Grail reported updated PATHFINDER study results showing improved positive predictive value for its multi-cancer blood test Galleri, reinforcing claims of better accuracy as the company nears an FDA filing. In analyses of nearly 36,000 adults, the test’s sensitivity for cancers detected over follow-up rose and the positive predictive value among positive tests increased toward 62 percent in longer-followed cohorts, according to STAT coverage. Grail emphasized detection of cancers not covered by existing screening programs, including pancreatic and liver cancers, and noted a substantial fraction of detections were earlier-stage tumors. Company spokespeople argue the data address prior concerns about false positives and downstream diagnostic burden. Experts caution that population-level screening impact, downstream diagnostic workflows and cost-effectiveness remain key open questions for regulators and payers as the firm pursues broader clinical adoption and potential FDA actions.
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