Transforming MASH Diagnostics with Next-generation
Clinical Testing Solutions
Metabolic Dysfunction-Associated Steatohepatitis (MASH) is a liver condition involving fat build up and inflammation which left unchecked, leads to liver damage in the form of increasing levels of scarring or fibrosis, ultimately progressing to cirrhosis. The main risk factor for MASH is fibrosis: with each stage of fibrosis corresponding to a doubling of liver-related mortality1,2 but still, its evaluation is challenging due to limits of current methods3,4. After decades of research and therapeutic development, the field reached a true inflection point in 2024 with the approval of the first-ever drug for the treatment of MASH with moderate to advanced fibrosis5,6*. And now, accurate fibrosis assessment becomes even more crucial to determine the best treatment option for patients in routine clinical practice.
Innovative Technology
HistoIndex’s advanced proprietary stain-free imaging and digital pathology platform leverages on Second Harmonic Generation (SHG) and Two-Photon Excitation Fluorescence (TPEF). SHG imaging detects fibrillar collagen in biological tissues with consistency, high-resolution and excellent signal-to-noise ratio, while TPEF allows visualization of pertinent cell structures – all without the use of any exogenous dyes. This overcomes the limitations and variability of traditional staining methods.
The high-quality, label-free images generated through SHG/TPEF imaging form the foundation for multiple quantitative assessments, including HistoIndex’s proprietary qFibrosis® technology. qFibrosis is an automated, AI-powered tool that utilizes these detailed images to provide objective, continuous-scale measurements of fibrosis severity in liver biopsies, particularly in patients with Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD) and Steatohepatitis (MASH).
HistoIndex’s imaging technology has been at the forefront of fibrotic liver disease research for years. Precise quantitative measurements of fibrosis changes for drug efficacy determination in MASH clinical trials are made possible by the underlying consistency and quality of SHG stain-free imaging. With over a decade of expertise, we have scanned and analyzed more than 10,000 patient biopsy samples from MASH clinical trials in collaboration with leading pharma and biotech partners, often revealing insights of drug action not detectable by standard assessments7,8,9,10.
Refer to our publications page here.
Laboratory Developed Tests
FibroSIGHT™ is the first of HistoIndex’s suite of next-generation digital pathology solutions. FibroSIGHT is designed to aid pathologists by enhancing the assessment of liver fibrosis in MASH patients.
FibroSIGHT™ Plus introduces a key advancement of AI-based quantitative assessment of liver fibrosis, providing clinicians with a sensitive and consistent tool with which to better characterize individual patients.
How to Get Started
- Testing is performed by our partner CLIA /CAP accredited lab: FibroSIGHT™ | FibroSIGHT™ Plus
- Available in the United States except specimens from New York state
- FibroSIGHT is validated on MASH liver biopsies only
- Full pathology services available – Contact Us
- Product & Services Disclosure
FAQs
If a pathologist’s expert assessment of fibrosis is required, choose FibroSIGHT. If you prefer an automated, quantitative assessment of fibrosis, select FibroSIGHT Plus.
MASH liver biopsy FFPE sections are required for testing.
As sample quality can vary, we recommend sending 3-5 unstained FFPE slides for either FibroSIGHT or FibroSIGHT Plus.
A report will be sent to you within 7 working days from sample receipt in the laboratory.
Yes, and we will work with our courier services to take care of the sample shipment. However, testing is currently unavailable for samples originating in New York state.
Both FibroSIGHT and FibroSIGHT Plus testing are performed in our CAP/CLIA accredited lab in Irvine, California.
A board certified pathologist will issue the FibroSIGHT report. A certified clinical lab scientist will issue the FibroSIGHT Plus report.
We cover the costs of shipping of the liver biopsy specimens within the US.
We will coordinate with the patient’s insurance provider to provide coverage for either FibroSIGHT or FibroSIGHT Plus testing. However, the patient may be responsible for out-of-pocket expenses including co-payments and deductibles depending on the health plan. We also provide cash pay for FibroSIGHT and FibroSIGHT Plus testing.
Yes. We provide full liver pathology services so we can provide more comprehensive care to patients. Contact us for more information.
No, FibroSIGHT and FibroSIGHT Plus testing can be done independently of H&E and MT staining. But if you would like full liver pathology service that includes FibroSIGHT and/or FibroSIGHT Plus to be performed for your patient, you can order our full pathology service.
FibroSIGHT and FibroSIGHT Plus are currently only validated on MASH liver biopsy sections. They have not been validated in other sample types.
Find out how our clinical testing solutions can be integrated in your workflow
Contact Us
Read Website Terms of Use Here
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. Naoumov et al. (2022). J Hepatol, 77(5), 1399-1409.
8. Sanyal et al. (2023). Nat Med, 29(2), 392-400.
9. Harrison et al (2023). J Hepatol, 78, S112.
10. Noureddin et al. (2024). [Poster presentation]. The Liver Meeting 2024 (AASLD).