Becton, Dickinson and Company has received the US Food and Drug Administration (FDA) 510(k) clearance and Clinical Laboratory Improvement Amendments (CLIA) waiver for its BD Veritor system for rapid detection of Flu A+B.
Developed in partnership with Alverix, BD Veritor is the first rapid influenza testing system that includes a digital readout of results to receive a CLIA waiver.
Becton, Dickinson and Company selected Alverix as a partner to develop and supply the digital reader, an important component of BD Veritor system.
The reader employs Alverix's novel optoelectronic and signal detection technologies.
The BD Veritor system delivers good positive and negative percent agreement when measured against polymerase chain reaction (PCR) results, the highest sensitivity standard currently available.
Alverix CEO Ric Tarbox said that Becton, Dickinson and Company has helped Alverix's mission to develop systems that offer a combination of speed, accuracy and convenience.
''We share with Becton, Dickinson and Company the belief that the BD Veritor system has the potential to change the way that doctors view in-office rapid flu testing,'' Tarbox added.
Unlike current CLIA-waived rapid influenza tests, the test results from the BD Veritor system are obtained on an easy to read digital display.