Waiv vs Stratipath (2026)
Both predict breast cancer risk from routine H&E slides under the EU IVDR, and neither is sold for diagnosis in the United States. Waiv, formerly Owkin Dx and independent since March 2026, sells RlapsRisk BC for distant relapse risk in ER positive, HER2 negative early breast cancer, labeled CE-IVDR, with validation reported in the TAILORx and NSABP B-28 populations. Stratipath Breast, CE marked under the IVDR in August 2026, assigns early invasive breast cancers to low or high risk, was validated in more than 2,700 patients from two Swedish cohorts with a head to head comparison against Prosigna, and is in routine use at Swedish sites.
- You also want colorectal work: MSIntuit prescreens microsatellite status to reduce confirmatory testing.
- You want the test called from your image management system through an API.
- Validation in the TAILORx and NSABP B-28 trial populations matters to you.
- You want a head to head comparison against a gene expression test: Stratipath Breast was compared with Prosigna.
- You want a test already in routine use, as at Unilabs at Capio S:t Göran's Hospital.
- You want it inside a platform you run: Proscia, Sectra or Roche navify.
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 | waiv.com | stratipath.com |
Side by Side
Select any grade to read the note behind it.
Each vendor in one paragraph
Written to be quoted whole. Each paragraph opens the AI Health Index profile of the vendor: what the product is, who buys it and what it does.
Paris based AI diagnostics company, formerly Owkin Dx, the diagnostics arm of Owkin, spun out in March 2026 as the independent company Waiv with $33 million in financing; Owkin's research and pharmaceutical business is a separate company.
Source: AI Health Index, September 2026
Stockholm based Karolinska Institutet spinout whose Stratipath Breast assigns early stage invasive breast cancers to low or high risk groups from routine H&E slides of resected tumors, positioned as a faster, cheaper alternative to gene expression tests. It is CE marked under the IVDR (August 2026), marketed for clinical use in the EU and the UK and not in the United States, and validated in over 2,700 patients from two Swedish cohorts (Breast Cancer Research) with a head to head comparison against Prosigna.
Source: AI Health Index, September 2026
Questions buyers ask
How do Waiv and Stratipath work with the EHR?
For Waiv, the Destra page describes the platform as interoperable with image management systems and laboratory information systems, platform agnostic and available across existing viewers, and offers a Destra API for integrating the tests into a laboratory's image management system; results can be exported as PDF, CSV and JSON.
The product page names integrations with Proscia's Concentriq Dx, Sectra's digital pathology system and Roche's navify Digital Pathology, and PathAI's AISight algorithm menu lists Stratipath Breast; the company also announced a collaboration with Roche to expand access. From the AI Health Index, drawn from each vendor's own published materials and the regulatory record, verified September 28, 2026. No vendor pays for placement.
How are Waiv and Stratipath priced and sold?
Waiv presents RlapsRisk BC as faster and cheaper than gene expression tests, which it describes as expensive and not always accessible, and MSIntuit CRC as a pre-screen that reduces the volume of confirmatory MSI testing, and its products page lists cost saving against traditional tests and minutes rather than weeks.
The product page says Stratipath Breast is provided as software as a service by subscription, and the company positions it as a faster and cheaper alternative to gene expression tests, returning a risk profile within the hour instead of weeks. From the AI Health Index, drawn from each vendor's own published materials and the regulatory record, verified September 28, 2026. No vendor pays for placement.
How do Waiv and Stratipath handle patient data?
The privacy policy covers only data for which Waiv is controller and excludes processing it does for others, which is where a laboratory's slides uploaded to Destra fall. Nothing published states how long uploaded slides are kept, whether they are de-identified, or whether customer cases may train Waiv's models, which matters for a company whose positioning rests on proprietary foundation models and a large patient data network.
Stratipath Breast is a subscription service, so customer slide images are sent to and processed by the company. The privacy policy covers personal data of business contacts, suppliers and job applicants processed through the company's channels, and does not address patient images, retention, deletion, de-identification or whether submitted cases may be used in model development. From the AI Health Index, drawn from each vendor's own published materials and the regulatory record, verified September 28, 2026. No vendor pays for placement.
Which settings and specialties do Waiv and Stratipath cover?
For Waiv, the company states intent to expand to further disease areas. Scanners and staining protocols validated for each product are not listed.
Stratipath Breast is for prognostic risk profiling of invasive early-stage breast cancer from H&E images of resected tumors, in pre- and postmenopausal patients, and is not to be used on metastatic recurrences. From the AI Health Index, drawn from each vendor's own published materials and the regulatory record, verified September 28, 2026. No vendor pays for placement.
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.
Neither is available for diagnosis in the United States. Certifications held by Owkin do not transfer to Waiv, so confirm what Waiv holds in its own name. Rewritten 28 Sep 2026 after both records were reviewed.