QuidelOrtho

QuidelOrtho is an American medical diagnostics company that develops and manufactures in vitro diagnostic products for use in clinical laboratories, hospitals, physician offices, and other healthcare settings. Its portfolio combines the historical capabilities of Quidel, known for rapid immunoassays, infectious-disease testing, molecular diagnostics, and the Sofia fluorescent immunoassay platform, with those of Ortho Clinical Diagnostics, whose business expanded the combined company’s laboratory diagnostics and transfusion-medicine reach. The Quidel business began operations in 1981 under the direction of Dr. David H. Katz and introduced its first products in 1984. Quidel Corporation was formed in 1991 through the merger of Quidel and Monoclonal Antibodies. Over subsequent decades, the company broadened its technology base through internal research and acquisitions. Metra Biosystems was acquired in 1999, adding capabilities associated with bone-health assessment, and Litmus Concepts was acquired in 2000. Diagnostic Hybrids joined Quidel in 2010, strengthening its infectious-disease and virology capabilities, while BioHelix was acquired in 2013 to expand molecular-diagnostic technology. Quidel’s most visible recent turning point came during the COVID-19 pandemic. In May 2020, the United States Food and Drug Administration granted Emergency Use Authorization to Quidel’s Sofia 2 SARS Antigen FIA. It was described as the first FDA-authorized rapid antigen test for COVID-19, establishing an important category of tests designed to detect viral proteins from nasal samples. The authorization increased Quidel’s visibility and placed its Sofia platform at the center of the company’s pandemic testing activities. In December 2021, Quidel announced an agreement to acquire Ortho Clinical Diagnostics Holdings for approximately $6 billion in cash and stock. The transaction was intended to combine Quidel’s rapid, molecular, and near-patient testing activities with Ortho’s laboratory diagnostics and transfusion-related businesses. The resulting organization adopted the QuidelOrtho name and presented itself as a broader diagnostics supplier rather than solely a rapid-test specialist. QuidelOrtho’s technology areas include lateral-flow testing, direct fluorescent antibody testing, microtiter-based assays, fluorescent immunoassays, and molecular diagnostics. Its named product families include QuickVue, Thyretain, Sofia, and AmpliVue. These products address infectious diseases, reproductive health, thyroid disorders, bone-health assessment, complement-pathway testing, and other clinical applications. The company’s stated capabilities include immunoassay development, monoclonal-antibody characterization, automated manufacturing, and molecular-assay development. The company has also faced intellectual-property disputes and leadership change. Quidel settled a 1997 patent dispute with Becton Dickinson by agreeing to obtain a product license and pay royalties, and it was involved in reciprocal patent litigation with Inverness Medical Innovations in 2004. In February 2024, Chief Executive Officer Douglas Bryant was dismissed and Michael Iskra became interim chief executive. QuidelOrtho therefore entered its current phase as a diversified diagnostics group balancing integration of the Ortho business, product development, regulatory requirements, and changing demand for infectious-disease testing.

QuidelOrtho traces its origins to Quidel, which began operations in 1981 under founder and physician-scientist Dr. David H. Katz. The company launched its first products in 1984. In 1988, Katz left his role as Quidel’s chief scientific officer to devote more time to the Medical Biology Institute, a nonprofit research organization in La Jolla, California associated with the company’s scientific activities. Quidel Corporation was established in 1991 after Quidel merged with Monoclonal Antibodies. During the late 1990s and early 2000s, Quidel expanded both its product portfolio and its corporate base. In 1997, it resolved patent litigation brought by Becton Dickinson concerning strep and chlamydia products. Under the settlement, Quidel agreed to license a relevant product and pay royalties on sales. In 1999, Quidel acquired Metra Biosystems, entering or strengthening its position in bone-health assessment. The following year it acquired Litmus Concepts, a privately held in vitro diagnostics company. Quidel continued to use acquisitions to add specialized technologies. Diagnostic Hybrids was acquired in 2010, reinforcing the company’s infectious-disease and virology capabilities. In 2013, Quidel acquired BioHelix Corporation, a molecular-diagnostics company founded in 2004, in a transaction that included a reported payment obligation to BioHelix shareholders. The company’s development efforts combined acquired technologies with internal work in immunoassays, monoclonal antibodies, automated manufacturing, and molecular assays. The company’s product families developed across several technical categories. Lateral-flow products addressed infectious diseases and reproductive health, while direct fluorescent antibody products focused on infectious disease and virology. Other activities involved microtiter-based products for bone and complement-pathway applications, fluorescent immunoassays sold through the Sofia platform, and molecular tests associated with the AmpliVue brand. Quidel received United States 510(k) clearance and European conformity authorization for the Sofia Analyzer in 2011. A Quidel Molecular hMPV Assay also received FDA 510(k) clearance during that period. Quidel became especially prominent during the COVID-19 pandemic. On May 8, 2020, the FDA granted Emergency Use Authorization to Quidel’s Sofia 2 SARS Antigen FIA. The authorization helped establish rapid antigen testing as a distinct testing category in the United States. The test uses nasal samples and detects viral protein fragments. Tim Stenzel, who had previously served as Quidel’s chief science officer and had overseen the initial Sofia instrument launch, was the FDA official responsible for the relevant authorization process. Quidel was also involved in patent litigation with Inverness Medical Innovations. Inverness sued Quidel for alleged patent infringement in February 2004, and Quidel filed a countersuit during the same month. The supplied reference material does not specify the final disposition of that dispute. In December 2021, Quidel announced that it would acquire Ortho Clinical Diagnostics Holdings for approximately $6 billion in cash and stock. The combination was intended to broaden Quidel’s capabilities and product range by joining its rapid, molecular, and antigen-testing activities with Ortho’s laboratory diagnostics and transfusion-related operations. Following the transaction, the combined business operated under the QuidelOrtho name and represented a significantly broader diagnostics organization. A subsequent leadership transition occurred in February 2024, when Douglas Bryant was removed as chief executive and Michael Iskra became interim CEO. QuidelOrtho’s current strategic context therefore includes integration of the combined portfolio, continued development of diagnostic platforms, regulatory compliance, and adaptation to demand cycles in infectious-disease testing.

• 2024

  Interim CEO appointed

  [1]QuidelOrthoen.wikipedia.org

  Michael Iskra became interim CEO after Douglas Bryant was dismissed.

• 2021

  Ortho Clinical Diagnostics acquisition announced

  [1]QuidelOrthoen.wikipedia.org

  Quidel announced a proposed approximately $6 billion cash-and-stock acquisition of Ortho Clinical Diagnostics Holdings.

• 2020

  First FDA-authorized rapid COVID-19 antigen test

  [1]QuidelOrthoen.wikipedia.org

  The FDA granted Emergency Use Authorization to Quidel’s Sofia 2 SARS Antigen FIA.

• 2013

  BioHelix acquired

  [1]QuidelOrthoen.wikipedia.org

  Quidel acquired molecular-diagnostics company BioHelix Corporation.

• 2011

  Sofia Analyzer receives regulatory clearances

  [1]QuidelOrthoen.wikipedia.org

  The Sofia Analyzer received United States 510(k) clearance and European conformity authorization.

• 2010

  Diagnostic Hybrids acquired

  [1]QuidelOrthoen.wikipedia.org

  The acquisition expanded Quidel’s infectious-disease and virology capabilities.

• 2000

  Litmus Concepts acquired

  [1]QuidelOrthoen.wikipedia.org

  Quidel acquired privately held in vitro diagnostics company Litmus Concepts.

• 1999

  Metra Biosystems acquired

  [1]QuidelOrthoen.wikipedia.org

  Quidel acquired Metra Biosystems to participate in bone-health assessment.

• 1997

  Becton Dickinson patent dispute settled

  [1]QuidelOrthoen.wikipedia.org

  Quidel settled litigation concerning alleged infringement involving strep and chlamydia products by obtaining a license and agreeing to pay royalties.

• 1991

  Quidel Corporation formed

  [1]QuidelOrthoen.wikipedia.org

  Quidel and Monoclonal Antibodies merged to form Quidel Corporation.

• 1984

  First Quidel products launched

  [1]QuidelOrthoen.wikipedia.org

  Quidel introduced its first products three years after commencing operations.

• 1981

  Quidel begins operations

  [1]QuidelOrthoen.wikipedia.org

  Quidel began operations under the leadership of founder Dr. David H. Katz.

A diversified in vitro diagnostics provider combining rapid, near-patient, molecular, laboratory, and transfusion-medicine testing capabilities.

• Fluorescent immunoassay platform

  Sofia

  Sofia is Quidel’s fluorescent immunoassay platform for near-patient and clinical diagnostic testing. It supports assays that use an analyzer to interpret fluorescent signals and has been associated with infectious-disease applications. The platform became particularly prominent during the COVID-19 pandemic through the Sofia 2 SARS Antigen FIA, which received FDA Emergency Use Authorization in 2020.

• Rapid COVID-19 antigen test · 2020

  Sofia 2 SARS Antigen FIA

  The Sofia 2 SARS Antigen FIA is a rapid antigen assay designed to detect viral protein fragments in nasal samples. In May 2020, it became the first COVID-19 rapid antigen test to receive Emergency Use Authorization from the United States FDA, making it a prominent product in Quidel’s pandemic-era diagnostic portfolio.

• Lateral-flow diagnostic tests

  QuickVue

  QuickVue is a Quidel rapid-testing family based primarily on lateral-flow formats. The range has focused on applications including infectious-disease and reproductive-health testing, offering comparatively rapid results for use outside centralized laboratory workflows.

• Thyroid diagnostic assays

  Thyretain

  Thyretain is a Quidel assay family associated with thyroid-disease diagnostics. It reflects the company’s use of immunoassay and biological-reagent expertise in endocrine and thyroid-related testing applications.

• Molecular diagnostic assays

  AmpliVue

  AmpliVue is a molecular-diagnostics brand associated with amplification-based testing. It represents Quidel’s expansion beyond immunoassays into molecular assays for the detection of infectious-disease targets and other clinically relevant analytes.

• 2024

  Chief executive transitionOther

  Background

  QuidelOrtho underwent a senior leadership change after the company removed CEO Douglas Bryant.

  Action taken

  Michael Iskra was appointed interim CEO.

  Aftermath

  The change placed interim leadership over the combined diagnostics business while the company continued operating under the QuidelOrtho name.

  Source

• 2021

  Acquisition of Ortho Clinical Diagnostics HoldingsM&A

  Background

  Quidel sought to broaden its rapid, molecular, and near-patient diagnostics portfolio with laboratory diagnostics and transfusion-medicine capabilities.

  Action taken

  Quidel announced an agreement to acquire Ortho Clinical Diagnostics Holdings for approximately $6 billion in cash and stock.

  Aftermath

  The transaction created the broader QuidelOrtho diagnostics organization and expanded the combined company’s product scope.

  Announced transaction value. Approximately $6 billion (December 2021 announcement)

  Source

• 2020

  COVID-19 rapid antigen testing launchProduct launch

  Background

  The COVID-19 pandemic created demand for rapid tests that could detect viral proteins from nasal samples.

  Action taken

  Quidel submitted its Sofia 2 SARS Antigen FIA for regulatory review and received FDA Emergency Use Authorization in May 2020.

  Aftermath

  The authorization helped establish rapid antigen testing as a major pandemic testing category and increased the visibility of Quidel’s Sofia platform.

  Source

• 1997

  License settlement with Becton DickinsonOther

  Background

  Becton Dickinson accused Quidel of infringing patents related to strep and chlamydia products.

  Action taken

  Quidel settled the dispute by agreeing to purchase a product license and pay royalties on product sales.

  Aftermath

  The settlement allowed Quidel to continue commercial activity under the agreed licensing arrangement.

  Source

1. 1QuidelOrthoen.wikipedia.org