Researchers have created a liquid biopsy test, which uses two circulating proteins, to test for major liver diseases. The test was found to be highly accurate, sensitive, and specific for both non-alcoholic steatohepatitis (NASH) and liver fibrosis. For the first time, a non-invasive test will allow for the determination of the staging of both diseases without recurring invasive liver biopsy.
NASH is the most severe form of non-alcoholic fatty liver disease (NAFLD) and is diagnosed among approximately 60 percent of NAFLD patients. NASH puts people at risk of progressing to advanced liver diseases such as liver fibrosis, cirrhosis, and liver cancer. Currently, NASH can only be diagnosed with invasive liver biopsy, which is the standard diagnosis, but is expensive and has co-morbidities and complications.
There is also no reliable blood (that is, liquid biopsy) tests for the diseases because of low sensitivity and specificity. Current blood tests are also unable to reliably predict NASH and fibrosis staging. Professor Geltrude Mingrone, from King’s College London and Catholic University of Rome in Italy, looked to find a more accurate liquid biopsy test. The paper, published in the leading journal Gut, identified two protein biomarkers, PLIN2 and RAB14, that were used as part of an algorithm to identify people with NASH and/or liver fibrosis.
The ability of these proteins to detect NASH was tested in cohorts of people with either biopsy-confirmed NASH or liver fibrosis. The algorithms, which used artificial intelligence, gave an overall accuracy of 92-93 percent for NASH.
For fibrosis, it was 98-99 percent accurate. In fact, for being much more accurate than all other currently available biomarkers, it can also predict the stages of the diseases without an invasive liver biopsy.
“This blood test will allow us to define the real prevalence of NASH in large and small populations, including children and adolescents, avoiding the need for invasive liver biopsy,” Mingrone said. “Importantly, it will also allow us to monitor the efficacy of NASH treatments over time, reducing screen failures and helping generate better drugs,” Mingrone added. These results show that liquid biopsy can provide rapid and cost-effective testing to combat the growing epidemic of NASH and liver fibrosis.
