In May 2022, Quidel Corporation and Ortho Clinical Diagnostics united as QuidelOrtho with an 80-year history of innovation. We combine industry-leading expertise in immunoassay and molecular testing with a global footprint in point-of-care settings, clinical labs, and transfusion medicine to advance critical diagnostic solutions at scale.
Our innovations have been pathbreaking. From dry chemistry that delivers testing access where there is none, to respiratory testing and tracking breakthroughs, we are at the forefront of diagnostic science and care. We introduced the first FDA-approved rapid antigen diagnostic test for influenza A and influenza B and launched the first-ever product to determine Rh+ or Rh− blood type. We also developed the world’s first tests for the detection of antibodies against HIV and hepatitis C. We stood at the forefront of diagnostics innovation throughout the coronavirus pandemic, developing one of the earliest molecular PCR assays for SARS-CoV-2, the first FDA emergency use authorized rapid antigen test that delivers results in 15 minutes, and highvolume antibody and antigen tests for COVID-19.
We have well-established track records for providing high-quality products and services to the global clinical laboratory and immunohematology communities. Hospitals, hospital networks, clinical laboratories and blood banks around the world depend on our innovative technology and tools (including our exclusive dryslide technology) to help ensure test results are fast, accurate, and reliable. Our customized solutions deliver affordability, efficiency, and automation – all supported by an award-winning service and support program that provides best-in-class technical, field and remote service in more than 130 countries and territories around the globe.
Spanning the full spectrum of customers and care – from the largest labs and hospitals to the smallest clinics and in our homes – our diverse suite of diagnostic solutions expands access to reliable answers, providing critical information when and where it is needed most.
QuidelOrtho Corporation (Nasdaq: QDEL) unites the power of Quidel Corporation and Ortho Clinical Diagnostics behind a shared mission of developing and manufacturing innovative technologies that raise the performance of diagnostic testing and create better patient outcomes across the entire healthcare continuum.
Ranked among the world’s largest in vitro diagnostics (IVD) providers with more than 120 years of collective experience, we combine industry-leading expertise in immunoassay and molecular testing with a global footprint in clinical labs and transfusion medicine.
Our company’s comprehensive product portfolio delivers accuracy, speed, automation and access, providing critical information when and where it is needed most. Inspired by a spirit of service, the QuidelOrtho family is committed to enhancing the well-being of people worldwide and happy in the knowledge we are making a difference.
The Asia Pacific region is a growth engine for most of the healthcare companies and it is no different for QuidelOrtho. Our strength in the region is our people, who are our biggest asset. It is because of our people that we are growing faster than the market in almost every geographic region consistently for the last few years.
While growth is a good indicator of our success, a more satisfying indicator is the number of lives touched. We are proud that we have been consistently exceeding our own expectations. What makes us feel proud is that our product and services are not just limited to the affluent strata of the society through corporate hospitals, but also include many government hospitals that cater to every section of society in developing countries. We are consciously working on increasing access to enhance and extend our services.
While access and awareness are the two important factors in developing markets, we cannot ignore awareness and adoption of the newer technologies. There are multiple awareness programs that we run in each country for all the stakeholders, not just limited to our products but more focused on improving patient care.
As an organization, our focus is on providing services to our customers to make them a partner for life to improve and save lives with diagnostics, thus creating a healthier future for all.
Building upon our legacy of groundbreaking innovation, we partner with customers across the healthcare continuum and around the globe focusing on building a new diagnostic frontier, one where insights and solutions know no bounds, expertise seamlessly connects and a more informed path is illuminated for each of us.
Our innovation strategy is grounded in a customer-centric, global perspective. We seek growth investments with a positive return on investment while endeavoring to reduce our environmental impact. We integrate customer feedback into actionable improvements, with the goal of keeping our solutions attuned to the real-world needs of healthcare providers.
Strategic investments in R&D allow us to expand our diagnostic testing platforms and foster improved healthcare access. Near-term, mid-term and longterm strategies are aimed at fulfilling unique market needs, increasing healthcare accessibility and revolutionizing the delivery of healthcare.
Our innovation is not just limited to products but also the processes and partnerships. Our ValumetrixTM Consulting use Lean and Six Sigma tools and effectively work with laboratories and blood banks to help and support them in optimizing their testing workflow to improve their service delivery.
As we continue to innovate and significantly differentiate ourselves in the market, we are focused on developing assays and panels that address unmet clinical needs. As an example, we have added syphilis to our Molecular Diagnostics POC STI panel. Syphilis is one of the fastest growing sexually transmitted infections (STIs), with a 74% increase in cases since 2017. And among those cases, newborns have surged with a 203% increase. The lack of sufficient diagnostic test methods for primary syphilis compounds this problem and those numbers are likely underestimated because of this.
This is just one example of how diagnostic testing can provide unique solutions to help combat devastating but easily treatable bacterial infections. We expect several planned panels to be de novo and to be differentiated as well. While we continue to expand our suite of products and capabilities, we are steadfast in driving our next phase of integration to create a highly efficient, agile organization rooted in operational experience. We know more today than we did previously and are aggressively focused on reducing complexity in the business, enhancing our culture and improving capital allocation and portfolio management and upgrading our global manufacturing operations and supply chain capabilities.
At QuidelOrtho, we envision a world where individuals, families and communities have the insight and clarity to spot trends sooner, respond quicker and confidently chart their course to better health; a future where we foster lifelong well-being in real time, disease is predicted and prevented before it takes hold, communities can anticipate, prepare and protect the health of their populations, and diagnostics solutions are readily accessible here and when they are needed most.
And while our individual solutions continue to advance diagnostic care across the continuum, this is just the beginning. We are forging a new diagnostic frontier where our capabilities converge, experts and expertise build and invent together, and systems seamlessly connect. Changing lives one test at a time.
While our services are focused on providing diagnostic solutions, we also understand our responsibilities towards our environment. Our VitrosTM Systems are unique in the diagnostics arena. They do not require water and they do not contaminate the environment with biohazardous liquid waste effluents, making Vitros analysers environmentally friendly.
Our point-of-care portfolio remains a cornerstone for managing a range of respiratory infections such as flu, RSV, COVID-19 and Strep A , and as we reflect on the COVID-19 pandemic, we played a critical role in the public response to contain the spread of this deadly virus. With the initial launch of the COVID-19 vaccine and subsequent booster shots over the last two years, there has been a shift away from asymptomatic testing and the necessity to produce a negative PCR test.
However, the public has taken greater responsibility for their individual health and understanding of how viruses spread. We are seeing a considerable volume from patients and influenza-like illness symptoms, turning to their medicine cabinet to self-administer our QuickVue® At-Home over-the-counter (OTC) COVID-19 test or asking their doctor for a test in the clinic. Further strengthening our position as a leader in COVID-19 testing capabilities, we recently received a CLIA waiver in the U.S. for our new Sofia® 2 SARS Antigen+ FIA in September.
This is the first rapid antigen test that detects COVID-19 to be awarded FDA market clearance through the agency's De Novo process. It is also now the first rapid antigen test to receive a CLIA waiver. In addition to our CLIA waiver, we were honored to receive an award from the U.S. government to provide the government with at-home COVID-19 tests that will be provided for free to American households. The top-line impact from this $29 million award commences in the fourth quarter and is expected to continue over 18 months and was not included in our 2023 financial guidance.
We were also among the first to receive the EUA for the COVID-19 Antibodies & Antigen tests on our fully automated Vitros analysers.
We believe we're doing what we can to help the government be prepared for another pandemic-level threat. COVID-19 has clearly moved into an endemic state. However, we expect it to remain a persistent respiratory pathogen for many years to come. Our testing capabilities allow patients and providers to be informed both quickly and accurately.
QuidelOrtho has developed an integrated Quality Management System (QMS) that encompasses our commitment to manufacturing quality, operational excellence, customer engagement and continuous improvement initiatives. To establish a more globally consistent QMS across the company, we have defined and implemented a shared Quality Manual and Quality Policy Statement, objectives and management review processes. We also maintain ISO 13485 certification, an international standard for medical device QMSs. This certification signifies our dedication to producing safe and effective devices across all stages of production, from design and development to distribution and customer feedback.
Our QMS is built on stringent testing and validation of materials, helping to ensure we embed quality into our products from the outset. Through this meticulous focus on quality control, we maintain a high level of confidence in our product performance, providing our customers with safe and reliable diagnostic solutions.
In addition, our QMS incorporates continuous improvement systems, including the monitoring of product performance, regular audits, inspections and management reviews. In our pursuit of operational excellence, our QMS supports us to achieve our quality metrics and key performance indicators. Through transparency and responsiveness within this system, we foster continuous improvement in our processes while upholding high standards of safety and quality.
As part of our customer engagement strategy, we actively monitor the performance of our products and solicit feedback from our customers. Our customer hotlines are open to address concerns, provide guidance and facilitate the optimal use of our diagnostic solutions. This engagement enables us to deliver better support and continuously enhance our offerings.
Regular inspections and audits at our manufacturing sites further enhance the safety, efficacy and reliability of our products. By tracking complaint rates and nonconformances and timely reporting nonconformance disposition requests, we demonstrate our ongoing commitment to improving product safety and quality. We employ a hybrid approach to auditing, incorporating electronic and paper-based inspections for enhanced efficiency.
This comprehensive approach fosters an efficient QMS that enables us to deliver high-quality and reliable healthcare solutions.
Our mid-term strategy focuses on developing lower-cost platforms for emerging markets and introducing additional immunoassay products. These innovations are expected to further increase healthcare accessibility in underserved communities, breaking down barriers to quality care.
QuidelOrtho recognizes that democratizing healthcare plays a vital role in improving patient outcomes and advancing global healthcare.
By improving the accessibility and affordability of our diagnostic solutions, we strive for a healthier world. We recognize that the democratization of healthcare is essential for advancing equitable access, particularly in underserved communities. The onset of the COVID-19 pandemic accelerated the demand, acceptance and adoption of POC diagnostic solutions, further underscoring the need for accessible and affordable healthcare. Our progress toward democratizing healthcare consists of the following initiatives such as low-cost platforms: We invest in the development of affordable diagnostic platforms and recertification and refurbishing, empowering underserved communities and emerging markets to improve overall health outcomes.
We are proud of the fact that the same high quality and reliable technologies and products that are used for diagnostic testing in developed markets like U.S., Japan, Australia, etc., are also accessible to patients in Tier 2/3 & 4 towns in India, Thailand, Philippines, etc.
QuidelOrtho’s services and informatics program is the evolution of how service, expertise, technology and data-driven solutions come together to create a more effective, efficient lab, so labs can focus on improving patient outcomes. Superior partnership and after sales service and training support are more important than ever as labs experience greater demand for more complex testing, challenging budgets and a workforce shifting from more specialists to more generalists. With QuidelOrtho solutions, labs get the partnership they need, along with next-level data services to continually improve the speed and quality of care. Our award-winning service and support program is one of the key reasons, our customers choose us and contribute to our 99% customer retention rates in Asia Pacific region. Our ValuMetrix consulting services use proven and globally recognized techniques of Lean Six Sigma thinking, design and process excellence to evaluate and optimize laboratory workflow and processes, helping customers do more with less.
QuidelOrtho in Asia Pacific region offer curated online as well as offline training and certification programs for various stakeholders like technologists, lab supervisors, quality managers, doctors, nurses, purchase heads and Chief Experience Officers.
The QuidelOrtho Global Service Organization is investing in digital transformation and building a nextgeneration customer experience program. Our approach is t o create delightful customer experiences throughout our customers’ journeys. It starts with our employee philosophy to invent ways to make our customers’ businesses more intelligent and their operations easier. Our exciting nextgen customer investments result in solutions that bring our customercentric thinking to life, so customers and employees have the freedom to focus. Our award-winning field service leverages Smart Service remote diagnostics.
Our comprehensive customer service offering includes:
At QuidelOrtho, we’re advancing the power of diagnostics, now and into the future. We envision a world where individuals, families and communities have the insight and clarity to spot trends sooner, respond quicker and confidently chart their course to better health. This is a future where: we foster lifelong well-being in real time; disease is predicted and prevented before it takes hold; communities can anticipate, prepare and protect the health of their populations; and diagnostics solutions are readily accessible where and when they are needed most.
We’ve relentlessly pursued the unknown for many years, blazing trails in testing, tracking and analysis. Today, we are one of the world’s largest pure-play diagnostics providers, driving better health for more people in more places. And while our individual solutions continue to advance diagnostic care across the continuum, this is just the beginning. Together we are forging a new diagnostic frontier where our capabilities converge, experts and expertise build and invent together, and systems seamlessly connect.
We are committed to advancements in dry-slide technology, launching additional immunoassay products and developing modular solutions. These long-term goals have the potential to revolutionize the delivery of healthcare by making diagnostic tools more accessible across various settings, benefiting a wider range of people.
At QuidelOrtho, we’re advancing t he power of diagnostics, now and into the future. We envision a world where individuals, families and communities have the insight and clarity to spot trends sooner, respond quicker and confidently chart their course to better health. This is a future where: we foster lifelong well-being in real time; disease is predicted and prevented before it takes hold; communities can anticipate, prepare and protect the health of their populations; and diagnostics solutions are readily accessible where and when they are needed most.
We’ve relentlessly pursued the unknown for many years, blazing trails in testing, tracking and analysis. Today, we are one of the world’s largest pure-play diagnostics providers, driving better health for more people in more places. And while our individual solutions continue to advance diagnostic care across the continuum, this is just the beginning. Together we are forging a new diagnostic frontier where our capabilities converge, experts and expertise build and invent together, and systems seamlessly connect.
