Abbott SARS-CoV-2 Antigen Test Receives EUA, Had $760 Million Deal Pending With Federal Government in Less Than 48 Hours

Rapid antigen test that doesn’t require analyzer scores large government contract within hours of receiving EUA

The US Food and Drug Administration (FDA) granted an emergency use authorization (EUA) for a fourth SARS-CoV-2 antigen test. This new EUA was announced Aug. 26, 2020, and was granted to Abbott Diagnostics Scarborough, Inc., for its BinaxNOW COVID-19 Ag Card.

This new antigen test is different from previously authorized antigen tests in that it does not require an analyzer to read. The results can be read directly from the card, and the test is simple to perform. The test results in 15 minutes and is anticipated to be more inexpensive than any other SARS-CoV-2 diagnostic test to date, the Wall Street Journal (WSJ) reported.

While this antigen test has definitive benefits, it is not as specific as PCR testing. Abbott said in a statement, “Due to the potential for decreased sensitivity compared to molecular assays, negative results from an antigen test may need to be confirmed with a molecular test prior to making treatment decisions. Negative results from an antigen test should be considered in the context of clinical observations, patient history and epidemiological information.”

Jeff Shuren, MD, JD, Director of the FDA’s Center for Devices and Radiological Health, released a statement when the new EUA was announced. “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,” Shuren said. “This means people will know if they have the virus in almost real-time. 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.”

Charles Chiu, MD, PhD, Professor of Laboratory Medicine at University of California, San Francisco — Dr. Chiu of UCSF

“Our nation’s frontline healthcare workers and clinical laboratory personnel have been under siege since the onset of this pandemic,” said Charles Chiu, MD, PhD, Professor of Laboratory Medicine at University of California, San Francisco, in a statement released by Abbott. “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.”

While the EUA for the Abbott BinaxNOW antigen test is an interesting development in and of itself, clinical laboratory leaders may find the immediate positive response by the federal government to be more meaningful.

Within hours of the initial announcement about the issuance of Abbott’s EUA, White House officials disclosed the government’s intention to announce a $750 million deal with Abbott to purchase 150 million of the new rapid antigen tests. “This is a major development that will help our country to remain open, get Americans back to work and kids back to school,” White House senior adviser Alyssa Farah said with the announcement.

Watch for HHS Abbott BinaxNOW Contract to Roll Out

The US Department of Health and Human Services (HHS) and Department of Defense (DOD) issued a release Aug. 27 for the $760 million federal contract award with Abbott for the BinaxNOW antigen test.

Abbott plans to start shipping tens of millions of tests in September and produce 50 million tests per month starting in October, Forbes reported.

Clinical laboratory leaders should be aware of this new development in the field of SARS-CoV-2 antigen testing. Such rapid point-of-care COVID-19 tests are increasingly becoming seen as a viable, scalable alternative to PCR testing. The low cost and quick turnaround time benefits appear to offset the disadvantages of the lower sensitivity of these tests.

Moreover, the availability of an antigen test that does not require an analyzer will further contribute to the trend of offering faster and cheaper coronavirus testing options. As a result, PCR test volumes may drop for clinical laboratories, thus decreasing their revenue from COVID-19 diagnostic testing.