The FDA has granted premarket approval (PMA) to the HepQuant SHUNT liver diagnostic test, a non-invasive tool designed to assess liver function in adults with Child-Pugh Class A compensated cirrhosis. By generating a Disease Severity Index (DSI) score, the test identifies patients who may safely forego invasive esophagogastroduodenoscopy (EGD) during routine clinical surveillance.
How the SHUNT Diagnostic Test Works
The test evaluates liver function by measuring the body’s ability to clear a specific tracer, providing a quantitative DSI score. According to the FDA’s device approval database, the test is indicated for patients aged 22 or older with compensated cirrhosis. A DSI score below the established threshold of 18.3 indicates a low probability of large esophageal varices. This allows clinicians to risk-stratify patients, potentially reducing the need for endoscopic procedures in those with a lower risk profile.
Clinical Validation and Study Data
The approval follows the results of the SHUNT-V Study for Varices, a prospective, multicenter trial. Researchers enrolled 195 adults with chronic liver disease, all of whom were scheduled to undergo EGD. The study population was representative of modern clinical challenges: 87% of participants were overweight, 64% were obese, 52% had diabetes, and 48% presented with metabolic dysfunction-associated steatohepatitis (MASH).
The study met its primary endpoints, demonstrating 100% sensitivity and 100% negative predictive value for the detection of large esophageal varices at the 18.3 DSI threshold. These findings indicate that the test serves as a reliable screening tool to rule out the presence of high-risk varices in this specific patient population.
Clinical Significance for Liver Disease Management
Standard of care for cirrhosis often involves periodic EGD to monitor for esophageal varices, which are dilated veins that can rupture and cause life-threatening bleeding. While EGD is the gold standard for diagnosis, it is invasive, requires sedation, and carries a small risk of complications.
The introduction of the SHUNT test offers a shift toward personalized diagnostic pathways. By using a blood-based measurement to determine the necessity of an endoscopy, providers can focus invasive resources on patients at higher risk for complications. Gregory T. Everson, MD, CEO of HepQuant, noted in a company statement that the PMA approval confirms the test meets the FDA’s rigorous standards for both safety and clinical effectiveness.
Frequently Asked Questions
- Who is the test for? It is intended for adults (22+) with Child-Pugh Class A compensated cirrhosis.
- What does the DSI score represent? The Disease Severity Index (DSI) reflects the patient’s liver function; a score below 18.3 suggests a low likelihood of large esophageal varices.
- Does this test replace EGD entirely? No. It serves as a tool to help clinicians decide which patients are unlikely to have large varices and may potentially avoid the need for an endoscopic procedure.
- Is it invasive? The test is designed as a non-invasive alternative to help guide clinical decision-making regarding the use of invasive endoscopy.