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GRAIL (GRAL) investor relations material
GRAIL Study Result summary
Complete event summary combining all related documents: earnings call transcript, report, and slide presentation.Study overview and design
PATHFINDER 2 is the largest U.S. interventional study of a multi-cancer early detection (MCED) test, enrolling over 35,000 adults aged 50+ across multiple centers to assess Galleri's performance and safety in a diverse, intended-use population.
The study is a prospective, multi-center, interventional trial with a single blood draw and CSO-guided diagnostic workup at physician discretion, with participants followed for up to three years.
The first 25,000+ participants with at least one-year follow-up formed the registrational dataset for FDA submission.
PATHFINDER 2 and NHS-Galleri are the two largest MCED studies, totaling nearly 400,000 participants in the clinical program.
The study included participants in remission or cured of cancer, requiring at least three years post-treatment.
Key efficacy and performance results
Galleri's positive predictive value (PPV) was 62%, with specificity at 99.6% (0.4% false positive rate) and negative predictive value (NPV) at 99.1%.
Overall episode sensitivity for all cancers was 40.4%, with higher sensitivity in key subgroups: 73.7% for the 12 deadliest cancers, 55% for cancers without screening options, and 74% for aggressive cancers responsible for two-thirds of cancer deaths.
Adding Galleri to standard-of-care screening increased cancer detection rate by over 7 times compared to standard screening alone.
73–75% of Galleri-detected cancers lacked recommended screening options, and over half (53.5%) were found at early stages (I or II).
Galleri detected about three times as many cancers when added to standard screening for five major cancers.
Diagnostic and operational outcomes
Galleri's cancer signal origin (CSO) prediction was accurate in 91.7–92% of true positives, enabling efficient diagnostic workups.
Median time to diagnostic resolution was 36 days for true positives and 46 days for all MCED-positive participants.
Only 0.6% of participants underwent an invasive procedure for a positive result, with such procedures twice as common in those diagnosed with cancer.
No serious study-related adverse events were reported.
Results require interpretation by healthcare providers and confirmatory diagnostics if positive.
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