ACON Laboratories, Inc. has been continuously monitoring the emergence of SARS-CoV-2 variants. According to the Centers for Disease Control and Prevention (CDC) COVID Data Tracker, the Omicron variant remains the dominant variant circulating in the United States, among the new Omicron variants, XBB.1.9.1.1.5.1 (FL.1.5.1) and XBB.1.9.2.5 (EG.5) represent the highest portion of new COVID-19 infections nationwide.

We have clinically verified that the Flowflex® COVID-19 Antigen Home Test can reliably detect the Omicron BA.1, BA.2, BA.4, BA.5 and BQ.1.1 variants with various nucleocapsid protein mutations, including many defining mutations for the Omicron variants. Therefore, our test has demonstrated broad sensitivity against a wide range of Omicron subvariants.

While we have not tested the live clinical Omicron XBB subvariant samples, the GISAID in-silico and pairwise sequence analysis show that 7 out of 8 defining mutations of XBB are detectable by our test. Therefore, we conclude that there is a high likelihood that the Flowflex COVID-19 Antigen Home Test can also detect the Omicron XBB subvariants (including FL.1.5.1 and EG.5). We anticipate testing virus samples, once they become available, to further verify the performance of our test in detecting the different Omicron subvariants.

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