the SomaSignalTM NASH tests:
4 key indicators, 1 liquid biopsy
Protein scanning is the only technology capable of predicting all 4 NASH components simultaneously and non-invasively
- Measures steatosis, inflammation, fibrosis, and ballooning
- Corresponds with staging as measured by liver biopsy
- Reveals drug-mediated improvements in disease severity
- Provides insight into treatment mechanism of action
Non-invasive testing enables frequent sampling
- Does not require specialized physicians/pathologists
- Simple blood draw is ideal for longitudinal studies
- Removes the subjectivity of pathologist scoring
Non-alcoholic fatty liver disease (NAFLD) is characterized by accumulation of fat in the liver and impacts as much as 1/3 of the US population. 30% of patients with NAFLD develop Nonalcoholic steatohepatitis (NASH), which can include fibrosis and signals risk for the development of cirrhosis and liver cancer. Diagnosing the severity of NAFLD and NASH has traditionally relied on invasive liver biopsies and histological examination by a highly trained hepatologist.
It was recently demonstrated that NASH and NAFLD can be characterized non-invasively using proteomics. By measuring ~5000 proteins in each of ~700 patients and comparing the results with liver biopsies, researchers developed machine learning models that can simultaneously detect all the key elements of a liver biopsy—steatosis, hepatocyte ballooning, lobular inflammation, and fibrosis—non-invasively, using just serum proteins. These models were subsequently used to characterize mechanisms of action for three different drugs in clinical trials.
A non-invasive, proteomics-based test for steatosis, ballooning, inflammation, and fibrosis is now available for research use only via the SomaSignal NASH tests. The SomaSignal NASH tests use a binary scoring system to characterize samples as positive or negative for the four different indicators independent of diabetes status or presence/absence of therapeutic intervention. The SomaSignal NASH tests are available on their own or in conjunction with the full menu of 5,000 protein measurements derived from the SomaScan Assay.
Additional somasignal tests
The SomaSignal NASH tests make up a subset of 18 SomaSignal tests available for research use. Any or all of the SomaSignal tests are available for a single flat cost.
The statements herein have not been evaluated by the Food and Drug Administration