Abbott Laboratories said on Wednesday it won U.S. marketing authorization for a COVID-19 portable antigen test that can deliver results within 15 minutes and will sell for $5.
The portable test is about the size of a credit card, requires no additional equipment to operate, and can be conducted using a less invasive nasal swab than traditional lab tests, Abbott executives said on a call with reporters.
Abbott expects to ship tens of millions of tests in September, ramping to 50 million tests a month from the beginning of October.
The test, BinaxNOW COVID-19 Ag Card, could be used to check that people participating in larger gatherings, such as those returning to schools or workplaces, do not have COVID-19 and could help aid the reopening of the U.S., the executives said.
Abbott created a downloadable app that people who have taken the test could present before entering venues to show that they are COVID-19 free, they said.
Antigen tests are cheaper and faster than molecular diagnostic tests but somewhat more likely to fail to identify positive cases of the virus than lab-based diagnostic tests.
The U.S. Food and Drug Administration granted the approval under its emergency use authorization program. Becton Dickinson and Co and Quidel Corp already market antigen tests.
The United States now has more cases of the coronavirus than any other country at more than 5 million, and hospitals and labs have struggled to meet the demand to test thousands of people.
Since March, the company has got U.S. authorizations for five other coronavirus tests, including one called the ID Now that can deliver results within minutes and is used at the White House.