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Agency clears first at-home, over-the-counter COVID-19 test

Australia-based Ellume COVID-19 Test Photo: Bloomberg

*The US Food and Drug Administration’s clearance could usher in new crop of more accessible tests as testing has been a key line of defence against the damaging Coronavirus pandemic

Isola Moses | ConsumerConnect

The US regulators Tuesday cleared the first COVID-19 test that can be performed entirely at home, and it can be acquired without a prescription in a non-medical setting.

It was learnt while availability will be limited initially, the new test and others in development could make virus screenings as accessible as over-the-counter pregnancy tests in the country for the first time ever.

The advance follows months of criticism that the Food and Drug Administration has been too slow to approve rapid home tests for the virus.

The kit manufactured by East Brisbane, Australia-based Ellume, is a self-administered, single-use nasal swab test that is small enough to fit in the palm of a person’s hand.

The device detects proteins on the virus’s surface in 15 minutes and delivers results to an app, according to agency report.

Company’s Chief Executive Officer (CEO) Sean Parsons in an interview before the FDA clearance said that the tests will be sold in pharmacies and online for about $30 each. Ellume plans to manufacture 100,000 a day starting in January, the firm said.

The company, which received about $30 million from a National Institutes of Health programme to scale up manufacturing, could have capacity to make a million tests a day by mid-2021, Parsons disclosed.

According to the CEO, “self-testing, from the things we’ve learned along the way, is a good deal harder than it looks.

“This product was designed to be put in the hands of consumers directly, and we believe we have shown comprehensively that users can use it correctly and can interpret the results.”

Testing has been a key line of defence against the virus but throughout the pandemic, US test-seekers have often faced long lines, slow turnaround times and high costs.

Meanwhile, Michael Mina, a Harvard epidemiologist who has called for making inexpensive tests widely available, called the clearance a tremendous advance, although he cautioned that access could remain a problem.

Mina said: “Keeping these tests purely in the free market is a disaster waiting to happen, and reflects an overall lack of public health agency to have a coordinated response.

“These will quickly be bought up by the rich and powerful.”

ConsumerConnect reports that currently, the vast majority of US COVID-19 tests are performed in a medical setting, and they require a prescription, including an at-home test from Lucira Health Inc. cleared by the FDA November 2020.

The regulatory agency recently cleared a test from Laboratory Corp of America Holdings that does not require medical authorisation but must undergo lab processing.

FDA Commissioner Stephen Hahn Tuesday, December 15 called the authorisation a “major milestone in diagnostic testing for COVID-19.”

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