FDA suspends Gates-backed at-home COVID-19 testing program

(Reuters) – 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 U.S. regulators to resume the program after being suspended by the Food and Drug Administration.

The Seattle Coronavirus Assessment Network (SCAN), which aims to monitor the spread of the novel coronavirus in the region, had 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.

“The FDA has not raised any concerns regarding the safety and accuracy of SCAN’s test, but we have been asked to pause testing until we receive that additional authorization,” SCAN said.

The Gates Foundation in March said it was providing technical assistance for SCAN, which had been approved by regulators in Washington state, one of the first U.S. states to be hit hard by the outbreak. Bill Gates has also privately funded SCAN, according to the foundation.

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 have been notified that a separate federal emergency use authorization is required to return results for self-collected tests,” SCAN 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. SCAN said it did not have an update on specific timing for when testing would restart.

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.