BD Announces FDA Emergency Use Authorization for Combination COVID-19, Flu Rapid Antigen Test

FRANKLIN LAKES, N.J., March 30, 2021 /PRNewswire/ -- BD (Becton, Dickinson and Company) (NYSE: BDX), a leading global medical technology company, today announced the U.S. Food and Drug Administration (FDA) granted emergency use authorization (EUA) for a new, rapid antigen test that can detect SARS-CoV-2, influenza A and influenza B in a single test.

The BD Veritor™ System for Rapid Detection of SARS-CoV-2 & Flu A+B assay takes about 15 minutes to run on the BD Veritor™ Plus System and distinguishes between SARS-CoV-2, influenza A and influenza B, by providing definitive positive or negative individual digital display readouts for all three.

"Given that symptoms for COVID-19 and the flu are very similar, having the ability to run a rapid combination test to distinguish between these viral infections may help save time and resources," said Dave Hickey, president of Life Sciences for BD. "BD will continue to offer both individual tests for SARS-CoV-2 and influenza A+B, as well as the new combination tests, to give health care providers the option to run the test that is most appropriate for their patients."

BD plans to launch the new test this summer for the 2021-2022 flu season. The test is intended for individuals who are suspected by a health care provider of having COVID-19, influenza A or influenza B within six days of symptom onset. The test follows the same, simple workflow as other rapid tests on the BD Veritor™ Plus System with a result in about 15 minutes.  

There are over 70,000 active BD Veritor™ Systems in use at hospitals, clinician offices, urgent care centers, nursing homes, retail pharmacies, schools, businesses and other testing locations in all 50 U.S. states. The BD Veritor™ System, which is slightly larger than a cell phone, has one-button functionality, workflow flexibility and ease-of-use make it an ideal solution for settings without laboratory personnel. It also offers customers real-time reporting capabilities through the optional BD Synapsys™ Informatics Solution, providing them with the ability to easily report data for disease monitoring and surveillance purposes.

About the BD Veritor™ System for Rapid Detection of SARS-CoV-2 and Flu A+B Assay
This product has not been FDA cleared or approved but has been authorized by FDA under an EUA for use by authorized laboratories. This product has been authorized only for the detection of proteins from SARS-CoV-2, influenza A and influenza B, not for any other viruses or pathogens; and 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. For more information, please see bdveritor.com.

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 70,000 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.

Forward Looking Statements
This press release contains forward-looking statements regarding the availability and use of BD's point-of-care test. Forward-looking statements involve risks and uncertainties that could cause actual results to differ materially from those expressed or implied in such statements, many of which are beyond the company's control, including risks relating to market acceptance of the test, events that could impact our manufacturing capabilities, and other challenges inherent in manufacturing and commercially launching new products. Further information on these risks and uncertainties is included in the company's most recent Annual Report on Form 10-K and other SEC filings. BD expressly disclaims any undertaking to update any such statements set forth herein to reflect events or circumstances after the date hereof, except as required by applicable laws or regulations.

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SOURCE BD (Becton, Dickinson and Company)