Freenome vs GRAIL (2026)
Both screen blood for cancer signals using cell free DNA methylation and machine learning, and they differ in scope and regulatory standing. Freenome's SimpleScreen CRC looks for one cancer: FDA approved it in July 2026 for colorectal cancer screening in average risk adults aged 45 and older, with a positive result followed by colonoscopy. GRAIL's Galleri looks for more than 50 cancer types and predicts where a signal comes from. It is offered as a laboratory developed test in addition to guideline screening, with its FDA application pending. The randomized NHS-Galleri trial of 142,250 people did not meet its primary endpoint of fewer stage III or IV cancers after three rounds. Freenome replaces or supplements one established screen with an approved test; Galleri adds a broad screen on top of existing ones, and its outcome evidence is still settling.
- A single cancer screen approved by FDA in July 2026, for colorectal cancer in average risk adults 45 and older.
- Validation in 48,995 adults, reporting 79.2 percent sensitivity for cancer and 12.5 percent for advanced precancerous lesions.
- US commercial rights held by Abbott, with launch planned for fall 2026.
- A multi cancer screen across more than 50 cancer types, with a predicted site of origin.
- A laboratory developed test used in addition to guideline screening, with an FDA application pending.
- A published list price of $949 per 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 | 2014 | 2016 |
| Headquarters | Brisbane, California | Sunnyvale, California |
| Website | freenome.com | grail.com |
Side by Side
Select any grade to read the note behind it.
Each vendor in one paragraph
Written to be quoted whole. Each paragraph opens the AI Health Index profile of the vendor: what the product is, who buys it and what it does.
Blood-based cancer screening company (NASDAQ: FRNM) whose multiomics platform reads cell-free DNA methylation at single base resolution, alongside protein and autoantibody signals, with machine learning classifiers producing the result.
Source: AI Health Index, September 2026
Multi cancer early detection company (NASDAQ: GRAL). The Galleri test uses targeted methylation sequencing of cell-free DNA from a blood draw, with machine learning classifiers that detect a cancer signal and predict its origin, across more than 50 cancer types. It is prescription only, offered as a laboratory developed test from GRAIL's CLIA certified, CAP accredited laboratory in Durham, North Carolina, and intended for use in addition to guideline recommended screening.
Source: AI Health Index, September 2026
Questions buyers ask
How do Freenome and GRAIL work with the EHR?
The health systems page offers Founding Partners Freenome Digital Health, described as EHR-native digital tools that identify eligible patients, engage patients and care teams and fit screening into routine care, with clinical and EHR workflow optimization as part of the program.
GRAIL announced a collaboration with Epic in April 2026 to make Galleri orderable, with results available, inside Epic through Aura, with implementation begun in the first quarter of 2026, early adopter programs underway and broad availability expected by the end of 2026; Ochsner Health's chief population health officer is quoted on the plan. From the AI Health Index, drawn from each vendor's own published materials and the regulatory record, verified September 29, 2026. No vendor pays for placement.
How are Freenome and GRAIL priced and sold?
Freenome sells its own configuration to health systems through a Founding Partner program: SimpleScreen Lung, a laboratory developed test, with SimpleScreen CRC and its digital tools. The company states that the approved test meets Medicare's coverage criteria.
For GRAIL, some TRICARE plans cover the test, and Priority Health covers it in two Medicare Advantage plans. From the AI Health Index, drawn from each vendor's own published materials and the regulatory record, verified September 29, 2026. No vendor pays for placement.
How do Freenome and GRAIL handle patient data?
Freenome's HIPAA notice of privacy practices (effective 13 July 2026) states that it never shares a patient's information for marketing or sale without written permission, and that it may use or share information for health research.
GRAIL's HIPAA notice of privacy practices covers test results and genetic information, and states that GRAIL will not sell a patient's PHI without written authorization and will not disclose it to third parties for marketing without authorization. From the AI Health Index, drawn from each vendor's own published materials and the regulatory record, verified September 29, 2026. No vendor pays for placement.
Which settings and specialties do Freenome and GRAIL cover?
For Freenome, the company also sells SimpleScreen Lung to health systems in its Founding Partner program, for adults aged 50 to 80 with a 20 pack-year smoking history who have not had low-dose CT screening. Its performance appears in a 2026 conference abstract, with no peer reviewed validation listed, so that part of the named coverage runs ahead of its evidence.
With GRAIL, the studies behind the test enrolled adults aged 50 and older (PATHFINDER 2, at US and Canadian sites) and aged 50 to 77 (NHS-Galleri, in England), and the indication before FDA is screening adults aged 50 and older. From the AI Health Index, drawn from each vendor's own published materials and the regulatory record, verified September 29, 2026. No vendor pays for placement.
Related comparisons
Other published head to head assessments involving these vendors or their closest peers.
Both records were reviewed on this site in September 2026. GRAIL publishes a list price of $949 for Galleri; Freenome does not publish a price. The randomized NHS-Galleri trial did not meet its primary endpoint of fewer late stage cancers.
Ask both what their test's false positive rate is in people your practice would screen, and what follow up it triggers.