The kits, developed with the help of a $US30 million grant from the US government, have not been approved for use in Australia, Ellume Health chief executive Sean Parsons said.
“As part of that [American grant], we said for the 2021 calendar year, all of the home tests we could make would go to the US,” he said.
“So we have not applied to the TGA [Therapeutic Goods Administration] for this product just yet.
“Our products are really designed for those environments where there is a lot of COVID spreading.”
More than 400,000 people have died of COVID-19 in the US, almost equalling America’s death toll during World War II.
Almost 25 million people have been infected there since the start of the pandemic.
Dr Parsons, who founded Ellume in 2010, said the tests would be able to detect new strains of COVID-19 as they examined a protein within the virus that did not change when strains mutated.
“These tests are all about early identification of people with COVID, so they can reduce transmission of cases in their community and decrease the total burden of disease. So, fewer people in hospital and fewer people dying,” Dr Parsons said.
A total of 10,000 tests were shipped to Los Angeles on Wednesday evening, and will be distributed to three different US states by next week.
“There are many more to come in the coming weeks and months,” Dr Parsons said.
Queensland taxpayers funnelled money into the biotech company via a grant to help it ramp up production capacity.
The amount of funding is under a commercial-in-confidence agreement, but was taken from a $50 million pot of money set aside to improve Queensland’s supply chain of essential goods.
Queensland Deputy Premier Steven Miles said the tests were needed more in countries that had not contained the virus, rather than in Australia.
“Really, the core benefit here for Queensland is in the jobs and economic benefit [rather than access to tests],” he said.
“The situation in the US really requires rapid testing so that you can avoid people infecting others between the period in which they are tested and when the results come back.
“By the end of this financial year, Ellume aims to provide more than 20 million tests for the United States – a country that’s seen the highest daily case rates in the world.”
Ellume employs 300 people at its Richlands laboratory in Brisbane’s west, but hopes to expand to a workforce of 600 as the companies rushes to roll out more testing kits.
The company is scaling up to manufacture more than 200,000 testing kits a day, and at full capacity the facility will be capable of producing 10 million tests a month.
Lydia Lynch is Queensland political reporter for the Brisbane Times