U.S. Department of Health and Human Services Provides $25 Million to Siemens Healthineers to Develop and Produce COVID-19 Antigen Diagnostic Tests | site |


Dual Contracts Will Yield Two New Antigen Tests and Update Massachusetts Facility to Produce up to 50 Million Tests Per Month


(Information contained in U.S. Department of Health and Human Services press release: November 19, 2020)

Today, 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. 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. Today's 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 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 support expansion of the company's domestic production through the Nov. 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.

HHS works to enhance and protect the health and well-being of all Americans, providing for effective health and human services and fostering advances in medicine, public health, and social services. In addition to supporting companies and federal partners in ramping up U.S.-based production of COVID-19 testing, the HHS Office of the Assistant Secretary for Health leads America to healthier lives through promoting vaccination across the lifespan, developing the nation's report card for health (Healthy People 2030), ending America's HIV epidemic, preventing and treating substance use disorders, and improving the lives of all suffering health disparities, with a special emphasis on sickle cell disease.

The mission of ASPR is to save lives and protect Americans from 21st century health security threats. Within ASPR, BARDA invests in the innovation, advanced research and development, acquisition, and manufacturing of medical countermeasures – vaccines, drugs, therapeutics, diagnostic tools, and non-pharmaceutical products needed to combat health security threats. To date, BARDA-supported products have achieved 56 FDA approvals, licensures or clearances. For more on BARDA's portfolio for COVID-19 diagnostics, vaccines and treatments and about partnering with BARDA, visit medicalcountermeasures.gov .

To learn more about federal support for the all-of-America COVID-19 response, visit coronavirus.gov .