There is mounting evidence that the Galleri blood test to detect multiple types of cancer from a single blood sample should not be used by the NHS, according to a report in the BMJ, and its selection for large-scale trials by NHS England was based on politics rather than good science.
The investigation led by Margaret McCartney of the University of St. Andrews and investigative journalist Deborah Cohen, highlights the doubts experts have on how well the Galleri blood test being developed by US biotechnology company Grail, actually performs and whether the bar for success has been set too low. With experts believing that the current trial ongoing in the NHS is unethical. There are also questions over just how this particular blood test was selected for evaluation and if the deal between the NHS and developer Grail, signed by the previous Conservative government, is “too industry friendly”.
The Galleri blood test is reported to be able to detect more than 50 types of cancer. The test analyses DNA fragments circulating in the blood, also known as cell free DNA (cfDNA). These cfDNA fragments from cancer cells have specific “methylation patterns.” Galleri uses machine learning and artificial intelligence to analyse methylation sites to detect whether cancer DNA is circulating. The theory is that this can lead to the detection of cancer at a much earlier stage than previous tests.
NHS England hopes that such a test would do away with the individual bowel, breast and cervical cancer tests, currently offered by the NHS, and radically transform the current NHS cancer screening programme, hopefully saving lives in the process. The test is considered by NHS England to be a major part of achieving the NHS’s long-term plan target of diagnosing 75% of cancers at stages I and II by 2028.
The ongoing NHS trial, which began screening patients in mid-2022, is costing £150 million and has recruited over 140,000 people aged between 50 and 77. Leaked documents seen by the BMJ, however, state that the criteria being used in the trial are unsuitable to justify a new national screening programme. With Mike Richards, the chair of the independent UK National Screening Committee, telling Amanda Pritchard, NHS England’s chief executive, that he has “serious concerns” about the trial and its ability to provide sufficient evidence “on whether the benefits of testing outweigh any potential harms and at reasonable cost.”
The documents seen by the BMJ, also note that the deal between the NHS and Grail raises questions about whether it is “too industry friendly.”
Under the deal, the NHS will buy one million tests after the first stage of the trial has been completed satisfactorily, and then the NHS will buy five million more tests by 2030 if the test fulfils certain criteria.
A “new state-of-the-art test processing and sequencing facility” would be built by Grail in the UK once the NHS commits to purchasing minimum annual volumes.
As other multicancer early detection tests are in development, there are concerns over why the NHS actually chose to proceed with such a large-scale trial with the Galleri test as it showed little promise in early trials. Data already published from trials conducted by Grail, found low levels of detection: in one trial in patients that already had cancer the test detected only 43.9% of stage I-III cancers and in another in 2021 the test sensitivity for stage I cancers was only 16.8%.
Clare Turnbull, professor of cancer genetics at the Institute of Cancer Research in London told the BMJ that these results are “strikingly low,” adding that “a good screening test would typically be anticipated to have high sensitivity for early stage cancers, as these are usually the cancers for which surgery would offer the patient a high likelihood of cure (or long term remission)”.
Grail’s owner Ilumina has been accused of over-hyping Grail’s results and in the USA, Ilumina is facing a class action lawsuit from investors who claim that the company exaggerated Galleri’s effectiveness to increase its share price and are now facing massive losses.
NHS England published interim results of the NHS trial at the end of May, but decided not to proceed with the large-scale programme as it said the results were not “compelling enough”. NHS England intends to wait for the final trial results, expected in 2026, before making any further rollout decision.
The independent UK National Screening Committee (NSC), which is usually involved in making decisions on what constitutes cost effective NHS screening seems to have been bypassed so far, according to Freedom of information requests by The BMJ, and there is considerable disquiet with the UK NSC telling NHS England that it might be unable to make a recommendation about the rollout of Galleri at the end of the project.
The NHS chose to spend thousands on trials of Galleri despite poor early results and no evidence that it will be good enough to incorporate into the NHS screening programme.
An anonymous NHS England source speaking to The BMJ said, “The clinical or scientific data doesn’t stack up, but that should have come first. This is not the way to do a trial—it should be done transparently. It’s not been thought through at all.”
So why did this particular test get chosen by the NHS despite poor early clinical trials? From emails obtained by the BMJ via freedom of information requests, it would appear that the close relationship between the US company Illumina, which owned Grail up until 2016 and then reacquired it in 2021, and ex-Conservative Prime Minister David Cameron played a role. Grail Europe’s President Harpal Kumar, a Grail shareholder, was knighted in 2016 while David Cameron was PM. Then in 2018 Cameron was a paid adviser to Illumina.
It should be noted that Ilumina’s relationship with Grail remained close, despite the company spinning it out as a separate company in 2016. In 2021 Ilumina reacquired Grail, but then after battling both US and European antitrust authorities for more than two years, Ilumina was forced to spin-out Grail once again and this was completed in June 2024.
The BMJ has seen correspondence in 2020 between Illumina, the parent company of Grail at the time, and Nadhim Zahawi, then a minister in the Department for Business, Energy and Industrial Strategy, requesting a meeting. Six weeks later the deal was done with an accompanying press release to announce it. The contract was never put out to tender.
David Cameron has been implicated in several contracts being awarded to Ilumina after he resigned as PM in 2016, including £870,000-worth of public contracts by Public Health England in late April 2021 and a £123m contract the week after Cameron appeared at a genomics conference with the then health secretary Matt Hancock.
The BMJ investigation highlights that the NHS’s involvement in the trial of Galleri might be based more on politics than sound science, and raises serious questions about the decision-making processes of the NHS in relation to private companies and whether decisions are made truly based on public health first and foremost.
Richard Sullivan, director of the Institute of Cancer Policy at King’s College London, told the BMJ investigation that the deal between the NHS and Grail “is following a pattern established in this country over the past decade where the regulatory or evidential bar is being set lower and lower in favour of the private sector, with the public sector (that is, our taxes) taking all the risk”.
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