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Coronavirus Variants Spur FDA To Write New Guidance For COVID-19 Test Developers

 
• By Shawn M. Schmitt

The US agency’s immediately-in-effect guidance document – released on 22 February – explains how makers of COVID-19 diagnostics can assess whether their tests are impacted by mutations of the virus.

New variant and mutating virus.

A new immediately-in-effect guidance document from the US Food and Drug Administration explains how makers of COVID-19 diagnostics can assess whether their tests are as effective when faced with coronavirus variants.

The guidance for test developers is one of four documents released by the FDA on 22 February. The other...

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