ADO Media Thread, page-1178

Kicking us in the shins’: rapid Covid test maker Ellume lashes out at Scott Morrison

Sean Parsons, thecritical care doctor turned chief executive of rapid Covid-19 test manufacturer Ellume, has accused Scott Morrison of making misleading comments about the company’s operations in the United States.

The Prime Minister thisweek said Ellume had its “approval pulled by the FDA in the US” in response toquestions that the Australian government had “ignored” the company producing100,000 rapid tests a day for the American market as Australia battles achronic shortage.

“There was no applicationfrom that company at that time that had been approved by the Therapeutic GoodsAdministration. In fact, one of the companies that people have spoken aboutactually had their approval pulled by the FDA in the US,” Mr Morrison said.

“We know in the US, oneof those companies actually had their approval pulled. So I understand thefrustration. Believe me, I understand it very well. But Australia is not goingto compromise on the health standards and the health advice that protectsAustralians.”

But Dr Parsons said MrMorrison’s comments were not true.

He said Ellume – which isbased in Brisbane and has recruited Joe Hockey’s Bondi Partners as an adviser – initiated a voluntary recall in the US after five per cent of its products displayed false positives, a problem that has since been resolved and one during which Ellume maintained its FDA approval at all times.

“It was never revoked. Itwas never cancelled. It was never paused, that the authorisation did not changethe whole way through. So that statement from the Prime Minister iscategorically incorrect,” Dr Parsons said.

“Some batches that had asmall percentage of false positives that we didn’t expect, and it was actuallya very small number … about 5 per cent. We told the FDA about the problem. Andwe’ve been shipping correct products since November.

“For us it’s in the rearviewmirror. For our big customers in the US it is in the rearview mirror. The onlygroup that it seems to not be in the rearview mirror, is the federal governmentand health department here in Australia who seem to be trying to kick us in theshins for reasons I don’t understand.”

The Prime Minister’sOffice has been contacted for comment.

In a statement last week,the Therapeutic Goods Administration highlighted Ellume’s US recall in responseto comments from rival supplier, Atomo – which Bondi Partners also advises– that the Australian approval process was holding up theimport of 20 million rapid tests from the US.

“In relation to Ellume ithas only recently submitted a self-test application but has yet to completeprovision of safety and efficacy data provided in relation to the 66 otherapproved products. The TGA notes that it was subject to a Class 1 productrecall by the FDA (potentially life threatening),” a TGA spokeswoman said atthe time.

Dr Parsons said he wasdisappointed by the comments and instead, he believes the conversation would befocused better on how to shore up local manufacturing – in a similar vein tovaccine production – to better respond to Covid-19 and future pandemics.

Despite Mr Morrisonhighlighting a company in Western Sydney making rapid tests, Dr Parsons saidthe bulk of the kits available in Australia were from China.

Dr Parsons said theclinical data that Ellume has supplied to the TGA as part of its applicationfor approval was from the US, given Ellume’s production has so far exclusivelyserved the American market. In contrast, he said it was unknown where theChinese manufacturers sourced their clinical data.

“The clinical trials forthose products would not have been run in Australia. They would have been runoverseas because we did not have enough Covid to run a clinical trial. So we‘rerelying very heavily on products made in China in clinical trials from goodnessknows where. I am obviously a bit anxious that they are not as good as they saythey are.”

Dr Parsons said hesupported the rigorous approval process fromthe TGA.

But the regulator hadbeen hamstrung by laws which only made home rapid testing legal at the start oflast November, he said.