Singapore-based HistoIndex has launched FibroSIGHT, its first Laboratory Developed Test (LDT) to assess Metabolic Dysfunction-Associated Steatohepatitis (MASH), in the US.
With the launch of FibroSIGHT, HistoIndex enters the clinical care sector for patients with MASH, a severe form of liver disease.
FibroSIGHT uses HistoIndex’s unique stain-free imaging technology to enhance the detection of fibrillar collagens for evaluating fibrosis severity in liver biopsy samples.
It eliminates the variability associated with traditional staining techniques, providing reliable and precise fibrosis assessments for MASH patients.
HistoIndex CEO Gideon Ho said: “I am excited to see how our core expertise in clinical trial assessments is now transcending into the realm of precise and personalized patient care.
“With FibroSIGHT, we aim to empower clinicians with a more definitive and accurate assessment of liver fibrosis.”
MASH is a progressive condition characterised by steatosis and inflammation, potentially leading to fibrosis, cirrhosis, liver failure, and a higher risk of liver cancer.
The presence of ballooned hepatocytes distinguishes MASH from simple steatosis.
Currently, pathologist assessments of liver biopsies are the gold standard for diagnosing MASH, but there is a growing demand for more accurate tools.
HistoIndex played a key role in developing MASH treatments and is now advancing patient care with FibroSIGHT, which easily integrates into clinical workflows.
Clinicians can order FibroSIGHT for patients needing definitive fibrosis assessments, at diagnosis or post-treatment, especially when non-invasive assessments are inconclusive.
HistoIndex conducts FibroSIGHT testing at its CAP/CLIA-accredited lab in Irvine, California.
Arizona Liver Health chief medical officer Naim Alkhouri said: “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.
“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.”
