One day after Abbott secured Emergency Use Authorization for its $5 coronavirus test, the White House awarded the company a $750 million contract to deliver 150 million Abbott BinaxNOW COVID-19 Ag Card Point of Care (POC) SARS-CoV-2 diagnostic tests to expand testing across the country.
The test, which delivers results in about 15 minutes without the necessary encumbrance of a laboratory, could be deployed to schools across the nation and assist with assessing potential outbreaks of the novel coronavirus in other special needs populations, the government said in its announcement. Rapid POC testing will help to enable opening of and also to lower the risk of COVID-19 spread, the government added. The BinaxNOW system, which is about the size of a credit card, uses a nasal swab and associated media placed on a strip that can detect COVID-19 and other viruses. The test can easily be performed in a doctor’s office.
“The introduction of Abbott’s antigen test is another incredibly valuable result of President Trump’s all-of-America approach to constructing our world-leading COVID-19 testing capacity,” Health and Human Services Secretary Alex Azar said in a statement. “By strategically distributing 150 million of these tests to where they’re needed most, we can track the virus like never before and protect millions of Americans at risk in especially vulnerable situations.”
Since the outbreak of the novel coronavirus at the end of 2019, there have been more than 24 million people diagnosed with the virus, including 5.8 million in the United States. There have been 832,419-related deaths across the globe, including 180,857 in the U.S.
Abbott’s test, which detects the infection through the use of the company’s proven lateral flow technology uses nasal swabs and is simple to use, inexpensive, and can be easily employed by medical personnel or trained operators in certain non-clinical environments operating through a CLIA certificate.
EUA for the BinaxNOW test was granted based on clinical data that showed the device demonstrated sensitivity of 97.1% (positive percent agreement) and specificity of 98.5% (negative percent agreement) in patients suspected of COVID-19 by their healthcare provider within the first seven days of symptom onset. Following the EUA from the U.S. Food and Drug Administration, shares of Abbott jumped more than 7% and have continued to climb this morning in premarket trading. Share prices are up to $114.18 this morning.
Following the FDA granting of EUA, Abbott said it plans to ship tens of millions of tests in September, ramping to 50 million tests a month at the beginning of October. The company has invested hundreds of millions of dollars since April in two new U.S. facilities to manufacture BinaxNOW at massive scale.
Admiral Brett Giroir, Assistant Secretary for Health, touted the leadership of the Trump administration in paving the way for the BinaxNOW test, as well as other diagnostics tests aimed at the coronavirus developed by Abbott and other companies. For Abbott, the EUA for the BinaxNOW test marked the sixth EUA the company has received for COVID-19-related diagnostics tools.
“Over the past months, our collaboration with Abbott has exemplified the administration’s whole-of-society approach to this pandemic, fully leveraging America’s industry and innovative spirit. The administration is now prepared to fully deploy this new testing asset to continue combatting the virus and safely and sensibly reopening our great nation,” Giroir said in a statement.