NHS Declines to Fast-Track Grail's Galleri Multi-Cancer Early Detection Test Amid Insufficient Evidence

The UK National Health Service (NHS) said on Wednesday that it would not accelerate the implementation of GRAIL, Inc.'s Galleri multi-cancer early detection test following a review of data from the first year of its clinical study.

"NHS England reviewed the preliminary data from the first year of the NHS-Galleri trial and did not find it compelling enough to justify launching a large-scale pilot program in NHS clinical practice while awaiting the final results of the trial," wrote Peter Johnson, NHS England's National Clinical Director for Cancer, in a blog post.

"Requiring the NHS to massively accelerate the implementation of this test just one year later would be an exceptional step that requires exceptional data support. While what we are seeing is very promising, the current data does not yet support moving forward at such a rapid pace," Johnson added.

The NHS will wait for the full results of a three-year study, expected to be published in 2026, before deciding whether to begin implementation of Galleri across China.

"This early look at certain selected endpoints only offers a limited perspective," wrote Harpal Kumar, President of GRAIL's Biopharmaceuticals Business and Europe, in a separate article. "As demonstrated in previous cancer screening trials, the results from the first round of screening do not always reflect the final outcomes, particularly regarding reductions in late-stage diagnoses. For instance, in the National Lung Screening Trial (NLST) in the U.S., participants underwent three annual screenings. Ultimately, the trial demonstrated a significant relative reduction in mortality among those screened with low-dose CT. However, a reduction in stage IV cancers was not observed in the first year of screening. This is because initial screening rounds often include many asymptomatic late-stage cancers that have not yet been 'cleared' by that year’s screening."

This decision came weeks after Grail officials heavily promoted it as a potential positive catalyst for the company, as it prepares to be spun off from Illumina. During an event held on May 13 for investors and stock analysts, Kumar hinted that the NHS decision would be made at some point this summer.

"It's terrible timing, [a favorable decision from NHS] will be an important part of Grail’s valuation," said Kyle Mikson, an analyst at Canaccord Genuity. Investors who are optimistic about Illumina spinning off Grail have been "pinning their hopes" on the NHS to help drive Galleri sales and accelerate regulatory approval in the U.S., he said. Illumina is working to finalize its spin-off terms by the end of June, and if Illumina chooses to proceed with an IPO, Grail may need to update certain documents it has filed with the Securities and Exchange Commission.

In Wednesday afternoon trading on Nasdaq, shares of Illumina fell 3% to $101.76.

Although Grail disclosed a "snapshot" review of the data in a blog post in March, it was not "incorporated into investor expectations," said Guggenheim Securities analyst Subbu Nambi, who attended the investor presentation in May.

Despite Johnson and Kumar’s optimism about the early data, Nambi suggested that at least some investors might view the decision negatively. However, such a reaction may be overblown. "These are complex scientific studies, and in most cases, the likelihood of achieving robust interim data is unrealistic," she said.

A spokesperson for Grail said in an email that "Galleri's clinical performance is very promising — consistent with or better than the clinical performance of Galleri observed in previously published studies," but did not provide additional details. Grail did not respond to questions about when it submitted a data snapshot to the NHS and when the NHS informed it that it would not expedite the implementation of Galleri.

Earlier this month, Kumar told investors and analysts that Grail would provide the NHS with data on positive predictive value, the number of stage IV cancers found, and the total number of cancers detected in the first year of the study. These are not the primary endpoints of the study, noted Johnson of the NHS.

"The NHS-Galleri trial is designed as a three-year consecutive screening, and it is crucial to evaluate the primary objectives and endpoints when the study concludes in 2026," he wrote. "The primary endpoint of the trial is the absolute reduction in the number of late-stage (Stage III and IV) cancer diagnoses, and cancer-specific mortality will also be analyzed after five years of follow-up."

"Many successful cancer screening trials initially failed to show stage migration," he added. "It is common to observe that the data from the first year will differ from the final trial results."

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