Abbott’s BinaxNow COVID-19 Ag Card [Image courtesy of Abbott]
FDA has 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 in the announcement yesterday evening 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) stock is up nearly 9% today, trading at more than $112 per share in afternoon trading. Stocks of other major companies in the COVID-19 testing space took a big hit — including Quidel (NSDQ: QDEL), –26%; Quest Diagnostics (NYSE:DGX) –7.6%; and Hologic (NSDQ:HOLX), –6%. Abbott’s announcement could wipe out at least $22 billion in market value across more than a dozen companies, according to Bloomberg.
Abbott 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.”
This story originally ran on the evening of Aug. 26, 2020. Updated Aug. 27 with the effect on medtech company stocks.