WASHINGTON, D.C. – The Food and Drug Administration announced Saturday that it has authorized an at-home sample collection kit that can then be sent to specified laboratories for COVID-19 diagnostic testing.
Specifically, the FDA issued an emergency use authorization (EUA) to Everlywell, Inc. for the Everlywell COVID-19 Test Home Collection Kit.
Everlywell’s kit is authorized to be used by individuals at home who have been screened using an online questionnaire that is reviewed by a health care provider. This allows an individual to self-collect a nasal sample at home using Everlywell’s authorized kit.
Once patients self-swab to collect their nasal sample, they will ship the sample overnight to a specific CLIA-certified lab that is running one of the in vitro diagnostic molecular tests. Results will be returned to the patient through Everlywell’s independent physician network and their online portal.
The FDA has also authorized two COVID-19 diagnostic tests, performed at specific laboratories, for use with samples collected using the Everlywell home collection kit.
The Everlywell home collection kit is currently the only authorized COVID-19 at-home sample collection kit for use with multiple authorized COVID-19 diagnostic tests. The kit and associated tests are available by prescription only.
Additional tests may be authorized for use with the Everlywell at-home collection kit in the future, provided data is submitted in an EUA request that demonstrate the accuracy of each test when used with the Everlywell at-home collection kit.
“The authorization 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,” said Jeffrey Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health. “Today’s action is also another great example of public-private partnerships in which data from a privately funded study was used by industry to support an EUA request, saving precious time as we continue our fight against this pandemic.”