HepQuant Tests & Laboratory Support Services for Pharma
HepQuant is currently working with major pharmaceutical companies and leading academic researchers in clinical trials, to test levels of hepatic impairment, under the Investigational Device Exemption (IDE) mechanism with the FDA. We have invested in infrastructure, regulatory, and operations to offer kit production and laboratory analysis compliant with the FDA IDE regulations and deliver results. If you are interested in working with us, please contact Brad Everson.
Hepatic Testing for Liver Disease Clinical Trials and Research
Our tests measure hepatic blood flow, portal blood flow, and portal-systemic shunt in patients with chronic liver disease. The tests are designed to evaluate the liver — and levels of hepatic impairment — regardless of the etiology of the liver disease. HepQuant provides liver testing support services to liver research centers and pharmaceutical companies.
These services include:
- Consultative Services – Analysis and assessments of research applications of HepQuant tests
- Lab Services – Processing and analysis of serum samples
- Modeling and Reporting Services – Analysis of data and relationship to utility and outcomes
If your organization is interested in learning more about our services and how they might match up with your core competencies, please connect with us via our contact us page.
The HepQuant Laboratory
HepQuant’s Lab Team
HepQuant’s Lab Team includes, from left: Keith Hoffman (Clinical Lab Manager), Koren Newman (Laboratory QA Specialist), Steve Helmke (Chief Scientific Officer), and Dziuleta Cepeniene (Laboratory Operations Manager). HepQuant’s Lab is located at 12635 E. Montview Blvd., Suite 175, Aurora, CO 80045.
A Look Inside the HepQuant SHUNT Test
Note: This video is intended as a scientific exchange of information with clinicians, researchers and HepQuant investors. HepQuant products are investigational combination drug / diagnostic devices and have not yet been evaluated or approved by the US Food and Drug Administration (FDA) for commercial sale. They are currently available for investigational use via the FDA IDE application process.
HepQuant Studies Across Stages of Disease
The HepQuant SHUNT test delivers the following metrics:
- Fasting Cholate concentration
- HepQuant STAT (single 45-60 min point)
- Portal HEPATIC FILTRATION RATE (oral clearance)
- Systemic HEPATIC FILTRATION RATE (systemic clearance)
- SHUNT (ratio of intravenous: oral clearances)
- HepQuant DSI™ (Disease Severity Index)
- HepQuant HR™ (Hepatic Reserve)
The HepQuant STAT™ test delivers:
- HepQuant STAT (single 60-min. time point)
- Estimated Portal HEPATIC FILTRATION RATE (oral clearance)
- Estimated HepQuant DSI™
HepQuant’s Test Kit
The HepQuant Test is administered in the sitting position.
Varices are one manifestation of shunting.
Healthy hepatocytes clear the cholate from blood quickly.