Next-Gen MASH Fibrosis Assessment: HistoIndex Debuts AI-Based LDT

Published: 13 Aug 2025

Author: Precedence Research

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Singapore medical technology innovator HistoIndex has released its new artificial intelligence-powered laboratory-developed test (LDT), FibroSIGHT Plus. That can transform how doctors diagnose and manage fibrosis in patients with metabolic dysfunction-associated steatohepatitis (MASH). The new assay, already available on the market in the United States, is an evolution of the company's earlier fibrosis measurement platform. This enables complete automation of analysis, allowing for the quantitative characterization of fibrosis, which is deemed to be consistent and precise at initial diagnosis and throughout disease monitoring.

FibroSIGHT Plus is based on exploring the microscopic tissue structure using a proprietary second-harmonic generation (SHG) imaging of MASH liver biopsies. Thus, offering a new, accurate, and reproducible way to measure fibrosis using HistoIndex's proprietary qFibrosis algorithm, which also enables prioritizing treatment options to manage or cure the patient. The results are converted into a one-fibrosis stage value so that clinicians can assess the degree of the disease with impressive granularity. Contrary to traditional systems that only classify patients into fibrosis categories,

FibroSIGHT Plus tracks fibrosis on a continuous scale, providing more refined details about a given patient's level of disease and hence enabling clinicians to adapt treatment approaches in both a timely and specific way. FibroSIGHT Plus reduces a significant gap in the management of liver disease because the tool allows clinicians to measure tiny changes in fibrosis accrued over time. The test accuracy may facilitate earlier intervention, better treatment choice, and possibly help in changing the course of disease in millions of patients.

At HistoIndex, the launch of FibroSIGHT Plus marks a strategic move to establish the company in the US, and support and meet the urgent clinical demands or needs in the management of liver diseases. This innovation has received positive acceptance in the clinical community. Dr. As Naim Alkhouri, Chief Academic Officer at Summit Clinical Research and Director of the Steatotic Liver Disease Program at the Clinical Research Institute of Ohio pointed out, precision in the measurement of fibrosis is essential: “The enhanced precision that can measure changes in fibrosis in such small increments is precisely what we need to make more effective interventions in MASH earlier and more specifically.”