Everlywell's at-home collection kit for COVID-19 testing gains FDA clearance

The FDA announced Saturday that Everlywell's at-home sample collection kit for COVID-19 diagnostic testing gained emergency-use authorisation (EUA). Specifically, the Everlywell COVID-19 Test Home Collection Kit has been approved for use by individuals at home who have been screened using an online questionnaire that is reviewed by a health-care provider.

The FDA noted that it has also authorised two COVID-19 diagnostic tests, performed at specific laboratories, for use with samples collected using the Everlywell COVID-19 Test Home Collection Kit. The first is Laboratory Corporation of America's COVID-19 RT-PCR Test, which uses a sample collected from the patient's nose with a nasal swab and transported in saline, while the second is Rutgers Clinical Genomics Laboratory's laboratory developed test, which permits testing of a saliva sample collected by the patient at home.

"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," remarked Jeffrey Shuren, director of the FDA's Center for Devices and Radiological Health.

According to the agency, once patients self-swab to collect their nasal sample with the Everlywell kit, the sample is shipped to a specific CLIA-certified laboratory that is running either LabCorp or Rutgers Clinical Genomics' in vitro diagnostic molecular tests. The FDA indicated that the laboratories able test specimens collected using the Everlywell at-home collection kit are Fulgent Therapeutics and Assurance Scientific Laboratories.

Everlywell spokeswoman Christina Song further explained that consumers will first take an online screening survey to determine whether they meet federal guidelines for the test, with the survey then being reviewed by health-care providers affiliated with PWNHealth, the company’s telemedicine partner. "From the moment that you hit the order button, to the moment that you get the test results on your phone or device, that process is designed to take three to five days," Song added. She indicated that the test kits will be available later this month at a cost of $135.