Exalenz Bioscience announced the initiation of a clinical study evaluating the potential of its BreathID test to diagnose nonalcoholic steatohepatitis. NASH is a progressive liver disease characterized by an accumulation of fat in the liver, inflammation and fibrosis, which can lead to cirrhosis, hepatocellular cancer and liver failure. Currently, a definitive diagnosis of NASH can only be achieved through liver biopsy, which is invasive and introduces potential for sampling errors as well as other interpretation limitations.

The 200-patient multicenter prospective study will investigate the clinical utility of BreathID to diagnose NASH compared to liver biopsy, standard pathological examinations and blood testing. Nonalcoholic fatty liver disease is a significant cause of chronic liver disease affecting both children and adults and its incidence continues to rapidly expand in the Western world. Cases of NASH, the most serious form of NAFLD, also are increasing.

A major challenge for healthcare system is the lack of accurate, non-invasive tools for diagnosing and monitoring the progression of the disease and the effect of therapies on NASH. The BreathID platform shows promise as a convenient, non-invasive diagnostic technology to assist clinicians in managing patients efficiently and rapidly. The BreathID ideally could determine which patients need to undergo further investigation (e.g. biopsy) and help decide which patients should be treated when therapies become available.

The results of this study will be used to optimize the company's proprietary algorithm for diagnosing and monitoring the progression of NASH and the effect of treatment on the disease. It is expected that the optimized algorithm will then be applied to data collected in larger studies in collaboration with pharmaceutical companies investigating treatments for NASH. Exalenz plans to launch additional clinical studies for the diagnosis and monitoring of additional liver indications in the near future, including hepatocellular carcinoma, and to participate in studies for acute liver failure and therapeutic NASH studies.

These goals will be achieved in part through partnering with companies developing therapies for these diseases.