Corporate Profile

Quidel Corporation (Nasdaq: QDEL) is a California-based leading manufacturer of diagnostic healthcare solutions serving to enhance the health and well-being of people around the globe. Through the development of diagnostic solutions that accurately and quickly diagnose infectious diseases, as well as cardiovascular and metabolic conditions, Quidel’s products allow healthcare workers to quickly test and treat at the point-of-care, which leads to improved patient outcomes and provides numerous economic benefits to the healthcare system. Quidel aims to democratize diagnostic testing beyond the point-of-care, and into the homes of consumers, allowing them test quickly and accurately.

Quidel’s core competencies and capabilities include instrumented immunoassay development, US-based automated manufacturing, monoclonal antibody characterization and development, and molecular assay development. Quidel’s current products fall into these categories: (1) Cardiac Immunoassay, which represents the acquired Alere Triage assets; (2) Rapid Immunoassay, where it is the market leader in infectious disease testing due to the installed base of approximately 70,000 Sofia instruments (as of March 2021); (3) Specialized Diagnostic Solutions, which include cell culture-based direct fluorescent antibodies (DFA), and ELISA microtiter-based Complement pathway and Bone Health testing for research institutions; and (4) its high-growth molecular diagnostics business, driven by Lyra® assays and the Solana MDx instrumented system. Additional molecular and Sofia tests are currently in development or in clinical trials as part of Quidel’s focus on innovation, and maintaining a robust product pipeline that can deliver future growth.

Quidel began operations in 1979 and launched its first products in 1983, as well as the world’s first rapid diagnostic test for Influenza A/B in 1999. Since that time, Quidel has experienced double-digit revenue growth and expanded its market reach through internal product development and key acquisitions, with a focus on investment in research and development to accelerate the rate of new product introductions.

In 2010, Quidel acquired Athens Diagnostic Hybrids, Inc., a leading provider of cell culture-based diagnostic tests sold direct to end-users. In 2011, Quidel acquired BioHelix, Inc., a manufacturer and developer of molecular diagnostic products, including BioHelix’s proprietary isothermal HDA molecular amplification technology. In December 2014, Quidel raised $172.5 million through an offering of convertible notes (3.25% coupon) that have since been paid off. Quidel’s largest acquisition came in October 2017, acquiring Alere’s Triage and Beckman BNP Businesses from Abbott, which effectively doubled the size of the company in terms of revenue and employees, reduced seasonal flu revenue volatility, and vastly expanded Quidel’s international footprint.

In 2020, Quidel rose to the challenge and responded to the largest pandemic in modern history by being the first to market a rapid SARS-CoV-2 antigen test in the U.S., receiving Emergency Use Authorization (EUA) from the FDA for its Sofia® SARS Antigen FIA. Under trusted brand names Sofia®, Solana®, Lyra®, and QuickVue®, Quidel quickly developed novel COVID diagnostics within multiple segments of the professional point of care market. In March 2021, Quidel received EUA for its QuickVue® At-Home OTC COVID-19 Test, unlocking a new market beyond the professional segment to include retail, employer testing, testing in schools, and at-home testing.

Moving forward, Quidel’s innovative diagnostic portfolio will continue to drive growth:

  • Continued expansion into the over-the-counter (OTC) market will be critical to bringing healthcare closer to the patient, and opportunities exist in developing OTC versions of Strep, Flu, RSV, and many others through Sofia® and QuickVue® antigen immunoassay platforms.
  • The EUA for Sofia Q®, received in June 2021 for the professional segment, could represent another leap into the at-home market, potentially enabling users to load tests and receive results on a mobile device, all in the comfort of their homes.
  • As a result of the pandemic, Sofia®’s installed base increased to over 70,000 instruments at the end of 2020 (from 42,000 instruments in 2019), and opportunities exist to increase assay utilization in this large installed base with an extensive menu of existing assays- such as Flu, Strep, and RSV- as well as proprietary assays in development- such as Strep98®, gastrointestinal assays, and others.
  • Quidel views Savanna® as its new flagship PCR platform. The sample-to-answer Savanna® molecular diagnostic platform, currently under development for the US market (received CE mark for European markets in July 2021), will compete in the high-growth molecular diagnostics segment in small hospitals, labs, and other point-of-care settings. Savanna® has immense value due to its ease of use, breadth of menu, and quick turnaround time for results. Savanna® achieves this all by combining a cost-effective instrument with flexible syndromic panels.
  • High Sensitivity Troponin (currently only for sale in Europe) is another exciting new product in Quidel’s innovative pipeline. Operating within the Point-of Care segment, High Sensitivity Troponin (HsT), if approved in the U.S, could address a $300+ million-dollar market globally.

Whether at its headquarters or manufacturing facilities in San Diego, California, at its research, development, and manufacturing operations in Ohio, Massachusetts, or in Stuttgart, Germany, or through its Commercial organization around the world, Quidel is dedicated to democratizing diagnostic testing by delivering fast, accurate tests to customers in reference labs, hospital labs, clinics, urgent care centers, physician offices, pharmacies and retail centers to drive improved patient outcomes.

Updated (September 2021)