Ortho Clinical Diagnostics serves the transfusion medicine community and laboratories around the world. We’re a leading provider of total solutions for screening, diagnosing, monitoring and confirming diseases early, before they put lives at risk.
Headquartered in Raritan, NJ, with manufacturing operations in Rochester NY, Pompano Beach, FL and Pencoed, Wales, Ortho Clinical Diagnostics has more than 4,500 employees worldwide. We are dedicated to investing significant resources to continuously improve our products and develop solutions to address unmet medical needs.
Our single focus is to help hospitals, laboratories and blood centers worldwide deliver results that help patients experience a better quality of life.
The Company maintains a leadership position in two major market segments:
Donor Screening - development and commercialization of instrument systems and reagents that screen blood for AIDS , Hepatitis and Chagas’ Disease, aimed at ensuring the safety of the world's blood supply.
- Immunohematology - Ortho Clinical Diagnostics is the worldwide leader in the marketing and development of instrumentation and reagent systems that enable blood typing, aimed at ensuring patient-donor compatibility in blood transfusions.
- Clinical Chemistry - patented dry-slide technology and systems for use in stat and random access in-vitro diagnostic testing. The Company offers a broad menu covering basic metabolites, classical chemistries, special chemistries, proteins, toxicology and therapeutic drug monitoring tests.
- Immunodiagnostics - enhanced chemiluminescence technology and systems offering immunoassay testing capabilities across menu categories of thyroid function, reproductive endocrinology, cardiology, anemia, metabolism, oncology and infectious diseases.
Ortho Clinical Diagnostics is a proud member of AdvaMed.
A History of Innovative Diagnostics Solutions
Ortho Clinical Diagnostics grew from the merger in 1997 of two Johnson & Johnson companies: Ortho Diagnostic Systems, a worldwide leader in transfusion medicine reagents and instrument systems, and Johnson & Johnson Clinical Diagnostics (formerly a division of Eastman Kodak Co. that was acquired by J&J in 1994), a worldwide leader in clinical laboratory systems. The Company's roots date back to 1937, when Johnson & Johnson established the Ortho Products Division. The division became a full and separate member of the Johnson & Johnson Family of Companies in 1974.
For nearly 70 years, Ortho Clinical Diagnostics has pioneered some of the most important technological advances in diagnostics. From early work with blood-type development to the latest advances in systems development, the Company has long provided the medical community with the means to make better medical decisions to better diagnose patients. Worldwide, health-care professionals rely on Ortho Clinical Diagnostics for innovative diagnostic solutions that enable effective diagnosis and enhance patient care.
• 1944: Dr. Philip Levine, a pioneer in the field of hematology, joined Ortho to continue his breakthrough research into the mechanics of the Rh system in human blood. This marked the beginning of the company's commitment to diagnostic medicine. Among Dr. Levine's many contributions was research that led to the development of Rh Immune Globulin to protect Rh-negative women against isoimmunization, saving the lives of thousands of babies.
• 1947: Developed the first blood bank anti-D test for the clinical market. This was a revolutionary advance in the burgeoning blood banking industry.
• 1978: Introduced patented thin-film dry-slide technology, once again revolutionizing the field of diagnostics by providing clinical professionals with the means to receive high-quality results quickly, cleanly and economically
• 1989: Introduced the first test for the detection of antibodies to hepatitis C.
• 1996: Introduced the first test kit to screen blood for antigens to HIV-1, the virus that is responsible for the vast majority of AIDS cases in the U.S.
• 1997: Introduced the most advanced immunodiagnostic system available in the industry. The innovative VITROS® ECi Immunodiagnostic System allows labs to conduct more sensitive tests such as thyroid, fertility, anemia, endocrinology and cardiology with greater speed, accuracy and cost-effectiveness.
• 1997: Introduced the Ortho AutoVue® System, the first fully automated blood banking system in Europe.
• 1999: Introduced the Ortho Summit™ System, the first fully automated blood and plasma screening system available in the U.S.
• 1999: Became one of the first diagnostic industry suppliers to offer contracted implementation services that can significantly reduce clinical laboratory costs through operational efficiencies and streamlined processes.
• 2000: Released the HCV Core Antigen ELISA Test System—the first test commercially available for the direct detection in blood and plasma of HCV core antigen, a marker of early infection in hepatitis C-infected individuals.
• 2000: Established Advanced Cellular and Diagnostic Systems (formerly Veridex and now Janssen Diagnostics), an independently managed franchise focused on bringing high value diagnostic, monitoring and screening solutions to cancer and other disease states such as CNS and cardiovascular.
• 2001: Became the first diagnostic company to receive U.S. FDA approval for automated random access hepatitis tests, on the VITROS® ECi Immunodiagnostic System.
• 2001: Developed Ortho trak-C™, the world’s first branded “Total HCV Core Antigen” test designed to provide reliable measures of HCV viremia that will lead to improvements in the management of patients with HCV infection.
• 2002: Acquired Micro Typing Systems of Pompano Beach, Florida, the manufacturer of the ID-Micro Typing System™ (ID-MTS) used in hospitals and donor centers to help to ensure safe and effective blood transfusions.
• 2003: Launched Ortho ProVue®, the first fully automated Immunohematology system for use with the ID-Micro Typing System™ (ID-MTS) Gel Test™ in North America.
• 2004: Launched VITROS® ECiQ Immunodiagnostic System and the Auto Vue Innova.
• 2004:Launched VITROS® 5, 1 FS Chemistry System, raising Industry standards for ease-of-use, integrity of results and operational efficiency.
• 2005: Launched VITROS® 350 Chemisty System.
• 2006: Launched the first FDA licensed test to screen blood donations for exposure to Chagas' disease.
• 2007: Launched VITROS®, Troponin I ES Assay used along with other cardiac tests, to help diagnose a heart attack and to detect and evaluate heart injury.
• 2010: Launched the VITROS® intact Parathyroid Hormone (iPTH) Assay, which consolidates routine and intraoperative testing, in the US.
• 2011: Gained approval of the VITROS® HBeAg assay – a test for the hepatitis B “e” antigen – for use on the VITROS® ECI/ECIQ immunodiagnostic systems in the U.S.
• 2011: Launched the VITROS® 4600 Chemistry System for mid- to high-volume laboratories.
• 2011: Announced availability of the VITROS® Immunodiagnostic Products Syphilis TPA assay in select ex-US countries.
2012: Introduced the VITROS® Immunodiagnostic Products 25-OH Vitamin D Total Assay outside the US, and in the US in 2013.
• 2012: Launched outside the US the VITROS® Immunodiagnostic Products Total PSA II Assay and VITROS® Immunodiagnostic Products Free PSA Assay, to aid in monitoring and detecting prostate cancer.
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