Novacyt launches CE-marked rapid Covid-19 variant test

Clinical diagnostics specialist Novacyt announced the launch of ‘SNPsig VariPLEX’ on Wednesday, as a CE-marked polymerase chain reaction (PCR) assay panel, able to detect the four currently-recognised Covid-19 variants of concern, and the two most biologically significant mutations, in a single kit.

The AIM-traded firm said VariPLEX was the latest addition to its SNPsig PCR genotyping assay portfolio, which identifies mutations known as single nucleotide polymorphisms, or SNPs.

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

VariPLEX could be deployed on-site in near-patient settings to generate results within two hours to facilitate same-day patient and public health decision-making when using Novacyt’s ‘q32’ instruments, or in any central laboratory with an open platform instrument with the ability to detect across at least four fluorescent channels.

That, the board explained, provided a rapid alternative to, or could complement, ‘next-generation’ sequencing, which requires up to 14 days of off-site analysis.

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

Following a risk assessment with a relevant expert committee, such as the World Health Organization, a variant under investigation could be designated as a variant of concern.

Novacyt described VariPLEX as a “fully customisable” assay panel, meaning new mutations could be added within weeks, as and when they became relevant.

At the same time, Novacyt said it was also making a research use only version of VariPLEX available for epidemiological application, and would be pursuing emergency use authorisations in a number of countries.

“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,” said chief executive officer Graham Mullis.

“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.”

At 0945 GMT, shares in Novacyt were up 2.75% at 746p.