BD Receives Emergency Use Authorization for Asymptomatic Screening for SARS-CoV-2 through Serial Rapid Antigen Testing
B
D (Becton, Dickinson and Company) (NYSE: BDX), a leading global medical technology company, today announced the U.S. Food and Drug Administration (FDA) has granted Emergency Use Authorization (EUA) for its rapid antigen test to be used for SARS-CoV-2 screening through serial testing of asymptomatic individuals.
Articles and studies in multiple peer-reviewed publications including the New England Journal of Medicine1 and the British Medical Journal2 have touted the benefits of serial, rapid antigen testing. In addition, a recent landmark RADx-funded study demonstrated that the serial use of diagnostic tests (at least twice per week), including rapid antigen tests, increased the ability to detect infection3. The BD Veritor Plus System supports this approach in everyday locations such as schools and businesses, along with serial testing in other situations, such as athletes and teams to ensure safe games and competitions.
The EUA for the BD Veritor Plus System includes SARS-CoV-2 screening through serial testing of asymptomatic individuals when tested twice over two or three days with at least 24 hours and no more than 48 hours between tests. Serial testing on the BD Veritor Plus System can be performed in any setting with a CLIA certificate of waiver.
BD is supporting the global efforts to return to normalcy as soon as possible, and this additional authorization for the BD Veritor System to be used in screening through serial testing of asymptomatic individuals is a large step forward, said Dave Hickey, president of Life Sciences for BD. 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.
Serial COVID-19 testing in everyday settings presents challenges in managing test subject demographics and reporting results to public health authorities. To assist with this reporting in a mass testing program, BD recently announced a collaboration with ImageMover to provide a companion mobile app that enables organizations 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. This enables compliance with reporting requirements and significantly reduces manual documentation.
✔️ BD Receives Emergency Use Authorization for Asymptomatic Screening for SARS-CoV-2 through Serial Rapid Antigen Testing
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