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BD Gains FDA Clearance for Combination COVID-19, Flu, RSV Molecular Test

NEW YORK – Becton Dickinson said Tuesday that the US Food and Drug Administration has given 510(k) clearance to the firm's combination COVID-19, influenza A/B, and respiratory syncytial virus molecular test. 

Called the BD Respiratory Viral Panel for BD Max, the RT-PCR test uses a single nasal or nasopharyngeal swab to detect and distinguish SARS-CoV-2, influenza A, influenza B, and RSV. The panel can return results in as little as two hours on the company's BD Max molecular diagnostic system.

"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," Nikos Pavlidis, VP and general manager for diagnostics at BD, said in a statement. "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."

Franklin Lakes, New Jersey-based BD has been selling the panel in the US since receiving FDA Emergency Use Authorization in February. The test was CE marked in May 2022.