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[Slashdot] - America's FDA Halts Bill Gates-Backed Coronavirus Testing Program

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America's Food and Drug Administration "halted, at least temporarily, a Seattle-based at-home coronavirus testing program backed by Bill Gates," reports Digital Trends: "Please discontinue patient testing and return of diagnostic results to patients until proper authorization is obtained," the FDA told the Seattle Coronavirus Assessment Network (SCAN) in a memo, according to The New York Times. "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," according to an update on the SCAN website. The delay "is the latest evidence of how a splintered national effort to develop, distribute and ramp up testing has left federal regulators struggling to keep up," reports the New York Times: Dr. Eric Topol, the director of the Scripps Research Translational Institute, who is not involved in the Seattle group, said it was "bizarre" that the F.D.A. would halt such a project. The Seattle partnership that is conducting the testing, the Seattle Coronavirus Assessment Network, said in a statement that it had been in conversation with the Food and Drug Administration about its program for about 10 weeks and submitted data a month ago. "We are actively working to address their questions," the group said... 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.... "We had previously understood that SCAN was being conducted as a surveillance study," the spokesperson said.

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