Ortho Clinical Diagnostics

Last updated
Ortho Clinical Diagnostics Holdings plc
Company type Public
Industry Medical diagnostics
Founded1939;85 years ago (1939)
Linden, New Jersey, U.S.
Headquarters1001 US-202, ,
U.S.
Area served
Worldwide
Key people
[1]
Revenue$1.8 billion (2018) [2]
Owner Quidel Corporation
Number of employees
4,400 (2019)
Website orthoclinicaldiagnostics.com

Ortho Clinical Diagnostics (now QuidelOrtho) is an in vitro diagnostics company that made products and diagnostic equipment for blood testing. Ortho served 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]

Contents

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. QuidelOrtho'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 operated as an independent company, [4] [5] [6] up until its acquisition by Quidel Corporation for $6 billion, on May 27, 2022.

History

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

1944: Philip Levine, 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.[ citation needed ]

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]

2021: Quidel announced it would acquire Ortho Clinical Diagnostics Holdings for $6 billion in cash and stock, increasing the range of COVID-19 antigen and antibody tests the business is able to offer. [15]

Business operations

Ortho produces in-vitro diagnostics equipment and associated assays and reagents, serving the clinical laboratories and immunohematology sectors of the medical field. [16]
Ortho sells its products in more than 125 countries and is targeting emerging markets for future growth. [2]

Related Research Articles

<span class="mw-page-title-main">ELISA</span> Method to detect an antigen using an antibody and enzyme

The enzyme-linked immunosorbent assay (ELISA) is a commonly used analytical biochemistry assay, first described by Eva Engvall and Peter Perlmann in 1971. The assay is a solid-phase type of enzyme immunoassay (EIA) to detect the presence of a ligand in a liquid sample using antibodies directed against the ligand to be measured. ELISA has been used as a diagnostic tool in medicine, plant pathology, and biotechnology, as well as a quality control check in various industries.

<span class="mw-page-title-main">Diagnosis of HIV/AIDS</span> Immunological test

HIV tests are used to detect the presence of the human immunodeficiency virus (HIV), the virus that causes acquired immunodeficiency syndrome (AIDS), in serum, saliva, or urine. Such tests may detect antibodies, antigens, or RNA.

Serology is the scientific study of serum and other body fluids. In practice, the term usually refers to the diagnostic identification of antibodies in the serum. Such antibodies are typically formed in response to an infection, against other foreign proteins, or to one's own proteins. In either case, the procedure is simple.

<span class="mw-page-title-main">Chiron Corporation</span> American biotechnology firm (1981-2006)

Chiron Corporation was an American multinational biotechnology firm founded in 1981, based in Emeryville, California, that was acquired by Novartis on April 20, 2006. It had offices and facilities in eighteen countries on five continents. Chiron's business and research was in three main areas: biopharmaceuticals, vaccines, and blood testing. Chiron's vaccines and blood testing units were combined to form Novartis Vaccines and Diagnostics, while Chiron BioPharmaceuticals was integrated into Novartis Pharmaceuticals. In 2014, Novartis completed the sale of its blood transfusion diagnostics unit to Grifols and announced agreements for the sale of its vaccines unit to GlaxoSmithKline.

The direct and indirect Coombs tests, also known as antiglobulin test (AGT), are blood tests used in immunohematology. The direct Coombs test detects antibodies that are stuck to the surface of the red blood cells. Since these antibodies sometimes destroy red blood cells they can cause anemia; this test can help clarify the condition. The indirect Coombs test detects antibodies that are floating freely in the blood. These antibodies could act against certain red blood cells; the test can be carried out to diagnose reactions to a blood transfusion.

<span class="mw-page-title-main">Immunohaematology</span> Branch of hematology and transfusion medicine

Immunohematology is a branch of hematology and transfusion medicine which studies antigen-antibody reactions and analogous phenomena as they relate to the pathogenesis and clinical manifestations of blood disorders. A person employed in this field is referred to as an immunohematologist or colloquially as a blood banker. Their day-to-day duties include blood typing, cross-matching and antibody identification.

Interferon-gamma release assays (IGRAs) are diagnostic tools for latent tuberculosis infection (LTBI). They are surrogate markers of Mycobacterium tuberculosis infection and indicate a cellular immune response to M. tuberculosis if the latter is present.

<span class="mw-page-title-main">Medical laboratory</span> Principles of management with special reference to medical science

A medical laboratory or clinical laboratory is a laboratory where tests are conducted out on clinical specimens to obtain information about the health of a patient to aid in diagnosis, treatment, and prevention of disease. Clinical medical laboratories are an example of applied science, as opposed to research laboratories that focus on basic science, such as found in some academic institutions.

This page is currently under construction.

Immudex is a Danish Reagents and Diagnostics company established in 2009. The company is operating from offices located in Copenhagen, Denmark, and in Fairfax, Virginia. Immudex specializes in the production of MHC Dextramers. MHC Dextramers are chemical reagents that are designed to detect antigen-specific T cells.

DiaSorin is an Italian multinational biotechnology company that produces and markets in vitro diagnostics reagent kits used in immunodiagnostics and molecular diagnostics and since July 2021, it is also active in the Life Science business. The group was founded in 2000 and is headquartered in Saluggia, Italy. Its production is at several plants located in Europe and the United States: Saluggia and Gerenzano (Italy), Dietzenbach (Germany), Stillwater, Minnesota (US), Dartford (UK). Following the acquisition of Luminex, the company acquired five additional production plants located in the United States and in Canada (Toronto). The company is a constituent of the FTSE MIB index.

QuidelOrtho Corporation is an American manufacturer of diagnostic healthcare products that are sold worldwide.

Viral load monitoring for HIV is the regular measurement of the viral load of individual HIV-positive people as part of their personal plan for treatment of HIV/AIDS. A count of the viral load is routine before the start of HIV treatment.

<span class="mw-page-title-main">David Dane</span> British pathologist and clinical virologist

David Maurice Surrey Dane, MRCS CRCP MB Bchir MRCP MRCPath FRCPath FRCP was a pre-eminent British pathologist and clinical virologist known for his pioneering work in infectious diseases including poliomyelitis and the early investigations into the efficacy of a number of vaccines. He is particularly remembered for his strategic foresight in the field of blood transfusion microbiology, particularly in relation to diseases that are spread through blood transfusion.

The Vel blood group is a human blood group that has been implicated in hemolytic transfusion reactions. The blood group consists of a single antigen, the high-frequency Vel antigen, which is expressed on the surface of red blood cells. Individuals are typed as Vel-positive or Vel-negative depending on the presence of this antigen. The expression of the antigen in Vel-positive individuals is highly variable and can range from strong to weak. Individuals with the rare Vel-negative blood type develop anti-Vel antibodies when exposed to Vel-positive blood, which can cause transfusion reactions on subsequent exposures.

The Junior blood group system is a human blood group defined by the presence or absence of the Jr(a) antigen, a high-frequency antigen that is found on the red blood cells of most individuals. People with the rare Jr(a) negative blood type can develop anti-Jr(a) antibodies, which may cause transfusion reactions and hemolytic disease of the newborn on subsequent exposures. Jr(a) negative blood is most common in people of Japanese heritage.

<span class="mw-page-title-main">Blood compatibility testing</span> Testing to identify incompatibilities between blood types

Blood compatibility testing is conducted in a medical laboratory to identify potential incompatibilities between blood group systems in blood transfusion. It is also used to diagnose and prevent some complications of pregnancy that can occur when the baby has a different blood group from the mother. Blood compatibility testing includes blood typing, which detects the antigens on red blood cells that determine a person's blood type; testing for unexpected antibodies against blood group antigens ; and, in the case of blood transfusions, mixing the recipient's plasma with the donor's red blood cells to detect incompatibilities (crossmatching). Routine blood typing involves determining the ABO and RhD type, and involves both identification of ABO antigens on red blood cells and identification of ABO antibodies in the plasma. Other blood group antigens may be tested for in specific clinical situations.

The Lan blood group system is a human blood group defined by the presence or absence of the Lan antigen on a person's red blood cells. More than 99.9% of people are positive for the Lan antigen. Individuals with the rare Lan-negative blood type, which is a recessive trait, can produce an anti-Lan antibody when exposed to Lan-positive blood. Anti-Lan antibodies may cause transfusion reactions on subsequent exposures to Lan-positive blood, and have also been implicated in mild cases of hemolytic disease of the newborn. However, the clinical significance of the antibody is variable. The antigen was first described in 1961, and Lan was officially designated a blood group in 2012.

The WHO model list of essential in vitro diagnostics, or WHO list of essential diagnostic tests (EDL) is a World Health Organization (WHO) priority list of medical tests that provides guidance for individual countries on which tests to use and which not to. It was first published in 2018, then revised in 2019, and a third edition was published in 2020.

<span class="mw-page-title-main">Antibody elution</span> Laboratory procedure

An antibody elution is a clinical laboratory diagnostic procedure which removes sensitized antibodies from red blood cells, in order to determine the blood group system antigen the antibody targets. An antibody elution is deemed necessary when antibodies of the immunoglobulin class G (IgG) are found sensitized (bound) to peripheral red cells collected from a blood product transfusion recipient. IgG antibodies are detected using an assay known as the direct antiglobulin test.

References

  1. "Ortho Clinical Diagnostics Leadership" . Retrieved 6 July 2016.
  2. 1 2 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. "News & Media | Carlyle".
  6. "Ortho Clinical Diagnostics Appoints Industry Veterans to Board of Directors". 27 April 2015.
  7. Flint, Peter B. (20 October 1987). "Dr. Philip Levine, 87, is Dead; Discovered Blood's Rh Factor". The New York Times.
  8. "Vitros Immunodiagnostic Products HBsAg Reagent Pack and Calibrator, and HBsAg Confirmatory Kit - P000044". www.fda.gov. Archived from the original on 2009-07-09.
  9. "Pharma commercial intelligence, news & analysis | Evaluate".
  10. "Blood Donor Screening for Chagas Disease --- United States, 2006--2007".
  11. "Carlyle Buys Johnson & Johnson Testing Division for $4.15 Billion". 16 January 2014.
  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 (18 December 2017). "Ortho Clinical Diagnostics Gets FDA Clearance for HIV Combo Test on Immunodiagnostic System". 360Dx.com. Retrieved 19 December 2017.{{cite web}}: CS1 maint: numeric names: authors list (link)
  15. "Quidel to buy Ortho Clinical for $6 bln to boost diagnostics portfolio". Reuters. 12 February 2024.
  16. Porter, Kiel (6 December 2017). "Carlyle Is Said to Hire Banks for Ortho Clinical Diagnostics IPO". Bloomberg News. Bloomberg LP. Retrieved 19 December 2017.