- No public price verified.
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Pathology
GRAIL
by GRAIL · US
Galleri blood test for multi-cancer early detection, sold as a CLIA lab test. Not FDA cleared or approved.
On this page
28/100
Not rated: too little independent evidence yet.
- Regulatory & Compliance0/28
No FDA clearance listed
- Clinical Integration0/6.6
No EHR integrations listed
- Evidence Strength16.2/28.8
1 peer-reviewed paper
- Vendor & Market8.4/18
Mid-tier funding and adoption
- Sentiment & Transparency0/5
No public pricing
▸ Show all 11 dimensions▾ Hide dimension detail
- FDA clearance0/18
No FDA clearance listed
- HIPAA / SOC2 / BAA0/10
No public HIPAA/SOC2/BAA attestation
- EHR integrations (count)0/4
No EHR integrations listed
- Top-3 EHR coverage (Epic / Oracle / Athena)0/2
None of the top-3 EHRs covered
- Peer-reviewed papers8/21
1 peer-reviewed paper
- RCT / meta-analysis / systematic review8/8
1 RCT/Meta-Analysis/Systematic Review
- Funding & adoption signal8/12
Mid-tier funding and adoption
- Years in market0/6
Founded year not recorded
- Pricing transparency0/5
No public pricing
Galleri blood test for multi-cancer early detection, sold as a CLIA lab test. Not FDA cleared or approved.
No public price verified.
Evidence record
No FDA decision cited in our research as of November 2, 2026.
1 study on PubMed: 1 RCT, published 2026. Read the literature summary
- Score computed November 2, 2026, method 1.2.0
- Review written November 2, 2026
MedAI Verdict, GRAIL record, https://medaiverdict.com/tools/grail, version November 2, 2026
Bottom line
GRAIL's Galleri is a multi-cancer early detection blood test, prescription only, run in GRAIL's CLIA-certified laboratory. The Galleri site states that the test has not been cleared or approved by the FDA. GRAIL submitted its premarket approval application in full on January 29, 2026, an FDA advisory panel met on September 23, 2026, and the NHS-Galleri trial missed its primary endpoint. GRAIL describes the test for adults 50 and older as an addition to guideline-recommended screening. A clinician who wants to add a test for such a patient fits that description, while a health system that wants the FDA's decision first has a PMA under review to follow.
What did the FDA advisory panel decide?
Galleri received Breakthrough Device designation in 2018. The Molecular and Clinical Genetics Devices Panel, with 10 voting members, met on September 23, 2026. According to GRAIL's release, 7 members voted that benefits outweigh risks, 2 voted no and 1 abstained. Safety was unanimous, and effectiveness drew 6 yes and 4 no. FDA has published an executive summary for the meeting.
GRAIL describes its PMA evidence as 25,490 consented participants in PATHFINDER 2 with one year of follow-up, the first screening round of NHS-Galleri and a bridging analysis.
What did the NHS-Galleri trial show?
A 2026 paper in Diagnosis is titled "Failure of the Galleri multi-cancer detection trial to meet its primary endpoint" (PMID 42035227). A 2026 Nature Medicine paper reports the performance of the test in the randomized controlled NHS-Galleri trial (PMID 42773209). A BMJ commentary argues that the NHS should not follow the US FDA in approving the test.
What else has been published?
A 2026 New England Journal of Medicine paper studies the effect of screening with a multicancer early-detection test on late-stage cancer diagnosis. A 2026 JAMA paper reports diagnostic delay rates in a population-based screening trial of a cell-free DNA multi-cancer detection test.
What does GRAIL say the test detects?
GRAIL describes a machine-learning classifier on cell-free DNA methylation that detects a cancer signal and predicts its tissue of origin. The company says Galleri looks for methylation patterns shared by many cancer types and identifies signals from more than 50 cancer types. It also says the test does not detect a signal for all cancers and produces false positives and false negatives.
How is Galleri sold?
Galleri is sold as a prescription test through GRAIL's CLIA-certified laboratory. galleri.com links a Pricing and Billing page and says the test may not be available directly through the site in some locations. No price is verified.
The verdict
Galleri is a prescription CLIA-lab test, and the FDA's decision is the open question. A clinician adding a multi-cancer test for an adult 50 or older is working within the use GRAIL describes. A health system that wants an FDA-decided product has the PMA under review to follow, and one that wants a trial meeting its primary endpoint has the NHS-Galleri miss to weigh.
Editorial review last generated November 2, 2026. Synthesized from clinician sentiment, peer-reviewed coverage, and our editorial silo picks. Refined by hand where vendor facts change.
What it costs
All tiers are custom-quoted. The vendor does not publish per-provider list pricing.
| Tier | Monthly | Annual | Notes |
|---|---|---|---|
| Enterprise | Not stated | Not stated | No public price verified. |
Source: vendor pricing page. Last checked November 2, 2026.
What the literature says
1 peer-reviewed study indexed on PubMed evaluate GRAIL in clinical contexts. The most relevant are shown below, ranked by editorial relevance score combining title match, study design, recency, and journal tier.
- Effect of Screening with Multicancer Early-Detection Test on Late-Stage Cancer Diagnosis. (opens in new tab)
- Sasieni P, Johnson P, Round T, et al.· N Engl J Med· 2026
- Whether screening with blood-based early-detection tests for multiple cancers in addition to usual care has clinical utility is unknown. In a randomized, controlled trial conducted in England, we obtained peripheral blood from persons 50 to 77 years of age at up to three annual visits. After baseline blood collection, participants were randomly assigned in a 1:1 ratio to the intervention group (participants whose blood was tested) or the control group (participants whose blood was stored). Participants and trial personnel were initially unaware of the group assignments. The primary end point…
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