The U.S. Food and Drug Administration issued an emergency use authorization (EUA) for Quidel Corporation’s (NASDAQ: QDEL) QuickVue At-Home COVID-19 Test on March 1.
The public company’s QuickVue At-Home COVID-19 Test is authorized for prescription home use with self-collected anterior nasal swabs from individuals ages 14 and older or individuals ages 8 and older with swabs collected by an adult. The test is authorized for individuals suspected of COVID-19 by their healthcare provider within the first six days of symptom onset.
“The FDA continues to prioritize the availability of more at-home testing options in response to the pandemic,” said Jeff Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health. “The QuickVue At-Home COVID-19 Test is another example of the FDA working with test developers to bring important diagnostics to the public.”
This new EUA for an over-the-counter test is in addition to the FDA authorization Quidel received in December 2020 for its QuickVue SARS Antigen Test which is authorized for use in laboratories certified under the Clinical Laboratory Improvement Amendments (CLIA) to perform high, moderate or waived complexity tests, as well as for point-of-care testing by facilities operating under a CLIA Certificate of Waiver.
Earlier this year, Quidel announced the opening of a new manufacturing facility in Carlsbad, which is expected to begin operations in the second half of 2021. The new plant will help ramp up production of its rapid tests to meet expected demand.