The Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) to Everlywell, Inc for the Everlywell COVID-19 Test Home Collection Kit.
The kit will be available only by prescription to individuals who have been screened using an online questionnaire that is reviewed by a healthcare provider. The kit includes nasal swabs for individuals to collect samples and a tube filled with saline to transport samples back to a specified CLIA-certified lab.
Individuals will be notified of their results through Everlywell’s independent physician network and online portal within 48 hours of the laboratory receiving the samples. Fulgent Therapeutics and Assurance Scientific Laboratories have been designated as the labs authorized to test specimens collected using the Everlywell kit. According to the FDA, additional tests and labs may be authorized for use with the Everlywell kit in the future.
“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, MD, JD, 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.”
The Company expects to have the kit available for individual purchase by the end of the month.
Previously, the FDA issued EUAs to Laboratory Corporation of America (LabCorp) COVID-19 RT-PCR Test that allows for testing of nasal samples self-collected by patients at home using the Pixel by LabCorp COVID-19 Test home collection kit and the TaqPath SARS-CoV-2 Assay, which allows for at-home collection of saliva samples that are tested at the Rutgers Clinical Genomics Laboratory.
For more information visit everlywell.com.