SEATTLE -- An innovative coronavirus testing program in the Seattle area -- promoted by 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
SEATTLE — An innovative coronavirus testing program in the Seattle area — promoted by 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.
“Please discontinue patient testing and return of diagnostic results to patients until proper authorization is obtained,” the FDA wrote in a memo. Dr. Eric Topol, director of the Scripps Research Translational Institute, who is not involved in the Seattle group, said it had “emerged as leading lights in this whole COVID-19 crisis.” He said it was “bizarre” that the FDA would halt such a project.
Gates, the Microsoft co-founder who has committed much of his wealth to global public health issues, has backed the Seattle study. He said in a blog post Tuesday that the program can detect cases and help guide public health responses. The two kinds of testing — surveillance and diagnostic — fall under different FDA standards. In a pure surveillance study, the researchers may keep the results just for themselves. But coronavirus testing has largely revolved around getting results returned to doctors who can share the results with patients.
Topol said it would not make sense to have people swab their noses for possible coronavirus and then not give them the results.At-home testing kits have been touted as a valuable alternative to in-office or drive-thru testing because they do not require a clinician to risk exposure when swabbing a symptomatic patient’s nose. They have also emerged at a time when public health leaders are looking for ways to rapidly expand testing to look for hot spots and trends.
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