The US Department of Health and Human Services (HHS) and the US Department of Defense (DoD) awarded Siemens Healthineers, Tarrytown, NY, a $12 million contract to support domestic production of two diagnostic tests for SARS-CoV-2, the virus that causes covid-19. The funding is in addition to a $13 million HHS contract awarded Nov. 2 to enable the company to develop the tests.
Combined, the two contracts represent another $25 million investment by the federal government to expand the types of tests for covid-19 and to ensure that sufficient numbers of tests are available in the United States.
The laboratory-based antigen tests under development will use a nose swab sample—or possibly a saliva sample—to detect viral antigens to determine whether a person is infected with the virus. The SARS-CoV-2 antigen (CoV2Ag) chemiluminescent immunoassay (IM) test kits will use Siemens’ existing ADVIA Centaur XP and XPT platforms and Atellica IM platform. Siemens has over 2,000 fully automated immunoassay analyzing platforms in hospitals and mid-to-high volume reference laboratories across all 50 states.
Siemens Healthineers will begin production after finalizing the new covid-19 antigen tests if the Food and Drug Administration authorizes use of the tests. The new contract will enable Siemens to purchase specialized equipment and modify its manufacturing facility in Walpole, Mass, to safely ramp up production to 50 million tests per month within a few months.
The development contract was awarded Nov. 2 by the Biomedical Advanced Research and Developmental Authority (BARDA), part of the HHS Office of the Assistant Secretary for Preparedness and Response (ASPR). BARDA’s development portfolio now includes more than 35 covid-19 diagnostic tests, 16 of which have received FDA emergency use authorization. BARDA-supported partners have shipped more than 50 million tests to healthcare providers across the country.
To learn more about federal support for the all-of-America covid-19 response, visit coronavirus.gov.
Featured image: This scanning electron microscope image shows SARS-CoV-2 (yellow)—also known as 2019-nCoV, the virus that causes COVID-19—isolated from a patient in the U.S., emerging from the surface of cells (pink) cultured in the lab.
Credit: National Institute of Allergy and Infectious Diseases-Rocky Mountain Laboratories, NIH