An at-home coronavirus testing project in Seattle backed in part by the Bill and Melinda Gates Foundation remains in limbo as U.S. regulators on Saturday announced approval of a separate home-based sample collection kit.
The Seattle Coronavirus Assessment Network (SCAN), which aims to monitor the spread of the novel coronavirus in the region, this week said it was suspending its testing of patient samples collected at home after the Food and Drug Administration tightened guidelines to require emergency approval first.
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.