The FDA’s Latest Initiative to Break the COVID-19 Rapid Diagnostics Bottleneck

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As the pandemic has evolved, so has the FDA’s perspective on moving tests for COVID-19 from laboratories to rapid point-of-care and home settings. Critics contend that the agency hasn’t moved fast enough, but FDA diagnostics chief Timothy Stenzel emphasizes the need to balance multiple interests and that submissions for home tests have been slow in coming. FDA believes its latest template streamlining claims for asymptomatic screening should ease lingering industry concerns.

Widespread use of accessible, inexpensive rapid point-of-care (POC) and at-home COVID-19 tests are a cornerstone of multiple strategies for getting the US and rest of the world back on track from the pandemic. Experts agree that large populations of asymptomatic people need to be screened for COVID-19 routinely if society is to go about its normal activities safely.

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