Key takeaways:
- The FDA granted premarket approval to the test for Child-Pugh Class A compensated cirrhosis.
- A prospective trial confirmed validation criteria for both sensitivity and negative predicative value of 100%.
The FDA has granted premarket approval to HepQuant’s liver diagnostic test for the treatment of adults with Child-Pugh Class A compensated cirrhosis, according to a company press release.
The SHUNT Liver Diagnostic Test (HepQuant) generates a Disease Severity Index score, which can help determine which patients can forego esophagogastroduodenoscopy during routine screening and surveillance.
The FDA has granted premarket approval to HepQuant’s liver diagnostic test for the treatment of adults with Child-Pugh Class A compensated cirrhosis.
“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,” Gregory T. Everson, MD, chief executive officer of HepQuant, said in the 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,” Everson continued.
A Disease Severity Index (DSI) score under “the clinically validated threshold of 18.3” can help identify patients with compensated cirrhosis, age 22 years or older, who are unlikely to have large esophageal varices, officials noted in the release.
The FDA based its decision on data from the prospective, multicenter SHUNT-V Study for Varices, which sought to validate the prespecified DSI score cutoff for identifying patients with chronic liver disease in 195 adults (mean age, 62 years; 49% male) scheduled for esophagogastroduodenoscopy. The study population included a high-risk liver disease cohort: 87% overweight, 64% obese, 52% with diabetes and 48% with metabolic dysfunction-associated steatohepatitis.
Validation criteria were met with 100% sensitivity and 100% negative predicative value for large esophageal varices, according to the release.
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