At a glance
- Level: Laboratory Update
- Audience: Clinical Laboratory Professionals
A/H5 influenza assay licensing for commercial manufacturers
Since identifying a human case of A/H5 Influenza in Colorado in 2022, the ÐÇ¿ÕÓéÀÖ¹ÙÍø Influenza Division (ID) has been collaborating with relevant ÐÇ¿ÕÓéÀÖ¹ÙÍø 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, ÐÇ¿ÕÓéÀÖ¹ÙÍø 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, ÐÇ¿ÕÓéÀÖ¹ÙÍø 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 ÐÇ¿ÕÓéÀÖ¹ÙÍø's FDA 510K cleared Influenza A/H5 Subtyping Diagnostic assay design, please contact [email protected] for further information.
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Thank you,
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 (ÐÇ¿ÕÓéÀÖ¹ÙÍø)