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Pathology
Stratipath Breast
by Stratipath AB · SE
AI prognostic risk score for early-stage invasive breast cancer from routine H&E slides, for pathology labs.
On this page
28/100
Not rated: too little independent evidence yet.
- Regulatory & Compliance0/28
No FDA clearance listed
- Clinical Integration0/6.6
No EHR integrations listed
- Evidence Strength18.6/28.8
3 peer-reviewed papers
- Vendor & Market3/18
Seed-stage or unfunded
- Sentiment & Transparency2.5/5
Pricing on request, no public amounts
▸ Show all 11 dimensions▾ Hide dimension detail
- FDA clearance0/18
No FDA clearance listed
- HIPAA / SOC2 / BAA0/10
No public HIPAA/SOC2/BAA attestation
- EHR integrations (count)0/4
No EHR integrations listed
- Top-3 EHR coverage (Epic / Oracle / Athena)0/2
None of the top-3 EHRs covered
- Peer-reviewed papers15/21
3 peer-reviewed papers
- RCT / meta-analysis / systematic review4/8
3 observational study (no RCT)
- Funding & adoption signal3/12
Seed-stage or unfunded
- Years in market0/6
Founded year not recorded
- Pricing transparency3/5
Pricing on request, no public amounts
AI prognostic risk score for early-stage invasive breast cancer from routine H&E slides, for pathology labs.
No public price.
Evidence record
No FDA decision cited in our research as of November 2, 2026.
3 studies on PubMed: 3 observational, published 2024 to 2026. Read the literature summary
- Score computed November 2, 2026, method 1.2.0
- Review written November 2, 2026
MedAI Verdict, Stratipath Breast record, https://medaiverdict.com/tools/stratipath, version November 2, 2026
Bottom line
Stratipath Breast returns one answer for early-stage invasive breast cancer, an increased or a low risk of disease progression, calculated from a digitized H&E slide, and the vendor says results arrive within one hour. It carries an IVDR CE mark announced on June 16, 2026, after a CE-IVDD mark in 2022 and clinical routine use since 2023. Pathology services in Sweden and Finland are among the customers the vendor names. Stratipath has no FDA record and its pages claim no FDA status, so the product is not cleared for US clinical use. Validation by authors outside the Karolinska group that developed the model is not shown.
Where does it come from?
Stratipath AB is a Stockholm company and a spin-out of Karolinska Institutet. Fredrik Wetterhall is CEO, with Johan Hartman as CMO and Mattias Rantalainen among the co-founders. Founding year and funding are not stated.
The vendor names Unilabs, Region Uppsala, Capio S:t Goran's Hospital and Helsinki University Hospital as customers, the last in an announcement of May 13, 2026.
How does it reach a lab?
It is delivered as software as a service, and partnership announcements place it inside other platforms: PathAI AISight Dx on September 4, 2025, Visiopharm on September 2, 2025 and Aiforia on August 25, 2026. A headline on the vendor's news page reads "Stratipath and Roche Join Forces," and the terms are not described.
Which papers name the product?
Three papers name Stratipath Breast, and the model was developed by the Karolinska group around the founders. A 2024 Breast Cancer Research paper validated risk stratification on routine digital histopathology images (PMID 39143539). A 2024 paper in Breast Cancer Research and Treatment compared the deep learning profile with an established multigene assay (PMID 38592541). A 2026 paper in The Breast validated the model in postmenopausal ER+/HER2- patients (PMID 41380230). Stratipath-affiliated papers on TIL and Ki67 describe other algorithms.
The vendor lists a TAILORx validation presented at ASCO 2026, as an abstract.
How does it compare?
Waiv's RlapsRisk BC predicts relapse risk from standard histopathology slides, per the vendor. PreciseBreast is a CLIA laboratory test that combines an AI-derived grade with clinical factors.
What does the vendor say about price?
Stratipath publishes no figures. It calls the product a "cost-effective alternative to gene expression tests" and a faster and cheaper one.
The verdict
European labs on PathAI AISight Dx, Visiopharm or Aiforia viewers can reach Stratipath Breast inside them, according to the vendor's partnership announcements. A lab seeking prognostic scoring for other tumor types is outside the product's scope, and the newest paper, from 2026, studied postmenopausal ER+/HER2- patients.
Editorial review last generated November 2, 2026. Synthesized from clinician sentiment, peer-reviewed coverage, and our editorial silo picks. Refined by hand where vendor facts change.
What it costs
All tiers are custom-quoted. The vendor does not publish per-provider list pricing.
| Tier | Monthly | Annual | Notes |
|---|---|---|---|
| Enterprise | Not stated | Not stated | No public price. |
Source: vendor pricing page. Last checked November 2, 2026.
What deploys cleanly
Carries CE per vendor documentation. Independent attestation review is the buyer's responsibility before clinical deployment.
What the literature says
3 peer-reviewed studies indexed on PubMed evaluate Stratipath Breast in clinical contexts. The most relevant are shown below, ranked by editorial relevance score combining title match, study design, recency, and journal tier.
- Validation of an AI-based solution for breast cancer risk stratification using routine digital histopathology images. (opens in new tab)
- Sharma A, Lövgren SK, Eriksson KL, et al.· Breast Cancer Res· 2024
- Stratipath Breast is a CE-IVD marked artificial intelligence-based solution for prognostic risk stratification of breast cancer patients into high- and low-risk groups, using haematoxylin and eosin (H&E)-stained histopathology whole slide images (WSIs). In this validation study, we assessed the prognostic performance of Stratipath Breast in two independent breast cancer cohorts. This retrospective multi-site validation study included 2719 patients with primary breast cancer from two Swedish hospitals. The Stratipath Breast tool was applied to stratify patients based on digitised WSIs of the d…
- Validation of a deep learning-based AI model for breast cancer risk stratification in postmenopausal ER+/HER2-breast cancer patients. (opens in new tab)
- Pouplier SS, Sharma A, Ruusuvuori P, et al.· Breast· 2026
- Breast cancer prognostication is crucial for treatment decisions, and the Nottingham Histologic Grade (NHG) system is widely used. However, NHG suffers from interobserver variability, and its division into three risk groups leaves the intermediate group (comprising ∼50 % of patients) overrepresented, making individualized treatment planning challenging as prognosis within this group differ widely. This study aimed to validate the prognostic value of Stratipath's low and high-risk categories and five risk groups and compare NHG performance with the Stratipath deep-learning-based mo…
- Clinical evaluation of deep learning-based risk profiling in breast cancer histopathology and comparison to an established multigene assay. (opens in new tab)
- Wang Y, Sun W, Karlsson E, et al.· Breast Cancer Res Treat· 2024
- To evaluate the Stratipath Breast tool for image-based risk profiling and compare it with an established prognostic multigene assay for risk profiling in a real-world case series of estrogen receptor (ER)-positive and human epidermal growth factor receptor 2 (HER2)-negative early breast cancer patients categorized as intermediate risk based on classic clinicopathological variables and eligible for chemotherapy. In a case series comprising 234 invasive ER-positive/HER2-negative tumors, clinicopathological data including Prosigna results and corresponding HE-stained tissue slides were retrieved…
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