FDA Approves HepQuant's SHUNT Liver Test to Flag Low Risk of Large Varices in Cirrhosis

The US Food and Drug Administration has granted premarket approval to HepQuant's SHUNT Liver Diagnostic Test, which the Aurora, Colorado, company says can help identify adults with compensated cirrhosis who can forgo an upper endoscopy during routine screening for esophageal varices, Healio reported on June 23, citing the company's release.

The FDA's premarket approval database lists the test under PMA P220016, received on September 14, 2022, with a decision date of June 18, 2026, and a notice date of June 23. The record lists the test as a combination product, under product code SIO and the clinical chemistry advisory committee.

How the test works

According to the approval order statement, the test measures two labeled compounds, 13C-cholate and d4-cholate, in serum from blood samples taken after the first is given intravenously and the second by mouth. It generates a Disease Severity Index (DSI) score from how quickly they are cleared. The FDA's summary of safety and effectiveness data says the compounds are non-radioactive and that blood is drawn at baseline and five time points over 90 minutes. Samples are processed at the collection site and shipped to the HepQuant Analytical Test Laboratory for analysis.

A DSI score below the validated threshold can be used in adults aged 22 or older with compensated (Child Pugh Class A) cirrhosis who are undergoing screening or surveillance for esophageal varices, to identify those unlikely to have large varices. The FDA record says the score "aids in identifying patients unlikely to require esophagogastroduodenoscopy (EGD) at the time of testing" and that the test is not a stand-alone test and should be used with other clinical and laboratory findings.

The SHUNT-V study

The approval rests on the prospective, multicenter SHUNT-V study, which enrolled 306 subjects at 23 sites between February 2019 and December 2020, according to the FDA summary. The final validation set included 195 adults with Child Pugh Class A cirrhosis, of whom 23 (11.8%) had large esophageal varices.

Using the prespecified DSI cutoff of 18.3, the test identified all 23 patients with large varices, for a sensitivity of 100.0%, and the negative predictive value was 100.0% (95% confidence interval 93.5% to 100.0%). Specificity was 32.0%: 55 of the 172 patients without large varices scored below the cutoff. The summary puts the positive predictive value at 16.4% and says providers should follow the standard of care for patients with a DSI above 18.3.

"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," chief executive Gregory T. Everson said in the company's release, as quoted by Healio. The company's release was distributed by Business Wire and reposted by the University of Colorado Anschutz innovations office.