QuidelOrtho Corporation is an American manufacturer of

diagnostic Diagnosis (: diagnoses) is the identification of the nature and cause of a certain phenomenon. Diagnosis is used in a lot of different academic discipline, disciplines, with variations in the use of logic, analytics, and experience, to determine " ...

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 respo ...

(FDA) issued to Quidel the first emergency use authorization (EUA) for a

COVID-19 rapid antigen test COVID-19 rapid antigen tests or RATs, also frequently called COVID-19 lateral flow tests or LFTs, are rapid antigen tests used to detect Severe acute respiratory syndrome coronavirus 2, SARS-CoV-2 infection (COVID-19). They are quick to implemen ...

, 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 (BD; also Becton Dickinson or Becton) is an American multinational medical technology company that manufactures and sells medical devices, instrument systems, and reagents. BD also provides consulting and analytic ...

. Quidel had been accused of infringing

patents A patent is a type of intellectual property that gives its owner the legal right to exclude others from making, using, or selling an invention for a limited period of time in exchange for publishing an sufficiency of disclosure, enabling discl ...

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 w ...

products. Quidel agreed to buy a product license and pay

royalties A royalty payment is a payment made by one party to another that owns a particular asset, for the right to ongoing use of that asset. Royalties are typically agreed upon as a percentage of gross or net revenues derived from the use of an asset or ...

on its product sales. In 1999, Quidel acquired Metra Biosystems, Inc. to participate in bone health assessment. In 2000, Quidel acquired Litmus Concepts, Inc., a privately held

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

diagnostic company. In February 2004, Inverness Medical Innovations sued Quidel for

patent infringement A patent is a type of intellectual property that gives its owner the legal right to exclude others from making, using, or selling an invention for a limited period of time in exchange for publishing an enabling disclosure of the invention."A ...

. 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

to be granted Emergency Use Authorization (EUA) by the FDA, approved by FDA director in charge of authorizing test EUAs, Tim Stenzel. Stenzel was also Quidel’s former Chief Science Officer who, while leading Quidel, oversaw the initial launch of the Sofia instrument. 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. In February 2024, CEO Douglas Bryant was fired, being replaced by Michael Iskra as interim CEO.

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 (now Quidel Corporation, 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: Medical laboratory, clin ...

(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 Research and development (R&D or R+D), known in some countries as OKB, experiment and design, is the set of innovative activities undertaken by corporations or governments in developing new services or products. R&D constitutes the first stage ...

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 immunoassay ...

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 antibodie ...

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, health care, and social activism that explores the health of an individual's Human reproductive system, reproductive system and sexual well-being during all stages of their life. Se ...

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

infectious disease An infection is the invasion of tissue (biology), tissues by pathogens, their multiplication, and the reaction of host (biology), host tissues to the infectious agent and the toxins they produce. An infectious disease, also known as a transmis ...

and

virology Virology is the Scientific method, 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 (biology), ...

; (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 Influenza, commonly known as the flu, is an infectious disease caused by influenza viruses. Symptoms range from mild to severe and often include fever, runny nose, sore throat, muscle pain, headache, coughing, and fatigue. These sympto ...

thyroid disease Thyroid disease is a medical condition that affects the structure and/or 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 ...

, 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