Everlywell's At-Home COVID-19 Nasal Swab Test Kit Gets FDA Nod

17 May 2020


New York: Health and wellness company Everlywell's at-home COVID-19 testing kit that allows people to self-collect a nasal sample at home and send it to specified laboratories for diagnostic testing has received an emergency use authorisation from US Food and Drug Administration (FDA).

The kit and associated tests are available by prescription only, the FDA said on Saturday.

"The authorisation of a COVID-19 at-home collection kit that can be used with multiple tests at multiple labs not only provides increased patient access to tests, but also protects others from potential exposure," Jeffrey Shuren, Director of the FDA's Center for Devices and Radiological Health, said in a statement.

The FDA also authorised two COVID-19 diagnostic tests, performed at specific laboratories, for use with samples collected using the Everlywell home collection kit.

Results will be returned to the patient through the company's independent physician network and their online portal.

Everlywell's emergency use authorisation request leveraged data from studies supported by The Bill and Melinda Gates Foundation and UnitedHealth Group to demonstrate stability of specimens during shipping.

This announcement follows two recent emergency clearance for diagnostic tests that also use at-home specimen collection -- one that uses a sample collected from the patient's nose with a nasal swab and transported in saline and another that permits testing of a saliva sample collected by the patient at home.