FDA approves first over-the-counter Covid-19 test

The US Food and Drug Administration has authorised emergency use of the first over-the-counter, self-testing Covid-19 antigen kit, which can produce results within 20 minutes.

The test, which was developed by Australia’s Ellume, consists of a nasal swab analyser that connects to an application on users’ smartphones, providing results without sending samples to a laboratory.

The US government, which provided a $30m grant to help develop the technology, hopes the test will help control spread of coronavirus ahead of the rollout of vaccines in 2021.

“Today’s authorisation is a major milestone in diagnostic testing for Covid-19,” said Stephen Hahn, FDA commissioner, adding that home use diagnostics could reduce the burden on hospitals, clinics and laboratories.

“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.”

Last month the FDA authorised the first prescription Covid-19 test for home use.

Experts have identified comprehensive testing as an important tool to slow the spread of the virus in the US and elsewhere. But high demand has put huge pressure on testing centres and laboratories required to process test results.

They hope the new $30 test, if rolled out quickly, could provide people with an alternative and alleviate long delays at testing centres.

Sean Parsons, Ellume chief executive, told the Financial Times that the test would act as a first line of defence against the virus.

“It can be widely available without the need for a prescription, enabling the US to respond to the pandemic in its most urgent stage,” he said.

Ellume plans to ship 100,000 tests per day to the US from next month and to deliver 20m tests within the first half of 2021. Further regulatory authorisations will be sought in Europe next year, the company said.

Mr Parsons, an emergency and intensive care clinician, founded Ellume in 2010 to develop home diagnostics tests.

The company partnered with GlaxoSmithKline to develop an influenza test and German pharmaceutical company Qiagen on a tuberculosis test, both of which are currently awaiting regulatory approval.

When the coronavirus pandemic struck, Ellume focused on producing a Covid-19 test, which uses the same core technology as its influenza and tuberculosis diagnostics.

The FDA said Ellume’s Covid-19 home 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.

Last week the Queensland state government said it would invest A$50m ($38m) in Ellume to increase production of its range of rapid diagnostic tests from 60,000 per day to 200,000 a day.

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