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PathAI will Present on Analytical and Clinical Validation of AI-based NASH Clinical Trial Digital Pathology Tool at the European Association for the Study of the Liver Congress 2023, and Announces Launch of new NASH Explore Product 

Company announces positive topline results from analytical and clinical validation of AIM-NASH and launch of complementary NASH Explore panel of 500+ quantitative, interpretable histologic features, enhancing their digital pathology solutions and clinical trial support for non-alcoholic steatohepatitis drug development  

BOSTON — June 21, 2023 — PathAI, a leading provider of AI-powered pathology, will give a late-breaker presentation on new results from analytical and clinical validation studies that tested their AIM-NASHTM product and workflow’s accuracy, repeatability, reproducibility, and clinical validity across thousands of samples from several clinical trials, at the European Association for the Study of the Liver’s International Liver Congress 2023 (EASL), which will be held in Vienna, Austria from June 21 to 24, 2023. During EASL, PathAI will also formally launch and release details on its new NASH ExploreTM product.  

PathAI’s analytical and clinical validation studies demonstrated that AIM-NASH-assisted pathologist reads of NASH resolution, hepatocellular ballooning, and lobular inflammation were superior to unaided pathologist assessment. Notably, there was a large improvement in scoring accuracy for ballooning and lobular inflammation, which are two of the most challenging components to score and standardize across pathologist reads. These results support PathAI’s vision to develop AI-powered digital pathology solutions to assist pathologists in achieving accurate and reproducible scoring, and complement prior results showing that AI-powered digital pathology is sensitive to drug effect that is not detected by categorical pathologist scoring[1, 2], while also having the potential to control placebo response rates in NASH clinical trials[3] 

“The results from these studies inspire confidence in the robustness and value of AIM-NASH, and will pave the way to ultimately adopting AI-assisted NASH scoring as our new gold standard to ensure the greatest confidence in measuring true drug effect in NASH clinical trials,” said Stephen Harrison, M.D., chairman of Summit Clinical Research and a pioneer in the field of liver research and lead author on the study. 

At EASL, PathAI is also unveiling NASH Explore, an AI-derived panel of >500 histopathology features that spatially characterize NASH biopsy tissue microarchitecture at the cellular-level from H&E whole-slide images. It characterizes the H&E liver biopsy microenvironment at unprecedented resolution, giving drug developers and clinical researchers the ability to unlock insights that will enable precision drug development in non-alcoholic steatohepatitis (NASH).  

“Manual ordinal histologic scoring of fat, inflammation, ballooning and fibrosis from liver biopsies has been the gold standard in NASH assessment for enrollment and therapeutic efficacy, but the NASH community has been pushing for more,” said Andy Beck, M.D., Ph.D., chief executive officer and co-founder of PathAI. “NASH Explore will help uncover new histologic signatures and biomarkers of therapeutic response that could be even more predictive of patient outcomes, and provide more precision in stratifying patients for targeted therapies.” 

In response to the NASH community’s request for more sensitive measures of fibrosis that can be seamlessly integrated into existing clinical trial workflows, NASH Explore was developed to not only infer the presence of fibrosis in whole slide images of H&E-stained tissue sections, but also 1) categorize fibrosis into clinically relevant subtypes, and 2) quantify the presence of these fibrosis subtypes in liver lobular zones. By enabling sensitive, specific fibrosis detection from whole slide images (i.e., without requiring proprietary scanning of physical glass slides), NASH Explore allows for rapid and scalable interrogation into patterns of fibrosis that reflect true disease progression and regression.  

NASH Explore complements PathAI’s current AIM-NASH product, an AI-powered digital pathology tool that assists pathologists in performing NASH CRN scoring.  

PathAI’s poster and oral presentation schedule at EASL: 

Characterizing the histologic implications of resmetirom-induced liver volume reduction using artificial intelligence-powered digital pathology (Abstract OS-029) 

In partnership with Madrigal Pharmaceuticals 

21 June, 9:00-18:00 CEST 

Analytical and clinical validation of AIM-NASH: a digital pathology tool for artificial intelligence-based measurement of nonalcoholic steatohepatitis histology (Abstract 4102) 

Oral presentation by: Stephen Harrison, MD, FAASLD 

22 June, 18:15-18:30 CEST 

For more information, visit booth F4 at EASL for a live demo of NASHExplore, or contact us at [email protected]. Additional information can be found at 

  1. A machine learning approach enables quantitative measurement of liver histology and disease monitoring in NASH.
  2. Comparison of manual vs machine learning approaches to liver biopsy scoring for NASH and fibrosis: a post hoc analysis of the FALCON 1 study.
  3. Comparison of the effects of semaglutide on liver histology in patients with non-alcoholic steatohepatitis cirrhosis between machine learning model assessment and pathologist evaluation.
About PathAI  

PathAI is the only AI-focused technology company to provide comprehensive precision pathology solutions from wet lab services to algorithm deployment for clinical trials and diagnostic use. Rigorously trained and validated with data from more than 15 million annotations, its AI-powered models can be leveraged to optimize the analysis of patient samples to improve efficiency and accuracy of pathology interpretation, as well as to better gauge therapeutic efficacy and accelerate drug development for complex diseases.  

PathAI, which is headquartered in Boston, MA, and operates a CAP/CLIA-certified laboratory in Memphis, TN, is proud to have a team of 600+ innovative thinkers from around the globe. For more information, please visit 

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