New RSV Test Provides Reliable Results in Minutes
BD Veritor System for Rapid Detection of RSV Receives 510(k) Clearance for Nasopharyngeal Wash, Aspirate and Swab in Transport Media Specimens
SAN JOSE, Calif.--(BUSINESS WIRE)-- 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 VeritorTM 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.
For more information on the BD Veritor System, please visit www.bd.com/ds/veritorsystem.
About Alverix, Inc.
Alverix is a leader in providing next-generation instrument and connectivity platforms for diagnostic Point-of-Care (POC) testing. Arising out of a 30-year legacy in consumer electronics within Hewlett Packard, Agilent, and Avago, Alverix’s systems enable laboratory class performance in a mobile, inexpensive format, extending testing beyond high volume sites to physician office labs, retail clinics, emerging markets and the home, where immediate results are critical to patient care. In addition to an exclusive license to 20 patents in the HP/Agilent/Avago portfolio for the field of human and veterinary diagnostics, Alverix now has 23 of its own granted patents. Alverix remains focused on growing its proprietary point-of-care platform business through co-development of near patient test systems with select test developers such as Becton Dickinson and Company, with whom the revolutionary BD Veritor System™ for Rapid Detection of influenza A+B was developed and launched. For more information on Alverix, please visit www.alverix.com.
Matt McLoughlin, 610-228-2123
Source: Alverix, Inc.