Real-world data and clinical experience from over 100,000 multi-cancer early detection tests.

ABSTRACT: Blood-based multi-cancer early detection (MCED) has the potential to simultaneously screen for multiple deadly cancers with high positive predictive value. To assess real-world performance, we evaluated the Galleri® MCED test (GRAIL, Inc.) across 111,080 individuals (median age 58 years, 55.5% males). This MCED test analyzes methylation patterns of cell-free DNA to detect presence of a cancer signal and predict the anatomical cancer signal origin (CSO) to facilitate diagnostic evaluation. Cancer signal detection rate was 0.91% (1011/111,080), consistent with clinical studies and independent modeled values. Providers reported clinical outcome for 459 of 1011 individuals with cancer signal detected MCED tests. Of these, 258 had an invasive cancer diagnosis, spanning 32 cancer types. The MCED

SUBMITTER: Matrana M 

PROVIDER: S-EPMC12578847 | biostudies-literature | 2025 Oct

REPOSITORIES: biostudies-literature