FDA this week awarded 510(k) clearance for Quidel’s Sofia Strep A fluorescent immunoassay (FIA) for the rapid detection of Group A Streptococcal infections.
The company said that, when used with its next-generation immunoassay system, the Sofia Analyzer, this FIA test can produce an accurate diagnostic result within five minutes. Quidel is already using this system for flu testing. It added that Group A Streptococcus bacteria are the most common cause of bacterial pharyngitis, and can also cause rheumatic fever, among other illnesses.
“We are confident that the Sofia Strep A FIA will provide customers with an easy-to-use, fast, and accurate solution for the diagnosis of Strep A infections, and will create added utilization for the Sofia platform beyond current influenza testing,” Douglas Bryant, Quidel president and CEO, said in a statement.
“In the short-term, the clearance of the Sofia Strep A FIA provides us with another catalyst for increasing Sofia placements in the field, and before the onset of the upcoming respiratory disease season,” Bryant added. “Over the long-term, our premium product addresses a market that, relative to influenza, represents a higher volume opportunity with less seasonality and less volatility.”
