Israel’s Exalenz Bioscience (TASE: EXEN), a developer and marketer of non-invasive medical devices for diagnosing and monitoring a range of gastrointestinal and liver diseases, announced the initiation of a clinical study evaluating the potential of its BreathID test to diagnose nonalcoholic steatohepatitis (NASH).
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.
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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. Renowned hepatologists, Prof. Vlad Ratziu, MD, Universite Pierre et Marie Curie Hospital and head of Hepatology at Hospital La Pitié-Salpêtrière, Paris, France, and Dr. Stephen Harrison, MD, Chief of Hepatology, Division of Gastroenterology and Hepatology, Brooke Army Hospital, San Antonio Military Medical Center, San Antonio, Texas, USA – are leading the study.
“Nonalcoholic fatty liver disease (NAFLD) 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, ” noted Dr. Harrison.
“Diagnosing NASH is of paramount clinical importance as it identifies patients at risk of progression and those in need of pharmacotherapy, ” said Prof. Ratziu.
“However, it has been extremely challenging using traditional non-invasive methods based on serum biomarkers or liver imaging. The current study aims to assess a new, and innovative diagnostic test to fulfill this major unmet clinical need within a comprehensive grading and staging of the disease.”
Exalenz plans to launch additional clinical studies for the diagnosis and monitoring of additional liver indications in the near future, including hepatocellular carcinoma (HCC), and to participate in studies for acute liver failure (ALF) and therapeutic NASH studies. These goals will be achieved in part through partnering with companies developing therapies for these diseases.