RE: WinterPLEX approved on CTDA27 Oct 2022 21:03
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CORRECTION: UK CTDA approval of Winterplex 3G
NOVACYT S.A.
Released 18:45:00 27 October 2022
RNS Number : 4115E
Novacyt S.A.
27 October 2022
This is a correction to the "UK Approval of genesig® SARS-CoV-2 Winterplex® 3G" announcement published at 7:00am on 26 October 2022 (RNS number 0989E) which incorrectly stated that Winterplex® 3G could use sputum and nasopharyngeal samples rather than anterior nasal samples (in addition to oropharyngeal samples)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).
All other information remains unchanged. The full corrected announcement is included below.
Novacyt S.A.
("Novacyt", the "Company" or the "Group")
Correction: Approval of genesig® SARS-CoV-2 Winterplex® 3 Gene assay panel in the UK under CTDA legislation
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 - 27 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 and anterior nasal 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 wi