We at ACON Laboratories, Inc. have been continuously monitoring the emergence of SARS-CoV-2 variants and the Omicron variant is no exception.

The Omicron variant is notable for the significant number of mutations in the Spike protein. Those mutations are not relevant to the Flowflex™ COVID-19 Antigen Home Test, which detects the SARS-CoV-2 Nucleocapsid protein.

According to the GISAID analysis and the pairwise sequence alignment comparison of the Nucleocapsid protein from all of the tested variants (B.1.351, B.1.1.7, P.1, and Delta variant B.1.617.2), there is a high likelihood that the SARS-CoV-2 Omicron Variant (lineage B.1.1.529) is detectable by the Flowflex COVID-19 Antigen Home Test.

We anticipate testing virus samples, once they become available to us, to further verify the performance of our test in detecting the Omicron Variant.

Furthermore, ACON will continue to monitor the evolution of COVID-19 variants in circulation worldwide and evaluate the performance of our assays against Omicron and future variants to maintain the high level of product performance our customers have come to rely upon.

Sincerely,

Michael Lynch
Vice President, Sales and Marketing