PathAI Announces New NASH/MASH Advisory Network to Guide Evidence Generation and Regulatory Strategy for AI-Powered Digital Pathology Product Development

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PathAI, a leading provider of precision pathology solutions, today announced the formation of a new advisory network to inform the companys vision to leverage AI-powered digital pathology to improve outcomes for individuals with non-alcoholic steatohepatitis/metabolic dysfunction-associated steatohepatitis (NASH/MASH).

According to the American Liver Foundation, approximately 2-5% of adults in the U.S. have NASH/MASH, a disease with no FDA-approved treatments currently available. Disease incidence has risen from 1.51% in 2010 to 2.79% in 2020. The American Liver Foundation predicts that by 2030, NASH/MASH will be the most frequent reason for liver transplants in the U.S., underscoring the severe impact of this disease. Given the burden of NASH/MASH and lack of available treatment options for patients, attention from industry and academia alike is increasing, with numerous clinical trials in progress to develop novel, efficacious therapies for patients.

PathAI has worked closely with experts in the field of NASH/MASH for years, including leading researchers, academics, patient advocacy groups, regulatory bodies and biotechnology and pharma partners, contributing to the development of solutions for this challenging disease. Previously, this close collaboration with NASH/MASH subject matter experts led to the development and validation of AIM-NASH, a tool that promises to reduce the impact of pathologist scoring variability on clinical trial outcomes by assisting pathologists in grading and staging key histologic features of NASH/MASH1,2,as well as NASH Explore, an AI-powered panel of more than 1000 quantitative Human Interpretable Features (HIFs) that spatially characterize NASH/MASH tissue biopsy microarchitecture at the zonal and cellular level from H&E whole slide images.

Now, PathAI will build on that collaboration by bringing together a diverse group of stakeholders across academia, medicine, regulatory science, patient advocacy, and industry to inform the evolution of the company portfolio. The networks first meeting was held in September and will be held quarterly moving forward.

Scoring liver biopsies by an expert pathologist is a crucial aspect of NASH/MASH clinical trials. However, this benchmark tool is limited both in the availability of liver pathologists and intra/inter-observer variability of their evaluation, Pierre Bedossa, Professor of Pathology at Groupe Hospitalier Paris Nord and visiting professor at the Institute of Cellular Medicine at Newcastle University, and PathAI advisor, pointed out. AIM-NASH developed by PathAI marks clearly a step forward. This tool alleviates some of the limitations by providing a trustworthy AI-based evaluation of liver biopsy functioning under pathologist supervision. Promising results of AIM-NASH in the context of NASH clinical trials strongly suggest that this tool may become essential to speed up drug evaluation and development for the benefit of patients.

Other members of the advisor network include:

  1. Stephen A. Harrison, medical director for Pinnacle Clinical Research and the president of Summit Clinical Research.

  2. Karoline Lackner, professor of pathology at the Medical University of Graz.

  3. Rohit Loomba, professor of medicine and director of hepatology at the University of California at San Diego.

  4. Romil Saxena, professor of pathology and laboratory medicine at Emory University School of Medicine and a diplomate of the American Board of Pathology.

  5. G. Mani Subramanian, founder, OrsoBio

  6. Chris Leptak, Senior Vice President; drugs and biologics at Greenleaf Health, Inc.

As a leader in digital pathology for liver diseases, we recognize the responsibility we have to advance the science towards effective treatments for NASH/MASH with cutting-edge technology, said Andy Beck, MD, PhD, co-founder and CEO of PathAI. At the same time, we recognize that only by incorporating the ideas and expertise of the leading minds in MASH will we truly achieve our mutual goal of improving patient outcomes for MASH patients.

The PathAI team will be attending the American Association for the Study of Liver Diseases annual meeting November 10-14 in Boston. Schedule time to talk about how PathAIs solutions can drive liver disease clinical development at our booth (# D3100) by emailing Read more about PathAIs robust AI-powered products for NASH, including AIM-NASH and NASH Explore, on PathAIs website.

1 Harrison et al., Retrospective AI-based Measurement of NASH Histology (AIM-NASH) Analysis of Biopsies From Phase 2 Study of Resmetirom Confirms Significant Treatment-induced Changes in Histologic Features of Nonalcoholic Steatohepatitis, EASL poster 2022.

2 Shevell et al. Comparison of manual vs machine learning approaches to liver biopsy scoring for NASH and fibrosis: a post hoc analysis of the FALCON 1 study. AASLD poster 2021

AIM-NASH & NASH Explore are authorized for research use only. Not approved for diagnostic use.

About PathAI

PathAI is a recognized leader in the biopharma partnering space, uniquely combining AI-powered pathology solutions with end-to-end central pathology and histology services. The company supports biopharma partners in executing clinical trials where pathology-based endpoints, biomarker classification, and/or superior histology quality are critical to successfully gauging therapeutic efficacy, accelerating drug development for complex diseases. PathAI has already supported multiple Phase 2 clinical trials in NASH, IBD, and breast cancer, as well as oncology neoadjuvant trials, and is now expanding into larger scale global Phase 3 studies, as well as additional indications.

PathAI provides a fully integrated approach to clinical trials, enabling pharma partners to leverage the power of AI without the heavy lift of implementation. This helps reduce the impact of challenges associated with clinical trials, including unreliable turnaround times, variable histology, stain or scan/digitization quality, and challenging assessment of histological endpoints. The lab offers all major immunohistochemistry staining platforms, with flexible workflows across different scanners, stains, and biopsy types, which improves the quality of clinical trials. Services include access to PathAIs extensive network of over 500 US Board Certified pathologists to perform high quality reading with rapid turnaround time in a cost-effective manner, plus seamless integration of PathAI's advanced AI-solutions to ensure high-quality, reproducible results with every scan.

PathAI is headquartered in Boston, MA, and operates its CAP/CLIA-certified diagnostics clinical laboratory (formerly known as Poplar Healthcare) one of the countrys largest anatomic pathology labs in Memphis, TN. For more information, please visit

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