NHS-Galleri: a multicancer blood test did not reduce stage III-IV cancer after three annual rounds

Design

Randomised controlled trial, three annual screening rounds

Population

142,250 people aged 50-77 in England

Primary outcome

Incidence of stage III-IV cancer across 12 cancer types

Effect

IRR 1.03 (95% CI 0.92 to 1.14); stage IV IRR 0.86 (0.74 to 1.00)

NHS-Galleri, a randomised controlled trial in the New England Journal of Medicine (22 September 2026), took blood from 142,250 people aged 50 to 77 in England at up to three annual visits. Half had their blood tested with a multicancer early-detection test on top of usual care; the other half had blood stored. The primary endpoint was the incidence of stage III or IV cancer across 12 prespecified cancer types.

Stage III-IV incidence did not differ (incidence rate ratio 1.03, 95% CI 0.92 to 1.14). Stage IV cancer, a key secondary endpoint, was lower in the tested group (IRR 0.86, 0.74 to 1.00), with an upper confidence limit at 1. Under 1% had trial-related adverse events, none serious. The trial was funded by the test's manufacturer.

Stage shift is a surrogate: the trial does not yet report cancer mortality, and the stage IV signal is secondary and borderline. Further follow-up may change the picture.

For now, the result answers the question patients are starting to ask: there is no randomised evidence that a multicancer blood test reduces advanced cancer, and it should not replace established screening.

• Do not recommend multicancer early-detection blood tests outside research; the primary endpoint was not met
• Keep patients on established screening — cervical, breast and colorectal — which have proven benefit
• Explain that a negative multicancer test does not rule out cancer
• Have a plan for investigating a positive result before any patient takes a test privately
• Watch for longer follow-up and mortality data from this trial

Why it matters

It is the first large randomised test of a technology already marketed directly to patients, and it did not meet its primary endpoint.

Don't overread it

The lower stage IV rate is a secondary endpoint with an interval touching 1; it is not evidence of benefit on its own.

The statistics, in plain English

An incidence rate ratio of 1.03 means late-stage cancer was diagnosed at essentially the same rate in both groups; the interval (0.92 to 1.14) rules out more than about an 8% reduction. The stage IV IRR of 0.86 has an upper limit of 1.00, so it only just reaches the edge of statistical significance.

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