The PATHFINDER 2 trial found that adding Galleri to routine screening increased cancer detection rates by 6.5-fold, according to trial results. However, the report did not establish a reduction in late-stage cancer or mortality outcomes. The trial enrolled 35,878 participants and is positioned as a key test of the clinical utility of multi-cancer screening assays. The results highlight the ongoing challenge in screening research: detecting more disease does not automatically translate into fewer deaths. For the biotech screening space, PATHFINDER 2 underscores that evidence requirements for approval and reimbursement depend not just on analytical performance or detection yield, but on downstream survival and stage-shift endpoints.
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