How Aussie doctor’s at-home Covid test won US approval

Author: Agencies

An Australian doctor who began inventing virus detection tools as a “hobby” is now helming a mammoth effort to ship the first non-prescription home Covid-19 tests cleared by US regulators.

Sean Parsons is the founder of Ellume, a medical tech firm based in a suburban industrial park, where rows of factory workers in sterile clothing swiftly assemble sleek grey kits roughly the size and shape of home pregnancy tests. Ellume’s product delivers results in just 15 minutes and will soon be available over the counter in pharmacies across the country worst-hit by the pandemic.

“We’re making the first product that’s headed for the US. So it is an important day,” Parsons told AFP on a recent tour of his company’s Brisbane facility. At the time, the Food and Drug Administration (FDA) in Washington had just approved Ellume’s kits for emergency use and the company was manufacturing 16,000 tests a day.

It is now rapidly scaling up production, aiming to hit 100,000 units a day this month and one million by mid-year. “The objective is to diagnose as many people as possible — millions of people with coronavirus — to enable and encourage them to reduce the transmission within the community,” Parsons said. The single-use kit comes with a self-administered nasal swab that is slotted into a tube containing a small analyser capable of detecting the virus. A free smartphone app walks users through the process and pairs with the analyser over Bluetooth to download test results. Though the vaccine rollout is already underway in the US, the pathway to herd immunity is expected to be long and rocky, and Parsons is confident his tests will be needed for “many years” to come.

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

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