As part of Walgreen’s ongoing efforts to increase access to COVID-19 testing in communities across the U.S., the company announced today it has entered into an agreement with Abbott to sell the BinaxNOW
“Even as vaccines become more widely available, COVID-19 testing remains a critical tool to keep our communities safe. The addition of this over-the-counter test in-store will help ensure our customers have access to testing solutions when and how they need it – at home or at one of our conveniently located testing sites,” said John Standley, president, Walgreens. “Working with Abbott and other partners, Walgreens now offers the most comprehensive suite of COVID-19 diagnostic testing options in America, helping encourage consistent, widespread testing.”
Walgreens has made significant strides to increase on-site COVID-19 testing capacity at more than 5,500 Walgreens pharmacies, with more than half of these locations located in socially vulnerable areas. By May, Walgreens will expand testing to 6,000 drive-thru testing sites with half of these sites offering the no-cost, rapid Abbott ID NOW COVID-19 test. This announcement builds upon Walgreens commitment to provide greater access to testing, helping reduce the spread of COVID-19 and improve the health of communities.
“The BinaxNOW Self Test opens the door for Americans to buy an accurate and affordable test on their own terms, when and where they need it,” said Andrea F. Wainer, executive vice president of Abbott’s rapid and molecular diagnostics business. “Together with vaccines and like-minded partners such as Walgreens, we can help people get back to doing what they love – like spending time with friends and family.”
Customers can self-administer the test collection using a short nasal swab (not the deep and invasive nasopharyngeal swab) and check test results in 15 minutes. The BinaxNOW COVID-19 Self Test is the most studied rapid antigen in the U.S., having first been approved in the U.S. for professional use in August 2020. The Self Test is the identical format and technology as the professional test and will come in a two-count box to meet the U.S. Food and Drug Administration’s (FDA) serial (frequent) testing requirements for non-prescription, over-the-counter purchase.
According to the manufacturer’s instructions for use, people using the test should test themselves twice with at least 36 hours between tests. The test can be used on children as young as two years old when samples are collected by an adult and for all people aged 15 years or older. Individuals who test negative should continue to stay cautious, including following social distancing, hand washing and wearing a mask. Individuals who test positive are encouraged to follow the latest U.S. Centers for Disease Control and Prevention (CDC) guidelines, which is to communicate your results to your healthcare provider, who is responsible for reporting your test results to the state health department.
On March 31, 2021, Abbott received U.S. Food and Drug Administration (FDA) Emergency Use Authorization (EUA) for over-the-counter, non-prescription, asymptomatic use of its BinaxNOW COVID-19 Self Test for detection of COVID-19 infection. This new indication allows individuals with or without symptoms to have access to this test without a prescription. Walgreens is one of the first mass retailers to make Abbott’s test widely available for purchase.
The BinaxNOW COVID-19 Ag tests have not been FDA cleared or approved. They have been authorized by the FDA under an emergency use authorization. The tests have been authorized only for the detection of proteins from SARS-CoV-2, not for any other viruses or pathogens, and are 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.