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Back to directoryGRAIL Galleri medical AI product profile
Prescription multi-cancer early detection test from GRAIL that uses cell-free DNA methylation and machine learning to screen for cancer signals across more than 50 cancer types.
Precision medicine and data
Best fit
Programs evaluating supervised cancer-screening access for adults at elevated cancer risk while preserving routine recommended screening, confirmatory diagnostic workflows, and oncology follow-up capacity.
- Primary use case
- AI-enabled multi-cancer early detection blood test that analyzes cell-free DNA methylation patterns, returns cancer signal detected or not detected, and predicts a likely cancer signal origin for follow-up workup
- Audience
- Health systems, primary care networks, oncology prevention programs, employer health programs, concierge practices, laboratory leaders, and population-health teams evaluating multi-cancer early detection workflows
- Risk level
- High
- Pricing signal
- Galleri lists a $949 price for patients and says costs may vary by practice setting or ordering provider; verify current health-system, employer, TRICARE, payer, self-pay, laboratory, blood-draw, and follow-up terms.
- Official sources
- 7 official sources
Compare within workflow: Precision medicine and data · comparison shortlist · source index
Regulatory, privacy, evidence, and workflow lens
Product-specific review. These product-specific signals summarize what the cited sources imply before treating GRAIL Galleri as safe for a local clinical, operational, or research workflow.
| Regulatory / FDA | Treat as a high-risk screening and laboratory workflow. Verify the current FDA PMA status, CLIA and CAP laboratory scope, state requirements, prescription-use boundaries, guideline status, and whether any local use is clinical care, employer benefit, research, or population-health pilot. |
|---|---|
| Privacy | Review HIPAA notice, privacy terms, HIE participation, genetic information handling, laboratory results, provider and patient portal access, billing, business associates, research disclosures, de-identification, retention, and whether PHI or genomic-derived data can support product improvement. |
| Evidence | Use published performance studies, PATHFINDER results, NHS-Galleri topline data, FDA submission materials, and local pilots to evaluate sensitivity by stage and cancer type, false-positive burden, PPV, diagnostic workup completion, stage shift, mortality evidence, patient anxiety, and equity. |
| Workflow | Best governed as a supervised screening-access program with primary care, oncology, genetics, radiology, laboratory, privacy, payer, navigation, and scheduling teams defining eligibility, ordering, result interpretation, diagnostic confirmation, follow-up ownership, and incident review. |
Where GRAIL Galleri fits
GRAIL describes Galleri as a prescription multi-cancer early detection blood test that identifies DNA shed by cancer cells, uses methylation patterns and a machine-learning algorithm to determine whether DNA fragments likely originate from healthy or cancer cells, and predicts a likely cancer signal origin for follow-up. Galleri and GRAIL materials state the test should be used in addition to recommended screening, does not diagnose cancer, does not detect all cancers, and can produce false positives and false negatives. GRAIL announced a January 2026 FDA PMA submission, while its safety information says the current test has not been FDA cleared or approved and is performed by a CLIA-certified, CAP-accredited laboratory. GRAIL's February 2026 NHS-Galleri topline release says the trial did not meet the primary endpoint for statistically significant combined Stage III-IV reduction, while reporting Stage IV and detection-rate signals that require careful governance.
Not for: Replacing guideline-recommended screening, diagnosing cancer, ruling out cancer after a negative result, testing unsupported populations, or deployment without clinician interpretation, confirmatory workup, privacy review, and evidence governance.
What to verify before using GRAIL Galleri
- Current FDA, CLIA, CAP, payer, guideline, state laboratory, health-system policy, and medical-necessity status before offering or ordering the test.
- Whether the intended population matches GRAIL's recommended elevated-risk adult use, exclusions for pregnancy, age, active cancer treatment, and local cancer-screening protocols.
- How blood samples, cell-free DNA, methylation data, results, provider orders, portals, health information exchange participation, PHI, genetic information, research use, retention, de-identification, and billing data are governed.
- How cancer signal detected, no signal detected, uncertain, false-positive, false-negative, unsupported, delayed, and discordant results are communicated, documented, routed for imaging or laboratory workup, and monitored.
- Local validation plan for uptake, equity, anxiety, false reassurance, positive predictive value, diagnostic cascade, imaging capacity, specialty access, missed cancers, stage shift, mortality evidence, and downstream cost.
Source links
Use these links to confirm current claims, terms, regulatory status, pricing, and deployment requirements.
- www.galleri.com
- www.galleri.com / health-systems
- www.galleri.com / patient / faqs
- www.galleri.com / hipaa-notice
- grail.com / galleri-test / the-test
- grail.com / press-releases / grail-submits-fda-premarket-approval-application-for-the-galleri-multi-cancer-early-detection-test
- grail.com / press-releases / landmark-nhs-galleri-trial-demonstrates-a-substantial-reduction-in-stage-iv-cancer-diagnoses-increased-stage-i-and-ii-detection-of-deadly-cancers-and-four-fold-higher-cancer-detection-rate
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