Australian Diagnostics Action Plan
MTPConnect and Pathology Technology Australia
Australia has the scientific and technical capability to develop and manufacture innovative diagnostic tests at the frontier of the world’s health needs.
Currently, more than 97 per cent of the in vitro diagnostic (IVD) tests and technologies used in Australia are imported and as a result, much of this technology is manufactured offshore, exposing Australia to supply shortages during periods of high demand and stress on global supply chains. While it is unrealistic for Australia to be fully self-sufficient in all aspects of health technologies and consumables, the COVID-19 pandemic has revealed an underlying need to develop and produce, reliably and sustainably, a critical few.
There are clear security, health and economic imperatives to establishing, retaining and strengthening supply resilience and sovereign manufacturing capabilities for key pathology technologies.
There is an opportunity to establish a regional centre of excellence for high technology, fit for purpose diagnostic technologies, manufactured for domestic and international consumers.
The objectives of this project are consistent with the Australian Government's Modern Manufacturing Initiative and the Medical Products National Manufacturing Priority Road Map which has identified diagnostics as a growth opportunity. MTPConnect’s 2022 Sector Competitiveness Plan also highlights diagnostic devices (point-of-care, lab and patients) as a key Knowledge Priority, reflective of the evolving market and its potential for growth.
Project Objective & Expected Outcomes
MTPConnect, in partnership with Pathology Technology Australia (PTA), will develop a national action plan for building end-to-end sovereign manufacturing capability for diagnostic tests, establishing Australia as a regional centre of excellence for diagnostic technology manufacturing. The Plan will be developed over 12-months through extensive consultation and a rigorous examination of the diagnostic testing landscape to identify gaps, opportunities and strategies to nurture world-class research and development. The report will outline the domestic capabilities that will build resilience for critical products. It will also examine supply chain and other barriers to position Australia to successfully produce IVD devices reliably and sustainably.
We will engage with stakeholders across the In-vitro Diagnostic (IVD) sector operating within Australia.
- Private and public health
- Governing bodies
- International bodies
- Funding bodies
- Policy makers
- National health services
Pathology Technology Australia
Pathology Technology Australia (PTA) is the peak body representing manufacturers and suppliers of about 95 per cent of all tests and technology used in pathology laboratories, hospitals, general practice and for self-testing.
PTA members develop and manufacture tests and the testing technology, conduct clinical trials and validation testing to meet the requirements for inclusion on TGA's Australian Register of Therapeutic Goods (ARTG), train doctors and scientists in the use of this technology, provide technical support to maintain devices operating at their optimum and maintain the supply chain - all of which makes pathology possible. The member companies of PTA strive to provide tests and testing technology that deliver the highest quality, accessible and affordable healthcare services to all Australians.
Relevant to this proposal, PTA's membership includes a cohort of Australian-based pathology technology developers and manufacturers. It is these companies who have significant 'coalface' experience and understanding of the barriers to success. They will provide valuable insights into the likely solutions.
Connect with the Diagnostics Industry Engagement Team
Dr Dharmica Mistry
Director, Diagnostics Industry Engagement
Lead Strategy Partner, Pathology Technology Australia
Project Officer, Diagnostics Industry Engagement