How an Australian doctor’s home Covid test won US approval


Brisbane (Australia) (AFP)

An Australian doctor who started inventing virus detection tools as a ‘hobby’ is now leading a massive effort to ship the first non-prescription Covid-19 home tests approved by US regulators.

Sean Parsons is the founder of Ellume, a medical technology company based in a suburban industrial park, where rows of factory workers in sterile clothing quickly assemble sleek gray kits in the size and shape of the tests. home pregnancy.

Ellume’s product works in just 15 minutes and will soon be available over the counter at pharmacies across the country hardest hit by the pandemic.

“We are making the first product for the United States. So this is an important day, ”Parsons told AFP during a recent visit to his company’s facilities in Brisbane.

At the time, the Washington Food and Drug Administration (FDA) had just approved Ellume’s kits for emergency use, and the company was making 16,000 tests a day.

It is now rapidly ramping up production, aiming to reach 100,000 units per day this month and a million by the middle of the year.

“The goal is to diagnose as many people as possible – millions of people with coronavirus – to enable and encourage them to reduce transmission within the community,” Parsons said.

The single-use kit comes with a self-administered nasal swab which is inserted into a tube containing a small analyzer capable of detecting the virus.

A free smartphone app guides users through the process and pairs with the analyzer via Bluetooth to download test results.

Although the vaccine’s deployment is already underway in the United States, the road to herd immunity is expected to be long and difficult, and Parsons is confident his testing will be needed for “many years” to come.

“There will be people who are not only worried about having coronavirus, but people who choose not to be vaccinated for whatever reason,” he said.

“Large-scale testing in the community is here to stay, as we are seeing. ”

– ‘A bit of a hobby’ –

Ellume’s seed was planted during the swine flu pandemic in 2010, when Parsons worked at a busy Brisbane hospital filled with worried people looking for tests.

At the end of his shift, the doctor treated a teenager who later tested positive for the disease.

“If he could have gotten the results earlier and not spent four hours in the waiting room spreading it out to God knows how many people, then we could have provided even better care,” Parsons said.

He tinkered with an invention that he hoped would eventually help detect flu-like illnesses early.

It started out as “a bit of a hobby,” but by the end of 2011 Ellume had attracted enough investment for Parsons to devote himself fully to the business.

When the coronavirus pandemic hit, the company had already invented a nanoparticle testing system used to do a home flu test and entered into a partnership to introduce TB testing in communities.

– ‘We must be ready’ –

As early as February – before Australia closed its international borders to prevent the pandemic – Parsons and his team “devoted their energy” to adapting their work to tests for Covid-19.

This attracted a $ 31 million investment from U.S. government agencies, paving the way for the home test to be delivered first.

A clinical trial found it to be 96 percent as effective as lab tests – positioning it as a supplement to traditional methods and ultimately convincing the FDA to grant emergency use clearance.

Ellume’s focus remains squarely on the United States, but Parsons wants to expand globally and hopes for EU approval later this year.

And although it took more than eight years to create the technology and eight months to adapt it to detecting Covid-19, Parsons is already working on how to respond more quickly to the next major disease outbreak.

“We are also building this capacity to respond to a future pandemic,” he said. “It’s inevitable and we have to be ready. ”


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