U.S. Government Operations
Overview
As a world leader of in vitro diagnostics, QuidelOrtho offers industry-leading expertise in immunoassay and molecular testing, clinical chemistry and transfusion medicine, bringing fast, accurate and reliable diagnostics when and where they are needed – from home to hospital, lab to clinic.
We are transforming the power of diagnostics into a healthier future for all.
Company profile
Strong partner to U.S. government and state government agencies
QuidelOrtho is a responsive, reliable partner to the U.S. government
On March 4, 2020, shortly after the first COVID-19 patient was diagnosed in the U.S., QuidelOrtho’s Chief Executive Officer was invited to meet with the newly formed White House Coronavirus Task Force to discuss testing. Two weeks later, the company began shipping its first emergency-use-authorized Lyra test for COVID-19. On May 8, 2020, QuidelOrtho introduced a test compatible with the with the Sofia and Sofia 2 analyzers – the first-ever 15-minute rapid antigen test to detect COVID-19.
QuidelOrtho is committed to meeting the needs of the U.S. government
In just two years, the company partnered with the National Institutes of Health’s Acceleration of Diagnostics to expand Sofia test manufacturing from 84 million test cassettes per year to more than 220 million cassettes per year. In 2021, the company received emergency use authorization (EUA) for its QuickVue® At-Home OTC COVID-19 Test and quickly opened a 128,000-square-foot facility with the capacity to manufacture the COVID-19 tests that tens of millions of Americans relied on during the pandemic.
QuidelOrtho believes in the value of public-private partnerships
QuidelOrtho works closely with the U.S. Department of Health and Human Services and the Department of Defense to help the government’s efforts to provide tests to Federally Qualified Health Centers, government agencies and American families.
Case studies
Working With U.S. Health and Human Services and Defense Logistics Agency to Bring Fast and Reliable At-Home Tests to the American Public
Challenge:
In March 2020, as COVID-19 began spreading rapidly across the U.S. and around the world, the U.S. government recognized that diagnostic tests, vaccines and therapeutics were going to be essential to protecting public health. From a testing standpoint, the U.S. government requested rapid development of an antigen test for mass distribution across the country. The test needed to be accurate, convenient, accessible and cost-effective, enabling individuals to test themselves easily and quickly at home.
Solution
In response to this urgent need, QuidelOrtho developed, tested, validated and received the first of 13 EUAs within 2 weeks of meeting with the White House Coronavirus Task Force.
Outcome
Over the course of the pandemic, working in partnership with the USG, QuidelOrtho has provided tens of millions of accurate, reliable and affordable tests to the public and donated tests to underserved communities where access to testing was difficult.
Conclusion
QuidelOrtho is proud of its role in partnering with the U.S. Government to protect public health throughout the pandemic.
Accelerating Manufacturing Capacity to Meet Unprecedented Demand: Our Partnership With NIH RADx
Challenge:
The rapid spread of COVID-19 created an unprecedented demand from the U.S. government for accurate, reliable, affordable and fast tests.
Solution
To meet this demand, QuidelOrtho entered into an agreement with the NIH RADx ATP initiative to support the expansion of manufacturing capacity in San Diego for its diagnostic assays that test for SARS-CoV-2 antigen.
Outcome
QuidelOrtho mobilized quickly to upgrade and add new manufacturing lines, thereby expanding the capacity for test cassettes from approximately 84 million cassettes per year to more than 220 million cassettes per year.
In 2021, QuidelOrtho opened Rutherford, a new manufacturing facility in Carlsbad, CA, dedicated to the production of the QuidelOrtho QuickVue line of products.
The 128,000-square-foot facility began operations in the second half of 2021, with the ability to produce approximately 1 billion QuickVue rapid antigen tests per year, including but not limited to tests for SARS, flu and RSV.
Since then, QuidelOrtho has hired hundreds of new employees, extended the production schedule to meet demand and kept all manufacturing lines open regardless of demand volatility and uncertainty.
U.S. employees by region*
*Approximate number of U.S.-only employees as of May 2023.
Our offerings
Labs
Clinical diagnostic testing systems that deliver fast, accurate, reliable test results for the clinicians and patients who need them.
Flexible and scalable automation solutions for labs of all sizes.
Transfusion Medicine
Semi-automated pre-transfusion card reader designed to automate reaction grading and elevate labs’ performance to the highest level.
Automated pretransfusion testing platform that automates over 99% of workload in the blood bank without compromising turnaround time.
Paired with the Ortho Optix Reader, provides a complete semi-automated testing platform, with combined incubation and centrifugation to provide an even smaller footprint in the lab.
Molecular Diagnostics
Open platform, high throughput molecular testing solutions that detect and identify infectious diseases with minimal steps.
Simple, sample-to-result operation that can run up to 12 unique analytes from a single patient sample in approximately 25 minutes.
Simplified platform that uses our proprietary helicase-dependent amplification (HDA) with fluorescence detection to make diagnosing infectious diseases faster and easier than before.
Point of Care
A family of rapid, visually read, lateral flow tests to produce accurate results in minutes.
Accurately detects the SARS-CoV-2 Omicron variant (among others).
Small bench-top analyzers that take rapid testing to a new level using proven lateral-flow technology and advanced fluorescence chemistry.
Comprehensive test menu that provides the diagnostic answers needed to assist in making rapid, cost-effective treatment decisions.
Ortho Care® Services and Informatics
Award-winning evolution of how service, expertise, technology and data-driven solutions come together to create a more effective, efficient lab so our customers can focus on improving patient outcomes.
Infectious disease data brief
Stay up to date on the latest infectious disease statistics for your state with a monthly report generated by data from connected instruments across the U.S.
Virena®
Data Analytics and Surveillance
Partnerships
QuidelOrtho understands and values the role small businesses play in our communities. Today, the company does business with more than 600 small businesses across the U.S., including several that are U.S. Government–certified small and disadvantaged companies.
With more than 300 diagnostic test products available around the world, QuidelOrtho invests heavily in research and development. The company has research relationships with a growing number of universities and colleges.
Learn more about QuidelOrtho’s relationships with the U.S. Government or colleges/universities
Certified Small and Disadvantaged Business Partners
- Cenmed Enterprises
- Hazlow Electronics Inc
- Keystone Environmental
- Pacific Technologies and Solutions
- Sino Biological U.S. Inc
- Tirone Electric Inc
- United Seal and Rubber Co Inc
Put our proven success with government contracts to work on your project
Email us at
USGovernmentAffairs@quidelortho.com
