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

Rapid antigen tests for the coronavirus are faster, cheaper and more user-friendly than standard diagnostic assays. An assessment now shows that some antigen tests — but not all — can tell with high accuracy who is likely to be most infectious. Antigen-based assays detect specific proteins, or antigens, on the surface of SARS-CoV-2 particles. Christian Drosten at the Charité — University Hospital Berlin and his colleagues analysed the performance of seven commercially available rapid antigen tests. The researchers applied the tests to a range of samples, including dozens of swabs from people who had already tested positive for SARS-CoV-2 or for other respiratory viruses using the gold-standard polymerase chain reaction test (V. M. Corman et al. Preprint at medRxiv https://doi.org/ghj3wt; 2020).

The five most sensitive antigen assays detected the presence of SARS-CoV-2 on 95% of the test runs for samples with concentrations of viral genetic material that ranged between the equivalent of 3.4 million and 74 million copies per millilitre of swab. Such high viral levels are observed during the first week of symptoms, when people are likely to spread the virus to others. The findings have not yet been peer reviewed.

Study cited available as preprint in medRxiv (November 13, 2020):

 https://doi.org/10.1101/2020.11.12.20230292