BD Veritor System for Flu A+B Featuring Alverix Technology Receives Regulatory Approval in Japan
SAN JOSE, Calif.--(BUSINESS WIRE)--Alverix announced today that BD (Becton, Dickinson and Company) has received approval from the Japanese Ministry of Health, Labour, and Welfare (MHLW) for the BD Veritor™ System Flu A+B Test.
The BD Veritor System was developed by BD which collaborated with Alverix for the development of the digital reader which employs Alverixs unique and proprietary near-patient testing platform. The BD Veritor System reader utilizes Alverixs novel optoelectronic and signal detection technologies. The BD Veritor System delivers very good positive and negative percent agreement when measured against polymerase chain reaction (PCR) results, the highest sensitivity standard currently available. Following a simple, convenient procedure, objective test results are provided on an easy-to-read digital display. Alverix manufactures and supplies the BD Veritor System reader to BD.
"Following the receipt of 510(k) clearance and CLIA waiver in the United States, this is another important achievement for the BD Veritor System," said Ric Tarbox, CEO of Alverix. "Not only does this product help to address an important health issue in a significant region of the world, but its approval by the Japanese MHLW is also a very meaningful validation of the systems performance."
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, Alverixs 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. www.alverix.com