5th February 2021 Product update: rapidmicrobiology staff writer
New Test for COVID-19 Variants Plus All-in-One Assay in Pipeline
Novacyt has announced the launch of a new and innovative portfolio of assays (under the brand name SNPsig®) to aid the diagnosis of the new variants of SARS-CoV-2.
Novacyt’s existing polymerase chain reaction (PCR) COVID-19 portfolio remains highly accurate in detecting all published SARS-CoV-2 variants. The launch of the new SNPsig® portfolio complements and expands the Company’s offering into the rapidly evolving requirement for PCR genotyping of variants.
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 (20I/501Y.V1 or B.1.1.7), South Africa (20H/501Y.V2 or B.1.351) and Brazil (20J/501Y.V3 or B.1.1.28) but are now prevalent globally1.
The emergence of these variants has been reported across Europe, in 32 US states2, Japan, Africa and Latin America and is expected to significantly impact the clinical care of individual patients, local community disease control and national epidemiological strategies3, due to suggested evidence that these variants are associated with an increase in mortality and transmission4.
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 efficaciousness5. The SNPsig® assays offer the ability to track variants on-site and to generate a result in hours, compared to the current approach of next-generation sequencing, which is typically constrained by limited capacity, cost and an off-site multi-day turnaround.
Novacyt’s bioinformatics surveillance group has worked with a global network of virologists tracking variants to identify the mutations, or Single Nucleotide Polymorphisms (SNPs), critical to each variant.
From this analysis, Novacyt has developed and patented the SNPsig® portfolio, which is one of the first commercially available for variant detection. The first three SNPsig® assays, launched today, 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 Organization6 in a single test.
Novacyt’s bioinformatics surveillance group remains highly vigilant and, as significant new mutations are identified, these will be added to the SNPsig® portfolio.
The SNPsig® 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.
Of note, the first three SNPsig® assays are also being deployed to an international consortium of leading academic and public health laboratories in the UK, Europe, US and Latin America7, assembled by Novacyt to support a global variant diagnostic surveillance study.
1. Emerging SARS-CoV-2 Variants, CDC
2. US COVID-19 Cases Caused by Variants, CDC
3. Risk Related to the Spread of New SARS-CoV-2 Variants of Concern in the EU/EEA
4. NERVTAG paper on COVID-19 variant of concern B.1.1.7
5. SARS-CoV-2 Vaccines and the Growing Threat of Viral Variants
6. SARS-CoV-2 Variant - United Kingdom of Great Britain and Northern Ireland
7. UK: University of B’ham, Cambridge, Edinburgh and QMUL, Europe: Gibraltar; USA: Oklahoma, Texas; Latin America: Mexico, Colombia and / or Dominican Republic.
Date Published: 5th February 2021
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Note: This content has been edited by a rapidmicrobiology staff writer for style and content.