RE: WinterPLEX approved on CTDA25 Oct 2022 23:25
Novacyt SA
("Novacyt", the "Company" or the "Group")
UK CTDA Regulatory Approval of genesig ® SARS-CoV-2 Winterplex ® 3 -Gene Test Panel
A multiplex PCR test for the detection of winter viruses, including the
SARS-CoV-2, influenza A and B, and RSV
Paris, France and Camberley, UK - October 26, 2022 - Novacyt (EURONEXT GROWTH: ALNOV; AIM: NCYT), an international specialist in clinical diagnostics, announces that its genesig ® Real-Time PCR SARS-CoV-2 Winterplex test panel ® 3G (Winterplex ® 3G) has been approved in the UK by the UK Health Safety Agency (Coronavirus Test Device Approvals) (Amendment) ("CTDA") Regulations 2021, becoming the company's sixth PCR test to be added to the CTDA Registry of Approved COVID-19 Diagnostic Products .
Winterplex ® 3G is a high-throughput multiplex screening test (with 96 reactions per kit) for the detection of influenza A, influenza B, respiratory syncytial virus (RSV), and SARS-CoV-2 (COVID-
(especially the detection of ORF1ab, S and M gene targets) from oropharyngeal, nasopharyngeal or saliva samples.
This approval comes ahead of winter virus season in the northern hemisphere and means the company can now sell Winterplex® 3G in the UK. The Winterplex® 3G enables healthcare systems to differentiate between common respiratory infections that present with similar symptoms. Faced with the spread of winter viruses, Novacyt continues to monitor all strains of influenza A, influenza B, RSV and SARS-CoV-2 through its bioinformatics monitoring program.
David Allmond, CEO of Novacyt Group, commented:
“We are proud that Winterplex® 3G has been approved under UK CTDA regulations. This product is a combined test which offers the advantage of testing several seasonal viruses at the same time, saving time and requiring only a single patient sample We believe this is important as the diagnostics market tends to favor respiratory panels over COVID-19 specific tests due to concerns about the parallel increase in COVID-19 cases and flu this winter. This latest approval positions us well with our consolidated COVID-19 portfolio for potential future outbreaks.as we continue to focus on our expanded respiratory product offering as part of our growth strategy."
The status of applications currently submitted to the CTDA by the Company is as follows:
#
Product Name
Current CTDA Status
1
genesig® COVID -19Real-Time PCR
Approved November 2021
2
PROmate® COVID -19 2G (q32)
Approved February 2022
3
PROmate® COVID -19 1G (q32)
Approved in April 2022
4
PROmate® COVID -19 1G (q16)
Approved May 2022
5
exsig™ COVID-19 Direct
Approved July 2022
6
genesig ® Real-time PCR SARS-CoV-2 Winterplex
Approved October 20, 2022
7
genesig ® COVID-19 3G Real-Time PCR
8
PathFlow® COVID -19 Rapid Antigen Pro
Evaluation in progress
9
PathFlow® COVID -19 Rapid Antigen Self-Test
- End -
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