FRANKLIN LAKES, N.J., July 30, 2020 /PRNewswire/ -- BD (Becton, Dickinson and Company) (NYSE: BDX), a leading global medical technology company, today announced a $24 million investment from the U.S. Department of Defense in collaboration with the U.S. Department of Health and Human Services to support the scale up of U.S. manufacturing capabilities for BD Veritor™ Solution for Rapid Detection of SARS-CoV-2 (see demo here).
The additional capital equipment will bolster domestic production and increase total production capacity by 50 percent. These investments will enable global production of more than 12 million test kits per month by the end of February 2021.
"Making COVID-19 diagnostic tests widely available is critical to expanding rapid detection of COVID-19 infections, and mitigating the impact of the disease by identifying affected patients, quickly quarantining infectious individuals and tracing their contacts," said Dave Hickey, president of Integrated Diagnostic Solutions for BD. "This investment will bolster our U.S. manufacturing capabilities helping us quickly scale our production of point-of-care COVID-19 tests to ensure we have a robust supply for our U.S. customers."
BD announced that it had received FDA emergency use authorization for the BD Veritor™ Plus SARS-CoV-2 antigen assay on July 6, 2020 and plans to leverage its growing U.S. installed base of more than 25,000 BD Veritor™ Plus instruments to enable the deployment of the SARS-CoV-2 assay across the U.S. The easy-to-use design of the instrument, slightly larger than a cell phone, makes it ideal for use in a variety of clinical settings including hospitals, clinician offices, urgent care centers, and retail pharmacies, where it has already been used in influenza, group A strep and RSV testing for several years.
The BD Veritor™ Plus System for Rapid Detection of SARS-CoV-2 Assay is deemed to be a CLIA-waived immunoassay designed to be used in health care settings to provide an aid to rapid diagnosis of COVID-19 in symptomatic individuals. BD clinical studies performed at more than 20 sites across the U.S. demonstrated that the test is capable of achieving 84% sensitivity and 100% specificity, which is in line with the performance from similar immunoassay tests for Flu A/B, RSV and Strep A on the BD Veritor™ Plus System — all of which are widely-used, highly relevant and clinically valid. Similar to all immunoassay tests, FDA recommends that negative test results be confirmed by a molecular method to confirm the result, if necessary, for patient management.
The BD Veritor™ Plus System for Rapid Detection of SARS-CoV-2 Assay has not been cleared or approved by FDA. The test has been authorized by FDA under an EUA for use by authorized laboratories. The test has been authorized only for the detection of proteins from SARS-CoV-2, not for any other viruses or pathogens; and, the test 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 Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or 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 65,000 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.
This press release contains certain forward-looking statements regarding the manufacturing of the BD Veritor™ COVID-19 diagnosic 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 these risks and uncertainties are beyond the company's control, including without limitation, disruptions caused by the coronavirus pandemic and other factors listed in our 2019 Annual Report on Form 10-K and other filings with the SEC. BD expressly disclaims any undertaking to update any forward looking statements set forth herein to reflect events or circumstances after the date hereof, except as required by applicable laws or regulations.