FDA Approves the HepQuant SHUNT® Liver Diagnostic Test
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FDA Approves the HepQuant SHUNT® Liver Diagnostic Test

FDA Approves the HepQuant SHUNT® Liver Diagnostic Test to Quantify Risk of Large Esophageal Varices in Adult Patients with Compensated Cirrhosis (Child Pugh Class A)

DENVER, Colo., June 23, 2026 —HepQuant announced that the U.S. Food and Drug Administration (FDA) has granted the premarket approval (PMA) for the HepQuant SHUNT® Liver Diagnostic Test. The test generates a Disease Severity Index (DSI) score which aids in identifying patients unlikely to require esophagogastroduodenoscopy (EGD) at the time of testing. A DSI score below the clinically validated threshold of 18.3 can be used in patients with compensated cirrhosis (Child Pugh Class A), age 22 years or older, undergoing screening or surveillance for esophageal varices to identify those patients unlikely to have large esophageal varices.

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