An at-home coronavirus testing project in Seattle backed in part by the Bill and Melinda Gates Foundation said on Saturday it was working with US regulators to resume the program after being suspended by the Food and Drug Administration.
Testing site for coronavirus disease in Greenwich, Connecticut. (Reuters)
On Thursday, SCAN in a statement said it has been in talks with the FDA since March 1 and initiated its request for emergency use authorization (EUA) on March 23, submitting data on April 13. “We are actively working to address their questions and resume testing as soon as possible,” it said.
Representatives for the Food and Drug Administration did not have an immediate comment on SCAN’s status. Representatives of King County Health Department referred questions to SCAN, which did not immediately respond to a request for comment.
Separately, the FDA on Saturday approved a standalone at-home sample collection kit for Everlywell Inc, a health and wellness company, which launched its kit in March.