The Food and Drug Administration (FDA) announced new state authority to authorize diagnostic tests and updated an existing policy to include commercial manufacturers. The agency also issued two additional Emergency Use Authorization (EUA) diagnostics to Hologic for its Panther Fusion SARS-COV-2 Assay and to Laboratory Corporation of America (LabCorp) for its COVID-19 RT-PCR test.
Similar to the authority granted to the New York State Department of Health (NYSDOH), the FDA is now allowing states to approve tests developed and used by laboratories in their state. The FDA details that states can set up a system in which they take responsibility for authorizing the tests, bypassing the need to pursue a EUA.
Additionally, the FDA updated an existing policy (WHG summary) to include commercial manufacturers and allow for the use and distribution of these diagnostic tests prior to a EUA being granted. The agency will allow manufacturers to validate and distribute their diagnostic test, while they are simultaneously preparing an EUA request. Manufacturers are granted 15 days from the point of validation to submit the EUA request to the FDA. The manufacturers must also provide instructions for the use of the test and post data about the test’s performance characteristics on their website.
The updated policy also includes recommendations for test developers who choose to develop validated serological tests for use during the COVID-19 outbreak. Serological tests measure the amount of antibodies present in the blood and can be used to identify antibodies to SARS-COV-2. The agency notes that results from serological tests should not be used as the sole basis to diagnose or exclude SARS-COV-2 infection or to inform infection status.