Below is a sample of the emails you can expect to receive when signed up to Abbott.
AUGUST 26, 2020
Abbott''s Fast, $5, 15-Minute, Easy-to-Use COVID-19 Antigen Test Receives FDA Emergency Use Authorization; Mobile App Displays Test Results to Help Our Return to Daily Life; Ramping Production to 50 Million Tests a Month
Abbott''s BinaxNOW™ COVID-19 Ag Card is a rapid, reliable, highly portable, and affordable tool for detecting active coronavirus infections at massive scale. Test delivers results in just 15 minutes with no instrumentation, using proven lateral flow technology with demonstrated sensitivity of 97.1% and specificity of 98.5% in clinical study. Abbott to offer a no-charge complementary phone app which allows people to display their BinaxNOW test results when asked by organizations where people gather such as workplaces and schools. Company will ship tens of millions of tests in September, ramping to 50 million tests a month at the beginning of October.
Abbott announced today that the U.S. Food and Drug Administration (FDA) has issued Emergency Use Authorization (EUA) for its rapid test for detection of COVID-19 infection. Abbott will sell this test for $5. It is highly portable (about the size of a credit card), affordable and provides results in 15 minutes. BinaxNOW uses proven Abbott lateral flow technology, making it a reliable and familiar format for frequent mass testing through their healthcare provider. 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 will also launch a complementary mobile app for iPhone and Android devices named NAVICA™. This first-of-its-kind app, available at no charge, will allow people who test negative to display a temporary digital health pass that is renewed each time a person is tested through their healthcare provider together with the date of the test result. Organizations will be able to view and verify the information on a mobile device to facilitate entry into facilities along with hand-washing, social distancing, enhanced cleaning and mask-wearing.
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. 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.
DECEMBER 16, 2020
BINAXNOW: FIRST AT-HOME, VIRTUALLY GUIDED RAPID COVID-19 TEST USING EMED''S DIGITAL HEALTH PLATFORM
• 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
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.
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