Friday 22 January 2021

Australian doctor’s at-home Covid test approved by FDA

(AFP) 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, founder and CEO of Australian digital diagnostics company Ellume, poses with a coronavirus home test unit. Photo: AFP

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.

- Advertisement -

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.

- Advertisement -

“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 analyzer capable of detecting the virus.

A free smartphone app walks users through the process and pairs with the analyzer 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.

“Testing at scale in the community is here to stay, as we see it.”

‘A bit of a hobby’

- Advertisement -

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

As his shift was ending, the doctor treated a teenager who later tested positive for the disease.

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

He tinkered away at the side on an invention he hoped would eventually help rapidly detect flu-like illnesses.

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

When the coronavirus pandemic struck, the firm had already invented a nanoparticle testing system used to make an at-home influenza test and had embarked on a partnership to bring tuberculosis testing into communities.

‘We need to be ready’

As early as February — before Australia had slammed shut its international borders to forestall the pandemic — Parsons and his team were “pouring their energies” into adapting their work for Covid-19 testing.

That attracted a $31 million investment from US government agencies, setting the stage for the at-home test to be delivered there first.

A clinical trial found it to be 96 percent as effective as lab testing — positioning it as a complement to traditional methods and eventually convincing the FDA to grant emergency use authorization.

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

And while it took more than eight years to create the technology and eight months to tailor it to detect Covid-19, Parsons is already looking ahead to how they can more quickly address the next major disease outbreak.

“We’re also building this capacity to respond to a future pandemic,” he said. “That is inevitable, and we need to be ready.”

- Advertisement -

FACT CHECK:
We strive for accuracy in its reports. But if you see something that doesn’t look right, send us an email. The Q reviews and updates its content regularly to ensure it’s accuracy.

Ricohttp://www.theqmedia.com
"Rico" is the crazy mind behind the Q media websites, a series of online magazines where everything is Q! In these times of new normal, stay at home. Stay safe. Stay healthy.

Related Articles

Costa Rica and Panama in times of Coronavirus

The worldwide pandemic has devastated the world’s health care systems. Poorer...

130 laboratories have authorization to perform covid-19 tests in Costa Rica

QCOSTARICA - The Ministry of Health and the Costa Rican Tourism...

MOST READ

Ana de Armas dumps Ben Affleck

Q MAGAZINE - Ben Affleck is single again after Ana de Armas broker off their relationship reported People. "Ben is no longer dating Ana," the...

Pfizer will reduce the deliveries of its covid-19 vaccines to adjust production process

QCOSTARICA - The American drugmaker, Pfizer, said in a statement on Friday that reduced deliveries were a temporary issue, affected by changes to its...

Hungry coyotes roam the TEC campus in Cartago

QCOSTARICA - In recent weeks coyotes have been seen roaming the TEC campus in Cartago, hungry and looking for food, especially on the shore...

“It is foreseeable that 2021 will be like an extension of 2020”: UNA epidemiologist

QCOSTARICA - Despite the arrival of the vaccine against Covid-19 in Costa Rica, 2021 will be like “an extension of 2020”, according to Juan...

Political pressure grows for medical marijuana and hemp

QCOSTARICA -A group of legislators is pressuring the government to take advantage of the current period of extraordinary sessions to process the legislation that...

Couple created a mobile mini-supermarket on wheels to bring back the shopping experience to the elderly

QCOSTARICA - Taking their inspiration from the traditional fruit carts that still make their way through many neighborhoods in Costa Rica and their affection...

Oxford Study: Electoral system allows politicians to camouflage the spread of ‘fake news’ in Costa Rica

QCOSTARICA - The ambiguity with which the political parties' spending reports are written makes it difficult for citizens to monitor what type of digital...

Guatemala uses tear gas and sticks to stop migrant caravan

Q24N - With a new administration in sight and the possible relaxation of immigration policies, thousands of migrants from Central America have decided to...

Legislators approve budget to ensure vaccines against covid-19

QCOSTARICA - The Legislative Assembly approved Tuesday afternoon the first extraordinary budget for the fiscal year of 2021, which ensures ¢40.5 billion colones for...

Want to stay up to date with the latest?

We would love to hear from you! Please fill in your details and get updates daily in your mailbox. It's that simple!

Log In

Forgot password?

Forgot password?

Enter your account data and we will send you a link to reset your password.

Your password reset link appears to be invalid or expired.

Log in

Privacy Policy

Add to Collection

No Collections

Here you'll find all collections you've created before.