Novacyt (NCYT) has received approval for its novel COVID-19 PCR test in the UK from the UK Health Security Agency under Coronavirus Test Device Approvals (CTDA) regulations.

The Group, which specialises in clinical diagnostics on an international level, said this COVID-19 test - the genesig® Real-Time PCR - is its first test to be added to the CTDA register and that it will now work towards resuming the sale of the product in the UK. 

The Company’s genesig® COVID-19 PCR test, which was originally launched on 30 January 2020, was one of the world's first commercially available tests for the COVID-19 virus. 

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, as documented in Novacyt's latest weekly bioinformatic surveillance report.

Novacyt announced earlier this month that it had submitted 11 products for review under the CTDA to meet the original submission deadline of 1 September 2021. At the time,  Novacyt's Primerdesign Ltd PROmate® COVID-19 test had been named on the temporary protocol.

The Company said it is now awaiting updates on the additional eight products submitted to the CTDA across its COVID-19 testing portfolio. To note, only validated products, or products on the temporary protocol, can be sold in the UK after 31 October 2021, it informed investors.

Novacyt has more than halved in value since early 2021. However, in the past month shares have climbed up 50%. Today, it was trading 12.65% higher at 371.9p following the news.

Earlier this month, Novacyt also stated that if no further products were added to the CTDA register, that the impact on full year revenues for 2021 would be around £3 million. 

With this approval, the financial impact on 2021 is expected to be significantly lower as the genesig® COVID-19 test accounts for around 30% of the circa £3 million revenue shortfall.

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 FDA1, 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."

Follow News & Updates from Novacyt here: