Background

Nonalcoholic steatohepatitis (NASH) is a major cause of liver cirrhosis that is characterized by hepatic inflammation and fibrosis. Currently, liver biopsies are extensively employed for disease diagnosis. However, given the heterogeneity of the disease pathology and apparent limitations with the invasiveness and variability with liver biopsies, development of non-invasive biomarkers to diagnose and predict disease progression are highly desirable.

Technology Overview

The present invention relates to a diagnostic assay, where plasma or serum SMOC2 (SPARCrelated modular calcium-binding protein 2) levels are used as diagnostic markers of Non-Alcoholic SteatoHepatitis (NASH), more specifically for determining an inflamed liver in NASH patients to enable a selection of patients for which liver biopsies should be performed. Figure 1. Disease Overview

The researchers has provided proof-of-concept in a smaller patient study (comparing obese patients with NASH with obese controls), showing a significant higher level of SMOC2 in plasma from NASH patients than from people without NASH, hereby providing data supporting the invention. Figure 2. POC Study Results

Applications

Significant unmet need – no specific NASH biomarkers on the market
High patient volume
- Diabetes type 2
- Obesity
High volume X moderate price ‑ attractive commercial opportunity

Use of Plasma or Serum SMOC2 as a Diagnostic Marker of Fibrosis and NASH

Patents

Seeking