BD Diagnostics Receives Go-ahead for RSV Test
BD Diagnostics, a segment of BD (Becton, Dickinson and Company), a leading global medical technology company, announced today that it 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 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.
"Early and reliable detection of RSV is critical among high-risk populations to treat and prevent the spread of this contagious virus and hospitalizations," said Tom Polen, President, BD Diagnostics – Diagnostic Systems. "The BD Veritor System for Rapid Detection of RSV has very high sensitivity and specificity when compared to viral cell culture methods, while providing an objective test result in only 10 minutes."
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.
BD is a leading global medical technology company that develops, manufactures and sells medical devices, instrument systems and reagents. The Company is dedicated to improving people's health throughout the world. BD is focused on improving drug delivery, enhancing the quality and speed of diagnosing infectious diseases and cancers, and advancing research, discovery and production of new drugs and vaccines. BD's capabilities are instrumental in combating many of the world's most pressing diseases. Founded in 1897 and headquartered in Franklin Lakes, New Jersey, BD employs approximately 29,000 associates in more than 50 countries throughout the world. The Company serves healthcare institutions, life science researchers, clinical laboratories, the pharmaceutical industry and the general public. For more information, please visit www.bd.com.
Source: BD-Becton Dickinson via PR Newswire