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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
    Micrograph of squamous cell carcinoma of the head and neck

    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
    Cirrhosis of the liver with hepatic steatosis and chronic hepatitis

    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
    The mucosa layer shows: surface mucous epithelium, gastric pits, fundic glands and muscularis mucosae with two layers of smooth muscle fibers. Below is the submucosa layer.

    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.
    Contact Us
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