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Stopped It

Outside experts have criticized the recent decision by the US Food and Drug Administration to stop an effort aimed at halting the spread of SARS-CoV-2 in the Seattle area, Stat News reports.

In early March, the Bill & Melinda Gates Foundation announced that it was going to fund home SARS-CoV-2 testing kits for Seattle. This effort, dubbed the Seattle Coronavirus Assessment Network, grew out of the Seattle Flu Study at the University of Washington that was tracking the spread of influenza, but changed gears to focus on the coronavirus, as the Seattle Times then noted.

But the New York Times reported earlier this month that the project, which was sending those testing kits to both healthy and sick people and had been operating with state approval, was informed it needed the OK from federal officials as well. In particular, the agency tells Stat News that the project didn't have the needed Emergency Use Authorization or institutional review board approval. Stat News adds that the project appears to have misinterpreted the FDA guidance on home testing, which had shifted throughout the early stages of the pandemic.

Still, experts tell it that the agency's move to shut the program down wasn't necessary, as it could have instructed SCAN to re-apply for ethics approval. "The FDA's position here is untenable," Eric Topol, director of the Scripps Research Translational Institute, which also has a coronavirus tracking effort, tells it. "If they really wanted to foster progress rather than take down our best academic effort to study this virus, that's what they would do."

The Scan

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