A multiplex PCR test for the detection of winter viruses including SARS-CoV-2, influenza A and B, and RSV
Paris, France and Camberley, UK – 26 October 2022 – Novacyt (EURONEXT GROWTH: ALNOV; AIM: NCYT), an international specialist in clinical diagnostics, announces that the Company’s genesig® Real-Time PCR SARS-CoV-2 Winterplex ® 3G assay panel (Winterplex® 3G) has been approved in the UK under the UK Health Security Agency’s Medical Devices (Coronavirus Test Device Approvals) (Amendment) Regulations 2021 (“CTDA”), making it the Company’s sixth PCR test to be added to the CTDA register of approved COVID-19 diagnostic products .
Winterplex® 3G is a high throughput multiplex screening assay (with 96 reactions per kit) for the detection of influenza A, influenza B, respiratory syncytial virus (RSV), and SARS-CoV-2 (COVID-19) (specifically the detection of ORF1ab, S and M genes targets) from oropharyngeal, nasopharyngeal or sputum samples.
This approval comes in advance of the winter virus season in the northern hemisphere and means the Company can now sell Winterplex® 3G in the UK. Winterplex® 3G allows healthcare systems to differentiate between common respiratory infections which present with similar symptoms. As the prevalence of winter viruses increases, Novacyt continues to monitor all strains of influenza A, influenza B, RSV and SARS-CoV-2 through its bioinformatics surveillance programme.
David Allmond, Group CEO of Novacyt, commented:
“We are pleased Winterplex® 3G has been approved under the UK’s CTDA legislation. This product is a combined assay which offers the benefit of testing for multiple seasonal viruses at the same time, saving time and requiring only one patient sample. We believe this is important as the diagnostics market moves towards favouring respiratory panels over COVID-19-specific testing due to concerns about the dual rise in COVID-19 and influenza cases this winter. This latest approval ensures we are well-positioned with our consolidated COVID-19 portfolio for any potential future outbreaks and as we continue to focus on our wider respiratory product offering as part of our growth strategy.”
The status of the Company’s current CTDA submissions is as follows:
David Allmond, Chief Executive Officer
James McCarthy, Chief Financial Officer
+44 (0)1276 600081
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