Quidel Corporation Opens Carlsbad, California, Production Facility
The company said it plans to install multiple manufacturing lines at the 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 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.
“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 from the U.S. Food and Drug Administration 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.
In the professional segment, Quidel noted it 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.
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