BD (Becton, Dickinson and Company) announced that the U.S. Food and Drug Administration (FDA) granted Emergency Use Authorization (EUA) for a rapid, point-of-care, SARS-CoV-2 diagnostic test for use with its broadly available BD Veritor Plus System. The launch of this new assay that delivers results in 15 minutes on an easy-to-use, highly portable instrument is critical for improving access to COVID-19 diagnostics because it enables real-time results and decision making while the patient is still onsite.
The BD Veritor System, which is slightly larger than a cell phone, is currently in use at 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 a solution for settings without laboratory personnel. It also 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.
BD is leveraging its global manufacturing network and scale and expects to increase capacity to be able to produce two million tests per week by the end of September. The company already expects to produce up to 10 million tests from July through September.
"This will be a game-changer for frontline health care workers and their patients to be able to access a quick diagnostic test for COVID-19, offering results in real-time at convenient locations like retail pharmacies, urgent care centers and doctors' offices," said Dave Hickey, president of Integrated Diagnostic Solutions for BD. "Such tests will also help communities be more informed and better prepared to help prevent new spikes and additional waves of COVID-19 by enabling public health workers to quickly identify infectious individuals and trace their contacts. The highly portable, easy-to-use, point-of-care format of this test, large quantity of test kits available and existing, expansive footprint of BD Veritor Plus instruments will help bring widespread access to COVID-19 testing in the United States and around the world as additional country-specific regulatory requirements are met."
The launch of the BD Veritor Plus System for Rapid Detection of SARS-CoV-2 Assay is the latest effort in the company's comprehensive response to address critical health needs related to the global pandemic. The new immunoassay test joins a portfolio of three molecular solutions for COVID-19 testing that have been registered for use with the BD MAX Molecular System, including two with EUAs and two with CE mark. So far this year, the company has provided health care providers globally with approximately 48 million swabs for flu and COVID-19 testing, more than 2.85 million COVID-19 rapid molecular diagnostic tests on the BD MAX System, and millions of products used in the treatment of COVID-19 patients, including infusion pumps, infusion sets and catheters.
All BD COVID-19 diagnostic products have regulatory authorizations in the markets where they are sold. BD intends to pursue 510(k) clearance for the BD Veritor Plus SARS-CoV-2 assay from the FDA at a later time. U.S. customers interested in BD diagnostic solutions for COVID-19 should contact [email protected].