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Top FDA Officials Explain Standards For Take-Home COVID-19 Tests

In an op-ed, two top US COVID-19 regulators say they have a lower threshold for sensitivity for take-home tests to encourage development and increase access to them.

FDA entrance sign 2016

Two top US Food and Drug Administration officials say the agency is willing to trade off some accuracy for greater access to allow more take-home COVID-19 tests to come to market. They say getting more Americans back to school and work is worth the trade-off.

Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health, and Tim Stenzel, director of the Office of In Vitro Diagnostics and Radiological Health, penned a 9 September...

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