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OncoFirm™ / Research / Global health
Pillar guide · Global health
The Global Need for Affordable Early Cancer Diagnostics: Evidence, Gaps and Solutions
Whether a person survives cancer depends heavily on where they live. Much of that gap starts before treatment, with whether the cancer is found at all, and how early. This guide brings together the 2026 evidence on the cancer burden, the diagnostics access gap and survival inequity. It then sets out what an affordable early diagnostic needs to do, and what it cannot do.
At a glance
Topic
Access to affordable, early cancer diagnosis worldwide
Burden
20.6 million new cases and 9.8 million deaths in 2024 (GLOBOCAN)
Access gap
47% of people have little or no access to diagnostics
Survival gap
Breast cancer: 87% five-year survival in high-income vs about 42% in low-income countries
OncoFirm™ status
Point-of-care protein assays in development; research use only
On this page
Key numbers
The global case in three numbers
20.6 Mnew cancer cases in 2024, rising to about 34 million a year by 2050
47%of the world's population has little or no access to diagnostics
87% vs 42%five-year breast cancer survival, high-income vs low-income countries
Sources: GLOBOCAN 2024 (Sung et al., 2026), the Lancet Commission on diagnostics (2021) and the WHO Global status report on cancer 2026.
The burden
A growing and unequal cancer burden
The latest GLOBOCAN estimates, published in July 2026, put the global burden at 20.6 million new cancer cases and 9.8 million cancer deaths in 2024. About one in five people will develop cancer during their lifetime. Lung, breast, colorectal, prostate and stomach cancers are the most commonly diagnosed; lung, colorectal, liver, breast and stomach cancers cause the most deaths.
Incidence is projected to reach about 34 million cases a year by 2050, an increase of roughly two-thirds driven mainly by population growth and ageing. The steepest relative growth is expected in countries with the fewest resources: based on GLOBOCAN 2022, WHO projected increases of 142% in low Human Development Index (HDI) countries and 99% in medium-HDI countries, compared with 77% globally.
The economic stakes are equally large. A 2023 JAMA Oncology study estimated the global economic cost of cancer at 25.2 trillion international dollars between 2020 and 2050. Low- and middle-income countries were projected to carry about 75% of cancer deaths over that period.
The diagnostics gap
Half the world cannot get a diagnosis
The Lancet Commission on diagnostics described diagnostics as a neglected part of health care. Its key findings remain the most cited measure of the gap:
- 47% of the global population has little or no access to diagnostics.
- Only 19% of people in low- and lower-middle-income countries have access to the simplest diagnostic tests at primary care level, excluding HIV and malaria tests.
- There is a global shortfall of about one million trained diagnostic staff, including laboratory scientists and pathologists.
- Supply is concentrated: four companies supply about half of all in vitro diagnostics.
- The Commission called for national diagnostic strategies, regional manufacturing, better regulation and wider use of point-of-care and self-testing.
Cancer care is often not covered either. A 2024 WHO survey of 115 countries found that only 39% covered the basics of cancer management in their health benefit packages. The WHO Global status report on cancer 2026 adds that fewer than one in three countries integrate cancer care into universal health coverage, and that at least 45% of people with cancer face financial hardship.
Survival inequity
Survival depends on where you live
Five-year net survival for women diagnosed with breast cancer in 2017–2021, by WHO region (Girardi, Nyangasi et al., Nature Medicine, 2026). Income-group figures are from the WHO Global status report on cancer 2026.
Breast cancer shows the gap most clearly because it is common everywhere and highly treatable when found early. Survival ranged from below 30% in some low-income sub-Saharan African countries to over 90% in some high-income countries. The authors attribute the persisting gap to profound inequities in health systems and in access to timely diagnosis and treatment.
Cervical cancer tells a similar story. It caused about 280,000 deaths in 2024, mostly in low- and middle-income countries, even though it is largely preventable through HPV vaccination, screening and treatment of precancer. In high-income countries, 74% of women have been screened for cervical cancer. See why early detection matters for how stage at diagnosis changes outcomes.
Why early diagnosis pays
Early diagnosis saves lives and money
WHO notes that cancer found early is more likely to respond to treatment and can be treated with less expensive, less intensive therapy. Late diagnosis means more complex care, higher costs, more lost income and lower survival. For health systems with limited budgets, moving diagnoses to an earlier stage is one of the highest-value investments available.
Two WHO initiatives turn that principle into measurable targets:
- Global Breast Cancer Initiative: reduce breast cancer mortality by 2.5% per year, saving an estimated 2.5 million lives over 20 years. Its three pillars aim for at least 60% of invasive cancers diagnosed at stage I or II, diagnostic evaluation within 60 days of first presentation, and at least 80% of patients completing multimodal treatment.
- Cervical Cancer Elimination Initiative: by 2030, 90% of girls fully vaccinated against HPV by age 15, 70% of women screened with a high-performance test by ages 35 and 45, and 90% of women with precancer or invasive cancer treated. WHO notes that self-collected samples for HPV testing are as reliable as clinician-collected samples.
Early diagnosis and screening are different. Early diagnosis means getting people with symptoms to an accurate diagnosis and treatment quickly; it applies to every cancer. Screening means testing people without symptoms; it is recommended only for a few cancers where trials show benefit. Affordable diagnostics serve both, but must be validated for the specific use.
Where the pathway breaks
The three steps of early diagnosis and their barriers
WHO describes early diagnosis as three linked steps. Each one fails in predictable ways where resources are scarce:
- Awareness and access to care. People recognize symptoms and reach a health worker. Barriers: distance, cost of travel and lost work, stigma, and limited awareness among both public and primary-care staff.
- Clinical evaluation, diagnosis and staging. Barriers: few laboratories, pathologists and imaging units outside cities; samples sent away for days or weeks; patients lost to follow-up between visits. This is where point-of-care testing and simple, robust instruments can help most.
- Access to treatment. Barriers: surgery, radiotherapy and essential medicines are often unavailable or unaffordable. WHO reports that only 9–54% of priority cancer medicines are available in low- and lower-middle-income countries, compared with 68–94% in high-income countries.
A test that speeds up step 2 is only valuable if steps 1 and 3 exist. For the lab side of the pathway, see what is biochemical diagnostics; for decentralized testing, see point-of-care oncology.
What makes a test affordable
The REASSURED checklist for low-resource settings
Price alone does not make a diagnostic accessible. The REASSURED criteria, developed for point-of-care tests in global health, describe what a test must do to be used in practice:
| REASSURED criterion | What it means for a cancer diagnostic |
|---|---|
| Real-time connectivity | Results reach clinicians, referral services and registries digitally, so positive results are followed up |
| Ease of specimen collection | Fingerstick blood, urine or self-collected swabs rather than venous draws or biopsies where possible |
| Affordable | Low cost per test and per instrument, with no expensive service contracts |
| Sensitive and Specific | Validated performance for a defined use and population, including people with benign or inflammatory conditions |
| User-friendly | Usable by trained health workers after short training, with built-in quality controls |
| Rapid and robust | Results during the same visit; reagents that tolerate heat and humidity without a cold chain |
| Equipment-free or simple | No equipment, or a small battery-powered reader instead of a full laboratory analyzer |
| Deliverable | Available, registered and supported where the people who need it live |
Lateral flow assays meet many of these criteria, which is why they are central to malaria, HIV and COVID-19 testing. Quantitative fluorescent lateral flow with a small reader aims to add numerical results to that format. See how lateral flow assays work and fluorescent LFA vs traditional testing.
Limits
What a low-cost test cannot do on its own
- Tumor markers are not general screening tests. Proteins such as CEA are used mainly for monitoring; PSA testing involves shared decision-making; AFP is used in surveillance of defined high-risk groups. None should be used to screen the general population on its own.
- Diagnosis still needs confirmation. Pathology and imaging remain essential to confirm cancer and its stage.
- A result without a referral pathway helps no one. Testing must be linked to diagnosis and treatment services.
- Quality must be assured. Regulatory approval, external quality assessment, training and supply chains matter as much as the test itself.
- Evidence must be local. Performance can vary between populations, so validation in the settings where a test will be used is essential.
OncoFirm™ roadmap
Our goal: quantitative protein testing where labs are scarce
OncoFirm™ is developing a fluorescent lateral flow platform intended to bring quantitative protein biomarker measurement closer to patients. The aim is to support clinicians in settings without a central laboratory, within validated clinical pathways, as described in rapid testing for global health impact.
Quantitative, at the point of care
Fluorescent lateral flow assays designed to report CEA (1–100 ng/mL) and PSA (0.5–50 ng/mL) on one handheld reader, with planned traceability to WHO international standards. Platform
Designed for REASSURED
Small sample volumes, a result-time target of 20 minutes or less, and a low-cost strip with a reusable reader. Digital readers · One reader, one strip
Connected results
Digital result capture designed to support referral, follow-up and quality monitoring. AI and early detection
Validation with partners
Plans to validate with clinical and public-health partners 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 and are not for sale. Designed ranges and result times are development targets, not validated performance claims.
FAQ
Frequently asked questions
Why is affordable early cancer diagnosis a global priority?
Cancer caused an estimated 9.8 million deaths in 2024, and new cases are projected to rise by about two-thirds by 2050. Survival is far higher when cancer is found early, but the Lancet Commission on diagnostics estimates that 47% of the world's population has little or no access to diagnostics. Affordable, decentralized testing is one of the main ways to close that gap.
How large is the survival gap between rich and poor countries?
For breast cancer, WHO reports five-year survival of 87% in high-income countries versus about 42% in low-income countries. A 2026 Nature Medicine study found regional survival ranging from 39.1% in the WHO African Region to 88.5% in the Americas.
Is early diagnosis the same as screening?
No. WHO distinguishes early diagnosis, which means recognizing symptoms and getting people with symptoms quickly to diagnosis and treatment, from screening, which means testing people without symptoms. Early diagnosis is relevant to every cancer and every health system; organized screening is recommended only for a few cancers where evidence shows benefit.
Can a low-cost blood test screen for cancer?
Not on its own. Most protein tumor markers, such as CEA, are not recommended for screening people without symptoms because they lack the sensitivity and specificity required. They are used for monitoring, risk assessment or in defined high-risk groups under clinical guidance. Affordable tests help only when they are validated for a clear purpose and connected to diagnosis and treatment.
What makes a diagnostic suitable for low-resource settings?
The REASSURED criteria describe the ideal: real-time connectivity, easy specimen collection, affordable, sensitive, specific, user-friendly, rapid and robust, equipment-free or simple, and deliverable to the people who need it.
Is OncoFirm™ selling tests in low- and middle-income countries?
No. OncoFirm™ fluorescent lateral flow assays and reader 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. OncoFirm™ is seeking clinical and public-health partners for future validation.
Keep reading
Related guides
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. Published online July 8, 2026. doi.org/10.3322/caac.70090
- World Health Organization. WHO calls for urgent action as new cancer cases are projected to nearly double by 2050 (Global status report on cancer 2026). July 8, 2026. www.who.int/news/item/08-07-2026-who-calls-for-urgent-action-as-new-cancer-cases-are-projected-to-nearly-double-by-2050
- Girardi F, Nyangasi M, et al. Global breast cancer survival estimates in 2017–2021 to advance the WHO Global Breast Cancer Initiative. Nature Medicine. 2026. www.nature.com/articles/s41591-026-04531-2
- Fleming KA, Horton S, Wilson ML, et al. The Lancet Commission on diagnostics: transforming access to diagnostics. The Lancet. 2021;398(10315):1997–2050. www.thelancet.com/journals/lancet/article/PIIS0140-6736(21)00673-5/fulltext
- Chen S, Cao Z, Prettner K, et al. Estimates and projections of the global economic cost of 29 cancers in 204 countries and territories from 2020 to 2050. JAMA Oncology. 2023;9(4):465–472. jamanetwork.com/journals/jamaoncology/fullarticle/2801798
- World Health Organization. Global cancer burden growing, amidst mounting need for services (GLOBOCAN 2022 and UHC survey). February 1, 2024. www.who.int/news/item/01-02-2024-global-cancer-burden-growing--amidst-mounting-need-for-services
- World Health Organization. Cancer: fact sheet. Updated July 3, 2026. www.who.int/news-room/fact-sheets/detail/cancer
- World Health Organization. Cervical cancer: fact sheet. Updated July 3, 2026. www.who.int/news-room/fact-sheets/detail/cervical-cancer
- World Health Organization. Global Breast Cancer Initiative implementation framework. 2023. www.who.int/publications/i/item/9789240065987
- Land KJ, Boeras DI, Chen XS, Ramsay AR, Peeling RW. REASSURED diagnostics to inform disease control strategies, strengthen health systems and improve patient outcomes. Nature Microbiology. 2019;4:46–54. doi.org/10.1038/s41564-018-0295-3
- World Health Organization. WHO Model List of Essential In Vitro Diagnostics (EDL). edl.who-healthtechnologies.org/
About this article. Written by the OncoFirm™ Scientific Team from WHO and IARC publications and peer-reviewed studies, all linked above. Figures reflect sources available on 1 October 2026. This update replaces an earlier version of this article; statements about regulatory filings, funding and test menus that did not reflect OncoFirm™’s current development stage have been removed. This article is for education and is not medical advice. OncoFirm™ assays are in development, have not been cleared or approved by the FDA and are not available for sale.
Partner on accessible early diagnosis
Ministries of health, NGOs, clinicians, researchers and investors working to widen access to early cancer diagnosis can reach the OncoFirm™ team. Collaboration inquiry · Investor inquiry