BD’s rapid COVID-19 test granted Emergency Use Authorization by FDA
The FDA has granted Emergency Use Authorization (EUA) for Becton, Dickinson and Company’s (BD) rapid antigen test to be used for COVID-19 screening of asymptomatic individuals.
The BD Veritor Plus system uses nasal swabs, either from people suspected of having COVID-19, or those without symptoms. It works by detecting SARS-CoV-2 nucleocapsid antigens on the swab.
The current EUA means that the systems can only currently be used by authorised laboratories, but it is hoped that the system will soon be approved for everyday locations such as schools and businesses, and for sporting events.
Articles and studies in multiple peer-reviewed publications including the New England Journal of Medicine and the British Medical Journal have touted the benefits of serial, rapid antigen testing. A recent landmark study, funded by RADx at the National Institute of Health in the US, demonstrated that the serial use of diagnostic tests (at least twice per week), including rapid antigen tests, increased the ability to detect infection.
Dave Hickey, President of Life Sciences at BD, said: ”BD is supporting the global efforts to return to normalcy as soon as possible, and this additional authorisation for the BD Veritor System to be used in screening through serial testing of asymptomatic individuals is a large step forward.
“Frequent testing of individuals without symptoms will enable those with negative results to resume their normal school or work routines and will help to identify and isolate positive cases of COVID-19 as early as possible to prevent further spread. Screening through serial testing is an important part of any back-to-school or back-to-work program, along with additional measures such as mask wearing and social distancing.”
BD also recently announced a collaboration with ImageMover to provide a companion mobile app that enables organisations performing point-of-care testing to efficiently capture required demographic details of those being tested, upload COVID-19 test results, report results to appropriate stakeholders and automate reporting to public health agencies.
The US Food and Drug Administration (FDA) has granted de novo marketing authorisation to the …
Biogen has announced that the US Food and Drug Administration (FDA) has approved Tofidence (tocilizumab-bavi) …