Ortho Clinical Diagnostics

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Ortho Clinical Diagnostics
Industry Medical diagnostics
Founded Linden, New Jersey, United States
(1939; 79 years ago (1939))
Headquarters 1001 US-202, Raritan, New Jersey, United States
Area served
Key people
  • Martin D. Madaus (Chairman) and (CEO)
  • Charles Wagner (CFO)
  • Robert Yates (COO)
  • Kristie K. Bouryal (CBO) and (CCO)
  • Michael Schlesinger (CLO)
Revenue $1.7 billion (2016)[2]
Number of employees
4,300 (2017)[2]
Website orthoclinicaldiagnostics.com

Ortho Clinical Diagnostics is an in vitro diagnostics company that makes products and diagnostic equipment for blood testing. Ortho serves two primary industries in the medical field: clinical laboratories, by producing platforms and assays that test for a variety of diseases, conditions, and substances; and immunohematology, by providing the means to ensure blood transfusion recipients receive appropriate and compatible blood.[3]
Johnson and Johnson acquired Eastman Kodak's Clinical Diagnostics Division in 1994 (to form Johnson & Johnson Clinical Diagnostics), which was then merged with Ortho Diagnostic Systems in 1997. Ortho's global corporate offices are in Raritan, New Jersey, while their global research and development center is in Rochester, New York.

In 2014, The Carlyle Group purchased the company from Johnson & Johnson for $4.15 billion. Ortho Clinical Diagnostics now operates as an independent company.[4][5]

Ortho Clinical Diagnostics (Ortho) unveiled its newly expanded executive leadership team following the acquisition of the company by The Carlyle Group from Johnson & Johnson. In his first act as Ortho's Chairman and CEO, Dr. Martin D. Madaus announced key appointments in finance, operations, legal and commercial to advance strategic sectors of the In Vitro Diagnostics (IVD) business.[6]


1939: Ortho Products, Inc., is formed in Linden, New Jersey, as a division of Johnson & Johnson.

1944: Dr. Philip Levine, a pioneer in the field of hematology, joins Ortho Products to continue his research into the mechanics of the Rh system in human blood.[7]

1997: Ortho Diagnostics Systems and Johnson & Johnson Clinical Diagnostics merge and begin operating as Ortho Clinical Diagnostics.

2001: Ortho becomes the first diagnostic company to receive US FDA approval for automated random access hepatitis tests.[8][9]

2006: Ortho launches the first FDA-licensed test to screen blood donations for exposure to Chagas disease.[10]

2014: The Carlyle Group acquires Ortho Clinical Diagnostics for $4.15 billion.[11]

2015: Ortho receives FDA clearance for its ORTHO VISION Analyzer, which automates the full range of immunohematology testing and helps improve the safety of blood transfusions by reducing laboratories' reliance on manual methods.[12][13]

2017: FDA approves Ortho's HIV Combo test for the VITROS® immunodiagnostic system. The test detects both HIV-1 and HIV-2 antibodies and the p24 antigen, and enables detection of HIV-1 acute infection earlier than previous assays.[14]

Business Operations[edit]

Ortho produces in-vitro diagnostics equipment and associated assays and reagents, serving the clinical laboratories and immunohematology sectors of the medical field.[15]
Ortho sells its products in more than 125 countries and is targeting emerging markets for future growth.[2]


  1. ^ "Ortho Clinical Diagnostics Leadership". OrthoClinicalDiagnostics.com. Retrieved 6 July 2016. 
  2. ^ a b c Roumeliotis, Greg; O'Donnell, Carl (9 November 2017). "Carlyle explores sale or IPO of Ortho-Clinical Diagnostics". Reuters. Retrieved 19 December 2017. 
  3. ^ "Who We Are". Ortho Clinical Diagnostics. Retrieved 6 July 2016. 
  4. ^ Daneman, Matthew (16 January 2014). "Carlyle to buy Ortho-Clinical for $4.15 billion". Democrat and Chronicle. Retrieved 23 March 2014. 
  5. ^ https://www.carlyle.com/news-room/news-release-archive/carlyle-group-completes-acquisition-ortho-clinical-diagnostics-inc-oc
  6. ^ http://www.businesswire.com/news/home/20150427006258/en/Ortho-Clinical-Diagnostics-Appoints-Industry-Veterans-Board
  7. ^ https://www.nytimes.com/1987/10/20/obituaries/dr-philip-levine-87-is-dead-discovered-blood-s-rh-factor.html
  8. ^ http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/DeviceApprovalsandClearances/Recently-ApprovedDevices/ucm088991.htm
  9. ^ http://www.evaluategroup.com/Universal/View.aspx?type=Story&id=13728
  10. ^ https://www.cdc.gov/mmwr/preview/mmwrhtml/mm5607a2.htm
  11. ^ https://dealbook.nytimes.com/2014/01/16/carlyle-buys-johnson-johnson-testing-division-for-4-15-billion/?_r=0
  12. ^ "First Hospital Installs Ortho Vision Analyzer". News-Medical.net. 13 Nov 2015. Retrieved 6 July 2016. 
  13. ^ Lawrence, Stacy (25 Apr 2016). "Ortho After the Carlyle Takeover: A Q&A with CEO Martin Madaus". Fierce Biotech. Retrieved 6 July 2016. 
  14. ^ 360Dx Staff. "Ortho Clinical Diagnostics Gets FDA Clearance for HIV Combo Test on Immunodiagnostic System". 360Dx.com. Retrieved 19 December 2017. 
  15. ^ Porter, Kiel (6 December 2017). "Carlyle Is Said to Hire Banks for Ortho Clinical Diagnostics IPO". Bloomberg News. Bloomberg LP. Retrieved 19 December 2017. 

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