New, large‑cohort data from the PATHFINDER program show improvements in Galleri’s positive predictive value and sensitivity when participants were followed longitudinally, strengthening Grail’s filing case for multi‑cancer early detection. The U.S. PATHFINDER 2 analysis reported roughly 40% sensitivity across detected cancers with improved detection of cancers outside existing screening programs and a positive predictive value near 62% in the followed cohort. Grail and independent analysts noted clearer signal for real‑world utility but cautioned that false positives and downstream diagnostic pathways remain open questions for regulators and payers. Samsung and other international partners also announced investment and distribution plans to expand Galleri into Asian markets, reflecting commercial momentum ahead of regulatory outcomes.