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New At-Home COVID Test: Results in Minutes

SOURCE: Abbott

DESCRIPTION:

We believe COVID testing should be more widely available, in more places, where people work, live, and study.

Today we’re pleased to say that our widely-used BinaxNOW rapid test, the size of a credit card and requiring no instrumentation, has received emergency use authorization (EUA) from the U.S. Food and Drug Administration (FDA) for use at home with a prescription through a virtually guided online service.

The BinaxNOW test, which provides results in minutes and detects the virus in the early part of the disease when people are most infectious, will be used with an online service, provided by eMed, which helps guide people through the testing process.

It’s a significant advancement compared to other at-home COVID-19 testing options where individuals collect their own samples without an expert’s guidance and then package the specimen, mail it to a lab and wait a couple days, or more, for results.

Just as important, our home test will be affordable, accessible and ensures confidence in the home-testing process. Costing $25 through eMed (plus shipping), BinaxNOW is the lowest available price for an at-home COVID-19 testing service. And our test, coupled with the NAVICA app, gives proof of a valid test result through a digitally-authenticated NAVICA pass and helps preserve the integrity of reporting so that public health officials get critical, real-time data on the disease and how it’s spreading during the pandemic.

The new EUA comes just three months after our original launch of BinaxNOW and it furthers our vision – to decentralize and democratize testing – by bringing testing to more people in more places to help slow the spread of the virus.

"As the pandemic has evolved, the need for rapid testing has only grown. Unfortunately, we’re still hearing that many people can’t access testing as quickly as they need it," said Robert B. Ford, Abbott’s president and chief executive officer. "That’s why Abbott is bringing our rapid BinaxNOW test and NAVICA platform into homes through this partnership with eMed, which allows us to maintain the integrity of the testing process, get even closer to people who need testing and help provide the confidence we need to help get back to living with a bit more normalcy."

Abbott and eMed expect to deliver and administer 30 million BinaxNOW tests in the first quarter of 2021, with an additional 90 million in the second quarter. Since launching BinaxNOW in August, Abbott has ramped up capacity to 50 million tests a month in its U.S. facilities. Those test are currently being distributed through the federal government. Abbott is expanding further so more people have access to the tests.

Here’s how it works

  • A person can access the eMed service through Abbott's NAVICA app – available in English and Spanish – which can be downloaded from the Apple and Android app stores.
  • Once eligibility requirements are met, the test kit is shipped directly to the home user or a pick-up location, allowing a person to remain isolated until their status is known.
  • When a BinaxNOW test kit arrives at the home, the home user logs into the eMed portal for their guided testing session. They can expect results in approximately 20 minutes through NAVICA, where a digital pass with a QR code appears that can be scanned by organizations that accept NAVICA.
  • The eMed certified guide is available to answer questions throughout the testing process to ensure a worry-free testing experience for the home user. Results are recorded by eMed and shared with public health authorities so they can monitor and manage the spread of the virus.

Adding to a robust portfolio

We've developed eight COVID-19 tests in the U.S. that have all received EUA. Each of our test types — antigen, molecular and serology — play a role in helping tackle the pandemic and giving people greater confidence to return to school, work and the other things they love.

Expanding our BinaxNOW test to at-home use could help slow virus transmission and relieve some testing burdens (such as lack of transportation and inconvenient testing times).

By the end of 2020, we will have shipped globally more than 300 million COVID-19 tests across all of our different platforms.

"We know that a majority of people aren’t yet fully comfortable with testing themselves at home from recent consumer research, so the eMed service is designed to provide a confident and seamless experience," said Chris Scoggins, senior vice president of rapid diagnostics at Abbott. "The simplicity and convenience of the at-home test and being able to display your results on the NAVICA app, coupled with vaccines and other protective measures, will give us all a shot at some semblance of normality and getting back to our lives."

For more information on our EUA for at-home use of BinaxNOW, check out these details.

The BinaxNOW™ COVID-19 Ag Card Home Test has not been FDA cleared or approved. It has been authorized by the FDA under an emergency use authorization. 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 Federal Food, Drug and Cosmetic Act, 21 U.S.C. § 360bbb-3(b)(1), unless the declaration is terminated or authorization is revoked sooner.

Tweet me: .@Abbott's widely-used BinaxNOW rapid test, the size of a credit card and requiring no instrumentation, has received emergency use authorization from the @US_FDA for use at home with a prescription through a virtually guided online service. https://bit.ly/2KGMlic @AbbottNews

KEYWORDS: Abbott, COVID Test, COVID, At-Home COVID Test, BinaxNOW, Chris Scoggins

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