NEWS
NHS-Galleri trial ends with mixed results
Cancer diagnostics firm GRAIL has announced the topline results from the landmark, randomised, controlled NHS- Galleri trial, which evaluated annual multi-cancer screening with the Galleri blood test in the NHS over three years in 142,000 demographically representative participants aged 50 to 77. As well as demonstrating a substantial
reduction in stage four cancer diagnoses, the test increased stage one and two detections of deadly cancers, and four-fold higher cancer detection rate. The primary endpoint of statistically significant
IVD for genetic variant associated with Alzheimer’s
Roche has announced that it has received CE Mark approval for its Elecsys Apolipoprotein E4 biomarker test – the first in vitro diagnostic (IVD) immunoassay to identify the presence of the ApoE4 gene variant in the bloodstream. The ApoE4 gene variant is associated with an increased risk of late- onset Alzheimer’s disease and is present in approximately 40–60% of Alzheimer’s patients. Until now, confirming ApoE4 carrier
status in Alzheimer’s patients has relied on molecular DNA testing. The Elecsys ApoE4 test offers a simple, fast and reliable option, using a minimally invasive blood sample, to identify whether an individual carries the ApoE4 variant. This allows reliable and efficient filtering of non-carriers, reserving genetic testing for patients who need it most. For those identified as carriers,
follow-up genetic testing can confirm their status and provide more detailed insights. This will be essential as the use of current disease-modifying therapies (DMTs) is influenced by a patient’s genetic profile. The Elecsys ApoE4 test works alongside Roche’s other blood-based Alzheimer’s disease biomarkers, including the recently CE-marked Elecsys pTau181 test, which is designed to assess the presence of key proteins associated with Alzheimer’s disease.
April 2026
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combined stage three-four reduction was not met, but a favourable trend was observed over time. The clinical performance of Galleri
has been rigorously established in several studies, and the NHS-Galleri trial was designed to demonstrate population-level impact through the reduction of late-stage cancer diagnoses and increased cancer detection rate within the NHS to inform a decision about a national screening programme in England. The primary endpoint of statistically significant stage three-four reduction
was not observed. However, there was a favourable trend toward fewer stage three-four cancers in a pre-specified group of 12 deadly cancers in the intervention arm after the prevalent screening round. Adding Galleri to standard of care
screening resulted in a reduction in stage four diagnoses across the 12 deadly cancers. Stage four diagnoses in these cancers decreased with each year of sequential screening, with a greater than 20% reduction in the second and third rounds.
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