Quidel Wins FDA Clearance for Sofia RSV Fluorescent Immunoassay
Quidel Corporation (NASDAQ: QDEL), a provider of rapid diagnostic testing solutions, cellular-based virology assays and molecular diagnostic systems, announced today that it has received 510(k) clearance from the United States Food and Drug Administration (FDA) for its Sofia RSV FIA test for use with the Sofia Analyzer for the rapid, objective detection of respiratory syncytial virus (RSV) infections. RSV is responsible for respiratory tract infections, principally among pediatric and elderly populations. In the pediatric setting, nearly half of all children become infected by RSV in their first year of life. In the United States, RSV is estimated to be responsible for 73,400 to 126,300 hospitalizations annually for bronchiolitis and pneumonia among children younger than one year.(1) Sofia is the brand name for Quidel's next-generation, immunoassay system. The Sofia Analyzer and Sofia RSV FIA employ unique immunofluorescence chemistry, advanced lateral flow technology, and failure alert and fail-safe systems designed to ensure a reliable, objective, highly accurate, diagnostic result within fifteen (15) minutes of application of the patient's specimen.
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