ABBOTT PARK - Abbott (NYSE: ABT) is announcing today the fulfillment of the federal government's order of 150 million BinaxNOW COVID-19 Ag tests.
These rapid tests were distributed through the Department of Health and Human Services (HHS) to states, territories and targeted entities, such as nursing homes, assisted living facilities, home health and hospice agencies, historically black colleges and universities (HBCUs), and the Indian Health Service.
Abbott is also in the final stages of completing its self-funded investment in U.S. manufacturing capacity and is now ready to make tens of millions of BinaxNOW tests available per month for direct purchase to organizations including schools, workplaces and pharmacies.
'We've intentionally developed the most comprehensive COVID testing portfolio and the most advanced family of rapid tests to have the greatest impact we can,' said Robert B. Ford, president and chief executive officer, Abbott. 'We're pleased to take this next step in making BinaxNOW and NAVICA available to support the opening of organizations, and get them to more places where people need them, such as schools and universities, workplaces and pharmacies.'
The University of Wisconsin System will be the first customer in the U.S. to secure BinaxNOW at scale, procuring 480,000 tests over six months for use at its universities and branch campuses.
'The University of Wisconsin System strives to be a national leader in combating COVID-19 and our robust testing strategy is one of our most effective means to do it,' said Tommy Thompson, president, University of Wisconsin System. 'We will continue to be aggressive in acquiring and implementing tests at our universities and our partnership with Abbott is key to making this happen.'
At the size of a credit card and with no equipment required, Abbott's BinaxNOW COVID-19 test sold directly to qualified organizations for $5 per test is already the country's most widely available and mass-produced rapid test, providing results in 15 minutes and detecting the virus when people are most infectious and therefore at the greatest risk of spreading it to others. An at-home, virtually and digitally guided version of the test is also available at $25 per test.
Abbott will continue supplying HHS with a total of 30 million tests between now and March 2021. A breakdown of the initial 150 million tests shipped to states, territories and targeted entities via HHS orders can be found here.
BinaxNOW and NAVICA work together to help organizations perform testing at scale
The BinaxNOW test can be paired with the no-charge NAVICA app, which was developed by Abbott to allow people who test negative to display that result through a temporary digital health certificate. People who test negative on BinaxNOW can receive a QR code (similar to a mobile boarding pass used to board an airplane) and organizations can scan and verify the information to manage entry into facilities that accept NAVICA.
'Since October 2020, Abbott has been providing testing for U.S. employees using BinaxNOW and the NAVICA platform. Through the thousands of employees who have been tested, Abbott has gained important insights on managing workflow and how to use NAVICA to allow people to store, access and display their test results,' said Mary Moreland, executive vice president, human resources, Abbott. 'Our experience shows that large organizations can effectively manage a high-throughput, rapid testing program across multiple sites and in different occupational settings.'
Since the pandemic began, Abbott has developed the most advanced and comprehensive portfolio of COVID-19 tests across its testing platforms-from high-throughput molecular tests on its m2000 RealTime and Alinity m lab-based systems; to serology tests on its Alinity i and ARCHITECT i1000SR and i2000SR instruments; to rapid molecular tests on the ID NOW instrument; to rapid antigen test options on BinaxNOW (available in U.S.) and the Panbio COVID-19 Ag Rapid Test Device.
The company will continue to study the role of testing as more becomes known about the long term efficacy of vaccines and how testing can be deployed to track outbreaks and more confidently return to group settings.
About the BinaxNOW COVID-19 Ag Card Rapid Test
The BinaxNOW COVID-19 Ag Card is an assay for the qualitative detection of specific antigens to COVID-19 in the human nasal cavity. A simple nasal swab is used to collect specimens from people suspected of having an active infection.
Under FDA EUA, the BinaxNOW COVID-19 Ag Card is for use by healthcare professionals and can be used in point-of-care settings that are qualified to have the test performed and are operating under a CLIA (Clinical Laboratory Improvement Amendments) Certificate of Waiver, Certificate of Compliance or Certificate of Accreditation. Within these settings, the test can be performed by doctors, nurses, school nurses, medical assistants and technicians, pharmacists, employer occupational health specialists and more with minimal training and a patient prescription.
Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 107,000 colleagues serve people in more than 160 countries.
The BinaxNOW COVID-19 Ag Test Card EUA has not been FDA cleared or approved. It has been authorized by the FDA under an emergency use authorization for use by authorized laboratories and patient care settings. The test has been authorized only for the detection of proteins from SARS-CoV-2, not for any other viruses or pathogens, and is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostic tests 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.