Resonance Health specialises in the delivery of imaging core laboratory services and the development of MRI related, quantitative diagnostic technology for the liver.
Resonance Health provides comprehensive clinical trial services for pharmaceutical companies using imaging end points in their Phase II, III and IV clinical trials. A fully compliant web based infrastructure enables image data and results to be securely transferred from anywhere in the world to and from our core lab in Australia. Our facility is ISO 13485 certified and our services broadly include project management, reporting and data management services.
Resonance Health provides objective, reproducible and quantified measurements of liver iron, liver fat and cardiac T2* in a central Service Centre in accordance with our unique Quality Assured Service Delivery model. We are also developing an MRI-based test for the measurement of liver fibrosis.
Resonance Health’s expertise in the provision of imaging core lab services for pharmaceutical clinical trials has been utilised in over 15 multicenter studies spanning 25 countries over 10 years.
Imaging biomarkers are increasingly used in clinical studies providing a safe non-invasive alternative to invasive procedures such as a liver biopsy. Imaging provides a better solution where repeat measurements are required over the life of the study.
Resonance Health has been involved in clinical studies where imaging has been used to assist in:
- The assessment of subject inclusion or exclusion
- Supporting primary and secondary end-points demonstrating drug efficacy
- Evaluating the safety profile of a new therapy
Resonance Health offers the following trial related services:
- Imaging trial design consultancy
- Development of an Imaging charter and other study specific documentation
- Project management and support
- Site selection, training and management to ensure standardisation of imaging
- Secure 21 CFR Part 11 compliant web-based infrastructure for image transfer and reporting
- ISO 13485 certified centralised quantitative image analysis and reporting – in accordance with agreed SOPs
- Clinical trial data management, cleaning and blinded or un-blinded reporting
- Electronic imaging tracking and management
- Full audit trail and documentation as required by the FDA
- Scanner verification using phantoms (in accordance with the FDA Draft Guidance Standards for Clinical Imaging Endpoints, Aug 2011)
Resonance Health is developing innovative imaging biomarkers specifically focused on liver disease. This enables us to deliver comprehensive services and innovative solutions for medical image analysis. Our proprietary solutions are currently focused on liver iron measurement and liver fat measurement.
Target Market: Iron Overload Disorders
Regulator Status: FDA (510K) cleared. Additional FDA clearance as a Companion Diagnostic Device. CE Mark and TGA approved.
IP: Patent protected
FerriScan is recognised in peer reviewed publications as the gold standard method for assessing liver iron concentration. FerriScan is used in pharmaceutical clinical trials as a primary end point to assess the efficacy of drugs under development. FerriScan is also used by the international clinical community in the management of patients with transfusional iron overload and haemochromatosis.
Target Market: Fatty Liver Disease
Regulator Status: FDA (510k) cleared. CE Mark and TGA approved
IP: Patent submitted
An estimated 20%-30% of the US population has fatty liver disease and NAFLD is the most common cause of liver disease in western countries. Fatty Liver disease can lead to liver fibrosis/cirrhosis, liver failure, and hepatocellular carcinoma. Fatty liver disease is also closely associated with diabetes and cardiovascular disease. HepaFat-Scan has been clinically validated against liver biopsy and provides a quantitative measure with high sensitivity and specificity reporting a % fat by volume.
Combined with our core lab services, HepaFat-Scan® is an ideal tool for clinical trials of new treatments for non-alcoholic fatty liver disease (NAFLD) or other indications requiring the quantitative assessment of liver fat.
Liver Fibrosis Measurement (R&D)
Target Market: Liver Fibrosis
Stage: Research and Development
Resonance Health is currently developing an MRI-based test to accurately assess liver fibrosis. If successful, the test could be used to replace the need for a liver biopsy to assess fibrosis.