HHS will 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 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, says BD. 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. 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.