When deciding whether to issue an Emergency Use Authorization (EUA) for a multi-analyte respiratory panel, FDA said it would weigh such factors as the extent to which the test aids differential diagnosis, whether the proposed intended use of the kit meets requirements for the Public Health Emergency Declaration and the panel’s suitability for current patient testing recommendations as put forward by public health authorities. An additional factor, said FDA, is the approval or clearance status of the individual tests within the panel.
In the Q&A, FDA also clarified that multi-analyte panels do not fall within the policies delineated in its Policy for Coronavirus Disease – 2019 Tests. “FDA expects developers of such tests to request and receive an EUA prior to offering or marketing their test,” said the Agency.
In another newly added Q&A, FDA clarified that developers may leverage validation data that was previously used for validation of another test. “FDA values collaboration between developers to reduce the burden for test validation,” so developers may grant right of reference to other developers to use validation data. The new developer must always seek permission for the right of reference from the originating developer, noted the Agency.
The US Centers for Disease Control and Prevention (CDC) has made available the performance data from their own EUA for a coronavirus-influenza multiplex assay for those requesting EUAs for multi-analyte panels that include SARS-CoV-2 tests. Similar right of reference is available for performance data from the earlier EUA for CDC’s 2019-nCoV Real-Time RT-PCR Diagnostic Panel.
Using the CDC’s tests as an example, the Q&A explains that if a developer has a test that is similar to a CDC assay, “they may be able to leverage the CDC’s in silico and cross reactivity data, rather than repeating it.”
Additionally, the Gates Foundation and UnitedHealth Group provided support for availability of swab stability data from a Quantigen Biosciences study. These validation data may be used by all EUA applicants to help support sample stability of both foam and polyester nasal swabs meant to be shipped dry or in saline. The stability data can be used to support EUAs for SARS-CoV-2 molecular diagnostic assays performed on specimens that are self-collected at home and then shipped for analysis.
FDA also updated the list of manufacturers that have validated diagnostic test kits for SARS-CoV-2 and intend to distribute the tests. The list of serology test kit manufacturers was also updated, as was the list of those that have been removed from the notification list and should no longer be offering serology tests.
REFERENCE: RAPS Regulatory Focus (News Articles 2020 9); 09 SEP 2020; Kari Oaks