Alverix, Inc., a world leader in the design and manufacture of next-generation platforms for diagnostic Point-of-Care (POC) testing, announced today 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 Flu A + B. This 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 POC diagnostic system, which offers users advanced performance with reliable, easy-to-read results. The new BD Veritor System for Rapid Detection of Flu A + B laboratory kit is specifically configured for testing liquid specimens obtained via nasopharyngeal wash, aspirate or swab in transport media. The 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 digital reader designed, developed and manufactured by Alverix, Inc. The BD Veritor System for Rapid Detection of Flu A + B demonstrated proven performance versus polymerase chain reaction (PCR) tests. This is the first rapid diagnostic flu test that has been referenced and FDA-cleared against this high-sensitivity standard.
“The clearance of the new BD Veritor System kit specifically for samples in transport media in clinical settings is a significant addition to the Flu A + B product line,” said Ric Tarbox, CEO of Alverix. “The BD Veritor System can now provide accuracy, consistency and convenience to all near patient testing environments allowing integrated delivery networks to realize all of the cost saving synergies normally associated with standardization of product and testing procedures. Alverix is truly excited to be associated with BD in delivering rapid results that physicians and laboratory professionals can trust.”
The BD Veritor System utilizes Advanced Particle and Adaptive Read technologies that are integrated into a proprietary hand-held digital reader from Alverix, Inc. The Advanced Particle Technology, along with improved chemistries, greatly increases the sensitivity of the test. The Adaptive Read technology reduces false-positive results through analyzing and compensating for many of the effects of non-specific binding resulting in improved specificity.