NEW YORK – An investigation conducted by The BMJ and published on Wednesday has uncovered concerns from UK health officials about Grail's Galleri multi-cancer early detection (MCED) test, its performance, and whether it would be appropriate to roll out the test to the country's entire population.
"Documents leaked to The BMJ suggest that the [UK NHS Galleri] trial is not suitable to justify a national screening test, while experts believe that Galleri has been overhyped and that the current trial is unethical," the journal said in a statement.
Moreover, exchanges between the UK National Screening Committee, an independent body that decides what constitutes cost-effective screening, and the NHS "have revealed major disquiet," the report said. It also outlined the NHS's "success criteria" for its Galleri trial and raised concerns about conflict of interest surrounding the beginning of the Grail-NHS partnership. Documents were obtained by freedom of information requests and through leaks to BMJ.
"The UK NSC has not contacted, informed, or notified Grail of any concerns related to the NHS-Galleri trial," a Grail spokesperson told GenomeWeb in a statement. "The trial was designed with three consecutive years of screening in order to achieve the primary endpoint, which is the absolute reduction in the number of ‘late stage’ (defined as stage III and IV) cancer diagnoses."
The BMJ report comes just after Grail has been pushed out of the nest for a second time by Illumina, which helped launch the liquid biopsy firm in 2016 and then acquired all of it in 2021 for approximately $8 billion. Under pressure from regulators and unhappy investors, Illumina spun off Grail again in late June, making it a publicly traded company.
The report also mentions a US investor class action lawsuit that claims Illumina and Grail officials oversold Galleri's potential. In an amended complaint filed June 21 in the US District Court for the Southern District of California, the plaintiffs alleged that Grail officials "had been directly informed by the US Food and Drug Administration in meetings in 2019 and in formal written feedback in February 2020 that the Galleri studies that Grail had proposed were wholly insufficient to support FDA approval. Specifically, the FDA privately informed Grail that FDA approval required clinical evidence to demonstrate that Galleri actually was effective in improving patient outcomes and treatment decisions for the intended test population — i.e., asymptomatic patients over the age of 50 in the United States. … [The studies] were thus wholly inadequate to support the statement that Galleri 'saves lives.'"
Moreover, the complaint alleges that the FDA told the company "that there was 'no way' that Grail could get approval for such a test through the clinical pathway Grail proposed. Specifically, the FDA pointed to the fact that the NHS and SUMMIT trial data would not support FDA approval because of the significant difference in the standard of care and practice of medicine for cancer diagnosis in the US and the UK."
When asked about the alleged communications, an FDA spokesperson said the agency "does not discuss or disclose conversations it may be having with any particular sponsor."
NHS announced in late May that it would not accelerate its implementation of the Galleri test following a review of the first year's data from the Galleri trial and would instead wait for the full results, due in 2026.
In Thursday morning trading on the Nasdaq, shares of Grail were down 2 percent at $17.30.