"All the discussion and announcement by Abbott sure did not mention sales and limited partners."
FDA announced EUA authorization for the test on 8/26/20.
U.S. Department of Health and Human Services (HHS) announcement the next day.
https://www.hhs.gov/about/news/2020/08/27/tru...-2020.html
FDA announced EUA authorization for the test on 8/26/20.
U.S. Department of Health and Human Services (HHS) announcement the next day.
https://www.hhs.gov/about/news/2020/08/27/tru...-2020.html
Quote:FOR IMMEDIATE RELEASE
August 27, 2020
Contact: HHS Press Office
202-690-6343
media@hhs.gov
Trump Administration Will Deploy 150 Million Rapid Tests in 2020
Today, as part of an historic initiative led by the U.S. Department of Health and Human Services (HHS) and the Department of and Defense (DOD), the Administration awarded a contract for $760 million to Abbott for delivery of 150 million rapid, Abbott BinaxNOW COVID-19 Ag Card Point of Care (POC) SARS-CoV-2 diagnostic tests to expand strategic, evidence-based testing in the United States. Testing will be potentially deployed to schools and to assist with serving other special needs populations.
“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,” said HHS Secretary Alex Azar. “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.”
The Abbott BinaxNOW COVID-19 Ag Card recently received emergency use authorization from the Food and Drug Administration , does not require instrumentation, and will deliver COVID-19 test results in 15 minutes or less. The Administration has laid the groundwork for this program with months of collaborative work, paving the regulatory and innovation pathways.
The BinaxNOW COVID-19 Ag Card test 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. Rapid POC testing will help to enable opening of and also to lower the risk of COVID-19 spread.
“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,” said ADM Brett Giroir, MD. “Under President Trump’s leadership we have worked closely with the private sector to stimulate testing innovations such as the Abbott BinaxNOW COVID-19 test. This is no small achievement and is of an unprecedented scale. 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.”
Abbott has the capability to scale up to meet the demand for antigen testing across the country and is the only known sources that can immediately provide the required items to meet HHS’s urgent needs. The system uses a nasal swab and associated media placed on a strip that can detect COVID-19 and other viruses.
