US FDA suspends Covid-19 at-home research program backed by Bill Gates

US FDA suspends Covid-19 at-home research program backed by Bill Gates

An at-home coronavirus research project in Seattle partially backed by the Bill and Melinda Gates Foundation said it was collaborating with U.S. officials to restart the program after being halted by the Food and Drug Administration on Saturday. The Seattle Coronavirus Assessment Network (SCAN), which seeks to track the spread of the region’s novel coronavirus, said it had halted its testing of patient samples obtained at home after the Food and Drug Administration had updated requirements to allow first emergency approval.

“The FDA has not raised any concerns about the safety and accuracy of the SCAN test, but we were asked to pause testing until we get that additional authorization,” SCAN said. In March, the Gates Foundation said it was offering technical assistance to SCAN, which had been approved by regulators in the state of Washington, one of the first U.S. states hard hit by the outbreak. Bill Gates has also privately funded SCAN, according to the foundation.

SCAN said in a statement on Thursday that it has been in talks with the FDA since 1 March and initiated its request for authorization for emergency use (EUA) on 23 March, with data submitted on 13 April. “We have been told that a separate authorization for federal emergency use is needed to return the results for self-collected tests,” SCAN said. Food and Drug Administration officials did not have an immediate response on the status of Check. King County Health Department officials referred questions to Search. SCAN said it didn’t have an update on specific timing when it would restart testing.