Pharma
Deployment record
In the tracker →- Organisation
- Roche
- System
- AISight
- Stage
- Live
- Function
- digital pathology
- Built on
- PathAI
- 01Roche aims to enhance drug development by integrating tissue sample analysis more effectively, utilizing PathAI's technology for clinical laboratories and biopharma research.
- 02Roche has agreed to acquire PathAI for $750 million upfront, with potential additional payments of up to $300 million, pending regulatory approvals.
- 03Roche and PathAI have been collaborating since 2021 to develop AI-enabled companion diagnostics that connect tissue analysis to targeted medicine development.
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- 04The FDA has qualified an AI-assisted tool from PathAI for assessing metabolic dysfunction-associated steatohepatitis (MASH) in clinical trials, addressing scoring variability among pathologists.
- 05Labcorp plans to deploy PathAI's AISight Dx technology across its network, aiming to integrate AI insights into routine care and enhance digital pathology workflows.
Roche
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A tissue sample can help a drug developer decide who might benefit from a treatment and assess what changed after treatment. Roche wants to make the analysis of those samples a more connected part of drug development.
The Swiss medicines and diagnostics company’s latest digital-pathology update, describes how PathAI’s technology could support clinical laboratories and biopharma research. Its focus includes simplifying implementation and support, alongside using tissue images to find biomarkers.
The update follows Roche’s May agreement to acquire PathAI for $750 million upfront, with up to $300 million in additional milestone payments. That announcement made completion subject to regulatory approvals and other closing conditions.
“Digital pathology has the potential to improve precision diagnosis of cancer and enable physicians to offer better tailored treatment regimens,” said Matt Sause, CEO of Roche Diagnostics.
From a Tissue Slide to Trial Evidence
Roche and PathAI began working together in 2021 and expanded the relationship in 2024 to develop AI-enabled companion diagnostics. These tests help identify patients for particular treatments, connecting tissue analysis to the development and use of targeted medicines.
PathAI’s clinical-trial technology also supports the work of reviewing tissue across studies. Its AISight Clinical Trials platform combines remote pathology reads with AI analysis for applications including patient eligibility and response monitoring.
An example comes from liver disease. In December 2025, the US Food and Drug Administration (FDA) qualified an AI-assisted tool to help pathologists assess metabolic dysfunction-associated steatohepatitis (MASH) in clinical trials.
PathAI markets the tool as AIM-MASH AI Assist; the FDA announcement used its earlier AIM-NASH name. It helps score liver biopsies for disease activity and fibrosis.
The FDA identified variable scoring between experts as a complication in MASH trials. The qualified workflow keeps pathologists responsible for the final interpretation, including accepting or rejecting the AI-generated scores.
The week's drug discovery, trials and health-system deployments. Wednesdays.
AstraZeneca is exploring another use for tissue analysis earlier in development. Its recent research collaboration with Tremont AI focuses on developing and evaluating models for preclinical toxicologic pathology, where specialists distinguish treatment-related tissue damage from normal biological variation.
While Roche’s PathAI strategy spans diagnostics and clinical-trial analysis, the AstraZeneca-Tremont work targets potential safety risks before human trials.
Getting the Software Into the Laboratory
Roche’s update also addresses the practical work behind adoption. It identifies managing multiple vendors, disjointed contracts and fragmented service teams as barriers to scaling digital pathology.
Roche says it wants to simplify that process through unified contracting, setup and support, while accommodating scanners and algorithms from other developers. AISight, PathAI’s image management system, sits at the center of that approach.
The product versions have different permitted uses. Roche identifies AISight as research-use-only, while AISight Dx is FDA-cleared for primary diagnosis in the United States. That platform clearance does not extend to every connected AI application.
Labcorp’s Planned Rollout
Labcorp’s February announcement shows how the technology is being introduced into a laboratory network. The company outlined plans to deploy AISight Dx across its national network of anatomic pathology laboratories and hospital collaborations.
“PathAI’s technology allows us to scale digital pathology nationwide and integrate AI insights into routine care,” said Marcia Eisenberg, chief scientific officer at Labcorp.
The planned workflows cover digital slide review and case management, alongside collaboration between pathologists. Labcorp also said it would incorporate digital pathology into its precision medicine products.
For Roche, the strategy brings laboratory operations and drug research into the same offering. The MASH qualification establishes a defined trial application, while the Labcorp announcement outlines a broader rollout.
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