Quidel Receives Emergency Use Authorization for QuickVue At-Home COVID-19 Test
Quidel 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.
Quidel 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.
“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.”
The QuickVue At-Home COVID-19 Test employs the same Quidel lateral flow technology used for decades by healthcare professionals and features the same SARS CoV-2 rapid antigen test strip and reagent solution that received an EUA from the FDA for use in professional settings in December 2020. Quidel’s contract with the National Institutes of Health’s Rapid Acceleration of Diagnostics initiative was expanded in late 2020 to include the QuickVue At-Home COVID-19 test, which expedited its emergency use authorization.
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