QuidelOrtho Corporation is a major American manufacturer of

diagnostic Diagnosis is the identification of the nature and cause of a certain phenomenon. Diagnosis is used in many different disciplines, with variations in the use of logic, analytics, and experience, to determine " cause and effect". In systems engin ...

healthcare products that are sold worldwide. On May 8, 2020 the U.S.

Food and Drug Administration The United States Food and Drug Administration (FDA or US FDA) is a List of United States federal agencies, federal agency of the United States Department of Health and Human Services, Department of Health and Human Services. The FDA is respon ...

(FDA) has issued the first

emergency use authorization An Emergency Use Authorization (EUA) in the United States is an authorization granted to the Food and Drug Administration (FDA) under sections of the Federal Food, Drug, and Cosmetic Act as added to and amended by various Acts of Congress, includ ...

(EUA) for a COVID-19 antigen test, a new category of tests for use in the ongoing pandemic. These diagnostic tests quickly detect fragments of proteins found on or within the virus by testing samples collected from the nasal cavity using swabs.

History

Quidel was founded by Dr. David H. Katz, M.D., commencing operations in 1981 and launched its first products in 1984. Quidel Corporation was formed in 1991 when Quidel and Monoclonal Antibodies merged. In 1988, Dr. Katz, a founder and chief scientific officer at Quidel, resigned to devote his energies to the Medical Biology Institute, a nonprofit research group in La Jolla, California that is closely allied with Quidel.Kraul, Chris
"The founder and chairman of Quidel ... resigns"
''The Los Angeles Times'', March 30, 1988. On June 18, 1997 Quidel settled a lawsuit with

Becton Dickinson Becton, Dickinson and Company, also known as BD, is an American multinational medical technology company that manufactures and sells medical devices, instrument systems, and reagents. BD also provides consulting and analytics services in certai ...

. Quidel had been accused of infringing patents on Becton's strep and

chlamydia Chlamydia, or more specifically a chlamydia infection, is a sexually transmitted infection caused by the bacterium '' Chlamydia trachomatis''. Most people who are infected have no symptoms. When symptoms do appear they may occur only several we ...

products. Quidel agreed to buy a product license and pay royalties on its product sales. In 1999, Quidel acquired Metra Biosystems, Inc.to participate in

bone health The human skeletal system is a complex organ in constant equilibrium with the rest of the body. In addition to support and structure of the body, bone is the major reservoir for many minerals and compounds essential for maintaining a healthy pH ...

assessment. In 2000, Quidel acquired Litmus Concepts, Inc., a privately held

in vitro ''In vitro'' (meaning in glass, or ''in the glass'') studies are performed with microorganisms, cells, or biological molecules outside their normal biological context. Colloquially called " test-tube experiments", these studies in biology ...

diagnostic company. In February 2004, Inverness Medical Innovations sued Quidel for patent infringement. That same month, Quidel countersued against Inverness. In 2010, Quidel acquired Diagnostic Hybrids, Inc. a privately held in vitro diagnostic company. In 2013, Quidel acquired BioHelix Corporation, established in 2004, and was to pay $10 million to the BioHelix shareholders. In May 2020, Quidel’s Sofia 2 SARS Antigen FIA has become the first COVID-19 antigen test to be granted Emergency Use Authorization (EUA) by the FDA, approved by former Quidel employee Tim Stenzel. in December 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.

List of mergers and acquisitions

The following is an illustration of the company's major mergers and acquisitions and historical predecessors: *Quidel (Est. 1991) ** Metra Biosystems, Inc. (Acq 1999) ** Litmus Concepts, Inc. (Acq 2000) ** Diagnostic Hybrids, Inc. (Acq 2010) ** BioHelix Corporation (Acq 2013) **

Ortho Clinical Diagnostics 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 ...

(Acq 2021) *** Ortho Diagnostics Systems **** Ortho Products, Inc. (Est. 1939) *** Johnson & Johnson Clinical Diagnostics

Expertise

Since its merger, Quidel has expanded its product base through internal development and acquisition with a focus on increasing its research and development efforts to accelerate the rate of new product introductions. Quidel's core competencies and capabilities include

immunoassay An immunoassay (IA) is a biochemical test that measures the presence or concentration of a macromolecule or a small molecule in a solution through the use of an antibody (usually) or an antigen (sometimes). The molecule detected by the immunoass ...

development, automated manufacturing,

monoclonal antibody A monoclonal antibody (mAb, more rarely called moAb) is an antibody produced from a cell Lineage made by cloning a unique white blood cell. All subsequent antibodies derived this way trace back to a unique parent cell. Monoclonal antibodies ...

characterization and development, and molecular assay development.

Products

Quidel's current products fall generally into these categories: (1) lateral flow, where it focuses on infectious disease and

reproductive health Sexual and reproductive health (SRH) is a field of research, healthcare, and social activism that explores the health of an individual's reproductive system and sexual wellbeing during all stages of their life. The term can also be further de ...

; (2) direct fluorescent antibodies (DFA), with expertise in

infectious disease An infection is the invasion of tissues by pathogens, their multiplication, and the reaction of host tissues to the infectious agent and the toxins they produce. An infectious disease, also known as a transmissible disease or communicable di ...

and

virology Virology is the scientific study of biological viruses. It is a subfield of microbiology that focuses on their detection, structure, classification and evolution, their methods of infection and exploitation of host cells for reproduction, th ...

; (3) micro-titer production, with a focus on bone and complement pathway markets; (4) fluorescent

products (Sofia); and (5) molecular diagnostic products. These products include assays such as QuickVue, Thyretain and the new Sofia and AmpliVue brands, which focus on diagnosing influenza,

thyroid disease Thyroid disease is a medical condition that affects the function of the thyroid gland. The thyroid gland is located at the front of the neck and produces thyroid hormones that travel through the blood to help regulate many other organs, meaning ...

, and many other diseases, and can improve the healthcare quality of hospitals. During 2011, the US

(FDA) and the European Conformity Mark provided Quidel with 510(k) clearance for selling Sofia Analyzer, and another 510(k) clearance for the Quidel Molecular hMPV Assay.

References

External links

* {{Authority control Companies listed on the Nasdaq Health care companies based in California American companies established in 1981