Clinical diagnostics specialist Novacyt has secured approval for its genesig Covid-19 real-time PCR test in the UK under the Health Security Agency’ medical devices regulations 2021.

Launched in January 2020, Novacyt’s genesig Covid-19 assay is said to be one of the world’s first commercially available tests for Covid-19. It is also the company’s first test to be added to the Coronavirus Test Device Approvals (CTDA) register.

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.”

Designed to target the ORF1ab gene, the genesig Covid-19 assay holds the potential to identify all known variants and mutations of Covid-19.

As per the company’s latest weekly bioinformatic surveillance report, the test has analysed more than 4.5 million sequences.

To meet the original submission deadline of 01 September this year, the company has submitted 11 products for review under the CTDA legislation.

Novacyt business unit Primerdesign’s PROmate Covid-19 test, which is on the temporary protocol, is supplying to the NHS under the PHE National Microbiology Framework.

The company is waiting for the response on additional eight products submitted to the CTDA across its Covid-19 testing portfolio.

Allmond said: “Our genesig Covid-19 test was launched in late January 2020 and is recognised globally by leading public health bodies, including the US FDA1, alongside long-term agreements with both UNICEF and the World Health Organisation.

“We continue to engage with the UK Health Security Agency and look forward to further updates on our tests still under review.”