BD nabs FDA authorization for SARS-CoV-2, influenza A/B, RSV combination test

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The U.S. Food and Drug Administration (FDA) has granted an emergency use authorization (EUA) for a Becton Dickinson (BD) molecular diagnostic combination test for SARS-CoV-2, influenza A/B, and respiratory syncytial virus (RSV), the firm said on Wednesday.

The test is run on the BD Max Molecular Diagnostic System and designed to help combat illness in the current and future respiratory virus seasons, BD said.

The combination test uses a single nasal swab or a single nasopharyngeal swab sample to identify and distinguish whether a patient has COVID-19, flu, RSV, or some combination of the three, with results available in two hours.

BD noted that 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.

"While fears of a tripledemic this respiratory season have largely diminished, accurately differentiating influenza and RSV from COVID-19 and providing appropriate treatment remains a challenge for our customers," Nikos Pavlidis, vice president of molecular diagnostics at BD, said in a statement.

BD developed the test with federal funds from the Department of Health and Human Services; Office of the Administration for Strategic Preparedness and Response; and Biomedical Advanced Research and Development Authority.

The contract value is $40.3 million.

The BD Respiratory Viral Panel assay for BD Max System was CE marked last year.

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