Agency to Provide Emergency Clearance for Multi-Analyte Respiratory Panels

We are now seven months into the COVID-19 public health emergency and flu season is rapidly approaching. Several diagnostics test producers have responded to this convergence by creating new multi-analyte tests that are capable of detecting (and differentiating) not only SARS-CoV-2 but also influenza and other respiratory viral infections. And while the U.S. Food and Drug Administration (FDA) has issued emergency use authorization (EUA) for SARS-CoV-2 assays, it had previously been unclear whether it would do the same for the multi-analyte tests. But now the FDA has confirmed that, yes, it will provide EUA for these tests.

As it customarily does, the FDA initiated this new policy not via regulation but informal guidance by posting a new Q&A to its website Questions & Answers for COVID-19 testing laboratories and test manufacturers. The new QA, which was posted on Sept. 9, notes “the overlap in signs and symptoms between SARS-CoV-2 and other respiratory viral infections, including influenza.” Multi-analyte panels capable of detecting and sorting out different viruses “are useful when multiple respiratory pathogens are circulated at the same time, as is expected with the upcoming flu season.” Tests that can kill two birds with one stone (our phrase, not the FDA’s) are also an efficient use of resources during the pandemic.

The FDA also listed the factors it would consider in deciding whether to issue an EUA for such tests, including:

• The extent to which the test aids differential diagnosis;
• Whether the proposed use meets the requirements for the public health emergency declaration;
• The panel’s suitability current patient testing recommendations by public health authorities; and
• The approval or clearance status of the individual tests in the panel.

Here are other key new FDA EUAs and clearances announced in late August through mid-September:

New FDA Emergency Use Authorizations (EUAs) & Approvals