FDA-Approved Test Identifies Low Risk of Large Esophageal Varices in Cirrhosis

However, endoscopy is invasive and resource-intensive, creating a need for better triage tools. A newly approved test now quantifies the risk of large esophageal varices and helps identify patients unlikely to need esophagogastroduodenoscopy at the time of testing.

HepQuant (Denver, CO, USA) has announced that the HepQuant SHUNT Liver Diagnostic Test has received premarket approval from the U.S. Food and Drug Administration (FDA). The assay generates a Disease Severity Index (DSI) score to aid in identifying patients unlikely to require esophagogastroduodenoscopy at the time of testing. A DSI below the clinically validated threshold of 18.3 can be used in adults 22 years or older with compensated cirrhosis (Child-Pugh Class A) undergoing screening or surveillance to identify those unlikely to have large esophageal varices.

The test assesses pathophysiologic processes common to chronic liver disease. It measures the clearances of intravenously administered cholate and orally administered cholate, which reflect liver-specific functions determined by systemic and portal blood inflows and by hepatocyte cholate uptake. Increasing impairment of these cholate clearances correlates with increasing liver-disease severity and risk for adverse clinical outcomes, and is incorporated into the DSI.

Clinical performance was evaluated in the SHUNT-V Study for Varices, a prospective, U.S., multicenter, single-arm diagnostic study in adults with chronic liver disease who were scheduled for esophagogastroduodenoscopy. The study validated the prespecified DSI cutoff of 18.3 for “rule out” of large esophageal varices, meeting validation criteria for negative likelihood ratio and sensitivity. 

Using the DSI 18.3 threshold, sensitivity was 100.00% (95% CI, 85.18%–100.00%), negative predictive value was 100.00% (95% CI, 93.51%–100.00%), specificity was 31.98% (95% CI, 25.08%–39.51%), and positive predictive value was 16.43% (95% CI, 10.71%–23.62%). The validation dataset included 195 evaluable subjects (age 23–85 years; mean age 62 years). Nearly half were male, more than half had diabetes, and 48% had metabolic dysfunction–associated steatohepatitis.  

“HepQuant is proud to reach this milestone for our company to enhance clinical management for the patients and clinicians we serve,” said Gregory T. Everson, M.D., Chief Executive Officer of HepQuant, “This approval validates years of scientific innovation, clinical research, and collaboration with leading medical centers, culminating in a technology that has met the FDA's most rigorous safety and effectiveness standard for medical devices. The FDA PMA approval pathway demands extensive evidence demonstrating that a diagnostic not only performs accurately and consistently but also provides clinically actionable information."

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