Gates-backed at-home COVID tests await approval as U.S. FDA OKs separate kit

(Reuters) - 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

Reuters May 17, 2020 00:05:49 IST
Gates-backed at-home COVID tests await approval as U.S. FDA OKs separate kit

Gatesbacked athome COVID tests await approval as US FDA OKs separate kit

(Reuters) - 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.

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 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.

(Reporting by Maria Ponnezhath in Bengaluru and and Susan Heavey in Washington; Editing by Matthew Lewis)

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