Novacyt SA said its genesig Coronavirus (COVID-19) real-time PCR test was approved by the UK Health Security Agency under Coronavirus Test Device Approvals (CTDA) regulations.
As a result, a full-year revenue shortfall previously forecast by the company will be "significantly lower".
The genesig COVID-19 test is Novacyt's first to be added to the CTDA register, the clinical diagnostics specialist said in a statement.
Novacyt submitted 11 products for review under the CTDA in time for the original submission deadline of 1 September 2021.
Earlier this month, the company warned if no further products were added to the CTDA register, the impact on its revenues for 2021 would be around £3mln.
Following today’s news, Novacyt said the financial impact will be “significantly lower” as the genesig test accounts for around 30% of the £3mln revenue shortfall it had predicted.
The company said its Primerdesign Ltd PROmate COVID-19 test, encompassing both the PROmate 1 Gene q16 and q32 products, remains on the temporary protocol and continues to be supplied to the NHS under the PHE National Microbiology Framework.
It is still waiting for updates on the additional eight products submitted to the CTDA across its COVID-19 testing portfolio.
To date, the genesig COVID-19 test, which targets the ORF1ab gene, continues to be able to detect all known variants and mutations of COVID-19, with over 4.5 million sequences analysed, Novacyt 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,” said chief executive David Allmond.
“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.
“We continue to engage with the UK Health Security Agency and look forward to further updates on our tests still under review."
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