In an interview with PharmaShots, Tony Ezell, President, North America and Chief Marketing Officer, BD shares its agreement with the USA Track and Field team for COVID-19 testing for the Olympic Trials.

Shots:

• BD's partnership with USATF is part of the company's commitment to helping get people back to their normal lives
• The BD Veritor Plus System is a portable, rapid, and easy-to-use POC antigen test that detects SARS-CoV-2 with results provided in just 15 minutes on a simple, digital display
• The BD Veritor Plus System has a sensitivity of 84% and specificity of 100% when used for symptomatic individuals

Tuba:  What is the BD Veritor Plus System? Discuss its specifications.

Tony:  The BD Veritor Plus System is a portable, rapid and easy-to-use point-of-care antigen test that detects SARS-CoV-2  the novel coronavirus that causes COVID-19  with results provided in just 15 minutes on a simple, digital display. It has received Emergency Use Authorization from the U.S. Food and Drug Administration (FDA) for SARS-CoV-2 screening through the serial testing of asymptomatic individuals, which enables its use in various settings, including everything from schools to sports. For example, USA Track & Field (USATF) is using rapid COVID-19 testing with the BD Veritor Plus System to help get athletes back on the track safely, as well as their coaches, event organizers and other personnel. Specifically, as the official COVID-19 testing partner of USATF, tests using the BD Veritor Plus System were conducted at multiple events throughout the Journey to Gold Tokyo Outdoor Track & Field Series and are also being used throughout the U.S. Olympic Team Trials  Track & Field.

Tuba:  Would you like to comment on how accurate and effective the rapid BD test is that is used with USATF?

Tony:  The BD Veritor Plus System has a sensitivity of 84% and specificity of 100% when used for symptomatic individuals.

Tuba:  Discuss the importance of your BD alliance with USATF.

Tony:  BD's partnership with USATF is part of the company's commitment to helping get people back to their normal lives. Ensuring people have a fast and reliable way to determine their COVID-19 status has been and will continue to be critical in slowing the spread of the virus.   

Tuba:  Why is there a need for rapid COVID-19 testing of USATF athletes?

Tony:  The US Olympic Team Trials bring together large groups of people  including the athletes who have been working and training for this enormous opportunity. They've already postponed their dreams for a year. Our partnership supports the USATF organization's effort to hold these important competitions safely for all involved. The testing protocol allows the athletes in particular focus on their performance with the peace of mind that their health and safety are being protected.

Tuba:  Discuss the importance of rapid testing of SARS-CoV-2 in combatting the pandemic.

Tony:  There are a number of reasons why rapid antigen testing is an important tool in fighting the spread of the virus. It's fast, easy and reliable. Even people who are not skilled laboratory technicians can successfully use a rapid test system like the BD Veritor Plus System, which is a fully portable device with a simple testing process and results that come back in as little as 15 minutes via a digital readout. Rapid antigen testing is also less expensive than lab-based PCR tests, while delivering a combination of simplicity, speed, portability, and reliable results. That makes it an ideal choice for use for non-healthcare settings in particular, like the USATF events, schools, entertainment venues and more.

Tuba:  What are BD's other efforts for the effective testing of COVID-19?

Tony:  In addition to helping these athletes get safely back to competition, the BD Veritor Plus System is helping the public get back on track with their normal lives through its widespread use in other settings like schools and entertainment venues. Also of note, the FDA has granted us an EUA for a new, rapid antigen test that uses the BD Veritor Plus System to detect SARS-CoV-2, influenza A and influenza B in a single test, which may prove to be particularly helpful this winter when flu cases are expected to rise. In addition to providing antigen- and molecular-based diagnostics, BD has also been on the forefront of the COVID-19 response by providing injection devices for vaccine administration, innovative solutions for immunology research and devices that aid in therapeutics.          

Tuba:  Why does USATF consider BD an ideal partner for testing the athletes?

Tony:  BD has been long known and trusted for our expertise in diagnostic testing. That expertise and the quality of our BD Veritor Plus System helped give USATF confidence that we are the right partner to help protect the health and safety of its professional athletes, their coaches, event organizers and other personnel throughout the U.S. Olympic Trials. We're proud to be partnering with them to support these world-class athletes as they compete to achieve their dreams.

Tuba:  Is the BD Veritor Plus System fully FDA approved for use in the U.S.?

Tony:  BD Veritor has been a trusted brand for nearly a decade. The BD Veritor System received its first clearance from the FDA in 2011 for its use in the rapid detection of Flu A+B. The FDA then provided subsequent approvals for its use in the detection of Respiratory Synctial Virus (RSV) and Group A Strep.

Early on in the pandemic, we began exploring its potential use in the development of a point-of-care test for SARS-CoV-2, confident that our long-term expertise in this area could help develop a COVID-19 test and give us a critically important tool in the fight against the virus. On July 6, 2020, the FDA granted an EUA for our rapid, point-of-care, diagnostic test for SARS-CoV-2 using the BD Veritor Plus System in health care settings.

Then, on March 30, 2021, the FDA granted us another EUA for a new, rapid antigen test using the BD Veritor Plus System that can detect SARS-CoV-2, influenza A and influenza B in a single test. And most recently, on April 1, 2021, the FDA amended the EUA for our BD Veritor Plus System to be used for SARS-CoV-2 screening through serial testing of asymptomatic individuals.     

Tuba:  Are you open to more collaboration for the betterment of athletes?

Tony:  BD recently announced that it is also the official COVID-19 testing partner of USA Swimming. Tests using the BD Veritor Plus System will be conducted at the U.S. Olympic Team Trials Swimming to enhance the safety of athletes seeking to qualify for the Tokyo games, as well as other 2021-2022 USA Swimming events where testing is required. 

Tuba:  Is BD working or in conversations with the organizing committee of the Tokyo Olympics to supply testing via the BD Veritor Plus System for all the Olympic teams?

Tony:  While we have had discussions with other individual USA national governing bodies,BD is not currently partnering with the International Olympic Committee. Our partnerships with USATF and USA Swimming are separate from the broader Olympic organizing committee.  

 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, not for any other viruses or pathogens; and, 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. Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C §263a, that meet the requirements to perform moderate, high or waived complexity tests. This test is authorized for use at the Point of Care (POC), i.e., in patient care settings operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation. For more information, please see bdveritor.com.  

About Tony Ezell:

Tony Ezell serves as the president of North America and chief marketing officer for BD. He leads the US and Canada regions and the Global Marketing organization and is responsible for an integrated commercialization approach to how we address and prioritize customer needs. He is also a member of the BD Executive Leadership Team.

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