BD Receives FDA Emergency Use Authorization for COVID-19, Influenza A/B, RSV Combination Test
Single Test on BD MAX™ Molecular Diagnostic System Identifies and Differentiates Multiple Respiratory Infectious Diseases
The test, 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.
"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
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.
Development of this combination test has been funded in whole or in part with federal funds from the
- This product has not been FDA cleared or approved but has been authorized for emergency use by FDA under EUA for use by authorized laboratories.
- This product has been authorized only for the detection and differentiation of nucleic acid of SARS-CoV-2, influenza A, influenza B, and respiratory syncytial virus, not for any other viruses or pathogens.
- The emergency use of this product is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 360bbb- 3(b)(1), unless the declaration is terminated or authorization is revoked sooner.
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 77,000 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
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