Galleri by GRAIL: status and timeline

Galleri

Enable early cancer detection when most treatable. Reduce cancer mortality through blood-based screening accessible to millions.

DeployStage 4 of 5

Available by prescription. FDA advisory endorsed Sept 23, 2026; approval expected Q4 2026.

Updated 18d agoChecked 11 Oct0 updates this week

Milestones

Next · PMA (Premarket Approval) expected

Galleri commercial launchJun 2021Complete.
NHS-Galleri trial enrollment completed2025Complete.
PATHFINDER 2 trial enrollment completed2025Complete.
FDA advisory committee endorsement23 Sep 2026Complete.
PMA (Premarket Approval) expectedTarget Q4 2026Not yet reached.

Most important, last 3 months

Upcoming

Q4 2026PMA (Premarket Approval) expected (next)
2027Clinical guideline adoption

Current obstacles

Locating tumors after detectionTest predicts cancer type but not location. Confirmatory imaging and biopsy still required; delays treatment.
False positives and PPV variancePositive predictive value varies by cancer type and age. Unnecessary workups cause anxiety and cost.
Sensitivity varies by cancer typeCancers shedding little DNA or in early stages may not be detected. Blood cancer and early-stage sensitivity lower.

Physics limits

DNA shedding varies by tumor propertiesShedding depends on tumor burden, vascularity, and histology. Early-stage cancers may be undetectable; late-stage ones may have high circulating DNA.
Tissue prediction is probabilisticWhen signal detected, test predicts type with probability; always needs confirmatory imaging and biopsy.

How it works

3 parts

Blood draw

Plasma sample collected

Standard blood draw; plasma isolated. Circulating cell-free DNA is extracted.

Methylation analysis

DNA methylation patterns detected

Sequencing identifies methylation signatures unique to cancer cells vs. healthy cells.

Machine learning

Predicts cancer presence and type

Algorithm identifies cancer signal and predicts tissue origin to guide imaging and biopsy.

Spec sheet

Spec	Galleri
Cancer types detected	Over 50 types^R (reported)
Sample type	Blood draw (plasma)^R (reported)
Current out-of-pocket cost	$949 per test^R (reported)
PATHFINDER 2 trial participants	35,878 (North America)^R (reported)
Detection increase vs. standard	6.5-fold^R (reported)

^R reported by the company

Update log

2 updates

Wed 23 Sep

Major: FDA Molecular and Clinical Genetics Advisory Committee endorses Galleri, recommending approval for multi-cancer early detectionRegulatorRegulatory

Tue 22 Sep

Major: PATHFINDER 2 trial results published in Nature Medicine, showing 6.5-fold increase in cancer detection with Galleri blood testPaperResearch

About GRAIL

The team behind Galleri

GRAIL

Galleri blood test, multi-cancer early detection, liquid biopsy

GRAIL is headquartered in Menlo Park, California, spun off from Illumina in June 2024 and publicly traded (GRAL). GRAIL develops Galleri, a blood test for multi-cancer early detection. FDA advisory committee endorsed Galleri in September 2026.

Galleri detects signals from 50+ cancer types using blood DNA methylation patterns.
NHS-Galleri (142,000+ UK) and PATHFINDER 2 (35,878 North America) are the largest MCED trials.
Galleri detection increased 6.5-fold vs. standard screening. FDA advisory recommended approval Sept 2026.

grail.com (opens grail.com)Company profile →

Founded: 201511 yrs
Headquarters: United States
Status: Public
Valuation: public
Works in: BiotechGenomics & sequencing
Coverage: 1 program · 2 updateslatest 18d agochecked 11 Oct
Partners: NHS (UK National Health Service)
Investors: Illumina
People: Joshua OfmanCEO

Spec

Galleri

Cancer types detected

Over 50 types^R (reported)

Sample type

Blood draw (plasma)^R (reported)

Current out-of-pocket cost

$949 per test^R (reported)

PATHFINDER 2 trial participants

35,878 (North America)^R (reported)

Detection increase vs. standard

6.5-fold^R (reported)