FDA approves first over-the-counter COVID home test

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The first Covid-19 test which can be performed entirely at home was authorized by US regulators on Tuesday and can be acquired without a prescription.

While availability will be limited initially, the new test and others in development could make virus screening as accessible as an over-the-counter pregnancy test in the United States for the first time. Breakthrough follows months of criticism that the Food and Drug Administration has been too slow to approve rapid home tests for the virus.

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

The tests will be sold in drugstores and online for around $ 30 each. Ellume plans to make 100,000 a day starting in January, CEO Sean Parsons said in an interview ahead of FDA clearance. The company, which has received around $ 30 million from a National Institutes of Health program to expand its manufacturing, may have the capacity to do a million tests per day by mid-2021, Parsons said.

“The self-test, from the things we’ve learned along the way, is a lot harder than it looks,” said Parsons. “This product was designed to be put directly into the hands of consumers, and we believe we have comprehensively demonstrated that users can use it correctly and interpret the results.”

Barriers to screening

Testing has been a key line of defense against the virus. Yet, throughout the pandemic, American researchers have often faced long queues, slow turnaround times, and high costs.

Michael mina, a Harvard epidemiologist who called for making cheap tests widely available, called the clearance a big step forward, while warning that access could remain a problem.

“Keeping these tests only on the open market is a disaster waiting to happen, and reflects a general lack of a public health agency to have a coordinated response,” he said. “These will be quickly bought by the rich and powerful.”

Currently, the vast majority of US Covid-19 tests are performed in a medical environment and require a prescription, including a home test from Lucira Health Inc. cleared by the FDA last month. Last week, the agency authorized a test from Laboratory Corp of America Holdings that does not require medical clearance but must undergo laboratory treatment.

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

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 mastered this if we had decided to take a different approach. “

‘Major step’

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

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

The U.S. government has recognized the need to make new types of testing technology available, including through the NIH Rapid Diagnostic Acceleration Program, or RADx, in which Ellume participated. The Department of Health and Human Services and the FDA also sponsored a design. a-thon in November aimed, among other goals, to use technology to solve challenges such as the data collection that come with making testing more accessible.

While the FDA has publishedorientationfor companies scrambling to conduct home testing without a prescription at the end of July, regulators have taken a cautious approach due to concerns about human error and test results not reported to public health officials .

A study by Ellume found that his 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. The results are shared with public health authorities via the accompanying mobile app, with users filling in their zip code and date of birth, the FDA said.

Like Ellume, other companies are also looking to technology solutions to ensure results are properly read and tracked.

‘Scan a check’

Another home Covid-19 test in development by Gauss Surgical Inc. and biotech Cellex uses an artificial intelligence-based mobile app to read the results of a test strip, “like scanning a check for your account. banking, ”said Gauss Chief Managing Director Siddarth Satish. “You can read it as you would expect a trained lab operator to read it.”

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

Cambridge, Massachusetts-based start-up E25Bio’s Covid-19 test can be read visually and a web app will allow users to share their results. Together with a Chinese manufacturing partner, E25Bio can produce tens of millions of tests every month, according to CEO Prashant Chouta.

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