FDA Gives Emergency Approval For $5 Rapid Coronavirus Test, Results In 15 Minutes

Abbott Laboratories (ABT) received emergency use authorization from the FDA for its coronavirus rapid test, which sells for only $5 and provides results in 15 minutes.

The test, known as the BinaxNOW COVID-19 Ag Card, tests for the coronavirus infection and is the size of a credit card, Abbott said. The test uses Abbott’s lateral flow technology to allow for frequent mass testing by healthcare providers.

No equipment is required for the test, which was designed to quickly identify those who have been infected with the coronavirus to help prevent the spread of the disease. The test is used to detect nucleocapsid protein antigens from COVID-19 in nasal swabs.

The BinaxNOW test demonstrated a 97.1% positive accuracy and 98.5% negative accuracy in a clinical study conducted by Abbott with several U.S. research universities. Patients were tested within seven days of symptoms.

The introduction of the test was complemented with a mobile app that can be used with an iPhone or Android device called NAVICA. The free app allows for the display of coronavirus test results along with the date of when the test was taken as part of a renewable temporary digital health pass.

NAVICA will allow for the verification of coronavirus test results to allow entry into facilities that require a negative coronavirus test.

"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," Robert B. Ford, president and chief executive officer at Abbott, said in a statement. "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."

The BinaxNOW test is approved for emergency use by healthcare professionals qualified to administer the test. Abbott said it will ship tens of millions of tests in September and 50 million tests a month, beginning in October.

"The massive scale of this test and app will allow tens of millions of people to have access to rapid and reliable testing," Joseph Petrosino, professor and chairman of Molecular Virology and Microbiology at Baylor College of Medicine, said in a statement. "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."

Shares of Abbott were trading at $111.13 as of 9:37 a.m. EDT, up $7.94 or 7.69%.