Quidel Corporation (NASDAQ: QDEL) (“Quidel”), a provider of rapid diagnostic testing solutions, cellular-based virology assays and molecular diagnostic systems, issued the following statement from Douglas Bryant, Quidel’s President and CEO, regarding Quidel’s ongoing efforts to evaluate COVID-19 mutations and confirm that its antigen tests continue to detect COVID-19 variants such as Omicron.
“At Quidel, we continuously monitor the evolution and activity of COVID-19 variants in circulation, and the Omicron variant is no exception. Recent testing using live South African samples confirmed that our QuickVue® At-Home OTC COVID-19 Test and our Sofia® SARS Antigen FIA are detecting the SARS-CoV-2 Omicron variant.”
Mr. Bryant said:
“At Quidel, we continuously monitor the evolution and activity of COVID-19 variants in circulation, and the Omicron variant is no exception. Recent testing using live South African samples confirmed that our QuickVue® At-Home OTC COVID-19 Test and our Sofia® SARS Antigen FIA are detecting the SARS-CoV-2 Omicron variant.
On December 22, 2021, the Food and Drug Administration (FDA) indicated that data generated in preliminary RADx laboratory studies, with heat-inactivated Omicron samples, suggested that the QuickVue antigen tests are able to detect the Omicron variant with similar performance as with other variants. Additional testing has now been completed by the same laboratory using live virus. These data also suggest that the QuickVue antigen tests are able to detect the live Omicron variant with similar performance as with other variants.
Quidel has been, and will continue to be, vigilant in evaluating our assays with both genetic sequencing and real-world virus sample studies to assure customers of our products’ efficacy as the coronavirus evolves.
In the meantime, we continue to increase our weekly production of COVID-19 antigen tests in an effort to provide our communities with access to affordable COVID-19 testing. Quidel has risen to the challenge and we are proud to be at the forefront of the diagnostic industry’s response to the pandemic.”
About Quidel Corporation
Quidel Corporation (Nasdaq: QDEL) is a leading manufacturer of diagnostic solutions at the point of care, delivering a continuum of rapid testing technologies that further improve the quality of health care throughout the globe. An innovator for over 40 years in the medical device industry, Quidel pioneered the first FDA-cleared point-of-care test for influenza in 1999 and was the first to market a rapid SARS-CoV-2 antigen test in the U.S. Under trusted brand names Sofia®, Solana®, Lyra®, Triage® and QuickVue®, Quidel’s comprehensive product portfolio includes tests for a wide range of infectious diseases, cardiac and autoimmune biomarkers, as well as a host of products to detect COVID-19. With products made in America, Quidel’s mission is to provide patients with immediate and frequent access to highly accurate, affordable testing for the good of our families, our communities and the world. For more information about Quidel, visit quidel.com.
View our story told by our people at www.quidel.com/ourstory
