Non-invasive biomarkers in NASH are beginning to show where and how they can upstage liver biopsies, with the first impact appearing in patient recruitment. The biggest value will come when they can serve as regulatory endpoints, allowing for shorter trials that cost less and spare patients unwelcome procedures.
Liver biopsies have been a mainstay in non-alcoholic steatohepatitis (NASH), where they are used for histological assessment of changes from baseline in fat accumulation, inflammation and fibrosis.
For most stages of NASH, FDA guidance calls for histological demonstration of either a reduction in NASH without worsening of fibrosis, or a reduction in fibrosis without worsening of NASH.
The problem is not only that biopsies are invasive and carry risk for patients, but that the samples only comprise about 1/50,000th of the liver, which means they may not be representative of the whole organ. Different pathologists can score biopsies differently, adding to the variability.
The need is for non-invasive alternatives, such as blood- or imaging-based biomarkers, that are safer and