Singapore-based medical technology manufacturer HistoIndex has introduced FibroSIGHT Plus, its second laboratory-developed test (LDT) for Metabolic Dysfunction-associated Steatohepatitis (MASH), in the US.
The new tool is designed to support the precise diagnosis and monitoring of MASH patients, enhancing fibrosis assessment.
It builds on FibroSIGHT, launched a few months ago, incorporating automated quantitative analysis, offering consistent fibrosis characterisation and tracking.
FibroSIGHT Plus features qFibrosis, an AI algorithm using second harmonic generation imaging.
It quantifies fibrosis-related collagen features in MASH liver biopsies, providing a continuous scale of fibrosis severity.
The approach offers clinicians detailed insights into disease progression and helps in monitoring subtle changes over time.
HistoIndex chief development officer Yukti Choudhury said: “We’re thrilled to deliver another advancement in MASH diagnostics, bridging our experience and capabilities in clinical trials all the way to clinical use.”
Houston Methodist Hospital professor of medicine and transplant hepatologist, and Summit and Pinnacle Clinical Research co-chairman Mazen Noureddin said: “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.”
FibroSIGHT Plus offers a standardised and objective fibrosis measurement across biopsy specimens, eliminating subjectivity and inter-reader variability.
It provides granular measurements, enhancing confidence in fibrosis assessments and supporting personalised, data-driven treatment decisions for MASH patients.
MASH, a progressive form of metabolic dysfunction-associated steatotic liver disease, may lead to fibrosis, cirrhosis, and liver cancer.
Summit Clinical Research chief academic officer Naim Alkhouri said: “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.”
