HepQuant Receives IDE Approval from U.S. FDA to Initiate Clinical Trial of the SHUNT Liver Diagnostic Kit
SAN FRANCISCO (Nov. 9, 2018) – While attending The Liver Meeting® 2018, HepQuant, LLC, a Greenwood Village, Colorado-based company with a unique, patented and patent-pending technology for evaluating the liver in patients with chronic liver disease, today announced that the Food and Drug Administration (FDA) has approved HepQuant’s request to conduct the pivotal SHUNT-V study of its Liver Diagnostic Kit.
This Investigational Device Exemption (IDE) approval enables HepQuant to move forward with a single arm, multi-center study investigating the use of the HepQuant SHUNT test in optimizing the clinical management of patients with chronic liver disease. The results of the study are expected to support a Pre-Market Approval (PMA) submission to the FDA.
“We are eager to begin this pivotal study,” said Dr. Gregory T. Everson, Founder and Chief Executive Officer of HepQuant, LLC. “We have engaged extensively with FDA and have arrived at a trial design that can demonstrate the potential clinical impact of access to information about liver function. This is an important first step in improving liver health assessment.”
Rick Whitcomb, Chief Operating Officer of HepQuant, added, “We are especially encouraged that the FDA approved the IDE without any outstanding study design considerations. In the letter issuing the IDE the FDA stated that the study, if successfully executed, could support market approval. This gives us a great deal of confidence that successful execution of the SHUNT-V study will provide the data we need for a successful PMA submission.”
The HepQuant SHUNT Liver Diagnostic Kit is used for assessment of liver function through the quantitative detection of 13C-cholate and d4-cholate in blood serum, collected after the intravenous administration of 13C-cholate and the oral ingestion of d4-cholate. The HepQuant SHUNT Liver Diagnostic Kit is being studied as an aid in the determination of the likelihood of large esophageal varices in patients with Chronic Liver Disease (CLD). The SHUNT-V study will enroll 420 subjects at up to 20 U.S. research sites.
Headquartered in Greenwood Village, Colorado, HepQuant, LLC, is a privately-held, early-stage combination drug and in-vitro diagnostic company. HepQuant’s products are investigational combination drug and in-vitro diagnostic devices and have not yet been evaluated or reviewed by the US Food and Drug Administration (FDA) for commercial sale. They are currently available for investigational use via the FDA IDE application process. For additional information, visit www.hepquant.com.
Director of Regulatory and Quality Affairs
Bradley C. Everson
Chief Business Development Officer