FDA approves at-home coronavirus sample kit, suspends Gates-backed test
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.
By REUTERSHealth workers start the process to test people in a car as they use a newly approved saliva-based coronavirus disease (COVID-19) test at a testing site during the outbreak of the coronavirus disease (COVID-19) in Edison, New Jersey, U.S., April 15, 2020(photo credit: REUTERS/EDUARDO MUNOZ)
The US Food and Drug Administration (FDA) on Saturday approved a standalone at-home sample collection kit for COVID-19 diagnostic testing.The regulator has given an emergency use authorization (EUA) to Everlywell Inc, a health and wellness company, for its COVID-19 test home collection kit.Everlywell launched the COVID-19 at-home collection kit in March.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.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 US 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.
