Quidel Opens New Manufacturing Facility to Boost COVID-19 Antigen Test Production

Quidel Corporation is stepping up its COVID-19 testing efforts in a big way.

The provider of rapid diagnostic testing solutions, cellular-based virology assays and molecular diagnostic systems recently opened a new manufacturing facility in Carlsbad, Calif., that will significantly increase its ability to produce its QuickVue product line. “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.”

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 to detect and diagnose 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.
 
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 percent of the time and negative results agreeing 99.3 percent 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 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.
 
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.