GRAIL vs Indica Labs HALO AI
Galleri is a blood test processed in GRAIL's CLIA laboratory and sold on prescription, and GRAIL's own site says the FDA has not cleared or approved it. HALO AP Dx, Indica's case-centric pathology platform, holds two 510(k)s on openFDA, K232833 from May 2024 and K252762 from November 2025. The platform is cleared with the Aperio GT 450 DX and Hamamatsu NanoZoomer S360MD scanners. HALO AI, the train-by-example add-on, is research use and is not among the cleared devices.
Indica's buyer is a pathology lab moving to digital primary diagnosis. Leica Biosystems is now exclusive reseller of Indica's IMS products and made a strategic investment in January 2025. The purchases sit with different people. Indica is a software contract for a lab, while Galleri is a test a physician orders for one patient at a time, and that decision does not involve the slide 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.
Indica Labs HALO AI
by Indica Labs
HALO image analysis and AI for pathology research, plus HALO AP Dx (FDA-cleared) and HALO Prostate AI (CE-IVD) for clinical use.
When to pick each one
GRAIL
- Multi-cancer blood test, prescription only
- Run in GRAIL's own CLIA laboratory
Indica Labs HALO AI
- HALO AP Dx has two 510(k)s
- Cleared with Aperio GT 450 DX scanner
- Leica Biosystems is exclusive IMS reseller
Score
Each row shows points earned of points available under the published rubric.
GRAIL
28of 100
Indica Labs HALO AI
33of 100
| Dimension | GRAIL | Indica Labs HALO AI | 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 | 0 / 6 | 0 |
Scroll horizontally to see every column.
Pricing
GRAIL
| Tier | Monthly | Annual | Notes |
|---|---|---|---|
| Enterprise | n/a | n/a | No public price verified. |
Indica Labs HALO AI
| Tier | Monthly | Annual | Notes |
|---|---|---|---|
| Enterprise | n/a | n/a | No public price. |
Evidence
GRAIL
FDA decisions
No FDA decision cited in our research as of November 2, 2026.
Peer-reviewed
1 PubMed record names GRAIL.
Indica Labs HALO AI
FDA decisions
K252762 (opens in new tab)510(k)2025-11-25
HALO AP Dx
K232833 (opens in new tab)510(k)2024-05-07
HALO AP Dx
Compliance and integrations
Documented from each vendor’s own pages.
| Spec | GRAIL | Indica Labs HALO AI |
|---|---|---|
| Free tier | ||
| HIPAA | ||
| SOC 2 Type II | ||
| EHR integrations | Not specified | Not specified |
| Founded | n/a | n/a |
| HQ | US | n/a |
Scroll horizontally to see both columns.
Common questions
Open the full pathology comparison
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