GRAIL vs PathAI AISight
Roche signed a definitive agreement on May 7, 2026 to acquire PathAI for $750M upfront plus up to $300M in milestones, with closing expected in the second half of 2026. A lab director signing an AISight contract now is buying from a company headed into Roche Diagnostics, which also sells its own digital pathology hardware. AISight Dx, cleared as K243391 in June 2025, covers primary diagnosis of FFPE slides on Hamamatsu and Leica scanners, and its algorithms are research use.
Galleri sits outside the slide workflow. Per GRAIL's release, an FDA advisory panel voted on September 23, 2026 with 7 yes, 2 no and 1 abstention that benefits outweigh risks, but only 6 of 10 voted yes on effectiveness. Its buyer is a physician ordering a blood test for an adult patient. PathAI's buyer is a pathology department choosing a cloud viewer.
Pathology · Reviewed November 2, 2026
GRAIL
by GRAIL
Galleri blood test for multi-cancer early detection, sold as a CLIA lab test. Not FDA cleared or approved.
PathAI AISight
by PathAI · founded 2016
Cloud image management for digital pathology with AISight Dx, cleared for primary diagnosis, plus biopharma AI services.
When to pick each one
PathAI AISight
- AISight Dx cleared for primary diagnosis, K243391
- CE-IVD for EEA, UK and Switzerland
- Cleared on Hamamatsu and Aperio GT 450 DX
Score
Each row shows points earned of points available under the published rubric.
GRAIL
28of 100
PathAI AISight
40of 100
| Dimension | GRAIL | PathAI AISight | Difference |
|---|---|---|---|
| FDA clearance | 0 / 18 | 18 / 18 | -18 |
| HIPAA / SOC2 / BAA | 0 / 10 | 0 / 10 | 0 |
| EHR integrations (count) | 0 / 4.2 | 0 / 4.2 | 0 |
| Top-3 EHR coverage (Epic / Oracle / Athena) | 0 / 2.4 | 0 / 2.4 | 0 |
| Peer-reviewed papers | 8.4 / 21 | 0 / 21 | +8.4 |
| RCT / meta-analysis / systematic review | 7.8 / 7.8 | 0 / 7.8 | +7.8 |
| Funding & adoption signal | 8.4 / 12 | 8.4 / 12 | 0 |
| Pricing transparency | 0 / 5 | 2.5 / 5 | -2.5 |
| Years in market | 0 / 6 | 6 / 6 | -6 |
Scroll horizontally to see every column.
Pricing
GRAIL
| Tier | Monthly | Annual | Notes |
|---|---|---|---|
| Enterprise | n/a | n/a | No public price verified. |
PathAI AISight
| Tier | Monthly | Annual | Notes |
|---|---|---|---|
| Enterprise | n/a | n/a | No public price. Billing period, trial and refund not stated. |
Evidence
GRAIL
FDA decisions
No FDA decision cited in our research as of November 2, 2026.
Peer-reviewed
1 PubMed record names GRAIL.
PathAI AISight
FDA decisions
K243391 (opens in new tab)510(k)2025-06-26
AISight Dx
K212361 (opens in new tab)510(k)2022-08-11
Novo
Compliance and integrations
Documented from each vendor’s own pages.
| Spec | GRAIL | PathAI AISight |
|---|---|---|
| Free tier | ||
| HIPAA | ||
| SOC 2 Type II | ||
| EHR integrations | Not specified | Not specified |
| Founded | n/a | 2016 |
| HQ | US | US |
Scroll horizontally to see both columns.
Common questions
Open the full pathology comparison
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