Singapore-based HistoIndex has launched FibroSIGHT Plus, its second AI-based laboratory developed test (LDT) in the United States for measuring fibrosis in patients with metabolic dysfunction-associated steatohepatitis (MASH). The new diagnostic tool represents a significant advancement in liver disease assessment, offering automated quantitative analysis that enables more consistent and precise characterization of fibrosis at diagnosis and during disease monitoring.
Advanced AI Algorithm Drives Precision
At the core of FibroSIGHT Plus is HistoIndex's proprietary qFibrosis algorithm, which leverages stain-free Second Harmonic Generation (SHG) imaging of MASH liver biopsies. The AI-driven system automatically quantifies multiple fibrosis-related collagen architectural and morphological features detected by SHG in various spatial zones of a liver biopsy, translating them into a single fibrosis stage value.
Unlike conventional pathology methods that categorize fibrosis in discrete stages, FibroSIGHT Plus expresses fibrosis on a continuous scale. This approach allows for more detailed insights into disease severity and provides clinicians with a sensitive tool to better characterize individual patients at diagnosis and monitor subtle changes in their disease over time.
"The ability to detect incremental changes in fibrosis with this level of precision is exactly what we need to guide earlier and more targeted interventions in MASH," said Dr. Naim Alkhouri, Chief Academic Officer at Summit Clinical Research and Director of the Steatotic Liver Disease Program at the Clinical Research Institute of Ohio.
Addressing Clinical Variability
FibroSIGHT Plus delivers standardized and objective measurements across entire biopsy specimens, addressing the variability inherent in conventional staining and interpretation methods. By removing subjectivity and inter-reader variability while offering granular measurements at single-fiber resolution across the entire spectrum of fibrosis in MASH, the test enhances confidence in fibrosis assessment and supports more personalized, data-driven treatment decisions.
Dr. Mazen Noureddin, Professor of Medicine and Transplant Hepatologist at Houston Methodist Hospital, noted that when benchmarked against reference fibrosis stages from expert pathologists' consensus, HistoIndex's qFibrosis algorithm "aligns closely, and demonstrates greater consistency than traditional histology. This level of reproducibility is essential in clinical practice and represents an important step toward replacing subjective scoring with reliable, quantitative metrics."
Expanding MASH Market Opportunity
The launch comes as the MASH market experiences significant growth. According to GlobalData estimates, there are approximately 4.9 million diagnosed cases of MASH among individuals 18 years and older in the US. Across seven major markets including the US, France, Germany, Italy, Spain, the UK, and Japan, GlobalData analysis projects the MASH market will reach approximately $25.7 billion by 2032.
The first pharmaceutical treatment for MASH, Madrigal Pharmaceuticals' Rezdiffra (resmetirom), received FDA approval in March 2024, marking a milestone in addressing this progressive liver disease characterized by fat buildup, inflammation, and potential organ damage that can lead to fibrosis, cirrhosis, liver failure, and increased liver cancer risk.
Building on Digital Pathology Innovation
FibroSIGHT Plus builds upon HistoIndex's earlier FibroSIGHT test, which debuted months earlier. "We're thrilled to deliver another advancement in MASH diagnostics, bridging our experience and capabilities in clinical trials all the way to clinical use," said Yukti Choudhury, Chief Development Officer at HistoIndex.
Founded in 2010, HistoIndex specializes in stain-free, fully automated imaging solutions for visualizing and quantifying fibrosis in biological tissues. The company combines cutting-edge biophotonic technology with AI-based analysis to provide tools for assessing fibrosis changes and drug efficacy in clinical research and pharmaceutical development.
