Caris Life Sciences vs Visiopharm
Visiopharm is software a pathology lab runs on its own scanned slides, and Caris is a tissue-sequencing service an oncologist orders. For a lab in the EU or UK the Visiopharm side is concrete: CE-IVD apps for ER, PR, HER2 and Ki-67, with nine diagnostic algorithms cleared under IVDR, the vendor says. Grundium Oy announced its acquisition of Visiopharm A/S on May 21, 2026, terms undisclosed. In the US the homepage labels products research use only unless otherwise stated, and an openFDA 510(k) search under the company name returned no match on October 14, 2026.
Caris sells MI Cancer Seek, PMA P240010, approved November 5, 2024, for FFPE tumor tissue. The MI Cancer Seek page gives a median turnaround of 8 days and also says 6 to 9. The vendor says orders integrate by EHR at 3,100+ locations and does not name the systems.
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.

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
Caris Life Sciences
- PMA-approved MI Cancer Seek sequencing assay
- Vendor says EHR ordering at 3,100+ locations
- Median 8 days, page also says 6 to 9
Visiopharm
- CE-IVD apps for ER, PR, HER2 and Ki-67
- ISO 13485 certificate valid to December 2027
- Vendor says it integrates with IMS and LIMS
Score
Each row shows points earned of points available under the published rubric.
Caris Life Sciences
65of 100
Visiopharm
43of 100
| Dimension | Caris Life Sciences | 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 | 21 / 21 | 21 / 21 | 0 |
| 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
Caris Life Sciences
| 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
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)
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 | Caris Life Sciences | Visiopharm |
|---|---|---|
| Free tier | ||
| HIPAA | ||
| SOC 2 Type II | ||
| EHR integrations | Not specified | Not specified |
| Founded | 2008 | 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.
