Novacyt launches new Covid-19 test assays for variant strains

Clinical diagnostics company Novacyt announced the launch of a new portfolio of assays under the brand name ‘SNPsig’ on Tuesday, to aid the diagnosis of the new variants of SARS-CoV-2, the virus which causes the Covid-19 disease.

The AIM-traded firm said its existing polymerase chain reaction (PCR) Covid-19 portfolio remained “highly accurate” in detecting all published SARS-CoV-2 variants, adding that the launch of the new SNPsig portfolio complemented and expanded its 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, being the UK, South Africa and Brazil, but were now prevalent globally.

It said the emergence of those variants had been reported across Europe, in 32 US states, Japan, Africa and Latin America, and was expected to “significantly impact” the clinical care of individual patients, local community disease control and national epidemiological strategies due to suggested evidence that the variants were associated with an increase in mortality and transmission.

The tracking of variants could also contribute to the effectiveness of vaccination efforts, especially if, as described in recent publications, the emergence of variants could have an impact on vaccine efficaciousness.

Novacyt said the SNPsig assays offered the ability to track variants on-site, and to generate a result in hours, compared to the current approach of next generation sequencing, which was typically constrained by limited capacity, cost and an off-site multi-day turnaround.

The company said its bioinformatics surveillance group ahd worked with a global network of virologists tracking variants to identify the mutations, or ‘single nucleotide polymorphisms’, critical to each variant.

From that analysis, Novacyt said it had developed and patented the SNPsig portfolio, which was one of the first commercially available for variant detection.

The first three SNPsig assays would 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, would be an assay panel known as ‘VariPLEX’, to detect those three variants and two other key mutations identified by the World Health Organization in a single test.

Novacyt said its bioinformatics surveillance group remained “highly vigilant” and, as significant new mutations were identified, they would be added to the SNPsig portfolio.

The SNPsig assays were designed to run on central laboratory systems, and on the company's ‘q16’ and ‘q32’ rapid PCR systems as research-use-only products.

Novacyt said it was expecting to launch the regulatory-approved clinical diagnostic assays in March.

“It is clear that we must stay highly vigilant as SARS-CoV-2 continues to mutate and may, therefore, remain as a global threat for many years,” said chief executive officer Graham Mullis.

“Diagnostic companies have a key role to play in aiding the clinical diagnosis of the variants of greatest concern.

“With this launch, Novacyt continues to demonstrate its ability to remain at the forefront of this rapidly evolving field, with market-leading intelligence and expertise that allows us to support scientists and clinicians around the world in the fight against this pandemic.”

At 0939 GMT, shares in Novacyt were up 7% at 882.75p.