HHS provides $25 million to Siemens Healthineers to produce COVID-19 antigen tests
The U.S. Department of Health and Human Services (HHS) and the U.S. Department of Defense (DoD) awarded Siemens Healthineers a $12 million contract to support domestic production of two diagnostic tests for SARS-CoV-2, the virus that causes COVID-19, reported HHS.
The funding is in addition to a $13 million HHS contract awarded November 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. This contract will enable Siemens to purchase specialized equipment and modify its manufacturing facility in Walpole, MA, to safely ramp up production to 50 million tests per month within a few months.
The development contract was awarded 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 U.S. Food and Drug Administration (FDA) emergency use authorization. BARDA-supported partners have shipped more than 50 million tests to healthcare providers across the country.
To support expansion of the company's domestic production through the November 17 contract, BARDA collaborated with HHS Office of the Assistant Secretary for Health, the Department of Defense Assisted Acquisition Cell and the Department of the Air Force's Acquisition COVID-19 Task Force. BARDA funded both contracts under the Paycheck Protection and Health Care Enhancement Act.
