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Cancer Atlas 2026 · Lung cancer
Lung Cancer Biomarkers and Early Detection in 2026: CT Screening, Driver Mutations and Blood Tests
Lung cancer is the most commonly diagnosed cancer and the leading cause of cancer death worldwide. In the United States, about half of cases are found after the cancer has spread, when five-year survival is about one in ten. This article covers what low-dose CT screening has proven, which biomarkers guide treatment, and what blood tests and AI have shown as of 1 October 2026.
At a glance
Burden
2.64 million new cases and 1.86 million deaths worldwide in 2024. US, 2026: 229,410 new cases and 124,990 deaths.
Stage
US five-year relative survival: 65.5% localized, 10.5% distant. 51% of cases are distant at diagnosis (SEER, 2016–2022).
Screening
Annual low-dose CT for ages 50 to 80 with 20 or more pack-years (USPSTF 2021, Grade B). About 1 in 5 eligible US adults are screened.
Key biomarkers
Driver alterations (EGFR, ALK, ROS1, MET, HER2, KRAS, NRG1) and PD-L1 guide treatment. Serum markers such as CEA have limited roles.
OncoFirm™ status
Assays in development; research use only; not cleared or approved by the FDA or any other regulatory authority; not for sale. No lung cancer claims.
On this page
Key numbers
Lung cancer in three numbers
2.64 Mnew lung cancer cases worldwide in 2024, with 1.86 million deaths
65.5%US five-year relative survival when diagnosed at localized stage
10.5%US five-year relative survival when diagnosed at distant stage
Sources: GLOBOCAN 2024 (Sung et al., 2026) and SEER Cancer Stat Facts: Lung and Bronchus Cancer (diagnoses 2016–2022), accessed 1 October 2026.
Burden
The leading cause of cancer death worldwide
Lung cancer was the most commonly diagnosed cancer and the leading cause of cancer death worldwide in 2024. GLOBOCAN 2024, the global estimate published in 2026, counts 2,637,005 new cases (12.8% of all cancers) and 1,861,839 deaths (19.1% of all cancer deaths). That is about one in eight cancer diagnoses but nearly one in five deaths.
In the United States, the American Cancer Society (ACS) estimates 229,410 new cases and 124,990 deaths in 2026, with more new cases in women (118,500) than in men (110,910). Death rates fell by 4.7% a year in men and 3.5% a year in women from 2014 to 2023.
Tobacco drives most of the burden, but not all of it. The GLOBOCAN authors point to lung cancer in people who never smoked, notably among women in China and women of Asian descent in the United States. Screening rules, however, are built on smoking history. This page is part of the OncoFirm™ Cancer Atlas 2026; for the basic terms, see Cancer biomarkers explained.
Why stage matters
Half of US cases are found after the cancer has spread
Five-year relative survival for lung and bronchus cancer by stage at diagnosis, United States, 2016–2022. Unstaged cases (4%, 17.5% survival) are not shown. Source: SEER Cancer Stat Facts: Lung and Bronchus Cancer, accessed 1 October 2026.
SEER, the US National Cancer Institute registry program, uses three summary stages: localized (confined to the organ where the cancer started), regional (spread to nearby lymph nodes or tissues) and distant (spread to other parts of the body).
For lung cancer diagnosed from 2016 to 2022, five-year relative survival (survival compared with similar people in the general population) was 65.5% at localized stage, 38.2% at regional stage and 10.5% at distant stage. The problem is the mix: only 24% of cases were localized, 21% were regional and 51% were already distant. Across all stages, survival was 29.5%.
Read this chart with care. The gap between 65.5% and 10.5% is the main argument for earlier detection, but it is not the gain a screening test would deliver. Lead-time bias (diagnosis moves earlier, death does not) and length bias (screening finds slower-growing cancers) inflate survival by stage. Only trials that count deaths can show benefit: see Why early detection matters and the Early detection evidence hub.
Screening
Low-dose CT is proven, but most eligible people are not screened
Low-dose computed tomography (LDCT) is a chest CT scan with a reduced radiation dose. It is the only screening test shown in randomized trials to reduce lung cancer deaths.
- USPSTF (9 March 2021, Grade B): annual LDCT for adults aged 50 to 80 with a 20 pack-year smoking history who currently smoke or quit within the past 15 years. One pack-year is one pack a day for one year. This grade remains in force as of 1 October 2026.
- ACS: the same age and pack-year thresholds. Its 2023 guidance dropped the years-since-quitting limit.
- Trial evidence: the National Lung Screening Trial (NLST) found a 20% relative reduction in lung cancer deaths compared with chest X-ray. The NELSON trial found a 24% reduction in men at 10 years.
- Uptake: ACS data from 2025 show that only about 1 in 5 eligible US adults are screened.
National programs are now reporting results. In England, more than 2 million people were invited to a Lung Health Check and 49.0% attended. By March 2025, 7,193 lung cancers had been diagnosed, of which 63.1% were stage 1 and 12.6% stage 2. Australia began its program on 1 July 2025 and reported almost 100,000 people screened and more than 230 lung cancers found in the first year.
Stage shift is not proof. About three quarters of the cancers found in England were stage 1 or 2, but finding cancers earlier does not by itself prove fewer deaths. The mortality case for LDCT rests on NLST and NELSON.
US recommendations do not cover people who never smoked. For that group there is no randomized evidence that screening reduces deaths.
Biomarkers
Established biomarkers guide treatment, not screening
After a diagnosis of non-small cell lung cancer (NSCLC, the most common group of lung cancers), the tumor is tested for driver alterations: gene changes the cancer depends on to grow. A predictive biomarker shows which treatment is likely to work. None of the markers below is a screening test.
| Biomarker | Type | Used for | Not used for |
|---|---|---|---|
| EGFR mutations (exon 19 deletion, L858R, exon 20 insertion) | Predictive, tumor DNA | Choosing EGFR-targeted drugs such as osimertinib | Screening |
| ALK and ROS1 fusions | Predictive, tumor DNA or RNA | Choosing ALK or ROS1 inhibitors | Screening |
| MET (exon 14 skipping; protein overexpression) | Predictive | Tepotinib; telisotuzumab vedotin (accelerated approval, May 2025) | Screening |
| HER2 (ERBB2) mutations | Predictive | Zongertinib and sevabertinib (accelerated approvals in 2025) | Screening |
| KRAS G12C | Predictive | Choosing a KRAS G12C inhibitor such as sotorasib | Screening |
| NRG1 fusions (rare) | Predictive | Zenocutuzumab (accelerated approval, December 2024) | Screening |
| PD-L1 | Predictive, tumor protein stain | Helping select immune checkpoint inhibitor therapy | Screening (it is a tissue test) |
| CEA, CYFRA 21-1, NSE, ProGRP | Serum proteins | Supportive roles in monitoring and prognosis | Screening; stand-alone diagnosis |
With this many targets, laboratories usually test many genes at once by sequencing. Some alterations can also be found in blood: the FDA list of companion diagnostics includes plasma tests for EGFR, KRAS G12C and HER2 alterations. This is liquid biopsy used to choose treatment, not to find cancer early. The same list is the reference for other long-standing targets (BRAF V600E, RET and NTRK fusions).
Serum markers and antigens
Serum protein markers and tumor-associated antigens have limited roles
A tumor-associated antigen is a non-mutated molecule that tumors make in abnormal amounts or altered forms. Normal tissue can make it too, so specificity is the usual weak point (see Tumor-associated antigens).
- Established, limited role: CEA (carcinoembryonic antigen), CYFRA 21-1 (a cytokeratin fragment), NSE (neuron-specific enolase) and ProGRP (pro-gastrin-releasing peptide) are covered by a National Academy of Clinical Biochemistry guideline. As generally summarized, none is recommended for screening or as a stand-alone diagnostic test. NSE and ProGRP can support the diagnosis of small cell lung cancer; CEA and CYFRA 21-1 carry prognostic and monitoring information in NSCLC.
- CEA in context: CEA is best established for monitoring after colorectal cancer. In lung cancer it is non-specific and can be raised in people who smoke and in benign conditions.
- Autoantibodies to tumor antigens: in the randomized ECLS trial of the EarlyCDT-Lung blood test (about 12,200 people at risk), 58.9% of lung cancers in the test arm were stage III or IV at two years, against 73.2% in the control arm, with no significant difference in lung cancer deaths. In people with lung nodules, pooled sensitivity was 22% and specificity 92%, rated poor by a UK health technology assessment.
- Research stage: altered sugar chains (glycans) on mucins such as MUC1 are studied as markers, including sialyl-Lewis antigens and the truncated O-glycans Tn, sialyl-Tn and Thomsen-Friedenreich (TF) antigen. None is validated for early detection of lung cancer.
Emerging
Emerging approaches in 2025 and 2026
- A blood test before CT: FirstLook Lung (DELFI Diagnostics) reads fragmentation patterns in cell-free DNA (fragmentomics). In a validation study of 958 people, reported results were 80% sensitivity, 58% specificity and a 99.8% negative predictive value (the chance that a negative result is truly negative). It is meant to help decide who goes on to LDCT, not to replace it. It is a laboratory-developed test (LDT), run in a single laboratory, and has not been cleared or approved by the FDA.
- AI on CT: Sybil is a deep-learning model that estimates future lung cancer risk from one LDCT scan. In a retrospective Asian cohort of 21,087 people (a 2025 conference abstract), its one-year AUC was 0.86, both overall and in never-smokers. (AUC runs from 0.5, chance, to 1.0, perfect.) A separate nodule model, trained on 16,077 NLST nodules and tested on Danish screening data, performed at the level of clinicians. Prospective results are still needed.
- Multi-cancer early detection (MCED): no MCED blood test is FDA approved as of 1 October 2026. The randomized NHS-Galleri trial (about 142,000 adults) missed its primary endpoint, a reduction in stage III and IV diagnoses. An FDA advisory panel backed the Galleri test on 23 September 2026, and the FDA decision is pending. An MCED test is not a substitute for LDCT.
- Still investigational: tests for tumor DNA in blood after surgery (minimal residual disease) and breath tests.
See also Emerging cancer diagnostic technologies, Multi-biomarker analysis and the guide to AI in cancer diagnostics.
Open questions
Open research questions
- Who should be screened beyond heavy smokers? Can risk models or AI find never-smokers who benefit without overdiagnosis (finding cancers that would never cause harm)?
- How can uptake rise? In England's program, about half of invited people attended.
- Does a blood test in primary care lead to more completed LDCT scans and fewer late-stage diagnoses?
- Can serum proteins add value in combination? CEA or CYFRA 21-1 might help alongside imaging or cell-free DNA when a nodule is assessed. This needs prospective evidence.
- Do MCED tests add anything for people already eligible for LDCT?
OncoFirm™ roadmap
How lung cancer relates to the OncoFirm™ roadmap
OncoFirm™ is developing quantitative fluorescent lateral flow assays read by a digital reader. None is a lung cancer test, and none is intended for screening. The link to this page is narrow: CEA is one of the serum proteins measured in lung cancer care, in a supportive role.
CEA assay, in development
The OncoFirm™ CEA assay is in development with a designed range of 1–100 ng/mL and planned traceability to the WHO international standard (73/601). It is for research use only. No lung cancer indication is claimed.
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 using peanut agglutinin are concept-stage. No glycan antigen is validated for early detection of lung cancer.
What OncoFirm™ does not claim
OncoFirm™ makes no screening or multi-cancer claims. Low-dose CT is the proven lung screening test. Researchers studying serum proteins 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
What is the recommended screening test for lung cancer?
Low-dose CT (LDCT) of the chest. It is the only lung cancer screening test shown in randomized trials to reduce lung cancer deaths: by 20% in NLST and by 24% in men at 10 years in NELSON.
Who is eligible for lung cancer screening in the United States?
The USPSTF (2021, Grade B) recommends annual low-dose CT for adults aged 50 to 80 with a 20 pack-year smoking history who currently smoke or quit within the past 15 years. Only about 1 in 5 eligible US adults are screened.
Is there a blood test for lung cancer screening?
Not an approved one. As of 1 October 2026, blood tests such as FirstLook Lung are laboratory-developed tests that have not been cleared or approved by the FDA. They are positioned to help decide who goes on to low-dose CT. No multi-cancer early detection test is FDA approved either.
Can CEA or other tumor markers detect lung cancer early?
No. Serum markers such as CEA, CYFRA 21-1, NSE and ProGRP are not recommended for lung cancer screening or as stand-alone diagnostic tests. They have supportive roles in monitoring and prognosis.
Which biomarkers are tested after a lung cancer diagnosis?
In non-small cell lung cancer, tumors are tested for driver alterations such as EGFR, ALK, ROS1, MET, HER2, KRAS and NRG1, and for PD-L1 protein. The results help choose targeted therapy or immunotherapy, not screen for cancer.
Does OncoFirm™ offer a lung 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 lung cancer screening or diagnostic claims.
Cancer Atlas 2026
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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: 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
- 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
- National Cancer Institute, SEER Program. Cancer Stat Facts: Lung and Bronchus Cancer. Accessed 1 October 2026. seer.cancer.gov/statfacts/html/lungb.html
- US Preventive Services Task Force. Lung Cancer: Screening. Recommendation statement, 9 March 2021. www.uspreventiveservicestaskforce.org/uspstf/recommendation/lung-cancer-screening
- National Lung Screening Trial Research Team. Reduced lung-cancer mortality with low-dose computed tomographic screening. New England Journal of Medicine. 2011. www.nejm.org/doi/full/10.1056/NEJMoa1102873
- de Koning HJ, et al. Reduced lung-cancer mortality with volume CT screening in a randomized trial (NELSON). New England Journal of Medicine. 2020. www.nejm.org/doi/full/10.1056/NEJMoa1911793
- American Cancer Society. Lung cancer early detection guidance. www.cancer.org/cancer/types/lung-cancer/detection-diagnosis-staging/detection.html
- American Cancer Society Pressroom. 2025 lung cancer screening data. pressroom.cancer.org/2025-lung-cancer-data
- Lee RW, Baldwin DR, et al. [Lung cancer screening program in England: results to March 2025]. Nature Medicine. 2026;32(5). www.nature.com/articles/s41591-026-04292-y
- Australian Government Department of Health. One year on: almost 100,000 Australians access life-saving lung cancer screening. Media release, 2026. www.health.gov.au/ministers/the-hon-mark-butler-mp/media/one-year-on-almost-100000-australians-access-life-saving-lung-cancer-screening
- Cancer Australia. National Lung Cancer Screening Program. www.canceraustralia.gov.au/key-initiatives/national-lung-cancer-screening-program
- Lung Cancer Research Foundation. FDA approvals in lung cancer (treatment advances). www.lungcancerresearchfoundation.org/research/why-research/treatment-advances/
- US 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
- 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
- National Academy of Clinical Biochemistry. Guidelines for the Use of Tumor Markers in Lung Cancer. www.researchgate.net/publication/242354126_National_Academy_of_Clinical_Biochemistry_Guidelines_for_the_Use_of_Tumor_Markers_in_Lung_Cancer
- Duarte A, et al. EarlyCDT Lung blood test for risk classification of solid pulmonary nodules. Health Technology Assessment. 2022;26(49). www.ncbi.nlm.nih.gov/books/NBK587810/
- DELFI Diagnostics. Blood-based lung cancer screening test study results published in Cancer Discovery. Press release, 3 June 2024. www.prnewswire.com/news-releases/landmark-blood-based-ai-lung-cancer-screening-test-study-results-published-in-cancer-discovery-302162028.html
- CancerNetwork. Cell-free DNA assay achieves high negative predictive value in lung cancer. 20 November 2024. www.cancernetwork.com/view/cell-free-dna-assay-achieves-high-negative-predicative-value-in-lung-cancer
- Kim YW, et al. [Sybil lung cancer risk model in an Asian cohort]. Am J Respir Crit Care Med. 2025;211:A5012 (abstract). www.atsjournals.org/doi/abs/10.1164/ajrccm.2025.211.Abstracts.A5012
- RSNA News. AI predicts lung nodule risk. July 2026. www.rsna.org/news/2026/july/ai-predicts-lung-nodule-risk
- 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
- 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, USPSTF and trial publications, regulator lists and company releases; company-reported results are labeled as such. 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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