Ortho Clinical Diagnostics
 | |
| Company type | Public |
|---|---|
| Industry | Medical diagnostics |
| Founded | 1939 Linden, New Jersey, U.S. |
| Headquarters | 1001 US-202, , U.S. |
Area served | Worldwide |
Key people |
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| Revenue | $1.8 billion (2018) |
| Owner | Quidel Corporation |
Number of employees | 4,400 (2019) |
| Website | orthoclinicaldiagnostics.com |
Ortho Clinical Diagnostics—currently operating as QuidelOrtho—is a firm focused on in vitro diagnostics, delivering diagnostic instruments and products primarily for blood testing. Its core clientele includes clinical laboratories, where it supplies testing platforms and assays for detecting diseases and medical conditions, as well as the immunohematology sector, which supports safe blood transfusion compatibility.
The company’s roots lie in Johnson & Johnson’s 1994 purchase of Eastman Kodak's Clinical Diagnostics Division, which led to the creation of Johnson & Johnson Clinical Diagnostics. This entity combined with Ortho Diagnostic Systems in 1997 to form Ortho Clinical Diagnostics. The main corporate office is situated in Raritan, New Jersey, while its international research and development hub is based in Rochester, New York.
In 2014, private equity firm The Carlyle Group acquired Ortho Clinical Diagnostics from Johnson & Johnson for $4.15 billion, managing it independently until its 2022 takeover by Quidel Corporation for $6 billion. This acquisition significantly broadened Quidel’s presence and influence within the global medical diagnostics market.
History
1939: Ortho Products, Inc. is founded in Linden, New Jersey as a division under Johnson & Johnson.
1944: Hematologist Philip Levine joins Ortho Products to further research efforts on the Rh blood group system.
1997: The merger between Ortho Diagnostic Systems and Johnson & Johnson Clinical Diagnostics results in the formation of Ortho Clinical Diagnostics.
2001: Ortho becomes the first diagnostics firm to obtain US FDA clearance for automated random access hepatitis testing.
2006: The company introduces the first FDA-approved screening test for Chagas disease in blood donations.
2014: Acquisition by The Carlyle Group at $4.15 billion marks a major investment milestone in the diagnostics sector.
2015: FDA approval is granted for the ORTHO VISION Analyzer, an automated immunohematology testing system that improves blood transfusion safety by minimizing manual intervention.
2017: The FDA authorizes Ortho's HIV Combo test on the Vitros immunodiagnostic platform, facilitating earlier detection of acute HIV-1 infection.
2021: Quidel announces its $6 billion acquisition of Ortho Clinical Diagnostics Holdings, enhancing its portfolio of COVID-19 antigen and antibody diagnostic tests.
Business operations
Ortho produces in-vitro diagnostic devices, test kits, and chemical reagents, catering to clinical labs and the immunohematology field. The firm maintains a presence in more than 125 nations, prioritizing growth by targeting emerging market opportunities.