FDA to Issue Emergency Use Authorization for Multi-Analyte Respiratory Panels During the Pandemic

The convergence of flu season with the global COVID-19 pandemic will create the need for new multi-analyte respiratory panel tests that are capable of not only detection of but also differentiation among influenza, SARS-CoV-2 and other respiratory viral infections. And now the Food and Drug Administration (FDA) has paved the way by allowing test makers to request emergency use authorization for such tests. Background & Context During a public health emergency, the FDA has authority to relax its usual premarket scrutiny and clear lab tests capable of diagnosing the particular pathogen involved on an expedited basis. This is called emergency use authorization (EUA) and literally hundreds of COVID-19 tests have received it since the pandemic began. But what had been unclear to this point is whether the agency can grant EUA clearance to multi-analyte panels targeting not only SARS-CoV-2 but also other respiratory viruses. What the FDA Guidance Says As it often does, the FDA decided to address this issue not via regulation but informal guidance by adding a new Q&A to its list of Questions & Answers for COVID-19 testing labs and test manufacturers making it clear that EUAs can be issued for multi-analyte respiratory panels during the pandemic. The new QA, which the agency posted on its website 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. Takeaway The new guidance is certainly welcome news for multi-analyte respiratory panel test makers like Luminex, Qiagen and Roche. But labs and manufacturers will still have to apply to the agency for EUA. The FDA 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.