BD (Becton, Dickinson and Company (BDX)) (NYSE: BDX), a leading global medical technology company, announced today a commitment from the U.S. Department of Health and Human Services (HHS) to purchase BD diagnostic solutions in expanding access to rapid point-of-care testing for COVID-19 through a broad, decentralized network of testing instrumentation.
HHS has committed to purchase 2,000 BD Veritor™ Plus Systems and 750,000 SARS-CoV-2 antigen test kits for use on the system. Distribution is set to begin next week.
“The BD Veritor™ Plus System for rapid detection of SARS-CoV-2 is the latest point-of-care testing advance that will significantly expand testing in distributed locations for the benefit of all Americans,” said Admiral Brett P. Giroir, M.D., assistant secretary for Health and COVID-19 testing coordinator. “This development will help identify community spread of the virus by further enabling rapid diagnosis of COVID-19.”
The U.S. Food and Drug Administration (FDA) granted BD an Emergency Use Authorization (EUA) for its BD Veritor™ Plus System for Rapid Detection of SARS-CoV-2 earlier this month. The test leverages BD Veritor™ Plus Analyzers, portable instruments that are slightly larger than a cell phone, which are already in use in more than 25,000 hospitals, clinician offices, urgent care centers and retail pharmacies in all 50 U.S. states. Its one-button functionality, workflow flexibility, and ease-of-use make it an ideal solution for settings without laboratory personnel. It offers customers real-time reporting capabilities through the BD Synapsys™ informatics solution, providing them with the ability to easily report data for disease monitoring and surveillance purposes.
“The ongoing pandemic has been devastating for individuals, families and businesses around the world,” said Dave Hickey, president of Integrated Diagnostic Solutions for BD. “Until there is an effective treatment or vaccine, rapid diagnostic testing is fundamental to controlling the spread of the disease. The BD Veritor™ Plus Analyzers, SARS-CoV-2 antigen test kits, and BD Synapsys™ Informatics Solution will play a critical role in helping clinicians identify individuals with COVID-19 while helping public health officials track COVID-19 incidence and identify emerging outbreaks in real-time.”
BD began shipping limited quantities of its BD Veritor™ Plus SARS-CoV-2 antigen test kits to distributors last week as it ramps up production capacity. BD is leveraging its global manufacturing network and scale and expects to increase capacity to be able to produce 2 million tests per week by the end of September. The company expects to produce up to 10 million tests from July through September.
In addition to a SARS-CoV-2 antigen assay for the BD Veritor™ Plus System, BD and a network of partners offer a portfolio of COVID-19 testing solutions including highly sensitive molecular diagnostic tests on the BD MAX™ System. All BD COVID-19 diagnostic products have EUA and BD intends to pursue 510(k) clearance with the FDA at a later time. U.S. customers interested in BD diagnostic solutions for COVID-19 should contact IDS.COVIDtests@bd.com.
About the BD Veritor™ SARS-CoV-2 Assay
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 FDA cleared or approved. The test has been authorized by FDA under an EUA for use by authorized laboratories. This 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.