Therapeutic Goods Administration reviewing all Covid-19 rapid tests, amid shortage in Omicron wave

Australia’s health regulator is reviewing all Covid-19 rapid tests including those it has already approved to see if they’re effective in detecting Omicron.

ASX-listed Atomo, led by John Kelly, has option to buy 20 million rapid test from US manufacturer Access Bio. Picture: Hollie Adams/The Australian

Australia’s health regulator is holding up the delivery of at least 20 million rapid antigen tests after it launched a review to see if the products are effective against detecting Omicron and other Covid-19 variants.

As Australia battles a shortage of rapid tests, the Therapeutic Goods Administration has begun a “post market review” of RATs, which also includes previously approved products. It is a move that has frustrated rapid antigen test suppliers, with the TGA perceived to be slowing down the distribution of rapid tests in Australia.

But the TGA says each new Covid-19 strain emerges – such as the highly infectious but less severe Omicron variant – rapid test manufacturers must ensure that their products remain effective. It is a process that requires rigorous analysis and comes as the World Health Organisation warns Omicron will not be the last Covid mutation.

“Variants of the virus due to mutations in the protein target of the genome may alter the structure of a viral protein. As a result, tests kits may no longer be able to detect the virus, leading to false negative results,” the TGA said.

The accuracy of rapid tests — which have a narrower window of detection than more expensive and government-funded pathology-based testing — is vital given they are increasingly becoming a tool used across businesses, the freight sector and schools and hospitals to segregate those infected with Covid-19.

But for ASX-listed diagnostics company, Atomo, the TGA’s review means it can’t exercise an option to import 20 million rapid tests from US manufacturer Access Bio until it can show that the tests can detect Omicron and other Covid-19 variants.

The review is compounding the shortage of rapid tests in Australia at time when Covid-19 and pandemic isolation rules is sparking chaos across the food supply chain and hospitality sector, fuelling grocery shortages and the forced closure of restaurants and cafes.

Industry Minister Angus Taylor said since applications for TGA approval for at-home rapid tests began in Australia in November, only one Australian manufacturer had successfully obtained the relevant approvals “Encouragingly, there are many Australian companies which have submitted an application for self-tests to the TGA for consideration and approval,” Mr Taylor said.

“The government continues to engage with industry to understand local manufacturing capability for RATs, both currently, and for the longer term.”

A TGA spokeswoman said the regulator had approved about 66 rapid tests for use at the point of care with a healthcare professional or at home as a self-tests. Despite Atomo saying it had an approved professional use test, the TGA spokeswoman said the company had yet to provide “sufficient primary data” for the Access Bio tests, and any approved product could continue to be sold during the post market review.

“This test is not yet approved by the TGA as it has yet to provide sufficient primary data and is therefore not subject to any post market review. Any such claim to the contrary is inaccurate,” the spokeswoman said.

“The TGA is assessing an application from the sponsor for approval as a priority however is still awaiting key data which other test sponsors have provided for 66 tests so far.

“As with all applications to the TGA for approval of Covid-19 RAT tests the sponsors must include data to show that the test meets the requirements for approval including its ability to reliably detect Covid-19.”

Atomo sold 90,000 tests on average each month in the December quarter but if it had access to the US kits it could lift that number to 1.7 million.

Atomo confirmed the delay in a statement to the ASX on Tuesday, saying the TGA had “introduced new requirements for suppliers”.

“Applicants were requested to provide additional study data for assessment by the TGA and the Doherty Institute is currently conducting further assessments on all rapid antigen test products at the request of the TGA,” Atomo said.

“Atomo’s approved Covid-19 professional use test, and its self-test product submission are therefore subject to this review process, and further updates will be provided to the market as information becomes available.”

Atomo’s has delivered unaudited half year revenue of $7m. This compares with generating $6.7m revenue for the entire previous financial year.

Another local diagnostics company, privately-owned Ellume based in Brisbane, is also preparing to submit an application to the TGA for approval of its locally produced rapid tests. Ellume has been sending more than 700,000 rapid tests to America each week after the US government granted the company $US30m to fast track production early in the pandemic.

Ellume — which previously struggled to gain traction as a influenza test maker — has since made it big in the US, with it also winning a $US235m Department of Defence contract to deploy its rapid tests across the US’s armed forces. It has also established a new factory in America to complement production in Brisbane.