December 1, 2021 – Quidel Corporation 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 American-made PCR and 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. Regarding our PCR assays, in silico analysis of the GISAID database showed that 100% of all 206 published sequences of the Omicron variant are covered by our primer and probe combinations. Regarding our antigen assays, GISAID analysis shows a high likelihood that the Omicron variant is detectable by our immunoassays. Of course, we are following up these analyses by testing live samples, and Quidel, like our industry peers, will know more in time.
“While our studies are ongoing, the early data give us confidence that our American-made PCR and rapid antigen tests can detect COVID-19 caused by the Omicron variant. 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 manufacturing capacity to a run-rate of 70 million tests per month by the end of the year in an effort to provide our communities with access to affordable COVID-19 testing. Quidel has been at the forefront of the diagnostic industry’s response to the pandemic and will continue to lead the response going forward.”