- The US Food and Drug Administration has ordered a Bill Gates-backed coronavirus testing program in Seattle to discontinue indefinitely, The New York Times first reported.
- SCAN, or the Seattle Coronavirus Assessment Network, was testing 300 people a day before it was ordered by the FDA to stop testing, and applications were to be made public soon.
- A partnership between five local medical organizations and funded in part by the Gates Foundation, SCAN had only previously received FDA approval surveillance testing, which does not allow researchers to return test results to patients or doctors.
- Since SCAN researchers returned test results to patients, the FDA specified that its testing protocol would need additional examination before it can receive emergency use authorization (EUA).
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The US Food and Drug Administration has ordered a Bill Gates-backed coronavirus testing program in Seattle to discontinue indefinitely, The New York Times first reported. The testing program, which offered at-home testing kits to Seattle-area residents under authorization from Washington state, was ordered to stop activities and wait for additional approval from the FDA.
SCAN, or the Seattle Coronavirus Assessment Network, was testing 300 people a day before it was ordered by the FDA to stop testing, and applications were to be made public soon. In a May 12 blog post, Gates said that SCAN wasn’t meant to replace widespread federal testing, but to “paint a clearer picture of how COVID-19 is moving through the community, who is at greatest risk, and whether physical distancing measures are working.”
But, on May 14, SCAN’s website posted an update saying the FDA required additional emergency use authorization (EUA) for self-collected coronavirus tests. The update specified that SCAN asked for EUA on April 13. “There are no issues or concerns with the safety and accuracy of SCAN’s test,” the update said.
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Instead, an FDA spokesperson told The Times, the issue seems to be with the categorization and use of SCAN’s tests. The tests are categorized as surveillance tests, which can be used by researchers but cannot be given to patients or doctors for diagnostic purposes. Since SCAN was returning results to patients, the FDA said that the program needed to be subjected to guidelines for diagnostic testing.
SCAN was launched in early March with funding from the Gates Foundation, and was a collaboration between the Seattle and King County Public Health Department, the Brotman Baty Institute, the medicine faculty University of Washington, the Fred Hutchinson Cancer Research Center, and the Seattle Children’s Hospital.
According to Gates’ blog post, the testing program is an extension of an early flu research program he helped found in 2018, the Seattle Flu Study. The Seattle Flu Study, which previously tracked the spread of the flu during the 2018 season, detected the first coronavirus case in the United States in February.
The World Health Organization says widespread testing is necessary for stopping the pandemic. However, numbers show that the US still lags behind other countries in per-capita testing.
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