FDA authorizes Everywell at-home COVID-19 test

The FDA has authorized the first at-home sample collection kit that can be used with multiple authorized COVID-19 lab tests.

The agency issued an emergency use authorization to Everlywell for its COVID-19 Test Home Collection Kit, which allows individuals (screened by their healthcare provider) to self-collect a nasal swab sample.

Separate EUAs were issued for the labs where those samples can be tested: privately held Assurance Scientific Laboratories, and Fulgent Therapeutics (NASDAQ:FLGT).

Results are then returned to the patient through Everlywell’s physician network and its online portal.

Everlywell’s request leveraged data from studies supported by The Bill and Melinda Gates Foundation and UnitedHealth Group.

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