FDA Grants Premarket Approval to HepQuant SHUNT Liver Diagnostic Test for Compensated Cirrhosis
核心洞察
The FDA has granted premarket approval to HepQuant (搜索)'s SHUNT Liver Diagnostic Test for adults with Child-Pugh Class A compensated cirrhosis (搜索), based on rigorous safety and effectiveness standards.
The test generates a Disease Severity Index (DSI) score; a value below 18.3 can identify patients unlikely to have large esophageal varices (搜索), potentially allowing them to forego esophagogastroduodenoscopy.
In the pivotal SHUNT-V study of 195 adults, the test achieved 100% sensitivity and 100% negative predictive value for ruling out large esophageal varices (搜索).
The U.S. Food and Drug Administration has granted premarket approval (PMA) to HepQuant (搜索)'s SHUNT Liver Diagnostic Test, a noninvasive blood-based assay designed to aid in the management of adults with Child-Pugh Class A compensated cirrhosis (搜索). The test generates a Disease Severity Index (DSI) score that can help clinicians identify patients who are unlikely to have large esophageal varices (搜索) and may therefore be able to forgo esophagogastroduodenoscopy (EGD) during routine screening and surveillance.
"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," said Gregory T. Everson, MD, Chief Executive Officer of HepQuant (搜索), in the company's press release. "The FDA PMA approval pathway demands extensive evidence demonstrating that a diagnostic not only performs accurately and consistently but also provides clinically actionable information."
Clinical Performance and the SHUNT-V Study
The FDA's decision was based on data from the prospective, multicenter SHUNT-V Study for Varices (ClinicalTrials.gov NCT03583996), which evaluated the clinical performance of the HepQuant (搜索) SHUNT test in 195 adults with chronic liver disease scheduled for EGD. The study sought to validate a prespecified DSI score cutoff of ≤18.3 for identifying patients unlikely to have large esophageal varices (搜索).
The validation criteria were met with compelling results: the test demonstrated 100% sensitivity (95% CI: 85.18% to 100.00%) and 100% negative predictive value (95% CI: 93.51% to 100.00%) for ruling out large esophageal varices (搜索). Specificity was reported at 31.98% (95% CI: 25.08% to 39.51%), with a positive predictive value of 16.43% (95% CI: 10.71% to 23.62%).
The study population reflected a high-risk liver disease cohort. The mean age was 62 years (range: 23–85), 49% were male, 87% were overweight, 64% were obese, 52% had diabetes, and 48% had metabolic dysfunction-associated steatohepatitis (搜索) (MASH). Other liver disease etiologies in the cohort included hepatitis C (24.6%), alcoholic liver disease (15.9%), cryptogenic cirrhosis (7.7%), autoimmune hepatitis (7.2%), hepatitis B (1.5%), hereditary hemochromatosis (1.0%), and primary biliary cholangitis (1.0%).
How the Test Works
The HepQuant SHUNT Liver Diagnostic Test (搜索) assesses the pathophysiologic processes common to chronic liver disease with Child-Pugh Class A cirrhosis. It measures the clearances of intravenously administered cholate (搜索) and orally administered cholate—liver-specific functions determined by systemic and portal blood inflows to the liver, respectively, as well as hepatocyte function related to cholate uptake. Increasing impairment of these cholate clearances correlates with worsening liver disease severity and elevated risk for adverse clinical outcomes.
Addressing a Significant Disease Burden
Chronic liver disease imposes a substantial clinical and economic burden on global healthcare systems, with over 52,000 deaths attributed to liver disease in the United States each year. The worldwide prevalence of compensated cirrhosis (搜索), across all etiologies, was estimated at 112 million in 2017. Patients often do not seek care until symptoms emerge after the disease has already progressed, highlighting the need for improved diagnostic and management tools.
HepQuant (搜索), a privately held diagnostics company based in Denver, Colorado, has developed a portfolio of noninvasive, blood-based, quantitative tests that assess liver health by measuring critical liver cell processes and blood flow. Sample analysis for the SHUNT test is limited to use in the company's CAP-accredited, CLIA-certified Analytical Testing Laboratory.