Leading rapid diagnostic test solutions provider Quidel Corp. (QDEL) has received 510 (k) clearance from the U.S. Food and Drug Administration (FDA) for its new virus test solution. The test, called “QuickVue RSV10”, is a lateral flow immunoassay (a biochemical test) designed to detect acute respiratory syncytial virus (RSV) infection.
 
RSV infection, a viral disease of the lungs, is a major cause of respiratory illness (such as bronchiolitis and pneumonia) in young children. According to the U.S. Centers for Disease Control and Prevention, RSV infection is responsible for between 75,000 and 125,000 hospitalizations annually in the U.S. Virtually all infants suffer from an RSV infection before the age of two. Early detection and management are critical, given the potentially serious complications associated with RSV infection.
 
QuickVue RSV10 is intended for use in children under six years of age, over 85% of whom experience an RSV infection. The test detects RSV antigen (viral fusion protein) directly from nasopharyngeal swab/aspirate samples from the affected pediatric patients.
 
The test results are available in just 10 minutes, allowing significant time savings. Moreover, a single nasal sample can be used to conduct both the QuickVue RSV 10 test and Quidel’s QuickVue branded Influenza tests.
 
Quidel develops and markets diagnostic solutions aimed at improving patient outcomes and offering economic benefits to the healthcare system. The company’s products are designed to detect and diagnose a host of critical diseases such as influenza, RSV, herpes and thyroid disease.
 
Quidel posted revenues of $25 million (up 2% year over year) in second quarter fiscal 2010 with test kit maker Diagnostic Hybrids Inc/DHI (acquired by Quidel in Feb 2010 for $130 million) contributing $10.1 million. Worldwide infectious disease revenues dipped 14% year over year, impacted by an absence of influenza revenues (booked in the year-ago quarter), partially offset by higher sales from DHI’s respiratory, urology and herpes products.
 
QuickVue RSV10 is one of Quidel’s exciting new products expected to boost its market share and bottom line, moving forward. The company recently received FDA clearance for RapidVue hCG, its pregnancy test solution. QuickVue RSV10 will be available in the upcoming RSV season, which typically begins in November.
 
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