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FDA Halts Bill Gates-Backed COVID-19 Testing Program

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FDA Halts Bill Gates-Backed COVID-19 Testing Program

About a month after Bill Gates criticized President Trump's decision to suspend funding to the World Health Organization (WHO), the federal government has just halted a Seattle-based COVID-19 testing program backed by Gates. 

What are the odds, right?

"Please discontinue patient testing and return of diagnostic results to patients until proper authorization is obtained," the Food & Drug Administration (FDA) wrote in a memo, addressed to the Seattle Coronavirus Assessment Network (SCAN), according to The New York Times.

SCAN posted an update on its website on Thursday (May 14) describing how the FDA had asked it to "pause" testing while it receives further guidance on new procedures for its COVID-19 test kits that collect samples at home. 

The FDA "recently clarified its guidance for home-based, self-collected samples to test for COVID-19. We have been notified that a separate federal emergency use authorization (EUA) is required to return results for self-collected tests," the post read.

"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 authorization." 

An FDA spokesperson told The Times, the home collection test kits raised some concerns about "safety and accuracy that required the agency's review." 

The issue in the Seattle case appears to be that the test results are being used not only by researchers for surveillance of the virus in the community but that the results are also being returned to patients to inform them.

The two kinds of testing — surveillance and diagnostic — fall under different F.D.A. standards. In a pure surveillance study, the researchers may keep the results just for themselves. But coronavirus testing has largely revolved around getting results returned to doctors who can share the results with patients.

"We had previously understood that SCAN was being conducted as a surveillance study," the spokesperson said.

SCAN is backed by The Bill and Melinda Gates Foundation and the University of Washington Medicine. The testing program was sending free test kits to participants' homes in the Seattle Metropolitan Area, with the goal of testing people in the region to get a sense of how the virus was spreading through the community. 

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from About a month after Bill Gates criticized President Trump's decision to suspend funding to the World Health Organization (WHO), the federal government has just halted a Seattle-based COVID-19 testing program backed by Gates. 

What are the odds, right?

"Please discontinue patient testing and return of diagnostic results to patients until proper authorization is obtained," the Food & Drug Administration (FDA) wrote in a memo, addressed to the Seattle Coronavirus Assessment Network (SCAN), according to The New York Times.

SCAN posted an update on its website on Thursday (May 14) describing how the FDA had asked it to "pause" testing while it receives further guidance on new procedures for its COVID-19 test kits that collect samples at home. 

The FDA "recently clarified its guidance for home-based, self-collected samples to test for COVID-19. We have been notified that a separate federal emergency use authorization (EUA) is required to return results for self-collected tests," the post read.

"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 authorization." 

An FDA spokesperson told The Times, the home collection test kits raised some concerns about "safety and accuracy that required the agency's review." 

The issue in the Seattle case appears to be that the test results are being used not only by researchers for surveillance of the virus in the community but that the results are also being returned to patients to inform them.

The two kinds of testing — surveillance and diagnostic — fall under different F.D.A. standards. In a pure surveillance study, the researchers may keep the results just for themselves. But coronavirus testing has largely revolved around getting results returned to doctors who can share the results with patients.

"We had previously understood that SCAN was being conducted as a surveillance study," the spokesperson said.

SCAN is backed by The Bill and Melinda Gates Foundation and the University of Washington Medicine. The testing program was sending free test kits to participants' homes in the Seattle Metropolitan Area, with the goal of testing people in the region to get a sense of how the virus was spreading through the community. 

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