Quidel Corporation

Quidel Corporation is a major American manufacturer of diagnostic healthcare products that are sold worldwide.

Quidel Corporation
TypePublic
IndustryPharmaceutical Industry
Founded1979
HeadquartersSan Diego, California, U.S.
Key people
Douglas C. Bryant, President & CEO
Randall J. Steward, CFO
[1]
ProductsDiagnostic healthcare manufacturer
Revenue $534.2 Million(2019)[2]
Number of employees
1500
Websitequidel.com

On May 8, 2020 the U.S. Food and Drug Administration (FDA) has issued the first emergency use authorization (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.[3]

History

Quidel was founded by Dr. David H. Katz, M.D., commenced operations in 1981 and launched its first products in 1984. Quidel Corporation was formed in 1991 when Quidel and Monoclonal Antibodies merged.[4]

On June 18, 1997 Quidel settled a lawsuit with Becton Dickinson. Quidel had been accused of infringing patents on Becton's strep and chlamydia products. Quidel agreed to buy a product license and pay royalties on its product sales.[5]

In February 2004, Inverness Medical Innovations sued Quidel for patent infringement. That same month, Quidel countersued against Inverness.[6]

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.[3][7]

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 development, automated manufacturing, monoclonal antibody 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; (2) direct fluorescent antibodies (DFA), with expertise in infectious disease and virology; (3) micro-titer production, with a focus on bone and complement pathway markets; (4) fluorescent immunoassay 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, and many other diseases, and can improve the healthcare quality of hospitals.[8]

During 2011, the US Food and Drug Administration (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.[9]

Acquisition

In 1999, Quidel acquired Metra Biosystems, Inc.to participate in bone health assessment.[10] In 2000, Quidel acquired Litmus Concepts, Inc., a privately held in vitro diagnostic company.[11]

In 2010, Quidel acquired Diagnostic Hybrids, Inc. a privately held in vitro diagnostic company.[12] In 2013, Quidel acquired BioHelix Corporation (BioHelix), established in 2004,[13] and was to pay $10 million to the BioHelix shareholders.[14]

References
  1. Plunkett, Jack W. (1 October 2008). Plunkett's Health Care Industry Almanac 2009 (E-Book): Health Care Industry Market Research, Statistics, Trends and Leading Companies. Plunkett Research, Ltd. p. 598. ISBN 9781593921323.
  2. https://ir.quidel.com/news/news-release-details/2020/Quidel-Reports-Fourth-Quarter-and-Full-Year-2019-Financial-Results/default.aspx
  3. Commissioner of Food and Drugs - Food and Drug Administration, Stephen M. Hahn M.D. (May 9, 2020). "Coronavirus (COVID-19) Update: FDA Authorizes First Antigen Test to Help in the Rapid Detection of the Virus that Causes COVID-19 in Patients". FDA. Retrieved 11 May 2020. This article incorporates text from this source, which is in the public domain.
  4. Mamo, Laura (August 14, 2007). Queering Reproduction: Achieving Pregnancy in the Age of Technoscience. Duke University Press. p. 266. ISBN 9780822390220.
  5. "Quidel Settlement". thepharmaletter. June 18, 1997. Retrieved 17 January 2017.
  6. Meland, Marius (February 23, 2004). "Quidel Strikes Back With Patent Lawsuits Against Rivals". Law360. Retrieved 17 January 2017.
  7. https://www.hospimedica.com/covid-19/articles/294782295/quidels-sofia-2-sars-antigen-fia-becomes-first-covid-19-antigen-test-to-secure-fda-emergency-use-authorization.html
  8. "Quidel to Present at Cowen 34th Annual Health Care Conference". finance.yahoo.com.
  9. "Quidel Corporation QDEL.O". Reuters.com.
  10. "Quidel Corporation Completes Acquisition of Metra Biosystems;".
  11. "QUIDEL CORPORATION COMPLETES ACQUISITION OF LITMUS CONCEPTS".
  12. "Quidel Corporation (QDEL) to Buy Diagnostic Hybrids, Inc. for $130 Million".
  13. "QDEL - Google Search". www.google.com.
  14. "Quidel Completes Acquisition of BioHelix Corporation". article.wn.com.
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