FDA Gives Approval For New At-Home COVID Test Kit

Axios reports:

An at-home coronavirus collection kit made by health care startup Everlywell has received emergency authorization from the Food and Drug Administration, the agency announced Saturday. This is the only kit that can be used with multiple coronavirus tests, although two other at-home swabs have received authorization from the FDA. The swabs collected at home will be sent to labs for diagnosis.

From the announcement:

The Everlywell COVID-19 Test Home Collection Kit permits testing of a sample collected from inside the patient’s nose using the authorized self-collection kit that contains nasal swabs to collect a sample and a tube filled with saline to transport the sample back to a specified lab.

Once patients self-swab to collect their nasal sample, they will ship the sample overnight to a specific CLIA-certified lab that is running one of the in vitro diagnostic molecular tests authorized under a separate EUA for use with the Everlywell at-home sample collection kit.

The labs authorized to test specimens collected using the Everlywell at-home collection kit are Fulgent Therapeutics and Assurance Scientific Laboratories. Results will be returned to the patient through Everlywell’s independent physician network and their online portal.