The new 128,000 sq. ft facility will become the San Diego-based company’s highest-volume production plant. It will begin operations during the second half of 2021 with a goal of producing 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 new facility and will hire approximately 400 new employees to scale production from 50 million QuickVue tests per year to 50 million tests per month, including non-COVID-19 diagnostic assays that are in-market or under development.
“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,” president and CEO Douglas Bryant said in a news release. “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 won FDA emergency use authorization for its COVID-19 QuickVue SARS Antigen test in December. The tests feature lateral-flow technology that can be visually read by the user to provide results in 10 minutes from nasal swab samples. The tests show positive results agreeing with PCR 96.6% of the time and negative results agreeing 99.3% of the time.