Clinical Development
At PathAI, we commit to your entire biomarker and clinical development program and take AI-powered algorithms through clinical trials, and diagnostic deployment and distribution.
Our Products
RUO/IUO Algorithms
Deploy clinical-trial ready AI-powered algorithms for more accurate and reproducible participant selection and endpoint assessment to support technical and regulatory success.
Oncology
● AIM-PD-L1-NSCLC: More accurate tumor proportion scoring, especially at low expression cut points; compatible with all four PD-L1 clones (22C3, 28-8, SP142, and SP263)
Hepatology
● AIM-NASH: automated and reproducible NASH-CRN scoring
Gastroenterology
● AIM-UColitis: automated and reproducible Geboes scoring and sub-category scoring for ulcerative colitis
Oncology
● AIM-PD-L1-NSCLC: More accurate tumor proportion scoring, especially at low expression cut points; compatible with all four PD-L1 clones (22C3, 28-8, SP142, and SP263)
Hepatology
● AIM-NASH: automated and reproducible NASH-CRN scoring
Gastroenterology
● AIM-UColitis: automated and reproducible Geboes scoring and sub-category scoring for ulcerative colitis
AISight for Clinical Development
Deploy PathAI algorithms on our web-based digital slide viewer that is integrated into both our own lab and partnered CROs/central labs for global trial utilization.
Learn More About AISight
Our Services
Deployment of Precision Pathology Algorithms in Prospective Clinical Trials
• As drug development tools for trial enrollment, stratification, and/or primary endpoint assessment
• As secondary endpoints for supportive claims development and regulatory submission
• As exploratory endpoints for cut-point and/or dose optimization
CAP/CLIA Anatomic and Digital Pathology Lab Operations and Workflow
As a central pathology lab for clinical trials, we work with your CRO and clinical operations team to deploy AI algorithms compliantly, efficiently, and effectively
• Protocol design and pathology charter - our clinical operations team develop and execute clinical trial pathology charters with a focus on AI deployment in pathology workflows
• Complete anatomical and digital pathology operations—from sample receipt and processing to staining, scanning, and scoring, our ability to control the full pathology workflow and quality management system allows us to operate rapidly, reliably, and accurately
Learn More About our BioPharma Lab Services• As drug development tools for trial enrollment, stratification, and/or primary endpoint assessment
• As secondary endpoints for supportive claims development and regulatory submission
• As exploratory endpoints for cut-point and/or dose optimization
CAP/CLIA Anatomic and Digital Pathology Lab Operations and Workflow
As a central pathology lab for clinical trials, we work with your CRO and clinical operations team to deploy AI algorithms compliantly, efficiently, and effectively
• Protocol design and pathology charter - our clinical operations team develop and execute clinical trial pathology charters with a focus on AI deployment in pathology workflows
• Complete anatomical and digital pathology operations—from sample receipt and processing to staining, scanning, and scoring, our ability to control the full pathology workflow and quality management system allows us to operate rapidly, reliably, and accurately
Connect With Our Team
Contact us to learn more about how we can help support your clinical development needs.
Contact Us