QuidelOrtho

QuidelOrtho Corporation is a major American manufacturer of diagnostic healthcare products that are sold worldwide.[3]

QuidelOrtho Corporation
TypePublic
IndustryPharmaceutical Industry
Founded1979 (1979)
FoundersDr. David H. Katz, M.D.
HeadquartersSan Diego, California, U.S.
Key people
Douglas C. Bryant, President & CEO
Joseph M. Busky, CFO
[1]
ProductsDiagnostic healthcare manufacturer
RevenueIncrease $534.2 Million(2019)[2]
Number of employees
6,500
Websitequidelortho.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.[4]

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.[5]

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.[6]

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.[7]

In 1999, Quidel acquired Metra Biosystems, Inc.to participate in bone health assessment.[8] In 2000, Quidel acquired Litmus Concepts, Inc., a privately held in vitro diagnostic company.[9]

In February 2004, Inverness Medical Innovations sued Quidel for patent infringement. That same month, Quidel countersued against Inverness.[10]

In 2010, Quidel acquired Diagnostic Hybrids, Inc. a privately held in vitro diagnostic company.[11] In 2013, Quidel acquired BioHelix Corporation, established in 2004,[12] and was to pay $10 million to the BioHelix shareholders.[13]

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,[4][14] approved by former Quidel employee Tim Stenzel.[15]

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.[16]

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 (Acq 2021)

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.[17]

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.[18]

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. "Quidel Reports Fourth Quarter and Full Year 2019 Financial Results".
  3. "Quidel Corporation Profile Dunn Bradstreet".
  4. 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.Public Domain This article incorporates text from this source, which is in the public domain.
  5. Mamo, Laura (August 14, 2007). Queering Reproduction: Achieving Pregnancy in the Age of Technoscience. Duke University Press. p. 266. ISBN 9780822390220.
  6. Kraul, Chris, "The founder and chairman of Quidel ... resigns", The Los Angeles Times, March 30, 1988.
  7. "Quidel Settlement". thepharmaletter. June 18, 1997. Retrieved 17 January 2017.
  8. "Quidel Corporation Completes Acquisition of Metra Biosystems;".
  9. "QUIDEL CORPORATION COMPLETES ACQUISITION OF LITMUS CONCEPTS".
  10. Meland, Marius (February 23, 2004). "Quidel Strikes Back With Patent Lawsuits Against Rivals". Law360. Retrieved 17 January 2017.
  11. "Quidel Corporation (QDEL) to Buy Diagnostic Hybrids, Inc. for $130 Million".
  12. "QDEL - Google Search". www.google.com.
  13. "Quidel Completes Acquisition of BioHelix Corporation". article.wn.com.
  14. "Quidel's Sofia 2 SARS Antigen FIA Becomes First COVID-19 Antigen Test to Secure FDA Emergency Use Authorization". 11 May 2020.
  15. "Here's Why Rapid COVID Tests Are So Expensive and Hard to Find".
  16. "Quidel to buy Ortho Clinical for $6 bln to boost diagnostics portfolio | Reuters". Reuters. 23 December 2021.
  17. "Quidel to Present at Cowen 34th Annual Health Care Conference". finance.yahoo.com.
  18. "Quidel Corporation QDEL.O". Reuters.com.
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