SINGAPORE, Aug. 11, 2025 -- HistoIndex, a pioneering leader in digital pathology solutions for chronic liver disease, has announced the launch of FibroSIGHT™ Plus, its second Laboratory Developed Test (LDT) available in the United States. Building on the foundation of FibroSIGHT™[1], which debuted just months earlier, FibroSIGHT™ Plus introduces an additional feature of automated quantitative analysis of fibrosis - a key advancement that enables more consistent and precise characterization at diagnosis and tracking of fibrosis 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.", said Yukti Choudhury, Chief Development Officer at HistoIndex.
At the core of FibroSIGHT™ Plus is qFibrosis®, HistoIndex's proprietary 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 the 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 Dr. Naim Alkhouri, MD, Chief Academic Officer at Summit Clinical Research and the 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 Dr. Mazen Noureddin, MD, MHSc, Professor of Medicine, Transplant Hepatologist at Houston Methodist Hospital and a Co-Chairman of the Board Summit and Pinnacle Clinical Research.
FibroSIGHT™ Plus marks another advancement in HistoIndex's efforts to integrate its digital pathology solutions into routine patient care. With more innovations underway, HistoIndex continues to push the boundaries of what's possible in improving outcomes for patients with MASH.
About MASH
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 complex and heterogeneous nature of the disease. As a result, 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.
About HistoIndex
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 innovative tools to improve the assessment of fibrosis changes and drug efficacy. HistoIndex's breakthrough digital pathology solutions are currently used in accelerating clinical research, expediting pharmaceutical drug development, and transforming medical standards.
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