Freenome vs GRAIL (2026)
The blood based cancer screening choice is really a choice of screening philosophy. GRAIL's Galleri is the multi cancer bet: a single draw screening for signals across more than 50 cancer types with tissue of origin prediction, backed by the deepest trial program in the space, PATHFINDER 2 at 25,490 participants and the NHS Galleri trial at more than 140,000, the only prospective randomised controlled trial of multi cancer early detection for population screening. Freenome is the single cancer depth play: SimpleScreen CRC targets colorectal screening specifically, with the PREEMPT CRC validation published in JAMA and blood based testing added to the American Cancer Society's colorectal guideline in 2026, commercialised through Exact Sciences and Abbott. Neither test is FDA approved: Galleri is offered as a laboratory developed test with its final PMA module submitted in January 2026, and SimpleScreen CRC's PMA has been under review since August 2025. If your failure mode is cancers no screening program looks for, start with GRAIL. If your failure mode is the colorectal screening gap specifically, start with Freenome.
- Colorectal is the specific gap you are closing: SimpleScreen CRC reported 85 percent sensitivity for colorectal cancer at 90 percent specificity in a 966 sample head to head validation, with the PREEMPT CRC study published in JAMA in 2025.
- Guideline tailwind: blood based colorectal screening entered the American Cancer Society's updated guideline in 2026, the recognition path a payer conversation runs on.
- Commercial machinery already attached: Exact Sciences holds exclusive US commercial rights and a separate Abbott collaboration covers bringing the test to market.
- Breadth is the argument: a signal across more than 50 cancer types with tissue of origin prediction from one draw, covering the cancers that have no standalone screening program.
- Trial scale no rival matches: PATHFINDER 2 enrolled 25,490 participants and NHS Galleri enrolled more than 140,000, the only prospective randomised controlled trial of a multi cancer early detection test for population screening.
- Regulatory momentum with a public evidence trail: the final PMA module was submitted in January 2026 on a test holding Breakthrough Device designation since 2018, available today as a laboratory developed test.
This comparison is published by AI Health Index, an independent research platform that compares healthcare AI vendors objectively. Freenome and GRAIL are each graded against the same capability taxonomy, from each vendor's own public materials and the regulatory record, under the AI Health Index verification standard. No vendor pays for placement, and no vendor has reviewed this page. How this evidence is graded
Plain facts
| Fact | Freenome | GRAIL |
|---|---|---|
| Primary category | Diagnostics & Genomics | Diagnostics & Genomics |
| Founded | Not recorded | 2016 |
| Headquarters | Brisbane, California | Menlo Park, California |
| Website | freenome.com | grail.com |
Side by Side
Each record in one paragraph
Written to be quoted whole. Each paragraph states what the AI Health Index verified about the vendor, with the caveats attached. Generated from this pair’s live capability grades, so it moves when a grade moves.
The AI Health Index awards Freenome its top capability grade on several axes, including Autonomy and Oversight Model, Clinical and Operational Evidence and FDA and Regulatory Status. Set against GRAIL, Freenome does not grade higher on any scored axis, though the two are level on several axes, including AI Centrality, Autonomy and Oversight Model and Clinical and Operational Evidence. Its thinnest published disclosure sits on Model Supply Chain Disclosure. Grades reflect evidence the AI Health Index could verify at the last review, so a low grade records disclosure the vendor has not published rather than a capability it has been shown to lack.
Source: AI Health Index, July 2026
The AI Health Index awards GRAIL its top capability grade on several axes, including Autonomy and Oversight Model, Model and Technology Transparency and Clinical and Operational Evidence. Set against Freenome, GRAIL grades higher on several axes, including Model and Technology Transparency, Model Supply Chain Disclosure and AI Safety and PHI Stewardship. Grades reflect evidence the AI Health Index could verify at the last review, so a low grade records disclosure the vendor has not published rather than a capability it has been shown to lack.
Source: AI Health Index, July 2026
Questions buyers ask
Should we choose Freenome or GRAIL?
The AI Health Index grades GRAIL higher than Freenome on every axis that separates them, several axes, including Model and Technology Transparency, Model Supply Chain Disclosure and AI Safety and PHI Stewardship. Freenome does not grade higher on any scored axis.
Where do Freenome and GRAIL differ most?
The widest separation the AI Health Index records between Freenome and GRAIL is on Model Supply Chain Disclosure, where Freenome grades D and GRAIL grades B. That axis sits in the AI Capability group, so it should carry the most weight for a buyer whose binding constraint is how much of the work the model itself is trusted to do.
Where do Freenome and GRAIL grade the same?
The AI Health Index grades Freenome and GRAIL the same on several axes, including AI Centrality, Autonomy and Oversight Model and Clinical and Operational Evidence. Neither holds an advantage the index can evidence on those axes, so they should not carry weight in a selection between these two.
What have Freenome and GRAIL not disclosed?
At the last review, at least one of Freenome and GRAIL published thin or absent detail on Model Supply Chain Disclosure. The AI Health Index treats an absent disclosure as a gap in the public record rather than a failure of the product, so these are the axes to get in writing during diligence instead of inferring from the grade.
Related comparisons
Other published head to head assessments involving these vendors or their closest peers. The full set for this category is on the Diagnostics & Genomics page.
Neither test is FDA approved. Galleri is offered as a laboratory developed test; SimpleScreen CRC is pending its PMA decision, anticipated in 2026, and its PMA has been under review since August 2025. Freenome's 22 percent sensitivity for advanced precancerous lesions at 90 percent specificity, from the same validation as the 85 percent cancer sensitivity figure, is a number screening committees should weigh alongside the headline result. Breakthrough Device designation is not approval. Sensitivity figures for both vendors come from company reported studies; NHS Galleri results should be read from the trial's own publications.