BD Launches Combination Test for COVID-19, Influenza A/B and Respiratory Syncytial Virus
BD (Becton, Dickinson and Company) has received CE marking for its BD MAX™ Respiratory Viral Panel (RVP), a diagnostic test that detects SARS-CoV-2, Influenza A + B, and RSV using a single nasal or nasopharyngeal swab. This test enhances diagnostic efficiency, crucial during flu season, by enabling quick differentiation and treatment for these viruses. The BD MAX™ System, which supports this assay, is widely utilized globally for various diagnostic tests. BD plans to seek Emergency Use Authorization from the FDA shortly.
- CE marking enhances the credibility and marketability of BD MAX™ RVP in Europe.
- The test improves diagnostic efficiency by allowing rapid differentiation between COVID-19, flu, and RSV.
- BD MAX™ System is already deployed in numerous laboratories, indicating strong market adoption.
- Dependence on European market as CE marking may not directly translate to U.S. approval.
- Potential delays in FDA Emergency Use Authorization could limit market entry in the U.S.
BD MAX™ Molecular Diagnostic Respiratory Viral Panel CE Marked to IVD Directive
FRANKLIN LAKES, N.J., June 30, 2022 /PRNewswire/ -- BD (Becton, Dickinson and Company) (NYSE: BDX), a leading global medical technology company, announced that the BD MAX™ Respiratory Viral Panel (RVP), a new molecular diagnostic combination test for SARS-CoV-2, Influenza A + B and Respiratory Syncytial Virus (RSV), has been CE marked to the IVD directive 98/79/EC.
The test uses a single nasal swab or a single nasopharyngeal swab sample to determine if a patient has COVID-19 or the flu or RSV. It helps eliminate the need for multiple tests or doctor visits and can help clinicians to implement the right treatment plan quickly. The co-testing approach also helps to increase testing capacity during the busy flu season and speeds the time to diagnosis.
"SARS-Cov-2, influenza and RSV are a triple threat, as patient symptoms and clinical presentation can be nearly identical," said Nikos Pavlidis, vice president of Molecular Diagnostics at BD. "A combined testing panel is key to enabling clinicians to quickly and efficiently diagnose, differentiate and treat patients to help manage the spread of the infections."
The BD MAX™ System, a molecular diagnostic platform, is already in use at thousands of laboratories worldwide, and each unit is capable of analyzing hundreds of samples over a 24-hour period. The BD MAX™ RVP assay is an RT- PCR assay that detects and differentiates the mRNA of SARS-CoV-2, flu A, flu B and RSV in approximately two hours, with the easy-to-use and automated workflow of the BD MAX™ System.
The BD RVP assay for BD MAX™ System is an important addition to the extensive number of assays available on the system across respiratory, STI, gastrointestinal, women's health and health care associated infections. The broad menu of assays in combination with the open system capabilities on a fully automated sample-to-result molecular platform make the BD MAX™ System a valued platform for infectious disease testing in thousands of labs worldwide.
BD MAX™ RVP is currently available in countries that recognize the CE mark. BD plans to submit for Emergency Use Authorization from the U.S. Food and Drug Administration in the coming weeks.
About BD
BD is one of the largest global medical technology companies in the world and is advancing the world of health by improving medical discovery, diagnostics and the delivery of care. The company supports the heroes on the frontlines of health care by developing innovative technology, services and solutions that help advance both clinical therapy for patients and clinical process for health care providers. BD and its 75,000 employees have a passion and commitment to help enhance the safety and efficiency of clinicians' care delivery process, enable laboratory scientists to accurately detect disease and advance researchers' capabilities to develop the next generation of diagnostics and therapeutics. BD has a presence in virtually every country and partners with organizations around the world to address some of the most challenging global health issues. By working in close collaboration with customers, BD can help enhance outcomes, lower costs, increase efficiencies, improve safety and expand access to health care. For more information on BD, please visit bd.com or connect with us on LinkedIn at www.linkedin.com/company/bd1/ and Twitter @BDandCo.
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SOURCE BD (Becton, Dickinson and Company)
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