FDA halts Bill Gates coronavirus testing program
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.
Gates, the billionaire founder of Microsoft who has dedicated much of his personal fortune to global health issues, said the program could be an effective tool in guiding public health responses.
“Not only will it help improve our understanding of the outbreak in Seattle, it will also provide valuable information about the virus for other communities around the world,” Gates wrote in a blog post this week.
An FDA spokesperson told The New York Times, which was the first to report on the pause, that the home testing kits raised concerns over safety and accuracy of the results.