Waiv vs Stratipath (2026)
Both read routine H and E slides to stratify breast cancer risk, both are CE marked with no FDA clearance, and both position against expensive molecular assays, so the choice turns on depth against breadth. If your failure mode is adopting a prognostic whose validation does not generalise, start with Stratipath: its evidence on one question is the deeper of the two, with a 2,719 patient validation across two independent cohorts, a head to head against an established multigene assay, and prospective trial validation now emerging. If your failure mode is running a separate pipeline for every biomarker question, start with Waiv, which answers breast relapse risk, colorectal microsatellite instability and more from the same slides through one platform. One caveat outweighs the others: Waiv became independent of Owkin in March 2026, so its former parent's certifications no longer apply to it.
- Breadth on a single platform: RlapsRisk BC for breast relapse risk, the MSIntuit Suite for colorectal microsatellite instability, BRCAura for gBRCA pre screening as research use only, and TLS Detect, all run through the Destra platform from slides the laboratory already produces, against Stratipath's single indication.
- Honest adjunct reporting, which is rare in this group: the breast model's contribution is published as a concordance index of 0.81 when combined with clinicopathological factors against 0.76 for those factors alone, and the company discloses its cohort enrichment openly rather than letting the headline figure stand unqualified.
- Depth of pharmaceutical collaboration: the colorectal and BRCA products were developed with named large drug developers, and a biopharma services line sits alongside the clinical portfolio, which matters to a laboratory that also supports trial recruitment and biomarker work.
- The stronger evidence base: a peer reviewed retrospective validation across 2,719 primary breast cancer patients in two independent Swedish cohorts, testing the generalisation that prognostic models most often fail, plus a head to head evaluation against an established multigene assay in clinically intermediate risk cases, which is the comparison a laboratory weighing molecular testing costs actually needs.
- Prospective evidence now emerging: validation within TAILORx, one of the largest prospective randomised trials in early breast cancer, presented at a major oncology congress in 2026, which addresses the retrospective limitation of the earlier work directly.
- Supplier settledness: independent since 2019 as a Karolinska Institutet spin out, against a counterparty that separated from its parent in March 2026 and has not yet republished security assurance in its own name. Continuity is a procurement criterion alongside accuracy.
This comparison is published by AI Health Index, an independent research platform that compares healthcare AI vendors objectively. Waiv and Stratipath are each graded against the same capability taxonomy, from each vendor's own public materials and the regulatory record, under the AI Health Index verification standard. No vendor pays for placement, and no vendor has reviewed this page. How this evidence is graded
Plain facts
| Fact | Waiv | Stratipath |
|---|---|---|
| Primary category | Digital Pathology AI | Digital Pathology AI |
| Founded | 2016 | 2020 |
| Headquarters | Paris, France | Stockholm, Sweden |
| Website | wearewaiv.com | stratipath.com |
Side by Side
Each record in one paragraph
Written to be quoted whole. Each paragraph states what the AI Health Index verified about the vendor, with the caveats attached. Generated from this pair’s live capability grades, so it moves when a grade moves.
The AI Health Index awards Waiv its top capability grade on AI Centrality. Set against Stratipath, Waiv grades higher on Commercial Transparency. Grades reflect evidence the AI Health Index could verify at the last review, so a low grade records disclosure the vendor has not published rather than a capability it has been shown to lack.
Source: AI Health Index, July 2026
The AI Health Index awards Stratipath its top capability grade on AI Centrality and Clinical and Operational Evidence. Set against Waiv, Stratipath grades higher on Clinical and Operational Evidence and EHR and Interoperability Depth. Grades reflect evidence the AI Health Index could verify at the last review, so a low grade records disclosure the vendor has not published rather than a capability it has been shown to lack.
Source: AI Health Index, July 2026
Questions buyers ask
Should we choose Waiv or Stratipath?
On the axes where the AI Health Index separates them, Waiv grades higher on Commercial Transparency, and Stratipath grades higher on Clinical and Operational Evidence and EHR and Interoperability Depth. Stratipath leads on the greater share of scored axes, but the split means the decision turns on which constraint is binding rather than on an overall winner.
Where do Waiv and Stratipath differ most?
The widest separation the AI Health Index records between Waiv and Stratipath is on Commercial Transparency, where Waiv grades B and Stratipath grades C. That axis sits in the Commercial group, so it should carry the most weight for a buyer whose binding constraint is contracting, scope and what the price actually covers.
Where do Waiv and Stratipath grade the same?
The AI Health Index grades Waiv and Stratipath the same on several axes, including AI Centrality, Autonomy and Oversight Model and Model and Technology Transparency. Neither holds an advantage the index can evidence on those axes, so they should not carry weight in a selection between these two.
Related comparisons
Other published head to head assessments involving these vendors or their closest peers. The full set for this category is on the Clinical Decision Support page.
Both are CE marked with no FDA clearance, neither publishes pricing or a security attestation, and neither publishes demographic subgroup analysis, which carries extra weight for a prognostic because a risk score that behaves differently across populations translates directly into differences in treatment intensity.
Waiv's breast validation cohort was enriched with relapse patients and confined to endocrine therapy only cases, which the company discloses and which inflates apparent discrimination relative to an unselected population; independent validation with a commercial pathology network was reported as underway. RlapsRisk BC has been recorded as carrying the older IVDD mark rather than IVDR certification, which a buyer should confirm given the transition deadlines.
One design nuance on the colorectal product: MSIntuit is a rule out placed upstream of confirmatory testing, so a false negative removes a patient from that testing entirely. Waiv separated from Owkin in March 2026 with independent financing, and certifications held by its former parent, including ISO 27001, do not transfer to the new entity, so a buyer should establish what Waiv holds in its own name and whether any transitional arrangement applies.
Stratipath's published evidence is drawn from Swedish cohorts, the TAILORx validation is so far conference presented rather than peer reviewed published, and the company states its product is not marketed in the United States.