Bd Secures 510(K) Clearance For Molecular Combination Test, Covering Covid-19, Influenza A/b, And Rsv

Wednesday, August 02, 2023

BD (Becton, Dickinson and Company), a leading global medical technology company, has announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for the BD Respiratory Viral Panel (RVP) for BD MAX™ System. This single molecular diagnostic combination test can identify and differentiate SARS-CoV-2, influenza A, influenza B, and Respiratory Syncytial Virus (RSV) in approximately two hours.

The BD RVP test, which has been available under Emergency Use Authorization (EUA) since February, allows clinicians to determine if a patient has COVID-19, influenza, or RSV using a single nasal or nasopharyngeal swab sample. By combining testing for these respiratory infections, the BD RVP test streamlines the diagnostic process, eliminating the need for multiple individual tests or doctor visits. This efficiency can help clinicians implement appropriate treatment plans quickly, increase testing capacity during the busy flu season, and expedite diagnosis times.

Nikos Pavlidis, Vice President and General Manager for Diagnostics at BD, highlighted the importance of the combined testing panel in managing the potential threat of COVID-19, flu, and RSV co-circulating during the respiratory season. The BD MAX™ System, a molecular diagnostic platform, is already used in numerous hospitals and medium-throughput laboratories worldwide, with each unit capable of analyzing hundreds of samples in a 24-hour period.

The BD MAX™ RVP test is an RT-PCR assay that detects and differentiates the RNA of SARS-CoV-2, influenza A, influenza B, and RSV. It leverages the advanced robotic architecture of the BD MAX™ System, automating manual and time-intensive processes and minimizing the need for human interaction.

The respiratory viral panel is a valuable addition to the range of assays available on the BD MAX™ System, covering various respiratory infections, sexually transmitted infections, gastrointestinal infections, women's health, and healthcare-associated infections. The BD MAX™ open system also allows customers to utilize research use only (RUO) assays and user-defined protocols (UDP) to address emerging needs swiftly.

Funding for the development of this combination test was provided, in part or in whole, by federal funds from the U.S. Department of Health and Human Services, Administration for Strategic Preparedness and Response, and Biomedical Advanced Research and Development Authority, under contract number 75A50121C00025.

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