BD Receives FDA Emergency Use Authorization for COVID-19, Influenza A/B, RSV Combination Test

Feb. 16, 2023
Single test on BD MAX Molecular Diagnostic System identifies and differentiates multiple respiratory infectious diseases.

BD (Becton, Dickinson and Company) has received Emergency Use Authorization from the U.S. Food and Drug Administration (FDA) for a new molecular diagnostic combination test for SARS-CoV-2, influenza A + B, and respiratory syncytial virus (RSV) to help combat illness in the current and future respiratory virus seasons.

The test — Respiratory Viral Panel for BD MAX System — for use on the BD MAX Molecular Diagnostic System, uses a single nasal swab or a single nasopharyngeal swab sample to identify and distinguish if a patient has COVID-19, the flu, RSV, or some combination of the three, with results available in as little as two hours. The test helps eliminate the need for multiple tests or doctor visits and can help clinicians implement the right treatment plan quickly. The co-testing approach also helps to increase testing capacity during the busy flu/RSV season and speed time to diagnosis. The BD MAX System is already in use at thousands of hospitals and laboratories worldwide, and each unit is capable of analyzing hundreds of samples over a 24-hour period.

BD release