QuidelOrtho
A United States-based manufacturer of in vitro diagnostic products sold in markets worldwide.
Last updated August 22, 2026
AI crawler reads
No AI crawler has read this profile since Oct 28, 2026.
Overview
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.
History
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]Michael Iskra became interim CEO after Douglas Bryant was dismissed.
- 2021
Ortho Clinical Diagnostics acquisition announced
[1]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]The FDA granted Emergency Use Authorization to Quidel’s Sofia 2 SARS Antigen FIA.
- 2013
BioHelix acquired
[1]Quidel acquired molecular-diagnostics company BioHelix Corporation.
- 2011
Sofia Analyzer receives regulatory clearances
[1]The Sofia Analyzer received United States 510(k) clearance and European conformity authorization.
- 2010
Diagnostic Hybrids acquired
[1]The acquisition expanded Quidel’s infectious-disease and virology capabilities.
- 2000
Litmus Concepts acquired
[1]Quidel acquired privately held in vitro diagnostics company Litmus Concepts.
- 1999
Metra Biosystems acquired
[1]Quidel acquired Metra Biosystems to participate in bone-health assessment.
- 1997
Becton Dickinson patent dispute settled
[1]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]Quidel and Monoclonal Antibodies merged to form Quidel Corporation.
Products and positioning
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.
Brand decisions
2024
Chief executive transitionOtherBackground
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.
2021
Acquisition of Ortho Clinical Diagnostics HoldingsM&ABackground
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)
2020
COVID-19 rapid antigen testing launchProduct launchBackground
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.
1997
License settlement with Becton DickinsonOtherBackground
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.
Recent events
- 2024
Douglas Bryant replaced as chief executive[1]
Leadership change
QuidelOrtho dismissed CEO Douglas Bryant and appointed Michael Iskra as interim CEO.
- 2021
Quidel announces acquisition of Ortho Clinical Diagnostics[1]
M&A
Quidel announced a proposed acquisition of Ortho Clinical Diagnostics Holdings in a cash-and-stock transaction valued at approximately $6 billion.
- 2020
FDA authorizes Quidel rapid COVID-19 antigen test[1]
Product launch · Regulation
The FDA granted Emergency Use Authorization to Quidel’s Sofia 2 SARS Antigen FIA, described as the first FDA-authorized rapid antigen test for COVID-19.
Sources1 sources
Cite this profile: Cite the canonical profile. /brand-wiki/quidelortho · Editorial policy · How profiles are compiled