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Becton, Dickinson's (BDX) System For RSV Testing Gets 510(K) Approval

 October 11, 2012 03:37 PM
 


(By Balachander) Becton, Dickinson and Co.'s (NYSE:BDX) system for rapid detection of respiratory syncytial virus (RSV) has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for nasopharyngeal wash, aspirate and swab in transport media specimens, says Alverix Inc.

Alverix collaborated with Becton in the development of the BD Veritor System for rapid detection of Flu A+B. BD selected Alverix to design, develop and supply the digital reader component of BDX unit's new Point-of-Care (POC) diagnostic system.

According to Alverix, the BD Veritor System for Rapid Detection of RSV joins the FDA-approved 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.

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The BD Veritor System provides objective tests results on an easy to read display, Alverix said.

"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.

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.

BDX shares added 0.77 percent to trade at $76.99 on Thursday.

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