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Some COVID-19 Molecular Diagnostics Can Skip Forward To Market For Pooled Screening

The US FDA says as long as the EUA-authorized tests provide a notification with validation data and procedural information, they can be used for pooled serial screening before additional review.

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The US Food and Drug Administration has issued an amendment for COVID-19 molecular diagnostic tests that already have an emergency use authorization to allow them to be used in pooled serial screening as long as the manufacturer can provide validation data and procedural information.

Pooled serial screening allows multiple specimens from a group of people to be collected and tested together. If the SARS-CoV-2...

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