Known as a “silent” liver disease, non-alcoholic steatohepatitis (NASH) is a classic example of an asymptomatic yet chronic disease that is significantly under-diagnosed. The disease does not manifest itself until it reaches advanced stages of inflammation and fibrosis; at times, even patients with cirrhosis remain undetected until it is too late for medical intervention. Further compounding this delay in diagnosis is the lack of simple tests that could identify at-risk patients in a timely manner.

The gold standard of NASH diagnosis is liver biopsy, which is a highly invasive procedure with a risk of severe complications for patients. GlobalData believes that a stand-alone, serum-based diagnostic test is an urgent unmet need in the NASH disease market, the development of which could enable earlier detection, increase diagnosis rates, and improve treatment outcomes.

Non-invasive diagnostic tests ideal, experts say

According to key opinion leaders (KOLs) interviewed by GlobalData, given the significant prevalence of NASH and the chronic nature of the disease, the ideal diagnostic test should be non-invasive, cost-effective, and easy to use, like a glucose test. None of the products currently available in the market fulfil all of these criteria. One of the most commonly used devices is the FibroScan, which is an effective mode for detecting fibrosis in advanced stages of NASH, and provides a definitive diagnosis in such patients.

However, it is not a reliable means of diagnosing patients with mild or moderate NASH, and it also has limitations in patients with obesity, which is a major comorbidity associated with NASH. Therefore, a liver biopsy is still the most definitive test for such patients.

Increased awareness of NASH in recent times has led to the development of a few other non-invasive tests across the US and EU. Among these, a novel and comparatively low-cost blood test developed by the Spanish biotech company, One Way Liver (OWL), appears promising as an alternative to biopsy for identifying patients at a high risk of developing NASH.

Unmet need in the disease space

Clinical trials for two pipeline drugs for NASH, Immuron’s IMM-124E and Galmed’s Aramchol, are being run in collaboration with OWL’s non-invasive diagnostic test, called OWLiver. A limitation of this method, however, is that the biomarkers are obesity-dependent, thus excluding the rest of the NASH population.

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It has been recognized that the proper diagnosis of NASH is also limited by the need for physician education, another unmet need in the disease space. According to GlobalData’s primary research, gastroenterologists and primary care physicians probably identify less than half of all patients living with the disease.

Therefore, raising disease awareness can also lead to improved diagnosis of NASH. However, GlobalData believes that the educational initiative needs to go hand-in-hand with the discovery of reliable serum-based biomarkers in order to significantly improve disease diagnosis.