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DiscernDx Liquid Biopsy Test Proves as an Alternative to Liver Biopsy for Diagnosing Nonalcoholic Steatohepatitis (NASH)

Nonalcoholic steatohepatitis (NASH) can progress to serious liver complications including cirrhosis and cancer. Diagnosing the severity of NASH has traditionally relied on invasive liver biopsies.

DiscernDx, a precision multi-omics diagnostics company, 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 nonalcoholic steatohepatitis (NASH) diagnosis as an alternative to liver biopsy.

The work will be presented at the 2021 Nonalcoholic Steatohepatitis – Therapeutic Agents (NASH-TAG) Conference, held virtually and in-person, March 11-13.

Excellent Performance

Blood samples were collected from 29 centres across the US and Canada forming a cohort of 517 patients suspected of having nonalcoholic steatohepatitis (NASH) F2-F4 fibrosis grades. Histopathological data were used to determine presence or absence of nonalcoholic steatohepatitis (NASH).

DiscernDx said epigenetic, proteomic, lipidomic and metallomic data were generated for the 362 patient samples passing inclusion and exclusion criteria.

In the development set of 90 samples, the performance of the liquid biopsy test characterised by the area under the receiver operating characteristic (AUROC) showed “excellent performance” in reproducing liver biopsy results, with an AUROC of 0.92, DiscernDx said.

According to CEO Chris Hall, the company develops its tests with the help of cloud-based computing and machine-learning techniques.

Specifically, DiscernDx uses “prospectively gathered samples with truth labels and applies its artificial intelligence engine to build signatures to predict disease from tens of thousands of data points gleaned from its multi-omics platform,” he added.

DiscernDx noted that the liquid biopsy test could be an accurate and non-invasive substitute for liver biopsy for patients suspected of having nonalcoholic steatohepatitis (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 nonalcoholic steatohepatitis (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 nonalcoholic steatohepatitis (NASH) with significant fibrosis with high accuracy, which is critical to avoid unnecessary liver biopsy for patients.”

Nonalcoholic Fatty Liver Disease (NAFLD)

Nonalcoholic fatty liver disease (NAFLD) is a progressive and prevalent liver disease affecting approximately a quarter of the adult population in the United States.

Approximately 20% of Nonalcoholic fatty liver disease (NAFLD) patients advance to nonalcoholic steatohepatitis (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 Nonalcoholic fatty liver disease (NAFLD) are liver fibrosis development and progression. The current gold standard for diagnosing nonalcoholic steatohepatitis (NASH) is liver biopsy, an invasive approach that is expensive and includes risk of complications.

About DiscernDx

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.

DiscernDx’s 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.

DiscernDx’s 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.

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