Salomon Group - Impact - Centre for Clinical Research

Quality management system

Associate Professor Salomon contributed to establishing a Quality Management System (QMS) within the Centre for Clinical Diagnostics (CCD), University of Queensland (UQ). He had a leadership role in implementing an ISO17025 QMS and securing NATA accreditation. Within the Centre, I established the formed Exosome Biology Laboratory, and now the Translational Extracellular Vesicles in Obstetrics and Gynae-Oncology Group to evaluate the clinical utility of extracellular vesicles as liquid biopsies, IVDs, and therapeutics. Much of his effort in this field has involved optimising isolation methods for extracellular vesicles and their analytical analysis – including the use of protein solution array (e.g., Luminex), mass spectrometry profiling (using MS/MS SWATH), and more recently miRNA analysis. Implementation of QMS in an academic environment ensures alignment of all activities with regulatory requirements for the development and delivery of medical devices to market. His UQ-based team has pioneered the development of EV genomic and protein biomarkers of disease that provide new opportunities to increase diagnostic performance – work conducted within UQCCR’s NATA-accredited facility that is compliant with international standards for the development and implementation of IVDs.

The ovarian cancer early detection alliance

One of the most significant contributions of my research program in the last 2 years has been the development of a test of early detection of ovarian cancer, OCRF-7, that displayed a classification efficiency of 98%. Based on these data, we successfully secured funding from two Medical Research Future Funding (MRFF) initiatives for a total of $4 million, and in both applications, the Ovarian Cancer Research Foundation (OCRF) is the partner organisation.

While the commercial pathway for developing a fit-for-purpose earlier detection test for ovarian cancer has proven to be extremely challenging, what is incontrovertible is that a global, collaborative (i.e, Prof. Usha Menon from The United Kingdom Collaborative Trial of Ovarian Cancer Screening (UKCTOCS)), and multidisciplinary approach will be required to develop and deliver such a test. To achieve this goal, Associate Professor Salomon has built a strategic alliance with the OCRF, LMRF, government (MRFF, NHMRC), industry, and national and international clinical key opinion leaders (KOLs) to:

Access a large cohort of prospectively collected appropriately-curated clinical samples;
Novel technological approaches to identify biomarkers of early-stage ovarian cancer;
A translational research facility compliant with regulatory-agency standards for the development of in vitro diagnostics (IVDs);
Advanced data mining and modelling expertise to develop robust multi-biomarker algorithms to deliver greater diagnostic accuracy;
Engagement of KOLs in the development and implementation of a new test;
Community educators and advocates; and
Commercialisation and distribution partners.

Moreover, a commercial partnership with ASX-listed company INOVIQ Ltd is providing access to novel technology platforms for EV biomarker discovery and future marketing and distribution opportunities.

The Ovarian Cancer Early Detection Alliance seeks to deliver the analytical and clinical performance data required by the TGA (and FDA) to advance the OCFR-7 test in a clinically feasible pathway to implementation to increase the survival rate of over 2000 women diagnosed with ovarian cancer in Australia annually. In collaboration with UniQuest and INOVIQ LTDA, when commercially available, the test will be distributed to major markets worldwide including USA, Europe, and Asia.

Salomon Group - Impact

Quality management system

The ovarian cancer early detection alliance

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