MODI’IN, ISRAEL and MANASQUAN, N.J., Jan. 24, 2018 (GLOBE NEWSWIRE) -- Exalenz Bioscience Ltd. (TASE:EXEN), a leader in developing and marketing non-invasive medical devices for diagnosing and monitoring a range of gastrointestinal and liver diseases, today announced that its BreathID platform, which is already commercially used as a standard of care test for Helicobacter pylori (H. pylori), showed positive clinical trial results in detecting clinically significant portal hypertension (CSPH) in non-alcoholic steatohepatitis (NASH) patients with compensated advanced chronic liver disease (cACLD). CSPH has been shown to be the most important independent predictor of several liver related complications in this population. Data from a total of 257 NASH patients who participated in two parallel studies comparing the use of the BreathID 13C-methacetin breath test (MBT) to invasive measurement of portal pressure demonstrate that MBT had high sensitivity and specificity in this patient population (88% and 85% respectively).
CSPH, a severe complication of chronic liver disease and cirrhosis characterized by elevated pressure in the vein carrying blood from the gastrointestinal tract to the liver, is closely associated with an increase in severe liver complications, morbidity and mortality. Current methods for detecting CSPH are invasive, complex and highly operator dependent, expose patients to radiation and require injection of contrast materials.
“Diagnosing CSPH in NASH patients is critical for effective intervention that can prevent further loss of liver function, improve patient outcomes and reduce the cost of care,” said Professor Scott Friedman, Dean for Therapeutic Discovery and Chief of the Division of Liver Diseases at the Icahn School of Medicine, Mount Sinai New York. “Current invasive and complex testing methods are not widely accessible and thus, a noninvasive CSPH test is essential for meeting the needs of the large and growing population of NASH patients. Results from these studies suggest that BreathID could be the first effective, noninvasive test that would allow us to improve the management of late-stage NASH patients who are at risk for portal hypertension.”
The study populations comprised 257 NASH patients with a mean age of 59 years, mean body mass index (BMI) of 34.6 and a CSPH prevalence of 62.3%. A preliminary model to detect CSPH using MBT was developed with an Area Under the Receiver Operator Curve (AUROC) of 0.88. Cutoffs were established to achieve 88% sensitivity and 85% specificity, with 10% indeterminate results.
