Virus World

- First at-home, virtually guided service to bring rapid, reliable and affordable testing into the home where the result is delivered in minutes

- 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

- $25 cost for the test and service is the lowest available for at-home testing, which supports the home user to ensure a successful testing process

- BinaxNOW is a highly portable, easy-to-use, 15-minute antigen test with no instrument that detects the virus when people are most infectious, which is critically important in slowing the spread of the virus

- Service uses Abbott's complementary NAVICA™ app to enable the testing process and display authenticated BinaxNOW test results verified by a trained guide - and supports consumer confidence in testing at home

ABBOTT PARK, Ill.,, Dec. 16, 2020 /PRNewswire/ -- Abbott (NYSE: ABT) announced today that the U.S. Food and Drug Administration (FDA) has issued Emergency Use Authorization (EUA) for virtually guided at-home use of its BinaxNOW™ COVID-19 Ag Card rapid test for detection of COVID-19 infection. Abbott is bringing BinaxNOW, the most affordable and widely distributed rapid test into the home, where the result is delivered in minutes without the need to send it out for processing. The $25 cost for the test and service is the lowest currently available for at-home testing.  To facilitate the delivery of the BinaxNOW test to the home and the guided collection and testing process, Abbott has partnered with digital health solutions provider eMed™. This agreement furthers Abbott's vision of making as many tests as possible available in a variety of different settings to improve accessibility, support consumer confidence in testing at home, and help people start returning to living their daily lives with more normalcy. Abbott and eMed expect to deliver and administer 30 million BinaxNOW at-home tests in the first quarter of 2021, with an additional 90 million in the second quarter. Scale is critical to provide broad access to people who need testing and Abbott has scale for all its eight COVID-19 lab and rapid tests. In fact, since launching BinaxNOW in August, Abbott has ramped up capacity to 50 million tests a month in its U.S. facilities that are currently being distributed through the federal government and is expanding further so even more people have access to the tests.

"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." The eMed service offering costs $25 a test, and eMed takes care of determining eligibility, the guided self-collection process, public health reporting requirements and gets people their results through their NAVICA app in a matter of minutes. The eMed offering could also remove some of the obstacles that individuals, governments and organizations face when seeking to provide or perform testing. These include mobility issues for people with disabilities or who may not have a reliable form of transportation, inconvenient testing windows for people who work non-traditional hours or have childcare or eldercare responsibilities, and discouragingly long lines at testing centers.

FDA Release Dec. 16, 2020:

https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-issues-new-authorization-binaxnow-covid-19-ag-card-home-test

Abbott Laboratories won Food and Drug Administration emergency clearance for its portable test for Covid-19 that will sell for just $5 and allow for “frequent mass testing” in schools and workplaces, the company said. The FDA’s “emergency use authorization” awarded to Abbott’s “BinaxNOW Covid-19 Ag Card” rapid test could be a game-changer given it turns around results within 15 minutes and could be administered in schools, workplaces and other sites. Such a test, which still requires a nasal swab by a health professional, is akin to a pregnancy test in its use of “lateral flow technology” and is about the size of a credit card. “With no equipment required, the device will be an important tool to manage risk by quickly identifying infectious people so they don't spread the disease to others,” Abbott said in announcing the FDA’s emergency use authorization. It’s the latest diagnostic test for Covid-19 that Abbott has developed. The company in March received an FDA emergency use authorization for the Abbott ID NOW Covid-19 rapid molecular “point-of-care” diagnostic test that can be used in temporary screening locations, doctor’s office labs and nursing homes to detect the Coronavirus strain COVID-19 within a half hour. But BinaxNOW is different than IDNow in that it requires “no instrumentation,” Abbott said. And the new BinaxNow includes a companion mobile app Abbott will launch for iPhone and Android devices and make available at no charge called NAVICATM” that quickly displays test results.

"The massive scale of this test and app will allow tens of millions of people to have access to rapid and reliable testing," Joseph Petrosino, professor and chairman or molecular virology and microbiology at the Baylor College of Medicine in Houston said in a statement provided by Abbott. "With lab-based tests, you get excellent sensitivity but might have to wait days or longer to get the results. With a rapid antigen test, you get a result right away, getting infectious people off the streets and into quarantine so they don't spread the virus."  Abbott said the new BinaxNOW tests will begin to be shipped by the end of the month with the company expecting to produce 50 million such tests a month by October. "We intentionally designed the BinaxNOW test and NAVICA app so we could offer a comprehensive testing solution to help Americans feel more confident about their health and lives," Abbott president and chief executive Robert Ford said. "BinaxNOW and the NAVICA app give us an affordable, easy-to-use, scalable test, and a digital health tool to help us have a bit more normalcy in our daily lives."