The PATHFINDER 2 trial reported a major diagnostic yield jump when Galleri was added to routine screening: cancers were detected at 6.5 times the rate versus screening alone. The study, led in a cohort of 35,878 people, however did not establish improvements in late-stage cancer reduction or mortality. For developers of multi-cancer early detection tests, the readout underscores the tradeoff between detecting more disease and proving downstream clinical benefit. It also highlights the need for longer follow-up and clearer endpoints beyond detection rates. The results may influence payer and guideline discussions on how such tests should fit into screening pathways, particularly where survival benefits remain unproven.
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