PathAI

Mission

PathAI's mission is to improve patient outcomes with AI‑powered pathology by:

• Enabling more accurate and reproducible diagnosis.
• Helping match patients with the most effective treatments.
• Supporting more life‑saving drug approvals through better biomarker and endpoint assessment.

Customers and partners

PathAI works with:

• Biopharma companies across all phases of drug and diagnostic development.
• Anatomic pathology and reference laboratories, health systems, and academic medical centers.
• A global network of digital anatomic pathology laboratories through the Precision Pathology Network.

Capabilities and expertise

• Deep expertise in machine learning, software, life sciences, medicine, regulatory affairs, and operations.
• AI models trained and validated on more than 32.5 million expert annotations and a large library of archived pathology data.
• A contributor network of more than 450 board‑certified pathologists.

Company milestones (selected)

• 2016 – Company founded to apply technology to pathology and improve accuracy and reproducibility.
• 2019 – Achieved ISO 13485 and MDSAP certification for its quality management system and ISO 27001 certification for information security.
• 2020 – Issued initial patents related to predicting survival time and tissue characteristics from pathology images, and published its first manuscript in Hepatology.
• 2021 – Entered clinical diagnostics via acquisition of Poplar Healthcare, an anatomic pathology laboratory services provider.
• 2022 – Built an in‑house CAP/CLIA‑certified GCLP histopathology lab to support end‑to‑end clinical trials; received initial FDA 510(k) clearance and CE Mark for AISight Dx for primary diagnosis.
• 2023 – Launched over 20 AI products, including PathExplore.
• 2024 – Announced a strategic partnership with Quest Diagnostics, including sale of PathAI Diagnostics and licensing of the AISight platform.
• 2025 – Launched the Precision Pathology Network (PPN), a global network of digital anatomic pathology laboratories; received further FDA clearance for the evolved AISight Dx platform with a Predetermined Change Control Plan (PCCP); AIM‑MASH AI Assist received EMA and FDA qualification as an AI‑powered pathology Drug Development Tool.
• 2026 – PathAssist Derm received FDA Breakthrough Device Designation for analysis of digital pathology whole slide images (WSIs) of skin lesions.

PathAI supports translational research by:

• Providing tested, ready‑to‑deploy translational AI products in oncology, MASH, and inflammatory bowel disease (IBD).
• Developing custom algorithms for disease areas that involve tissue samples.
• Performing AI‑based spatial analyses on H&E and IHC images and signatures.
• Leveraging access to more than 50 million slides and samples across oncology, gastrointestinal, and other diseases from partner institutions and PathAI‑associated labs.

Clinical trial services

PathAI helps enable clinical trial success through:

• Trial‑ready algorithms developed under GCP/GCLP/CAP/CLIA/state regulations for patient enrollment, stratification, and endpoint measurement.
• Molecular phenotype pre‑screening using AI‑powered predictions from H&E images.
• End‑to‑end clinical trial operations and laboratory services, including core pathology, expert manual pathology review, and pathology protocol strategy.
• Integration of the AISight Clinical Trials platform with a large share of global central lab providers.

Diagnostic development and commercialization

PathAI supports diagnostic and companion diagnostic programs by:

• Coordinating design, development, and validation of software as a medical device (SaMD) to meet region‑specific regulatory requirements.
• Providing regulatory and market access strategy, including engagement with laboratories, physicians, regulators, and payers.
• Building strategic partnerships across assay developers, cloud providers, and image management system vendors to support global commercialization.

Real‑world data

For real‑world evidence and data‑driven insights, PathAI offers:

• Quantitative histopathology data products linked to structured clinical and molecular data from partner reference labs, academic medical centers, and real‑world data providers.
• Datasets for identifying novel histopathology‑based prognostic and predictive biomarkers and signatures in large real‑world patient cohorts.
• Resources for validating translational research findings and understanding mechanisms of action and drug pathways by linking molecular and clinical data to histopathology.

Market footprint

Based on information published on the PathAI website:

• A large majority of the top 15 biopharma companies use PathAI technology.
• PathAI has supported more than 100 translational research projects.
• PathAI algorithms have been used in dozens of clinical trials.
• PathAI partners with a network of clinical and commercial labs within its global footprint.

AISight Dx for primary diagnosis

• AISight Dx is a digital pathology platform from PathAI that has received FDA clearance and a CE Mark for use in primary diagnosis.
• The evolved AISight Dx platform has additional FDA clearance that includes a Predetermined Change Control Plan (PCCP), enabling certain future enhancements without the need for new submissions.

AISight for clinical trials

• The AISight Clinical Trials platform is integrated with a large portion of global central lab providers.
• It is designed to support end‑to‑end clinical trial workflows that rely on digital pathology and AI‑based image analysis.

Precision Pathology Network (PPN)

• The Precision Pathology Network is a global network of digital anatomic pathology laboratories that use PathAI's technology.
• It aims to standardize and scale digital pathology and AI adoption across multiple institutions.

Selected AI‑powered pathology products

Based on information published on the PathAI website:

• PathAI has launched more than 20 AI products, including offerings such as PathExplore.
• AIM‑MASH AI Assist has received regulatory qualification by both the EMA and FDA as an AI‑powered pathology Drug Development Tool (DDT) for MASH clinical trials.
• PathAssist Derm has been granted FDA Breakthrough Device Designation to aid pathologists in reviewing digital pathology whole slide images (WSIs) of skin lesions.

Intended users

• Biopharma sponsors running translational studies and clinical trials.
• Anatomic pathology laboratories, reference labs, health systems, and academic medical centers.
• Digital pathology labs that are part of the Precision Pathology Network.

Ask anyway — the agent will say plainly that it is not published rather than guess.