The NHS-Galleri trial, a large randomized controlled trial run by the UK’s National Health Service in partnership with GRAIL, enrolled roughly 142,000 asymptomatic adults aged 50-77 to test whether adding an annual Galleri multi-cancer early detection (MCED) blood test — which looks for cell-free DNA signals shared across more than 50 cancer types — to standard cancer screening could catch cancers earlier and reduce late-stage diagnoses (ClinicalTrials.gov NCT05611632; ISRCTN91431511). Full results, presented at the 2026 ASCO Annual Meeting and published in the Journal of Clinical Oncology (DOI 10.1200/JCO.2026.44.17_suppl.LBA100), reported that the trial’s PRIMARY endpoint — a statistically significant reduction in COMBINED stage III and IV cancer diagnoses — was NOT met. Reported secondary findings were more favorable: annual Galleri testing reduced stage IV diagnoses by 22% in the trial’s second screening round and 26% in its third round, increased the overall cancer detection rate roughly four-fold when added to standard screening, found more stage I and II cancers than all of the NHS’s existing single-cancer screening programs combined, and reduced cancer diagnosis via emergency-department presentation by 25%. Galleri is not currently FDA-approved for cancer screening in the United States; in the US it is offered as a laboratory-developed test.

The FDA approved Cologuard Plus, a next-generation multitarget stool DNA test from Exact Sciences, for colorectal cancer screening in adults ages 45 and older at average risk. The approval was based on the pivotal BLUE-C study (ClinicalTrials.gov NCT04144738; primary publication in the New England Journal of Medicine, DOI 10.1056/NEJMoa2310336, PMID 38477986), one of the largest prospective, head-to-head colorectal cancer screening studies conducted, in which 20,176 participants provided a stool sample tested with both Cologuard Plus and a fecal immunochemical test (FIT). Cologuard Plus demonstrated 95% sensitivity for colorectal cancer and 94% specificity (no findings on colonoscopy), outperforming FIT on several measures including sensitivity for advanced precancerous lesions.

An 18-gene urine-based test (MPS2) is reported to improve detection of higher-grade prostate cancer across validation studies. Primary validation: PMID 38635241, https://pubmed.ncbi.nlm.nih.gov/38635241/, DOI https://doi.org/10.1001/jamaoncol.2024.0455. Non-digital-rectal-exam validation: PMID 39836866, https://pubmed.ncbi.nlm.nih.gov/39836866/, DOI https://doi.org/10.1097/JU.0000000000004421. This is a diagnostic/biomarker story, not a treatment story. It must NOT be presented as diagnosing every prostate cancer, as replacing all PSA screening, or as proof that improved diagnostic accuracy alone establishes improved long-term mortality outcomes — that inference is not supported by a diagnostic validation study design. [Identifiers as supplied, attributed to independent verification outside this environment — not independently re-verified live here.]