F.D.A. Halts Coronavirus Testing Program Backed by Bill Gates

F.D.A. Halts Coronavirus Testing Program Backed by Bill Gates


SEATTLE — An innovative coronavirus testing program in the Seattle area — promoted by the billionaire Bill Gates and local public health officials as a way of conducting wider surveillance on the invisible spread of the virus — has been ordered by the federal government to stop its work pending additional reviews.

The program involved sending home test kits to both healthy and sick people in the hope of conducting the kind of widespread monitoring that could help communities safely reopen from lockdowns. Researchers and public health authorities already had tested thousands of samples, finding dozens of previously undetected cases.

But the program, a partnership between research groups and the Seattle and King County public health department that had been operating under authorization from the state, was notified this week that it now needs approval directly from the federal government. Officials with the Food and Drug Administration told the partnership to cease its testing and reporting until the agency grants further approval.

“Please discontinue patient testing and return of diagnostic results to patients until proper authorization is obtained,” the F.D.A. wrote in a memo.

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. Amid concerns about the reliability of a burgeoning number of coronavirus antibody tests — which check whether someone may have previously had the virus — the F.D.A. responded last week by ordering companies to submit data proving the tests’ accuracy.



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