Novacyt S.A. ("Novacyt", the "Company" or the "Group")

Launch of CE-Mark test to detect multiple COVID-19 variants of concern

Regulatory News:

Novacyt (EURONEXT GROWTH: ALNOV; AIM: NCYT), an international specialist in clinical diagnostics, announces that, further to the announcement on 2 February 2021, the Company will launch SNPsig VariPLEX this week as a CE-Mark approved polymerase chain reaction (PCR) assay panel able to detect the four COVID-19 variants of concern (VOC) that are currently recognised and the two most biologically significant mutations in a single kit.

VariPLEX is the latest addition to Novacyt’s innovative and expanding PCR genotyping assay portfolio, SNPsig, to identify mutations (single nucleotide polymorphisms (SNPs)). The VariPLEX panel detects the variants originally identified in the UK (20I/501Y.V1), South Africa (20H/501Y.V2), Brazil (20J/501Y.V3) and California (20C/S.452R), and mutations N501Y and E484K, which are now all prevalent globally.¹

VariPLEX can be deployed on-site in near-patient settings to generate results in under two hours to facilitate same-day patient and public health decision making when using the Company’s q32 instruments or in any central laboratory with an open platform instrument with the ability to detect across at least four fluorescent channels. This provides a rapid alternative or could complement next generation sequencing, which typically requires up to 14 days of off-site analysis.

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).² Following a risk assessment with the relevant expert committee, such as the World Health Organization, a VUI may be designated as a VOC. Due to the concerning properties, Novacyt recognises the importance and need to closely monitor VOC and significant mutations. Therefore, VariPLEX is a fully customisable assay panel and new mutations can be added to the panel within weeks as and when they become relevant.

Concurrently, Novacyt is also making a research use only (RUO) version of VariPLEX available for epidemiological application and will be pursuing emergency use authorisations in a number of countries.

Graham Mullis, Chief Executive Officer of Novacyt, commented:

“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. 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.”