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    May 31

  • 04:52 PM

SCAN testing shut down by FDA

REUTERS,

Added 17 May 2020

tracking-corona

A scanning electron micrograph of an apoptotic cell (blue) infected with SARS-COV-2 virus particles (red), also known as novel coronavirus, isolated from a patient sample. Image captured at the NIAID Integrated Research Facility (IRF) in Fort Detrick, Maryland. National Institute of Allergy and Infectious Diseases, (Reuters)

SEATTLE – 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 United States regulators to resume the programme after being suspended by the Food and Drug Administration (FDA).

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 authorisation,” 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 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 authorisation (EUA) on March 23, submitting data on April 13.

“We have been notified that a separate federal emergency use authorisation 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.

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. (Reuters)

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