Novacyt (NCYT ) has launched two new polymerase chain reaction (PCR) assays, thereby expanding its genesig® COVID-19 and SNPsig® SARS-CoV-2 variant detection portfolios. 

Since the onset of the pandemic, Novacyt, a specialist in clinical diagnostics, has established two distinct portfolios; genesig®, a range of PCR kits for pathogen detection and the SNPsig® portfolio which is initially focused on detecting the most significant mutations of the virus. 

Novacyt said its new CE-marked genesig® three-gene assay, which will complement the group’s existing one-gene, two-gene, and high-throughput tests, has been developed in recognition of rapidly changing testing needs dictated by SARS-CoV-2 mutations.  

Since the assay has been shown to detect the ORF1ab, M gene, and S gene targets of SARS-CoV-2, this means the test fulfills several international testing requirements, including Fit to Fly Certificate, Test to Release and US Food and Drug Administration regulations. 

In line with this, the firm explained to investors that the creation of this three-gene assay is intended to capture a wider share of the growing global travel market for COVID-19 testing.  

In addition to this assay, Novacyt has launched NPsig® EscapePLEX SARS-CoV-2, a first-to-market assay panel which is able to detect the four most critical mutations currently recognised and which is combined with a confirmatory two-gene assay for COVID-19. 

Shares in Novacyt were trading 2.77% higher this morning at 355.4p following the news. 

In particular, the kit detects the biologically significant 'escape' mutations E484K, K417N, K417T and P681R, present in the Alpha, Beta, Gamma and Delta Variants of Concern (VoC).  

Additionally, Novacyt explained how the research-use-only kit also incorporates the two gene (ORF1ab and M) assay which can provide a confirmatory detection of SARS-CoV-2. 

Overall, the company’s SNPsig® portfolio is initially focused on detecting the most significant mutations, VoC and variants of SARS-CoV-2, with the portfolio currently covering 13 assays.  

Addressing investors this morning, Novacyt said it believes the SNPsig® EscapePLEX assay will be ‘crucial’ in helping clinicians and public healthcare centres globally identify SARS-CoV-2 mutations which can impact transmissibility, immunity, and infection severity.  

“The success of our COVID-19 PCR assays has been built around robust design principles and our real-time bioinformatics surveillance programme to monitor new SARS-CoV-2 genome sequences,” commented Graham Mullis, Chief Executive Officer of Novacyt. 

“As a result, our genesig® COVID-19 portfolio is highly accurate despite mutations, and we believe our SNPsig® portfolio is the world's largest for detecting SARS-CoV-2 variants.  

The addition of both of these new assays ensures that Novacyt's COVID-19 solutions remain robust and that pragmatic options are available to support both public health and private sector testing alike,” he added.  

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