‘Tripledemic’ concerns spur FDA to issue emergency authorization for flu-COVID-19 combination test

Dive Brief:

The Food and Drug Administration has expanded the U.S. COVID-19 testing arsenal ahead of a potentially tough winter, granting an emergency use authorization (EUA) to one flu combination assay and two rapid antigen tests for SARS-CoV-2.
Lucira Health secured the authorization for the combination COVID-19 and flu kit, specifically its nucleic acid amplification test, after achieving at least 90% agreement with highly sensitive tests of the two pathogens.
The FDA also awarded an EUA to antigen tests from Azure Biotech and CorDX, bringing the number of tests and sample collection devices authorized by the agency up to 439.

Dive Insight:

There are conflicting forecasts about how heavy a burden SARS-CoV-2 and other respiratory pathogens will place on the U.S. healthcare system over the coming weeks and months. White House Chief Medical Advisor Anthony Fauci, in what may have been his last appearance in the White House briefing room before retirement, said on Tuesday the Biden administration is optimistic that “we’re not going to see a repeat of what we saw last year.”

At the same time, STAT published an opinion piece by public health practitioners and infectious disease specialists who warned that “a viral hurricane is making landfall” as cases of respiratory syncytial virus, influenza and COVID-19 — the so-called tripledemic — rise simultaneously.

Against that backdrop, the FDA is continuing to authorize more COVID-19 tests for use in the U.S. The authorization of Lucira’s flu-COVID-19 combination test in the latest crop of EUAs adds to the small set of multiplex assays available ahead of a winter in which multiple respiratory pathogens that cause similar symptoms may be circulating at high levels.

“This authorization demonstrates our continued commitment to expand the availability of multiplex tests for COVID-19 and flu and provide a streamlined approach to developers to increase the availability of these types of tests,” Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health, said in a statement.

Shuren added that the regulator stands “ready to authorize additional multi-analyte tests, including at-home tests, to meet current public health testing needs,” indicating that the agency’s door remains open even as it tries to move away from EUAs for many COVID-19 diagnostics.