COVID testing kit a hit overseas but banned at home

COVID-19 testing kits developed in Queensland and used overseas don’t have approval for use in Australia, as an independent MP calls for legislative changes to bring them to the domestic market.

Jul 21, 2021, updated Jul 21, 2021
Deputy Premier and former health minister Steven Miles (centre) during a visit to Ellume this week.

Deputy Premier and former health minister Steven Miles (centre) during a visit to Ellume this week.

Two locally developed rapid COVID-19 testing kits part funded by the Queensland government have succeeded in international markets but are without Therapeutic Goods Administration (TGA) approval.

Traeger MP Robbie Katter is urging the state government to work with its federal counterparts and initiate approvals processes for both Queensland-produced tests.

“These outbreaks are going to continue and we all need to find a way to live with this situation sustainably and be able to get on with our lives,” he said.

Brisbane biotech firms Ellume and Anteotech, are both bound by stringent TGA processes on par with the US Food and Drug Administration (FDA).

Ellume has secured a $300 million dollar deal with the US Defense Department to scale up and provide rapid COVID-19 tests in America, using a facility in Brisbane to produce tests for shipping.

But their home COVID-19 test cannot be sold or marketed in Australia because federal government laws prohibit home testing of notifiable diseases, under which COVID-19 falls.

Anteotech by comparison has entered European and Southeast Asian markets with their Eugeni Rapid Test following $1.4 million from the state government’s advanced manufacturing program.

Unlike the legislative hurdles Ellume faces, Anteotech anticipates domestic entry once its quality accreditation is submitted in September, chairman Jack Hamilton says.

“TGA requirements require a higher level of quality requirements placed on us as a manufacturer,” he said.

“A number of Southeast Asian countries have become more flexible, whereas previously they may have only accepted FDA, they are actually now with the pandemic been open to accepting European registration.

“On current expectations we would expect TGA approval through quarter four, but obviously that’s in the hands of the TGA.”

On Monday, Anteotech announced its Australian distributor and had jointly begun business activities in advance of TGA approval, Hamilton said.

The Eugeni test is expected to be widely distributed as soon as it’s TGA approved.

But Hamilton said the importance of future rapid testing kits couldn’t be understated, with 13 million Australians currently in lockdown.

“Frequent rapid testing similar to Anteotech’s quality … is similar in confidence of detection of what a PCR gives you once a week,” he said.

“We see that there will still be a very much ongoing need for this type of testing and screening.

“Just to understand what happens with the virus as things open up and, hopefully, we return to increasing opportunity for people movement – domestic or international.”

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