- Ellume, the Australian company which secured $303 million to produce at-home COVID-19 tests for the US, is unable to sell them domestically.
- Therapeutic goods legislation currently bars the sale or advertisement of self-test kits on the Australian market.
- But Ellume says it is willing to work with the Therapeutic Goods Administration and the government should those regulations change.
- Visit Business Insider Australia’s homepage for more stories.
The Australian medical diagnostics firm which signed a $303 million contract with the US government to supply at-home COVID-19 tests is unable to sell or advertise them locally due to current therapeutic goods legislation.
On Tuesday, Brisbane-based company Ellume revealed it has secured funding to help produce millions of at-home COVID-19 tests for the US market.
The firm will build a US facility to produce the test units, which have been granted emergency approval by the US Food and Drug Administration (FDA).
The FDA states the Ellume home-testing units are 96% accurate in detecting positive cases of COVID-19.
Until the new US facility is operational, the company says its Brisbane unit will provide 100,000 at-home tests per month for export.
They will become an “essential tool for the broader pandemic response in the US,” Ellume founder Dr. Sean Parsons said in a statement.
But it is currently unlawful to even advertise those tests here.
“In Australia, the advertising and supply of self-tests for serious infectious diseases, such as COVID-19, is prohibited under therapeutic goods legislation,” the Therapeutic Goods Administration (TGA) said in April 2020 alert.
“COVID-19 tests are designed to be used under the direction of a health professional.
“Home tests may give a false positive or false negative result, which could be extremely dangerous for yourself and others if relied on.”
How the at-home tests work
Ellume tests allow users to administer their own mid-turbinate nasal swab before placing those samples in a Bluetooth-capable analysis unit.
That hardware then connects to a user’s smartphone. A dedicated Ellume app processes data from the sample, returning a test result in about 15 minutes.
“Results can be shared with healthcare professionals to enable optimal therapy,” the company states.
The process is markedly different from the polymerase chain reaction (PCR) method deployed by COVID-19 testing sites across Australia.
Those tests generally take longer to provide an accurate result, require deeper nasal swabs, and lean on dedicated laboratory equipment.
Australia and the US are fighting different battles
While the at-home tests have been hailed as a considerable boost for the US in its fight against the virus, Australia’s comparatively low infection rate and the prevalence of PCR testing means at-home testing is not an immediate priority.
ABC reports Trade Minister Simon Birmingham has downplayed the immediate need for at-home tests in Australia, pointing to PCR testing as the backbone of the domestic healthcare response.
Ellume spokesperson Patrick Condren told Business Insider Australia the company has “no reason” to submit its at-home COVID-19 tests for TGA approval while current regulations are in place.
“The future of any change to the existing legislative barriers is a matter between the Federal Government and the TGA,” he said.
But the company is prepared to seek TGA approval should those regulations change.
“Ellume would be more than happy to take part in any public process the government and or the TGA embarked on around [at-home testing] for Australia,” Condren said.