Freenome vs Visiopharm
Freenome starts with a blood sample and Visiopharm with a scanned slide. SimpleScreen CRC was approved as PMA P250029 on July 24, 2026 for colorectal cancer screening in adults 45 and older at average risk, and a positive result is followed by colonoscopy. A physician screening those adults is the buyer, and a patient under 45 or at higher than average risk falls outside the indication.
Visiopharm is bought by pathology labs that score biomarkers on scanned slides. The homepage lists CE-IVD apps under IVDR for breast, lung and prostate biomarkers, and the vendor says nine diagnostic algorithms are cleared under IVDR for EU and UK customers. The ISO 13485 certificate runs to December 27, 2027. The homepage lists IMS and LIMS integrations and states no EHR integration. Grundium Oy announced its acquisition of Visiopharm A/S on May 21, 2026.
Pathology · Reviewed November 2, 2026
Freenome
by Freenome · founded 2014
FDA-approved SimpleScreen CRC blood test for colorectal cancer screening in adults 45 and older at average risk.
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
Freenome
- PMA-approved, P250029, July 2026
- Blood test for colorectal screening, adults 45 and older
Visiopharm
- CE-IVD apps for breast, lung and prostate biomarkers
- ISO 13485 certificate valid to December 2027
- Homepage lists IMS and LIMS integrations
Score
Each row shows points earned of points available under the published rubric.
Freenome
40of 100
Visiopharm
43of 100
| Dimension | Freenome | Visiopharm | Difference |
|---|---|---|---|
| FDA clearance | 18 / 18 | 0 / 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 | 0 / 21 | 21 / 21 | -21 |
| RCT / meta-analysis / systematic review | 0 / 7.8 | 7.8 / 7.8 | -7.8 |
| Funding & adoption signal | 8.4 / 12 | 6 / 12 | +2.4 |
| Pricing transparency | 2.5 / 5 | 2.5 / 5 | 0 |
| Years in market | 6 / 6 | 0 / 6 | +6 |
Scroll horizontally to see every column.
Pricing
Freenome
| Tier | Monthly | Annual | Notes |
|---|---|---|---|
| Enterprise | n/a | n/a | No public price. |
Visiopharm
| Tier | Monthly | Annual | Notes |
|---|---|---|---|
| Enterprise | n/a | n/a | No public price. |
Evidence
Freenome
FDA decisions
P250029 (opens in new tab)PMA2026-07-24
SimpleScreen CRC
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 | Freenome | Visiopharm |
|---|---|---|
| Free tier | ||
| HIPAA | ||
| SOC 2 Type II | ||
| EHR integrations | Not specified | Not specified |
| Founded | 2014 | 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.