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.