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Roche Diagnostics gets OK from FDA to mass-produce at-home COVID-19 test

The tests are good for individuals 2 and older and yield results in 20 minutes.

INDIANAPOLIS — Tens of millions.

That’s how many rapid COVID-19 tests Indianapolis-based Roche Diagnostics plans to make, now that they have the green light from the Food and Drug Administration. 

The FDA granted emergency use authorization Friday for an at-home COVID-19 test developed by Roche.

The test is for individuals ages 2 and older and can be collected and tested at home via nasal swab, with results in 20 minutes. According to Roche, the test gives results for all COVID-19 variants, including omicron.

The test is intended to be used by individuals within the first six days of experiencing COVID-19 symptoms. The test is also designed for individuals without symptoms, but they should take two tests in a three-day period, with at least 24 hours between the tests for the most accurate results.

In the wake of nationwide shortages, the FDA prioritized authorizing the test kits after President Joe Biden announced a plan to send 500 million at-home rapid tests to American homes next year. The pharmaceutical company said the tests will be made available across the United States in January, and it has the capacity to produce tens of millions of tests each month.

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“This over-the-counter test will not need a prescription and it is available for use to those with symptoms within the first 6 days,” said Doctor Jamie Phillips with Roche. 

Here’s how it works:

The test uses a nasal swab and can test anyone over 2. Results are ready within 15 minutes. 

“We know the cases are increasing due to Omicron circulating and so having these tests available as over the counter, meaning a prescription is not needed, we hope it will aid with reducing the number of infections,” said Phillips. 

According to Phillips, manufacturing has already started and the tests could be on the shelves by the end of January. 

"Expanding access to rapid testing solutions for all patients in the United States is essential to public health and the pandemic response," said Matt Sause, president and CEO of Roche Diagnostics North America. "As long as there remains a need for reliable testing, Roche will continue to invest in effective solutions to ensure there are testing options available to those who need them."

The tests will be produced in partnership with SD Biosensor Inc., which has previously launched similar antigen tests in other countries. This is the first time Roche has received emergency use authorization for a rapid antigen COVID test.

MORE: At-home COVID-19 test kits in short supply

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