GMDx Clinical Trials and Studies

HEALTHY POPULATION & PLATFORM VALIDATION STUDY

A clinical trial was conducted to evaluate the Innate Immune Fitness test platform performance characteristics and its suitability for clinical use. In collaboration with the Hudson Institute of Medical Research, blood and saliva samples from 24 healthy volunteers were collected and sequenced. The proprietary GMDx IIF platform was used for the analysis of all genomic data and provides end-to-end validation of our pipeline.

This trial has been completed. Using the GMDx IIF Platform, we successfully demonstrated that saliva and blood both provide quality sources of DNA for whole exome sequencing, with no difference in ability to resolve variants and deaminase-associated metrics.

A preprint of this trial is posted on bioRxiv: www.biorxiv.org/content/10.1101/807073v1

HBV CLINICAL STUDY

Over 350 million people are infected with the hepatitis B virus (HBV) worldwide, with more than 150,000 chronically infected in Australia. The outcomes of HBV infection are age-dependent and include asymptomatic infection, acute hepatitis B, chronic HBV infection, cirrhosis and hepatocellular carcinoma (HCC). Nucleos(t)ide analogue (NA) therapy is effective at maintaining viral control, but duration of treatment is uncertain in hepatitis B e antigen (HBeAg) negative disease.

GMDx partnered with local and international collaborators in prospective and retrospective translational studies. Blood and saliva samples have undergone genomic sequencing to establish determinants of sustained remission following discontinuation of NA therapy in two cohorts of chronic hepatitis B patients. IIF profiles were generated at multiple time points after cessation of NA treatment. IIF analysis was conducted using our proprietary platform to determine metrics that differ between patients that recover compared to patients that relapse. These translational studies have the potential to impact clinical practice by personalising HBV NA treatment regimes.