A Lab Developed Test (LDT) using AI-Assisted Scoring for MASLD/MASH staging
Introducing AI.Dx MASH: A World’s First Lab Developed Test (LDT) using AI-Assisted Scoring for MASLD/MASH staging
Instances of Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD) are Growing
- 8% of the global adult population is estimated to have Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)1
- 5-6% of the U.S. adult population is estimated to have Metabolic Dysfunction-Associated Steatohepatitis (MASH)2,3
- 8 Million people are estimated to be living with significant fibrosis without cirrhosis2
Significant Variability Exists in Inter- and Intra-observer Scores
While biopsy is the gold standard for histologic scoring and staging of MASH,4,5 there is significant variability in inter- and intra-observer scores of each histologic feature that contributes to the overall Clinical Research Network (CRN) Score to assess whether a patient has MASH and how far the disease has progressed:6,7
- 31% Discordance between pathologists on MASH diagnosis7
- 59% Intra-reader agreement on MASLD Activity Score when reviewing the same case7
An inaccurate assessment of disease progression can mean that the patient is unaware of the severity of their disease,8,9 with each change in fibrosis stage resulting in a two-fold increase in liver-related mortality9
Utilizing AI to Reduce Scoring Variability
A world’s first, AI.Dx MASH utilizes AI, generated from over 100,000 annotations across over 5,900 biopsies to significantly reduce scoring variability in CRN Scoring for MASH histologic scoring.6,10,11
- Image overlay showing the extent of steatosis, lobular inflammation, hepatocellular ballooning and fibrosis10,11*
- Area quantification of histologic features10,11*
1. Riazi K, Azhari H, Charette JH, Underwood FE, King JA, Afshar EE, et al. The prevalence and incidence of NAFLD worldwide: a systematic review and meta-analysis. The Lancet. 2022;7(9):851-861.
2. Estes C, Razavi H, Loomba R, Younossi Z, Sanyal AJ. Modeling the epidemic of nonalcoholic fatty liver disease demonstrates an exponential increase in burden of disease. Hepatology. 2018;67(1):123-133.
3. Diehl AM, Day C. Cause, pathogenesis, and treatment of nonalcoholic steatohepatitis. N Engl J Med. 2017;377(21):2063-2072.
4. Berger d, Desai V, Janardhan S. Con: Liver Biopsy Remains the Gold Standard to Evaluate Fibrosis in Patients With Nonalcoholic Fatty Liver Disease. Clin Liver Dis (Hoboken). 2019 Apr; 13(4): 114–116.
5. Arab JP, Barrera F, Arrese M. The evolving role of liver biopsy in non-alcoholic fatty liver disease. Annals of Hepatology (2018); 17(6):899-902.
6. Kleiner DE, Brunt EM, Van Natta M, et al. Design and validation of a histological scoring system for nonalcoholic fatty liver disease. Hepatology 2005;41:1313–21.
7. Davison B, et al. Suboptimal reliability of liver biopsy evaluation has implications for randomized clinical trials. J Hepatol (2020);73(6):1322-1332.
8. Taylor RS et al. Association Between Fibrosis Stage and Outcomes of Patients With Nonalcoholic Fatty Liver Disease: A Systematic Review and Meta-Analysis. Gastroenterology. 2020;158:1611-1625.
9. Pokkala H, et al. Machine Learning Models Identify Novel Histologic Features Predictive of Clinical Disease Progression in Patients With Advanced Fibrosis Due to Nonalcoholic Steatohepatitis. EASL ILC 2020 Poster 2497.
10. Carrasco-Zevallos O, et al., AI-based histologic measurement of NASH (AIM-NASH): A drug development tool for assessing clinical trial endpoints, EASL 2021 Abstract 1611.
11. Harrison SA, et al. Analytical and Clinical Validation of AIM-NASH a Digital Pathology Tool for Artificial Intelligence-based Measurement of Nonalcoholic Steatohepatitis Histology. EASL 2023.
*The clinical relevance and impact of image heat maps and area quantitation has not been determined.
Laboratory Developed Test (LDT). This test was developed and its performance characteristics determined by Poplar Healthcare (dba PathAI Diagnostics) in a manner consistent with CLIA requirements. This test has not been cleared or approved by the U.S. Food and Drug Administration. This test is intended to be used as an adjunct to existing clinical and pathologic information currently used for diagnosis of Non-alcoholic steatohepatitis (NASH) by liver biopsy.