04/16/2024: Lab Update: Clarification for A/H5 Influenza Assay Licensing

CDC's Laboratory Outreach Communication System (LOCS)

Audience: Clinical Laboratory Professionals

Level: Laboratory Update

Since identifying a human case of A/H5 Influenza in Colorado in 2022, the CDC Influenza Division (ID) has been collaborating with relevant CDC offices and external commercial manufacturers to prepare the U.S. for commercial manufacturing of A/H5 assays in the event of a public health outbreak response. On April 15, 2024, CDC hosted a Laboratory Outreach Communication System (LOCS) Call which included a situational update and testing guidance for highly pathogenic Avian Influenza A(H5N1) virus. For clarification, CDC will not be providing its inventory of A/H5 tests to commercial diagnostic companies. If commercial developers of diagnostic tests are interested in a royalty-free license to the CDC’s FDA 510K cleared Influenza A/H5 Subtyping Diagnostic assay design, please contact flusupport@cdc.gov for further information.

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The Laboratory Outreach Communication System

Laboratory Outreach Communication System (LOCS) | Division of Laboratory Systems (DLS)

Center for Laboratory Systems and Response (CLSR)

Centers for Disease Control and Prevention (CDC)