A coronavirus testing program promoted by the billionaire Bill Gates as a way of conducting wider surveillance on the spread of the virus has been shut down by the federal government pending further reviews.
Per the NY Times, 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 Hill reports the Food and Drug Administration (FDA) halted a coronavirus testing program promoted by billionaire Bill Gates and Seattle health officials pending reviews.
The program sought to send test kits to the homes of people both healthy and sick to try to bring the country to the level of testing officials say is necessary before states can begin safely reopening. The program, which had already gone through thousands of tests, found dozens of cases that had been previously undiagnosed.
The Seattle Coronavirus Assessment Network (SCAN) said on its website that the FDA had asked it to pause testing while it receives additional authorizations, but maintained its procedures are safe.
“[T]he Food & Drug Administration (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 program said. “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.”
The pause is emblematic of the fractured national response to the coronavirus, with federal officials proposing guidelines but leaving much of the implementation and administering of tests to states and localities.
Concerns have recently arisen over the reliability of coronavirus antibody tests, which can gauge if someone previously had the illness. However, the SCAN tests do not test for antibodies, and the program said it is working to get back up and running.
“We are actively working to address their questions and resume testing as soon as possible,” the program said.