FDA suspends Gates-backed at-home COVID-19 testing program [View all]
Source: 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 SCANs test, but we have been asked to pause testing until we receive that additional authorization, SCAN said.
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.
Read more: https://www.reuters.com/article/us-health-coronavirus-tests/fda-suspends-gates-backed-at-home-covid-19-testing-program-idUSKBN22S0QA
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