BREAKING: Abbott wins EUA for COVID-19 test that runs off a card

FDA this evening announced an emergency use authorization for Abbott’s BinaxNow COVID-19 Ag Card — a speedy antigen test for the virus that can be directly read off the testing card.
The agency compared the test’s design to some pregnancy tests. A healthcare provider swabs the patient’s nose and twirls the sample on a test card with a testing reagent added. After waiting 15 minutes, the card displays a result: one line for a negative result and two for a positive result.
Abbott (NYSE:ABT) says a clinical study conducted at several leading U.S. research universities showed that the BinaxNow has 97.1% sensitivity (positive percent agreement) and 98.5% specificity (negative percent agreement) among people with suspected COVID-19 cases seeking tests within seven days of exhibiting symptoms.
Abbott plans to ship tens of millions of tests in September, ramping to 50 million tests a month at the start of October. They’ll sell for $5 apiece.
“Due to its simpler design and the large number of tests the company anticipates making in the coming months, this new antigen test is an important advancement in our fight against the pandemic,” said Dr. Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health.
Abbott is touting BinaxNow as a way for schools and other organizations to help keep people in facilities safe. The tests come with a free mobile app called Navica that allows people who test negative to display a temporary digital health pass that includes the date of the health result. The health pass gets renewed every time they test again and come up negative.

“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 CEO Robert B. Ford said in a news release. “BinaxNow and the Navica app give us an affordable, easy-to-use, scalable test, and a complementary digital health tool to help us have a bit more normalcy in our daily lives.”

Original Article: (https://www.massdevice.com/breaking-abbott-wins-eua-for-covid-19-test-that-runs-off-a-card/)