BioPharma Services
Using AI-powered pathology to advance every phase of drug and diagnostic development.
Discovery & Translational Research
Partner with and work alongside our team of translational scientists, in-house pathologists, data scientists and machine learning engineers to advance and deepen understanding of disease pathophysiology, biomarker expression, and drug response at the tissue and cellular level.
Services include:
Characterization and quantification of spatial digital biomarkers using >600 human interpretable features (HIFs) extracted from H&E whole slide images
Development of machine learning algorithms tailored to specific drug development programs/mechanisms of action
Correlation of HIFs with multimodal data, including genomic and transcriptomic data; molecular phenotypes; and/or clinical outcomes, to identify predictive and prognostic features
Monoplex IHC, multiplex IHC and IF, and special stain algorithm and ‘wet lab’ assay development
Discovery and Translational Research ServicesServices include:
Clinical Development
Drive more powerful precision medicine strategies and development by using more effective patient selection and stratification strategies and more accurate endpoint measurements – all powered by our trial-ready algorithms under all applicable quality and regulatory standards.
Services include:
Deployment of PathAI’s clinical trial algorithms (CTA) for patient stratification and/or selection, primary or secondary endpoint measurements, and/or exploratory endpoint analysis
In-house CAP/CLIA and GCLP anatomic and digital pathology lab operations and workflow, including wet-lab services (accessioning, grossing, sectioning, staining, and scanning) and manual pathology reads leveraging our network of over 450 US Board Certified pathologists
Digital and anatomic pathology workflow integration with leading CROs and central labs using our cloud-based AISight platform, developed and deployed under GCLP standards
Clinical Development ServicesServices include:
Diagnostic Development & Commercialization
Move rapidly and seamlessly from development to commercial launch of novel AI-powered in vitro and companion diagnostics that enable precision medicine strategies globally.
Services include:
Medical device development and validation of diagnostic algorithms under 21CRF part820 and IVDR regulations
Regulatory and market access strategy, including stakeholder engagement across laboratories, physicians, regulatory bodies, and payers
Centralized and decentralized testing models through PathAI Diagnostics and our network of lab partners
Diagnostic Development and Commercialization ServicesServices include:
BioPharma Lab
Power rapid and robust assay development and algorithm deployment using our in-house CAP/CLIA-certified GCLP histopathology lab for biopharma research and clinical trials.
Our services include:
Full anatomic and digital pathology lab services: sample receipt, grossing, processing, sectioning, staining, and scanning with industry-leading turnaround time and quality
Slide-level consensus scoring and model training and validation using PathAI’s extensive pathologist network of over 450 US board-certified pathologists
Assay development, optimization, and validation for immunohistochemistry (IHC), special stains, in-situ hybridization (CISH and FISH) and multiplex immunofluorescence (mIF)
BioPharma Lab ServicesOur services include:
Get In Touch with our Team
PathAI’s technology is transforming the way pathology is done for 90% of the top 15 biopharmaceutical companies and within health systems and clinical labs nationwide. At PathAI Diagnostics, we have over 25 years of experience in diagnostic pathology and laboratory services.
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