GRAIL vs Visiopharm
Visiopharm sells CE-IVD image analysis apps under IVDR for ER, PR, HER2, Ki-67 and other biomarkers in breast, lung and prostate cancer, and the vendor says it has at least nine diagnostic algorithms cleared under IVDR for EU and UK customers. An openFDA 510(k) search on October 14, 2026 for applicant visiopharm returned no match, so its fit is an EU or UK pathology lab. The Danish company, based in Hørsholm, was acquired by Grundium Oy in a deal announced May 21, 2026.
GRAIL says its PMA package rests on PATHFINDER 2, with 25,490 consented participants and one year of follow-up, plus first-round data from NHS-Galleri, a trial that missed its primary endpoint. The PMA is under review.
A lab director and an ordering physician do not meet over these two. Visiopharm's apps go to pathology labs scoring biomarkers such as HER2, while A clinician writes the Galleri order, and the sample goes to GRAIL's CLIA lab.
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.
Visiopharm
by Visiopharm
Pathology image-analysis software with CE-IVD apps for breast, lung and prostate biomarkers and a research-use platform.
When to pick each one
GRAIL
- Prescription-only blood test, CLIA lab
- PATHFINDER 2 had 25,490 consented participants
Visiopharm
- CE-IVD apps for ER, PR, HER2 and Ki-67
- Breast, lung and prostate diagnostic apps
- ISO 13485 certificate on homepage
Score
Each row shows points earned of points available under the published rubric.
GRAIL
28of 100
Visiopharm
43of 100
| Dimension | GRAIL | Visiopharm | 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 | 8.4 / 21 | 21 / 21 | -12.6 |
| RCT / meta-analysis / systematic review | 7.8 / 7.8 | 7.8 / 7.8 | 0 |
| Funding & adoption signal | 8.4 / 12 | 6 / 12 | +2.4 |
| 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. |
Visiopharm
| 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.
Visiopharm
FDA decisions
No FDA decision cited in our research as of October 20, 2026.
Peer-reviewed
5 PubMed records name Visiopharm.
- Inter-rater agreement of HER2-low scores between expert breast pathologists and the Visiopharm digital image analysis application (HER2 APP, CE2797). (opens in new tab)
- Clinical implementation of artificial-intelligence-assisted detection of breast cancer metastases in sentinel lymph nodes: the CONFIDENT-B single-center, non-randomized clinical trial. (opens in new tab)
- Head-to-Head Comparison of 2 Artificial Intelligence Tools for Detecting Lymph Node Metastases in Whole-Slide Pathology Images Within and Beyond Their Intended Use. (opens in new tab)
Compliance and integrations
Documented from each vendor’s own pages.
| Spec | GRAIL | Visiopharm |
|---|---|---|
| Free tier | ||
| HIPAA | ||
| SOC 2 Type II | ||
| EHR integrations | Not specified | Not specified |
| Founded | n/a | n/a |
| HQ | US | DK |
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.