Exalenz Bioscience Launches Pivotal Study of World’s First Breath-Based Test to Diagnose Clinically Significant Portal Hypertension
Portal hypertension is the most common complication of cirrhosis of the liver, accounting for significant morbidity and mortality. Hepatic portal vein hypertension is currently diagnosed by measuring HVPG (Hepatic Venous Pressure Gradient), an invasive and expensive test that requires local anesthesia and the use of contrast material that may harm the kidneys, and exposes the patient to radiation. In addition, the test requires a high degree of skill, time and resources that are not available in most medical centers.
In contrast, Exalenz is pitching its BreathID test as a non-invasive, rapid, safe and significantly less expensive alternative test for this large market, estimated by the company to be approximately $100 million and possibly more as the cost and complexities of currently available modalities to detect Clinically Significant Portal Hypertension (CSPH) could be limiting the identification of many patients with this serious condition. Underpinning the study is Exalenz’s flagship BreathID® Hp test, which detects the presence of the H. pylori bacteria, associated with various illnesses including for example gastric cancer.
To prove its effiacy as a diagnostic tool in CSPH, Exalenz is conducting a multinational study in Europe and the U.S. The pivotal study will investigate the potential of its BreathID test as a non-invasive tool to diagnose CSPH. The multinational study will compare the patient-friendly BreathID test to Hepatic Venous Pressure Gradient (HVPG).
The 200-patient first stage of the study will recruit patients with chronic liver disease. Data collected during this stage will be used to build the index algorithm to compare the BreathID test with HVPG. During the second stage of the study, expected to start in 2016, investigators will verify the algorithm.
Following completion of the pivotal study, Exalenz plans to submit data to the U.S. FDA for PMA approval.
Incidentally Exalenz also plans to launch clinical studies for the diagnosis and monitoring of additional liver indications including NASH (non-alcoholic steateohepatitis), HCC (hepatocellular carcinoma) and ALF (acute liver failure). These will be achieved in part through partnering with companies developing therapies for these diseases.
Prof. J. Bosch, Hospital Clinic, University of Barcelona, Spain, a study investigator and world leader in diagnosing and treating portal hypertension, said “I am very impressed with the potential of this unique technology by Exalenz Bioscience that is based on measuring different parameters in the patient’s breath. This technology can definitely be a breakthrough in the non-invasive detection of liver diseases.”
“The start of this pivotal study represents an important milestone in our strategic plan to launch a broad portfolio of liver diagnostics based on our patient-friendly BreathID test,” said Larry Cohen, CEO of Exalenz Bioscience. “We believe that the availability of a less-invasive test will enable clinicians to detect CSPH in a greater number of chronic liver disease patients, while helping reduce healthcare costs.”
Source: Exalenz Biosciences.