- FDA has for the first time authorized multiple laboratories to test for coronavirus in nasal samples collected by consumers using an at-home kit.
- In an emergency use authorization issued Friday to Everlywell, FDA has permitted consumers to self-collect nasal specimens with the kit for analysis at designated, Clinical Laboratory Improvement Amendment-certified laboratories, using two COVID-19 diagnostics approved under separate EUAs. Fulgent Therapeutics and Assurance Scientific Laboratories are currently authorized to test the samples.
- Friday's authorization by the agency follows earlier EUAs that allowed LabCorp and Rutgers Clinical Genomics Laboratory to collect at-home specimens for analysis at their own labs.
The LabCorp and Rutgers authorizations made it possible for some people with suspected SARS-CoV-2 infections to provide samples from home. However, FDA only authorized LabCorp and Rutgers to test specimens collected at home in their own laboratories. That means LabCorp and Rutgers are unable to ship samples collected using their kits to third parties for analysis, limiting at-home testing capacity.
Everlywell was one of several companies that sought to provide at-home testing in the U.S. early in the COVID-19 crisis. However, FDA put the kibosh on those plans in March by stating at the time that its coronavirus testing guidelines "do not apply to at-home testing." The agency statement was in reaction to "unauthorized fraudulent test kits" that were being marketed to consumers to test for the virus at home.
FDA's statement prompted Everlywell to donate its tests to hospitals and healthcare systems while working to gain authorization to provide its at-home sample collection kits to the wider public. Everlywell received that authorization late last week.
The EUA goes some way to lessening at-home capacity constraints. With the Everlywell authorization, FDA has, for the first time, permitted multiple laboratories to test specimens gathered using an at-home sample collection kit.
Fulgent Therapeutics and Assurance Scientific Laboratories are currently authorized to test specimens collected using the Everlywell kit. The EUA leaves the door open for more sites to analyze samples collected using the kit, stating only that labs must be CLIA-certified to run high complexity tests, designated by Everlywell and use a FDA-authorized nucleic acid amplification test.
So far, FDA has authorized two COVID-19 diagnostic tests to be performed at the labs using samples collected with the Everlywell kit. Additional tests may be authorized in the future for use with the kit "provided data are submitted in an EUA request that demonstrate the accuracy of each test," according to the agency.
Everlywell secured its EUA with a filing that addressed concerns about the ability of people to take samples at home and the stability of specimens sent in the mail. To validate its approach to sample collection, the company cited several years of data on its other at-home test kits that showed 95% are returned to labs successfully. Everlywell used third-party data to address stability concerns.
In conjunction with the EUA, Everlywell has created instructions to guide people through the sample collection process. The document details how to collect and identify a sample, and how to safely send it to a laboratory for analysis.
Everlywell is working with third-party physician network PWN Health on the program. PWN has put together a screening process to assess if someone is eligible for at-home testing. If a person clears the screening process, PWN will write their prescription for testing and contact them if their result is positive or inconclusive. PWN will notify people who test negative by email, phone or online portal.