Dive Brief:

• The U.S. Food and Drug Administration has granted marketing authorization to a COVID-19 antigen test using its traditional premarket review process for the first time. 
• QuidelOrtho Corp. received the De Novo authorization for Sofia 2 SARS Antigen+ FIA, a prescription-use only lateral flow assay suitable for use in point-of-care settings. 
• The authorization marks the start of the next phase of COVID-19 antigen test regulation. With the FDA establishing special controls as part of the De Novo assessment, the process has laid the groundwork for other tests to come to market via the 510(k) pathway.

Dive Insight:

In September, the FDA indicated its intent to review only a small subset of EUA requests for COVID-19 tests and encouraged developers to use its De Novo and 510(k) pathways. The change in policy has now resulted in the first authorization of a COVID-19 antigen test through the traditional review process. 

The authorization covers a test designed for use with Quidel’s Sofia 2 fluorescent immunoassay analyzer. Quidel received EUA for the Sofia SARS Antigen FIA in May 2020, making it the first company to receive emergency authorization for a rapid antigen test in the U.S., and has incorporated improvements into its newly authorized successor. 

Sofia 2 SARS Antigen+ FIA provides results in 10 minutes, compared to 15 minutes for its predecessor, and uses prefilled reagent vials. The new product will contribute to the $300 million to $500 million in COVID-19 revenues that Quidel expects to generate this year. Quidel filed its De Novo request in June 2021. 

In conjunction with the authorization, the FDA created special controls for point-of-care devices that directly detect SARS-CoV-2 viral targets from clinical specimens in near-patient settings. The special controls, which cover the intended use, sample collection, labeling and more, provide a roadmap for companies that want to bring similar tests to market via the 510(k) pathway.