Quidel Receives FDA Clearance For Sofia RSV Fluorescent Immunoassay

(RTTNews) - Quidel Corp. (QDEL) Monday said it has received clearance from the U.S Food and Drug Administration, or FDA, for its Sofia RSV fluorescent immunoassay test used with Sofia Analyzer for detection of respiratory syncytial virus, or RSV, infections.

RSV is said to be responsible for respiratory tract infections, principally among pediatric, with nearly half of all children become infected by RSV in their first year of life.

The Sofia Analyzer, along with Sofia RSV FIA employ unique immuno fluorescence chemistry and fail-safe systems to ensure a reliable, objective, diagnostic result within 15 minutes of application of the patient's specimen. Sofia is the brand name for Quidel's next-generation, immunoassay system.

"With its rapidly expanding menu, our Sofia System now offers a comprehensive menu of accurate and easy-to-use assays for the diagnosis of key respiratory diseases and pregnancy, " said Douglas Bryant, President, CEO.