What Waiv does

Waiv is a Paris-based AI precision medicine company that develops and commercializes clinical-grade digital pathology tests for oncology, spun out of Owkin in March 2026. The company's core product is the Destra platform, an AI-native SaaS infrastructure that delivers a portfolio of diagnostic tests analyzing routine H&E and IHC stained whole slide images: RlapsRisk BC (CE-IVD marked breast cancer relapse risk profiling with C-index 0.81), MSIntuit Suite / MSIntuit CRC (CE-IVD marked microsatellite instability screening for colorectal, endometrial, and gastric cancers with 96-98% sensitivity), BRCAura (germline BRCA1/2 mutation prediction with 80% AUC), and TLS Detect (97%-sensitivity tertiary lymphoid structure detection, research use). The technology is built on proprietary foundation models, notably the Phikon-v2 vision transformer pre-trained on 460 million pathology tiles across 30+ cancer types and a distilled H0-mini model, with the platform interoperable with Proscia, Roche Diagnostics, Sectra, and Tribun Health IMS/viewer systems.

Waiv serves two primary customer segments: hospital pathology labs and diagnostic organizations, which deploy Waiv tests either directly through the Destra platform or embedded within existing IMS workflows, and pharmaceutical and biotech companies, which engage Waiv for biomarker discovery, patient stratification, and companion diagnostic co-development under multi-year collaboration agreements. Named biopharma partners include MSD (Merck & Co.), AstraZeneca, and Daiichi Sankyo. The revenue model combines enterprise subscription licensing for clinical diagnostic tests with professional services revenue from biopharma R&D collaborations, milestone payments, and potential downstream royalties on companion diagnostics.

The company was incorporated as Owkin Dx, a French société par actions simplifiée, and operates from its Paris headquarters at 14-16 Boulevard Poissonnière. Following the 2026 spinout, Waiv is led by CEO and Co-Founder Meriem Sefta and Co-Founder Lionel Guillou, with Owkin retaining a minority equity stake and a strategic partnership for continued access to the parent's hospital data network and foundational research. Total disclosed funding is $35 million, raised across a $33 million initial financing round co-led by OTB Ventures and Alpha Intelligence Capital in March 2026 and a $2 million follow-on from CRB Health Tech in April 2026.

Name

Waiv

Legal name

Waiv

Website

https://wearewaiv.com

Company type

Private

Founded year

2026

Operating status

Operating

Headcount range

251–500 employees

Short description

Waiv is a Paris-based AI digital pathology company delivering CE-IVD marked precision oncology tests from H&E slides to hospital pathology labs and pharmaceutical partners. Spun out of Owkin in 2026, it operates its Destra platform and proprietary foundation models for prognostic, MSI, and BRCA screening.

Ownership category

akta.pro rank

Product category

Precision Oncology Digital Pathology AI Diagnostics

NAICS

Medical and Diagnostic Laboratories (6215), Analytical Laboratory Instrument Manufacturing (334516), Research and Development in Biotechnology (except Nanobiotechnology) (541714)

SIC

In Vitro & In Vivo Diagnostic Substances (2835), Services-Medical Laboratories (8071)

akta.pro primary industry

Cytology & Histopathology Diagnostics (IHC, ISH, tissue-based assays) (HLAAALAI)

akta.pro secondary industries

Oncology Diagnostics (tumor profiling, MRD, liquid biopsy) (HLAAALAE), Target Identification & Validation Platforms (omics-driven, chemoproteomics, genetic validation) (HLAAAIAI), Specialty & Biomarker Laboratory Services (Immunoassays/Flow/Cytometry) (HLAGAEAB)

Keywords

• Digital pathology software
• AI precision diagnostics
• Oncology biomarker testing
• Computational pathology platform
• Medical imaging AI

Headquarters

HQ city

New York

HQ country

United States

HQ region

North America

Offices1 record

Markets served

GTM type

B2B

Offering type

Software

Cost components

Technology or R&D, Personnel, Operations, Marketing or Sales, Infrastructure

Revenue model

1. Clinical diagnostic test licensing and deployment: Waiv commercializes CE-IVD marked AI precision tests (RlapsRisk BC, MSIntuit CRC) to hospital pathology labs, diagnostic organizations, and healthcare providers through its Destra platform or integrated into existing IMS/viewer systems. Revenue generated through test licensing subscriptions or per-test fees deployed via SaaS platform.
2. Biopharma companion diagnostics and biomarker discovery partnerships: Waiv collaborates with pharmaceutical companies (MSD, AstraZeneca, Daiichi Sankyo) on AI-driven biomarker discovery, patient stratification, and companion diagnostic development for drug programs. Revenue from R&D collaboration fees, milestone payments, and potential royalties on companion diagnostics developed alongside drug programs.

Pricing tiers

Go-to-market motion1 record

Distribution channels3 records

Marketing channels7 records

Core offering

Waiv develops and commercializes CE-IVD marked AI-powered precision diagnostic tests for oncology, analyzing digitized H&E and IHC whole slide images to deliver prognostic risk profiling, MSI screening, BRCA mutation prediction, and tertiary lymphoid structure detection. Its product suite includes the Destra SaaS platform, RlapsRisk BC (breast cancer prognosis), MSIntuit Suite/CRC (MSI screening), BRCAura (gBRCA mutation screening, research use), and TLS Detect (research-use deep learning tool). The company also provides biopharma R&D services for biomarker discovery and companion diagnostic development.

Product overview

Waiv is an AI precision testing company that has spun out from Owkin (formerly Owkin Dx), building on seven years of medical-AI research to deliver clinical-grade, AI-powered diagnostic tests for precision oncology. The company operates a platform-plus-products architecture centered on its Destra digital pathology platform, which delivers multiple clinically validated AI tests including RlapsRisk BC (breast cancer prognosis), MSIntuit Suite (MSI screening for colorectal, endometrial, and gastric cancers), BRCAura (gBRCA mutation screening), and TLS Detect (tertiary lymphoid structures detection). Products leverage foundation models trained on hundreds of thousands of histopathology images from an international data network spanning academic institutions, hospitals, and laboratories. The portfolio includes both CE-IVDR marked clinical diagnostics and research-use-only products, with commercial deployment via Destra's interoperable platform and partnerships with pharmaceutical companies including MSD, AstraZeneca, and Daiichi Sankyo for biomarker discovery and companion diagnostics.

Differentiator

Problem solved

Functional benefit

Brands

• Destra: AI-native digital pathology platform built for clinical workflows that delivers Waiv's best-in-class AI precision tests into pathologists' hands.
• RlapsRisk BC
• MSIntuit Suite
• BRCAura
• TLS Detect

Products and services

• Destra Platform AI-native digital pathology SaaS platform that delivers Waiv's AI precision tests (RlapsRisk BC, MSIntuit Suite, BRCAura) into pathologist workflows. Provides interoperable access via API and through integrations with Proscia, Roche Diagnostics, Sectra, and Tribun Health viewer/IMS systems, with clinically compliant outputs and scalable SaaS infrastructure.
• RlapsRisk BC CE-IVDR marked AI precision test that predicts breast cancer relapse risk directly from standard digitized H&E histopathology slides and clinical data, delivering genomic-level risk profiling without extensive additional molecular testing. C-index of 0.81 vs 0.76 for clinical factors alone. For hospital pathology labs and breast cancer treatment decision-making.
• MSIntuit Suite (including MSIntuit CRC) CE-IVDR marked AI-enabled MSI (Microsatellite Instability) screening test suite that operates on H&E stained slides across colorectal, endometrial, and gastric cancers. Sensitivity 0.96-0.98 and specificity 0.47-0.46, designed to rule out approximately half of non-MSI patients from further testing. For pathology labs needing rapid, scalable MSI pre-screening to accelerate access to targeted immunotherapies.
• BRCAura RUO Research-use-only AI digital pathology test designed to identify germline BRCA1/2 mutations from routine histology slides of HR+/HER2- breast cancer. AUC of 80% with 93% sensitivity, able to rule out approximately 40% of patients unlikely to carry gBRCA mutations. For research and translational research use.
• TLS Detect Deep learning software that detects Tertiary Lymphoid Structures (TLS) from digitized H&E whole slide images across tumor types. Sensitivity of 97% on external validation, providing prognostic insights and predictive biomarkers for immunotherapy response, delivered via PDF report and dynamic heatmap. For research use only.
• Biopharma Solutions End-to-end computational pathology services for pharmaceutical and biotech partners covering biomarker discovery, tumor microenvironment analysis across H&E and IHC, AI-derived outcome prediction, and co-development of companion diagnostics for oncology drug and ADC programs. For pharmaceutical development teams seeking biomarker and patient stratification support.

Quantifiable outcome

• RlapsRisk BC achieves C-index of 0.81 vs 0.76 for clinical factors alone, with cumulative sensitivity of 0.69 vs 0.63 and dynamic specificity of 0.80 vs 0.76 compared to clinical factors alone for 5-year MFS prediction.
• +4 more outcomes

Named customers5 records

Segments3 records

Ideal customer profiles3 records

Technology focussed Yes

API detail

Has API

Yes

API docs

API detail

Core technology

AI maturity

App detail

Integration5 records

AI capability7 records

Feature8 records

Partnerships

Nine partnerships are on record, tiered core and minor.

• Daiichi SankyocoreStrategic or Co-development Partner · 6 May 2026Collaboration under which Waiv applies its end-to-end computational pathology platform to Daiichi Sankyo's antibody-drug conjugate (ADC) program. Waiv will perform tumor microenvironment (TME) analysis across H&E and IHC stained samples, biomarker discovery, and outcome prediction aimed at identifying biomarkers of treatment response for early-phase clinical trial optimization.
• OwkincoreStrategic or Co-development Partner · 27 February 2025Waiv spun out from Owkin as an independent company. Owkin retains a minority stake without operational governance involvement. Waiv remains a strategic partner in Owkin's patient validation ecosystem, leveraging Owkin's decade of foundational medical AI research, patient data network of over 800 hospitals, and hospital partnerships.
• AstraZenecacoreStrategic or Co-development Partner · 2 October 2024Partnership to develop an AI gBRCA pre-screen solution for breast cancer, building on prior Owkin collaboration on BRCAura. AstraZeneca collaborated on BRCAura development to accelerate identification of BRCA mutations for targeted treatment decisions. Owkin's K Pro platform was used under a separate multi-year licensing agreement.
• MSD (Merck & Co.)coreStrategic or Co-development Partner · 19 December 2023Collaboration agreement to develop and commercialize AI-powered digital pathology diagnostics for the EU market. Waiv collaborates with MSD to assess the clinical impact of MSIntuit CRC. MSD is an existing pharmaceutical partner for biomarker discovery and AI-guided precision testing.
• Gustave RoussycoreStrategic or Co-development PartnerWorld-class cancer research institute in Villejuif, France, and co-developer of RlapsRisk BC and BRCAura. Gustave Roussy contributed patient data for RlapsRisk BC validation and BRCAura development. Part of Waiv's network of academic partners contributing to clinical validation studies.
• Institut BergoniécoreStrategic or Co-development PartnerComprehensive Cancer Center in Bordeaux, France. Development partner for TLS Detect, contributing annotated data for deep learning model development. Also contributing data for MSI Pan-Tumor Dx project and clinical validation studies.
• Institut CuriecoreStrategic or Co-development PartnerLeading French academic cancer research center in Paris. Academic partner in the RlapsRisk BC validation study under the Unicancer network. Contributed patient data for clinical validation of Waiv's diagnostic tests.
• UnicancercoreStrategic or Co-development PartnerFrench academic cancer research network acting as data controller for the RlapsRisk BC validation study. Coordinates academic hospital data sharing across the French hospital network for Waiv's clinical validation studies.
• 4baseCareminorStrategic or Co-development PartnerPrecision oncology research collaboration announced between Owkin and 4baseCare to advance inclusive precision oncology research, jointly pursuing research initiatives.

Scale indicators3 records

Recent moves7 records

Expansion highlights6 records

Direct peers

• PathAI: PathAI develops AI-powered pathology diagnostics for oncology and provides biopharma services for biomarker discovery and clinical trial support, directly mirroring Waiv's dual clinical-product and pharma-services model with overlapping H&E-based biomarker targets.
• Paige AI: Paige offers AI-based digital pathology products including FDA-cleared prostate cancer detection and enterprise pathology platforms; serves biopharma for biomarker and companion diagnostic development with similar foundation-model-based histology analysis to Waiv.
• Ibex Medical Analytics: Ibex provides AI-powered cancer diagnostics deployed in clinical pathology workflows, including breast and prostate cancer detection, with similar H&E-based tissue analysis value proposition and integration with IMS systems.
• ArteraAI: ArteraAI develops AI-based multimodal prostate cancer prognosis and treatment-decision tests from H&E slides with FDA clearances; directly comparable to Waiv's RlapsRisk BC breast cancer prognostic product in clinical AI biomarker prediction from routine pathology.
• Proscia: Proscia is a digital pathology platform that distributes AI applications including Waiv's through its Concentriq IMS; comparable as both an integration channel and a competitor developing its own AI pathology applications.

Broad incumbents

• Owkin: Owkin is Waiv's parent company, a broader AI biotech providing federated learning, drug discovery, and diagnostic services; retains minority stake in Waiv and remains its data and hospital network partner across oncology biomarkers.
• Sectra: Sectra provides enterprise imaging and pathology IMS platforms used by hospitals; while a distribution partner for Waiv tests, its installed base and AI strategy position it as a broader incumbent in the pathology IT stack.
• Tempus AI: Tempus operates a broad precision medicine platform combining molecular diagnostics, multimodal data, and AI for oncology; competes with Waiv's biopharma services and biomarker discovery offerings from a much larger installed base.
• Roche Diagnostics: Roche is both a Waiv distribution partner and a major incumbent in IVD and digital pathology with the navify Digital Pathology platform; comparable as an established player whose installed base could either accelerate or compete with Waiv's AI tests.

Emerging players

• Mindpeak: Mindpeak offers AI image analysis solutions for pathology including IHC quantification and biomarker scoring, with overlapping technology in tissue-based AI diagnostics; smaller scale than Waiv but directly competitive on certain use cases.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat5 records

Key risks6 records

Key highlights7 records

Customer concentration

• YouTubeyoutube.com/@we-are-waiv
• LinkedInlinkedin.com/company/we-are-waiv

Compliance3 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles2 records

Funding overview

Funding rounds9 records

Investors17 records

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M&A

Investments2 records

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about Waiv