Following from a Sydney newspaper published this morning.
Washington: Australian diagnostics company Ellume has won approval from US
regulators to sell the first rapid at-home COVID-19 tests that don't require a
prescription.
The Brisbane-based company was granted an emergency use authorisation on
Wednesday (AEDT) by the US Food and Drug Administration (FDA) to sell its overthe-counter tests.
Stephen Hahn, the head of the FDA, hailed the authorisation as "a major
milestone in diagnostic testing for COVID-19".
Alongside vaccinations, health experts believe rapid at-home testing will provide
a crucial tool to bring the pandemic under control.
"By authorising a test for over-the-counter use, the FDA allows it to be sold in
places like drug stores, where a patient can buy it, swab their nose, run the test
and find out their results in as little as 20 minutes," Hahn said in a statement.
Lamar Alexander, the chair of the Senate health committee, said: "This is a
genuine breakthrough in COVID-19 testing."
The US is currently testing around 2 million people a day, but health experts say
that figure should be far higher. It can still take several days in many parts of the
US to receive a test result.
Studies showed the Ellume test correctly identified 96 per cent of positive samples
and 100 per cent of negative samples in individuals with COVID-19 symptoms.
For those without symptoms, the test correctly identified 91 per cent of positive
samples and 96 per cent of negative samples.
Ellume has said it plans to ship over 100,000 tests per day from January, and to
deliver 20 million COVID-19 tests to the US within the first half of 2021.
The new at-home COVID-19 test will make it easier for Americans to discover whether they
have the coronavirus.
The tests can be used by anyone over two years old and deliver results via
smartphone.
The company received US$30 million ($40 million) in funding from the US
government to develop the tests.
Sean Parsons, Ellume's founder and chief executive, said: "We've been furiously
working for months to create the at-home test so it's very pleasing to see all of the
hard work pay off."
He said the company's main focus was on the US rather than countries such as
Australia where the virus is much more under control.
"Our technology is best suited to places where the coronavirus numbers are
making it hard for the healthcare system to keep up," he said.
"When we're supplying as much as America can use we will look at other countries
but right now it's all about the US."
Parsons founded Ellume in 2010 after working on the swine flu pandemic, and
went on to create the first at-home test for influenza.
The company has around 200 employees, most of them in Australia.
End.
A far more comprehensive article appears on the FDA website.
Regards Ron