Galleri is a blood test made by GRAIL that looks for DNA methylation signals shed by many types of cancer and predicts where in the body a detected signal came from.
- List price
- $949; 0% installments up to 12 months by phone [1]
- FDA status
- Not approved; advisory panel voted 7 to 2 that benefits outweigh risks (1 abstained) [2]
- Detection rate (PATHFINDER 2)
- Flagged 40.4% of all cancers in the study period; 73.7% of 12 deadly cancers [3]
- Randomized trial
- NHS-Galleri missed its primary endpoint; stage IV diagnoses 14% lower [4]
What you will pay
| Channel | Price | What is included | Checked | Source |
|---|---|---|---|---|
| GRAIL list price | $949 | Galleri test run in GRAIL's lab | Oct 17 2026 | [1] |
| GRAIL payment plan | $949 over up to 12 months, 0% interest | Arranged by phone | Oct 17 2026 | [1] |
| Function Health add-on | Not published | Listed as an optional add-on for members | Oct 17 2026 | [7] |
| Medicare and most insurers | Not covered | n/a | Oct 17 2026 | [1] |
Hidden costs
In PATHFINDER 2, 0.93% of people tested got a cancer signal [3]. A signal is not a diagnosis. It leads to imaging and often a biopsy to find out whether cancer is there, and those tests are billed separately under your insurance or in cash. In the same study, 61.6% of people with a signal turned out to have cancer, so about 4 in 10 signals were false alarms [3].
How accurate is the Galleri test?
GRAIL presented PATHFINDER 2 at ESMO in Oct 2025. The results below come from the company's press release, covering 23,161 people aged 50 and over [3].
| Measure | Result | What it means |
|---|---|---|
| Cancer signal rate | 0.93% | About 1 in 107 people got a positive result |
| Positive predictive value | 61.6% | Share of positive results that were cancer |
| Specificity | 99.6% | Share of people without cancer who tested negative |
| Sensitivity, all cancers | 40.4% | Most cancers found in the period were not flagged |
| Sensitivity, 12 deadly cancers | 73.7% | Higher for the cancers that cause most deaths |
| Signal origin accuracy | 92% | How often the predicted body site was right |
| Early stage share | 53.5% | Detected cancers that were stage I or II |
What the randomized trial found
NHS-Galleri is the first randomized trial of a multi-cancer test. It enrolled 142,942 adults aged 50 to 79 for three yearly rounds. Its primary goal, fewer stage III and IV cancers across 12 cancer types, was not met. Stage IV diagnoses were 14% lower in the screened group, and screen-detected cancers numbered 1,173 versus 290. There are no data yet on whether it reduces deaths [4]. We found no USPSTF recommendation for multi-cancer blood tests in our research.
FDA status
Galleri is sold as a lab-developed test run in GRAIL's CLIA lab, and GRAIL states it has not been cleared or approved by the FDA [1]. On Sept 23 2026 the FDA's Molecular and Clinical Genetics Panel voted unanimously on safety, 6 to 4 on effectiveness and 7 to 2 (1 abstaining) that benefits outweigh risks. The proposed use is adults 50 and over, by prescription. FDA had not decided as of Oct 17 2026 [2].
Insurance and Medicare
Galleri is not covered by Medicare or most insurers today [1]. The Nancy Gardner Sewell Medicare Multi-Cancer Early Detection Screening Coverage Act became law on Feb 3 2026. It lets CMS cover FDA-approved multi-cancer tests through an evidence review [5]. AZBio reports coverage could begin in 2028 or 2029, with age eligibility phased in and a limit of one test every 11 months [6].
Ways to pay less
- Use GRAIL's 0% plan to spread $949 over up to 12 months [1].
- Ask your HSA or FSA administrator whether the test qualifies before paying.
- Ask your primary doctor or a concierge doctor whether your standard screenings are current; GRAIL presented Galleri as an addition to USPSTF A and B recommended screenings, not a replacement [3].
Galleri compared with other screening buys
More: full body MRI cost, Ezra vs Prenuvo, Function Health vs InsideTracker, coronary calcium score, longevity blood tests, Function Health review, and the longevity clinic guide.
Questions people ask
How much does the Galleri test cost?
GRAIL listed Galleri at $949 on Oct 17 2026, with a 0% installment plan of up to 12 months arranged by phone [1].
Is the Galleri test covered by insurance?
Is Galleri FDA-approved?
How accurate is the Galleri test?
In GRAIL's PATHFINDER 2 results, 61.6% of positive results were cancer, specificity was 99.6%, and the test flagged 40.4% of all cancers found in the study period (73.7% of 12 deadly cancers) [3].
Does Galleri reduce cancer deaths?
That is not known yet. The NHS-Galleri randomized trial of 142,942 adults missed its primary endpoint of fewer stage III and IV cancers, found 14% fewer stage IV diagnoses, and has no mortality data yet [4].
Who can get the Galleri test?
Sources
11 cited
- Galleri test cost. GRAIL, accessed 2026-10-17.
- FDA advisory committee votes in favor of approval of multi-cancer early detection test. The ASCO Post, Sep 24, 2026.
- PATHFINDER 2 results (company press release, ESMO 2025). GRAIL, Oct 17, 2025.
- Annual Galleri screening reduced stage IV diagnoses but missed primary endpoint in first randomized MCED trial. The ASCO Post, Jun 2, 2026.
- MCED coverage and legislation. Prevent Cancer Foundation, Feb 2026.
- Legislation on multi-cancer early detection tests for Medicare beneficiaries becomes law. AZBio, Feb 3, 2026.
- Function Health: what is included. Function Health, accessed 2026-10-17.
- Ezra scans and prices. Ezra, accessed 2026-10-17.
- Prenuvo pricing. Prenuvo, accessed 2026-10-17.
- Coronary artery calcium scan cost. GoodRx, Aug 28, 2025.
- Function Health pricing. Function Health, accessed 2026-10-17.
This page is general information, not medical advice. Talk with a licensed clinician about your own care.