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Home » FDA authorizes BD’s combo COVID-flu-RSV test

FDA authorizes BD’s combo COVID-flu-RSV test

February 8, 2023 By Sean Whooley

BD Max System COVID-19 Flu RSV combination panel diagnostic test FDA emergency use authorization EUA
The BD Max system. [Image courtesy of BD]
BD (NYSE:BDX) announced today that it received FDA emergency use authorization (EUA) for a COVID-19, flu and RSV combination diagnostic.

The company designed the molecular test to detect SARS-CoV-2, influenza A and B and respiratory syncytial virus (RSV). It’s used on the BD Max molecular diagnostic system.

The test uses a single nasal or nasopharyngeal swab sample. It identifies and distinguishes if a patient has one or some combination of the three viruses. Results come through in as little as two hours, according to a news release. BD said the test helps to eliminate the need form multiple tests or doctor visits. It also allows clinicians to implement the right treatment plan quickly and increases testing capacity during the busy respiratory virus season.

BD addresses viruses ‘early in the course of infection’

“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,” said Nikos Pavlidis, VP of molecular diagnostics at BD. “This diagnostic test provides the ability to identify multiple pathogens using a single sample and can quickly pinpoint the causative virus or viruses and enable clinicians to administer appropriate treatment early in the course of infection.”

Thousands of hospitals and laboratories worldwide already use the BD Mas system. Each unit can analyze hundreds of samples over a 24-hour period. This specific respiratory viral panel that picked up EUA is a RT-PCR assay. It detects and differentiates the nucleic acid of each virus.

BD developed the combination test in whole or in part with federal funds. Those funds came from the Department of Health and Human Services; Office of the Administration for Strategic Preparedness and Response; Biomedical Advanced Research and Development Authority.

The BD respiratory viral panel assay for BD Max received CE mark approval in May 2022.

Filed Under: Diagnostics, Featured, Food & Drug Administration (FDA), Genomics/Molecular Diagnostics, News Well, Regulatory/Compliance, Respiratory Tagged With: BD, FDA

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About Sean Whooley

Sean Whooley is a senior editor who mainly produces work for MassDevice, Medical Design & Outsourcing and Drug Delivery Business News. He received a bachelor's degree in multiplatform journalism from the University of Maryland, College Park. You can connect with him on LinkedIn or email him at [email protected].

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