every quantitative marker assay.

Assays in development

The OncoFirm™ CEA assay (designed range 1–100 ng/mL) and PSA assay (0.5–50 ng/mL) are in development and for research use only. Neither is a pancreatic cancer test.

Reader and strip platform

The fluorescent lateral flow platform pairs one reader with one strip design. The result-time target of 20 minutes or less is a development target, not a validated claim.

Glycan antigen concepts

Assay concepts for TF antigen are concept-stage. No glycan other than CA 19-9 is in clinical use for pancreatic cancer.

What the evidence asks for

Any new marker needs prospective testing in the people who would be tested, not only case-control data. Researchers can propose a collaboration.

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

Is there a screening test for pancreatic cancer?

Not for people at average risk. The USPSTF recommends against screening adults without symptoms (2019, Grade D). People at high inherited or familial risk may be offered imaging surveillance in specialist centers.

What is CA 19-9 used for?

CA 19-9 is a blood marker used to monitor treatment and prognosis in people already diagnosed with pancreatic cancer. It is not a screening test: in people without symptoms its positive predictive value is only 0.5 to 0.9%. It can also rise in pancreatitis and bile duct obstruction.

Why can CA 19-9 be normal in someone with pancreatic cancer?

About 5 to 10% of people are Lewis antigen-negative, a blood group trait, and cannot make CA 19-9. In them the level stays low even when cancer is present, so a normal result does not rule out cancer.

What changed in pancreatic cancer treatment in 2026?

On 26 August 2026 the FDA approved daraxonrasib, a RAS inhibitor, for previously treated metastatic pancreatic adenocarcinoma. In the RASolute 302 trial, median overall survival was 13.2 months versus 6.7 months with chemotherapy. KRAS mutations are found in more than 90% of patients.

Are the new pancreatic cancer blood tests ready for screening?

No. Tests such as PAC-MANN, PANXEON and a four-protein panel reported 85 to 88% detection of early-stage cancer, but in retrospective or case-control studies. None is FDA approved and none has prospective screening evidence as of 1 October 2026.

Does OncoFirm™ offer a pancreatic cancer test?

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

Sources

References

  1. 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: A Cancer Journal for Clinicians. 2026. doi:10.3322/caac.70090. www.cancer.org/content/dam/cancer-org/research/cancer-facts-and-statistics/global-cancer-facts-and-figures/global-cancer-statistics-2024.pdf
  2. American Cancer Society. Cancer Facts & Figures 2026. www.cancer.org/content/dam/cancer-org/research/cancer-facts-and-statistics/annual-cancer-facts-and-figures/2026/2026-cancer-facts-and-figures.pdf
  3. National Cancer Institute, SEER Program. Cancer Stat Facts: Pancreatic Cancer. Accessed 1 October 2026. seer.cancer.gov/statfacts/html/pancreas.html
  4. US Preventive Services Task Force. Pancreatic Cancer: Screening. Recommendation statement, 6 August 2019. www.uspreventiveservicestaskforce.org/uspstf/recommendation/pancreatic-cancer-screening
  5. Blackford AL, et al. [Pancreatic cancer surveillance outcomes in high-risk individuals, CAPS]. JAMA Oncology. 2024. jamanetwork.com/journals/jamaoncology/fullarticle/2820691
  6. Zogopoulos G, Simeone DM, et al. [PRECEDE Consortium baseline imaging in high-risk individuals]. J Natl Compr Canc Netw. 2024. pmc.ncbi.nlm.nih.gov/articles/PMC12344727/
  7. Early Detection Initiative: a randomized controlled trial of algorithm-based screening in patients with new onset hyperglycemia and diabetes (protocol paper). pmc.ncbi.nlm.nih.gov/articles/PMC8844106
  8. Ballehaninna UK, Chamberlain RS. The clinical utility of serum CA 19-9 in the diagnosis, prognosis and management of pancreatic adenocarcinoma. Journal of Gastrointestinal Oncology. 2012. jgo.amegroups.org/article/view/181
  9. Lee T, Teng TZJ, Shelat VG. [Review of CA 19-9 as a tumor marker]. World Journal of Gastrointestinal Surgery. 2020;12:468–490. www.wjgnet.com/1948-9366/full/v12/i12/468.htm
  10. National Cancer Institute. Tumor Marker Tests in Common Use. www.cancer.gov/about-cancer/diagnosis-staging/diagnosis/tumor-markers-list
  11. Golan T, et al. Maintenance olaparib for germline BRCA-mutated metastatic pancreatic cancer. New England Journal of Medicine. 2019. www.nejm.org/doi/full/10.1056/NEJMoa1903387
  12. OncLive. FDA grants accelerated approval to zenocutuzumab for NRG1-positive NSCLC and pancreatic adenocarcinoma. 2024. www.onclive.com/view/fda-grants-accelerated-approval-to-zenocutuzumab-for-nrg1-nsclc-and-pancreatic-adenocarcinoma
  13. Dana-Farber Cancer Institute. FDA approves daraxonrasib for metastatic pancreatic cancer following landmark clinical trial led by Dana-Farber. News release, 2026. www.dana-farber.org/newsroom/news-releases/2026/fda-approves-daraxonrasib-for-metastatic-pancreatic-cancer-following-landmark-clinical-trial-led-by-dana-farber
  14. CancerNetwork. FDA approves daraxonrasib for previously treated metastatic pancreatic cancer. 2026. www.cancernetwork.com/view/fda-approves-daraxonrasib-for-previously-treated-metastatic-pancreatic-cancer
  15. Altered glycosylation in pancreatic cancer and beyond. Journal of Experimental Medicine. 2022;219(6):e20211505. rupress.org/jem/article/219/6/e20211505/213200/Altered-glycosylation-in-pancreatic-cancer-and
  16. Glycan motif profiling reveals plasma sialyl-Lewis X elevations in pancreatic cancers that are negative for sialyl-Lewis A. Molecular & Cellular Proteomics. www.mcponline.org/article/S1535-9476(20)32879-6/fulltext
  17. The ASCO Post. Novel blood test may help to identify pancreatic ductal adenocarcinoma at an earlier stage (PAC-MANN). February 2025. ascopost.com/news/february-2025/novel-blood-test-may-help-to-identify-pancreatic-ductal-adenocarcinoma-at-an-earlier-stage/
  18. National Cancer Institute. Early pancreatic cancer detection: four-protein blood panel. Press release, 30 January 2026. www.cancer.gov/news-events/press-releases/2026/early-pancreatic-cancer-detection
  19. Xu C, Mannucci A, Goel A, et al. [PANXEON: a microRNA signature with CA 19-9 for early detection of pancreatic cancer]. Nature Medicine. 2026. www.nature.com/articles/s41591-026-04625-x
  20. Immunovia. Immunovia announces new performance data for PancreaSure ahead of upcoming application for Medicare coverage. Company release, 15 June 2026. www.inderes.fi/en/releases/immunovia-announces-new-performance-data-for-pancreasure-ahead-of-upcoming-application-for-medicare-coverage
  21. The ASCO Post. AI model enables earlier detection of pancreatic cancer on routine CT scans (REDMOD). May 2026. ascopost.com/news/may-2026/ai-model-enables-earlier-detection-of-pancreatic-cancer-on-routine-ct-scans/
  22. GRAIL. Full results from the NHS-Galleri trial at the 2026 ASCO Annual Meeting. Press release, 30 May 2026. www.prnewswire.com/news-releases/grail-reports-full-results-from-nhs-galleri-trial-demonstrating-substantial-reduction-in-stage-iv-cancer-diagnoses-at-2026-asco-annual-meeting-302786216.html
  23. Targeted Oncology. FDA panel votes on the Galleri multi-cancer early detection test. September 2026. www.targetedonc.com/view/fda-panel-galleri-multi-cancer-early-detection-test

About this article. This article draws on GLOBOCAN 2024, American Cancer Society and SEER statistics, the USPSTF statement, peer-reviewed studies and institutional or company releases; the daraxonrasib approval is described from trade and cancer center reports, not the FDA label. Part of the OncoFirm™ Cancer Atlas 2026, written by the OncoFirm™ Scientific Team from the sources linked above and reflecting public information as of 1 October 2026. 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.

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