The FDA announced that it issued emergency use authorization for Everlywell’s at-home sample collection kit for COVID-19 diagnostic testing.
Everlywell’s kit has authorization for use by individuals at home who have been screened using an online questionnaire that is reviewed by a healthcare provider. The collection kit can then be sent to specified laboratories for COVID-19 testing.
The FDA also authorized two COVID-19 diagnostic tests (under two separate EUAs) for use with samples collected using the Everlywell COVID-19 home collection kit. The administration is open to authorizing additional tests should data be submitted that demonstrates the accuracy of the test when used with Everlywell’s kit.
Using the Everlywell kit that contains nasal swabs, a sample is collected from inside the patient’s nose and used with a tube filled with saline to transport the sample back to a specified lab. Patients will ship their samples overnight to a specified laboratory. Currently, Fulgent Therapeutics (Morrisville, N.C.) and Assurance Scientific Laboratories (Birmingham, Ala.) are authorized for use with this kit.
According to an FDA news release, the Everlywell kit is the only authorized COVID-19 at-home sample collection kit for use with multiple authorized COVID-19 diagnostic tests. The kit and tests are available by prescription only.
“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,” FDA Center for Devices & Radiological Health director Dr. Jeffrey Shuren said in the release. “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 FDA previously warned against unauthorized at-home tests that companies, including Everlywell, had been marketing as “for sale” while awaiting authorization.
After announcing in March that it had 30,000 tests ready to ship, Everlywell learned that it would not immediately be able to sell the kits. Following the FDA’s announcement, an Everlywell spokesperson said the company was working directly with the FDA to understand what the agency wanted. Nearly two months later, the company can now officially offer its test kits.
Earlier this month, FDA expanded the previous EUA it granted for the saliva-based COVID-19 test out of Rutgers University — allowing people to collect samples at home and return the samples to the Rutgers Clinical Genomics Laboratory in a sealed package for testing.