Novacyt launches two new PCR assays including for variation detection

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

• genesig COVID-19 3G is a CE-Marked three-gene assay to detect the ORF1ab, M gene, and S gene targets of SARS-CoV-2, enabling fulfilment of certain international testing requirements, including Fit to Fly Certificate, Test to Release and US Food and Drug Administration regulations. 
• SNPsig EscapePLEX SARS-CoV-2 is a first-to-market assay panel in a single kit able to detect the four most critical SARS-CoV-2 mutations currently recognised, combined with a confirmatory two-gene assay for COVID-19. The research-use-only kit detects the biologically significant ‘escape’ mutations E484K, K417N, K417T and P681R, present in the Alpha, Beta, Gamma and Delta Variants^[1] of Concern (VoC), and also incorporates the two gene (ORF1ab and M) assay to provide a confirmatory detection of SARS-CoV-2.

Novacyt’s genesig portfolio is a range of PCR kits for pathogen detection. The new three-gene assay for COVID-19 has been developed in recognition of rapidly changing testing needs dictated by SARS-CoV-2 mutations and complements the company’s existing one-gene, two-gene, and high-throughput tests. The company aims to capture a wider share of the growing global travel market for COVID-19 testing with the three-gene test. 

The SNPsig portfolio is initially focused on detecting the most significant mutations, VoC and variants of SARS-CoV-2 and currently includes 13 assays. The company believes the SNPsig EscapePLEX SARS-CoV-2 will be crucial in helping clinicians and public healthcare centres globally identify SARS-CoV-2 mutations which can impact transmissibility, immunity, and infection severity. 

Graham Mullis, chief executive officer of Novacyt, said: “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. 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.”