BD today announced U.S. Food and Drug Administration (FDA) 510(k) clearance for the BD Respiratory Viral Panel (RVP) for BD MAX System, a single molecular diagnostic combination test that identifies and distinguishes SARS-CoV-2, influenza A, influenza B, and Respiratory Syncytial Virus (RSV) in approximately two hours.
The test previously received FDA Emergency Use Authorization (EUA) for use on the BD MAX System on February 3, 2023.
A single nasal swab or a single nasopharyngeal swab sample determines if a patient has COVID-19 or the flu or RSV. The BD RVP test helps eliminate the need for multiple individual tests or doctor visits and can help clinicians implement the right treatment plan quickly. The co-testing approach also helps increase testing capacity during the busy flu season and speed up the time for diagnosis.
“Last year, we experienced a threat of a ‘tripledemic’ with COVID, flu and RSV circulating simultaneously, and that threat remains for the coming respiratory season. As patient symptoms and clinical presentation can be nearly identical, a combined testing panel is key to enabling clinicians to quickly and efficiently diagnose, differentiate and treat patients, and help manage the spread of the infections.”Nikos Pavlidis, vice president and general manager for Diagnostics at BD
The BD MAX System, a molecular diagnostic platform, is already in use at thousands of hospitals and medium-throughput laboratories worldwide, and each unit is capable of analyzing hundreds of samples over a 24-hour period.
Development of this combination test has been funded in whole or in part with federal funds from the U.S. Department of Health and Human Services; Administration for Strategic Preparedness and Response; Biomedical Advanced Research and Development Authority (BARDA).
BARDA and BD initially partnered in September 2021 to develop COVID-19 tests across the BD family of diagnostic platforms. These platforms reach various test settings across the nation, from point-of-care to medium- and high-throughput testing facilities. Developing a combination of diagnostics and platforms provides end-users with options that best fit their use-case.
Respiratory infections often present with similar symptoms but can have vastly different treatment strategies. Enabling healthcare providers to quickly identify the pathogen causing the infection is crucial for informing earlier treatment, improving equitable diagnostic access, reducing burdens on the health care system, and helping to mitigate the impacts of outbreaks. Additionally, diagnostic technologies that test for multiple pathogens in a single sample can help to reduce the need for multiple tests and allow patients to receive a clinical diagnosis and inform appropriate treatment earlier.