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Australia Rapid tests denied to Australians despite millions being used in the UK

00:01  26 january  2022
00:01  26 january  2022 Source:   smh.com.au

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Australians are being denied a chance to use a rapid antigen test approved by Britain's health authority and issued free to millions of people over the past year, in a tussle over standards after a ban on the kits in the United States.

Australian importers have struggled to gain local approval to sell the Biotime test despite its widespread use in Britain, where the National Health Service (NHS) rebadges the kit with the government brand so that people can test themselves and record the results online.

With households facing a shortage of kits across the country, the long dispute over the Biotime rapid antigen test (RAT) has kept one of the world's biggest RAT suppliers out of the country since the first application for its approval in December 2020.

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The test is produced by Xiamen Biotime Biotechnology of China and has been bought by the NHS in large volumes under contracts worth an estimated £3.7 billion ($6.98 billion) for the product's distributor as part of the British government's "Operation Moonshot" bid for mass daily testing.

Sydney company Rapid Test & Track wants approval from the Therapeutic Goods Administration (TGA) to sell the same tests but believes the process has taken too long because of a controversy over the product with the US Food and Drug Administration (FDA).

"I think we've been unfairly assessed and [the TGA's] view has been tainted by the FDA criticisms and they have been unwilling or unable to call upon the UK regulator to verify that the product is suitable and should be deployed immediately," the company's chief executive, Alan Higgins said.

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The controversy centres on the US distributor of the kits, Innova Medical Group of California, which breached FDA standards last year by selling the tests without marketing approval, clearance, or authorisation from the peak US agency.

The FDA forced Innova to recall products and told Americans they should not use the kits.

"The FDA has significant concerns that the performance of the test has not been adequately established, presenting a risk to health," it said.

"Labelling distributed with certain configurations of the test includes performance claims that did not accurately reflect the performance estimates observed during the clinical studies of the tests.

"Finally, the test has not been authorised, cleared, or approved by the FDA for commercial distribution or use in the United States, as required by law."

The TGA has not rejected the Biotime test, but Mr Higgins said the process had been too slow.

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Mr Higgins, said he could have shipped 240 million kits to Australia in January if the TGA had approved the kits last year.

"That chance, this late in the month, has been missed, but I could get 240 million every month from February onwards," he said.

Britain's peak regulators, including a Health Security Agency and University of Oxford team, passed the Biotime test in September 2020 and confirmed its approval in an update on 20 January this year. It examined 160 tests and approved about 30 per cent of them.

One week after the FDA warning letter in the US, Britain's Medicines and Healthcare Products Regulatory Agency (MHRA) issued a statement saying it had looked again at the Biotime test and reached a "satisfactory outcome" to extend its emergency use.

"We have now concluded our review of the risk assessment and are satisfied that no further action is necessary or advisable at this time," said Graeme Tunbridge, the MHRA director of devices, last June.

The Biotime kit was distributed in NHS packages to thousands of delegates to the United Nations climate summit in Glasgow in November, when Australians travelling with Prime Minister Scott Morrison used the tests each day and recorded the results with the NHS in order to gain entry to the summit.

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TGA chief John Skerritt said the regulator was approving the test kits at a greater rate than the FDA even though the US agency was 15 times larger.

"There's a lot of demand for RATs and companies, quite frankly, want to do the right thing and serve that demand, and some of them also obviously make a lot of money when they can," Professor Skerritt said last week.

"We have had a lot of trouble with companies making false claims that, for example, they've even submitted applications to us when they haven't even put in an application for approval.

"So, we've been working all through the Christmas and New Year period, looking at and approving RATs when we have the data."

The Sydney Morning Herald and The Age have seen documents that confirm the Biotime kit is being considered by TGA officials.

Mr Higgins said his company lodged its first application with the TGA in December 2020, made a final submission in March 2021 but encountered concerns about the Innova problems and chose to withdraw in November.

"The TGA has never rejected a submission from us," he said. "We elected to withdraw and resubmit, which we did on 23rd December 2021."

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