Exalenz Bioscience (Modiin, Israel) just announced that its BreathID test system is starting a trial to gauge whether it can be used to diagnose non-alcoholic steatohepatitis (NASH). The disease causes the buildup of fat in the liver, as well as inflammation and fibrosis, often leading to liver failure. Right now the only way to diagnose it is through a liver biopsy, so a simple breath test can be of great benefit for diagnosing NASH.
The study will involve 200 patients and will compare the BreathID urea breath test to biopsies, pathological exams, and blood testing. One of the goals of the clinical trial will be to tune the device to best detect NASH so that BreathID can be used on larger patient populations while providing consistent results. Previously, the BreathID technology has been shown to detect the presence of Helicobacter pylori through exhaled breath, the cause of many peptic ulcers.
“Diagnosing NASH is of paramount clinical importance as it identifies patients at risk of progression and those in need of pharmacotherapy,” said Prof. Vlad Ratziu, MD, Universite Pierre et Marie Curie Hospital and head of Hepatology at Hospital La Pitié-Salpêtrière, Paris, France. “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.”
Flashbacks: BreathID Hp Non-Invasively Test Spots H. Pylori in Exhaled Breath…; Let’s Smell Your H. pylori! BreathID Racks Up New Positive Trial on Road to FDA Approval…; BreathID for Simple Liver Disease Identification Gets FDA’s Trial OK…;
Source: Exalenz Bioscience…