MTPConnect and Pathology Technology Australia to Develop Action Plan to Build Sovereign Manufacturing Capability in Diagnostic Tests

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06 April 2022

MTPConnect has secured funding from the Australian Government to develop a national Action Plan for building end-to-end sovereign manufacturing capability for diagnostic tests.

The Action Plan will be developed in close partnership with Pathology Technology Australia (PTA) - the peak body representing manufacturers and suppliers of tests and technology used in pathology laboratories, hospitals, general practice and for self-testing.

The Plan will examine supply chain and other barriers to positioning Australia to reliably and sustainably produce in vitro diagnostic devices (IVDs). The IVDs range from Lateral Flow (RAT) and Polymerase Chain Reaction (PCR) tests to diagnostics for influenza, point-of-care tests for common infectious diseases and nucleic acid (DNA and RNA) based tests for contagions, early cancer detection and drug resistant infections.

MTPConnect Interim CEO, Stuart Dignam, has welcomed the funding and the opportunity to contribute to establishing Australia as a regional centre of excellence for diagnostic technology manufacturing.

“The COVID-19 pandemic has highlighted the importance of ready access to high quality diagnostic tests and there’s no doubt Australia has the scientific and technical capability to develop and manufacture innovative tests at the frontier of the world’s health needs,” Mr Dignam said.

“Working with PTA, we’ll carefully examine the barriers faced by innovative manufacturers in Australia when gaining access to the local market so we can work to boost the resilience of our supply chains for this technology.

“There are clear security, health and economic imperatives to establish, retain and strengthen supply resilience and sovereign manufacturing capabilities for key pathology technologies and that’s what we’re aiming to achieve with this Action Plan,” he said.

PTA CEO, Dean Whiting, believes his organisation’s members will make a valuable contribution to the Action Plan.

“Our membership includes a cohort of Australian-based pathology technology developers and manufacturers which have significant ‘coalface’ experience and understanding of the barriers to success,” said Mr Whiting.

“Our 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, train doctors and scientists in the use of this technology, provide technical support to maintain devices and maintain the supply chain - their expertise will be critical to identifying likely solutions and ensuring the Action Plan has real impact.

“When you consider that 100 per cent of cancer diagnosis and more than 70 per cent of all medical diagnosis and management decisions rely on pathology test results, the case for strengthening our domestic IVD manufacturing capabilities is compelling.”

MTPConnect and PTA will develop the Action Plan over 12-months through extensive consultation and a rigorous examination of the diagnostic testing landscape to identify gaps and opportunities.

The Action Plan initiative is supported by the Australian Government as part of its commitment to developing supply chain resilience and sovereign manufacturing capability on critical medical supplies and is consistent with the Modern Manufacturing Strategy and the Medical Products National Manufacturing Priority Road Map which identifies diagnostics as a growth opportunity.