HistoIndex, a global leader in stain-free digital pathology solutions for managing fibrotic diseases, has announced the launch of its first laboratory developed test (LDT) FibroSIGHT.
This marks a significant milestone for the company as it enters clinical care for patients with Metabolic Dysfunction-Associated Steatohepatitis (MASH). "I am excited to see how our core expertise in clinical trial assessments is now transcending into the realm of precise and personalised patient care," said Dr Gideon Ho, Chief Executive Officer of HistoIndex." With FibroSIGHT, we aim to empower clinicians with a more definitive and accurate assessment of liver fibrosis."
MASH has long been a challenging and progressive liver disease, characterised by fat build-up and inflammation that, if left untreated, leads to fibrosis and, ultimately, cirrhosis. After decades of research and therapeutic development, the field reached a pivotal moment in 2024 with the approval of Rezdiffra - the first drug for the treatment of MASH with moderate to advanced fibrosis. As treatment options expand, accurate fibrosis assessment becomes even more critical in guiding clinical decisions and optimising patient outcomes. HistoIndex has been playing a key role in the development of MASH treatments and is now leading the way in this next phase of patient care with FibroSIGHT., with the test now available in the US.
FibroSIGHT integrates into routine clinical workflows, leveraging HistoIndex's proprietary stain-free imaging technology to enhance the sensitivity of fibrillar collagens detection — key in evaluating fibrosis severity in liver biopsy samples. The illustration above compares FibroSIGHT’s Second Harmonic Generation Versus Masson’s Trichrome Staining, demonstrating FibroSIGHT’s detection of fine collagen fibres with exceptional clarity and an excellent signal-to-noise ratio. By eliminating variability associated with traditional staining techniques, FibroSIGHT delivers reliable and precise fibrosis assessment for MASH patients.
"By providing more accurate and objective evaluation of fibrosis, FibroSIGHT will enable more personalised treatment strategies and better evaluations of effectiveness of treatment leading to overall better care for patients," commented Dr Naim Alkhouri, MD, Chief Medical Officer of Arizona Liver Health. "Where biopsy evaluation is needed for a MASH patient, I can see incorporating FibroSIGHT in the workup, and in doing so, benefiting the entire MASH clinical care community."