• The founder of an Australian firm which produces at-home COVID-19 testing kits says the federal government appears “unwilling” to consider testing alternatives.
• Ellume founder Sean Parsons told “Sunrise” the kits, which have been approved for use in the U.S., could be helpful during lockdowns to reduce long queues for traditional testing centres.
• Therapeutic goods legislation currently bars home COVID-19 tests from being sold or advertised in Australia, with the nation’s drug watchdog citing fears over faulty test results.
• Visit Business Insider Australia’s homepage for more stories.

An Australian-based manufacturer of rapid COVID-19 tests says the federal government appears “unwilling” to consider its products for home use, after the United States’ drug watchdog approved the products for use in both domestic and clinical settings.

Brisbane firm Ellume has rolled out an at-home COVID-19 test which it claims can provide highly accurate results within 15 minutes.

Unlike polymerase chain reaction (PCR) testing, which is utilised by testing clinics and pathologists across Australia, the Ellume test offers rapid antigen testing in an over-the-counter package.

The testing unit allows users to conduct their own nasal swab and deposit the sample in a Bluetooth-enabled analysis unit, which feeds the result to a dedicated smartphone app.

The U.S. Food and Drug Administration (FDA) last year approved their use in home settings after finding the units to be between 91% and 96% accurate.

Ellume has secured $303 million in U.S. government funding to produce the tests abroad, and the Australian reports the FDA has now approved those same units for use in clinical settings, in addition to PCR testing.

However, the Therapeutic Goods Administration (TGA), Australia’s equivalent organisation, has held off on approving the Ellume unit, or any other form of at-home COVID-19 test.

Such tests cannot be sold or advertised in the Australian market under current therapeutic goods administration.

“COVID-19 tests are designed to be used under the direction of a health professional,” the TGA states. “Home tests may give a false positive or false negative result, which could be extremely dangerous for yourself and others if relied on.”

In February, an Ellume spokesperson told Business Insider Australia the company had “no reason” to submit its tests for TGA approval while such legislation is in place.

With new COVID-19 lockdowns now covering most of the Australian population and the number of incoming passengers dramatically slashed to ease the strain on state hotel quarantine systems, Ellume founder Sean Parsons says the company would still “love” to introduce its products to the domestic market.

“The government needs to chart a course out of the current situation,” Parsons told “Sunrise” Monday morning. “We can’t keep having these lockdowns and these hotel quarantines, we cannot be Fortress Australia forever.”

While ceding that existing testing systems remain integral to the nation’s COVID-19 response, Parsons called on the federal government to consider alternative measures.

“Everywhere else in the world is focusing on vaccination and widespread community testing, and we have countries banging down the door for a test, and our government seems to be unwilling to explore these new technologies.”

In a statement obtained by the Australian, Health Minister Greg Hunt said the company is welcome to apply for approval for use in clinical settings.

Parsons said the point-of-care market is currently tight, as clinics are not reimbursed for the COVID-19 testing they provide to patients.

The company is still preparing to submit its tests for TGA approval in point-of-care settings, Parsons told the paper.

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