Aiforia vs GRAIL
Galleri is an Rx-only blood test, grail.com says it has not been cleared or approved by the FDA, and GRAIL runs it in a laboratory it calls CLIA-certified. Aiforia sells image analysis to clinical, preclinical and academic labs, with clinical suites for breast, lung, prostate, colon and gastric tissue. One is ordered by a clinician for a patient, the other bought by a lab for its slides.
Galleri is meant for adults 50 and older in addition to guideline-recommended screening, which puts it in front of physicians deciding on cancer screening. GRAIL submitted its PMA in full in January 2026. On September 23, 2026 the FDA advisory panel voted 7 yes, 2 no and 1 abstention that benefits outweigh risks, and 6 yes to 4 no on effectiveness.
Aiforia's prostate suite is CE-IVD marked and carries a research-use label outside the EU and EEA, which fits an EU pathology lab reading prostate biopsies. The company has traded on Nasdaq First North in Helsinki since December 2021, and its security page lists ISO 27001, SOC 2 Type II and ISO 13485.
Pathology · Reviewed November 2, 2026
When to pick each one
Aiforia
- CE-IVD prostate cancer biopsy suite
- Security page lists ISO 27001 and SOC 2 Type II
GRAIL
- Galleri blood test for adults 50 and older
- Advisory panel voted 7 to 2 on benefit and risk
Score
Each row shows points earned of points available under the published rubric.
Aiforia
31of 100
GRAIL
28of 100
| Dimension | Aiforia | GRAIL | Difference |
|---|---|---|---|
| FDA clearance | 0 / 18 | 0 / 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 | 14.7 / 21 | 8.4 / 21 | +6.3 |
| RCT / meta-analysis / systematic review | 3.9 / 7.8 | 7.8 / 7.8 | -3.9 |
| Funding & adoption signal | 6 / 12 | 8.4 / 12 | -2.4 |
| Pricing transparency | 2.5 / 5 | 0 / 5 | +2.5 |
| Years in market | 0 / 6 | 0 / 6 | 0 |
Scroll horizontally to see every column.
Pricing
Aiforia
| Tier | Monthly | Annual | Notes |
|---|---|---|---|
| Enterprise | n/a | n/a | No public price. The pricing page returns a 404. |
GRAIL
| Tier | Monthly | Annual | Notes |
|---|---|---|---|
| Enterprise | n/a | n/a | No public price verified. |
Evidence
Aiforia
FDA decisions
No FDA decision cited in our research as of October 20, 2026.
Peer-reviewed
3 PubMed records name Aiforia.
- A deep-learning algorithm (AIFORIA) for classification of hematopoietic cells in bone marrow aspirate smears based on nine cell classes-a feasible approach for routine screening? (opens in new tab)
- Comparing non-machine learning vs. machine learning methods for Ki67 scoring in gastrointestinal neuroendocrine tumors. (opens in new tab)
- A machine learning model of lamina propria fibrosis in eosinophilic esophagitis for prediction of fibrostenotic disease. (opens in new tab)
GRAIL
FDA decisions
No FDA decision cited in our research as of November 2, 2026.
Peer-reviewed
1 PubMed record names GRAIL.
Compliance and integrations
Documented from each vendor’s own pages.
| Spec | Aiforia | GRAIL |
|---|---|---|
| Free tier | ||
| HIPAA | ||
| SOC 2 Type II | ||
| EHR integrations | Not specified | Not specified |
| Founded | n/a | n/a |
| HQ | FI | 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.