https://www.abc.net.au/news/2022-01-14/australian-made-rats-await-approval-amid-test-shortage/100754808
Sam Lanyon is the executive chairman of Melbourne-based Lumos Diagnostics, another company whose tests are awaiting TGA approval.
He told ABC News that his company approached the federal and state governments around a year-and-a-half ago advocating the local production of COVID RATs.
"It does take time to set up manufacturing, to validate your facility, get your product into manufacture and then out the other side, and then start supplying it to global market," he explained.
"So mid-2020 the company was providing proposals around, if you start to focus on the recovery phase, we need 12 months of time to get everything in place so that we actually have domestic capability in place."
His advice, he said, fell on deaf ears, with Australian governments preferring "gold standard" PCR tests over rapid antigen tests.
"For that reason, we set up our manufacturing capability out of Florida and California, which is there today, providing our range of tests into the US, European and Canadian markets at this point in time," Mr Lanyon said.
That was before a sudden about-face during the Delta outbreak in New South Wales, Victoria and the ACT, when the federal government changed legislation to allow for the approval of at-home testing not performed by health professionals.
"We were just quite surprised how fast it changed based on the needs of the pandemic, and Delta coming along, and driving a whole bunch of legislative changes that I think fundamentally would have been good to be in place back when we started the company [in 2015]," said Mr Lanyon, whose firm had, until then, been focusing on RATs administered by healthcare professionals.
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