Manufacturers ‘in limbo’ as local RATs head overseas

By Denham Sadler

Several Australian companies are manufacturing rapid antigen tests locally with government support, but are sending the kits overseas due to approval delays, with federal Labor blaming the government for leaving them ‘in limbo’.

Starting this week, concession card holders can access 10 free RATs at pharmacies nationwide over a three-month period, if there is stock.

But the Pharmacy Guild said up to 90% of chemists will not have enough stock to supply the free tests, saying that of 5,500 pharmacies not associated with Chemist Warehouse, only 700 have RATs in stock as of Monday .

Demand for RATs is only set to increase, with NSW and Victoria recently announcing that students will be required to undergo two rapid COVID-19 tests per week during the first month of the school term.

The shortage of such tests exists despite the fact that there are at least three Australian companies capable of manufacturing RATs locally, some of which do so but then export them to the United States and Europe.

This is partly because these companies are still awaiting Therapeutic Goods Administration (TGA) approval to use RATs in Australia, with two Australian companies now having waited over four months.

Queensland-based AnteoTech and Melbourne-based Lumos Diagnostics both submitted TGA applications in September last year for their rapid antigen tests, but are still awaiting confirmation.

Lumos Diagnostics now manufactures its tests in the United States and exports them to America, Europe and Canada.

Queensland company Ellume is also shipping large quantities of locally made RATs to the US, and it appears to be making an imminent request to the TGA for use in Australia.

Shadow Industry Minister Ed Husic questioned why the federal government hadn’t done more to prepare the industry to manufacture RATs locally.

Husic said: “It is easier to get an Australian RAT in the US and parts of Europe than in the very country where they are made.

“The Morrison-Joyce government has left Australian manufacturers in limbo – they clearly lack the faith to support local craftsmanship. Mr Morrison’s failure to listen and act on industry warnings last year about the need for more RAT means everyday Australians are now paying the price.

Several of Australia’s RAT manufacturers have also received federal and state government funding.

AnteoTech has received $1.4 million in funding from the Queensland Government’s Critical Goods and Supply Chain Program. The company also recently announced a $1.96 million tax incentive refund for federal research and development.

AnteoTech applied to the TGA in September for its EuGeni reader and rapid COVID test. In December, the TGA requested additional information from the company on how well its tests are able to detect new variants of the virus.

Lumos Diagnostics offers the CoviDx rapid test, which was already approved by Canada in November.

The company approached the federal government in 2020 to push for local manufacturing of RAT, but has since established manufacturing capacity in Florida and California pending approval. Lumos Diagnostics tests are supplied in the United States, Europe and Canada.

Ellume, based in Queensland, currently manufactures over 100,000 RATs every day in Brisbane, which are exported to the United States.

The company last year received part of a $50 million grant from the Queensland government to expand its manufacturing plant in Brisbane.

Earlier this month, the Federal Department of Health signed contracts worth more than $60 million for the “urgent” supply of rapid antigen tests.”

Contracts are with Australian-based companies that have been approved by the TGA to sponsor overseas-made RATs, all of which are made in China.

This story first appeared in InnovationAus

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Melvin B. Baillie