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Abbott Receives FDA EUA for SARS-CoV-2 Antigen Test Used Without Analyzer

NEW YORK – The US Food and Drug Administration announced Wednesday it has granted Emergency Use Authorization for Abbott's BinaxNow COVID-19 Ag Card, a SARS-CoV-2 antigen test that doesn't require an analyzer to read the results.

The $5 test provides results in 15 minutes from a nasal swab that is twirled on a test card with a testing reagent added. The results can be read directly from the card, like a pregnancy test, with one line indicating a negative result and two lines indicating a positive result, the FDA said. The lateral flow test is authorized for use by healthcare providers in patients within seven days of symptom onset and can be used at CLIA-waived point-of-care settings such as doctors' offices, emergency rooms, or schools, the agency continued. 

"This new COVID-19 antigen test is an important addition to available tests because the results can be read in minutes, right off the testing card," said Jeff Shuren, director of the FDA's Center for Devices and Radiological Health. "This means people will know if they have the virus in almost real-time." 

The BinaxNow COVID-19 Ag Card demonstrated sensitivity of 97 percent and specificity of 98.5 percent in patients suspected of having COVID-19 within a week of symptom onset, according to a clinical study conducted by Abbott. It qualitatively detects the nucleocapsid protein antigen from SARS-CoV-2, the firm said. 

The FDA noted that antigen tests are often not as sensitive as molecular tests, so negative results may need to be confirmed with a molecular test before making any treatment decisions.

Abbott said in a statement that it will ship "tens of millions" of the tests in September and plans to ramp to 50 million tests per month at the beginning of October. 

"The availability of rapid testing for COVID-19 will help support overburdened laboratories, accelerate turnaround times and greatly expand access to people who need it," Charles Chiu, professor of laboratory medicine at the University of California, San Francisco, added in the statement.

The prescription test is accompanied by a free phone app called Navica that will display the patient's test results along with the date of the result when requested, the company said. Abbott said the app "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."

The Abbott Park, Illinois-based company noted that it has provided more than 27 million COVID-19 tests in the US so far, including 14 million detection tests and 13 million antibody tests. 

In Thursday pre-market trading on the New York Stock Exchange, Abbott's shares were up 10 percent at $113.40.