As the number of cases of the Omicron variant of COVID continues to rise, so does the level of frustration at the difficulty in obtaining Rapid Antigen Tests (RATs) across Australia. At chemists and supermarkets everywhere, shoppers are greeted by a familiar sign: “Rapid Antigen Tests out of stock”.
That frustration is exacerbated for those who have learnt that several Australian producers of RATs have been waiting months for their tests to be approved by the government’s Therapeutic Goods Administration (TGA).
In at least two cases, RATs that are waiting on TGA approval in Australia are freely available in Europe and North America. As contradictory as this seems, it’s unlikely eyebrows would have been raised if the supply of RATs from overseas was plentiful.
Shipments of RATs have been ordered, but with 16 of the 22 Australian-approved tests being sourced from China, there are concerns those supplies will be redirected internally as reports of a worsening outbreak in that country circulate.
Why are Australian-made RATs being used overseas and not here?
On face value, it seems nonsensical that tests manufactured in Australia and currently being sold in the US and Europe have not been approved for use in the country that made them.
Executive chairman of Lumos Diagnostics, Sam Lanyon, believes things could have been very different. Lumos Diagnostics is a Melbourne-based producer of RATs and, in an interview with the ABC, Mr Lanyon said the company approached both state and federal governments as long ago as mid-2020 pushing for local production of tests. But with Australian case numbers low by world standards at that stage, the focus of governments was on Polymerase Chain Reaction (PCR) testing, which is regarded as “gold standard”.
As a result of its calls being ignored in Australia, the company chose to set up manufacturing bases in the US.
With a dramatic rise in positive cases via the Delta and subsequent Omicron variants of COVID, the National Cabinet has finally now shifted its focus to RATs, but the approval process appears to remain slow. Brisbane-based AnteoTech lodged an application for approval of its RATs in September, the same month as Lumos Diagnostics, but that approval has not yet been received.
The TGA says that in many cases, the cause of the delay lies with the companies themselves, as their applications have initially failed to comply with requirements. But AnteoTech CEO Derek Thompson says the regulatory requirements has been tightened twice by the TGA, slowing the process.
Either way, it is of little comfort to those who have been close contacts or are symptomatic and are desperately searching for RATs. Many are going to extraordinary lengths, such as using the Airtasker app to track down tests and offering to pay exorbitant prices.
The federal government, now under extreme pressure to alleviate these long delays, last week published five tenders for RATs valued at around $62 million, citing “extreme urgency or unforeseen events” as its rationale.
In the meantime, the shortage of RATs is likely to drag on for several more weeks.
Have you been affected by the RAT shortage? What’s your view on the TGI approval delays? Why not share your experience in the comments section below?
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