DiscernDx, a precision multi-omics diagnostics company, announced preliminary study results evaluating their non-invasive liquid biopsy test for diagnosing early stages of nonalcoholic steatohepatitis (NASH). The results illustrated the novel combination of multi-omics and machine learning for NASH diagnosis as an alternative to liver biopsy. The work will be presented at the 2021 NASH-TAG Conference, held virtually and in-person, March 11-13.
Nonalcoholic fatty liver disease (NAFLD) is a progressive and prevalent liver disease affecting approximately a quarter of the adult population in the United States. 20% of NAFLD patients progress to NASH, which can progress into liver cirrhosis and is expected to be the most frequent cause of liver transplants by 2030. Liver fibrosis development and progression are key predictors of outcomes in NAFLD. The current gold standard for diagnosing NASH is liver biopsy, an invasive approach that is expensive and includes risk of complications.
“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,” said Chris Hall, CEO, DiscernDx. “Our noninvasive, 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. We look forward to advancing the development of our test for NASH.”
Blood samples were prospectively collected from 29 centers across the United States and Canada which resulted in a cohort of 517 patients suspected of having NASH F2-F4 fibrosis grades. Histopathological results were used to determine presence or absence of NASH. Epigenetic, proteomic, lipidomic, and metallomic data were generated for 362 samples passing inclusion and exclusion criteria.
Preliminary performance of the liquid biopsy test characterized by the area under the receiver operating characteristic (AUROC) in the development set of 90 samples demonstrated excellent performance in reproducing liver biopsy results, with an AUROC of 0.92 (95% CI [0.86, 0.97]).
DiscernDx’s liquid biopsy test could provide an accurate and noninvasive alternative to liver biopsy for patients suspected of having NASH in the United States. This non-invasive test could dramatically reduce the need for liver biopsy and expensive imaging as well as facilitate earlier disease diagnosis and clinical trials for NASH therapeutics.
DiscernDx is a precision multi-omics diagnostic company pioneering the development of accurate and actionable liquid biopsy tests to transform the diagnosis of chronic diseases. Our AI-driven platform powers predictive multi-disease discovery by integrating unbiased multi-omics assays to detect chronic diseases with one simple, blood-based test. The DiscernDx Navigator Liquid Biopsy Test is a single test that diagnoses major chronic diseases, to democratize precision medicine for all. The company has achieved preliminary results in cardio-metabolic diseases, including NASH. Our mission is to use the power of multi-omic information to diagnose chronic diseases earlier to impact care. DiscernDx is headquartered in Palo Alto, California. For more information visit www.discerndx.com.