Posted on 30 October 2023
The Galleri test can detect signals shared by more than 50 types of cancer in a sample of a person's blood. This potentially means that cancers are detected before symptoms emerge and at a stage when treatment is likely to be more effective.
The NHS has partnered with GRAIL, the company who created the Galleri test, to run the NHS-Galleri Trial – a clinical trial involving 140,000 participants across England to assess the test's capability as a screening tool in asymptomatic people.
The trial is entering its third and final year, with its participants set to return to provide their third annual blood sample in the next 12 months.
Benefits and risks
Commissioned by NHS England, University of York researchers will analyse data from the trial results to provide a detailed assessment of the benefits and risks of any future nationwide use of the test as a national screening programme.
Professor Marta Soares, from Centre for Health Economics (CHE) at the University of York, said: “The goals of this evaluation are to understand whether a national roll-out of a population-based screening programme using the Galleri test will deliver more benefits than harm at a reasonable cost and to understand the total impact of a national roll-out.
“Our independent assessment will help inform questions of cost-effectiveness, budget impact, and the potential impact of other resource constraints in the NHS system that may affect the success of this screening programme.”
Researchers are expected to report their findings in 2026, and in the meantime, the NHS is set to assess initial results for the first year, with a year follow-up of the trial, when they become available next spring, and if they are sufficiently positive it will pilot the test at a larger scale using up to one million tests in 2024 and 2025.
Body of evidence
Results from the University of York evaluation will sit alongside data from the larger scale pilot, if it goes ahead, adding to the body of evidence the UK National Screening Committee (UK NSC) - the independent scientific body that advises ministers and the NHS - will use to decide whether to recommend adopting the test as a national screening programme.
Professor Soares said: “The test is potentially transformative as only three cancer types are routinely screened for in the UK. Early detection has long been recognised as a critical factor in improving cancer survival rates. With the Galleri test, patients may have the opportunity to receive timely and potentially life-saving interventions at the very beginning of cancer development.
“Whilst the test shows promise, the evidence on how well it works, and on its risks, is still evolving. As this evidence develops, we have been commissioned to understand how to best utilise this evidence to determine the value of this test to patients and the UK's healthcare system.”
Positive recommendations
The UK NSC would only make a positive recommendation for a national screening programme using the Galleri test if its assessment of all the evidence finds that screening would meet its criteria and be safe, viable, effective and appropriate.
Professor Peter Johnson, National Clinical Director for Cancer at NHS England, said: “Many cancers are currently hard to detect early because they often don’t have symptoms until they become more advanced, so the 140,000 participants in the NHS-Galleri Trial are part of something potentially very special, playing their part in us assessing a test that could prove to be transformational.
“We have asked the University of York researchers to comprehensively analyse the trial results and to consider the wider benefits and risks of any future national roll out of the test as a screening programme, to add to the base of evidence the National Screening Committee will need to use to make such a recommendation in the future.”
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