Alverix Inc. announced that BD Diagnostics, a segment of Becton Dickinson and Co. (BDX) received 510(k) clearance from the U.S. Food and Drug Administration or FDA for nasopharyngeal wash, aspirate and swab in transport media specimens on the BD Veritor System for Rapid Detection of respiratory syncytial virus or RSV. Alverix said that the new product is cleared for use in clinical settings.
BD selected Alverix to design, develop and supply the digital reader component of BD's new Point-of-Care or POC diagnostic system. The BD Veritor System, with proprietary technologies, eliminates the subjective result interpretation of visually read assays and helps deliver an accurate read by providing reliable, objective results on a hand held reader with an easy-to-read digital display. The system utilizes Advanced Particle and Adaptive Read Technologies coupled with a special hand-held analyzer.
Alverix noted that BD Veritor System for Rapid Detection of RSV joins the previously FDA-cleared and CLIA-waived BD Veritor System assays for Rapid Detection of Flu A+B. This assay for rapid detection of RSV on the BD Veritor System represents the third offering of many planned assays on this new platform.
According to the U.S. Centers for Disease Control and Prevention, RSV is the most common cause of pneumonia and bronchiolitis in the United States in children under one year of age. Almost all children have been infected with the virus by the time they are two years old, leading to approximately 75,000 to 125,000 hospitalizations annually. Most children hospitalized for RSV infection are under six months of age.
by RTTNews Staff Writer
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