06 Dec Approval of genesig® COVID-19 3G PCR test in the UK under CTDA legislation
Paris, France and Eastleigh, UK – 6 December 2022 – Novacyt (EURONEXT GROWTH: ALNOV; AIM: NCYT), an international specialist in clinical diagnostics, announces that the Company’s genesig® COVID-19 3G Real-Time PCR test 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 seventh PCR test to be added to the CTDA register of approved COVID-19 diagnostic products.
The genesig® COVID-19 3G test, CE marked in April 2021, is designed to detect three separate SARS-CoV-2 gene targets (ORF1ab, M gene, and S genes) from combined nasal and oropharyngeal sample types. As seen during the COVID-19 pandemic, the prevalence of mutations with biological significance within the spike protein of SARS-CoV-2 meant the need to test for more than one gene target at a time increased.
James McCarthy, Acting Group CEO of Novacyt, commented:
“The approval of our COVID-19 3G test, our seventh product to be approved under the UK’s CTDA legislation, reinforces the market-leading quality of our tests. We believe the ability of our COVID-19 3G test to simultaneously target three separate genes within SARS-CoV-2 provides a highly accurate option for detection. 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 diagnostic product offering as part of our growth strategy.”
The status of the Company’s current CTDA submissions is as follows:
|#||Product name||Current CTDA status|
|1||genesig® COVID-19 Real-Time PCR||Approved November 2021|
|2||PROmate® COVID-19 2G (q32)||Approved February 2022|
|3||PROmate® COVID-19 1G (q32)||Approved 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 20 October 2022|
|7||genesig® COVID-19 3G Real-Time PCR||Approved 1 December 2022|
|PathFlow® COVID-19 Rapid Antigen Pro
PathFlow® COVID-19 Rapid Antigen Self-Test