- No public price.
- Not disclosed
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- FR
Pathology
Waiv
by Waiv · FR
AI tests on H&E slides for breast cancer relapse risk and colorectal MSI prescreening, for pathology labs and oncologists.
On this page
6/100
Not rated: too little independent evidence yet.
- Regulatory & Compliance0/28
No FDA clearance listed
- Clinical Integration0/6.6
No EHR integrations listed
- Evidence Strength0/28.8
No peer-reviewed coverage
- 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 papers0/21
No peer-reviewed coverage
- RCT / meta-analysis / systematic review0/8
No RCT, meta-analysis, or systematic review
- 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 tests on H&E slides for breast cancer relapse risk and colorectal MSI prescreening, for pathology labs and oncologists.
No public price.
Evidence record
No FDA decision cited in our research as of November 2, 2026.
- Score computed November 2, 2026, method 1.2.0
- Review written November 2, 2026
MedAI Verdict, Waiv record, https://medaiverdict.com/tools/owkin-dx, version November 2, 2026
Bottom line
Waiv, the Paris company that spun out of Owkin in March 2026 and carries on the Owkin Dx products, sells two AI tests that read routine H&E slides: RlapsRisk BC for breast cancer relapse risk and MSIntuit CRC for colorectal MSI pre-screening. Both announced IVDR CE marks on April 16, 2026, and the vendor says the marks authorize clinical deployment across EU member states. Pathology labs and oncologists in the EU are the intended users. No FDA submission appears on Waiv's site or in the press, and no 510(k) record exists under Owkin or Waiv, so neither test is cleared for US clinical use.
Which products does Waiv sell?
RlapsRisk BC, in the vendor's words, "predicts breast cancer relapse risk directly from standard histopathology slides," a prognostic profile built from H&E. MSIntuit CRC offers "rapid, scalable Microsatellite Instability (MSI) screening from H&E slides" and "rapidly identifies and rules out non-MSI patients," which makes it a pre-screen ahead of molecular MSI testing.
BRCAura estimates germline BRCA1/2 status and is labeled research use only by the vendor. Waiv also runs its own platform, Destra.
Which CE marks and integrations does Waiv list?
The April 16 announcement covers RlapsRisk BC and MSIntuit CRC under IVDR. The IVDR class and the notified body are not stated. Proscia, Roche Diagnostics, Sectra and Tribun Health are the vendor's named integrations, alongside Destra, and scanner support is not stated.
Where does the validation come from?
RlapsRisk BC has a 2025 Nature Communications paper on deep learning assessment of metastatic relapse risk from digitized breast cancer histological slides (PMID 40593633), and the development and validation are Owkin-affiliated. MSIntuit has a 2023 Nature Communications validation as a pre-screening tool for MSI detection on colorectal histology slides (PMID 37932267), also Owkin-affiliated. A 2024 review in Digestion (PMID 38865982) mentions the tool without validating it.
How does it compare?
Stratipath Breast and PreciseBreast also profile breast cancer prognosis from H&E slides. Oncotype DX and MammaPrint are the molecular tests in breast, and PCR or IHC testing is the molecular route for MSI that MSIntuit is meant to screen ahead of.
Who funds Waiv?
Waiv announced $33 million on March 12, 2026, led by OTB Ventures and Alpha Intelligence Capital, and reached $35 million in total on April 24 with new money from CRB Health Tech. Daiichi Sankyo signed a collaboration on May 6, 2026 for AI-derived biomarkers in an ADC program. Waiv gives no customer or clinician counts.
Is there a published price?
Waiv has no published pricing, and trial and refund terms are not described.
The verdict
A European breast or GI pathology service weighing an H&E-based relapse profile or MSI pre-screen has two IVDR-marked products to evaluate, and a US-only lab sits outside the EU deployment the marks authorize. The validation behind both comes from Owkin-affiliated development. Proscia, Roche Diagnostics, Sectra, Tribun Health and Destra are the integrations Waiv names, and BRCAura sits outside clinical use as a research use only model.
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.
Who builds it
It was previously known as Owkin Dx, an acquisition or rebrand that healthcare-AI buyers should track when reviewing prior independent coverage.
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