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FDA Authorizes First At-Home Coronavirus Test

The many of us who are unwilling to leave our homes to get a coronavirus test now have a home testing solution authorized by the Food and Drug Administration. The agency announced earlier this week that it has granted Emergency Use Authorization (EUA) for in-home use to Lucira Health's COVID-19 All-In-One test kit.

According to Lucira, a privately held company, the test is a single-use prescription product. Users must be suspected of having an infection by their healthcare provider, and self-administer a nasal swab. They must also be at least 14 years old.

Image source: Getty Images.

The swab is stirred into the unit's sample vial, which is then inserted into the testing unit. After that, the device's light-up display shows a negative or positive result. The kit can apparently produce a result within 30 minutes.

"This new testing option is an important diagnostic advancement to address the pandemic and reduce the public burden of disease transmission," the FDA quoted its commissioner, Stephen Hahn, as saying.

Lucira has not specified a price for the product, although news media reports said it would cost under $50. It is also unclear when it will be generally available to the public, and where and how it will be sold.

Image source: Lucira.

Many diagnostics specialists in the healthcare sector produce coronavirus tests that work in a variety of ways. Becton, Dickinson (NYSE: BDX), for one, has an antigen-based rapid diagnostic that hooks into the company's portable testing device.

The test earned an EUA from the U.S. regulator in July, and last month Becton, Dickinson was authorized to sell the test in Europe.

Perhaps due to the Lucira EUA, Becton, Dickinson stock fell marginally on Thursday, in contrast to the S&P 500 index's gain.

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Eric Volkman has no position in any of the stocks mentioned. The Motley Fool recommends Becton, Dickinson. The Motley Fool has a disclosure policy.


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