Alverix receives FDA 510(k) clearance for new BD Veritor System kit

Oct 12 2012

Alverix, Inc., a world leader in the design and manufacture of next-generation platforms for diagnostic Point-of-Care (POC) testing, today announced that BD Diagnostics, a segment of Becton Dickinson and Company (NYSE:BDX), a leading global medical technology company, received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for nasopharyngeal wash, aspirate and swab in transport media specimens on the BD Veritor^TM System for Rapid Detection of respiratory syncytial virus (RSV). This new product is cleared for use in clinical settings.    

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.

"The clearance of the new BD Veritor System kit specifically for RSV testing in clinical settings is a significant addition to the BD Veritor upper respiratory infectious disease product line," said Ric Tarbox, CEO of Alverix. "Alverix is truly excited to be associated with BD in delivering rapid results that physicians and laboratorians can trust."

BD selected Alverix to design, develop and supply the digital reader component of BD's new 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. The Advanced Particle Technology along with improved chemistries helps improve the sensitivity of the test while the Adaptive Read Technology helps reduce false-positive results by examining and compensating for many of the effects of non-specific binding which improves specificity.

The 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.