Update Regarding New Variant Strains of SARS-CoV-2

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UK SARS-CoV-2 Variant Strain B.1.1.7

A new variant strain of SARS-CoV-2, referred to as SARS-CoV-2 VOC 202012/01 or B.1.1.7, was first identified in the UK and has recently been identified in the U.S. Based on the design of the Rheonix COVID-19™ MDx Assay, we are confident that the Rheonix COVID-19™ MDx Assay will detect the SARS-CoV-2 virus harboring these mutations.

The new variant SARS-CoV-2 strain B.1.1.7 carries a series of mutations, including a mutation in the receptor binding domain (RBD) of the spike protein (N501Y mutation). The Rheonix COVID- 19™ MDx Assay detects SARS-CoV-2 RNA through reverse transcriptase PCR amplification of nucleic acid sequences corresponding to one target site residing within the nucleocapsid protein gene sequence. Therefore, our assay’s ability to detect SARS-CoV-2 should not be affected by this new variant strain, since the assay targets the nucleocapsid protein gene region and not the spike protein region.

Because of the expectation of evolving mutations in viral genomes leading to new variants, Rheonix will continue to monitor newly released SARS CoV-2 genome sequences to identify mutations that may develop within the target primer and probe regions. As new variant strains emerge, we will continue to provide updates on possible implications for our assay.

More information on the variant strain can be found at https://www.cdc.gov/coronavirus/2019-ncov/more/scientific-brief-emerging-variant.html

South African SARS-CoV-2 Variant Strain 501Y.V2

The South African government announced the emergence of a new variant of SARS-CoV-2 known as 501Y.V2.  The variant strain 501Y.V2 harbors a number of mutations, including a N501Y mutation in the spike protein (N501Y mutation).  Phylogenetic analysis has shown that the UK and South Africa virus variants are different.  It is understood that the UK and South African strains emerged independently of each other and are not related.  Based on the design of the Rheonix COVID-19™ MDx Assay, we are confident that the assay will detect the SARS-CoV-2 virus harboring these mutations.

The Rheonix COVID-19™ MDx Assay detects SARS-CoV-2 RNA through reverse transcriptase PCR amplification of nucleic acid sequences corresponding to one target site residing within the nucleocapsid protein gene sequence.  Therefore, our assay’s ability to detect SARS-CoV-2 should not be affected by this new variant strain, since the assay targets the nucleocapsid protein gene region and not the spike protein region.    

More information on the South African variant strain can be found at https://www.who.int/csr/don/31-december-2020-sars-cov2-variants/en/

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