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Galleri Blood Test Confirms Cancer in 62% of Positive Screens in Major Trial

Results presented at ESMO highlight high specificity alongside limited sensitivity in real‑world screening.

Overview

  • PATHFINDER 2 analyzed 23,161 asymptomatic adults with at least 12 months’ follow‑up, reporting 61.6% positive predictive value and 99.6% specificity.
  • Overall sensitivity in participants followed for more than a year was 40.4%, with detection stronger for a subgroup of 12 cancers that shed more tumor DNA.
  • The test identified the likely tissue of origin in 92% of confirmed cases, streamlining subsequent diagnostic work‑ups.
  • More than half of Galleri‑detected new cancers were stage I–II (53.5%), and 69.3% were stage I–III, with roughly three‑quarters from cancers lacking standard screening.
  • Adding Galleri to recommended screening increased cancers found within a year by more than sevenfold, as the NHS continues a >140,000‑person trial with topline results expected next year and experts calling for mortality and cost‑effectiveness data before broad rollout.