First Patient Enrolled in a Pivotal Trial of the HepQuant SHUNT Liver Diagnostic Test
Study Aims to Enroll 420 Subjects in 20 U.S. Research Sites
DENVER (Feb. 14, 2019) — HepQuant, LLC, a Greenwood Village, Colo.-based company with a unique, patented and patent-pending technology for evaluating the liver in patients with chronic liver disease, today announced the enrollment of the first patient in its pivotal SHUNT-V study of its Liver Diagnostic Kit. 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 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 SHUNT-V study will enroll 420 subjects at up to 20 U.S. research sites.
In November, HepQuant received an Investigational Device Exemption (IDE) to enable it to move forward with this multi-center study. The results of the study are expected to support a SHUNT Test Pre-Market Approval (PMA) submission to the FDA.
“We are pleased with this benchmark of enrolling the first patient in this pivotal study of our test,” said Dr. Gregory T. Everson, Founder and Chief Executive Officer of HepQuant, LLC. “Our end goal is to optimize the clinical management of patients with chronic liver disease and this milestone marks our continued progress along this pathway.”
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.
Sean Bundy | Director of Regulatory and Quality Affairs | [email protected]
Bradley C. Everson | Chief Business Development Officer | [email protected]