FDA moves to streamline development of molecular diagnostic tests for sample pooling, POC and respiratory diseases

The U.S. Food and Drug Administration (FDA) has updated the Molecular Diagnostic templates on FDA.gov, according to its website.  

The Molecular Diagnostic templates include recommendations for laboratories and commercial manufacturers who may use the templates to help facilitate the preparation and submission of requests for emergency use authorization (EUA) for tests for use: 

·       With sample pooling,

·        In point of care, and

·        For detection and differentiation of SARS-CoV-2 and other respiratory organisms, such as the viruses that cause influenza. 

FDA has the information.

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