Update Regarding Variant Strains of SARS-CoV-2

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United States public health agencies regularly monitor SARS-CoV-2 genetic lineages through epidemiological investigations, laboratory studies and genetic sequence-based surveillance. The US government SARS-CoV-2 Interagency Group (SIG) has designated the following classes of SARS-CoV-2 variants of public health interest:  Variants of High Consequence (VOHC), Variants of Concern (VOC), Variants of Interest (VOI), and Variants Being Monitored (VBM).*

Rheonix has conducted analysis of the potential impact of all classes of variants being monitored and has determined that they should not impact performance of the Rheonix COVID-19™ MDx assay.

Rheonix continually evaluates publicly available SARS-CoV-2 genetic sequences to identify the potential impact of variants on our assay performance. Our assessments indicate that all characterized SARS-CoV-2 variants currently being monitored should be detected by the Rheonix COVID-19 MDx assay, as summarized in the table below. We will continue to monitor the available sequences weekly to identify any potentially concerning mutations as they emerge.

WHO Label PANGO Lineage CDC Variant Classification* Impact to Rheonix COVID-19™ MDx Assay
Delta B.1.617.2 and AY lineages VOC No impact
Omicron B.1.1.529, including BA lineages VOC No impact
Alpha B.1.1.7 and Q lineages VBM No impact
Beta B.1.351 and descendent lineages VBM No impact
Gamma P.1 and descendent lineages VBM No impact
Epsilon B.1.427/B.1.429 VBM No impact
Eta B.1.525 VBM No impact
Iota B.1.526 VBM No impact
Kappa B.1.617.1 VBM No impact
N/A B.1.617.3 VBM No impact
Mu B.1.621, B.1.621.1 VBM No impact
Zeta P.2 VBM No impact

*Source:  SARS-CoV-2 Variants of Concern | CDC