Novacyt (NCYT ) has unveiled the launch of SNPsig® VariPLEX™, a CE-marked polymerase chain reaction (PCR) assay panel which is able to detect six key mutations of SARS-CoV-2. 

The CE-marked test is able to detect the four COVID-19 variants of concern (VOC) that are currently recognised as well as the two most biologically significant mutations in a single kit. 

VariPLEX™ is the latest addition to Novacyt's PCR genotyping assay portfolio, SNPsig® to identify mutations (single nucleotide polymorphisms (SNPs)). Novacyt’s SNPsig® portfolio was unveiled in February as a portfolio to aid the diagnosis of new SARS-CoV-2 variants.  

The VariPLEX™ panel detects the variants originally identified in the UK, South Africa, Brazil and California, as well as mutations N501Y and E484K, which are now all prevalent globally. 

Novacyt noted that the VariPLEX™ panel can be offered as ‘a rapid alternative’ since the test can be deployed on-site in near-patient settings to generate results in under two hours. 

The panel’s rapid turnaround means it can facilitate same-day patient and public health decision making when using Novacyt’s q32 instruments or in any central lab with an open platform instrument with the ability to detect across at least four fluorescent channels.  

The Company added that the use of the VariPLEX™ panel as a rapid test could complement next generation sequencing, which typically requires up to 14 days of off-site analysis. 

Shares in Novacyt have increased by over 8% in value in the past month alone. The stock ticked up by 1.80% in value this morning to 742.5p as a result of the announcement. 

Novacyt said it recognises the importance and need to closely monitor variants of concern (VOC) and significant mutations since they are considered to have 'concerning' properties. 

At present, if SARS-CoV-2 variants are considered to have 'concerning' properties, including causing higher infection rate, reduced vaccine efficacy or resistance to antibody treatment, they are raised for formal investigation and classified as a variant under investigation (VUI). 

Following a risk assessment with the relevant expert committee, such as the WHO, a VUI may be designated as a VOC. In response to this, Novacyt has highlighted the significance of the VariPLEX™ panel as a fully customisable assay panel due to the fact that new mutations can be added to the panel within weeks ‘as and when they become relevant.’ 

Meanwhile, the company said it is currently in the process of making a research use only (RUO) version of the VariPLEX™ panel available for epidemiological application. The group added that it will be pursuing emergency use authorisations across a number of countries. 

Commenting on the launch, Graham Mullis, Chief Executive of Novacyt said, “This is an important step in our response to COVID-19. As we reach a point where vaccination efforts are increasing globally, we are also seeing a worrying rise in the number of variants of the virus, all of which bring subtly different challenges to healthcare systems around the world.” 

He added, “With VariPLEX™, we are offering an affordable, scalable and time efficient alternative to next generation sequencing which allows for reliable testing of key variants in a single test. By providing an on-site solution which reads out in less than two hours, we are ensuring that it is possible to track variants and the infections they cause on a global scale." 

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