HistoIndex Premieres its AI-Based Quantitative Fibrosis Test

HistoIndex has launched its second Laboratory Developed Test (LDT) in the United States, FibroSIGHT Plus. Building on the foundation of the previously-released FibroSIGHT¹ (several months ago), FibroSIGHT Plus introduces an additional feature of automated quantitative analysis of fibrosis—a key advancement that enables more consistent and precise characterization at fibrosis diagnosis and tracking in patients with Metabolic Dysfunction-associated Steatohepatitis (MASH). 

“We’re thrilled to deliver another advancement in MASH diagnostics, bridging our experience and capabilities in clinical trials all the way to clinical use,” HistoIndex Chief Development Officer Yukti Choudhury stated.

At FibroSIGHT Plus’s core is qFibrosis, HistoIndex’s proprietary artificial intelligence (AI)-driven algorithm. By leveraging stain-free Second Harmonic Generation (SHG) imaging of MASH liver biopsies, qFibrosis automatically quantifies multiple fibrosis-related collagen architectural and morphological features detected by SHG in various spatial zones of a liver biopsy and translates them into a single value or stage for fibrosis.² The result is fibrosis expressed on a continuous scale, rather than in discrete categories. This allows more detailed insights into disease severity and offers clinicians a sensitive tool with which to better characterize individual patients at diagnosis and to monitor subtle changes in their disease over time.

“Having worked with HistoIndex for many years, I have witnessed firsthand the value that Second Harmonic Generation imaging brings to fibrosis assessment in MASH clinical trials, with highly sensitive and consistent detection and quantification of fibrosis in liver biopsies. Automated solutions like FibroSIGHT Plus represent the future of liver pathology. 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 Naim Alkhouri, M.D., chief academic officer at Summit Clinical Research and director of the Steatotic Liver Disease Program at the Clinical Research Institute of Ohio.

Unlike conventional pathology methods, which are prone to variability in staining and interpretation, FibroSIGHT Plus delivers a standardized and objective measurement across the entire biopsy specimen. By removing subjectivity and inter-reader variability, as well as offering granular measurements at single-fiber resolution on the entire spectrum of fibrosis in MASH, the FibroSIGHT Plus test enhances confidence in fibrosis assessment and supports more personalized and data-driven treatment decisions.

“When benchmarked against reference fibrosis stages from expert pathologists’ consensus, HistoIndex’s qFibrosis 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,” added Mazen Noureddin, M.D., professor of Medicine, Transplant Hepatologist at Houston Methodist Hospital and a co-chairman of the Board Summit and Pinnacle Clinical Research.

Metabolic Dysfunction-associated Steatohepatitis (MASH) is a progressive form of Metabolic Dysfunction-associated Steatotic Liver Disease (MASLD) characterized by steatosis, ballooning degeneration and inflammation, which can lead to fibrosis (scarring), cirrhosis, liver failure and an increased risk of liver cancer. Pathologist assessment of liver biopsy remains the gold standard for diagnosing and assessing the severity of MASH. Histological categorial scoring systems are often used as surrogate endpoints to evaluate drug efficacy in MASH clinical trials. These endpoints are limited in capturing the disease’s complex and heterogeneous nature. Thus, there is a growing need for more accurate and reliable tools, such as AI-based digital pathology solutions, to improve the assessment of treatment response and disease severity in MASH.

Founded in 2010, HistoIndex pioneers in stain-free, fully automated imaging solutions for visualizing and quantifying fibrosis in biological tissues. By combining cutting-edge biophotonic technology with AI-based analysis, HistoIndex provides tools to improve fibrosis changes assessment and drug efficacy. HistoIndex’s digital pathology solutions are currently used in accelerating clinical research, expediting pharmaceutical drug development, and transforming medical standards.

References
¹ https://histoindex.com/fibrosight
² https://histoindex.com/qfibrosis