Quidel Corp Profile
QuidelOrtho Corporation develops and manufactures intelligent diagnostic solutions that transform the power of diagnostics into a healthier future for everyone. The company’s expertise in immunoassay and molecular testing, clinical chemistry and transfusion medicine helps clinicians and patients make better informed decisions across the globe. The company’s global infrastructure and commercial reach support its customers across more than 130 countries and territories with quality diagnostics, a broad test portfolio and market-leading service.
The company’s expertise in immunoassay and molecular testing, clinical chemistry and transfusion medicine helps clinicians and patients make better informed decisions across the globe. The company’s global infrastructure and f test portfolio and market-leading service. The company operates globally with manufacturing facilities in the U.S. and U.K. and with sales centers, administrative offices and warehouses located throughout the world.
The company sells its products directly to end users through a direct sales force and through a network of distributors, for professional use in physician offices, hospitals, clinical laboratories, reference laboratories, urgent care clinics, leading universities, retail clinics, pharmacies, wellness screening centers, other point-of-care (POC) settings, blood banks and donor centers, as well as for individual, non-professional, over-the-counter (OTC) use. The company reached significant new markets as it introduced its QuickVue At-Home OTC COVID-19 test for at-home consumer use, school districts, health departments and many other locations.
The company generates its revenue primarily in the following business units: Labs, Transfusion Medicine, Point of Care and Molecular Diagnostics.
Business Units and Products
The company provides diagnostic testing solutions under various brand names, including among others, the following: AdenoPlus, BIOVUE, D3, ELVIRA, ELVIS, FastPoint, FreshCells, InflammaDry, Lyra, MicroVue, Ortho, Ortho Clinical Diagnostics, Ortho Vision, Quidel, QuickVue, QuickVue+, QVue, ReadyCells, Savanna, Sofia, Solana, Thyretain, Triage, Virena and Vitros.
Services and Informatics
In addition to the products it provides, the company’s services and informatics are a critical element of how it delivers value to its customers. As of January 1, 2023, the company had approximately 1,000 service teammates globally. The company employs highly trained service professionals, including laboratory specialists with advanced qualifications.
The company’s highly valued suite of ORTHOCARE service offerings includes:
Guarantee 98% up-time to the company’s e-connected U.S. customers-High instrument reliability and a proactive maintenance program.
E-CONNECTIVITY Remote Monitoring Software-More than 80% of the company’s installed base of VITROS 5600, XT 7600 and ORTHO VISION platforms are e-connected, enabling remote monitoring and improved analyzer availability.
Laboratory Informatics-Solutions designed to deliver incremental value to the laboratory, including inventory planning, laboratory productivity metrics and technical documentation.
ValuMetrix-A highly valued consulting service proven to increase laboratory workflow, productivity and laboratory service levels utilizing lean principles and process excellence. This service offering provides actionable insights into demand for new products, services and workflow.
Global Technical Solution Center-Seven technical solution centers delivering first-line support in over 15 languages, meaning the company can resolve service issues remotely without an on-site visit approximately two-thirds of the time.
Smart Service Mobile App-First-in-class technology enabled on iPhone and Android devices that allows the company’s service teams to receive up-to-date analyzer health checks, proactive alerts and performance monitoring to help ensure the highest level of reliability is achieved.
Training and Education-Flexible educational resources for the lifetime of the customer relationship, including virtual technical training, continuing education and professional development.
Smart Start-Concierge implementation program led by certified project managers. Easier implementation using collaborative software to keep up to date with real-time progress reports, customized dashboards and status updates.
Merged Reality-Enables product experts to provide remote ‘side by side’ assistance to field service engineers and customers through mobile devices, including smart glasses. This allows both parties to see the same thing at the same time and provide guided instruction leading to better and faster fix rates.
The company also provides its Virena wireless cellular data management and surveillance system that operates as a cloud-based solution connecting Sofia and Solana instruments across a healthcare system and automatically transmitting de-identified test results to a secure database. With Virena, a health system, physician office laboratory (POL), urgent care center or retail clinic has the ability to compile, analyze, map and generate reports of de-identified test results, improving operational efficiencies, quality and patient outcome initiatives.
Digital Solutions and Innovation
The company is developing a growing portfolio of digital and data solutions, which improve its customers’ clinical and operational outcomes. The company’s focus is on enabling its customers to deliver smart, connected care across various clinical environments. The company strives to turn its instruments into data assets for healthcare providers, labs and policymakers through proprietary and third-party connectivity solutions, such as laboratory information systems and middleware partnerships and connectivity to its information systems. Building on this interoperability, the company offers a number of solutions to simplify and automate the testing and instrument management process, including ORTHO Connect, Ortho Plus and Virena. The company also plans to develop other digital solutions that turn test results into specific clinical insights and actions via physician or patient facing solutions, such as the QVue mobile application for COVID-19 at-home testing.
Strategy
In the short term, the company’s strategy is to invest in R&D to offer a broader test menu to more settings for more patients. The company has also entered the at-home testing market and see opportunities to benefit from additional at-home tests, such as for the flu and RSV.
Additionally, the company has made investments to design and develop solutions that are intended to drive laboratory automation and efficiency, improve access to new and novel diagnostics, and enable patients and providers to experience the full benefits of a remote and digitized healthcare system.
Longer term, the company intends to continue to invest in areas with unmet clinical needs. The company plans to continue to explore the technology and content landscapes for strategic assets. The company intends to pursue strategic opportunities that could result in new and relevant technologies and capabilities, or accelerate its commercial growth in attractive end-markets and geographies.
The key elements of the company’s strategy are to develop and deliver products that represent significant market opportunities, and compete effectively in market segments where service and quality are important; focus its R&D efforts; leverage its large direct sales team to enhance its cross-selling capabilities across its four business units, and strengthen its relationships with integrated delivery networks, laboratories and hospitals; continue to invest in its digital health solutions, including its mobile applications, to expand into new and growing markets; and pursue potential acquisitions to support its strategic initiatives.
Research and Development
The company’s research and development expenses included $190.5 million for the fiscal year ended January 1, 2023, which includes the impact of Ortho’s operations from the date of the Combinations.
Sales, Marketing and Distribution
The company’s business strategy is designed to serve the continuum of healthcare delivery needs globally, from POC clinicians located in doctor’s office practices, to moderately complex POLs, and to highly complex hospitals, laboratories and blood and plasma centers. The company is also increasingly prioritizing retail and online outlets, such as large pharmacies, to market and distribute its QuickVue At-Home OTC COVID-19 tests. Within the inherent operational diversity of these various segments, it focuses on differentiating ourselves and enhancing its market leadership by specializing in the diagnosis and monitoring of select disease states, conditions and wellness categories.
The company generally sells or places instruments under long-term contracts, which support the ongoing sale of its assays, reagents and consumables. It sells products globally and markets and distributes products worldwide in a variety of ways, including through a mix of direct, indirect and hybrid distribution strategies. Across its global footprint, the company operates a region-specific sales model. The company’s developed markets, specifically in North America and Western Europe, are served primarily through direct sales; however, it generally utilizes a combination of direct sales and third-party distributors in emerging markets, such as China, the Asia Pacific, the Middle East, Africa, Eastern Europe and Latin America, as this model is more commercially effective in those regions. The company’s primary distribution centers are located in North America and Europe.
In North America, the company uses a generalized sales force for each of its business units other than for donor screening within Transfusion Medicine, which utilizes a separate specialist sales force. The company’s North America distribution strategy takes into account the highly fragmented POC market, with many small or medium-sized customers. To reach customers using POC diagnostic tests, a network of national and regional distributors is employed, as well as the company’s own sales force. The company has expanded the size of its North America sales force in the past few years. This sales force works closely with the company’s key distributors to drive market penetration of its products.
In Europe, the company employees support sales and marketing activities in key countries, such as Germany, Italy, France and the U.K. In addition, the company has created shared service centers in Galway, Ireland, Prague, the Czech Republic and Strasbourg, France to support general and administrative, technical support and customer service functions in Europe.
In the Asia Pacific region, which includes China, Japan and India, its employees support sales and marketing activities, primarily for the Point of Care, Labs and Transfusion Medicine business units. In addition, the company has created shared service centers in Shanghai, China and Hyderabad, India to support general and administrative, technical support and customer service functions.
In Latin America, the company’s employees support sales and marketing activities in key countries, such as Brazil and Mexico.
The company’s global team strives to deliver best-in-class customer service and support by surrounding its customers with devoted and experienced professionals. The company’s call center team and laboratory specialists serve as the first line of contact for its customers and are available to provide customer training and ongoing customer support. In addition, the company’s network of field engineers is responsible for installing its instruments and providing onsite customer support if necessary.
The company derives a significant portion of its total revenues from a few customers and distributors. Two of the company’s customers, including one of the company’s distributors, which is considered to be among the market leaders, exceeded 10% of its total revenues for fiscal year 2022.
Marketing
The company seeks to conduct its manufacturing in compliance with QMS regulatory requirements of the U.S., Australia, Brazil, Canada, Japan, Europe, South Korea and certain other countries. The company’s manufacturing facilities have passed routine regulatory inspections confirming compliance with the QMS regulatory requirements. The company’s facilities are registered with various regulatory bodies, including the FDA and other international and local public health and regulatory agencies.
Competition
The company’s principal competitors include among others, Abbott Laboratories, Thermo Fisher Scientific, Danaher, Siemens Healthineers, Diasorin, Bio-Rad, Hologic, Qiagen, bioMerieux and PerkinElmer.
Seasonality
Sales of the company’s respiratory products are subject to, and significantly affected by, the seasonal demands of the cold and flu seasons, typically prevalent during the fall and winter. Historically, sales of the company’s influenza products have varied from year to year (year ended January 1, 2023) in volume and timing based, in large part, on the severity, length and timing of the onset of the cold and flu season. In addition, the SARS-CoV-2 virus may have similar seasonal demands and impacts on the company’s revenues in the future.
Government Regulations
Any devices the company manufactures or distributes pursuant to FDA clearance or approvals are subject to continuing regulation by the FDA and certain state agencies, including adherence to Quidel System Regulations relating to testing, control, documentation and other quality assurance requirements. The company must also comply with Medical Device Reporting requirements, which mandates reporting to the FDA of any incident in which a device may have caused or contributed to a death or serious injury, or in which a device malfunctioned and, if the malfunction were to recur, would be likely to cause or contribute to a death or serious injury.
For marketing outside the U.S., the company is subject to foreign regulatory requirements governing human clinical testing and marketing approval for its products. These requirements vary by jurisdiction, differ from those in the U.S., and may require it to perform additional or different preclinical or clinical testing regardless of whether it has obtained FDA clearance or approval.
The company’s initial focus for obtaining marketing approval outside the U.S. is typically in the European Union (EU), Australia, Brazil, Canada, China, Japan, and the U.K. For the company’s products marketed in Canada, Japan, Brazil, Australia and the U.S., the Medical Device Single Audit Program (MDSAP) is a single regulatory audit of its QMS that satisfies the requirements of all five of these jurisdictions.
The company’s products are subject to various healthcare-related laws regulating fraud and abuse, R&D, pricing, sales and marketing practices, and the privacy and security of health information. Among other things, these laws and others generally prohibit the provision of anything of value in exchange for the referral of patients or for the purchase, order, or recommendation of any item or service reimbursed by a federal healthcare program, including Medicare and Medicaid; require that claims for payment submitted to federal healthcare programs be truthful; and require the maintenance of certain government licenses and permits. Specific health-care laws and regulations that the company is subject to include the federal Physician Self-Referral Law; the federal Anti-Kickback Statute; the federal civil and criminal false claims laws, including the False Claims Act (FCA); the federal Civil Monetary Penalties Law; the Health Insurance Portability and Accountability Act of 1996 (HIPAA); the federal Physician Payments Sunshine Act; and the U.S. Federal Food, Drug, and Cosmetic Act (the FDCA). The company is subject to the U.S. Foreign Corrupt Practices Act (the FCPA), the U.K. Bribery Act of 2010 (the Bribery Act), the Brazilian Anti-Bribery Act (also known as the Brazilian Clean Company Act) and various other similar anti-corruption and anti-bribery laws.
History
The company was founded in 1979. It was incorporated in 2021. The company was re-incorporated as Quidel Corporation in the state of Delaware in 1987. It was formerly known as Monoclonal Antibodies, Inc. and changed its name to Quidel Corporation in 1987 and to QuidelOrtho Corporation in May 2022.
