FDA approves first at-home, over-the-counter COVID test

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The first Covid-19 test that can be performed entirely at home was cleared by U.S. regulators on Tuesday, and it can be acquired without a prescription.

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

Manufactured by East Brisbane, Australia-based Ellume, the self-administered, single-use nasal swab test is small enough to fit in the palm of a person’s hand. It detects proteins on the virus’s surface in 15 minutes and delivers results to an app.

Tests will be sold in pharmacies and online for about $30 each. Ellume plans to manufacture 100,000 a day starting in January, Chief Executive Officer Sean Parsons said in an interview before the FDA clearance. The company, which received about $30 million from a National Institutes of Health program to scale up manufacturing, could have capacity to make a million tests a day by mid-2021, Parsons said.

“Self-testing, from the things we’ve learned along the way, is a good deal harder than it looks,” Parsons said. “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.”

Screening Obstacles

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

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.

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

Currently, the vast majority of U.S. Covid-19 tests are performed in a medical setting and require a prescription, including an at-home test from Lucira Health Inc. cleared by the FDA last month. Last week, the agency cleared a test from Laboratory Corp of America Holdings that doesn’t require medical authorization but must undergo lab processing.

Tests that cost $5 or $10 “are possible and coming, and I’d love to see them, because you need both a low price point so lots of people use it and you need plenty of production,” said Ashish Jha, dean of the Brown University School of Public Health.

Still, “we should have had this in May, June,” Jha said in an interview. “We could have ended this pandemic in America. We could have brought this under control if we had decided to pick a different approach.”

‘Major Milestone’

FDA Commissioner Stephen Hahn on Tuesday called the authorization a “major milestone in diagnostic testing for Covid-19.”

While Ellume’s product isn’t as accurate as a lab-based test, “the fact that it can be used completely at home and return results quickly means that it can play an important role in response to the pandemic,” Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health, said in a release. A small portion of positive and negative results from the test could be inaccurate, the FDA said.

The U.S. government has recognized a need to make new kinds of testing technologies available, including through the NIH’s Rapid Acceleration of Diagnostics program, or RADx, which Ellume took part in. The Department of Health and Human Services and the FDA also sponsored a design-a-thon in November aimed, among other goals, at using technology to resolve challenges like data collection that accompany making testing more accessible.

While the FDA put out guidance for companies working to make home-based, non-prescription tests in late July, regulators took a cautious approach because of concerns about human error and test results going unreported to public-health officials.

A study run by Ellume found that its test produced accurate results more than 90% of the time in people with and without symptoms, including correctly identifying 96% of positive samples from symptomatic individuals. Results are shared with public-health authorities through the accompanying mobile app, with has users fill out their zip code and date of birth, the FDA said.

Like Ellume, some other companies are also turning to technological solutions to ensure results are read correctly and tracked.

‘Scanning a Check’

Another at-home Covid-19 test being developed by Gauss Surgical Inc. and the biotech Cellex uses an artificial intelligence-powered mobile app to read the results from a test strip, “like scanning a check for your banking account,” said Gauss Chief Executive Officer Siddarth Satish. “You can read it the way you might expect a trained laboratory operator to read it.”

The Gauss and Cellex test kit will cost $30 to $40 initially, with plans to produce a million tests in December and 10 million by the end of January, Satish said. The companies are working with a partner to report results to public-health departments.

Cambridge, Massachusetts-based startup E25Bio’s paper strip Covid-19 test, meanwhile, can be read visually, and a web app will allow users to share their results. Working with a Chinese manufacturing partner, E25Bio can produce tens of millions of tests each month, according to Chief Executive Officer Prashant Chouta.

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