FibroSIGHT™
A NEW STANDARD IN CLINICAL CARE OF MASH PATIENTS
Empowering clinicians with
accurate & consistent fibrosis assessment
What is FibroSIGHT™
HistoIndex’s first Laboratory-Developed Test (LDT) is developed to aid pathologists with reliable and consistent fibrosis assessment in MASH patients. The test exploits our unique stain-free imaging methodology finely tuned to the sensitive detection of collagen fibers – an excess of collagen fibers is the underlying cause of fibrosis – in liver biopsy samples. FibroSIGHT overcomes the inconsistencies associated with traditional staining methods and can integrate seamlessly into existing histopathology workflows. FibroSIGHT’s imaging readouts have the ability to empower clinicians to more objectively evaluate a patient’s condition, help inform treatment plans at diagnosis and to assist in evaluating response to treatments – crucially addressing the central role of managing liver fibrosis in MASH patients.
Liver biopsies of fibrosis stages 0 to 4, by NASH-CRN staging system captured with FibroSIGHT
Why Choose FibroSIGHT™
Accurate Assessment
FibroSIGHT enables sensitive detection and visualization of MASH liver fibrosis, eliminating the variability associated with traditional staining techniques. This greatly improves pathologists’ ability to evaluate fibrosis in liver biopsies. When using FibroSIGHT, pathologists show significantly higher agreement (with each other) on the degree of MASH fibrosis compared to standard assessments7,8.
Better Health Economics
Conventional pathology assessment of fibrosis is highly subjective, limiting resource-efficient patient care planning. By increasing accuracy, FibroSIGHT has the potential to increase the clinical yield from MASH liver biopsy evaluations, whenever biopsies are appropriate. With better matching of patients to the right treatment at the right time, healthcare costs and resource utilization can be potentially optimized.
Enhanced Disease &
Treatment Monitoring
FibroSIGHT provides an unparalleled detailed view of the progression and regression of liver fibrosis features, enabling clinicians to monitor disease status over time⁹.
This could support a more effective monitoring of treatment efficacy and response, ensuring timely adjustments to care plans.
Reliable &
Augmented Reporting
Every FibroSIGHT assessment, developed for standardized and dependable results, is performed by a board-certified pathologist and is grounded in the NASH-CRN staging system¹⁰. High-quality FibroSIGHT image readouts included in reports provide clinicians visual acuity on their patient’s fibrosis condition.
Who May Benefit from FibroSIGHT™
Clinicians order FibroSIGHT for MASH patients for whom liver biopsies are required for fibrosis assessment 6,14 :
1) At MASH diagnosis, to help inform treatment decisions
When non-invasive assessments of degree of fibrosis are inconclusive or discordant
2) After treatment, for patients not showing improvement
When non-invasive assessments show lack of improvement – to help understand treatment response
How FibroSIGHT™ Stands Out
Observe FibroSIGHT resolve equivocal fibrosis assessments in MASH patients:
CASE ONE
➤ VCTE indicated a high liver stiffness measurement of 13 kPa
➤ But, ELF score was low at 8.2
➤ Liver biopsy-based fibrosis assessment recommended
CASE TWO
➤ MRE reported borderline degree of liver stiffness of 2.9 kPa
➤ But, ELF score was high at 9.5
➤ Liver biopsy-based fibrosis assessment recommended
*These cases are hypothetical and meant for demonstration only.
FibroSIGHT™ FAQs
FibroSIGHT™ is HistoIndex’s first laboratory-developed test (LDT) designed to provide sensitive and consistent detection of liver fibrosis in patients with Metabolic Dysfunction-Associated Steatohepatitis (MASH) using proprietary stain-free imaging technology that visualizes collagen fibers with high clarity.
By leveraging HistoIndex’s stain-free imaging approach (based on Second Harmonic Generation microscopy), FibroSIGHT™ reduces the variability associated with traditional staining methods and enables more reliable evaluation of fibrosis in liver biopsies, improving agreement between pathologists.
Stain-free imaging eliminates the inconsistency of chemical staining, preserves the native tissue structure, and produces high-resolution images of collagen, a major component in fibrosis, enabling clearer visualization and analysis of fibrotic changes.
Clinicians order FibroSIGHT™ for MASH patients who require liver biopsy evaluation, particularly when non-invasive tests are inconclusive or when precise assessment of fibrosis severity is critical for diagnosis, treatment planning, or monitoring.
FibroSIGHT™ integrates seamlessly with routine histopathology workflows, enabling pathologists to analyze unstained FFPE liver biopsy sections with advanced imaging and produce more consistent fibrosis assessments.
Yes, FibroSIGHT™ provides detailed images and standardized reporting that support clinicians in observing progression or regression of fibrosis features over time, which may help inform adjustments to treatment plans.
Each assessment is performed by a board-certified pathologist and is grounded in established scoring systems (e.g., NASH-CRN) with high-quality image readouts included in the report to aid clinical interpretation.
Yes, the test is available for clinicians in the U.S. and has been launched as a clinical option for improving fibrosis assessment in MASH patients.
Unlike traditional stains like Masson’s trichrome that can suffer from variability, FibroSIGHT™ provides stain-free, high-contrast visualization of fibrillar collagen with improved signal-to-noise ratio, which may yield more accurate fibrosis detection.
References
1. Dulai et al. (2017). Hepatology, 65(5), 1557-1565.
2. Sanyal et al. (2021). N Engl J Med, 385(17), 1559-1569.
3. Davison et al. (2020). J Hepatol, 73(6), 1322-1332.
4. Anstee et al. (2022). J Hepatol, 76(6), 1362-1378.
5. U.S. Food and Drug Administration. (2024, Mar 14). https://www.fda.gov/news-events/press-announcements/fda-approves-first-treatment-patients-liver-scarring-due-fatty-liver-disease
6. Noureddin et al. (2024). Clin Gastroenterol Hepatol, 22(12), 2367-2377. (*consistent with stages F2 to F3 fibrosis, also referred to in the literature as “MASH with significant fibrosis,” “MASH and moderate fibrosis,” or “at-risk MASH.”)
7. Abdurrachim et al. (2024). J Hepatol. https://doi.org/10.1016/j.jhep.2024.11.032
8. Soon et al. (2023). Clin Gastroenterol Hepatol, 21(7), 1940-1942.
9. Naoumov et al. (2022). J Hepatol, 77(5), 1399-1409.
10. Kleiner et al. (2005). Hepatology, 41(6), 1313-1321.
11. Sanyal et al. (2023). Nat Med, 29(2), 392-400.
12. Harrison et al (2023). J Hepatol, 78, S112.
13. Noureddin et al. (2024). [Poster presentation]. The Liver Meeting 2024 (AASLD).
14. EASL; EASD; EASO (2024). J Hepatol. 81(3):492-542.