Galleri Multi-Cancer Early Detection

GRAIL

Liquid biopsy pan cancer

Methylation-based multi-cancer early detection test for individuals at elevated risk; signals cancer and tissue of origin.

Regulatory

Regulatory status	LDT
LDT	Yes
CLIA-certified lab	Yes

Laboratory-developed test (LDT) offered under CLIA. Not reviewed or cleared by the FDA. Validation is the responsibility of the offering CLIA-certified laboratory.

Validation summary

Study design	Prospective
Cohort size	6,621 patients — 6,662 enrolled adults ≥50 years without cancer symptoms; 6,621 with analysable results (63.5% women, 36.5% men, 91.7% White).
Number of validation sites	7
Site geography	Multi-center (US)
Comparator	Clinical outcomes
Primary endpoint	Positive / negative predictive value
Primary result	Cancer signal detected in 92/6,621 participants (1.4%). True positives 35/92 (PPV 38.0%); false positives 57/92 (62.0%). 29 new cancers diagnosed in the cohort; 14/29 (48%) Stage I or II. Specificity ~99.1%. Median time to diagnostic resolution 79 days (IQR 37–219). 74% of cancers detected lacked USPSTF screening recommendations.
External validation	Yes — Prospective cohort drawn from 7 US health networks; independent of GRAIL's original Circulating Cell-free Genome Atlas (CCGA) training cohort. · PPV 38%; specificity ~99.1%; 48% of new cancers Stage I/II at detection.
Peer-reviewed	Yes
FDA decision summary	—

Key publications

Blood-based tests for multicancer early detection (PATHFINDER): a prospective cohort study pivotal
The Lancet · 2023

Limitations noted

PATHFINDER is a single-arm prospective study with no comparator arm and an over-representation of White (91.7%) and well-resourced US participants. Test-version PPV was 38% (later versions report 43% per GRAIL but not in this paper). The trial does not establish mortality benefit — only test characteristics. Galleri remains an LDT pending FDA review of PATHFINDER 2.

Deployment

Available

Yes

Sources

https://www.galleri.com/ · company · 2026-04-20

How to cite this entry

Elbakri A. OncologyAI Registry: Galleri Multi-Cancer Early Detection. Available at: https://oncologyairegistry.org/tools/grail-galleri.html. Accessed [date].