QuidelOrtho
 | |
| Company type | Public |
|---|---|
| |
| Industry | Pharmaceutical Industry |
| Founded | 1979 |
| Founder | Dr. David H. Katz, M.D. |
| Headquarters | San Diego, California, U.S. |
Key people | Brian Blaser (CEO) Joseph M. Busky (CFO) |
| Products | Diagnostic healthcare manufacturer |
| Revenue |  Template:US$ (2023) |
Number of employees | 7,100 (December 31, 2023) |
| Website | quidelortho |
QuidelOrtho Corporation is a U.S.-based producer of diagnostic healthcare solutions operating on a worldwide scale.
On May 8, 2020, Quidel received the initial Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) for its rapid antigen test targeting COVID-19, facilitating swift identification of viral proteins from nasal swab specimens.
History
Established by Dr. David H. Katz, M.D., Quidel commenced business activities in 1981 and introduced its inaugural products by 1984. The present-day corporation emerged in 1991 following the merger between Quidel and Monoclonal Antibodies.
In 1988, Dr. Katz departed to dedicate efforts to the Medical Biology Institute, a nonprofit organization closely associated with Quidel.
A 1997 patent infringement dispute with Becton Dickinson concluded with Quidel agreeing to license certain products and remit royalties.
Quidel expanded its operations through strategic acquisitions: Metra Biosystems in 1999 to enter the bone health sector; Litmus Concepts in 2000, specializing in in vitro diagnostics; Diagnostic Hybrids in 2010; and BioHelix Corporation in 2013, thereby broadening its diagnostic offerings.
The company was involved in patent litigation with Inverness Medical Innovations starting in 2004, including mutual infringement claims.
In May 2020, Quidel’s Sofia 2 SARS Antigen FIA became the first FDA-authorized rapid antigen test for COVID-19, utilizing technology developed under former Chief Science Officer Tim Stenzel.
Quidel announced a $6 billion acquisition of Ortho Clinical Diagnostics Holdings in December 2021, significantly enhancing its portfolio of COVID-19 antigen and antibody tests.
In February 2024, Michael Iskra was appointed interim CEO following the departure of Douglas Bryant during organizational leadership changes.
List of mergers and acquisitions
Significant mergers and acquisitions for the company include:
- Quidel (Founded 1991)
- Metra Biosystems, Inc. (Acquired 1999)
- Litmus Concepts, Inc. (Acquired 2000)
- Diagnostic Hybrids, Inc. (Acquired 2010)
- BioHelix Corporation (Acquired 2013)
- Ortho Clinical Diagnostics (Acquired 2021)
- Ortho Diagnostics Systems
- Ortho Products, Inc. (Established 1939)
- Johnson & Johnson Clinical Diagnostics
- Ortho Diagnostics Systems
Expertise
Following its merger activities, Quidel has diversified its product range through both organic innovation and acquisitions, prioritizing robust research and development efforts to accelerate product introductions.
Its core strengths encompass immunoassay creation, automated production processes, detailed monoclonal antibody analysis, and advancements in molecular assay technologies.
Products
Quidel offers a range of products focusing on infectious diseases and reproductive health, organized into five primary categories: lateral flow assays; direct fluorescent antibody (DFA) tests with an emphasis on infectious diseases and virology; micro-titer assays targeting bone and complement pathways; fluorescent immunoassay systems (Sofia); and molecular diagnostic solutions.
Key diagnostic tools such as QuickVue, Thyretain, Sofia, and AmpliVue are designed to detect illnesses like influenza and thyroid disorders, contributing to improved clinical outcomes in hospital settings.
In 2011, Quidel achieved 510(k) clearance from the FDA and received the European Conformity Mark for both the Sofia Analyzer and the Quidel Molecular hMPV Assay, underscoring its adherence to regulatory standards and readiness for market distribution.