---
title: "Performance of a Multi-Cancer Early Detection Test in the NHS‑Galleri Randomized Trial"
id: "nature-3-performance-of-a-multi-cancer-early-detection-test-in-the-randomized-controlled"
canonical_url: "https://medichelpline.com/clinical-feed/nature-3-performance-of-a-multi-cancer-early-detection-test-in-the-randomized-controlled"
content_type: "clinical_feed_article"
specialty: "Oncology"
source_name: "Nature Medicine"
source_url: "https://www.nature.com/articles/s41591-026-04652-8"
published_at: "2026-09-22T12:00:00.000Z"
evidence_level: "Journal Feed"
license: "CC-BY-NC-4.0 / Informational Use"
---
# Performance of a Multi-Cancer Early Detection Test in the NHS‑Galleri Randomized Trial
## Provenance & Clinical Metadata
- **Canonical URL:** https://medichelpline.com/clinical-feed/nature-3-performance-of-a-multi-cancer-early-detection-test-in-the-randomized-controlled
- **Specialty:** [Oncology](https://medichelpline.com/clinical-feed/oncology.md)
- **Primary Source:** Nature Medicine
- **Source URL:** [Original Journal Publication](https://www.nature.com/articles/s41591-026-04652-8)
- **Published At:** 2026-09-22T12:00:00.000Z
- **Evidence Rating:** Journal Feed
## Executive GIST (TL;DR)
- The NHS‑Galleri randomized controlled trial evaluated a blood-based **multi-cancer early detection** (MCED) test (Galleri) added to usual care in 142,250 participants aged 50–77 randomized 1:1 to intervention or control. - The trial’s primary endpoint — reduction in incidence of stage III/IV cancers in the intervention arm — was previously reported as not met; this report describes prespecified secondary descriptive analyses of test performance across three annual screening rounds among evaluable intervention participants. - Positive MCED results were returned in rounds 1–3 for 722/70,325 (1.03%), 518/64,498 (0.80%) and 561/62,323 (0.90%) participants, respectively. - Aggregate MCED-detected primary cancers numbered 937. Per-round cancer detection rates were 0.60%, 0.40% and 0.41% for rounds 1–3. - Per-round positive predictive values (PPV) were 58.0% (419/722), 50.4% (261/518) and 45.8% (257/561). Negative predictive values were approximately 98.9% across rounds. - **Specificity** across rounds ranged from 99.50% to 99.60%; episode sensitivity for all cancers ranged from 26.7% to 37.2%, and for 12 prespecified cancer types from 47.6% to 63.4%. - The test reported a predicted **cancer signal origin (CSO)** to guide NHS standard-of-care diagnostic referrals; CSO accuracy across rounds ranged from 91.1% to 93.6%. - Analyses were descriptive with no hypothesis testing; diagnostic workups for positives followed existing NHS pathways informed by CSO predictions. - These performance data provide real-world insights into MCED test behavior in population screening within the NHS; trial identifiers are ClinicalTrials.gov NCT05611632 and ISRCTN91431511.
## Clinical Analysis & Structured Key Points
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[nature](https://www.nature.com/) 2. [nature medicine](https://www.nature.com/nm) 3. [articles](https://www.nature.com/nm/articles?type=article) 4. article Performance of a multi-cancer early detection test in the randomized controlled NHS-Galleri trial [ Download PDF ](https://www.nature.com/articles/s41591-026-04652-8.pdf) [ Download PDF ](https://www.nature.com/articles/s41591-026-04652-8.pdf) * Article * [Open access](https://www.springernature.com/gp/open-science/about/the-fundamentals-of-open-access-and-open-research) * Published: 22 September 2026 # Performance of a multi-cancer early detection test in the randomized controlled NHS-Galleri trial * [Richard D. Neal](https://www.nature.com/articles/s41591-026-04652-8#auth-Richard_D_-Neal-Aff1)[1](https://www.nature.com/articles/s41591-026-04652-8#Aff1), * [Saoirse Dolly](https://www.nature.com/articles/s41591-026-04652-8#auth-Saoirse-Dolly-Aff2)[2](https://www.nature.com/articles/s41591-026-04652-8#Aff2), * [Peter Johnson](https://www.nature.com/articles/s41591-026-04652-8#auth-Peter-Johnson-Aff3)[3](https://www.nature.com/articles/s41591-026-04652-8#Aff3), * [Helen Jones](https://www.nature.com/articles/s41591-026-04652-8#auth-Helen-Jones-Aff4)[4](https://www.nature.com/articles/s41591-026-04652-8#Aff4), * [Sir Harpal Kumar](https://www.nature.com/articles/s41591-026-04652-8#auth-Sir_Harpal-Kumar-Aff5)[5](https://www.nature.com/articles/s41591-026-04652-8#Aff5), * [Lennard Y. W. Lee](https://www.nature.com/articles/s41591-026-04652-8#auth-Lennard_Y__W_-Lee-Aff6)[6](https://www.nature.com/articles/s41591-026-04652-8#Aff6), * [Yujin Lee](https://www.nature.com/articles/s41591-026-04652-8#auth-Yujin-Lee-Aff7)[7](https://www.nature.com/articles/s41591-026-04652-8#Aff7), * [Wei Liang](https://www.nature.com/articles/s41591-026-04652-8#auth-Wei-Liang-Aff5)[5](https://www.nature.com/articles/s41591-026-04652-8#Aff5), * [Thomas Round](https://www.nature.com/articles/s41591-026-04652-8#auth-Thomas-Round-Aff8)[8](https://www.nature.com/articles/s41591-026-04652-8#Aff8), * [Rebecca Smittenaar](https://www.nature.com/articles/s41591-026-04652-8#auth-Rebecca-Smittenaar-Aff5)[5](https://www.nature.com/articles/s41591-026-04652-8#Aff5), * [Jane Warwick](https://www.nature.com/articles/s41591-026-04652-8#auth-Jane-Warwick-Aff7)[7](https://www.nature.com/articles/s41591-026-04652-8#Aff7), * [Peter Sasieni](https://www.nature.com/articles/s41591-026-04652-8#auth-Peter-Sasieni-Aff7) [ORCID: orcid.org/0000-0003-1509-8744](https://orcid.org/0000-0003-1509-8744)[7](https://www.nature.com/articles/s41591-026-04652-8#Aff7) [na1](https://www.nature.com/articles/s41591-026-04652-8#na1) & * … * [Charles Swanton](https://www.nature.com/articles/s41591-026-04652-8#auth-Charles-Swanton-Aff9-Aff10) [ORCID: orcid.org/0000-0002-4299-3018](https://orcid.org/0000-0002-4299-3018)[9](https://www.nature.com/articles/s41591-026-04652-8#Aff9),[10](https://www.nature.com/articles/s41591-026-04652-8#Aff10) [na1](https://www.nature.com/articles/s41591-026-04652-8#na1) Show authors [_Nature Medicine_](https://www.nature.com/nm) (2026) [Cite this article](https://www.nature.com/articles/s41591-026-04652-8#citeas) [ Save article ](https://www.nature.com/articles/s41591-026-04652-8/save-research?_csrf=knGIQC0xvqf4d3fEpuLxZ59b2RzKadwz) [ View saved research ](https://www.nature.com/saved-research) ## Abstract The NHS-Galleri trial was a randomized controlled trial evaluating a multi-cancer early detection (MCED) test added to usual care. We reported elsewhere that the primary endpoint of a reduction in the incidence of stage III/IV cancer diagnoses in the intervention arm versus control arm was not met. Here we report prespecified secondary test performance endpoints among evaluable intervention arm participants across three annual screening rounds. These analyses were descriptive; there was no hypothesis testing. Participants aged 50−77 years (_N_ = 142,250) were randomized 1:1 into intervention (MCED) or control arms. Intervention arm participants with positive MCED results were referred to National Health Service (NHS) standard-of-care pathways for diagnostic workup, with referrals informed by the predicted cancer signal origin (CSO). Positive test results were returned for 722 of 70,325 (1.03%), 518 of 64,498 (0.80%) and 561 of 62,323 (0.90%) participants in rounds 1−3, respectively. In aggregate, 937 participants had MCED-detected primary cancers. Respective by-round cancer detection rates were 0.60%, 0.40% and 0.41%; positive predictive values were 58.0% (419/722), 50.4% (261/518) and 45.8% (257/561); and negative predictive values were 98.98% (68,895/69,603), 98.90% (63,278/63,980) and 98.86% (61,058/61,762). Across rounds, specificity ranged from 99.50% to 99.60%; episode sensitivity ranged from 26.7% to 37.2% for all cancers and from 47.6% to 63.4% for 12 prespecified types; and CSO accuracy ranged from 91.1% to 93.6%. These data provide insights on the performance of the MCED test in population screening within the NHS setting. ClinicalTrials.gov: [NCT05611632](https://clinicaltrials.gov/study/NCT05611632); ISRCTN: [ISRCTN91431511](https://www.isrctn.com/ISRCTN91431511). ### Explore related subjects Discover the latest articles and news in related subjects. * [Biotechnology](https://www.nature.com/subjects/biotechnology) * [Cancer screening](https://www.nature.com/subjects/cancer-screening) ## Main Cancer screening is associated with improved outcomes, driven partly by earlier-stage diagnosis that can result in a meaningful extension of survival[1](https://www.nature.com/articles/s41591-026-04652-8#ref-CR1 "Siegel, R. L., Kratzer, T. B., Wagle, N. S., Sung, H. & Jemal, A. Cancer statistics, 2026. CA Cancer J. Clin. 76, e70043 \(2026\)."),[2](https://www.nature.com/articles/s41591-026-04652-8#ref-CR2 "Goddard, K. A. B. et al. Estimation of cancer deaths averted from prevention, screening, and treatment efforts, 1975−2020. JAMA Oncol. 11, 162 \(2025\)."),[3](https://www.nature.com/articles/s41591-026-04652-8#ref-CR3 "Cancer Survival in England, cancers diagnosed 2015 to 2019, followed up to 2020 https://digital.nhs.uk/data-and-information/publications/statistical/cancer-survival-in-england/cancers-diagnosed-2015-to-2019-followed-up-to-2020 \(NHS Digital, 2022\)."),[4](https://www.nature.com/articles/s41591-026-04652-8#ref-CR4 "Routes to Diagnosis https://nhsd-ndrs.shinyapps.io/routes_to_diagnosis/ \(National Disease Registration Service, 2024\)."). Earlier detection of cancer may also increase opportunities for treatment with curative intent for certain cancer types, even in those with stage III disease[5](https://www.nature.com/articles/s41591-026-04652-8#ref-CR5 "Sinicrope, F. A. et al. Randomized trial of standard chemotherapy alone or combined with atezolizumab as adjuvant therapy for patients with stage III deficient DNA mismatch repair \(dMMR\) colon cancer \(Alliance A021502; ATOMIC\). J. Clin. Oncol. 43, LBA1 \(2025\)."),[6](https://www.nature.com/articles/s41591-026-04652-8#ref-CR6 "Adkins, D. et al. Neoadjuvant and adjuvant pembrolizumab plus standard of care \(SOC\) in resectable locally advanced head and neck squamous cell carcinoma \(LA HNSCC\): exploratory efficacy analyses of the phase 3 KEYNOTE-689 study. J. Clin. Oncol. 43, 6012–6012 \(2025\)."),[7](https://www.nature.com/articles/s41591-026-04652-8#ref-CR7 "Chi, S. A. et al. Trends in survival rates of non–small cell lung cancer with use of molecular testing and targeted therapy in Korea, 2010−2020. JAMA Netw. Open 6, e232002 \(2023\)."),[8](https://www.nature.com/articles/s41591-026-04652-8#ref-CR8 "Cao, S. et al. Recurrence and survival of patients with stage III endometrial cancer after radical surgery followed by adjuvant chemo- or chemoradiotherapy: a systematic review and meta-analysis. BMC Cancer 23, 31 \(2023\)."). However, screening is currently recommended only for limited cancer types (for example, breast, cervical, colorectal and lung (high-risk individuals))[9](https://www.nature.com/articles/s41591-026-04652-8#ref-CR9 "UK NSC Recommendations https://view-health-screening-recommendations.service.gov.uk/ \(UK National Screening Committee, 2026\)."),[10](https://www.nature.com/articles/s41591-026-04652-8#ref-CR10 "U.S. Preventive Services Task Force. A and B Recommendations https://www.uspreventiveservicestaskforce.org/uspstf/recommendation-topics/uspstf-a-and-b-recommendations \(2025\)."), leaving most cancers unscreened. As a result, only approximately 6% of cancers in England (in 2020) and approximately 14% of cancers in the United States (in 2017) are detected through guideline-recommended population screening[4](https://www.nature.com/articles/s41591-026-04652-8#ref-CR4 "Routes to Diagnosis https://nhsd-ndrs.shinyapps.io/routes_to_diagnosis/ \(National Disease Registration Service, 2024\)."),[11](https://www.nature.com/articles/s41591-026-04652-8#ref-CR11 "NORC at the University of Chicago. Percent of Cancers Detected by Screening in the U.S. https://cancerdetection.norc.org/ \(2022\)."). Population-wide implementation of many additional single-cancer screening programs to detect the majority of cancer types for which screening is not currently recommended is not feasible given the low prevalence of individual cancer types, cumulative burden of false positives, high cost, logistical complications and the lack of candidate technologies. Blood-based MCED tests, however, can screen for multiple cancer types concurrently by detecting a shared signal while maintaining a low false-positive rate[12](https://www.nature.com/articles/s41591-026-04652-8#ref-CR12 "Kisiel, J. B. et al. Shifting the cancer screening paradigm: developing a multi-biomarker class approach to multi-cancer early detection testing. Life \(Basel\) 14, 925 \(2024\)."),[13](https://www.nature.com/articles/s41591-026-04652-8#ref-CR13 "Brito-Rocha, T., Constâncio, V., Henrique, R. & Jerónimo, C. Shifting the cancer screening paradigm: the rising potential of blood-based multi-cancer early detection tests. Cells 12, 935 \(2023\)."),[14](https://www.nature.com/articles/s41591-026-04652-8#ref-CR14 "Klein, E. A. et al. Clinical validation of a targeted methylation-based multi-cancer early detection test using an independent validation set. Ann. Oncol. 32, 1167–1177 \(2021\)."),[15](https://www.nature.com/articles/s41591-026-04652-8#ref-CR15 "Schrag, D. et al. Blood-based tests for multicancer early detection \(PATHFINDER\): a prospective cohort study. Lancet 402, 1251–1260 \(2023\)."),[16](https://www.nature.com/articles/s41591-026-04652-8#ref-CR16 "Nabavizadeh, N. et al. Performance and safety of a multi-cancer early detection test: the PATHFINDER 2 study. Nat. Med. https://doi.org/10.1038/s41591-026-04618-w \(2026\)."). One MCED test, Galleri (GRAIL Inc.), detects tumor methylation patterns in cell-free DNA isolated from peripheral blood and returns a positive (cancer signal detected) result with predicted CSO(s) to guide diagnostic evaluations[14](https://www.nature.com/articles/s41591-026-04652-8#ref-CR14 "Klein, E. A. et al. Clinical validation of a targeted methylation-based multi-cancer early detection test using an independent validation set. Ann. Oncol. 32, 1167–1177 \(2021\)."),[17](https://www.nature.com/articles/s41591-026-04652-8#ref-CR17 "Liu, M. C. et al. Sensitive and specific multi-cancer detection and localization using methylation signatures in cell-free DNA. Ann. Oncol. 31, 745–759 \(2020\)."). Previous large-scale case−control studies[14](https://www.nature.com/articles/s41591-026-04652-8#ref-CR14 "Klein, E. A. et al. Clinical validation of a targeted methylation-based multi-cancer early detection test using an independent validation set. Ann. Oncol. 32, 1167–1177 \(2021\)."),[17](https://www.nature.com/articles/s41591-026-04652-8#ref-CR17 "Liu, M. C. et al. Sensitive and specific multi-cancer detection and localization using methylation signatures in cell-free DNA. Ann. Oncol. 31, 745–759 \(2020\)."),[18](https://www.nature.com/articles/s41591-026-04652-8#ref-CR18 "Jamshidi, A. et al. Evaluation of cell-free DNA approaches for multi-cancer early detection. Cancer Cell 40, 1537–1549 \(2022\)."), prospective studies[15](https://www.nature.com/articles/s41591-026-04652-8#ref-CR15 "Schrag, D. et al. Blood-based tests for multicancer early detection \(PATHFINDER\): a prospective cohort study. Lancet 402, 1251–1260 \(2023\)."),[16](https://www.nature.com/articles/s41591-026-04652-8#ref-CR16 "Nabavizadeh, N. et al. Performance and safety of a multi-cancer early detection test: the PATHFINDER 2 study. Nat. Med. https://doi.org/10.1038/s41591-026-04618-w \(2026\)."),[19](https://www.nature.com/articles/s41591-026-04652-8#ref-CR19 "Atwood, C. et al. REFLECTION: real-world evidence study of multi-cancer early detection \(MCED\) among veterans in the Veterans Affairs Healthcare System \(VA\) https://grail.com/wp-content/uploads/2025/10/Atwood.EDCC-2025.REFLECTION-VA.Slides_Final-1.pdf \(2025\).") and real-world analyses[20](https://www.nature.com/articles/s41591-026-04652-8#ref-CR20 "Matrana, M. et al. Real-world data and clinical experience from over 100,000 multi-cancer early detection tests. Nat. Commun. 16, 9625 \(2025\)."),[21](https://www.nature.com/articles/s41591-026-04652-8#ref-CR21 "Hurt, R. T. et al. Implementation of a multicancer detection \(MCD\) test in a tertiary referral center in asymptomatic patients: an 18-month prospective cohort study. J. Prim. Care Community Health 16, 21501319251329290 \(2025\)."),[22](https://www.nature.com/articles/s41591-026-04652-8#ref-CR22 "O’Donnell, E. K. et al. Diagnostic outcomes among patients with positive multi-cancer early detection test results. Cancer Res. Commun. 6, 511–515 \(2026\)."),[23](https://www.nature.com/articles/s41591-026-04652-8#ref-CR23 "Agarwal, G., Carlson, J. W. & Broyles, D. R. Implementation of a multi-cancer early detection test using a centralized model within a multi-state health system. J. Clin. Oncol. 41, 1526 \(2023\)."),[24](https://www.nature.com/articles/s41591-026-04652-8#ref-CR24 "Sue, E. et al. Implementation of a multi-cancer early detection \(MCED\) test in a private practice: adoption, performance, and repeat-testing patterns. J. Clin. Oncol. 44, 10532 \(2026\).") have demonstrated the test’s performance (positive predictive value (PPV) 43.1−78.6%, specificity 99.3−99.6%, top-1 CSO prediction accuracy 85.7−93.3%)[14](https://www.nature.com/articles/s41591-026-04652-8#ref-CR14 "Klein, E. A. et al. Clinical validation of a targeted methylation-based multi-cancer early detection test using an independent validation set. Ann. Oncol. 32, 1167–1177 \(2021\)."),[15](https://www.nature.com/articles/s41591-026-04652-8#ref-CR15 "Schrag, D. et al. Blood-based tests for multicancer early detection \(PATHFINDER\): a prospective cohort study. Lancet 402, 1251–1260
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