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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 Services

    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 Services

    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 Services

    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 Services

    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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