Abbott Laboratories announced that the FDA has issued an emergency use authorization for its BinaxNOW rapid COVID-19 test for detection of infection.
Abbott, located in Lake Bluff, will ship tens of millions of tests in September, ramping to 50 million tests a month at the beginning of October.
The test, which sells for $5, is highly portable (about the size of a credit card) and provides results in 15 minutes. 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.
NAVICA mobile app will help facilitate test results
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.
If test results are negative, the app will display a digital health pass via a QR code, similar to an airline boarding pass. If test results are positive, people receive a message to quarantine and talk to their doctor. As they’re required to do for all COVID-19 tests, healthcare providers in all settings will be required to report positive results to the CDC and other public health authorities, regardless of whether they use the app. The digital health pass is stored in the app temporarily and expires after the time period specified by organizations that accept the app.
“The massive scale of this test and app will allow tens of millions of people to have access to rapid and reliable testing,” said Joseph Petrosino, Ph.D., professor and chairman, Molecular Virology and Microbiology, Baylor College of Medicine, whose labs have been leading efforts to provide COVID-19 testing for the college and Harris County. “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 Laboratories has invested hundreds of millions of dollars since April in two new U.S. facilities to manufacture BinaxNOW at massive scale. The company plans to hire 2,000 temporary workers at its Gurnee facility to help make the new, rapid COVID-19 test.