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news.Quidel has received the CE Mark for its immunoassay system, Sofia RSV FIA for use on the Sofia Analyzer to diagnose respiratory syncytial virus (RSV).
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On receiving CE Mark, Quidel now plans to launch the product in Europe. The product has already carved a place in some parts of the world market, including Asia, Africa, and the Middle East.
The Sofia Analyzer and Sofia RSV FIA are a combination of fluorescent chemistry, lateral flow technology and failure alert and fail-safe systems, which would provide a reliable and rapid diagnostic result.
The RSV assay, inspite of receiving 510(k) clearence and Clinical Laboratory Improvement Amendments (CLIA) waiver by the US FDA, is presently not for sale in the US.
Quidel Corporation president and chief executive officer Douglas Bryant said the product will help healthcare workers to detect respiratory disease of infants and young children, a disease which is sometimes confused with influenza.
”RSV is the third assay for infectious diseases available on the Sofia system and will soon be joined by other tests that are in development, expanding the system’s utility and appeal worldwide," Bryant added.
Quidel chief scientific officer Tim Stenzel said the disease accounts for nearly 45% of all hospitalizations for children under two years of age with lower respiratory tract infections in Europe.
"This situation is similar in the United States where RSV infection is the most common cause of bronchiolitis and pneumonia in children under one year of age, accounting for approximately 125,000 hospitalizations each year," Stenzel added.