FDA lets Everlywell sell its COVID-19 home collection kit direct to consumers

Everlywell announced today that it received FDA emergency use authorization for its COVID-19 test home collection kit DTC.

Under EUA, the home collection kit made by Everlywell can now be used directly by individuals who are not experiencing symptoms and have no suspected exposure and who are without a doctor’s prescription, according to a news release.

Austin, Texas-based Everlywell received its first EUA for the home collection kit in May 2020 with an indication for use by individuals at home who have been screened using an online questionnaire that is reviewed by a healthcare provider. The collection kit would then be sent to specified laboratories for COVID-19 testing. It launched the kit the following month.

The mail-in home collection kit for COVID-19 testing is suitable for anyone 18 years old and up and is processed using rt-PCR technology to identify the presence of the virus in individuals who are symptomatic or asymptomatic.

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  • February 17, 2021
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FDA authorizes at-home COVID-19 test kit

(Image from Unsplash)

The FDA announced that it issued emergency use authorization for Everlywell’s at-home sample collection kit for COVID-19 diagnostic testing.

Everlywell’s kit has authorization for use by individuals at home who have been screened using an online questionnaire that is reviewed by a healthcare provider. The collection kit can then be sent to specified laboratories for COVID-19 testing.

The FDA also authorized two COVID-19 diagnostic tests (under two separate EUAs) for use with samples collected using the Everlywell COVID-19 home collection kit. The administration is open to authorizing additional tests should data be submitted that demonstrates the accuracy of the test when used with Everlywell’s kit.

Using the Everlywell kit that contains nasal swabs, a sample is collected from inside the patient’s nose and used with a tube filled with saline to tran…

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  • May 18, 2020
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