The COVID De Novo Path Blazed by BioFire

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Executives at BioFire Diagnostics talk with Market Pathways about their route to the first de novo authorization of a SARS-CoV-2 test, a potential predicate for the hundreds of molecular COVID-19 assays with Emergency Use Authorizations.

The mad rush to gain Emergency Use Authorizations for SARS-CoV-2 tests has dominated the attention of the diagnostics industry and FDA over the past year. Now with more than 350 COVID-19 tests with EUAs, the rate of new emergency authorizations has slowed as companies and FDA put more acute focus on a subset of assays to support at-home and point-of-care screening. But that does not mean the volume of COVID-19 work for the agency’s In Vitro Diagnostics office is slowing down anytime soon.

In addition to the continuing EUA work, there is a new wave of submissions starting to crash on to FDA’s shores: efforts by companies to convert their test EUAs into conventional marketing authorizations, i.e., de novos or 510(k)s. While not all makers of emergency authorized tests will pursue that end, FDA officials have said they expect EUA conversion submissions to be a major source of reviewer workload in 2021. (See “Jeff Shuren on Novel Devices, MDUFA Talks, and the Toils of COVID,” Market Pathways, February 10, 2021.) The agency has assured companies that it is planning a measured transition process where existing EUAs will not immediately be revoked on the day the Public Health Emergency (PHE) officially ends. Still, FDA says, it is ultimately a priority to fully validate tests via its standard, non-emergency review pathways. And it is highly likely that SARS-CoV-2 will need to be part of standard respiratory pathogen diagnostics for years to come, after the pandemic has ended.


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