Brisbane Young Entrepreneur of the Year Dr Sean Parsons has achieved a breakthrough in the US after the Food and Drug Administration (FDA) approved his company Ellume's rapid COVID testing kit.
Ellume's groundbreaking fluorescent immunoassay technology can generate results in the space of 20 minutes with a very high accuracy level, according to the FDA.
The US government agency has issued an emergency use authorisation for the Ellume product, which will become the first over-the-counter at-home diagnostic test for COVID-19.
"Today's authorisation is a major milestone in diagnostic testing for COVID-19," says FDA commissioner Stephen M. Hahn.
"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."
Related story: An entrepreneur for the times: Ellume COVID test developer Sean Parsons wins Brisbane business award
Ellume is already producing the tests in commercial quantities from its recently opened 4,400sqm manufacturing facility in Brisbane, pumping out around 100,000 rapid COVID-19 tests a day.
The company's efforts have been supported by US$30 million (AUD$40 million) received from the US National Institutes of Health (NIH) to scale up production.
Parsons founded the company initially to develop simple-to-use high-performance diagnostics for common infectious diseases such as flu, and to respond to what he perceived was a future flu pandemic.
The company had already developed global partnerships with major international pharmaceutical companies, including Germany's Qiagen and UK-based GlaxoSmithKline ahead of the pandemic's outbreak this year.
Parsons says Ellume's self-test will provide critical support to the United States as it transitions out of the pandemic, delivering rapid, accurate test results and facilitating a safe return to workplaces, educational institutions, and travel.
"As COVID-19 case numbers hit record highs, the world needs access to fast, affordable, easy-to-use home testing," he says.
"Ellume's COVID-19 Home Test delivers this important first line of defence it can be widely available without the need for a prescription, enabling the US to respond to the pandemic in its most urgent stage."
The Ellume COVID-19 home test uses a mid-turbinate nasal swab to detect certain proteins of the virus known as antigens. The FDA says the Ellume test correctly identified 96 per cent of positive samples and 100 per cent of negative samples in individuals with symptoms.
In people without symptoms, the test correctly identified 91 per cent of positive samples and 96 per cent of negative samples.
The test is used in conjunction with an app that is free for download and provides easy-to-read, step-by-step instructions including a how-to-use video. All analysis is performed by the test's electronic analyser, with a result displayed on the user's smartphone within 15 minutes.
Through a secure cloud connection, Ellume's COVID-19 Home Test can provide real-time reporting of test results to health authorities, employers, and educators, for efficient COVID-19 mapping.
Ellume expects to produce more than three million tests in January next year, and 20 million tests in the first half.Never miss a news update, subscribe here. Follow us on Facebook, LinkedIn, Instagram and Twitter.
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