AI-Powered Digital Pathology, from Discovery to the Clinic
From Slide to Insight. From Biomarker to Breakthrough.
Waiv partners with you to unlock the full potential of digital pathology to accelerate your translational research, de-risk clinical trials, and bring AI-powered diagnostics to clinical routine.
The teams that get biomarker strategy right early win at every stage
AI-driven biomarker discovery for your clinical program
& Commercialization
The full path: AI biomarker discovery through approved CDx
Most programs stall at the research-to-regulatory transition, and there is a need for an established, end-to-end path to guide AI biomarker discovery to a commercially deployed AI digital pathology diagnostic.
We offer co-development partnerships spanning the full journey from AI biomarker discovery, through to algorithm validation, SaMD development, regulatory strategy (CE-IVD / FDA), and CDx commercialization, with scientific and technical continuity at every handoff.
Validation and productization of a new biomarker linked to therapy eligibility
SaMD development to meet US/EU/global regulatory requirements and submissions: CE-IVDR and FDA pathways
Regulatory strategy and submissions: CE-IVD and FDA pathways
Commercialization strategy and global lab distribution network
Unlock hidden signal in your pathology data
Digital pathology is generating more biological information than any team can manually interrogate. Waiv gives you the AI-powered tools to turn that data into actionable insight whether you're characterizing an existing cohort or searching for a biomarker signal within a clinical program.
Quantitative H&E tissue analysis: cell classification, tissue segmentation, spatial feature detection including TILs and TLS
Quantitative IHC scoring: subcellular DAB quantification, H-Scoring, biomarker spatial scoring
Custom AI-driven biomarker development linked to your specific clinical program
Signal searching on clinical trial data to identify and validate spatial correlates for therapy eligibility
Accelerate Enrollment. Strengthen Endpoints. Reduce Risk.
Endpoint selection is complex, patient stratification is imprecise, and finding eligible patients slows timelines and inflates cost. These failures are also the most visible to regulators.
AI-powered patient screening and stratification tools deployed within clinical trial operations, using H&E-based molecular phenotyping or IHC-derived quantitative spatial scoring can identify drug-responsive patients earlier, while generating regulatory-grade evidence for endpoint validity.
AI-powered screening using H&E slides to predict molecular phenotype to streamline trial eligibility
Prospective patient stratification and enrichment for trial enrollment
AI-derived endpoints with reduced inter-reader variability compared to manual pathology reading
Regulatory expertise for AI-based endpoint and enrichment strategy
Accelerate patient access and drive lab adoption at scale
Even validated biomarkers suffer from slow clinical uptake. It takes time for labs to adopt new testing protocols, reducing patient access and the commercial return on precision medicine investment.
We can drive adoption programs that integrate AI-powered testing into clinical routine rapidly and at scale covering diagnostics linked to known biomarkers (e.g., MSI, gBRCA, HER2) and ready-to-deploy Waiv tests through pharma commercial and market access strategies.
Dx linked to known biomarkers (MSI, gBRCA, HER2) for streamlined therapy eligibility assessment
Lab onboarding support and pathologist training programs to accelerate adoption
Platform-agnostic solutions deployable across your lab ecosystem
Real-world evidence generation to demonstrate clinical and economic utility
Integration with pharma market access and commercial strategies
Built for the full precision medicine journey
Fast, seamless access to a vast academic and clinical data network, providing high-quality patient cohorts for AI training, validation, and real-world evidence generation.
Foundation models, representation learning, and transfer learning for generalizable, best-in-class solutions that perform across institutions and scanner platforms.
Proven CE-IVD experience and deep knowledge of FDA and global SaMD pathways — supporting your program from first submission to market clearance.
A strong and growing network of laboratory distribution partners. Platform-agnostic, generalizable-by-design solutions that integrate across scanner ecosystems and lab workflows worldwide.
Partner case studies
Identifying which patients will respond to an ADC therapy from pathology slides alone, with fewer than 100 patients, is one of oncology drug development’s hardest problems.
Waiv is collaborating with Daiichi Sankyo to apply its AI-powered digital pathology platform to early-phase data, surfacing biomarkers of treatment response and carrying them through to clinically validated, deployable tests.
gBRCA mutation testing is not routinely performed across all breast cancer patients, limiting access to PARP inhibitor therapy for eligible patients.
AstraZeneca and Waiv co-developed an AI-powered gBRCA screening solution for breast cancer, predicting BRCA status from routine H&E slides.
MSI-H testing is inconsistently applied across cancer types, leaving eligible patients without access to pembrolizumab therapy.
MSD and Waiv partnered to develop MSIntuit® improving MSI-H testing rates across four indications: endometrial, gastric, small intestinal, and biliary cancers.
Ready to accelerate your biomarker program?
Citations
- Clinical development success rates 2011-2021: Statista 2023, 8% vs 16% phase 1 to approval success rate
- Thomas, D. W., Burns, J., Audette, J., Carroll, A., Dow-Hygelund, C., & Hay, M. (2016). Clinical Development Success Rates 2006–2015
- https://society.asco.org/sites/new-www.asco.org/files/content-files/advocacy-and-policy/documents/2022-Biomarker-Tests-Cancer-Care-Brief.pdf; https://www.accc-cancer.org/acccbuzz/blog-post-template/accc-buzz/2023/12/12/the-cost-of-biomarker-testing-moving-from-support-based-to-sustainable-solutions