Carlsbad, CA facility aims to reach a run rate of 600 million QuickVue® tests per year by end of 2021
Future plans call for production of numerous popular QuickVue® diagnostic tests to serve the emerging at-home testing market
SAN DIEGO–(BUSINESS WIRE)–Quidel Corporation (NASDAQ: QDEL) (“Quidel”), a leading provider of rapid diagnostic testing solutions, cellular-based virology assays and molecular diagnostic systems, today announced the opening of a new manufacturing facility in Carlsbad, CA that will be dedicated to the production of Quidel’s popular QuickVue® line of products. The 128,000 square-foot facility will be the company’s highest-volume production plant in the world and begins operations in the second half of 2021 with a mission to produce 600 million QuickVue® SARS rapid antigen tests per year for the detection and diagnosis of COVID-19 infections.
Quidel plans to install multiple manufacturing lines at the Carlsbad facility and hire approximately 400 new employees with a mission to scale Quidel’s operations from 50 million QuickVue® tests per year to 50 million tests per month at full capacity, including non-COVID-19 diagnostic assays currently in-market or under development. The company is actively hiring to fill open positions including engineers, chemists, technicians, manufacturing, purchasing, sourcing and support services.
“From the first days of the pandemic, Quidel has stepped up to meet the COVID-19 challenge head-on with innovative diagnostic technologies to detect coronavirus infections and expanded manufacturing to democratize access to affordable and high-quality testing,” said Douglas Bryant, president and CEO of Quidel Corporation. “The opening of our massive new QuickVue® manufacturing plant is our boldest move yet and is expected to provide Quidel with the scale necessary to serve the needs of communities and institutions for frequent testing now and for years to come.”
Quidel received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) for its QuickVue® SARS Antigen Test for COVID-19 in December. The company’s QuickVue® lateral-flow technology is visually read by the user and provides results in 10 minutes from nasal swab samples. Initial applications for QuickVue® COVID-19 tests range from hospitals and physician offices to schools and pharmacies. Quidel is seeking EUA for a new QuickVue® At-Home COVID-19 Test for over-the-counter sale directly to consumers.
Quidel’s new QuickVue® SARS Antigen test offers excellent performance for the detection of SARS-CoV-2, with positive results agreeing with PCR 96.6% of the time and negative results agreeing 99.3% of the time, thereby providing quick, reliable results to patients, their families and healthcare workers alike.
In the professional segment, Quidel has manufactured the QuickVue® line for over 30 years. Quidel was the first company to introduce a visually read flu test, the QuickVue® Influenza A/B Test, which received FDA approval in September of 1999. QuickVue® was also the first flu test cleared by the FDA for use in CLIA-Waived point-of-care facilities like doctors’ offices, urgent care clinics and pharmacies.
Today, Quidel’s QuickVue® diagnostic products that test for Influenza, RSV, Strep A, fecal occult blood, pregnancy, chlamydia, infectious mononucleosis, adenoviral conjunctivitis and H. pylori. Over the years, more than 150 million QuickVue® diagnostic testing units have been sold.
To learn more about our available positions, please visit: https://careers.quidel.com/
Throughout this pandemic, Quidel has been at the forefront of diagnostic innovation. From the company’s Lyra® PCR tests, to its Sofia® rapid antigen tests for COVID-19, to its Sofia® “ABC” combination test for the Influenza A+B and coronavirus, to its QuickVue SARS-CoV-2 test authorized for emergency use by the FDA in December, Quidel has significantly advanced the science and the scale of its operations.
Quidel was the first company to receive EUA from the FDA for a rapid point-of-care antigen test for COVID-19 and remains at the forefront of the battle against the coronavirus pandemic.
Sofia® 2 is Quidel’s best-selling cartridge-based, instrument-read rapid diagnostic system for infectious disease testing, which utilizes fluorescent chemistry design, an intuitive graphical user interface, and optics system to provide a highly accurate, objective and automated result in 15 minutes. The Sofia® 2 system also comes connected to Virena®, Quidel’s data management system, which provides aggregated, de-identified testing data to public health authorities in near real-time.
In 2020, Quidel quickly increased its production of Sofia® rapid antigen tests from approximately 500,000 units per week to a rate of over 2 million tests per week at the end of December. Quidel is building additional production lines with a goal to reach a run-rate of over 240 million Sofia® tests per year by the third quarter of 2021. In 2020, the company also increased the installed base of Sofia® diagnostic instruments to more than 65,000 point-of-care locations.
Quidel’s QuickVue® and Sofia® SARS Antigen test kits are made in the greater San Diego metropolitan area of California.
About Quidel Corporation
Quidel Corporation (Nasdaq: QDEL) is a leading manufacturer of diagnostic solutions at the point of care, delivering a continuum of rapid testing technologies that further improve the quality of health care throughout the globe. An innovator for over 40 years in the medical device industry, Quidel pioneered the first FDA-cleared point-of-care test for influenza in 1999 and was the first to market a rapid SARS-CoV-2 antigen test in the U.S. Under trusted brand names Sofia®, Solana®, Lyra®, Triage® and QuickVue®, Quidel’s comprehensive product portfolio includes tests for a wide range of infectious diseases, cardiac and autoimmune biomarkers, as well as a host of products to detect COVID-19. With products made in America, Quidel’s mission is to provide patients with immediate and frequent access to highly accurate, affordable testing for the good of our families, our communities and the world. For more information about Quidel, visit quidel.com.
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