The UK Health Security Agency has approved Novacyt’s genesig Covid-19 real-time PCR test under its Medical Devices (Coronavirus Test Device Approvals) (Amendment) Regulations 2021 (CTDA).
Introduced on 31 January last year, the assay is claimed to be the company’s first test to be added to the CTDA register.
The genesig Covid-19 assay is designed to target the ORF1ab gene and has the potential to detect all known Covid-19 variants and mutations.
The test has analysed more than 4.5 million sequences as mentioned in the company’s latest weekly bioinformatic surveillance report.
Novacyt Group CEO David Allmond said: “I am delighted to announce that our genesig Covid-19 test has become the seventh product to be approved and added to the CTDA register.
“With the associated resumption of the sale of this product in the UK, we look forward to ensuring our customers continue to have access to this market leading test during the winter season.
“Our genesig Covid-19 test was launched in late January 2020 and is recognised globally by leading public health bodies, including the US FDA, alongside long-term agreements with both UNICEF and the World Health Organization.”
The company has submitted 11 products for review under the CTDA legislation as announced earlier this month.
Novacyt stated that the PROmate Covid-19 test of its business unit Primerdesign is on the temporary protocol and is being supplied under the PHE National Microbiology Framework to the NHS.
In June this year, the company announced plans to launch two PathFlow COVID-19 antigen lateral flow tests (LFTs) to strengthen its Covid-19 portfolio.