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

The program allows people in the Seattle area to easily take a coronavirus test at home. Researchers say such testing is essential for future monitoring of the virus. The Centers for Disease Control and Prevention also provided an in-person technical adviser to the project.

A nasal swab is opened for a demonstration of a coronavirus test kit being used in the Seattle area.
Credit…Grant Hindsley for The New York Times

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.

“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.

But the Seattle program does not test for antibodies and has wide backing, including from public health leaders, the Fred Hutchinson Cancer Research Center and Mr. Gates, whose foundation has been deeply involved in fighting the pandemic. The Centers for Disease Control and Prevention also provided an in-person technical adviser to the project.