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

Sean Parsons, the CEO of Brisbane-based biotech Ellume, says comments Scott Morrison made about the company’s rapid antigen tests were misleading.

Joe Hockey, left, and Ellume chief executive Sean Parsons at Ellume’s factory in Brisbane. Picture: Lyndon Mechielsen

Sean Parsons, the critical 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 this week said Ellume had its “approval pulled by the FDA in the US” in response to questions that the Australian government had “ignored” the company producing 100,000 rapid tests a day for the American market as Australia battles a chronic shortage.

“There was no application from that company at that time that had been approved by the Therapeutic Goods Administration. In fact, one of the companies that people have spoken about actually had their approval pulled by the FDA in the US,” Mr Morrison said.

“We know in the US, one of those companies actually had their approval pulled. So I understand the frustration. Believe me, I understand it very well. But Australia is not going to compromise on the health standards and the health advice that protects Australians.”

But Dr Parsons said Mr Morrison’s comments were not true.

He said Ellume – which is based 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. It was never cancelled. It was never paused, that the authorisation did not change the whole way through. So that statement from the Prime Minister is categorically incorrect,” Dr Parsons said.

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

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

A spokesman for the Prime Minister said Mr Morrison was referring to the FDA’s advice on the recall, which the US regulator said was “the most serious type of recall. Use of these tests may cause serious adverse health consequences or death”.

“The federal government wants to grow medical manufacturing in Australia and see our world leading scientists and medical experts develop their products on home soil,” the Prime Minister’s spokesman said.

“The TGA continues to prioritise and expedite the assessment of Covid-19 rapid antigen self- tests for home use. The TGA has approved 66 Rapid Antigen Tests for use by health care professionals or for home use, with more in the late stages of the TGA review processes. The federal government is always happy to work with any company once they pass through the safety approvals with the TGA.”

The recall involved 2.2 million of Ellume’s tests, manufactured between February 24 and August 11 last year. Since the company rectified the problem last year, it has been shipping about 700,000 test a week to the US and is about to open a new factory in Maryland to boost US supply.

The FDA said the reliability of negative tests were not affected in the recalled products.

“For these tests, a false positive test result shows that a person has the virus when they do not have it and could lead to: delayed diagnosis or treatment for the actual cause of the person’s illness, which could be another life-threatening disease that is not Covid-19,” the FDA said at the time.

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

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

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

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

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

“The clinical trials for those products would not have been run in Australia. They would have been run overseas because we did not have enough Covid to run a clinical trial. So we‘re relying very heavily on products made in China in clinical trials from goodness knows where. I am obviously a bit anxious that they are not as good as they say they are.”

Dr Parsons said he supported the rigorous approval process from the TGA.

But the regulator had been hamstrung by laws which only made home rapid testing legal at the start of last November, he said.

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