November 29, 2021
Omicron1 is a new SARS-CoV-2 variant first reported in South Africa and Botswana. The World Health Organization (WHO) designated Omicron a Variant of Concern (VOC) due to its large number of mutations, including over 30 mutations in the spike protein region alone, which could affect transmission. Currently, no cases have been reported in the United States.
The Omicron variant is quickly expanding to other countries. Globally, Australia, Austria, Belgium, Botswana, Canada, Czech Republic, Denmark, Germany, Hong Kong, Israel, Italy, Netherlands, Portugal, South Africa, Spain, and United Kingdom reported cases2. WHO continues to closely monitor this variant.
Detection on FINDER 1.5
The FINDER SARS-CoV-2 Test targets the nucleocapsid gene. We analyzed 141 Omicron nucleocapsid gene sequences available in the GISAID database as of November 29, 2021. Preliminary analysis reveals no detrimental mutations within the gene region that would cause a loss of reactivity and it is predicted to have 100% inclusivity for the Omicron (B.1.1.529) variant on the FINDER SARS-CoV-2 Test.
*Validation of the instrument and test system has been completed at Baebies but has not been reviewed by FDA. Review under the EUA program is pending. Distributed in accordance with the guidance on Policy for Coronavirus Disease-2019 Tests During the Public Health Emergency, Section IV.C.2.