Business
Quidel Receives Emergency Use Authorization for QuickVue® At-Home COVID-19 Test
Easy-to-use at-home test provides results in ten minutes with a doctor’s prescription SAN DIEGO--(BUSINESS WIRE)-- Quidel Corporation (NASDAQ: QDEL)
About this update from Quidelortho Corporation
[{"type":"text","content":"\nEasy-to-use at-home test provides results in ten minutes with a doctor’s prescription\n\n SAN DIEGO--(BUSINESS WIRE)--\nQuidel Corporation (NASDAQ: QDEL) (“Quidel”), a leading provider of rapid diagnostic testing solutions, cellular-based virology assays and molecular diagnostic systems, announced today that it has received an Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA), allowing the company to market its new QuickVue® At-Home COVID-19 Test for the qualitative detection of the nucleocapsid protein antigen from SARS-CoV-2. This test is authorized for prescription home use with self-collected (unobserved) anterior nares (NS) swab specimens directly from individuals aged 14 years and older who are suspected of COVID-19 by their healthcare provider within the first six days of the onset of symptoms. This test is also authorized for prescription home use with adult-collected anterior NS samples directly from individuals aged 8 years or older who are suspected of COVID-19 by their healthcare provider within the first six days of the onset of symptoms.\n\nQuidel has provided rapid COVID-19 testing through doctors and health care providers throughout the pandemic, manufacturing and shipping millions of Sofia® tests last year. Now, Quidel’s QuickVue® At-Home COVID-19 Test will allow patients with a prescription to easily perform the test themselves and get results in 10 minutes. The QuickVue® At-Home COVID-19 Test shows excellent performance, with positive results agreeing with PCR 84.8% of the time, and negative results agreeing 99.1% of the time, delivering confidence to patients running the test and facilitating informed discussions with doctors.\n\n“Quidel’s employees have truly risen to the challenge of the SARS pandemic. Our mission is to provide greater access to frequent, affordable and highly accurate diagnostic testing, and ultimately to enable individuals to take charge of their own health and help them make prudent decisions to protect themselves and their loved ones,” said Douglas Bryant, president and CEO of Quidel Corporation. “This is an important first step in a two-step process that, once additional ongoing studies are completed, will further expand access to frequent testing at home.”\n\nThe QuickVue® At-Home COVID-19 Test employs the same Quidel lateral flow technology used for...