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AI-based MASH Scoring

PathAI has developed AI-based measurement (AIM) tools that provide Clinical Research Network (CRN) MASLD Activity Score (MAS) component grades and fibrosis stages.

AIM-MASH AI Assist1 delivers accurate and reproducible histologic assessment with pathologist review

AIM-MASH AI1 aids pathologists in MASH CRN scoring to reduce the impact of reader variability and capture drug effect in clinical trials. This tool is currently under review by the FDA and qualified by the EMA to “aid a single central pathologist for enrollment/inclusion of patients into clinical phase 2 and phase 3 trials in MASH” and for the “evaluation of study outcomes (primary or secondary) in case this is intended to be based on histology evaluation.2

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Improve Scoring Confidence

Reduce the impact of scoring variability in MASH clinical trials and research.

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Streamlined Workflows

Streamline trial workflows and conserve valuable resources by accelerating time-to-result with an AI-assisted single reader.

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Robust Development

Trained on a vast and diverse dataset of >5,900 biopsies from across six different clinical trials.

AIM-MASH AI Assist Specifications

  • Intended Use: Research Use Only
  • Indications: MASH
  • Scanners: Leica Aperio®  AT2
  • Inputs: 1 H&E and 1 Masson’s Trichrome image
  • Outputs: Pathologist AI-assisted ordinal MASH CRN scores; AI-alone ordinal MASH CRN scores
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AIM-MASH+1 provides a nuanced and deeper understanding of histological changes within CRN grades/stages

AIM-MASH+1 outputs AI-alone ordinal and continuous MASH CRN scores to drive more nuanced and deeper understanding of changes within CRN grades/stages.

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Robust, High-Resolution Read Outs

AI-based continuous scoring of MASH histologic features can reveal smaller degrees of change which can lead to improved precision medicine strategies.

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Directly Comparable

Direct association between ordinal and continuous CRN score measures enables granularity without compromising.

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Added Assurance

AI-only ordinal scores provide objective, independent and reproducible output to test or confirm findings from pathologist read.

AIM-MASH+ Specifications

  • Intended Use: Research Use Only
  • Indications: MASH
  • Scanners: Leica Aperio®  AT2
  • Inputs: 1 H&E and 1 Masson’s Trichrome image
  • Outputs: AI-alone ordinal MASH CRN scores; AI-derived continuous MASH CRN scores; Artifact model QC features
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PathAI support throughout various stages of the MASH therapeutic development pipeline

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Connect With Our Team

Contact us to explore opportunities to accelerate your MASH Clinical Program.

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1 AIM-MASH AI Assist and AIM-MASH+ are authorized for research use only. Not approved for diagnostic use.

2 https://www.ema.europa.eu/en/news/ema-qualifies-first-artificial-intelligence-tool-diagnose-inflammatory-liver-disease-mash-biopsy-samples