DiscernDx has reported that preliminary study results from its non-invasive liquid biopsy test for diagnosing early stages of nonalcoholic steatohepatitis (NASH) showed the multi-omics and machine learning combination for NASH diagnosis as an alternative to liver biopsy.
Blood samples were collected from 29 centres across the US and Canada forming a cohort of 517 patients suspected of having NASH F2-F4 fibrosis grades.
The liquid biopsy test’s preliminary performance characterised by the area under the receiver operating characteristic (AUROC) in the development set of 90 samples showed exceptional performance in reproducing liver biopsy results, with an AUROC of 0.92.
DiscernDx noted that the liquid biopsy test could be an accurate and non-invasive substitute for liver biopsy for patients suspected of having NASH in the US.
It could lower the requirement for liver biopsy and costly imaging and could aid in earlier disease diagnosis and clinical trials for NASH treatments.
DiscernDx CEO Chris Hall said: “We’re excited to present this data for the first time, as there is a huge unmet medical need for a highly accurate, non-invasive test for early detection of liver fibrosis.
“Our non-invasive, potentially first-to-market liquid biopsy test is able to diagnose NASH with significant fibrosis with high accuracy, which is critical to avoid unnecessary liver biopsy for patients.”
A progressive and prevalent liver disease, nonalcoholic fatty liver disease (NAFLD) affects around a quarter of adults in the US.
Approximately 20% of NAFLD patients advance to NASH, which can progress into liver cirrhosis. By 2030, it is estimated to be the most frequent cause of liver transplants.
Major predictors of outcomes in NAFLD are liver fibrosis development and progression.