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FDA Approves Over-The-Counter Coronavirus Test

"Today's authorization is a major milestone in diagnostic testing for COVID-19."

12. 15. 20 / Dan Robitzski
Ellume Health
Image by Ellume Health

On Tuesday, the U.S. Food and Drug Administration (FDA), the regulatory body that evaluates and regulates new pharmaceuticals, approved its first over-the-counter test for COVID-19.

The test, developed by the biotech firm Ellume Health, is the first entirely at-home diagnostic for the coronavirus that doesn’t require a doctor’s prescription. Given that many parts of the country still face long lines for tests or only dole them out at a doctor’s appointment, the authorization of this nasal swab test could mark the beginning of improved access to testing and a clearer look at the scope of the pandemic.

“Today’s authorization is a major milestone in diagnostic testing for COVID-19,” FDA Commissioner Dr. Stephen Hahn said in a press release. “By authorizing 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.”

It could be a major step forward — and hopefully one that will make testing much simpler and safer for people who fear they may have caught the coronavirus.

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“As we continue to authorize additional tests for home use, we are helping expand Americans’ access to testing, reducing the burden on laboratories and test supplies, and giving Americans more testing options from the comfort and safety of their own homes,” Hahn said in the release.

But the test still isn’t a perfect solution, the FDA warns.

Ellume’s test correctly identified 96 percent of coronavirus-positive samples and 100 percent of negative samples taken from patients with symptoms. But those numbers dropped for asymptomatic patients, only identifying 91 percent of positive samples and 96 percent of the negative.

Those numbers aren’t bad by any means, especially since the test gives results in just 20 minutes. But, at the same time, they’re far from perfect.

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