Novacyt has launched a portfolio of assays under the brand name SNPsig to aid the diagnosis of the new variants of SARS-CoV-2.
As noted by the US Centers for Disease Control and Prevention, multiple SARS-CoV-2 variants emerged in late 2020. The three most notable variants were originally identified by their reporting origin, the UK, South Africa and Brazil but are now prevalent globally. The emergence of these variants has been reported across Europe, in 32 US states, Japan, Africa and Latin America and is expected to significantly impact the clinical care of individual patients, local community disease control and national epidemiological strategies, due to suggested evidence that these variants are associated with an increase in mortality and transmission.
The tracking of variants could also contribute to the effectiveness of vaccination efforts, especially if, as described in recent publications, the emergence of variants may have an impact on vaccine efficaciousness. The SNPsig assays offer the ability to track variants on-site and to generate a result in hours, Novacyt says.
The company’s bioinformatics surveillance group has worked with a network of virologists tracking variants to identify the mutations, or Single Nucleotide Polymorphisms (SNPs), critical to each variant. From this analysis, it developed and patented the portfolio. The first three assays enable the identification of the non-variant virus and the UK, South Africa or Brazil variants, as well as any variant carrying the N501Y mutation.
The next product in the SNPsig portfolio, planned to launch shortly, will be an assay panel known as VariPLEX, to detect these three variants and two other key mutations identified by the World Health Organization in a single test, Novacyt claims.
The assays are designed to run on central laboratory systems and on the company’s q16 and q32 rapid PCR systems as research-use-only products. The company expects to launch the regulatory approved clinical diagnostic assays next month.
The first three assays are also being deployed to an international consortium of leading academic and public health laboratories in the UK, Europe, US and Latin America, to support a global variant diagnostic surveillance study.