Exalenz Biosciences said today it inked a collaborative deal with the Acute Liver Failure Study Group to support a study of the BreathID methacetin breath test’s ability to predict outcomes in patients with acute liver failure.
The trial is slated to enroll 200 ALF patients over 2 years across 12 sites in the U.S. to test the newly FDA investigative device exemption-approved BreathID, Israel-based Exalenz said.
“We are looking forward to assessing the technological abilities of BreathID and how it can improve physician decision making when treating ALF patients. Over the years, the ALF Study Group has been able to better understand ALF disease progression and to improve patient survival dramatically. We believe that the breath test information can potentially supply an additional tool to diagnose these critically ill patients, and the BreathID prove technologically beneficial in disease progression prediction,”ALFSG founder & study lead Dr. William Lee said in a press release.
ALF patients are typically monitored in ICUs with clinical and laboratory tests which Exalenz said are often insufficient to determine whether a liver transplant is required or if recovery can be expected.
In the study, which is supported by the National Institute of Health’s National Institute of Diabetes and Digestive and Kidney Diseases, patients will receive 5 breath tests during their 1st week of hospitalization. An earlier study in 2013 reported that BreathID breath test results provided important information to assist in predicting rapid deterioration and the need for liver transplant.
“We are pleased to announce this collaboration with the leading group of ALF researchers. This study is another important step in evaluating the advantages of BreathID as a non-invasive and accurate diagnostic and monitoring tool with lifesaving potential, in the broad field of liver disease,” Exalenz BioScience CEO Raffi Werner said in prepared remarks.
Exalenz said the study is part of a growing series of investigational diagnostic aplication studies using the BreathID to diagnose serious liver conditions.