Caris Life Sciences vs PathAI AISight
Roche signed a merger agreement for PathAI on May 7, 2026, $750M upfront plus up to $300M in milestones, with closing expected in the second half of 2026. AISight Dx, cleared as K243391 in June 2025 after Novo (K212361) in 2022, is image management software for primary diagnosis on digital FFPE slides, cleared with the Hamamatsu NanoZoomer S360MD and Leica Aperio GT 450 DX scanners. The clearances cover the viewer, while the AI algorithms remain research use. A hospital lab building a digital workflow starts with PathAI.
Caris delivers lab results. For a tumor board that needs a tissue-of-origin call, GPSai and FOLFIRSTai are offered as professional services outside the FDA-approved scope of MI Cancer Seek. The MI Cancer Seek page claims EHR ordering at 3,100+ locations and names no systems, while PathAI names its cleared scanners and has a change control plan for adding others.
Pathology · Reviewed November 2, 2026
Caris Life Sciences
by Caris Life Sciences · founded 2008
FDA-approved MI Cancer Seek tumor profiling test for oncologists. The GPSai tissue-of-origin AI is a lab service outside that approval.
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
Caris Life Sciences
- GPSai and FOLFIRSTai offered as lab services
- Vendor says EHR ordering at 3,100+ locations
PathAI AISight
- AISight Dx cleared for primary diagnosis, K243391
- Hamamatsu S360MD and Leica GT 450 DX scanners
- CE-IVD for EEA, UK and Switzerland
Score
Each row shows points earned of points available under the published rubric.
Caris Life Sciences
65of 100
PathAI AISight
40of 100
| Dimension | Caris Life Sciences | PathAI AISight | Difference |
|---|---|---|---|
| FDA clearance | 18 / 18 | 18 / 18 | 0 |
| 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 | 21 / 21 | 0 / 21 | +21 |
| RCT / meta-analysis / systematic review | 0 / 7.8 | 0 / 7.8 | 0 |
| Funding & adoption signal | 8.4 / 12 | 8.4 / 12 | 0 |
| Pricing transparency | 2.5 / 5 | 2.5 / 5 | 0 |
| Years in market | 6 / 6 | 6 / 6 | 0 |
Scroll horizontally to see every column.
Pricing
Caris Life Sciences
| Tier | Monthly | Annual | Notes |
|---|---|---|---|
| Enterprise | n/a | n/a | No public price. |
PathAI AISight
| Tier | Monthly | Annual | Notes |
|---|---|---|---|
| Enterprise | n/a | n/a | No public price. Billing period, trial and refund not stated. |
Evidence
Caris Life Sciences
FDA decisions
P240010 (opens in new tab)PMA2024-11-05
MI Cancer Seek
Peer-reviewed
5 PubMed records name Caris Life Sciences.
- An AI Approach to Differentiating Lung Squamous Cell Carcinoma From Metastases of Other Origins. (opens in new tab)
- Proactive identification of candidates for newly approved targeted therapies using a clinical decision support program. (opens in new tab)
- ERBB2/HER2 landscape and prognostic impact: large-scale, real-world analysis across solid cancers. (opens in new tab)
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 | Caris Life Sciences | PathAI AISight |
|---|---|---|
| Free tier | ||
| HIPAA | ||
| SOC 2 Type II | ||
| EHR integrations | Not specified | Not specified |
| Founded | 2008 | 2016 |
| HQ | US | US |
Scroll horizontally to see both columns.
Common questions
Open the full pathology comparison
Digital pathology workflows with FDA-cleared cancer detection (prostate, breast, colon), IHC scoring (HER2, Ki67), and AI-powered image management. Tempus, PathAI, Proscia dominate.