FDA Suspends Gates Supported COVID-19 Trial Program


FILE PHOTO: The ultrastructural morphology presented by the Novel Coronavirus 2019 (2019-nCoV), which has been identified as the cause of an epidemic of respiratory disease detected for the first time in Wuhan, China, can be seen in a published illustration by the Centers for Disease Control and Prevention (CDC) in Atlanta, Georgia, USA, January 29, 2020. Alissa Eckert, MS; Dan Higgins, MAM / CDC / Document to distribute via REUTERS / File Photo

(Reuters) – A Seattle home coronavirus testing project supported in part by the Bill and Melinda Gates Foundation said 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 new coronavirus in the region, said it was suspending testing of patient samples taken at home after the Food and Drug Administration tightened its guidelines for require emergency approval.

“The FDA did not raise any concerns regarding the safety and accuracy of the SCAN test, but we were asked to suspend the test until we receive this additional authorization,” said SCAN.

In March, the Gates Foundation said it was providing technical assistance to SCAN, which had been approved by regulators in Washington State, one of the first states in the United States to be hit hard by the epidemic. According to the foundation, Bill Gates also privately funded SCAN.

SCAN said in a statement on Thursday that it has been in talks with the FDA since March 1 and launched its Emergency Use Clearance (EUA) application on March 23, submitting data on April 13.

“We have been advised that a separate federal emergency use authorization is required to return the results of the self-collected tests,” said SCAN.

Food and Drug Administration officials did not immediately comment on the status of SCAN. Representatives from the King County Health Department referred questions to SCAN. SCAN has indicated that it does not have an update on when to restart testing.

The FDA also approved an autonomous home sample collection kit for Everlywell Inc., a health and wellness company, which launched the kit in March.

Report by Maria Pinezhath in Bengaluru and and Susan Heavey in Washington; Editing by Matthew Lewis

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