FDA approved HepQuant's SHUNT Liver Diagnostic Test on June 18. The PMA, P220016, covers adults 22 and older with compensated cirrhosis (Child Pugh Class A). A Disease Severity Index score below 18.3 identifies patients unlikely to have large esophageal varices, who may then skip a screening endoscopy. FDA received the application on September 14, 2022; the decision came 1,373 days later.
The test is a combination product. Patients receive intravenous 13C-cholate and oral d4-cholate. Serum samples measure how quickly the liver clears each one, which reflects both portal blood flow and hepatocyte uptake. HepQuant runs the assay in its own CLIA-certified, CAP-accredited laboratory in Colorado.
SHUNT-V was a prospective multicenter U.S. study of 195 evaluable patients, mean age 62, 49% male. At the 18.3 threshold, sensitivity and negative predictive value for ruling out large varices were both 100%. FDA's labeling calls it an adjunct to other clinical and laboratory findings, not a stand-alone test. CEO Gregory T. Everson, MD, announced the approval on June 24.
Nearly four years from filing to approval on a 195-patient dataset is what a first-in-kind Class III diagnostic can cost in review time. A startup choosing the PMA route for a novel analyte should budget runway for the review, not just the study.