The UK’s National Health Service will wait until 2026 before deciding whether to roll out Grail’s cancer test to one million people, a setback for Illumina and its plan to divest the diagnostics company this year.
On Wednesday, the NHS said data from the first year of a three-year study were promising but not exceptional enough to justify a large order of Grail’s test, which is designed to detect 50 kinds of cancer in the bloodstream. Instead, the NHS will wait until the final results of the study in two years before making the call on a large-scale rollout.
The decision comes at a bad time for parent firm Illumina, which is trying to sell or spin out Grail, after antitrust regulators blew up the $8 billion deal. Grail had hoped that early results would convince the NHS to order tests this year, which would have made the company more attractive for dealmaking.
A pioneer in early cancer detection testing, Grail now operates at a steep loss. The NHS decided to hold off after taking input from a multidisciplinary panel.
“Committing to accelerate implementation of the test in the NHS at scale would have been an exceptional step, requiring exceptional data after just one year, and while what we have seen is very promising, the data so far do not support moving at such a fast pace,” wrote Peter Johnson, a professor of medical oncology at the University of Southampton and NHS advisor, in announcing the decision.
A Grail spokesperson said in an email that first-year results from the UK’s 140,000-person study have been “consistent with or better than” earlier published studies. But in a blog post on Wednesday, the company added that more evidence must be collected, including to gauge whether its test can reduce late-stage diagnoses.
An Illumina spokesperson declined to comment. In a Wednesday regulatory filing, the company said that the UK study could facilitate worldwide adoption.
But Nephron analyst Jack Meehan said the NHS news doesn’t bode well for Illumina and Grail. “Not only does this dampen the short-term commercial prospects for the test, but as Grail’s disclosure notes, there could be broader implications into the value of the test in the full study,” Meehan said.
Grail’s test has divided doctors, some of whom urge mass adoption while others want more test validation.